Plaintiffs in all fifty states have brought multidistrict litigation (MDL) against your company over a drug it manufactures. The FDA approved a change to the product label over two years ago to warn of the potential association between use of the drug and the injuries at issue in the litigation. Your company sent Dear Doctor letters soon afterward to inform physicians of the label change. National and local media outlets featured the label change prominently in their news coverage for weeks, and advertisements by plaintiffs’ law firms have blanketed television and print media for years. Meanwhile, suits alleging warning defects in the former product label — the one your company changed two years ago — continue to mount, even from jurisdictions with two-year statutes of limitations. All of these plaintiffs invoke the discovery rule, which generally tolls the running of the statute of limitations until the date the plaintiff knew, or in the exercise of reasonable diligence, should have known of her injury and its potential causal link to the defendant’s product. But did the public events surrounding your company’s drug put these plaintiffs on notice of their potential claims and thus trigger all of the relevant statutes of limitations to begin running by a universally applicable date?

During the past ten years, the concept of establishing universal bar dates has slowly but consistently gained acceptance among state and federal courts overseeing pharmaceutical multidistrict and consolidated litigations, with five courts establishing a universal bar date. No bright-line test has emerged for the appropriateness of a universal bar date. Rather, the courts have engaged in fact-intensive inquiries into whether there is a “last possible date” by which all plaintiffs should have known of their potential claims. Courts have considered many factors when establishing bar dates, including the existence of widespread publicity regarding the alleged side effects, Dear Doctor and Dear Patient letters, label changes, press releases, the publication of scientific studies and other medical literature, plaintiffs’ attorney advertisements, and even FDA Advisory Panel votes.

1. IN RE DIET DRUGS MDL

In the Diet Drugs multidistrict litigation, the plaintiffs filed their claims more than five years after the diet drugs were withdrawn from the market but argued they could not have discovered that the drugs caused their injury within the statute of limitations period.¹ The court rejected this argument, noting the “pervasive” and “widespread publicity accompanying the withdrawal of the diet drugs from the market in September, 1997,” including extensive local media coverage, “leading stories on major television network news programs, including NBC Nightly News, CBS Evening News, and The Today Show” and a front-page story in USA Today.² Moreover, the manufacturer, Wyeth, issued a press release, published full-page ads in leading newspapers, and issued a Dear Doctor letter, all advising patients and physicians of the potential association between use of the drugs and valvular heart disease.³ Finally, the court pointed to the “comprehensive publicity campaign surrounding the nationwide class action Settlement Agreement with Wyeth” which lasted until March of 2000.⁴ Based on these events, the court established a universal bar date coinciding with the end of the publicity campaign in March 2000, finding the campaign “put plaintiffs on inquiry notice that their alleged heart problems would be detectable through an echocardiogram.”⁵

2. IN RE VIOXX MDL

The Vioxx multidistrict litigation involved an “avalanche of media coverage” regarding the “largest and most-publicized prescription drug withdrawal in this country’s history”:

On the morning of September 30, 2004, the national television network morning shows reported extensively on the withdrawal of Vioxx, including NBC’s The Today Show, ABC’s Good Morning America, CBS’s Early Show, and CNN’s American Morning. National coverage continued throughout the day with reports on National Public Radio and the networks’ evening news broadcasts. The next day, October 1, 2004, saw more television coverage of the withdrawal and an onslaught of front-page stories in newspapers across the country.⁶

Merck argued that certain plaintiffs’ tort claims were barred under “any conceivably applicable statute of limitations” because “at the very latest, the various limitations periods began to run on September 30, 2004, when Vioxx was withdrawn from the market.”⁷ Finding that this media coverage was “sufficient to put the plaintiffs on notice of a potential link between their alleged injuries and the use of Vioxx,” the court entered summary judgment against the plaintiffs.⁸ Whether plaintiffs had “actual knowledge” of the potential link between Vioxx and their alleged injuries was immaterial to the court’s legal analysis.⁹

3. IN RE AVANDIA MDL

In the Avandia multidistrict litigation, GlaxoSmithKline (“GSK”) sought to “establish a ‘bar date,’ i.e., the date by which any plaintiffs [could] be presumed as a matter of law to have been on notice of a possible link between Avandia and their injuries, and therefore to pursue any tort claims.”¹⁰ Several events occurring in 2007 had served to establish a potential link between use of Avandia and an increased risk of heart attack, beginning with a meta-analysis study which was published in the New England Journal of Medicine on May 21, 2007.¹¹ In response to the study’s publication, the American College of Cardiology, the American Diabetes Association, and the American Heart Association issued a consensus statement expressing concern and advising patients taking the drug to speak with their physicians.¹² In July of 2007, the FDA convened an Advisory Committee meeting, which resulted in a 20–3 vote concluding that Avandia may increase cardiac ischemic risks.¹³ The FDA required GSK to revise the label for Avandia, and a new black box warning regarding heart risk was approved on August 14, 2007.¹⁴ From May through November 2007, GSK sent eight Dear Doctor letters to healthcare providers regarding studies of Avandia and cardiovascular health, as well as regulatory developments.¹⁵ On June 1, 2007, GSK also published a “Dear Avandia Patient” letter, defending the drug from “press coverage about the safety of Avandia.”¹⁶ The publication of the meta-analysis study, as well as the November 2007 label change, generated “substantial interest in the media” including lead stories in the national evening news and articles in national and local newspapers.¹⁷

Based on the “cumulative effect” of the 2007 events and the “information available both to the general public and treating physicians throughout 2007,” the court held that “a reasonable person who knew that he or she had suffered cardiovascular injury and had taken Avandia would have been put on notice by the end of 2007 to investigate a possible link between Avandia and the injury.”¹⁸ The court held that the statutes of limitations applicable to two plaintiffs’ claims began to run by December 31, 2007, but noted that “the laws of certain states may have a different view of when a claim is tolled.”¹⁹

4. IN RE ZYPREXA MDL

Unlike Vioxx and Avandia, the Zyprexa litigation did not involve extensive national and local media attention.²⁰ However, the manufacturer, Eli Lilly & Company (“Lilly”), revised the Zyprexa Package Insert on September 16, 2003, to include a warning to prescribing physicians about the risk to patients of weight gain and development of diabetes.²¹ Lilly issued a press release the next day announcing the label change.²² In November 2003, the American Diabetes Association, the American Psychiatric Association, the American College of Clinical Endocrinologists, and the North American Association for the Study of Obesity released a consensus statement finding that Zyprexa increased the risk of diabetes.²³ On March 1, 2004, Lilly sent a Dear Doctor letter informing physicians of the 2003 label change.²⁴

The court found that the March 1, 2004, Dear Doctor letter would be considered the “latest possible date on which members of the medical community knew or should have known about Zyprexa’s obesity and diabetes- related risks.”²⁵ Applying the “learned intermediary” doctrine, the court imputed this knowledge to each of the individual plaintiffs, holding that March 1, 2004, was also the “latest possible date […] from which the statute of limitations may run as to any individual plaintiff.”²⁶

The Zyprexa MDL also involved claims alleging a causal link between the drug and pancreatitis.²⁷ On November 17, 2001, Lilly revised the “ADVERSE REACTIONS” section of the Patient Package Insert to include information regarding postmarketing reports of pancreatitis.²⁸ The court held the November 17, 2001, label change was the “date from which the statute runs as to pancreatitis,” noting that the warning had been designed to alert consumers,²⁹ as opposed to the diabetes warning which had been “designed for prescribing doctors” and “did not mention weight gain or diabetes in the ‘warning to patients’ section.’”³⁰ Notably, the only other events cited by the court as potentially putting plaintiffs on notice of their claims were advertisements by plaintiffs’ firms which ran from 2003 to 2007.³¹ The November 17, 2001, bar date selected by the court predated these advertisements and was therefore based solely on the label change.

5. DELAWARE CONSOLIDATED SEROQUEL LITIGATION

In the Delaware consolidated Seroquel litigation, the Superior Court of Delaware analyzed that state’s “time of discovery” exception to the running of the statute of limitations, which looks to when “someone from the scientific community found and revealed publicly a link between the physical condition and the exposure to the toxic substance.”³² Three of the plaintiffs were diagnosed with diabetes in 2004 but argued that they were not on notice of their claims until 2007 when they saw television advertisements aired by plaintiffs’ law firms seeking potential plaintiffs for the Seroquel litigation.³³

The court found that, as early as 2003, both medical and lay sources had published information regarding the possible link between Seroquel and diabetes.³⁴ Moreover, by January of 2004, the Seroquel label was changed to include a warning regarding the possible risk of diabetes.³⁵ The manufacturer, AstraZeneca, alerted the medical community to the new label in a Dear Doctor letter sent in January of 2004³⁶ and again in a second Dear Doctor letter sent in April of 2004. The court held that, under the applicable Delaware law, the latest possible date on which plaintiffs were on notice of their claims was January 30, 2004, the date of the first Dear Doctor letter.³⁷

ESTABLISHING A UNIVERSAL BAR DATE

Establishing a universal bar date can potentially preclude a large number of claims with one dispositive motion. It may also prevent a mass tort from being litigated in near perpetuity. Because of these powerful qualities, counsel should consider possible bar dates early in the litigation and begin gathering facts and evidence to convince the court to adopt one of those dates. It is important to document significant media exposure, press releases, regulatory activity, medical literature, and attorney advertising. However, other events unique to the history of the drug should be considered as well, given the flexibility demonstrated by the courts. In most cases, counsel would be well advised to wait until the summary judgment stage to present the issue to the court, as all of the supporting cases have been decided on a full summary judgment record, and a loss on a Rule 12(b)(6) motion may predispose the court to disfavor the argument when it is renewed at the sum

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[i] Accadia v. Wyeth, In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab. Litig., 2004 U.S. Dist. LEXIS 26754, *3 (E.D. Pa. June 30, 2004).

[ii] Id. at *11-22.

[iii] Id. at *14-15.

[iv] Id. at *15.

[v] Id. at *22.

[vi] In re Vioxx Prods. Liab. Litig., 522 F.Supp.2d 799, 803 (E.D. La. 2007).

[vii] Id. at 804.

[viii] See Vioxx, supra, 522 F.Supp.2d at 807-811 (applying the Pennsylvania, Illinois, and Puerto Rico statutes of limitations); In re Vioxx Prods. Liab. Litig., 2007 U.S. Dist. LEXIS 83709, *7-8, 13 (E.D. La. Nov. 8, 2007) (applying the Kentucky and Tennessee statutes of limitations).

[ix] Vioxx, supra, 2007 U.S. Dist. LEXIS 83709 at *7.

[x] Faheem v. GlaxoSmithKline, LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2012 U.S. Dist. LEXIS 111272, *4 (E.D. Pa. Aug. 7, 2012).

[xi] Id. at *11.

[xii] Id. at *12.

[xiii] Id.

[xiv] Id.

[xv] Id. at *13.

[xvi] Id.

[xvii] Id. at *14.

[xviii] Id. at *15-18.

[xix] Id. at *19-20.

[xx] See e.g., Belcher v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 2009 U.S. Dist. LEXIS 105431 (E.D.N.Y. Oct. 9, 2009) aff ’d, 394 Fed. Appx. 821 (2d Cir. 2010) (unpublished).

[xxi] Id. at *98.

[xxii] Id. at *100.

[xxiii] Id. at *101.

[xxiv] Id. at *100.

[xxv] Id. at *105.

[xxvi] Id. at *106-107.

[xxvii] See Ortenzio v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 2009 U.S. Dist. LEXIS 47573, 68 (E.D.N.Y. June 1, 2009).

[xxviii] Id. at *81.

[xxix] Id. at *81, *90.

[xxx] See Belcher, 2009 U.S. Dist. LEXIS 105431 at *98, *100; see also Cunningham v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 2010 U.S. Dist. LEXIS 49676, 14 (E.D.N.Y. May 19, 2010).

[xxxi] Cunningham, (In re Zyprexa), 2010 U.S. Dist. LEXIS 49676 at *35.

[xxxii] Burrell v. Astrazeneca LP, C.A. No. 7C-01-412 (SER), 2010 Del. Super. LEXIS 393, *2 (Del. Super. Ct. Sept. 20, 2010).

[xxxiii] Id. at *3-5; *23-24.

[xxxiv] Id. at 25.

[xxxv] Id.

[xxxvi] Id.

[xxxvii] Id.

Finis