THOMAS B. RUSSELL, Senior District Judge.
This matter is set for trial on January 9, 2012. In anticipation of the final pretrial conference, the parties have filed a number of motions in limine. These motions have been fully briefed and are now ripe for adjudication. Below is the Court's ruling on each of these matters.
Zometa and Aredia are two FDA-approved intravenous bisphosphonate ("IV BP") drugs, manufactured by Defendant Novartis Pharmaceuticals Corporation ("NPC"). Both are used to combat a variety of advanced cancers that have presented themselves in patients' bones. Within cancer patients suffering this type of affliction,
Pamela Kay Kyle ("Kyle") was diagnosed with breast cancer in 1997, which later metastasized to her skull. Her oncologist prescribed Zometa in October of 2003 as part of her treatment and she continued taking it until November 4, 2004. Kyle succumbed to her cancer on October 1, 2008.
Plaintiff Natasha Kyle Mahaney ("Plaintiff") brings this action against NPC on behalf of Kyle's estate. Plaintiff alleges that prior to her death, Kyle developed osteonecrosis of the jaw ("ONJ"). ONJ is a condition that results in the necrosis (or death) of jaw bone. Plaintiff claims the type of ONJ that Kyle contracted was caused by IV BP drugs, commonly referred to as either bisphosphonate-related ONJ ("BRONJ"), bisphosphonate-induced ONJ ("BIONJ"), or bisphosphonate ONJ ("BONJ"). Plaintiff pursues this action under the state-law theories of strict liability, negligence, and breach of implied warranties. Her principal complaint is NPC failed to adequately warn Kyle of Zometa's dangers and side effects.
Motions in limine provided in advance of trial are appropriate if they eliminate evidence that has no legitimate use at trial for any purpose. Jonasson v. Lutheran Child & Family Serv., 115 F.3d 436, 440 (7th Cir.1997); Bouchard v. Am. Home Products Corp., 213 F.Supp.2d 802, 810 (N.D.Ohio 2002) ("The court has the power to exclude evidence in limine only when evidence is clearly inadmissible on all potential grounds." (citing Luce v. United States, 469 U.S. 38, 41 n. 4, 105 S.Ct. 460, 83 L.Ed.2d 443 (1984))). Only where the evidence satisfies this high bar should the court exclude it; if not, "rulings [on evidence] should be deferred until trial so that questions of foundation, relevancy and potential prejudice may be resolved in proper context." Gresh v. Waste Serv. of Am., Inc., 738 F.Supp.2d 702, 706 (E.D.Ky. 2010) (quoting Indiana Ins. Co. v. Gen. Elec. Co., 326 F.Supp.2d 844, 846 (N.D.Ohio 2004)). Even if a motion in limine is denied, the court may revisit the decision at trial when the parties have more thoroughly presented the disputed evidence. See id. ("Denial of a motion in limine does not guarantee that the evidence will be admitted at trial, and the court will hear objections to such evidence as they arise at trial.").
NPC moves to exclude portions of the testimony by Kyle, Plaintiff, and Kyle's best friend, Pamela Lowe. The Court will address the relevant background, the offered objections, and its decisions.
Before her death, Kyle gave a videotaped deposition. Plaintiff will offer it into evidence at trial. NPC references portions of Kyle's deposition it hopes to strike. See Kyle Depo p. 118-121, DN 106-2, p. 17-20. Here, Kyle makes statements that she discontinued her use of Zometa because it made her bones "too hard." The pertinent testimony that concerns the Court is as follows:
Kyle Depo. p. 119-21, DN 106-2 at 18-20. NPC moves to exclude this testimony because Kyle is unqualified to give opinions on medical causation and this is not a proper lay opinion under Federal Rule of Evidence 701. Plaintiff responds that Kyle's statements are consistent with the testimony of her physicians and that the jury is entitled to know her subjective impression of why she stopped taking the Zometa.
Under Rule 701, a lay witness may provide opinion testimony only when such opinions are "(a) rationally based on the perception of the witness, (b) helpful to a clear understanding of the witness' testimony or the determination of a fact in issue, and (c) not based on scientific, technical, or other specialized knowledge...." Fed.R.Evid. 701. "The primary purpose of Rule 701 is to allow nonexpert witnesses to give opinion testimony when, as a matter of practical necessity, events which they have personally observed cannot otherwise be fully presented to the court or the jury." Randolph v. Collectramatic, Inc., 590 F.2d 844, 846 (10th Cir.1979) (citation omitted). Trial courts are afforded broad discretion when admitting lay opinion testimony. Heritage Mut. Ins. Co. v. Reck, 127 Fed.Appx. 194, 199 (6th Cir. 2005).
Kyle's statement that Zometa "caused" her bones to harden is inadmissible opinion evidence under Rule 701. Kyle could not have perceived the changes in her bone density, and while she may have "felt" changes to her body during the Zometa treatment, the advanced stage of her cancer and the presence of other medical procedures during the same time frame substantially undermine the reliability of her statements. Ergo, the previously quoted passage on causation represents improper testimony. This ruling does not affect statements by Kyle about why she stopped taking Zometa that are not linked to medical causation.
Before her death, Kyle was diagnosed with trigeminal neuralgia, a condition unrelated to her ONJ. Kyle Depo. p. 18-21, DN 106-2 at 4-7. Trigeminal neuralgia is a syndrome characterized by "severe, episodic pain in the area supplied by the trigeminal nerve." Trigeminal Neuralgia Definition, Dorlands.com, http://www.dorlands.com/def.jsp?id=100071619 (last visited October 11, 2011). The trigeminal nerve is located in and around a person's jaw. Kyle testified in her deposition that this condition may have caused some of her jaw pain before the apparent onset of ONJ. Kyle Depo. p. 102-05, DN 106-2 at 12-15. She was able to differentiate, to a
NPC now moves to limit Plaintiff's direct testimony on three bases. The first two mirror the objections previously raised against Kyle's testimony: Plaintiff is not an expert on Zometa, ONJ, or medicine and is therefore unqualified to offer statements about causation or the effects of Zometa. The Court declines to answer these objections at present. Whereas Kyle's testimony is static since it has been prerecorded, Plaintiff will testify at trial and thus it is difficult to predict how these statements will present themselves. NPC may offer these objections at trial should the need arise. The Court will, however, issue a warning to Plaintiff: she is not an expert on causation and her opinions on Zometa and ONJ do not meet the requirements of Rule 701. Statements to that effect, absent a close nexus to the non-hearsay remarks of Kyle's physicians, are inadmissible.
NPC also argues that given Kyle's trigeminal neuralgia, Plaintiff cannot distinguish between the pain Kyle suffered as a result of this condition as opposed to the ONJ. NPC says Plaintiff should be precluded from offering testimony on the pain in Kyle's mouth because it invites speculation. The Court rejects such a contention — this is a legitimate basis for undermining Plaintiff's testimony on cross examination but not its exclusion. Plaintiff may also testify about personally observing Kyle's difficulty eating and brushing her teeth. Finally, regarding Kyle's statements about having pain in her mouth, this evidence might be admissible under the hearsay exception of a then-existing "state of mind, emotion, sensation, or physical condition." Fed.R.Evid. 803(3). Since the Court has not confronted this testimony directly, the Court does not decide if it is admissible; instead, it opts to do so at trial.
Simply put, Plaintiff may testify on what she observed and the subjects about which she has personal knowledge. She may not speak to causation or why she thinks Zometa and NPC are responsible for her mother's injuries. Plaintiff is not qualified to give such opinions and the Court warns her against straying into these areas.
Lowe offers deposition testimony that she and Kyle were close friends for more than twenty years. In the final months of Kyle's life, Lowe provided day-to-day care for her, including most of her dental hygiene. Lowe says she noticed a foul odor coming from Kyle's mouth and that her teeth had a general discoloration and "rotting" quality. In her deposition, Lowe is candid that she is not a doctor and unqualified to draw a causal connection between Zometa and the condition of Kyle's mouth prior to her death.
NPC explains that any attempt for Lowe to offer statements on causation is improper because she lacks the requisite medical or scientific background. Lowe's testimony must be limited to her own, personal observations. She is permitted to describe Kyle's pain to the extent she observed it and such statements meet prerequisites of Rule 803(3). She is allowed to testify about any disfigurement Kyle experienced. Lowe may not testify on the causation between Zometa and ONJ. Lowe is further precluded from opining on what caused Kyle's pain or disfigurement.
During her deposition, Lowe said the cause of Kyle's death was ultimately starvation. NPC contends this statement is inadmissible since it falls outside a layperson's opinion provided for in Rule 701. The Court agrees. As noted, Lowe is not a medical expert and the causes of Kyle's
NPC targets statements Lowe makes about Kyle's state of mind, such as how she felt about her jaw problems and the instant lawsuit. Lowe Depo. p. 77, 86, DN 106-7 at 27, 33. It alleges these portions of her testimony should be excluded. Although this testimony contains the hallmarks of inadmissible hearsay and conjecture, the Court will wait for trial and the manner in which it is offered to the jury before rendering a decision.
The Court ends this ruling with the following advice: Plaintiff's counsel should first approach the bench before soliciting information from Plaintiff or Lowe that could arguably be characterized as causation or expert-related testimony. Statements of this ilk from these individuals will not be tolerated as these lay witnesses are not qualified to provide these opinions.
NPC moves to preclude Plaintiff from presenting evidence or arguments that imply it had a duty to warn anyone but Kyle's treating physician (Dr. Steven Smith) about the alleged risks of Zometa. It cites the Kentucky Supreme Court decision of Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky.2004), for the proposition that pharmaceutical companies are relieved from liability where they have provided an adequate warning to the prescribing physician. NPC thereby concludes it is contrary to the applicable law for Plaintiff to argue NPC is liable for failing to warn Kyle's dentist, oral surgeon, periodontist, or her other health care providers.
In Larkin v. Pfizer, Inc., the Sixth Circuit Court of Appeals reviewed a products liability action under Kentucky law where the plaintiff had suffered an adverse reaction to two medications prescribed by his physician. The record in the lower court established the plaintiff's physician was warned by Pfizer's literature that the adverse reaction was a possible side effect. Id. at 760. On appeal, the Sixth Circuit certified the following question to Kentucky's highest court:
Id. at 761. The court answered in the affirmative, describing the newly adopted rule as follows:
Id. at 762 (quoting Restatement (Third) of Torts: Prods. Liab. § 6(d) (1998)) (formatting altered). Courts within Kentucky's
Underlining certain passages, NPC says Larkin opted for the restrictive view of the learned intermediary rule that states pharmaceutical companies are only required to warn a patient's prescribing physician. While this argument is not completely disjointed from the opinion's language, the Kentucky Supreme Court's holding was unambiguous: "we now adopt Restatement (Third) of Torts: Products Liability § 6(d) (duty to warn of possible side effects satisfied if adequate warning given to patient's health care provider, subject to exceptions)."
Beginning with the restatement's language, the learned intermediary rule provides cover to pharmaceutical companies who have given reasonable instructions to "prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." Restatement (Third) of Torts: Prods. Liab. § 6(d)(1) (1998) (emphasis added); see Larkin, 153 S.W.3d at 762. The restatement's commentary continues in this vein with the following:
Id. § Comment D. Accordingly, the restatement's text and commentary debunk NPC's assertion that Kentucky's version of the learned intermediary rule excludes all other physicians save the one actually prescribing the medicine in issue.
Not surprisingly, other courts considering the issue have applied the learned intermediary rule to nonprescribing physicians. In Holley v. Burroughs Wellcome Co., 74 N.C. App. 736, 330 S.E.2d 228 (1985), the North Carolina Court of Appeals
In fact, courts interpreting this very motion have declined to adopt NPC's view of the learned intermediary rule. Zometa and its supposedly inadequate labeling have been the targets of several lawsuits prior to this one. In Stevens v. Novartis Pharm. Corp., 358 Mont. 474, 247 P.3d 244, (2010), the Montana Supreme Court reviewed, among other things, whether the state's learned intermediary rule prohibited the plaintiff from pursuing the theory that NPC should have warned health care providers besides the prescribing physicians. Id. at 257-59. After reviewing the language from the Restatement (Third) of Torts and comparing it to other legal decisions interpreting the doctrine, the court found "Novartis' duty to warn ... would presumably include at least the [group of treating oncologists] who counseled Stevens on dental surgery, if not the nurses who routinely administered Zometa...." Id. at 260. An identical conclusion was reached in Hogan v. Novartis Pharm. Corp., No. 06-CV-0260, 2011 WL 1533467, at *8-10 (E.D.N.Y. April 24, 2011). There, Judge Cogan denied NPC's attempts to limit the scope of its duty to warn under the learned intermediary rule. In so deciding, he found that none of the cases upon which NPC had relied for its narrow interpretation stood "for the proposition that prescribing physicians are the only treating medical professionals who must be warned." Id. at *9 (emphasis in original). Perhaps most persuasive to this Court is both Hogan and Stevens employed section 6(d) of the Restatement (Third) of Torts, the version adopted by the Kentucky Supreme Court in Larkin, in reaching their conclusions. See id. at *10; Stevens, 247 P.3d at 257.
The above-cited decisions, in tandem with the section 6(d)'s plain language, lead the Court to reject NPC's motion. It is impossible to read the learned intermediary rule through NPC's proposed lens given the interplay between multiple physicians, numerous procedures, and countless drugs to which cancer patients are subjected. Nevertheless, the Court limits this opinion to the specific facts of this case; it is not endorsing a view that all medical professionals should be forewarned of a drug's potential side effects or deciding what procedures a pharmaceutical company should follow to meet such a requirement. Rather, under these particular circumstances, the Court finds NPC's limiting instruction inappropriate and will reject this motion.
NPC asks the Court to exclude twelve documents, mainly emails, because they
Evidence is relevant if it has "any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." Fed.R.Evid. 401. Evidence which the Court finds irrelevant is inadmissible. Fed.R.Evid. 402. Courts however have set the bar relatively low for relevancy under Rule 401. See Churchwell v. Bluegrass Marine, Inc., 444 F.3d 898, 905 (6th Cir.2006) (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 587, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). If the evidence "tend[s] to prove the matter sought to be prove[d]," then it satisfies this the rule's threshold. Fed.R.Evid. 401 (advisory committee notes).
Even if evidence is relevant, it may be excluded "if its probative value is substantially outweighed by the danger of undue prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, or needless presentation of cumulative evidence." Fed.R.Evid. 403. "District courts are given broad discretion in making a Rule 403 determination." United States v. Bonds, 12 F.3d 540, 567 (6th Cir.1993). "Unfair prejudice does not mean the damage to a [party]'s case that results from the legitimate probative force of the evidence; rather it refers to evidence which tends to suggest [a] decision on an improper basis." United States v. Newsom, 452 F.3d 593, 603 (6th Cir.2006) (quoting Bonds, 12 F.3d at 567).
Where a suit is pursued against a corporation or an entity, documents or correspondences created by its directors, employees, or agents may be construed as non-hearsay statements, depending on their context. See Fed.R.Evid. 801(d)(2) (describing admissions by a party-opponent); Avondale Mills, Inc. v. Norfolk Southern Corp., No. 1:05-CV-2817-MBS, 2008 WL 6953956, at *4-5 (D.S.C. Feb. 21, 2008) (admitting non-executive employee emails as non-hearsay in suit against a corporation); Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd., 454 F.Supp.2d 966 (C.D.Cal.2006) (same); see also Rambus, Inc. v. Infineon Techs. AG, 348 F.Supp.2d 698 (E.D.Va.2004) (admitting emails under the business records exception, Fed.R.Evid. 803(b)). For non-hearsay treatment, the party's agent or servant must have made the statement within "the scope of the agency or employment [and]... during the existence of the relationship." Fed. R. 801(d)(2)(D). "[T]he party seeking admission `bears the burden of establishing the proper foundation for the admissibility of [hearsay] statements.'" Thompson v. City of Lansing, 410 Fed. Appx. 922, 930 (6th Cir.2011) (quoting Liadis v. Sears, Roebuck & Co., 47 Fed. Appx. 295, 303 (6th Cir.2002)).
Below are the Court's rulings on these particular documents:
NPC asks the Court to exclude the following pictures, should Plaintiff attempt to present them at trial: (1) photographs of persons other than Kyle with ONJ, (2) photographs of Kyle's condition or treatment, and (3) photographs of Kyle prior to her cancer diagnosis. It argues these items are irrelevant and overly prejudicial, and thus in violation of Rules 401 and 403. Neither party has provided the Court copies of these photographs.
It is easy to imagine how photographs in this case both hold the promise of aiding the jury to visualize the symptoms of this disease and the peril of shocking and prejudicing the same with graphic and emotional images. The Court encourages the parties to disclose any questionable photographs to each other in advance of trial and reach an accord on which ones should be introduced.
In the absence of an agreement, the Court will delay ruling on this motion until trial; to act otherwise would be to improperly judge these photographs sight unseen. Certainly, some photographs of Kyle prior to her diagnosis and after she contracted ONJ will be admissible.
Adverse drug experience ("ADE") reports are brief statements by doctors or patients, compiled by pharmaceutical companies and then forwarded to the Food and Drug Administration ("FDA") that document "any adverse event associated with the use of a drug in humans, whether or not considered drug related." 21 C.F.R. § 314.80(a); see Dunn v. Sandoz Pharm. Corp., 275 F.Supp.2d 672, 682 (M.D.N.C.2003). A large number of ADE reports were sent to NPC relating to Zometa and ONJ. See Marx Expert Report ¶ 61, DN 113-2 at 15. NPC now petitions the Court to find inadmissible many of these ADE reports.
The motion seeks to exclude those reports that are not substantially similar to the events alleged in this case and those sent to NPC after Kyle started taking Zometa on October 24, 2003. It argues Plaintiff's witnesses should not be allowed to rely on specific ADE reports unless they are analogous to Kyle's medical background. NPC continues, pushing for the exclusion of references to the number of ADE reports by witnesses because the individual reports are premised on impermissible hearsay. Finally, NPC claims the ADE reports are improper evidence if they were created after Kyle began her treatment because they could not have impacted her oncologist's decision to prescribe Zometa.
First, courts recognize the tenuous role ADE reports play when showing a causal link between a drug and a side effect. See Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989-90 (8th Cir.2001) ("Case reports make little attempt to screen out alternative causes for a patient's condition. They frequently lack analysis. And they often omit relevant facts about the patient's condition."); Dunn, 275 F.Supp.2d at 682 (remarking that ADE reports "are not controlled studies", "cannot be verified through peer review", "do not include information about the patient's medical history", and "are not scientific proof of causation"). That is not to say courts endorse the general rule of exclusion for which NPC is advocating. ADE reports are proper to prove "causation in correlation" when appearing alongside other evidence In re Levaquin Products Liab. Litig., No. 08-MDL-1943, No. 08-CV-5743, 2010 WL 4676973, at *4 (D.Minn. Nov. 9, 2010); accord Bartlett v. Mutual Pharm. Co., Inc., No. 08-CV-358, 2010 WL 3092649, *1 (D.N.H. Aug. 2, 2010) (permitting the plaintiff's experts to rely on ADE reports to the extent they were "reasonably relied upon by experts in the particular field"); In re Fosamax Products Liab. Litig., 645 F.Supp.2d 164, 184-85 (S.D.N.Y.2009) ("[A] large number of [ADE] reports adds greater weight to the reliability of an opinion on causation.").
The medical causation opinions of Professor Wayne A. Ray and Dr. Robert Marx, experts for Plaintiff, are based in part on the number of ADE reports that arose out of patients taking Zometa and Aredia. The issues of hearsay that are necessarily implicated with ADE reports should not preclude this testimony because experts may use otherwise inadmissible evidence to reach their opinions. Fed. R.Evid. 703. Thus, Plaintiff's experts may rely on and make reference to the aggregate number of Zometa-related ADE reports to prove medical causation, insofar as they relied on it to form their opinions. On cross examination, NPC may address its complaints over whether the medical scenarios underlying the ADE reports are substantially similar to Kyle. Still, substantial similarity is not relevant to opinions on medical causation, so long as the expert offering the opinion did not differentiate between these ADE reports when employing his methodology. Hearsay issues will however bar experts from mentioning specific ADE reports during this portion of their testimony.
Second, ADE reports may show notice on pharmaceutical manufacturers of the drug's side effects. See Hogan, 2011 WL 1533467, at *13; Bartlett, 2010 WL 3092649, *1; Golod v. La Roche, 964 F.Supp. 841, 855-56 (S.D.N.Y.1997). As case reports are of questionable reliability, courts typically impose the yard stick of "substantial similarity" to ferret out those ADE reports that could not be expected to raise the manufacturer's awareness. Bartlett, 2010 WL 3092649, at *1; cf. Soldo v. Sandoz Pharm. Corp., 244 F.Supp.2d 434, 550-51 (W.D.Pa.2003) ("[E]vidence of other injuries is not admissible unless the circumstances of the other occurrences are `substantially similar' to those in the case at bar." (citing Barker v. Deere and Co., 60 F.3d 158, 162 (3d Cir. 1995))). This Court will follow suit. If Plaintiff introduces specific ADE reports to show notice to NPC of Zometa's side effects, those reports must be substantially similar to the matter at hand. For substantial
Third, after Kyle's tooth was extracted, subsequent ADE Reports could not have provided notice to NPC since it would have been impossible to warn her of the drug's alleged connection to ONJ. The individual reports submitted to NPC or the FDA after January of 2005 are therefore irrelevant to showing notice on NPC. Still, reports falling after this temporal dividing line are admissible to the extent they were relied upon by Plaintiff's experts to create their opinions on medical causation. They may not however be specifically referenced by the expert or introduced by the Plaintiff.
In this motion, NPC seeks to exclude arguments and evidence surrounding its corporate activities after Kyle was prescribed and began taking Zometa on October 24, 2003. It insists its actions following this date are inapposite since the prescribing physician could only have considered Zometa's warnings prior to the start of her therapy. NPC affirms that whatever subsequent knowledge or notice it possessed about the drug's alleged connection to ONJ would be similarly irrelevant since it would have arisen after Kyle began her treatment. In the alternative, NPC petitions the Court to draw a time boundary for admission of its activities in November of 2004 (the date Kyle stopped taking Zometa) or January of 2005 (the date Kyle's tooth was removed).
Conceptually, this request makes sense; practically, it does not. No matter which date the Court chooses, documents or actions by NPC after that date could bear (or may be interpreted by a jury as bearing) on NPC's earlier knowledge about ONJ and Zometa. To ensure legitimate evidence was not excluded simply as a result of the date it was created, the Court would have to review all evidence dated after the temporal dividing line and determine whether it implicates NPC's knowledge at an earlier stage in Zometa's development.
Such a course is improper for two reasons. First, it is unduly burdensome. The record for this matter is vast and to conduct such a review before trial would embroil the Court and parties in a pitched battle over countless documentary exhibits. Second, deciding what a jury could or could not infer from a potential exhibit would require the Court to make impermissible judgments on fact issues that are reserved strictly for the jury. Tennant v. Peoria & P.U. Ry. Co., 321 U.S. 29, 35, 64 S.Ct. 409, 88 L.Ed. 520 (1944) ("It is the jury, not the court, which is the fact-finding body. It weighs the contradictory evidence and inferences, judges the credibility of witnesses, receives expert instructions, and draws the ultimate conclusion as to the facts.").
Rather than intruding into the jury's arena, the Court will deny NPC's request for a strict rule deciding the admissibility of documents between the beginning of Kyle's treatment, its termination, and her tooth extraction. NPC may instead point out the temporal discrepancies in documents and its actions during its own arguments and during the cross examination of Plaintiff's witnesses. It may also offer
NPC also claims the subsequent labeling changes to Zometa and Aredia in November of 2007 and December of 2008 are impermissible evidence. Federal Rule of Evidence 407 prevents the admission of subsequent remedial measures to show "a defect in a product's design" or "a need for a warning or instruction" if such action "would have made the injury or harm less likely to occur." Fed.R.Evid. 407. Where pharmaceutical companies have altered a drug's labeling on their own accord, courts have consistently precluded juries from considering these changes as evidence of a defect in the original warning or instruction. E.g., Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 271 n. 10 (5th Cir. 2002); DeLuryea v. Winthrop Labs., a Div. of Sterling Drug, Inc., 697 F.2d 222, 229 (8th Cir.1983); Krasnopolsky v. Warner-Lambert Co., 799 F.Supp. 1342, 1348 (E.D.N.Y.1992). But see In re Levaquin Products Liab. Litig., MDL No. 08-1943(JRT), 2010 WL 4882595, at *1 (D.Minn. Nov. 24, 2010) (where FDA ordered labeling change, Rule 407 was inapplicable); Bartlett v. Mutual Pharm. Co., Inc., No. 08-CV-358-JL, 2010 WL 3092649, at *2 (D.N.H. Aug. 2, 2010) (same).
The labeling changes for Zometa and Aredia in November 2007 and December 2008 fall squarely within the protections of Rule 407. DN 114-7 at 6; DN 114-8 at 9. Both mention ONJ under the subsection "Warnings and Precautions", encourage patients taking the drugs to "maintain good oral hygiene", and urge patients to "avoid invasive dental procedures if possible." DN 114-7 at 6; DN 114-8 at 9. Use of these changes during trial would subvert the policy of Rule 407-encouraging manufactures to disseminate open and accurate information to consumers without the possibility of admitting fault.
For this reason, the changes of November 2007 and December 2008 to Zometa's and Aredia's labels may not be relied upon by the jury to show liability, a defect in a product's design, or the need for a warning or instruction. Fed.R.Evid. 407. To the extent Zometa's and Aredia's labels were altered at a time prior to November of 2007, NPC has not moved for their exclusion or attached them to the instant motion. The Court therefore does not reach the question of whether they too are impacted by Rule 407. Lastly, Plaintiff may introduce the November 2007 and December 2008 labels for appropriate purposes under Rule 407, such as impeachment. Counsel must approach the bench before taking such actions so the Court may determine the intended evidentiary purpose of these labels.
The Court previously admitted Dr. Robert Marx's expert testimony on the causal relationship between IV BP drugs and ONJ, and the steps that can be taken to prevent and treat BIONJ in the individuals receiving BP therapy. Memo. & Op. Ord. p. 27-28, DN 151 at 27-28. Marx has extensive experience treating patients with ONJ as well as researching the connection between the disorder and BP drugs like Zometa. According to the motions before the Court, Marx has seen 238 patients suffering from ONJ. NPC asks the Court to limit his testimony at trial and prevent
Insofar as this motion could be construed as limiting the broad strokes of Marx's expertise on ONJ, NPC's request is denied. Marx developed his opinions on ONJ-specifically its symptoms, treatment, and causes-by evaluating patients with the illness. Thus, he may testify generally about the disease, his opinion on causation, and how he developed the opinions in the context of the other patients he has treated. Marx may also speak toward the aggregate number of patients he has seen with ONJ, how that number is relevant to his opinions, and the diagnostic or medical similarities those patients share as it pertains to his expert opinions. To find otherwise would thwart the Court's earlier decision admitting him as an expert witness.
So far as Marx seeks to introduce more particularized evidence of the patients he has treated, the Court repeats the conclusion reached above for the ADE reports. Patients that have a substantially similar medical history as Kyle (those who took Zometa and subsequently developed ONJ or analogous disorders) could bear on issues of notice to NPC and causation. Marx may speak about specific patients that are substantially similar to Kyle if they helped him form his opinion on causation, if NPC's officials examined these patients during their visit to his clinic, or if NPC was given notice of these patients' condition through an ADE report or via some other avenue.
NPC asks the Court to prohibit Plaintiff from introducing evidence or arguments that it should have warned of Zometa's or Aredia's possible connection to ONJ earlier than September of 2003. The motion confronts several pieces of evidence and potential testimony.
NPC offers an omnibus motion in limine seeking an evidentiary ruling on potential statements by Plaintiff's witnesses and counsel. Each is confronted below.
Plaintiff has filed her own omnibus motion in limine. Each objection is discussed below.
IT IS HEREBY ORDERED:
