Up in smoke: CSA affirms verdict for drugmaker in Actos litigation

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In the end, Diep An’s years of smoking blocked any chance his widow and three children had of collecting the more than $1.75 million a Baltimore City Circuit Court jury tentatively awarded them last year against a drug company whose diabetes medication was linked to his bladder cancer.

The same jury that found the company negligent for failing to warn doctors of the drug’s risk also found An contributorily negligent in his cancer death due to his smoking. Maryland is one of a handful of states where contributory negligence is an absolute bar to recovery in a negligence action.

The family’s attorney tried to revive the award on appeal.

Their lawyer, Stuart O. Simms, argued that a “negligent” failure to warn is essentially the same as “strict liability” for the failure because both claims involve the company’s breach of its duty to warn doctors of the drug’s harmful side effect, which the company knew or should have known about.

But in a 3-0 decision last week, the Court of Special Appeals rejected that argument.

Maryland law regards the failure-to-warn claims as “two separate actions,” with strict liability focusing on the product and negligence on the manufacturer’s conduct, the intermediate appeals court held.

Specifically, a company is strictly liable if its lack of adequate warning made the product unreasonably dangerous. The jury rejected that claim by the family, the opinion notes.

Negligence, on the other hand, concerns a company’s failure to exercise due care in formulating and updating the warning, Judge Michele D. Hotten wrote in the Court of Special Appeals’ unreported opinion.

“[I]n this case, a reasonable jury could have concluded that Actos was not unreasonably dangerous, but that Takeda was negligent in the size or location of the warning,” Hotten added in quoting Baltimore City Circuit Judge M. Brooke Murdock explanation for why she rejected the family’s challenge to the jury’s verdict in September 2013.

The jury deliberated less than a day after a four-week trial, in which the family’s attorneys argued that Takeda ignored clinical test results indicating a strong link between Actos use and bladder cancer. The company’s lawyers insisted the tests were inconclusive.

Deerfield, Ill.-based Takeda Pharmaceuticals America praised the Court of Special Appeals’ decision.

“We believe the ruling is in keeping with the evidence presented in the case,” the company said in a statement Tuesday. “Patient safety is a critical priority for Takeda. We remain confident in the therapeutic benefits of Actos as a treatment for type 2 diabetes.”

Simms, the family’s attorney, did not return telephone and email messages seeking comment on the decision and whether an appeal to Maryland’s top court — the Court of Appeals — is in the offing. Simms is with Brown Goldstein Levy LLP in Baltimore.

Takeda’s appellate counsel, James C. Fraser, declined to comment on the decision. Fraser is with Venable LLP in Baltimore.

In their lawsuit, An’s widow and three children said he died of bladder cancer on Jan. 14, 2012, because Takeda did not meet its legal duty to warn of the cancer risk from Actos beginning in 2007, when An began taking the drug for his type 2 diabetes.

The jury’s award of damages — rendered moot by An’s contributory negligence — included $540,000 to his widow, Camhong, for loss of consortium; $330,000 to the estate for non-economic damages; $295,000 to the estate for past medical expenses; and $200,000 to each of the three children.

The case is Camhong An et al. v. Takeda Pharmaceuticals America Inc. et. al, No. 2112, Sept. Term 2013.

Other litigation

The An family’s claim was one of at least three similar lawsuits that have been filed against Takeda in state and federal courts in Maryland.

On March 2, 2012, the estate and family of John Dunlavey Sr. filed suit in Baltimore City Circuit Court.

Dunlavey, a type 2 diabetic, began taking Actos in 2006, was diagnosed with bladder cancer in January 2009 and died March 15, 2009, according to the lawsuit filed by Michael Miller, a solo practitioner in Orange, Va. The case was removed to the U.S. District Court in Baltimore on April 19, 2012, on the company’s motion.

The estate and son of Myrtle Hunt filed suit in the U.S. District Court in Baltimore on April 9, 2012. Hunt, a type 2 diabetic who died of bladder cancer on Sept. 12, 2009, had taken Actos for approximately two years, according to the lawsuit filed by attorney Austin B. Kirk, of Saiontz & Kirk P.A. in Baltimore.

Both the Dulavey and Hunt cases have been transferred to federal court in Lafayette, La., which was chosen to handle the Actos cases under the federal multi-district litigation statute. The cases are pending.

In the first verdict at the federal court, a jury this year found Takeda and its former Actos sales and marketing partner Eli Lilly and Co. liable for New Yorker Terrence Allen’s bladder cancer, awarding him $9 billion in punitive and $1.75 million in compensatory damages. U.S. District Judge Rebecca F. Doherty reduced the punitive damages award to $36.8 million in October, with Takeda responsible for $27.6 million.

Takeda and Eli Lilly said they plan to appeal.

Actos has also had a checkered regulatory history.

The U.S. Food and Drug Administration approved the drug in 1999 for type 2 diabetes, the most common form, but released a safety advisory on June 15, 2011, stating that using Actos for more than one year “may be associated with an increased risk of bladder cancer.” That same month, Germany and France suspended distribution of the drug due to its suspected link to bladder cancer.