JOHN R. TUNHEIM, District Judge.
Plaintiff Robert L. Huggins brings claims against medical device companies Stryker Corporation and Stryker Sales Corporation (collectively, "Stryker"). Huggins alleges that pain pumps manufactured and distributed by Stryker, which a surgeon inserted into Huggins' shoulder following surgery in February 2002, caused chondrolysis (a condition involving rapid cartilage degeneration) in his shoulder. Huggins advances various product liability theories, sounding in both strict liability and negligence. This matter is currently before the Court on Huggins' motion to transfer, Stryker's motion for summary judgment, and Stryker's motion to exclude certain proposed expert testimony.
First, the Court will deny Huggins' motion to transfer. The balance of relevant factors does not sufficiently favor transferring the action to the District of Oregon. Second, the Court will deny Stryker's motion for summary judgment. A reasonable jury could find that Stryker should have known at the time of Huggins' surgery that continuous infusion of anesthetics into the shoulder joint using a pain pump could cause cartilage damage. The Court will also find that Stryker is not entitled to summary judgment on the basis of the statute of limitations. Finally, the Court will deny Stryker's motion to exclude expert testimony for the reasons described below.
Dr. A. Brooke Benz performed arthroscopic surgery on Huggins' shoulder on February 21, 2002. (Decl. of Tim Griffin, Ex. 16, June 28, 2012, Docket No. 175.) There is no dispute that Dr. Benz inserted a Stryker pain pump
Stryker (and Stryker's predecessor, McKinley Medical) received 510(k) clearance
Huggins alleges that Stryker failed to conduct a review of the medical literature to assess the risks of continuous infusion of anesthetics into the intra-articular space prior to marketing pain pumps to orthopedic surgeons. (See Powers Decl., Ex. 4 (Dep. of Rodney D. Parker) 45:17-48:13.) Huggins also alleges that Stryker failed to conduct or commission safety tests that would identify whether intra-articular pain pump use posed a risk of cartilage damage. (Id. 43:5-46:9.)
Huggins has provided a variety of pieces of evidence regarding Stryker's marketing of pain pumps. For example, a surgeon who was a consultant to Stryker testified in a prior action that Stryker sales representatives communicated to surgeons that pain pumps could be used in the joint space. (Powers Decl., Ex. 30 (Dep. of Dr. Lonnie Paulos) 33:15-34:10.) Huggins' experts also summarize numerous internal documents from Stryker that discussed intra-articular pain pump use and discussed marketing pain pumps to orthopedic surgeons. (See Powers Decl., Ex. 12 (Report of Dr. Peggy Pence) at 54-58.) Further, in 2000, Stryker considered designing a pain pump that had two separate catheters, one of which was specifically intended
The first peer reviewed article explicitly recognizing a potential causal link between pain pumps and chondrolysis appeared in July 2007. See Brent P. Hansen et al., Postarthroscopic Glenohumeral Chondrolysis, 35 Am. J. Sports Med. 1628 (2007). Stryker maintains that there is still uncertainty regarding the causes of chondrolysis. However, on the basis of a growing body of literature and case reports, the FDA issued a notice on November 13, 2009, that chondrolysis had been repeatedly reported in connection with intra-articular pain pump use and the FDA encouraged health care professionals to not use pain pumps "for continuous intra-articular infusion of local anesthetics after orthopedic surgery." (Powers Decl., Ex. 25.)
For purposes of the present case, the relevant question is not what is known about the risks of pain pumps today, but what was known about the risks of pain pumps at the time of Huggins' first surgery in February 2002. Huggins' primary evidence regarding the scope of scientific knowledge at the time of his surgery is provided by Drs. Stephen Badylak, Carl Basamania, and Peggy Pence. These experts review the scientific literature and opine that, prior to 2002, the literature was sufficient to put a medical device manufacturer on notice that continuous infusion of anesthetics over a period of multiple days into the intra-articular joint space could cause serious cartilage damage. (Badylak Report at 2-6; Powers Decl., Ex. 10 (Addendum to General Causation Report of Dr. Carl Basamania ("Basamania Addendum")) at 3-6; Pence Report at 59-61.)
Huggins' experts discuss the general anatomical and physiological properties of joint spaces and cartilage that were familiar to the scientific community prior to 2002. (See, e.g., Badylak Report at 2-4.) They explain that articular cartilage is fragile and that exposing it to any solution may damage it. (See, e.g., Basamania Addendum at 5 ("[L]ong before the introduction of pain pumps to the market, the tenuous and delicate nature of cartilage and its intraarticular environment was well documented.").) The experts also discuss specific articles published between 1933 and 2002 that they contend demonstrated the risk of cartilage damage posed by continuous injection of anesthetics. (Badylak Report at 3-6; Basamania Addendum at 3-6; Pence Report at 59-61.) Many of the articles involved substances other than anesthetics, but the experts explain why each article is relevant to their conclusion. Generally speaking, the articles highlight the risks of exposing articular cartilage to foreign solutions and suggest that the risks increase as the length of exposure increases. The experts focus on the following articles
The present case is one of many similar cases that have been filed across the country, including several in this district. See Mack v. Stryker Corp., 893 F.Supp.2d 976, 982-83 (D.Minn.2012) (compiling cases). While it is important to note that the specific evidence presented varies slightly from case-to-case and that the laws of each state are not identical, it is clear that results in both the district and circuit courts have been mixed. See, e.g., Rodriguez v. Stryker Corp., 680 F.3d 568, 577 (6th Cir.2012) (affirming grant of summary judgment); Krumpelbeck v. Breg, Inc., 491 Fed.Appx. 713, 722 (6th Cir.2012) (reversing, in part, grant of summary judgment); Phillippi v. Stryker Corp., 2:08-CV-02445, 2010 WL 2650596, at *3 (E.D.Cal. July 1, 2010) (granting summary judgment); Hackett v. Breg, Inc., Civ. No. 10CV1437, 2011 WL 4550186, at *4 (D.Colo. Oct. 3, 2011) (denying summary judgment); Kildow v. Breg, Inc., 796 F.Supp.2d 1295, 1299-300 (D.Or.2011) (denying summary judgment). In this district's first case to reach summary judgment motions on the ground that the risks of intra-articular pain pump use were unforeseeable, the court granted summary judgment for the defendant. See Mack, 893 F.Supp.2d at 988.
Before turning to Stryker's motion for summary judgment, the Court must address Huggins' motion to transfer the action to the District of Oregon. As the Court will explain, plaintiffs are not prohibited from bringing transfer motions despite having chosen the initial venue. See Ferens v. John Deere Co., 494 U.S. 516, 529, 110 S.Ct. 1274, 108 L.Ed.2d 443 (1990).
Transfer under 28 U.S.C. § 1404(a)
"In general, federal courts give considerable deference to a plaintiff's choice of forum and thus the party seeking a transfer under section 1404(a) typically bears the burden of proving that a transfer is warranted." Id. at 695. Thus, courts in this district often require a movant to show that the balance of factors "strongly favors" transfer. See, e.g., Brockman v. Sun Valley Resorts, Inc., 923 F.Supp. 1176, 1179 (D.Minn.1996). On the other hand, the plaintiff's choice is entitled to less deference when the plaintiff is not a resident of the selected forum and when the underlying events giving rise to the action occurred outside the forum. See Nelson v. Soo Line R. Co., 58 F.Supp.2d 1023, 1026 (D.Minn.1999). Based on that rule, Huggins' choice, Minnesota, would be entitled to significantly less deference because Huggins is an Oregon resident and the events occurred in Oregon.
Despite the rules outlined above, it is not entirely clear what burden Huggins should face on the instant motion to transfer. The rules above regarding deference to plaintiff's choice of forum developed in cases where the
Stryker suggests that Huggins is required to show changed circumstances in order to prevail on his motion to transfer because he chose the forum in the first instance.
Id. at 529, 110 S.Ct. 1274. Under Ferens, it is clear that Plaintiffs are free to move to transfer even though they selected Minnesota to take advantage of its statute of limitations. The Eighth Circuit has not created a "changed circumstances" requirement for plaintiffs moving to transfer and it is not clear that a strict changed circumstances requirement would be consistent with Ferens.
That said, the Court recognizes that a plaintiff's motion to transfer raises concerns about forum shopping, judge shopping, and harassment of defendants. One commentator suggests that "to avoid harassment of defendants and to ensure the judicious use of Section 1404(a) transfers, it is appropriate that plaintiff be put to a higher burden of persuasion over defendant's objection." 17 Moore's Fed. Prac. § 111.16[1] (Matthew Bender 3d ed.); see also Leiker v. Jarvis Prods. Corp., No. 90-1179-C, 1990 WL 112974, at *2 (D.Kan. July 10, 1990) ("If [plaintiff's subsequent choices for venue] were accorded the same favored status, a motion to transfer venue could become an unchecked tool for the plaintiff to shop among forums and between judges.").
In this case, the Court need not determine whether to apply a heightened burden to Huggins' motion to transfer. Based on the Court's weighing of the relevant factors below, the Court finds that the factors do not favor transferring the action and would deny Huggins' motion whether or not Huggins faced a heightened burden.
The first factor to consider under § 1404(a) is the convenience of each venue for the parties. Huggins lives in Oregon and Stryker is based in Michigan. (Am. Compl. ¶¶ 4-5, 7, Dec. 22, 2010, Docket No. 103.) There is no doubt that Oregon would be more convenient for Huggins. On the other hand, Oregon would be somewhat less convenient for Stryker because Minnesota is closer to Michigan. The collective convenience of the parties weighs slightly in favor of transferring the present action, but granting the motion to transfer would also shift some inconvenience to the party resisting the motion, which counsels in favor of denying the motion. See Nelson, 58 F.Supp.2d at 1027 ("Transfer should not be granted if the effect is simply to shift the inconvenience to the party resisting the transfer.") Thus, the Court finds that convenience of the parties is a neutral factor in the present case.
The second factor to consider under § 1404(a) is the convenience of each venue for witnesses. Huggins' surgery and subsequent health care all occurred in Oregon. Huggins asserts that he will call many witnesses who reside in Oregon, such as the surgeon, subsequent health care providers, and potentially Huggins' employer and a friend or family member. Stryker notes, however, that the surgeon, Dr. Benz, is the only Oregon-based witness Huggins identified in his Rule 26(a)(1)(A)(i) disclosures, see Fed.R.Civ.P. 26(a)(1)(A)(i), and in response to an interrogatory asking him to identify all persons with knowledge of relevant facts. Huggins has also identified Dr. Frederick Matsen, who performed a later operation on Huggins, and is based in Seattle. Oregon would be substantially more convenient than Minnesota for witnesses based in Oregon and somewhat more convenient for witnesses based in Washington. On the other hand, relevant evidence and testimony will likely come from Michigan-based employees of Stryker, for whom Oregon will be slightly less convenient than Minnesota. The parties have not made arguments
The final factor to consider under § 1404(a) is the interest of justice. In assessing the interest of justice, the Court considers "(1) judicial economy, (2) the plaintiff's choice of forum, (3) the comparative costs to the parties of litigating in each forum, (4) each party's ability to enforce a judgment, (5) obstacles to a fair trial, (6) conflict of law issues, and (7) the advantages of having a local court determine questions of local law." Terra Int'l, 119 F.3d at 696. Some courts treat the interest of justice as the most important factor in the analysis. See, e.g., Farm Boy Co-Op & Feed Co. v. Red River Clothing, Inc., Civ. No. 09-2936, 2010 WL 935747, at *3 (D.Minn. Mar. 12, 2010).
Several of these factors require little discussion here. The Court considered the relevance of Huggins' choice of forum above. Each party's ability to enforce a judgment, obstacles to a fair trial, and conflict of law issues appear to have no significance here.
The Court is also not strongly influenced by the comparative costs of litigating in either forum. Stryker contends that litigating in Oregon will be more costly because it and its witnesses will face additional travel expenses. However, the additional expenses would not be dramatic because Stryker and its employees will have to travel out of state whether or not the case is transferred. Huggins does not discuss costs in detail, but the Court has considered that litigating in Oregon would reduce travel expenses for Huggins and for any fact witnesses based in Oregon. On balance, the Court is not convinced that litigating in one forum would be dramatically costlier than the other.
The remaining considerations cut significantly in favor of denying the motion to transfer. As for judicial economy, the Court has already held a hearing on Stryker's motion for summary judgment and motion to exclude expert testimony. Although the District of Oregon is well-equipped to efficiently handle another pain pump case due to its familiarity with the issues, the Court is familiar with the specific facts of the present case. The Court finds that judicial economy is better served by the Court ruling on Stryker's dispositive motion and moving the action toward resolution than by transferring the action and perhaps forcing the parties to endure delays before receiving a ruling on their dispositive motions.
The final consideration is the advantages of having a local court decide questions of local law. The action will be governed by Minnesota's statute of limitations regardless of the Court's resolution of the motion to transfer, and the parties strongly disagree about whether Huggins' claims are timely under Minnesota law.
Summary judgment is appropriate where there are no genuine issues of material fact and the moving party can demonstrate that it is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a). A fact is material if it might affect the outcome of the suit, and a dispute is genuine if the evidence is such that it could lead a reasonable jury to return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A court considering a motion for summary judgment must view the facts in the light most favorable to the non-moving party and give that party the benefit of all reasonable inferences that can be drawn from those facts. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).
Before addressing the merits of the parties' dispute, the Court must determine whether Huggins' claims are barred by the applicable statute of limitations. Minnesota's statute of limitations for negligence actions is six years, Minn.Stat. § 541.05, subd. 1(5), and Huggins commenced the present action in May 2009, more than six years after his February 2002 surgery. However, Huggins contends that he had no evidence of the causal connection between Stryker's pain pump and his shoulder damage until several years after his surgery.
Federal courts applying Minnesota law have concluded that Minnesota applies a "discovery rule" in products liability actions, which mean that a cause of action does not accrue until two elements are satisfied: "(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission." See Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir.1987); see also Mack v. Stryker Corp., Civ. No. 10-2993, 2010 WL 4386898, at *2 (D.Minn. Oct. 28, 2010). Were these the only relevant authorities, the issue would easily be resolved in Huggins' favor. But caselaw from Minnesota makes the issue less clear. Minnesota courts have
On the one hand, Minnesota courts have held on a number of occasions that "ignorance of a cause of action does not toll the running of the statutory limitations period," including in product liability cases. See, e.g., MacRae v. Grp. Health Plan, Inc., 753 N.W.2d 711, 719 (Minn.2008); Dalton v. Dow Chem. Co., 280 Minn. 147, 158 N.W.2d 580, 584 (1968). And Minnesota courts have rejected a discovery rule in cases where the issue is whether the plaintiff must have knowledge of his or her injury before the cause of action accrues. In MacRae, the Minnesota Supreme Court explained:
MacRae, 753 N.W.2d at 722 n. 8 (internal citations and emphases omitted). MacRae dictates that the limitations period begins to run when a compensable injury exists, not when the plaintiff discovers, or has the opportunity to discover, the injury.
On the other hand, the Minnesota Supreme Court has suggested in a products liability action that a cause of action will not accrue until the plaintiff has some evidence of causation, though the evidence need not be definitive. In Dalton, the Court stated:
Dalton, 158 N.W.2d at 585 (emphases added). While it does not do so explicitly, Dalton appears to hold that the limitations period will not run if the plaintiff at least has evidence allowing him or her to suspect a causal relationship.
This district recently confronted the exact issue facing the Court today in another pain pump case. See Mack, 2010 WL 4386898, at *2. The Mack court analyzed Minnesota law and held that the rule from Hildebrandt would apply because it found no indication that Minnesota courts disagree with Hildebrandt's explicit holding. Id. ("[I]t appears that, for products liability
Other than the statute of limitations argument, Stryker's sole challenge to Huggins' claim at this stage is that the risks associated with intra-articular pain pump use were unforeseeable and Stryker, therefore, cannot be liable for failing to warn of such risks. Huggins' response goes beyond the foreseeability issue and discusses other elements of his various claims. For the purposes of this motion only, the Court will limit its discussion to those grounds on which Stryker moved for summary judgment.
Broadly speaking, a failure to warn claim has three elements: "(1) whether there exists a duty to warn about the risk in question; (2) whether the warning given was inadequate; and (3) whether the lack of a warning was a cause of plaintiff's injuries." Seefeld v. Crown, Cork & Seal Co., 779 F.Supp. 461, 464 (D.Minn.1991) (citing Balder v. Haley, 399 N.W.2d 77, 81 (Minn.1987)). As noted above, at this stage, Stryker focuses exclusively on the first element — duty.
A manufacturer has a duty to provide warnings of foreseeable risks. See Germann v. F.L. Smithe Mach. Co., 395 N.W.2d 922, 924 (Minn.1986). That is, if a manufacturer "knew
The center of the parties' dispute in the present case is whether the risks associated with intra-articular pain pump use were foreseeable. Courts across the country have confronted this issue with inconsistent results. See, e.g., Rodriguez, 680 F.3d at 577 (affirming grant of summary judgment); Krumpelbeck, 491 Fed.Appx. at 722 (reversing, in part, grant of summary judgment); Phillippi, 2010 WL 2650596, at *3 (granting summary judgment); Hackett, 2011 WL 4550186, at *4 (denying summary judgment); Kildow, 796 F.Supp.2d at 1299-300 (denying summary judgment).
Under Minnesota law, manufacturers are subject to certain specific duties that bear on the issue of what risks are foreseeable and, therefore, bear on whether a manufacturer has a duty to warn of a particular risk. For example, "[a] manufacturer is held to the skill of an expert in its particular field of endeavor, and is obligated to keep informed of scientific knowledge and discoveries concerning that field." Karjala v. Johns-Manville Prods. Corp., 523 F.2d 155, 159 (8th Cir.1975) (internal quotation marks omitted).
Failure to test is not an independent cause of action under Minnesota law, but manufacturers' "duty to test their products ... to discover defects or dangers associated with use of the products... is a subpart of duties to design a product non-negligently, manufacture a product non-negligently, and provide adequate warnings of dangers associated with its use."
Stryker acknowledges that Minnesota law imposes on manufacturers the duties outlined above, but nonetheless contends that the risk in question in the present case was unforeseeable. Stryker focuses on O'Hare v. Merck & Co., in which the Eighth Circuit held that "[t]he manufacturer's duty to warn users of the potential danger inherent in its product is commensurate with its actual knowledge of the risk involved to those users or the knowledge constructively imparted to it by available scientific or other medical data." 381 F.2d 286, 291 (8th Cir.1967).
There are two problems with Stryker's argument. First, the question is not whether the specific risk of chondrolysis was foreseeable. Several courts have rejected the argument that the exact risk, chondrolysis, must have been foreseeable in order for pain pump manufacturers to face liability. See, e.g., Mack, 893 F.Supp.2d at 984 n. 6; Schoenborn v. Stryker Corp., 801 F.Supp.2d 1098, 1102 (D.Or.2011). Under Minnesota law, "[a] manufacturer has a duty to warn of dangers where it knew or should have known of the risk or hazard involved." Harmon, 493 N.W.2d at 151. Crucially, "[t]he test is not whether the precise nature and manner of the plaintiff's injury was foreseeable, but whether the possibility of an accident was clear to the person of ordinary prudence." Domagala, 805 N.W.2d at 27 (internal quotation marks omitted).
Second, Stryker's attempt to limit its duty to warn to risks that are explicitly identified in the literature at the time is contrary to the flexible nature of the manufacturer's duty to warn of risks "which it could discover through the exercise of reasonable care." See O'Hare, 381 F.2d at 291. It also ignores the manufacturer's duty to test. In certain cases, "reasonable care" might require a manufacturer to extrapolate from existing medical literature or conduct tests to discover potential risks when the medical literature contains clues or red flags that the manufacturer's desired course of action is dangerous. See Karjala, 523 F.2d at 158 ("A manufacturer has a duty to test and inspect his products, and the extent of such research and experiment must be commensurate with the dangers involved."). The Court will not endorse a rule that "reasonable care" never requires manufacturers to identify a risk that has not already been explicitly identified in the medical literature.
Turning to the evidence presented in this case, Huggins relies largely on his experts' opinions that the medical literature existing prior to Huggins' surgery was sufficient to put a manufacturer on notice that continuously injecting anesthetic into the intra-articular joint space for several days could cause serious cartilage damage. While no single article or study presented exactly this conclusion, Huggins' experts opine that a number of studies are relevant by analogy and would have presented clear red flags to Stryker. After considering the state of the literature and what was known generally about the anatomy of cartilage and joint spaces, Huggins' experts conclude that a manufacturer who conducted a thorough literature review prior to the time of Huggins' surgery would have known that intra-articular pain pump use could cause serious cartilage damage.
Additionally, Huggins has presented evidence that Stryker did not conduct or commission tests to determine the risks of post-operative continuous infusion of anesthetic into the intra-articular space. Huggins' experts opine that such testing was feasible prior to Huggins' surgeries and would likely have revealed that using a pain pump to continuously infuse anesthetics into the intra-articular space could cause serious cartilage damage. (See, e.g., Badylak Report at 4.)
The experts' conclusions regarding the scientific literature and the feasibility of safety testing are significant in light of the manufacturer's duties to keep abreast of scientific literature and conduct reasonable safety testing. The evidence could allow a jury to reasonably find that Stryker would have been aware of the risk of cartilage damage presented by intra-articular pain pump use if the company had exercised reasonable care in complying with those duties.
Huggins has also presented evidence that FDA reviewers repeatedly denied the efforts of Stryker (and Stryker's predecessor)
Huggins' evidence regarding Stryker's interactions with the FDA and subsequent marketing is relevant as part of a body of evidence, including the available scientific literature and the feasibility of safety testing, that sheds light on what risks a jury could reasonably find that Stryker should have discovered. "The manufacturer is held accountable as an expert in its field only for those dangers of which it has knowledge or those which it could discover through the exercise of reasonable care." O'Hare, 381 F.2d at 291. What constitutes "reasonable care" depends on the surrounding circumstances. See Bilotta v. Kelley Co., 346 N.W.2d 616, 621 (Minn.1984). Here, those circumstances include Stryker's interactions with the FDA and its marketing strategies.
Considering all of the evidence in the light most favorable to Huggins, the Court finds that a genuine issue of material fact remains as to whether Stryker should have known the risks of intra-articular pain pump use. In light of a manufacturer's duties to keep abreast of scientific knowledge and conduct reasonable safety testing, and in light of the evidence Huggins' has presented regarding the scientific literature, the feasibility of safety testing, Stryker's interactions with the FDA, and Stryker's marketing, a jury could reasonably find by a preponderance of the evidence that Stryker should have known the risks of intra-articular pain pump use. If the jury finds that Stryker should have known these risks, it follows that Stryker had a duty to provide a warning of these risks.
Having resolved Stryker's motion for summary judgment, the Court will now address Stryker's motion to exclude various aspects of the proposed testimony of Huggins' expert witnesses.
Under Federal Rule of Evidence 702, expert testimony must satisfy three prerequisites to be admitted:
Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001) (citations and internal quotation marks omitted). The district court has a gate keeping obligation to make certain that all testimony admitted under Rule 702 satisfies these prerequisites and that "any and all scientific testimony or evidence admitted is not only relevant, but reliable." Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The proponent of the expert testimony has the burden of establishing by a preponderance of the evidence that the expert is qualified, that his methodology is scientifically valid, and that "the reasoning or methodology in question is applied properly to the facts in issue." Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 758 (8th Cir.2006).
The Supreme Court in Daubert outlined particular factors for courts to consider in assessing reliability, such as (1) whether the opinion is based on scientific knowledge, is susceptible to testing, and has been tested; (2) whether the opinion has been subjected to peer review; (3) whether there is a known or potential rate of error associated with the methodology; and (4) whether the theory has been generally accepted by the scientific community. See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149-50, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) (summarizing Daubert factors). However, in Kumho Tire, the Court explained that "the test of reliability is `flexible,' and Daubert's list of specific factors neither necessarily nor exclusively applies to all experts or in every case. Rather, the law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination." Id. at 141-42, 119 S.Ct. 1167. The reliability inquiry is designed to "make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes
"Courts should resolve doubts regarding the usefulness of an expert's testimony in favor of admissibility." Id. at 758; see also Kumho Tire, 526 U.S. at 152, 119 S.Ct. 1167 ("[T]he trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable."). "Only if the expert's opinion is so fundamentally unsupported that it can offer no assistance to the jury must such testimony be excluded." Bonner v. ISP Techs., Inc., 259 F.3d 924, 929-30 (8th Cir.2001) (quoting Hose v. Chi. Nw. Transp. Co., 70 F.3d 968, 974 (8th Cir. 1996)).
Stryker challenges the proposed testimony of three of Huggins' experts — Drs. Stephen Badylak, Carl Basamania, and Peggy Pence — on several grounds. Stryker claims that (1) Drs. Badylak and Basamania are not qualified to opine on what a reasonably prudent medical device manufacturer should have done or known; (2) the experts' opinions about the medical literature prior to 2002 are unreliable because they misinterpret certain articles, ignore others, and draw a conclusion that is not present in the literature; (3) the experts' opinions about the medical literature prior to 2002 are irrelevant because the experts do not opine that the medical literature contained any indication that there was a risk of chondrolysis, specifically; and (4) testimony regarding the results that safety testing would have produced is too speculative to be admissible. For the reasons explained below, the Court will deny Stryker's motion.
Dr. Badylak is a doctor and a professor who specializes in the study of musculoskeletal tissues. (Badylak Report at 1.) He specializes in tissue engineering and regenerative medicine. (Id.) He has conducted studies relating to cartilage, and he has experience with the FDA's investigation and approval process of medical devices. (Id.) Dr. Badylak opines that "[t]here existed in the literature, multiple peer reviewed medical articles during or prior to 2000, and any reasonably prudent search of the peer reviewed medical literature by a medical device manufacturer would have found multiple articles that at a minimum would have raised a red flag if not an alarm concerning the placement of foreign substances in contact with articular cartilage and the potential for a negative effect upon the health of articular cartilage." (Id. at 4.)
Dr. Basamania is an accomplished orthopedic surgeon. (Id., Ex. 2.) Like Dr. Badylak, he opines that "[h]ad any prudent medical device manufacturer conducted even a basic search of the medical literature, they would have found multiple articles that would have suggested that any alteration, dilution or disruption of normal synovial fluid could be harmful to the health of articular cartilage." (Id., Ex. 3 (Addendum to General Causation Report of Dr. Carl Basamania ("Basamania Addendum")) at 3.)
Stryker argues that Drs. Badylak and Basamania are not qualified to opine on what a reasonably prudent pain pump manufacturer should have done or known.
Huggins does not respond to Stryker's specific argument that Drs. Badylak and Basamania are unqualified to opine on what a reasonably prudent medical device manufacturer should have done or known. As was the McClellan court, the Court is somewhat skeptical that these doctors possess expertise on the customs and standards within the medical device manufacturing industry, but for the reasons explained below the Court will deny Stryker's motion at this stage.
The core opinion of Drs. Badylak and Basamania is their conclusion that the medical literature that existed prior to 2002 would have put a manufacturer on notice that intra-articular pain pump use could cause cartilage damage. Drs. Badylak and Basamania also opine on general causation. The Court finds that both doctors are qualified to review medical literature within their field, opine on what red flags are contained within the literature, and opine on how those red flags relate to intra-articular pain pump use. The Court also finds that they are qualified to opine on general causation based on their knowledge of the literature and their experience in the field.
Although Dr. Badylak refers to a "reasonably prudent search of the peer reviewed medical literature" and Dr. Basamania refers to a "prudent medical device manufacturer," neither expert appears to actually opine on what standards of care apply to medical device manufacturers, what medical device manufacturers
As an initial matter, there does not seem to be a real dispute about the legitimacy of the experts' "methodology," which is to review the medical literature and draw a conclusion about what teachings or red flags were contained within the literature. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) ("Trained experts commonly extrapolate from existing data."). Stryker's arguments relate to the reliability of the experts' applications of their methodology and to the relevance of their conclusions. Stryker argues that Huggins' experts extrapolate a conclusion from the literature that is visible only with the benefit of hindsight, that some of the sources they cite contradict their conclusions, and that they ignore sources that undermine their conclusions.
With respect to the reliability, a difference of opinion regarding an expert's conclusions is usually a topic for cross-examination and competing testimony, not a reason to exclude testimony. See Daubert, 509 U.S. at 595, 113 S.Ct. 2786
Taking into account what was known generally about the fragility of intra-articular cartilage at the time, Huggins' experts claim that the existing literature would have raised a red flag to a manufacturer considering marketing pain pumps to orthopedic surgeons for intraarticular use because the literature demonstrated that exposing intra-articular cartilage to any foreign substance could cause cartilage damage, and that the risks increased as the length of exposure increased.
Stryker claims that the Nole article and the Fulkerson article both undermine rather than support the experts' conclusions. While the two articles are subject to various interpretations, the Court finds that the interpretation offered by Huggins' experts is sufficiently reliable. The Nole article provided that "[b]upivacaine itself seems to be fairly well tolerated by articular cartilage," (Nole at 126), but the authors noted that "[c]onsidering the toxicity of bupivacaine to certain other cell types..., the possibility of long-term effects must be considered even though there is no clinical evidence of this as of yet" and also that "further studies should be made to find optimal ways of administering local anesthetics into human joints" because "adult human articular cartilage has no blood supply of its own and will be directly affected by whatever solution is injected into a joint," (id.). The Fulkerson article explained that bupivacaine has an impact on cartilage that
Stryker also points to three publications that Stryker claims contradict the experts' conclusions, which the experts did not analyze. It is possible for an experts' omission of articles to render his or her opinion inadmissible on reliability grounds,
Stryker's final challenge to the experts' testimony is that any evidence regarding the results that additional safety testing would have produced is "irrelevant and inherently speculative." As to relevance, Huggins' claim is that Stryker should have known the risks associated with intra-articular pain pump use. As described above, under Minnesota law, a manufacturer's duty to test bears on what risks are considered foreseeable to a manufacturer. See Willmar Poultry, 378 N.W.2d at 836. Therefore, testimony regarding what tests were feasible prior to Huggins' surgeries and what the results of such tests might have been is relevant to whether a jury could reasonably find that Stryker should have been aware of the risks of intra-articular pain pump use.
The Court also finds that evidence relating to what tests Stryker could have conducted and what the results of such tests would have been is not so speculative that it is inadmissible. As an initial note, the manufacturer's duty to test, which Minnesota courts have recognized bears on the foreseeability of risks to a manufacturer, would be meaningless if defendants could successfully argue that it requires too much speculation to opine on what the results of tests that were not performed would have been. By recognizing that a duty to test may be relevant to what risks are treated as foreseeable to a manufacturer, Minnesota courts approved of plaintiffs arguing that a manufacturer
Here, Huggins' expert opines that "[t]est methods to address the toxic effects of [bupivacaine], including in vitro test methods and preclinical animal studies, have always been available and could have been used to address any questions regarding the safety of these compounds." (Badylak Report at 4.) As Huggins notes, such tests have now actually been conducted and revealed that intra-articular pain pump use poses a series risk of cartilage damage. The fact that the tests in question have occurred takes much of the speculation out of hypothesizing about what the results would have been had the tests been conducted prior to Huggins' surgery. The Court is not holding that arguments regarding hypothetical testing can never be rejected on the ground that they are too speculative, but the evidence Huggins seeks to present to the jury here is not "so fundamentally unsupported that it can offer no assistance to the jury[.]" See Bonner, 259 F.3d at 929 (quoting Hose, 70 F.3d at 974).
This case will be placed on the Court's next available trial calendar.
Based on the foregoing, and all the files, records, and proceedings herein,
1. Plaintiff's Motion to Transfer [Docket No. 161] is
2. Defendants' Motion for Summary Judgment [Docket No. 172] is
3. Defendants' Motion to Exclude Expert Testimony [Docket No. 185] is
The Court also notes that none of Huggins' claims may hinge on the assertion that Stryker violated federal law. A claim that Stryker is liable in tort
