13 July 2014
The Supreme Court of Iowa handed Schwarz Pharma Inc. and Pfizer Inc. a win on Friday, affirming that the companies don't have to face claims from a woman who took a generic version of Schwarz's brand name drug Reglan. The woman's lawyers had argued that her claims against the brand drugmakers should be reinstated under a theory known as innovator liability, but the court called such an approach a "slippery slope."
"We are unwilling to make brand manufacturers the de facto insurers for competing generic manufacturers," Iowa Supreme Court Justice Thomas Waterman wrote in Friday's 91-page decision.
The ruling, however, revives claims against drugmaker Pliva Inc., which distributed the generic version of Reglan taken by the plaintiff. Pliva had previously persuaded two lower courts that the plaintiff's state-law failure-to-warn claims were preempted under federal drug labeling laws, citing the company's own U.S. Supreme Court win in Pliva Inc. v. Mensing. But the court concluded Friday that the preemption defense didn't apply to generic Reglan sold without a stronger warning label for the branded drug that the Food & Drug Administration approved in 2004.
The plaintiff, Theresa Huck, developed tardive dyskinesia—a severe, often irreversible neurological disorder that leads to involuntary, uncontrollable body movements—after taking generic Reglan to treat acid reflux in 2004. A lower court will now reconsider Huck's claims against Pliva based on the generic's failure to adopt FDA-approved warning language related to the risks of prolonged Reglan use.
After acquiring the Reglan brand around 1989, Wyeth Inc. sold the rights and liabilities associated with the drug to Schwarz Pharma in 2001. In addition to the branded Reglan tablets, a generic form of the drug was made and distributed by Pliva. Huck sued Pliva, Schwarz and Wyeth in 2008, a year before Wyeth was acquired by Pfizer.
We reached out to Huck's lawyer, Terrence Donahue Jr. of McGlynn Glisson & Mouton, but didn't immediately hear back. Jeffrey Peck at Ulmer & Berne, who represents Pliva, referred us to a company spokesman who couldn't immediately be reached.
Mayer Brown partner Hank Bullock, who represents Schwarz Pharma, delivered the winning arguments for the brand companies before the Iowa Supreme Court in January. Just last month, Bullock scored a similar victory at the U.S. Court of Appeals for the Sixth Circuit, which tossed claims against Eli Lilly and Xanodyne by plaintiffs who took generic versions of the drugs Darvon and Darvocet.
Bullock said Friday that his client was pleased with the Reglan decision. He said it follows a long line of decisions refusing to hold branded drugmakers liable for claims related to other companies' generic versions of their drugs.
Wyeth had counsel from Bradley Arant Boult Cummings. Nyemaster, Goode, West, Hansell & O’Brien served as local counsel for both brand-name companies.
Reprinted with permission from the July 13, 2014 edition of The Litigation Daily © 2014 ALM Properties, Inc. All rights reserved. Further duplication without permission is prohibited.