MARCIA MORALES HOWARD, District Judge.
THIS CAUSE comes before the Court as a products liability action pertaining to
On August 1, 2014, Bard filed four motions seeking to exclude the testimony of certain of Tillman's expert witnesses. See Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion to Exclude the Opinions of Michael Freeman, Ph.D. and Memorandum of Law in Support (Doc. 95; Motion to Exclude Freeman); Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.'s Motion and Memorandum of Law to Exclude the Opinions of William A. Hyman (Doc. 96; Motion to Exclude Hyman)
In addition, both parties filed motions for summary judgment on August 1, 2014. See Plaintiff's Motion for Partial Summary Judgment Against Defendant C.R. Bard and Bard Peripheral Vascular, Inc. (Doc. 93; Tillman Motion)
This case concerns a medical device known as an inferior vena cava (IVC) filter. An IVC filter is a "device that's implanted into the inferior vena cava. . . . And its responsibility essentially is to capture a clot that may become dislodged from a [deep vein thrombosis] and potentially be a life-threatening pulmonary embolism to the patient." See Deposition of Andrew Stockland, M.D. (Doc. 137-7; Stockland Dep.) at 13. These filters originated in the 1960's and 1970's, and were first used as permanently implanted devices. See Bard Motion, Ex. A: Report of Clement J. Grassi, M.D. (Doc. 98-1; Grassi Report) at 2-3. With advances in technology and design, manufacturers began developing "retrievable" or "option" filters. Id. Bard's expert, Clement J. Grassi, M.D., a physician and interventional radiologist, explains that all IVC filters carry the risk of complications. See id. at 4. "Well known" filter complications include "filter migration, filter fracture, component embolization, access site thrombosis, IVC occlusion, filter tilt, penetration or perforation, and others." Id.; Stockland Dep. at 14-17. According to Grassi, "there is no perfect filter device available in the market today." Grassi Report at 4. Indeed, Matthew Begley, Ph.D., one of Tillman's engineering experts, concedes that it is not possible to design an IVC filter that never migrates, tilts, perforates, or fractures.
Bard originally marketed a permanent IVC filter known as the Simon Nitinol Filter (SNF), and later developed a retrievable filter named the Recovery. See Tillman Response, Ex. EE: Report of Jeffrey Hull, M.D. (Doc. 134-16; Hull Report) at 2. The FDA approved the Recovery filter as a permanent filter in November 2002, and as a retrievable filter in July 2003. See Tillman Response, Exs. F, G. Bard obtained this approval via the "§ 510(k) process," through which the FDA will clear a device for marketing if it is substantially equivalent to a predicate device.
In early 2008, Tillman, who was in a rehabilitation center recovering from two knee replacement surgeries, woke up with leg pain. See Bard Motion, Ex. B: Deposition of Lessie Tillman (Doc. 98-2; Tillman Dep.) at 70-71. Testing revealed the pain was caused by a blood clot in her leg. Id. As a result, on February 19, 2008, Dr. Luis Anez ordered the implantation of an IVC filter. See Tillman Dep. at 71-72; Tillman Response, Ex. Z. According to Tillman, she was informed that the filter was needed to protect her from "the blood clot that was in my left leg to make sure that it didn't go all the way up." See Tillman Dep. at 80. Andrew Stockland, M.D., an interventional radiologist, performed the placement procedure that same day, implanting a G2 filter manufactured by Bard. See Tillman Response, Ex. Z; Stockland Dep. at 10, 32. Stockland states that the Filter was centered in the IVC when it was placed, and "was very vertical" in his opinion. See Stockland Dep. at 79.
In the Final Report following the implantation, Stockland notes that "[t]his filter may remain as a permanent device, or be potentially retrieved within 12 months. Given the patient's young age, consider retrieval in the very near future when her current medical issues have resolved." See Tillman Response, Ex. Z. Stockland explains that
See Stockland Dep. at 63. Stockland explains that "[t]he preference is to place a retrievable with the hope of getting it out. But unless I . . . was convinced that someone needed a permanent filter, I would place a temporary or a retrievable. But there's always an understanding that a retrievable can turn into a permanent device." Id. at 75.
Tillman saw Dr. Kedra Williams on June 18, 2008, "[t]o have some medications refilled and to follow up some labs that were done." See Bard Motion, Ex. D: Deposition of Kedra Williams, M.D. (Doc. 98-4; Williams Dep.) at 24. At that time, Tillman was taking Coumadin to treat her previous deep vein thrombosis (DVT), and Williams ordered a venous Doppler examination of Tillman's legs to see if the DVT had cleared. See id. at 24-25. Williams commented in Tillman's medical records on that visit that "[w]ill need to follow up with a vascular surgeon for the filter—Greenfield filter removal when Dopplers are negative." Id. at 25. On July 24, 2008, Williams assessed that the Doppler results were negative such that Tillman could stop taking Coumadin, and included a note in her records that Tillman was to talk to her surgeon about getting the Filter removed. Id. at 29-30. Although Williams does not recall whether she told Tillman to follow up with the surgeon that placed the Filter, it would have been her typical practice to do so. Id. at 25.
Tillman saw Williams again in October 2008, and February 2009. On the February 4, 2009 visit, Williams referred Tillman to a vascular surgeon for the removal of the Filter. Id. at 41. Tillman underwent a venous procedure on March 4, 2009, in an attempt to remove the Filter. The Final Report from that procedure states that "[a] scout film was obtained which demonstrated the previously placed G-2 Bard IVC filter to have slightly migrated and is now tilted to the left." See Bard Motion, Ex. F at 2.
Three days after the attempted retrieval, on March 7, 2009, Tillman returned to the hospital because she felt "sick and couldn't stand up." See Tillman Dep. at 137; Tillman Response, Ex. CC. According to Tillman, she was informed that she had a blood clot in her kidney "that came from the pulling up to try to get the filter out." See Tillman Dep. at 138. Tillman was treated with Coumadin, and by June 2009, the clot had cleared. Id. at 138-39; Williams Dep. at 53-54. Since that time, Tillman has not been diagnosed with another DVT or clot. See Tillman Dep. at 140. Tillman and her husband met with Williams in September 2013, to discuss their concerns about the Filter. See
See Williams Dep. at 80. According to Tillman, Moore did not tell her that the Filter's tilted position or perforation of her IVC was causing any of her symptoms. See Tillman Dep. at 217.
When asked what injuries, damages, or problems she claims are caused by the Filter, Tillman responds that:
See Tillman Dep. at 153. She further explains that "it's there, and it needs to be taken out. I just don't want anything to happen, like it rupture or something or fall apart or start pulling apart and moving around in my body or something like that . . . ." Id. at 166-67. Tillman also believes that "Dr. Moore said . . . that it needs to be watched to make sure that it doesn't break loose." Id. at 170. In addition, Tillman indicates that although she has not experienced any emotional problems or depression as a result of the Filter, she does worry "about what's going to happen with it being in." Id. at 171. After meeting with Dr. Moore, Tillman began to "really kind of start worrying about the rupture or coming apart or something like that or it's stretching out." Id. at 171-72. Tillman emphasizes that if she had known "that [the Filter] wasn't going to be able to be taken out, I would have never had it put in . . . ." See Tillman Dep. at 154, 208-09.
Rule 702 of the Federal Rules of Evidence (Evidence Rule(s)) provides:
Fed.R.Evid. 702.
See United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir.2004). The burden of establishing qualification, reliability and helpfulness lies with the party offering the expert opinion. See McClain v. Metabolife Int'l, Inc., 401 F.3d 1233, 1238 (11th Cir. 2005). For the purpose of conducting the reliability inquiry mandated by Daubert, the Supreme Court has suggested that a trial court consider a number of factors, which include: (1) whether the theory or technique can be, and has been, tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error; and (4) whether the theory has attained general acceptance in the relevant scientific community. See Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. These factors are not exhaustive, and the Eleventh Circuit Court of Appeals has also considered whether an expert has relied on anecdotal evidence, such as case reports; temporal proximity; and improper extrapolation. See Allison v. McGhan Med. Corp., 184 F.3d 1300, 1312 (11th Cir.1999). The Court's inquiry under Evidence Rule 702 must focus on the methodology, not conclusions, but the Court is not required to admit opinion testimony only connected to existing data by an expert's unsupported assertion. See Daubert, 509 U.S. at 595, 113 S.Ct. 2786; Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997).
In addition to determining the reliability of the proposed testimony, Daubert instructs that Evidence Rule 702 requires the Court to determine whether the evidence or testimony assists the trier of fact in understanding the evidence or determining a fact in issue. See Daubert, 509 U.S. at 591, 113 S.Ct. 2786. This consideration focuses on the relevance of the proffered expert testimony or evidence. The Court explained that to satisfy this relevance requirement, the expert testimony must be "relevant to the task at hand." Daubert, 509 U.S. at 591, 113 S.Ct. 2786. Because scientific testimony does not assist the trier of fact unless it has a justified scientific relation to the facts, the Eleventh Circuit has opined that "there is no fit where a large analytical leap must be made between the facts and the opinion." McDowell v. Brown, 392 F.3d 1283, 1289 (11th Cir.2004) (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997), finding too great an analytical gap between data suggesting that one type of cancer was caused in mice and the conclusion or opinion that such data established causation of another type of cancer in humans).
The proponent of expert testimony need not show that the opinion proffered is scientifically correct, but only, based upon a preponderance of the evidence, that the opinion is reliable. See Allison, 184 F.3d at 1312. Thus, absolute certainty is not required. See Jones v. Otis Elevator Co., 861 F.2d 655, 662 (11th Cir.1988). However, an expert must know "facts which enable
Robert Ritchie, Ph.D. is the "H.T. & Jessie Chua Distinguished Professor of Engineering and Professor of Materials Science and Engineering and of Mechanical Engineering at the University of California, Berkeley." See Motion to Exclude Ritchie, Ex. A (Doc. 113; Ritchie Report) at 1. He has extensively researched "the problem of fracture and fatigue of metallic alloys and other structural materials" and has "extensive experience in the analysis of failures in a wide range of structures and components, in particular from the medical device industries." Id. Bard does not challenge Ritchie's qualifications as an expert. See generally Motion to Exclude Ritchie. Instead, Bard contends that Ritchie's opinions regarding the causes of fracture in Bard's Recovery and G2 filters do not fit the facts of this case. Id. at 2. In addition, to the extent Ritchie does offer opinions specific to the complications Tillman experienced, Bard argues that those opinions are "neither the product of reliable scientific methodology nor based on sufficient data." See id.
Ritchie's opinions are "based on [his] personal knowledge, education, training and decades of experience." Ritchie Report at 1. He examined fourteen failed G2 filters, and has previously examined ten failed Recovery filters. Id. He also scrutinized four "exemplar" unimplanted filters of each type. Id. Of course, because Tillman's Filter remains implanted in her IVC, Ritchie has not been able to examine that specific device. Id. at 22. In addition, Ritchie reviewed various depositions pertaining to this case, as well as documentary evidence produced in discovery. Id. at 2. Ritchie is further informed by his knowledge of the fatigue and fracture of Nitinol (a Ni-Ti alloy from which the filters are made), obtained from twenty years of research on this material. Id. Based on his analysis of the foregoing, Ritchie concludes that Bard IVC filters "were inadequately and defectively designed and manufactured to withstand the physiological loading that they experienced in vivo," causing these filters to fail in service. Id. at 19.
Specifically, Ritchie addresses the causes of fracture in the Recovery and G2 filters. He asserts that fractures are caused by "cyclic fatigue failure involving fatigue cracks that initiated on the surface of the wire arms (and legs) . . . ." See Ritchie Report at 18. These cracks spread through the wire until it completely fractures "due to ductile overload failure (microvoid coalescence)." See id. Ritchie explains that the presence of "surface gouges" or other imperfections on the surface of the wires "could be directly identified with the initiation of the fatigue crack that fractured the wire." Id. Ritchie maintains that these gouges and imperfections are defects which could have been removed by "electropolishing" or avoided by improved manufacturing procedures. Id. at 18-19. In addition, Ritchie asserts that fractures initiate where the wires emerge from the filter sleeve, specifically where the wire contacts the edge of the inner-diameter rim. Id. at 19. According to Ritchie, the inner rim of the filter sleeve is inadequately chamfered such that it has an exceedingly sharp radius of curvature. Id. Ritchie posits that this lack of chamfer "represents a severe design and/or manufacturing defect." Id. Ritchie also opines that fractures can occur when a filter tilts, migrates, or perforates the IVC. Id. Ritchie adds that Bard
Bard is correct that there is no evidence that the Filter implanted in Tillman's IVC has fractured. See, e.g., Ritchie Report at 22. Rather, the medical records demonstrate that the Filter has tilted and perforated her IVC such that it cannot be removed, and may or may not have slightly migrated. See Bard Motion, Ex. F; Tillman Response, Exs. DD, EE at 6; Stockland Dep. at 78, 101-102; see also Hull Dep. at 111. Ritchie, himself, acknowledges that "the medical reports do not provide evidence of the fracture of any specific arms or legs in Mrs. Tillman's filter or of the migration of fragments . . . ." See Ritchie Report at 22. As such, Bard contends that Ritchie's opinions on filter fracture do not "fit" the facts of this case. However, Tillman argues that the defects Ritchie identifies create an increased risk of fracture such that she is exposed to an "on-going present danger with the G2 filter lodged in her body." See Ritchie Response at 7. Because of this risk, Tillman seeks the cost of medical monitoring necessary to detect the onset of physical harm, see Complaint ¶ 49, and absent any argument from Bard to the contrary, it appears such damages are recoverable under Florida law. See Petito v. A.H. Robins Co., Inc., 750 So.2d 103, 104-06 (Fla. 3d Dist.Ct.App.1999); see also Bouldry v. C.R. Bard, Inc., 909 F.Supp.2d 1371, 1375-76 (S.D.Fla.2012). Thus, evidence that G2 filters are prone to fracture due to design or manufacturing defects is relevant to Tillman's claim for medical monitoring damages. In addition, having found that Ritchie's fracture opinions are relevant to this case, the Court also rejects Bard's unsupported contention that these opinions are somehow unduly prejudicial. Therefore, the Court will deny Bard's Motion to Exclude Ritchie to the extent Bard requests the exclusion of Ritchie's fracture opinions.
As to Tillman's current complications, Ritchie concedes that "[l]acking the failed filter itself, we do not have direct structural evidence for the cause of the migration, tilting and probable perforations of the struts of Mrs. Tillman's filter . . . ." Id. Nonetheless, Ritchie draws the following conclusion regarding the Filter:
Id. at 22-23. However, Ritchie offers no explanation or analysis to support the leap from his contention that the identified defects cause fracture to his conclusion that the identified defects also cause tilt, migration and perforation. Id. Indeed, as Bard aptly points out, Ritchie's analysis of tilt, migration and perforation in the body of his Report is limited to the ways in which these events can lead to fracture, and includes no discussion of what or how the purported design or manufacturing defects can also cause tilt, migration or perforation. See Ritchie Report at 12, 19. A number of Daubert decisions "warn against leaping from an accepted scientific premise to an unsupported one." See Allison, 184 F.3d at 1314 (collecting cases). Here, Ritchie does precisely that in leaping from his scientifically supported opinions regarding the causes of filter fracture, to his unsupported conclusion that, absent any evidence of fracture, these same deficiencies cause tilt, migration and perforation. Even accepting Ritchie's assumption that Tillman's Filter has the same surface defects and lack of chamfering that are present in the filters he examined, Ritchie offers nothing more than his own ipse dixit to conclude that those conditions also cause tilt, migration, and perforation. As such, the Court determines that Ritchie's opinion on the cause of tilt, perforation and migration is not sufficiently reliable under Daubert and will grant Bard's Motion to Exclude Ritchie as to that opinion only. See McDowell, 392 F.3d at 1289.
Robert M. McMeeking, Ph.D. is a "Tony Evans Professor of Structural Materials and Professor of Mechanical Engineering," and Matthew R. Begley, Ph.D. is a "Professor of Mechanical Engineering and Professor of Materials," both at the University of California, Santa Barbara. See Motion to Exclude McMeeking/Begley, Ex. A (Doc. 112; McMeeking/Begley Report) at 1. McMeeking and Begley (the Engineers) have performed "extensive research" into "problems of mechanical failure in a wide range of structural components, including biomedical implants." Id. at 2. The Engineers issued a joint report based on their "personal examination of the Bard design and qualification documentation produced during discovery . . . in cases [they] previously worked on," and the Report describes "the design, mechanical analysis, finite element analysis (FEA) and testing of Bard filters." See McMeeking/Begley Report at 1. Bard seeks exclusion of the Engineers' opinions in their entirety. See Motion to Exclude McMeeking/Begley at 2. As with Ritchie, Bard argues that the Engineers' opinions on filter fatigue and fracture do not "fit" the facts of this case because Tillman's Filter did not fracture.
First, the Engineers' opinions concerning filter fracture are relevant to Tillman's claims for the same reasons that Ritchie's opinions on fracture are relevant. As discussed above, Tillman contends that the Filter is defectively designed such that it poses an unreasonable risk of fracture and requires her to obtain ongoing medical monitoring. The Engineers' opinions with respect to whether G2 filters contain design defects which make them unreasonably prone to fracture, and whether Bard adequately tested its filters for this risk, are relevant to this claim. Bard does not challenge the Engineers' qualifications or the reliability of their opinions on this issue, thus, the Court finds no basis to exclude the Engineers' opinions on filter fracture, and will deny Bard's Motion to Exclude McMeeking/Begley in that respect.
Next, the Engineers opine that Bard failed to conduct adequate testing on the risk of tilt, perforation and migration. Bard argues that these opinions should be excluded as unhelpful to the jury because the Engineers "cannot identify a single defect—or anything else—that allegedly caused [Tillman's] filter to tilt, perforation [sic], or migrate." See Motion to Exclude Begley/McMeeking at 16. Evidence Rule 702 requires that "the evidence or testimony `assist the trier of fact to understand the evidence or determine a fact in issue.'" See Daubert, 509 U.S. at 591, 113 S.Ct. 2786 (quoting Evidence Rule 702). However, "[t]he expert need not have an opinion on the ultimate question to be resolved by the trier of fact in order to satisfy this requirement." Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir.2000). Indeed, "the testimony need only assist the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue." City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 565 (11th Cir.1998). The Engineers' "data and testimony need not prove [Tillman's] case by themselves, they must merely constitute one piece of the puzzle that [Tillman] endeavor[s] to assemble before the jury." Id.
Upon review, the Court finds that the Engineers' opinions regarding the adequacy of Bard's testing for the risk of perforation, tilt and migration would be helpful to a jury in determining a fact in issue, specifically whether Bard breached its duty of care in designing the G2 filter, or failing to issue adequate warnings, as alleged in Count One. See Adams v. G.D. Searle & Co., Inc., 576 So.2d 728, 730-31 (Fla. 2d Dist.Ct.App.1991) ("The duty to test . . . is a subpart of a manufacturer's duty to design a product with reasonable care, and thus is subsumed in the plaintiffs' claims for defective design and failure
Bard also seeks to exclude the Engineers' opinion that Bard does not exert sufficient control over its manufacturing processes such that there is variability in certain aspects of the G2 filters leading to failure in some devices. See Motion to Exclude McMeeking/Begley at 9-10. Specifically, Bard challenges the Engineers' opinions that the magnitude of the bend in the arm of the G2 Filter is an "arbitrary outcome of the manufacturing process," and that "the radius of the sheath edge where it contacts the arms and legs is not controlled in the manufacturing process and therefore it can vary considerably." See McMeeking/Begley Report at 7, 11. As support for these opinions, the Engineers observe that "the radius of the bend is not specified in any of Bard's engineering drawings that we have reviewed." Id. at 7. In addition, the Engineers note differences in the radius of the sheath shown in micrographs obtained from other experts, but have not "cut open a filter to look at that" themselves. See Motion to Exclude McMeeking/Begley, Ex. C: April 22, 2014 Deposition of McMeeking (Doc. 99-3; McMeeking Dep.) at 146. However, McMeeking concedes that he "would not claim to know in detail what" the manufacturing controls are, and does not know in specific detail "how uncontrolled or how variable the filters coming off the line were" for the Recovery and G2 filters. See id. at 146-47. As such, Bard contends that these opinions "are unsupported by facts and are unreliable," and that the Engineers "have no qualifications that would provide them the expertise to proffer
It is Tillman's burden to demonstrate that the expert opinions on which she relies satisfy the Daubert standards. See McClain, 401 F.3d at 1238. In her Response, although she broadly discusses the Engineers' general qualifications, Tillman does not specifically explain how the Engineers are qualified to opine on Bard's manufacturing processes. See McMeeking/Begley Response at 3-5, 9. Indeed, she identifies the Engineers' particular area of expertise as "theoretical and computational stress/strain analysis." Id. at 9. Notably, she does not include these particular manufacturing opinions in her summary of the Engineers' findings. See id. at 8. Likewise, Tillman does not rely on the Engineers' opinions on the variability of Bard's manufacturing process in her summary judgment briefing. See Tillman Response at 11-12. As such, it is unclear whether Tillman intends to offer the Engineers as experts on the manufacture of these devices. Nonetheless, upon review of the Report, the Court finds that while the Engineers are qualified to opine on mechanical failure and stress-strain analysis, they do not identify any qualifications specific to the area of manufacturing controls and processes. See McMeeking/Begley Report at 2. Moreover, the experts do not identify any documents or materials pertaining to Bard's manufacturing process that they reviewed in preparing their Report. Id. at 3. While McMeeking states that he has "read some of the documents that describe" Bard's manufacturing controls, he "would not claim to know in detail what those controls are." See McMeeking Dep. at 146. Rather, it appears McMeeking's opinion in this respect is based on his examination of Bard's finite element calculations. Id. at 146-47 ("[T]hey made a variety of assumptions about boundary conditions . . . . And that suggests to me that they realized that there was a variability in the constraint of the weld imposed on the wires, and that that was something they were accounting for in their calculations."). Accordingly, with respect to Bard's manufacturing process in particular, Bard's argument is well-taken and the Engineers will not be permitted to opine on Bard's manufacturing controls or lack thereof.
Last, Bard argues that the Engineers' opinions characterizing Bard's conduct as reckless, negligent, incompetent, misleading, or unethical are legal conclusions which should be excluded. Tillman responds in a conclusory fashion that "Plaintiffs [sic] would simply assert that the use of such terms in the experts' reports does not constitute a proper basis for a Daubert challenge as these terms do not render the experts incompetent to testify nor does such language establish that the experts' testimony is not reliable." See McMeeking/Begley Response at 12. Tillman does not offer any legal authority in support of this argument. Id. Throughout their Report, the Engineers assert that Bard was incompetent, negligent and reckless in its failure to run certain tests or calculations, as well as in the manner in which it tested design features. See generally McMeeking/Begley Report. In addition, the Engineers opine that Bard acted "unethically, unprofessionally and recklessly" in asserting to the FDA, and stating in its marketing brochures,
Id. at 5-6. Based on an internal memorandum, the Engineers further opine that "Bard was fully aware that its claims regarding improved fatigue resistance for the G2 filter were false, misleading and reckless." Id. at 6.
Evidence Rule 704 provides that "[a]n opinion is not objectionable just because it embraces an ultimate issue." However, "courts must remain vigilant against the admission of legal conclusions, and an expert witness may not substitute for the court in charging the jury regarding applicable law." See United States v. Milton, 555 F.2d 1198, 1203 (5th Cir. 1977)
Based on the foregoing, the Court will exclude the Engineers' opinions that Bard acted negligently or recklessly. These terms carry special meaning under the law
However, throughout their Report the Engineers also identify flaws in Bard's testing of the Recovery and G2 filters' ability to withstand stresses and strains, and conclude that as a result of these flaws, Bard's engineering analyses were incompetent. The term incompetence does not carry with it a legal definition and is not contingent on a legal standard of care, but rather on the applicable principles of science and engineering. Bard does not dispute that the Engineers are qualified to testify regarding stress-strain analysis, nor does Bard contend that the engineering analyses performed by these experts is unreliable. Indeed, the Engineers explain that their assessment is "typical of those routinely conducted during the design validation and verification of devices." See McMeeking/Begley Report at 2. The testimony that Bard performed its testing in a scientifically incompetent manner would be helpful to the trier of fact in determining whether Bard breached its duty of care and the Court does not find it to be unduly prejudicial. Accordingly, the Court will not exclude the Engineers' opinions that the testing performed was incompetent as a matter of engineering and design principles.
As to the Engineers' opinions on Bard's claim that G2 filters are twelve times more fatigue resistant than Recovery filters, the Court finds that the Engineers' may not opine that Bard's conduct was unethical and unprofessional. Tillman offers no argument or information to show that the Engineers are qualified to opine on the ethical or professional standards in the industry. Moreover, Tillman fails to demonstrate that these opinions are reliable or relevant to this case. The Engineers themselves do not purport to have any expertise on the relevant ethical or professional standards, and they do not identify the ethical or professional standard on which they base this opinion. As such, these opinions appear to be simply their subjective views on how a medical device manufacturing company should act, and therefore, are due to be excluded as unreliable. See In re Rezulin, 309 F.Supp.2d at 543. Moreover, Bard's compliance with an unidentified standard of ethical or professional conduct is not relevant to the issues in this case. See id. at 543-44. Rather, the issues here are limited to whether the Filter is defective in its design, manufacture, or warnings, whether Bard breached a legal duty to Tillman in designing, manufacturing, or labeling the device, and whether the defects or breaches caused Tillman's damages. Id. at 544. "While [Bard] may be liable in the court of public opinion, or before a divine authority for any ethical lapses, expert opinion as to the ethical character of their actions is not relevant" to this lawsuit. See id.
In addition, to the extent the Engineers offer opinions on Bard's intent, state of mind, or motivations, this testimony is outside the bounds of appropriate expert testimony. Id. at 546-47; In re Flonase Antitrust Litig., 884 F.Supp.2d 184, 193 (E.D.Penn.2012); Kaufman v. Pfizer Pharms., Inc., No. 1:02-CV-22692, 2011 WL 7659333, at *9 n. 8 (S.D.Fla. Aug. 4, 2011); In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, 2009 WL 3806436, at *5 (M.D.Fla. July 20,
However, the Engineers also opine that it is misleading for Bard to claim that G2 filters are twelve times more fatigue resistant than Recovery filters, and upon consideration, the Court finds this opinion to be permissible. See Deutsch v. Novartis Pharms. Corp., 768 F.Supp.2d 420, 440 (E.D.N.Y.2011). The Engineers reviewed the testing done to support Bard's claim and determined that the claim is misleading based on their analysis of what that testing actually showed. An opinion that Bard's claim was misleading because it was not supported by the tests performed does not relate to legal standards, nor is it a question of Bard's state of mind or intent. Whether the scientific data supported the claim made regarding the G2 filters is within the realm of the Engineers' expertise and would be helpful to a fact-finder. See In re Seroquel, 2009 WL 3806436, at *8 Accordingly, the Court will deny Bard's request for the exclusion of this opinion.
William A. Hyman, Sc.D., P.E., is an engineer with a masters and doctorate degree from Columbia University in engineering mechanics. See Motion to Exclude Hyman, Ex. A (Doc. 110; Hyman Report) at 1. He has extensive educational and professional experience in biomedical engineering, biomaterials, biomechanics, medical device design and system safety, and FDA regulatory processes. See Hyman Report at 1-2. He has spent a substantial amount of time researching, writing, teaching and consulting in these areas, and has published on topics of medical device design and system safety, as well as FDA regulatory issues. Id. To generate his Report, Hyman employed the following methodology:
Id. at 3. Based on the foregoing qualifications and methodology, Hyman draws several conclusions regarding Bard's filters, including, inter alia, that the design of the G2 filter was defective, that Bard's design, testing, and marketing of the G2 filter was below industry standards, that Bard conducted
Bard maintains that the Court should exclude Hyman's opinions because Hyman "lacks sufficient knowledge, skill, experience, training, and education to qualify as an expert regarding Bard's [IVC] filter testing, design, and labeling." See Motion to Exclude Hyman at 1. In addition, Bard asserts that Hyman's opinions are unhelpful to the jury in that they are summaries of documents which do not require expertise to understand, regulatory opinions which are improper conclusions of law, improper opinions on corporate knowledge or intent, and irrelevant opinions on alleged fracture and migration complications. Id. at 1-2. Bard also maintains that Hyman's opinions are not based on sufficient facts or data, and that his opinions are not the product of reliable principles and methods. Id. at 2.
First, with respect to Hyman's qualifications, the Court finds that Hyman is qualified to testify regarding the applicable FDA regulations, as well as medical device design and testing. Bard challenges Hyman's qualifications to render opinions on the design and testing of the G2 filter because Hyman "lacks any meaningful training or experience with implantable medical devices, let alone IVC filters." See Motion to Exclude Hyman at 4. In support, Bard relies on cases where courts have found experts unqualified due to their lack of expertise with the particular product at issue. See id. at 4-5. However, the cases on which Bard relies are distinguishable because, unlike Hyman, the experts in those cases had only general engineering or scientific backgrounds and lacked any expertise in the design of medical devices. See Cason v. C.R. Bard, Inc., 1:12-CV-1288-MHS, slip op. at 25-28 (N.D.Ga. Feb. 12, 2015) (discussing and distinguishing the cases Bard cited for this proposition).
However, with respect to Hyman's opinions on the adequacy of Bard's warnings, Tillman fails to establish that Hyman is qualified to opine on this issue. Although Hyman has had "input" into instructions for use (IFU) on a "few" occasions, he has never drafted an entire IFU.
Next, Bard seeks to exclude Hyman's opinions regarding "FDA regulations (including the 510(k) clearance process), FDA guidelines, and Bard's compliance or alleged noncompliance with these regulations and guidance documents." See Motion to Exclude Hyman at 7. Bard does not challenge Hyman's qualifications as an expert on the FDA regulation of medical devices, but contends that these opinions would not be helpful to the jury. Id. In addition, Bard argues that "[a]ny allegation that Bard misled the FDA or committed fraud on the FDA is preempted." Id. These arguments are unavailing. Hyman's testimony on FDA guidelines and regulations, and Bard's compliance therewith, is helpful to the trier of fact because "[a] lay jury cannot be expected to understand the complex regulatory framework that informs the standard of care in the [medical device] industry." See In re Fosamax, 645 F.Supp.2d at 191. Moreover, because Tillman is not alleging any claim for fraud on the FDA, Bard's preemption arguments are inapposite. Indeed, the court in Cason considered these same arguments and determined that Hyman's regulatory opinions were permissible. See Cason, 1:12-CV-1288-MHS, slip op. at 34-37. This Court agrees with the reasoning in Cason, and holds that Hyman "may testify regarding the regulatory process by which medical devices like the G2 Filter are brought to market, and he may express his opinion as to whether Bard complied with all FDA regulatory requirements applicable to the G2 Filter." Id. at 36; see also In re Fosamax, 645 F.Supp.2d at 192. However, as in Cason, Hyman "will not be allowed to express any opinion as to whether Bard should have done more than was required by FDA regulations to address the hazards of the G2 Filter." Cason, 1:12-CV-1288-MHS, slip op. at 37.
Finally, Bard argues that Hyman's opinions on the testing, design and warnings should be excluded because they are based on inadequate facts or data, and are unreliable. Upon review, the Court again agrees with the well-reasoned decision in Cason, and holds that Hyman's opinions are not based on sufficient facts or data, and are not the product of reliable principles and methods. See Cason, 1:12-CV-1288-MHS, slip op. at 30-34. Hyman did not conduct any tests, examine a Bard G2 filter or any other type of IVC filter, and has never seen in person or touched an IVC filter. See Hyman Dep. at 23-24. Moreover, Hyman concludes that the G2 filter is defective without assessing the risks versus the benefits of the filter, the availability and safety profiles of other filters on the market, or the viability of a safer, alternative design. See McGee v. Evenflo Co., Inc., No. 5:02-CV-259-4(CAR), 2003 WL 23350439, at *5-6 (M.D.Ga. Dec. 11, 2003). Thus, based on the foregoing, and for the reasons discussed in Cason, the Court finds that Bard's Motion to Exclude Hyman is due to be granted, in part, as to Hyman's opinions on the design, testing and labeling of the G2 filter.
Michael Freeman, Ph.D. is an epidemiologist with a doctorate degree in public health. See Motion to Exclude Freeman, Ex. A (Doc. 95-1; Freeman Report) at 3. He is currently an Affiliate Professor of Epidemiology at the Oregon Health and Science University in Portland, Oregon, and has held this position since 2010. Id. at 26. Freeman offers two primary opinions in his expert report. First, Freeman
Bard moves to exclude Freeman's opinion that Bard filters were failing at an "alarmingly high" rate because it is based on data which, according to Bard, cannot be used to calculate rates for adverse events or complications. See Motion to Exclude Freeman at 2. As such, Bard maintains that Freeman's opinions are based on insufficient and unreliable data. Id. Bard also challenges Freeman's opinion that the G2 filter was fracturing and migrating at higher rates than filters manufactured by competitors as irrelevant. In addition, Bard argues that Freeman's opinions on Bard's corporate conduct should be excluded because Freeman has "no expertise in either IVC filters or corporate responsibility of a medical device company," such that he is not qualified to opine on this subject. Id. Last, Bard maintains that the probative value of Freeman's opinions is "substantially out-weighed by a danger of unfair prejudice and confusing the issues for, or misleading, the jury." Id.
First, Bard challenges the reliability of the data underlying Freeman's opinions. Freeman's opinions on the failure rates of Bard's filters are based on his analysis of adverse event reporting data obtained from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. See Freeman Report at 3. He then used "IMS (device sales) and Bard sales data in order to derive failure and event rates for each device that could then be compared." Id. Bard argues that "the MAUDE database does not accurately estimate the actual number of adverse events for a particular device, because what constitutes a reportable adverse event in the database is the subject of federal regulations . . . which can be interpreted differently by different doctors, hospitals, and device companies." See Motion to Exclude Freeman at 7. Bard cites to the FDA's warning that the MAUDE database "`cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.'" Id. at 7-8 (citing MAUDE Database search page, available at http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfmaude/search.cfm). Bard also challenges the reliability of the IMS sales data. Id. at 8 n. 2. In support, Bard cites several cases in which courts have rejected expert opinions premised on the anecdotal reports that make up adverse event data. See id. at 9 n. 3, 10 n. 4.
In his Report, Freeman acknowledges the weaknesses in the MAUDE data and explains his reasoning for finding this data to be a reliable source of information in the context of IVC filters. See Freeman Report at 4. Moreover, Freeman clarifies in his deposition that "as a broad overarching conclusion," his principal opinion in this case is that "at certain times, [as] delineated in [his] reports, [he] think[s] Bard had a signal about its products based on whatever data it had pulled together."
Upon review, the Court determines that Bard's criticisms are more appropriately directed to the weight, rather than the admissibility of this evidence. See In re Chantix (Varenicline) Prods. Liab. Litig., 889 F.Supp.2d 1272, 1282 (N.D.Ala.2012); In re Fosamax, 645 F.Supp.2d at 178 ("Under Daubert, an expert need not base his or her opinion on the best possible evidence, regardless of availability, but upon `good grounds' based on what is known.'" (quoting Daubert, 509 U.S. at 590, 113 S.Ct. 2786)). Bard does not identify an alternative source of data that would have been more accurate, and indeed, Freeman relies on the same MAUDE and IMS data that Bard used to analyze its products. See generally Lehmann Report. Moreover, the cases Bard cites generally address the use of adverse event reports to generate opinions on the effects of pharmaceutical drugs. Freeman acknowledges the "criticisms of the use of the FDA adverse event reporting system (AERS) as a basis for comparing the rate of adverse reactions to drugs," but explains that this "is a much less significant issue when evaluating the relative failure rate of medical devices." See Freeman Report at 3. Freeman elaborates that "when used to track a device failure the MAUDE database is a highly reliable source of information, as a device failure is not attributable to any cause other than a failure of the device." See id. at 3.
In addition, Bard's cited authority discusses the unreliability of using this type of evidence to generate opinions specific to causation. See, e.g., In re Accutane Prods. Liab., 511 F.Supp.2d 1288, 1298 (M.D.Fla. 2007) (stating that the adverse event reports were "unreliable as proof of causation because, in general, the events were not observed in such a way as to rule out coincidence or other potential causes"); McClain, 401 F.3d at 1250 (holding that adverse event reports were "one of the least reliable sources to justify opinions about both general and individual causation"); but see In re Baycol Prods. Litig., 532 F.Supp.2d 1029, 1041-42 (D.Minn. 2007) (excluding expert opinion that drug was the most toxic of its variety because expert's comparative analysis used adverse event data). However, Freeman explains in his deposition that he is not using the adverse event reports to generate an opinion as to causation. See Freeman Dep. at 126. Rather, Freeman draws inferences from the available data about the comparative failure rates among IVC filters, and he explains his reasoning for why the data is reliable to support his conclusions. See Freeman Report at 3-4. As such, the Court does not find the cited authority on causation to be persuasive in this context. Rather, Bard's arguments concerning the weaknesses of the underlying MAUDE and IMS data go to the weight rather than the admissibility of the opinion. See Deutsch, 768 F.Supp.2d at 432, 441 (finding that objections to the factual bases for the experts' opinions on the incidence rate "go to the weight and not the admissibility of their testimony"). Bard may explore
Next, to the extent Freeman opines on Bard's corporate conduct or how Bard should have responded to the data in its possession, Tillman fails to establish that Freeman is qualified to opine on this subject. Freeman is an expert in the particular scientific discipline of epidemiology and forensic medicine. Freeman's areas of expertise do not include "knowledge or even experience in the manner in which corporations and the [medical device] marketplace react, behave or think regarding their non-scientific goals of maintaining a profit-making organization that is subject to rules, regulations, standards, customs and practices among competitors and influenced by shareholders or public opinion." See In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., No. MDL 1203, 2000 WL 876900, at *9 (E.D.Penn. June 20, 2000). Moreover, the Court finds that these opinions are not helpful to the jury. See In re Rezulin, 309 F.Supp.2d at 547; In re Fosamax, 645 F.Supp.2d at 192. Bard's intent or motivations are "lay matters which a jury is capable of understanding and deciding without the expert's help." In re Rezulin, 309 F.Supp.2d at 546. However, to the extent Freeman merely discusses what information was available and possessed by Bard prior to Tillman's procedure, this testimony is helpful and relevant to determining whether Bard acted reasonably and does not improperly comment on Bard's "state of mind." In re Flonase, 884 F.Supp.2d at 192-93. Thus, Freeman may opine on what information and knowledge was available to Bard, but may not go beyond that to offer opinions on Bard's intent, motive, or what it should have done with that information. Id.; see also In re Seroquel, 2009 WL 3806436, at *3-4; Deutsch, 768 F.Supp.2d at 443 ("However, whether [the expert] can opine on [the manufacturer's] state of mind is distinct from whether [the expert] can opine on his interpretation of whether certain information contained in [the manufacturer's] internal documents indicated certain risks. . . .").
Under Rule 56, Federal Rules of Civil Procedure (Rule(s)), "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Rule 56(a). The record to be considered on a motion for summary judgment may include "depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials." Rule 56(c)(1)(A).
The party seeking summary judgment bears the initial burden of demonstrating to the court, by reference to the record, that there are no genuine issues of material fact to be determined at trial. See Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir.1991). "When a moving party has discharged its burden, the non-moving party must then go beyond the pleadings, and by its own affidavits, or by depositions, answers to interrogatories, and admissions on file, designate specific facts showing that there is a genuine issue for trial." Jeffery v. Sarasota White Sox, Inc., 64 F.3d 590, 593-94 (11th Cir.1995) (internal citations and quotation marks omitted). Substantive law determines the materiality of facts, and "[o]nly disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment." Anderson, 477 U.S. at 248, 106 S.Ct. 2505. In determining whether summary judgment is appropriate, a court "must view all evidence and make all reasonable inferences in favor of the party opposing summary judgment." Haves v. City of Miami, 52 F.3d 918, 921 (11th Cir.1995) (citing Dibrell Bros. Int'l, S.A. v. Banca Nazionale Del Lavoro, 38 F.3d 1571, 1578 (11th Cir.1994)).
"Strict liability is defined as negligence as a matter of law or negligence per se; it relieves the plaintiff of the burden of proving specific acts of negligence." Barrow v. Bristol-Myers Squibb Co., No. 96-689-CIV-ORL-19B, 1998 WL 812318, at *27 (M.D.Fla. Oct. 29, 1998). In West v. Caterpillar Tractor Co., Inc., 336 So.2d 80, 87 (Fla.1976), Florida adopted the strict products liability standard of the Restatement (Second) of Torts § 402A. See West, 336 So.2d at 87; Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999). "Under this standard, the manufacturer of a defective product can be held liable if the manufacturer made the product in question, if the product has a defect that renders it unreasonably dangerous, and if the unreasonably dangerous condition is the proximate cause of the plaintiff's injury." Jennings, 181 F.3d at 1255. Under Florida law, "`a product may be defective by virtue of a design defect, a manufacturing defect, or an inadequate warning.'" Id. (quoting Ferayorni v. Hyundai Motor Co., 711 So.2d 1167, 1170 (Fla. 4th Dist.Ct.App.1998)). In this case, Tillman asserts all three defects.
A defendant is strictly liable for a failure to warn where a plaintiff proves that the defendant "(a) is a manufacturer or distributor of the product at issue, and (b) did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of the manufacture and distribution." See Thomas v. Bombardier Recreational Prods., Inc., 682 F.Supp.2d 1297, 1300 (M.D.Fla. 2010). Because the G2 filter is a prescription medical device, the learned intermediary doctrine applies to Tillman's claim. See Rounds v. Genzyme Corp., 440 Fed. Appx. 753, 755 n. 2 (11th Cir.2011).
In this case, because Bard did provide some warnings regarding its G2 filters, "the issue is whether the warning provided to the physician is adequate." Rounds, 440 Fed.Appx. at 755. "When the warning is accurate, clear, and unambiguous, its adequacy is a question of law. When the warning is not accurate, clear, or unambiguous, its adequacy is a question of fact that a jury may resolve." Kaufman v. Wyeth, LLC, No. 1:02-CV-22692, 2011 WL 10483576, at *5 (S.D.Fla. Aug. 15, 2011) (internal citations omitted). In Upjohn Co. v. MacMurdo, 562 So.2d 680 (Fla.1990) the Florida Supreme Court set forth a general rule that, because the duty to warn of a prescription product's dangerous side effects is to the physician, not the patient, "the adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony." See Upjohn, 562 So.2d at 683; see also Barrow, 1998 WL 812318, at *30; Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1369 (S.D.Fla.2007); Kaufman, 2011 WL 10483576, at *5. As such, in Upjohn, the Florida Supreme Court found that the manufacturer was entitled to judgment on the patient's failure to warn claim where "no medical expert testified that the package insert was insufficient to put a doctor on notice that the symptoms displayed by [the patient]. . . could result from the use of [the drug]." See Upjohn, 562 So.2d at 683.
Bard maintains that Tillman's failure-to-warn claims fail under the learned intermediary doctrine because "the evidence demonstrates that Bard adequately warned Dr. Stockland, the implanting physician, of the risk of relevant complications in the Filter." See Bard Motion at 19. Stockland testified that "[e]very time one of the new Bard devices came out I would review the new instruction booklet." See Stockland Dep. at 28. The IFU accompanying the G2 filter included warnings regarding filter fracture, movement or migration of filters, and the possibility that the complications described "may affect the recoverability of the device and result in the clinician's decision to have the device
Id. In addition, the IFU references a clinical study of 100 patients in which 61 patients underwent the filter retrieval procedure and 58 patients had a successful retrieval. Id. Notably, the three failed retrievals "resulted from inability to engage the filter apex with the Recovery Cone® Removal System due to filter tilt leading to embedding of the filter apex into the vena caval wall." Id. Indeed, Stockland testified that he was aware that IVC filters carried risks of fracture, migration, perforation, and tilt, as well as the risk that complications may make it impossible or unadvisable to remove a retrievable filter intended to be temporary. See Stockland Dep. at 15-18, 27, 38, 56-57.
Based on the foregoing, not only did the IFU accompanying the G2 filter warn of the specific complications that Tillman experienced, but Stockland was otherwise aware of these potential risks. Nonetheless, Tillman contends that these warnings were inadequate, and that the learned intermediary doctrine should not apply because Stockland was not fully informed of the risks and was misled by the language in the IFU.
Tillman argues that this Court is faced with analogous facts. Tillman points to language in the IFU which refers to migration as a "known complication," as well as language that there have been "reports" of filter fracture but that "most cases of filter fracture, however, have been reported without any adverse clinical sequelae." See Tillman Response at 18. According to Tillman, such language is similar to the language found to be inadequate and misleading in Zanzuri. See Zanzuri, 748 F.Supp. at 1516-17 ("An increased risk of pelvic inflammatory disease associated with the use of IUDs has been reported. While unconfirmed, this risk appears to be greatest for young women who are nulliparous. . . ."). However, unlike Zanzuri, Tillman fails to cite to the opinion of any qualified expert who has analyzed the IFU and found that it "did not adequately convey the information . . . as reflected in medical literature," or that the language used misrepresented the actual risks. Compare Zanzuri, 748 F.Supp. at 1517 with Tillman Response at 17-18.
Bard offers three primary arguments in support of its request for summary judgment on Tillman's strict liability design defect claim. First, Bard contends that Tillman's claim is "precluded by application of comment k to § 402A of the Restatement (Second)." See Motion at 14-15. Second, Bard argues that Tillman's design defect claim must fail because she "has not provided any evidence pinpointing what exactly was defective about the Filter, or how any such alleged defect caused the Filter to tilt, migrate, or perforate [her] IVC." Id. at 15-16. Last, Bard contends that Tillman's claim must fail because Florida law requires her to identify a reasonable alternative design and she fails to provide any evidence of an alternative design the omission of which rendered the Filter unsafe. Id. at 16-17. Upon review, the Court finds that there is an issue of fact as to whether the design of the Filter is defective. Tillman presents evidence that the Filter, as designed, has a propensity to tilt, migrate, or perforate the IVC, complications which can also lead to fracture. In addition, the Filter's geometry and lack of chamfer on the inner-rim of the filter sleeve increase the Filter's risk of fracturing. In response to this evidence, Bard fails to demonstrate the absence of a question of fact as to whether the Filter is as safe as current testing and research permit, and that its benefits out-weigh its risks, such that comment k is inapplicable. Finally, the Court determines that Florida law does not require Tillman to identify an alternative reasonable design in the context of a products liability action pertaining to a medical device.
The definition of design defect is in a "state of flux in Florida." See In re Standard Jury Instructions in Civil Cases—Report No. 09-10 (Prods. Liab.), 91 So.3d 785, 789 (Fla.2012) (Pariente, J., concurring). Currently, the Florida jury instruction on design defect instructs that: "A product is unreasonably dangerous because of its design if [the product fails to perform as safely as an ordinary consumer would expect when used as intended or in
The "consumer-expectation test" is derived from the strict liability doctrine set forth in section 402A of the Restatement (Second) of Torts. See Edic ex rel. Edic v. Century Prods. Co., 364 F.3d 1276, 1285 (11th Cir.2004); Restatement (Second) of Torts § 402A (1965), cmt. i. However, "[d]ue to the difficulty in applying the consumer expectation standards to all types of product defects, many thoughtful commentators have suggested that it should be rejected, particularly as to those defects arising from design, in favor of a test that would weigh the utility of the design versus the magnitude of the inherent risk." See Cassisi v. Maytag Co., 396 So.2d 1140, 1145 (Fla. 1st Dist.Ct.App. 1981). Although Florida courts generally continue to rely on the consumer-expectation test, some courts have observed that "there may . . . be products that are too complex for a logical application of the consumer-expectation standard." See Force, 879 So.2d at 106; Tran v. Toyota Motor Corp., 420 F.3d 1310, 1314 (11th Cir.2005). At least one District Court of Appeal in Florida has rejected the consumer-expectation test entirely. See Agrofollajes, S.A. v. E.I. Du Pont de Nemours & Co., Inc., 48 So.3d 976, 997 (Fla. 3d Dist. Ct.App.2010). Because this case pertains to a complex medical device, accessible to the consumer only through a physician, the Court finds that the consumer-expectation test is not applicable here. See Rydzewski v. DePuy Orthopaedics, Inc., No. 11-80007-Civ, 2012 WL 7997961, at *2 (S.D.Fla. Aug. 14, 2012) (rejecting the consumer-expectation test in a design defect claim pertaining to a medical device); In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 170 n. 4 (S.D.N.Y.2010) (applying Florida law and rejecting consumer-expectation test in a design defect claim pertaining to a prescription drug).
Consistent with this well-reasoned authority, to analyze Tillman's design defect claims, the Court will apply a risk-utility test. However, the exact contours of the risk-utility test are also unclear under Florida law. Under one version of the test, a product is defective in design where "the plaintiff demonstrates that the product's design proximately caused his injury and the defendant fails to establish, in light of the relevant factors, that, on balance, the benefits of the challenged design outweigh the risk of danger inherent in such design." See Cassisi, 396 So.2d at 1145-46. Under this test, "[o]nce the plaintiff establishes a prima facie case showing that his injuries were caused by a product's design, the burden is shifted to the defendant to prove the design was not defective by presenting evidence of factors, such as the gravity of the danger posed by the challenged design, the feasibility of a safer design, the financial cost of improved design, etc." Id. Although the Cassisi
Notably, the aforementioned risk-utility analysis appears to embody the intent of comment k in the Second Restatement. See Restatement (Second) of Torts § 402A, cmt. k. Comment k addresses "[u]navoidably unsafe products," described as "products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs." Id. The comment cites the treatment for rabies as an "outstanding example" of such a product because, while the treatment can lead to very serious and damaging consequences, the disease itself invariably leads to a dreadful death. Id. Thus, "the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve." Id. According to comment k, "[s]uch a product, properly prepared, and accompanied by proper directions and warnings, is not defective nor is it unreasonably dangerous." Id. As such:
Id. The comment suggests that this reasoning applies to many other drugs, vaccines and the like which, because of their danger, can only be sold to physicians or under prescription. Id.
In Adams, Florida's Second District Court of Appeal explained that "by its terms comment k applies to products which current knowledge and technology cannot make safe for their ordinary use, but for which society has a need great enough to justify using the product despite its dangers." Adams, 576 So.2d at 731. Noting that the comment "adopts a risk/benefit analysis," the court reasoned that the comment should not uniformly protect all prescription drugs or medical products. Id. at 732. Rather, only "a product which is as safe as current testing and research permits should be protected. The reverse is also true; a product which is not as safe as current technology can make it should not be protected." Id. Accordingly, the court concluded that comment k "is an affirmative defense to a strict liability claim," such that "the seller has the burden to establish the application of comment k." Id. at 733. Whether comment k applies should be based on a risk-benefit analysis, and "if reasonable minds might differ, then the matter must be submitted to the jury." Id. Thus, to be protected under comment k, a defendant must show that the product is as safe as current testing and research permit, and that the product's benefits outweigh the known risks as of the date the product is distributed. Id. at 732-33. "If new information later tips the balance toward the risk of a product, or if new developments make possible a safer design, at that point further distributions of the product are not protected by comment k." Id. at 733; see also Zanzuri, 748 F.Supp. at 1518-20.
In support of its comment k defense, Bard relies on Stockland's testimony that IVC filters can be life-saving medical devices. See Stockland Dep. at 14. In addition, Stockland testified to his awareness of the risks associated with IVC filters, and explained that he decides whether to use a medical device by considering the risk-benefit ratio. Id. at 15-22, 27. Stockland states that "[i]f the device in any way aids the patient's outcome or health and that outweighs the risk of the device being implanted, that's how we decide." Id. at 12-13. Because Stockland implanted the filter in Tillman despite his awareness of the risks associated with the use of IVC filters, Bard maintains that the potentially life-saving benefits of the device out-weigh the known risks. Id. at 15. In addition, Bard maintains that the IVC filter is incapable of being made safe and cites to Begley's testimony that it is impossible to design an IVC filter that never migrates, tilts or fractures. See id., Ex. I: Begley Dep. at 43.
Rather than respond to Bard's arguments directly, or cite to specific evidence that would create an issue of fact, Tillman unhelpfully responds, in summary fashion, that Bard "has presented no evidence establishing that the G2 Filter is such a special device needed to satisfy an exceptional social/medical need that the benefits exceed its risks, or that the device could not have been made safer at the time of manufacture and distribution." See Tillman Response at 14. Nonetheless, the Court finds that Bard fails to establish that it is entitled to protection under comment k. To receive the protection of comment k, Bard must show that "the product is as safe as current testing and research permit" at the time of distribution. Adams, 576 So.2d at 732-33. Bard does not cite to any evidence in its Motion to support a finding that the Filter was as safe as testing and research would permit at the time of distribution. See Bard Motion at 15. Indeed, Tillman presents expert opinions that Bard's testing was insufficient to demonstrate the safety of the device, and that certain design changes would have reduced the risk of fracture and made the device safer. See Ritchie Report at 10-11; McMeeking/Begley Report at 1, 10, 18-22. Of note, Ritchie opines that the lack of a chamfer on the rim of the filter cap, as well as the failure to electropolish the filters to remove surface defects increased the stresses and strains on the device leading to fatigue failure. See Ritchie Report at 6, 10. Thus, there is a question of fact whether the fracture risk of the Filter could have been reduced.
Additionally, Tillman submits evidence that the G2 filter experiences higher adverse
In light of the foregoing, Bard's reliance on Stockland's decision to implant the Filter as evidence that its benefits outweigh its risks is unavailing. Although Stockland's testimony suggests that IVC filters in general satisfy a medical need to protect against a life-threatening pulmonary embolism, this evidence does not establish that the G2 filter in particular provides benefits which outweigh its risks. Notably, Stockland testifies that he was unaware of the information indicating that the adverse event report rate for the Recovery in categories such as filter fracture, movement, embolization, and death, was significantly higher than with other retrievable IVC filters. See Stockland Dep. at 89-90; see Lehmann Report at 2; Freeman Report at 5. He states that such information would have been significant to him and could have influenced his decision to use the G2 filter on Tillman. See Stockland Dep. at 89-90. Stockland also stated that he was never provided the information that the safety profiles of the Recovery and G2 filters were different than that of the predecessor filter, the SNF, and that such information could be very important to him in deciding whether to use a Bard filter. Id. at 93-95. Thus, while Stockland was aware of the general risks attendant with the use of IVC filters, he was not aware of the quantum of risk associated with the use of this Bard filter in particular. As such, the Court is not persuaded by Bard's argument that Stockland's decision to use the G2 filter establishes that its benefits outweigh its risks.
In addition, Hull, Tillman's medical expert, remarks from his observation of the Recovery filter in practice, that
See Hull Report at 3. Because of the G2 filter's propensity to perforate the vessel wall, Hull finds that it "is at an increased risk of fracture." Id.; see also Ritchie Report at 19. In addition, Hull notes that "these filters do not have a common strut, wire or other instrument to connect the struts of the device to one another." See Hull Report at 3. As such, "when the device experiences fracture of one (or more) of the struts, the design of the filter allows fractured struts to independently embolize from their position through the vasculature to the body's vital organs (i.e., the heart, lungs, and other organs/anatomical locations)." Id. Hull maintains that in his professional opinion and the opinion of his colleagues in the field of interventional radiology, "fracture rates that result in embolization or potential embolization of the fractured portions of the device for vena cava filters should be well less than 1%, and, as close to zero % as possible." Id. at 6. According to Hull, "[t]he vena cava wall perforation, limb fracture with embolization and migration through the body or to organs is a unique, dangerous and unexpected complication of having a vena cava filter." Id. at 5.
Hull concludes that "[b]ased upon my observations, review of the medical literature, and evidence adduced to date in this litigation, it is my opinion that the G2 filter presents risks of harm to patients that are unacceptable, and which outweigh the benefits provided by the device." See id. at 4. Hull adds that
Id. at 8. The Court expresses no opinion on whether the risks of the G2 filter out-weigh its benefits, however it is enough at this stage in the proceedings to find that, based upon the evidence before the Court, "reasonable minds might differ" on the matter. See Adams, 576 So.2d at 733. Therefore, in light of the foregoing evidence, the Court finds that Tillman has demonstrated an issue of fact as to whether the G2 filter is unreasonably dangerous, and therefore defectively designed, and Bard fails to establish that it is entitled to summary judgment pursuant to the comment k affirmative defense.
Alternatively, Bard relies on a slightly different version of the risk-utility test, described in the Restatement (Third) of Torts, to argue that Tillman's claim fails because she does not provide evidence of a reasonable alternative design. See Bard Motion at 16.
Relying on this version of the risk-utility test, Bard argues that Tillman's claims must fail because she has not presented evidence of a reasonable alternative design. See Bard Motion at 16-17. The language of the Third Restatement does require a plaintiff with a design defect claim to prove the availability of a "reasonable alternative design." See Aubin, 97 So.3d at 897.
Id. Thus, unless Florida has now adopted section 2 of the Third Restatement, the availability of an alternative design is merely one of the factors to be considered in determining whether a product is "unreasonably dangerous."
Upon careful consideration, the Court finds that regardless of whether the Third Restatement applies under Florida law in other contexts, in a medical device case such as this, Florida law does not apply this standard. The Florida cases in which courts have applied or acknowledged the test set forth in section 2 of the Third Restatement did not concern pharmaceutical drugs or medical devices. See Aubin, 97 So.3d at 890 (construction materials including chrysotile asbestos); Kohler Co., 907 So.2d at 598 (small engines); Agrofollajes, S.A., 48 So.3d at 980 (fungicide); see also Scheman-Gonzalez, 816 So.2d at 1136 (tire and wheel rim); Tran, 420 F.3d at 1312 (seatbelt); Force, 879 So.2d at 105 (seatbelt). This is significant because the Third Restatement actually contains a separate provision specifically tailored to medical devices. See Restatement (Third) of Torts: Products Liability § 6(c). Section 6 of the Third Restatement instructs that a medical device has a design defect if it is not reasonably safe in that "the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients." Id. Thus, even if the Third Restatement applied under Florida law, the reasonable alternative design test advocated by Bard is not the appropriate standard for a medical device case such as this. As no court in Florida has adopted section 6 of the Third Restatement, the Court determines that the risk-utility test articulated in Cassisi and embodied in comment k is the appropriate standard. Thus, to the extent Bard argues that the Court should enter summary judgment on Tillman's design defect claim because she
Bard asserts that Tillman's manufacturing defect claim fails because Tillman does not provide any evidence that "the Filter varied from other G2® filters in its lot." See Bard Motion at 18. Absent evidence that the Filter deviated from its intended design, Bard contends that summary judgment is appropriate in its favor on this claim. In Response, Tillman argues that the Court should infer the existence of a manufacturing defect based on a principle of Florida law known as the Cassisi inference. See Tillman Response at 16-17 (citing Cassisi v. Maytag Co., 396 So.2d at 1148). Specifically, Tillman argues that because the Filter cannot be removed and examined, it is appropriate to infer that a manufacturing defect exists based on the Filter's malfunction during normal use. See Tillman Response at 16-17. Alternatively, Tillman contends, without elaboration, that her experts and Dr. Robert Carr, Jr., the designer/patent holder of the original SNF filter technology, "have unequivocally established a defect and have shown that the G2® Filter `does not conform to its intended design' in that it `fails to perform as safely as the intended design would have performed.'" Id. at 17. Tillman then cites the Court to "supra" and provides no specific citation as to what evidence purportedly supports this proposition or where in the extensive record and lengthy expert reports it is located.
First, Tillman's argument that the Court should infer the existence of a manufacturing defect based on the Cassisi inference is unavailing. This inference provides that "when a product malfunctions during normal operation, a legal inference, which is in effect a mirror reflection of the Restatement's standard of product defect, arises, and the injured plaintiff thereby establishes a prima facie case for jury consideration." See Cassisi, 396 So.2d at 1148. For the inference of a defect to apply, a plaintiff must demonstrate "two essential predicate facts . . . (1) a malfunction (2) during normal operation." See Hall v. Sunjoy Indus. Grp., Inc., 764 F.Supp.2d 1297, 1302 (M.D.Fla. 2011). In an unpublished decision, a panel of the Eleventh Circuit has explained that the Cassisi inference applies "where a `product malfunctions that would not malfunction but for the defect,'. . . ." Beauregard v. Cont'l Tire N. Am., Inc., 435 Fed. Appx. 877, 880 (11th Cir.2011). However, a malfunction is not established merely because a product breaks. Rather, a plaintiff "must present evidence, through expert testimony, that [the product] did not perform properly under the circumstances." Id. As such, to demonstrate a malfunction, Tillman must show that "based on the design of the unit, it should not have [performed as it did]." See Edic, 364 F.3d at 1285-86.
Upon review, the Court finds that Tillman fails to submit any evidence that the Filter, as designed, should not have performed as it did. Indeed, tilt, perforation, and migration are all well-known potential complications with the use of IVC filters, including G2 filters. Grassi Report at 4. Thus, it is entirely possible that Tillman's Filter migrated, tilted, and perforated her
Nonetheless, the Court finds that there is sufficient evidence in the record of a manufacturing defect in G2 filters to create an issue of fact on this claim. "Under Florida law, a manufacturing defect requires (1) a product that `does not conform to its intended design' such that it (2) `fails to perform as safely as the intended design would have performed.'" See Citizens Prop. Ins. Corp. v. Simkar LLC, 813 F.Supp.2d 1356, 1363 (M.D.Fla.2011) (quoting Fla. Std. Jury Instr. (Civil) PL 4). "Manufacturing defects are generally limited to situations where something goes wrong in the manufacturing process. . . ." See Benitez v. Synthes, Inc., 199 F.Supp.2d 1339, 1344 (M.D.Fla.2002). These are "aberrational" defects or "unintended configurations," as opposed to defects occurring throughout an entire line of products, or intended configurations that produce unintended results. Id. In this case, Ritchie examined several G2 filters, both used and unused, and noted
See Ritchie Report at 11. Ritchie explains that these defects "could have been readily removed by electropolishing (or in the case of the gouges avoided by improved manufacturing procedures and/or quality control). . . ." Id. at 18-19.
Bard next argues that it is entitled to summary judgment on Tillman's negligence and strict liability claims because Tillman "has not provided admissible evidence of causation-that, but for the presence of a design, manufacturing defect, or inadequate warnings, she would not have been damaged." See Bard Motion at 24. Bard maintains that Tillman "cannot provide any evidence pinpointing what exactly was defective about the Filter, let alone that she suffered injury caused by such a defect." Id. at 25. As discussed above, there is sufficient evidence to support a finding that the Filter is unreasonably dangerous due to its design because its propensity to migrate, tilt, perforate the IVC, and fracture outweigh its benefits. As such, an issue of fact exists as to whether the G2 Filter is defectively designed. In addition, the Court has determined that there is an issue of fact concerning whether the Filter is defectively manufactured in light of the surface defects present on the device. Thus, the Court turns to the question of whether there is a triable issue as to the question of whether these defects caused damage to Tillman.
Bard maintains that Tillman has failed to produce evidence that the Filter caused her any injury. See Bard Motion at 25. Bard contends that Tillman has not identified any physical injury, emotional distress, pain or other symptom caused by the Filter. Id. In her Response, Tillman asserts that the Filter migrated, tilted, and perforated her IVC such that it cannot be removed leading to "renal vein thrombosis, pain, hospitalization, expense of hospitalization and continued risk of filter fracture and injury and the need for ongoing medical monitoring." See Tillman Response at 19. Thus, the Court must determine whether there is sufficient evidence to demonstrate that the alleged defects caused the Filter complications in Tillman, and whether those complications have resulted in any damages. As to the first step in the analysis, the parties do not dispute that migration, tilt, and perforation, are inherent risks in the use of Bard's G2 filter. See Grassi Report at 4; Bard Motion, Ex. P: IFU. In addition, Tillman offers the Hull Report in which Hull opines that Tillman:
See Hull Report at 6. Thus, in sum, Tillman's causation evidence is that these complications are inherent in the design of the G2 filters, she experienced these complications, and there is no evidence that any other factor caused the complications she experienced. A factfinder could conclude from the foregoing evidence that the complications Tillman claims to have experienced with her Filter were the result of the Filter's defective design. See C.R. Bard, Inc. v. Mason, 247 So.2d 471, 471-72 (Fla. 2d Dist.Ct.App.1971) (finding sufficient evidence of causation where evidence showed some devices contained defect which caused fracture, plaintiff's device fractured, and all other possible causes excluded); Worsham v. A.H. Robins Co., 734 F.2d 676, 683-84 (11th Cir.1984) ("Elimination of alternative causes is one of several accepted types of proof for establishing product defect.").
The Court next considers whether Tillman has presented evidence that the Filter caused damaging complications. Tillman argues that she experienced renal vein thrombosis, pain, and subsequent hospitalization as a result of the failed removal, which was caused by the Filter's complications. However, Tillman does not cite to any evidence in the record that the failed removal actually caused those damages. Although the medical records indicate that the Filter could not be removed due to "the extensive nature of the tilting of the device, length of the duration of placement of the device and probable incorporation into the left renal vein," see Tillman Response, Ex. BB, Tillman presents no probative evidence that the failed removal then caused the renal vein thrombosis, pain, and subsequent hospitalization. Indeed, Tillman cites only to her own deposition testimony that after the attempted removal "I had to go back to Mayo, because I didn't know what was going on. I was just sick and couldn't stand up. And then when I went back, that's when they said I had a blood clot in the kidney from trying to remove the filter." See Tillman Dep. at 137. Tillman does not identify who the "they" who told her this information are, and without any medical or expert testimony to demonstrate a causative link between the failed removal and the subsequent blood clot, Tillman cannot recover those damages. See Jacob v. Korean Air Lines Co., Ltd., No. 12-CV-62384, 2014 WL 1584444, at *6 (S.D.Fla. Mar. 20, 2014) ("Although causation is an issue generally left to a jury, medical causation falls beyond the scope of a layperson's knowledge and requires competent medical testimony.") (collecting cases).
In addition, Tillman argues that design and manufacturing defects in the Filter expose her to an ongoing medical risk of filter fracture and require medical monitoring. Although Tillman cannot recover damages merely for an "increased risk" of harm, her experts opine that the design and manufacturing defects in the G2 Filter make it prone to fracture. See Ritchie Report at 10-11; McMeeking/Begley Report at 10-12. Notably, the fact that Tillman's Filter has tilted and perforated her IVC appears to increase the risk that the Filter will fracture. See Ritchie Report at 12, 22 ("[E]vidence strongly suggests that [perforations] are a prime reason that motivates the fracture of the struts of these filters; in many cases this has resulted in the migration of fragments of the broken struts to other parts of the body, and are often with associated serious medical complications."); Carr Dep. at 94-95. As a result of this propensity and the fact that the Filter cannot be removed, Tillman argues that she requires ongoing medical
See Hull Report at 4-5. Hull bases this opinion on his observation of fractured/embolized limbs of Bard filters migrating from one position to another within the body. Id. Hull adds that a patient who has a G2 filter remaining inside her body should undergo a "CT scan of the abdomen annually," so long as the device remains implanted, and that "regularly scheduled physician's visits with a primary care physician, or the like, is reasonable and necessary to monitor the condition of the filter, or portions thereof." Id. at 5. Bard offers no argument or evidence to dispute Tillman's contention that she requires such medical monitoring as a result of the Filter's permanent presence in her body and propensity to fracture.
In light of the foregoing, the Court finds that Tillman presents sufficient evidence to permit a factfinder to conclude that her Filter tilted, migrated, and perforated her IVC as a result of its defective design. Because the Filter malfunctioned in this way, it cannot be removed, and as a result of its defective design and manufacturing defects, a jury could conclude that the Filter exposes her to a real risk that it will fracture and cause potentially life-threatening harm. Tillman maintains that due to this risk she requires ongoing medical monitoring and offers evidence to support this contention. The Court finds that this evidence is sufficient to create an issue of fact on causation, and as such, will deny Bard's Motion for Summary Judgment on Tillman's strict liability design and manufacturing defect claims, as well as her negligence claim, to the extent Tillman seeks medical monitoring damages.
Florida law provides that "[a] defendant may be held liable for punitive damages only if the trier of fact, based on clear and convincing evidence, finds that the defendant was personally guilty of intentional misconduct or gross negligence." See Fla. Stat. § 768.72(2). The statute defines "intentional misconduct" to mean that "the defendant had actual knowledge of the wrongfulness of the conduct and the high probability that injury or damage to the claimant would result and, despite that knowledge, intentionally pursued that course of conduct, resulting in injury or damage." Fla. Stat. § 768.72(2)(a). In addition, "`[g]ross negligence' means that the defendant's conduct was so reckless or wanting in care that it constituted a conscious disregard or indifference to the life, safety, or rights of persons exposed to such conduct." Fla. Stat. § 768.72(2)(b).
Bard argues that Tillman's claim for punitive damages fails "because she cannot provide any `clear and convincing evidence' that Bard acted with `intentional misconduct or gross negligence' with regard to the Filter." See Bard Motion at 26. Bard maintains that Tillman fails to present any evidence that it had "actual knowledge" of a high probability that the Filter would cause Tillman harm, or any evidence that "Bard reacted to the information available to it in a grossly negligent manner or acted in away that could constitute intentional misconduct." Id. In Response, Tillman contends that she "has established evidence of Bard's knowledge that the G2® Filter is inherently dangerous,
Upon review, the Court finds sufficient evidence to warrant sending this issue to the jury. Evidence in the record shows that Bard had data in its possession indicating the dangerous propensities of its retrievable filter design. See Freeman Report at 5; Lehmann Report at 2, 22; McMeeking/Begley Report at 16-17 ("[T]his [May 22, 2007] report warned Bard that the stresses and strains in the filter could exceed safe levels and that therefore the G2 filter would be prone to fatigue failaure. [sic]."). In addition, Tillman's experts opine that Bard conducted insufficient and incompetent testing on its devices to assess these risks. See generally McMeeking/Begley Report; see also Ritchie Report at 19. Indeed, a jury could find that although Bard was aware of the problems with its Recovery filter design, Bard released the "enhanced" G2 filter without conducting adequate testing to determine whether these problems had been adequately improved or resolved. See McMeeking/Begley Report at 14, 19-22. Soon after the G2 filter's release in 2005, Bard had information in its possession signaling that the new G2 filter suffered from many of the same problems as the Recovery. See Freeman Report at 5. Viewed in the light most favorable to Tillman, the jury could conclude that this evidence supports a conscious disregard or indifference to Tillman's safety. See Domke v. McNeil-P.P.C., Inc., 939 F.Supp. 849, 852 (M.D.Fla.1996) ("[P]unitive damages may be imposed when the defendant knows of the defect but chooses not to remedy the dangerous condition."); see also Cason, 1:12-CV-1288-MHS, slip op. at 16-18; Phillips, 3:12-cv-344-RCJ-WGC, slip op. at 18-19. Accordingly, the Court will deny Bard's request for summary judgment on Tillman's claim for punitive damages.
Tillman moves for partial summary judgment on Bard's affirmative defenses set forth in paragraphs 4, 16, 25, and 38 of the Answer and Defenses of Defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. and Demand for Trial by Jury (Doc. 15; Answer). See Tillman Motion at 1. Paragraphs 4 and 25 set forth an affirmative defense of assumption of risk and comparative negligence. See Answer at 19, 22-23. In paragraph 16, Bard asserts that it "neither had nor breached any alleged duty to warn with respect to the product, with the result that [Tillman] is not entitled to recover in this cause." Id. at 21. In paragraph 38, Bard maintains that "[n]o act or omission of [Bard] was malicious, willful, wanton, reckless, or grossly negligent, and, therefore, any award of punitive damages is barred." Id. at 25. In its Response, Bard states that it will withdraw the assertions in paragraphs 16 and 38 "to the extent they are viewed as `affirmative defenses,' because they simply deny or rebut the elements that [Tillman] must prove for a prima facie claim for negligent failure to warn and for punitive damages." See Bard Response at 1; see also Home Design Servs., Inc. v. Hibiscus Homes of Fla., Inc., No. 603CV1860ORL19KRS, 2005 WL 3445522, at *6 (M.D.Fla. Dec. 14, 2005) ("Defenses which seek to negate an element of the plaintiff's prima facie case are excluded from the definition of an affirmative defense in Federal Rule of Civil Procedure 8(c)."). Bard emphasizes that it "is not waiving its right—and is, in fact, expressly reserving its right—to assert at the summary judgment stage or at trial that Plaintiff has failed to carry her burden with respect to her claims for negligent failure
Tillman argues that the implied assumption of risk affirmative defense is not available to Bard because this defense "does not exist" in Florida. See Tillman Motion at 10. According to Tillman, the implied assumption of risk defense has merged into "the defense of contributory negligence and the principles of comparative negligence," and those principles apply in any case where assumption of risk is asserted. Id. at 11. Thus, with regard to Bard's comparative negligence defense, Tillman contends that she "could not have avoided the inherent danger of the G2 IVC Filter since she understood the filter to be temporary." Id. She maintains that she "neither consented to a severely tipped risk-benefit profile nor contributed in any way to her current condition of having a perforated inferior vena cava. Moreover, she neither consented to nor contributed to the long term risk to her health." Id. at 12. Accordingly, Tillman requests summary judgment in her favor on these defenses.
Bard agrees with Tillman that the implied assumption of risk doctrine is merged into the defense of contributory negligence. See Bard Response at 8. However, Bard contends that Tillman "voluntarily exposed herself to the risk that the G2® Filter could not be retrieved and could become a permanent implant, and, thus, under the principles of comparative negligence, her recovery, if any, should be barred or reduced." Id. at 8-9. Bard maintains that Tillman "should have known that the G2® Filter may not be able to be retrieved and, thus, become a permanent filter." Id. at 10. Bard contends that a jury could also "find that [Tillman] failed to exercise reasonable care by agreeing to have a potentially permanent medical device implanted, given her alleged fear and desire not to have a permanent implant." Id. at 10.
In Blackburn v. Dorta, 348 So.2d 287 (Fla.1977), the Florida Supreme Court discussed the doctrine of assumption of risk at length, in an attempt to unravel this "enigma wrapped in a mystery." Id. at 290 (internal quotation omitted). First, the court addressed "primary assumption of risk," and explained that this term "is simply another means of stating that the defendant was not negligent, either because he owed no duty to the plaintiff in the first instance, or because he did not breach the duty owed." Id. at 290. For example, "[i]t can be said that a passenger assumes the risk of lurches and jerks which are ordinary and usual to the proper operation of the train, but that he does not assume the risk of extraordinary or unusual lurches and jerks resulting from substandard operation of the train." Id. at 291. Although articulated in terms of assuming the risk, this concept is more appropriately framed in terms of the standard of care, i.e.
Id. Thus, "primary assumption of risk," rather than an affirmative defense, is instead an attempt to negate that any breach of a duty occurred.
The affirmative defense version of the assumption of risk doctrine precludes recovery where a plaintiff voluntarily and unreasonably exposes herself to a known risk, albeit a risk created by a defendant's negligence. Id. The Florida Supreme Court offers the example of a landlord who has negligently permitted his tenant's premises to become highly flammable and a fire ensues. Id. If the tenant returns from work to find the premises ablaze, but unreasonably rushes into the fire to retrieve his favorite hat, his claims against the landlord would be subject to the assumption of risk doctrine. Id. Because the tenant's conduct is clearly unreasonable, the Blackburn court explains that "this conduct can just as readily be characterized as contributory negligence. . . . It is the failure to exercise the care of a reasonably prudent man under similar circumstances." Id. As such, the court found no reason "to maintain a distinction between the affirmative defense of contributory negligence and assumption of risk." Id. at 292. Thus, under Florida law, "the affirmative defense of implied assumption of risk is merged into the defense of contributory negligence and the principles of comparative negligence . . . shall apply in all cases where such defense is asserted." Id. at 293.
In the context of a products liability action such as this, "`the form of contributory negligence which consists in voluntarily and unreasonably proceeding to encounter a known danger, and commonly passes under the name of assumption of risk, is a defense'" to strict liability. See West, 336 So.2d at 90 (quoting Restatement (Second) of Torts § 402A, cmt. n). Thus, "[c]ontributory negligence of the consumer or user by unreasonable use of a product after discovery of the defect and the danger is a valid defense." Id. (emphasis added). Significantly, contributory negligence is a defense in a strict liability action only if "based upon grounds other than the failure of the user to discover the defect in the product or the failure of the user to guard against the possibility of its existence." Id. at 92. Moreover, because Florida has adopted principles of comparative negligence, the defense of contributory negligence, including negligence in the form of assuming the risk, is available to apportion "the negligence of the manufacturer of the alleged defective product and the negligent use made thereof by the consumer." Id. at 90.
In considering this defense, the Court notes that comparative negligence is an issue in this case only if a jury determines that the Filter is, in fact, defective. If a jury finds that the Filter is not defective, i.e., not unreasonably dangerous, then Bard is not liable and the inquiry would
Here, the evidence shows that Tillman signed an informed consent document prior to implantation. See Bard Motion, Ex. Q; Tillman Dep. at 83-84. The document states:
See Bard Motion, Ex. Q. In addition, as summarized in Part IV.A.i., Stockland was aware of the risk that Tillman's G2 Filter could tilt, perforate, migrate, fracture, or become unavailable for removal. Stockland read the IFU issued with G2 filters, and the IFU warned of these potential complications as well. See Bard Motion, Ex. P; see supra Part IV.A.i. However, Bard presents no evidence that either Tillman or Stockland were aware that the Filter was unreasonably dangerous, that is, that the design or manufacture of the Filter made it unreasonably prone to these complications. See supra Part IV.A.ii. As such, Tillman did not know of the conditions that created the peril, nor did she appreciate the danger that she was encountering. Stated another way, because Tillman did not know of the conditions which made the Filter unreasonably dangerous, Bard fails to show that she acted negligently in encountering the danger by agreeing to the implantation of the Filter. See Riegel v. Beilan, 788 So.2d 990, 991 (Fla. 2d Dist.Ct.App.2000). In the absence of any evidence that Tillman discovered the defective condition of the Filter, Bard cannot maintain its contributory negligence and assumption of risk defense. See West, 336 So.2d at 90.
Indeed, upon review of Bard's Response, it appears that Bard fails to acknowledge that the assumption of risk defense applies only to the extent that the G2 Filter is found to be defective. Bard's argument is essentially that Tillman assumed the reasonable risks associated with the use of IVC filters. This argument is akin to the Blackburn court's train hypothetical. Like the passenger on the train who assumes the risk of lurching and jerking, Tillman assumed the reasonable risks associated with the use of an IVC filter. If those reasonable risks are the only ones involved, then it is not a matter of assumption of risk, but rather, Bard would prevail because it did not breach its duty to design a non-defective device. However, the Court is denying Bard's request for summary judgment on the design and manufacturing defect claims because there are issues of fact as to whether the Filter's risks are unreasonable as a result of its arguably defective design or manufacture. Bard presents no evidence to suggest that Tillman had knowledge of the excessive risk accompanying the use of a defective Filter, and as such, she did not assume this risk or act negligently in agreeing to its implantation. Accordingly, the Court finds that Tillman's Motion for Summary Judgment is due to be granted.
The instant Order resolves various Daubert motions as well as competing summary
In accordance with the foregoing, it is
See McMeeking/Begley Report at 22. However, in his June 19, 2014 Deposition, Begley testified that he could not identify the specific factors that caused Tillman's Filter in particular to migrate. See June Begley Dep. at 39. Indeed, Begley explains that he "cannot state with certainty [as to Tillman's specific filter] whether or not the percentage was greater than 50 percent that these considerations were contributing factors or less than. It could be less than, it could be more than, and I've stated that it's the lack of the designers' awareness about whether or not these risks were less than or greater than 50 percent that I find objectionable." See id. at 83. As such, the Court does not consider the opinions in the McMeeking/Begley Report to pertain to the issue of specific causation, and the Engineers will not be permitted to offer an opinion on that issue.
Id. Thus, case law construing the former Rule 56 standard of review remains viable and is applicable here.
Additionally, while Tillman does not rely on this evidence in her Response, she cites to the testimony of Christine L. Brauer, Ph.D. in the Tillman Motion. See Tillman Motion at 6-7. Brauer has a masters degree in microbiology and molecular biology, and a doctorate degree in women's health and research methods. See Tillman Motion, Ex. X: Deposition of Christine Brauer, Ph.D. (Docs. 97-13 to 97-25; Brauer Dep.), Ex. 2. She has "worked in the regulation of medical devices for over 20 years, including positions within FDA, industry, and as a consultant." Id. Brauer testifies that "statements of increased migration resistance and enhanced fracture resistance" included in some of the G2 filter's advertising materials "are not accurate, if you're comparing G2 to the Simon Nitinol." See Brauer Dep. at 216-25. Nonetheless, this evidence is not sufficient to create an issue of fact on Tillman's failure to warn claim because Tillman cites to no evidence that Stockland was aware of these alleged misrepresentations. Moreover, Brauer does not testify that the warnings given in the IFU were insufficient as a result of these inaccuracies. Notably, Tillman does not explain if Brauer is qualified as an expert in FDA warning labels pertaining to G2 filters, and although Tillman states that Brauer is "designated as an expert in the case at bar," the citation given does not support this assertion. See Tillman Motion at 6, Ex. T.
Fla. Stat. § 768.1256(1). "Florida's [Government Rules Defense] `has not yet been thoroughly interpreted, and the contours and operation of the presumption are still largely unsettled.'" See Rydzewski, 2012 WL 7997961, at *2 (quoting Emerson v. Novartis Pharm. Corp., 446 Fed.Appx. 733, 735 (6th Cir.2011)). Bard simply states in a conclusory fashion that it is entitled to this presumption, but fails to offer any argument or citation to the record to demonstrate that Bard complied with the relevant statutes and regulations as required for application of the presumption. The Court could decline to apply the presumption on this basis alone. See Kaufman, 2011 WL 10483576, at *7. Nonetheless, even if the presumption applies, it is rebuttable by evidence that the Filter's design is defective or unreasonably dangerous. Id. For the reasons discussed above, the Court finds an issue of fact on this question, and will not grant summary judgment in favor of Bard based on the Government Rules Defense. Id.; Rydzewski, 2012 WL 7997961, at *2; In re Aredia & Zometa Prods. Liab. Litig, No. 3:06-MD-1760, 2010 WL 813459, at *2 (M.D.Tenn. Mar. 3, 2010).
