A brand-name drugmaker can be held liable for labeling-related fraud or misrepresentation even when the product in question is simply a copy of one of its branded medicines sold by a competitor, according to a ruling from the Alabama Supreme Court.
The plaintiff, Alabama resident Danny Weeks, brought suit against several drugmakers after he said he suffered from the movement disorder tardive dyskinesia as a result of using generic versions of the acid reflux drug Reglan. In addition to suing Actavis and Teva, the companies that produced the generic version of the drug, he also sued Pfizer, Wyeth, and Schwarz Pharmaceuticals, which sold and made the brand name version.
Though the brand name producers sought to dismiss the claim, arguing they had no responsibility to warn about the risks associated with the use of a product manufactured by competitors producing a generic version, the court said that under Alabama law brand name manufacturers do have a duty to provide a warning to doctors about the long-term risks of the drug.
“Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company,” the court said in its ruling.
That’s good news for Weeks, who may have trouble advancing his claims against the generic drugmakers. In 2011, the U.S. Supreme Court in the case of Pliva v. Mensing ruled that since generic drugmakers are required to use the same label as the branded version of the drug and cannot change warning labels without violating federal requirements, failure-to-warn claims cannot be brought against generic drug manufacturers.
“It is not fundamentally unfair to hold the brand-name manufacturer liable for warning on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer,” the court said.
An attorney for Pfizer called told The New York Times that the ruling was a “surprise” because it ran contrary to the rulings of more than 70 court decisions nationwide. Only two other courts have shared the view of this ruling.
Though the ruling is based on Alabama law, it could have ramifications beyond the state’s borders as plaintiff’s attorneys are expected to see in it a new avenue of pursuit in similar cases.
January 18, 2013
http://www.burrillreport.com/article-court_ruling_creates_liability_for_branded_drugmakers.html