Brand-Name Drug Makers' Liability for Generics Upheld by Ala. Court
The Alabama Supreme Court has upheld its earlier ruling that brand-name drug manufacturers can be held liable for warning labels on generic versions of their drugs.
The ruling allows an Alabama man who claims he was injured by a generic version of the heartburn drug Reglan to bring suit against Pfizer (which bought Wyeth, the company that originally produced Reglan), even though the man never actually took any of the drugs manufactured by the company, The Wall Street Journal reports.
What was the court's rationale in allowing the man to bring suit?
2013 Ruling Applied 'Innovator Liability'
The court first ruled on the case, Weeks v. Wyeth, in 2013. Plaintiff Danny Weeks claimed he suffered from a movement disorder caused by taking a generic form of Reglan; the disorder was not included in the drug's side-effect warnings. But thanks to a 2011 U.S. Supreme Court case, generic drug manufacturers are no longer liable for the information included on drug warning labels. So Weeks instead sought to sue the brand-name drug maker Pfizer for failure to warn.
In holding that Weeks could indeed bring suit against Pfizer, the court seemed to invoke a somewhat novel legal theory known as "innovator liability" in which the creator of a technology is responsible for future harm caused by products using that technology, even when those products are produced by someone else.
Rehearing Finds Ruling 'Not Fundamentally Unfair'
After rehearing the case, the Alabama Supreme Court held last week that "it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce," in part because generic drug manufacturers are bound by law to match the warnings provided on the brand-name versions of the drugs they are replicating.
The Alabama Supreme Court is careful to note, however, that rather than promulgate so-called innovator liability on a wider basis, the court's ruling in the case is specific to prescription drugs. As the court explained, a prescription drug is "a product that, unlike any other product on the market, has unprecedented federal regulation."
- Alabama high court upholds generic drug decision (USA Today)
- Lawsuit Over Hormone Drug Forces Wyeth and Pfizer to Pay (FindLaw's Injured)
- Pfizer to Face Defective Birth Control Lawsuits? (FindLaw's Injured)
- Post-PLIVA Plaintiff Loses Failure to Warn Claim (FindLaw's U.S. Fifth Circuit Blog)