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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

United States District Court, N.D. Illinois, Eastern Division

May 29, 2017

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings This Document relates to all s and to Konrad: Konrad
AbbVie, Inc., Case No. 15 C 966 Mitchell
AbbVie, Inc., Case No. 14 C 9178 MDL No. 2545


          MATTHEW F. KENNELLY United States District Judge

         In separate cases in this multidistrict litigation proceeding, plaintiffs Jeffrey Konrad and Jesse Mitchell have sued AbbVie Inc. and Abbott Laboratories (collectively AbbVie). Konrad and Mitchell both allege that they suffered heart attacks as a result of taking AbbVie's testosterone replacement therapy (TRT) drug AndroGel. The Court has selected Konrad's and Mitchell's cases as bellwether trial cases and has scheduled the cases, respectively, as the first and second bellwether trials in this proceeding. Both sides have filed motions in limine, many of which relate to all of the AbbVie-specific bellwether trial cases against AbbVie, and some of which relate only to Konrad's and Mitchell's cases. In ruling on the parties' motions, the Court assumes familiarity with its prior decisions.

         A. Evidence AbbVie has moved to exclude

         1. "Waived claims"

         AbbVie argues that plaintiffs should be barred from introducing evidence that AbbVie's submissions to the FDA were misleading or incomplete because plaintiffs waived any claim that the FDA was misled by AbbVie's submissions or that the FDA would have acted differently had AbbVie disclosed complete or accurate information. On this issue, the Court has already ruled that plaintiffs may not assert a claim that AbbVie defrauded the FDA or that the FDA would have acted differently on the basis of other information. See In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, No. 14 C 1748, 2017 WL 1836443, at *20 (N.D. Ill. May 8, 2017) (In re TRT Off-Label Marketing Ruling). The Court has also ruled, however, that evidence of what information AbbVie provided to, and withheld from, the FDA is relevant to plaintiffs' claims that AbbVie misled the public, including plaintiffs and their prescribing physicians. Id. AbbVie argues that any information it withheld from the FDA is information it was not required to submit, and thus withholding that information was not misleading. AbbVie will be free to press this point on cross-examination. Plaintiffs may introduce evidence that AbbVie's submissions to the FDA misled the public; AbbVie's arguments to the contrary go to the weight, rather than the admissibility, of that evidence. AbbVie's motion to exclude evidence of information it submitted to the FDA is denied.

         2. FDA activity subsequent to the dates plaintiffs stopped using AndroGel

         Konrad stopped using AndroGel in 2010, and Mitchell stopped using the drug in 2012. AbbVie moves to exclude evidence of changes to the AndroGel label or other regulatory activity that occurred after plaintiffs stopped using the drug. In their response, plaintiffs argue that they should be allowed to present evidence about revisions to the AndroGel label that took place in 2015. AbbVie contends that evidence regarding subsequent strengthening of its warnings labels is inadmissible as a subsequent remedial measure under Federal Rule of Evidence 407. As a number of courts have ruled, however, Rule 407's exclusion of evidence regarding subsequent remedial measures does not extend to measures that are mandated, rather than undertaken voluntarily. See, e.g., Lolie v. Ohio Brass Co., 502 F.2d 741, 744 (7th Cir. 1974) (primary basis for Rule 407 inapplicable where evidence offered against party that did not initiate remedial measures); In re Yasmin & Yaz (Drospirenone) Mktg., Sales Practices & PMF Prod. Liab. Litig., No. 3:09-CV-10012-DRH, 2011 WL 6740391, at *8 (S.D. Ill.Dec. 22, 2011) (concluding Rule 407 did not apply where FDA asked pharmaceutical company to take corrective action); In re Levaquin Prod. Liab. Litig., No. 08-5743 JRT, 2010 WL 4882595, at *1 (D. Minn. Nov. 24, 2010) ("Rule 407 does not bar evidence of subsequent remedial measures that are mandated by a governmental agency[.]"). Because the FDA required AbbVie to make the 2015 changes to its label, the Court concludes that Rule 407 does not apply. "[T]he policy goal of encouraging remediation would not necessarily be furthered" by excluding that evidence. O'Dell v. Hercules, Inc., 904 F.2d 1194, 1204 (8th Cir. 1990).

         AbbVie maintains that even if Rule 407 does not apply, evidence of label changes or other regulatory activity that post-dates plaintiffs' use of AndroGel is irrelevant to any of plaintiffs' claims. The Court disagrees. To the extent the changes FDA required indicate its views on AndroGel's ability to cause heart attacks, the evidence is relevant on the issue of causation. The 2015 label revisions are also relevant, when considered with evidence of how plaintiffs' prescribing physicians and other physicians changed their prescribing practices in response to those revisions, on the question of what plaintiffs' prescribing physicians would have done had AndroGel's label been different at the time they prescribed the drug to plaintiffs. AbbVie's motion to exclude is denied with respect to the 2015 revisions to the AndroGel label.

         3. Marketing materials other than those seen or relied upon by plaintiffs or their prescribing physicians

         AbbVie moves to exclude AndroGel marketing materials that neither plaintiffs nor their prescribing physicians viewed or relied upon in deciding to take or prescribe the drug. According to AbbVie, the only marketing materials relevant to plaintiffs' claims are those with some causal link to plaintiffs' decision to use the drug or their doctors' decision to prescribe. Thus AbbVie seeks to exclude all other marketing materials, including internal marketing plans, communications between AbbVie and its marketing firm, drafts of advertisements that were never used, notes of meetings between sales representatives and doctors other than plaintiffs' prescribing doctors, evidence of educational programs AbbVie sponsored, and marketing materials targeting conditions plaintiffs did not actually suffer. There is evidence that plaintiffs and their prescribing physicians were aware of AndroGel marketing materials and that some of those materials may have influenced their decisions to take or to prescribe the drug. Plaintiffs maintain that the materials viewed by plaintiffs and their physicians were part of a larger, extensive marketing campaign that used false or misleading statements to create a market for off-label AndroGel use.

         The Court concludes that even if certain marketing materials played no direct causal role in plaintiffs' use of the drug, those materials may still be relevant on the question of AbbVie's knowledge that its marketing was misleading or its intent to create an off-label market. See, e.g., In re TRT Off-Label Marketing Ruling, 2017 WL 1836443, at *15 (admitting testimony regarding AbbVie's knowledge, motivations, and intent in marketing); In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prod. Liab. Litig., No. 3:09-CV-10012-DRH, 2011 WL 6812683, at *2-*3 (S.D. Ill.Dec. 27, 2011) (admitting evidence of internal market conversations as relevant on claims involving off-label marketing). AbbVie represents that plaintiffs have identified over 100 examples of marketing materials on their exhibit list, most of which were never viewed by plaintiffs or their physicians. Although the Court has found these materials generally relevant and admissible, at some point the Rule 403 balance will tip toward exclusion based on cumulativeness or, perhaps, the danger of unfair prejudice. The tipping point may vary depending on whether plaintiffs' claims for punitive damages will be presented to the jury along with their liability claims in a unitary trial or will be bifurcated. With these caveats, however, the Court denies AbbVie's motion to exclude other marketing materials.

         4. Other AbbVie drugs and TRT manufacturers other than AbbVie

         AbbVie moves to exclude evidence relating to AbbVie drugs other than AndroGel and to other manufacturers of TRT products. Except with respect to communications from the FDA to other TRT manufacturers that AbbVie received and which put AbbVie on notice of its marketing obligations, the Court grants AbbVie's motion. Evidence of AbbVie's alleged improper conduct with respect to Depakote, another of its drugs, is inadmissible evidence of AbbVie's corporate character. See Fed. R. Evid. 404(b). Plaintiffs argue that a "corporate integrity agreement" that AbbVie entered into in connection with Depakote is relevant because it shows that AbbVie agreed, in general, that it would act to deter off-label activity and other improper conduct by its sales representatives. Had AbbVie entered into the corporate integrity agreement prior to the dates that plaintiffs began taking AndroGel, the agreement likely would be relevant to show that AbbVie had notice of the need to police its sales representatives and yet failed to live up to the standards to which it had agreed. The agreement, however, was signed in May 2012, after plaintiffs' physicians had prescribed AndroGel. Plaintiffs argued at the final pretrial conference that the agreement still is admissible to establish a certain standard of care, but because there is no evidence the standard was established or agreed upon at the time plaintiffs were prescribed AndroGel, the agreement is not relevant and is thus inadmissible in Konrad and Mitchell's cases.

         AbbVie also moves to exclude evidence related to a drug it was developing using dihydrotestosterone (DHT) to treat hypogonadism. AbbVie abandoned development of the drug in the early 2000s. Plaintiffs argue that evidence regarding AbbVie's DHT drug is relevant because communications from the FDA in 1997 about DHT show that the FDA was concerned about the need to study DHT (a metabolite of testosterone) in older men. The Court is not persuaded that the FDA's concern this far in the past has significant probative value on the issue of AbbVie's obligation to study the effects of TRT. Any probative value the evidence has is outweighed by its potential to confuse the jury. See Fed. R. Evid. 403.

         Evidence regarding other manufacturers of TRT has similar potential for confusion or unfair prejudice. Other manufacturers' TRT products have different marketing and regulatory histories, and thus testimony or other evidence about those products may be misleading unless it is placed in the proper context. Establishing that context would take up a significant amount of time and would also be unfairly prejudicial to AbbVie, as plaintiffs have access-through discovery with other defendants in the MDL-to information about other TRT manufacturers that AbbVie lacks.

         The Court concludes, however, that at least one item of evidence regarding another manufacturer of TRT is relevant and does not pose a substantial risk of unfair prejudice or confusion. A 2010 letter from the FDA to Slate Pharmaceuticals explains that Slate was engaging in improper marketing of its own TRT product. Plaintiffs contend that the alleged improper marketing was parallel to AbbVie's marketing and that AbbVie received a copy of the letter soon after Slate did, thus giving AbbVie notice that its own off-label marketing was inappropriate. Because evidence introduced for that purpose can be understood without the need for extended background on Slate's TRT drug, it is admissible.

         5. "Unofficial" public statements made by Dr. Daniel Shames

         AbbVie moves to exclude evidence of "unofficial" public statements made by Dr. Daniel Shames, who worked for the FDA at the time as its Deputy Director for the Office of Drug Evaluation III. AbbVie argues that Dr. Shames' statements in the mainstream media have little probative value because they were informal and did not represent the FDA's official position. According to AbbVie, plaintiffs' true purpose for introducing the evidence is to show that alleged off-label marketing had a public profile, which AbbVie contends would be unfairly prejudicial. The Court concludes, however, that the statements' probative value outweighs the potential for unfair prejudice and therefore denies AbbVie's motion. The statements are relevant on the question of AbbVie's notice of the alleged need to conduct additional studies regarding TRT and of its alleged off-label promotion, and plaintiffs' experts, Drs. David Kessler and Peggy Pence, have appropriately relied on Dr. Shames' statements in forming their own expert opinions, which the Court has already deemed admissible.

         The Court defers ruling on AbbVie's general hearsay objection to Dr. Shames' statements until the Court can evaluate the context in which plaintiffs seek to introduce specific statements at trial.

         6. Foreign regulatory actions and labeling

         AbbVie moves to exclude evidence of AndroGel labels used in foreign countries and foreign regulatory action regarding the drug. The Court denies the motion in part. The Court generally agrees with AbbVie that foreign labeling or regulatory actions have little relevance on the question of whether a defendant's U.S. label is adequate. In addition, the Court acknowledges the danger that allowing evidence of foreign regulatory procedures could "result in a series of 'mini-trials'" that might confuse the jury and waste time. In re Seroquel Prod. Liab. Litig., 601 F.Supp.2d 1313, 1318 (M.D. Fla. 2009). Yet the Court is persuaded that the evidence plaintiffs seek to offer regarding a particular action by Canadian regulators regarding AndroGel is sufficiently narrow in scope that it can be admitted without the need for an extended discussion of Canadian regulatory procedure. Specifically, plaintiffs seek to counter AbbVie's contention that it was unaware that different categories of hypogonadism might be interpreted as having separate indicated uses. According to plaintiffs, communications between AbbVie and a Canadian regulatory agency reflects that AbbVie knew hypogonadism could be separated into different categories with different corresponding indications. Evidence of those communications is relevant regarding whether AbbVie knew that it was engaging in off-label marketing, and understanding the evidence does not require extensive understanding of Canadian regulatory procedure. Its probative value thus outweighs its potential to be misleading or to unfairly prejudice AbbVie.

         7. Wealth, profits, or employee compensation of AbbVie

         AbbVie seeks to exclude evidence of its wealth or compensation levels of its employees. The Court grants AbbVie's motion. The Court has already ruled that, to the extent punitive damages claims are presented to the jury, plaintiffs may present evidence of AbbVie's net worth but that other evidence of AbbVie's wealth is unnecessary. As discussed in that ruling, the probative value of AbbVie's wealth and profits and of its employees' compensation is outweighed by the substantial danger of unfair prejudice. See Fed. R. Evid. 403. The potential bias or interest of particular AbbVie employees who testify is sufficiently shown by their connection to the company; admission of their salaries is unnecessary.

         8. General criticisms of the FDA

         AbbVie moves to exclude general criticisms of the FDA that are unrelated to its specific regulation of AndroGel, such as arguments that the FDA is ineffective or lacks adequate resources. The Court grants AbbVie's motion in part and denies it in part. Plaintiffs concede that they may not elicit testimony regarding why the FDA acted or failed to act with respect to AndroGel's marketing materials. Nevertheless, should AbbVie argue or introduce evidence suggesting that FDA's actions or inactions indicate FDA's approval of AbbVie's marketing or conduct, plaintiffs will be permitted to rebut that evidence by suggesting that, for example, FDA's resources do not allow it to address all actions or misconduct by drug manufacturers.

         9. Prescriber misconduct

         AbbVie seeks to exclude evidence of prescriber misconduct. Specifically, AbbVie argues that plaintiffs should be precluded from offering evidence about "men's clinics, " which some doctors established to administer and prescribe TRT off label, as well as allegedly inaccurate statements by doctors about TRT's benefits. According to AbbVie, though that evidence may show that certain physicians acted inappropriately, it does not tend to show that AbbVie acted inappropriately.

         The Court grants AbbVie's motion. Plaintiffs contend that evidence of this alleged misconduct of physicians is relevant because it is the direct outgrowth of AbbVie's off-label marketing plan. Plaintiffs, however, have not established that the connection between AbbVie's off-label marketing and the actions taken by physicians is sufficiently direct that the evidence's probative value outweighs its potential for unfair prejudice. The Court notes that there is no evidence that Mitchell or Konrad attended a "men's clinic" or that either of their physicians made statements about AndroGel similar to the statements plaintiffs seek to introduce. The connection between AbbVie's marketing and the allegedly inappropriate conduct of physicians is too attenuated and too far removed from the facts of this case to outweigh the significant potential for unfair prejudice.

         10. Use of the phrase "bought ...

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