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High court will hear Actos failure-to-warn appeal

     ANNAPOLIS — With more than $1.75 million at stake, Maryland’s top court said it will consider whether a pharmaceutical company could be held financially liable for negligently failing to warn doctors about a drug’s potentially carcinogenic side effect even though the cancer victim contributed to the fatal disease by smoking cigarettes.

     The case before the Court of Appeals marks a challenge to the breadth of Maryland’s contributory negligence defense, in which defendants are absolved of any financial liability for their negligent acts if the plaintiffs contributed to their injuries at all through their own negligence. Maryland is one of a handful of states that hold contributory negligence to be a complete bar to recovery.

     In papers filed with the Court of Appeals, Diep An’s widow and children argue that Takeda Pharmaceuticals America Inc.’s negligent failure to warn doctors that its diabetes drug Actos could cause bladder cancer should be treated as a strict liability cause of action under Maryland law.

     If deemed a strict liability claim, Takeda’s successful trial defense of contributory negligence would not apply – and a jury’s award of more than $1.75 million could be reinstated.

     The Court of Appeals, which agreed on Friday to review the case, is expected to hear arguments in the case during its 2015-2016 session, which begins in September. A decision is expected by Aug. 31, 2016, in the case, Camhong An et al. v. Takeda Pharmaceuticals America Inc. et al., No. 19 Sept. Term 2015.

     The Baltimore City Circuit Court jury’s award in September 2013 for Takeda’s negligent failure to warn was struck by operation of law when the jurors concluded that An had contributed to his cancer by smoking cigarettes. The intermediate Court of Special Appeals upheld that verdict in December, concluding that a negligent failure to warn is distinct from a strict liability offense.

     But An’s family, in papers filed with the high court, said strict liability applies when a company fails to issue an adequate warning – regardless of the reason. Thus, the jury’s finding that Takeda negligently failed to warn should be viewed strictly as a failure to warn, stated Andrew D. Levy, the family’s lead appellate attorney, in the successful petition for the high court’s review of the case.

     “The jury found that Takeda negligently failed to issue an adequate warning, but as to the strict liability claim found that Takeda did not fail to issue an adequate warning,” wrote Levy, of Brown, Goldstein & Levy LLP in Baltimore.

     “This inconsistent verdict is impossible to reconcile,” Levy added. “It cannot be the case that Takeda adequately warned of Actos’s risk but at the same time negligently failed to do that very thing. A warning is either adequate or it is not, regardless of whether it is actionable under negligence or strict liability.”

     Levy cited the 4th U.S. Circuit Court of Appeals’ 1980 decision in Werner v. Upjohn Co. that a jury’s verdict of a negligent failure to warn was “obviously inconsistent” with its finding that the company was not strictly liable for an inadequate warning that its antibiotic Cleocin could cause colitis. Levy’s co-counsel are his law partners Stuart O. Simms, Andrew D. Freeman and Trevor H. Coe, as well as Michael J. Miller and Jeffrey Travers, of The Miller Firm LLC in Orange, Va.

     Takeda, through its counsel, responded that the Maryland Court of Appeals is not bound to follow decisions of the 4th Circuit on matters of state law. The company, in its failed request that the high court not hear the appeal, said the jury’s finding that Takeda was negligent is consistent with its conclusion that the drug maker is not strictly liable for a failure to warn.  

     A strict-liability claim focuses on the adequacy of the product itself — including the warning label approved by the federal Food and Drug Administration — and not on the manufacturer’s conduct, the company said. A negligence claim, by contrast, focuses on the alleged failure of the manufacturer “to do something that a corporation using reasonable care would do,” stated the company’s lead attorney, James C. Fraser, in papers filed with the Court of Appeals.

     Fraser is with Venable LLP in Baltimore, as are his co-counsel, Bruce R. Parker and Craig A. Thompson.

     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 state for non-economic damages; $295,000 to the estate for past medical expenses; and $200,000 to each of the three children.

     Actos has 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.

     Deerfield, Ill.-based Takeda Pharmaceuticals America has said it remains “confident in the therapeutic benefits of Actos as a treatment for type 2 diabetes.”