Products Liability Law Daily Failure to warn question remains regarding Armenians’ awareness of drug risks
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Wednesday, April 18, 2018

Failure to warn question remains regarding Armenians’ awareness of drug risks

By Robert B. Barnett Jr., J.D.

In an interesting twist on the well-publicized raft of lawsuits against GlaxoSmithKline (GSK) for failure to warn of the cardiovascular risks of the diabetes drug Avandia®, a California appellate court has reversed a trial court’s grant of summary judgment for GSK on statute of limitations grounds. Given that the plaintiffs were Armenians with poor English language skills, a triable issue of fact remained as to when they learned of the connection between Avandia and cardiovascular disease. Another court considering this matter had established that the general public was made aware of the connection no later than December 31, 2007. The correct rule to apply in this case, however, was whether these plaintiffs, given their limited access to the English language media reports that put everyone else on notice, should have been aware of information that would have put a reasonable person on inquiry notice more than two years before their suit was filed in 2011 (Tsaturyan v. GlaxoSmithKline, LLC, April 16, 2018, Perluss, D.).

Four Armenian-Americans living in California began taking Avandia between 2002 and 2007 to treat type 2 diabetes. All four Armenians developed cardiovascular disease. In May 2007, the New England Journal of Medicine published a study finding that Avandia significantly increased the risk of myocardial infarction. Release of the study triggered widespread publicity, which caused the FDA to force GSK to add a warning box on Avandia’s product labeling. Later in 2007, the FDA again forced GSK to revise the warning, and, in September 2010, the FDA restricted access to Avandia. All of these events were widely reported in the media, and Congressional hearings were held. Publicity was such that, by October 2007, all of the federal lawsuits from 37 jurisdictions that had been filed were consolidated in a Pennsylvania federal district court. One result of this multidistrict litigation was that the court established that the general public, due to the widespread publicity, was made aware of the connection between Avandia and cardiovascular disease no later than December 31, 2007.

Meanwhile, in 2011, the four Armenians sued GSK in Los Angeles county court for failing to warn of the risks, asserting causes of action for negligence, strict liability, and fraud. In January 2016, the trial court granted GSK’s motion for summary judgment, ruling that they were on notice of the connection no later than December 31, 2007, which meant that the two-year statute of limitations for product liability claims had lapsed. They appealed to the Second Appellate District, contending that the trial court erred when it imputed the widespread media coverage to them because they had no access to English-language media and they spoke or understood English poorly.

Discovery rule. California has a two-year statute of limitations for injury to an individual caused by the wrongful act or neglect of another. The well-known discovery rule, however, delays accrual of the cause of action until the plaintiff has, or should have, inquiry notice of the cause of action. When that date occurs, the appellate court said, is generally a question of fact. While it is undisputed that widespread publicity surrounded Avandia and its connection to cardiovascular disease, it is also undisputed that GSK offered no evidence that the extensive news coverage extended to Armenian-language broadcasting or print media (the Armenians contended that they did not learn of the connection until they saw advertisements on Armenian television in 2010). In determining how the discovery rule applied to these facts, the appellate court actually rejected both parties’ interpretation of the discovery rule.

The court rejected the Armenians’ contention that the rule is a partially subjective determination whether these plaintiffs possessed information that would cause a reasonable person to inquire about his or her injuries. It also, however, rejected GSK’s contention that the previous determination that a reasonable person would have been on notice in 2007 was imputed to the Armenians. The correct rule of law, the appellate court said, was whether these plaintiffs should have been aware of information that would have put a reasonable person on inquiry notice. It is possible, as the court admitted, that GSK will be able to prove that the Armenians had a reasonable opportunity to obtain information about Avandia’s risks (for example, from their doctors). At present, however, no such evidence existed, which meant that the trial court erred when it granted summary judgment to GSK.

The case is No. B275168.

Attorneys: Terence J. Mix (Terence J. Mix, Attorney at Law) for Sofik Tsaturyan. Sonja S. Weissman (Reed Smith LLP) for GlaxoSmithKline LLC and McKesson Corp.

Companies: GlaxoSmithKline LLC; McKesson Corp.

MainStory: TopStory SofLReposeNews DrugsNews WarningsNews CaliforniaNews

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