COVID-19 Resource Center

May 28, 2014

Innovator Liability Possible on the Rise

The plaintiff's bar continues to try novel theories to escape the effects of the United States Supreme Court decision of Pliva v. Mensing. In Mensing, the Supreme Court held that generic drug manufacturers are immune from liability as long as they had the same label as the innovator or brand name drug manufacturer. The Mensing decision made it nearly impossible for a consumer to sue a generic drug manufacturer on state causes of action, including strict liability and failure to warn. Since Mensing, generic drug users have been searching for possible avenues of legal recovery after incurring an injury. Surprisingly, the pharmaceutical industry was hit with two rare and unforeseen setbacks. In recent decisions by the Alabama Supreme Court and the Northern District Court in Illinois, the courts held that a drug company can be held liable for the ingestion of a generic drug it did not produce.

In Wyeth, Inc., et al v. Danny Weeks, et al., Mr. Weeks alleged that he suffered injuries allegedly caused by his ingestion of the generic version of the acid reflux drug, Reglan. His case sounded in fraud and misrepresentation and sued Wyeth, although the company did not manufacture the drug that he took and had exited the market by 2002, five years before he took the drug. The court ruled that Wyeth could be liable for Week’s injuries because the generic manufacturer cannot change the warning labels on its product based on FDA regulations and is only allowed to copy verbatim the Wyeth label.

Likewise, in Dolan v. Smithkline Beecham Corp. (GSK), the plaintiff claimed that her husband committed suicide after ingesting paroxetine, a generic version of the drug Paxil. She sued on the theories of negligence and strict liability and argued that GSK was responsible because the generic drug’s design and warnings were based on those of Paxil as required by Federal Law. The court dismissed the strict liability claims on summary judgment, but declined to dismiss the negligence claims. The court reasoned that since the generic labeling had to mirror that of GSK, GSK had, in fact, essentially labeled the generic version of the drug. The court also stated that they were not constrained under Illinois law to construe the common law claims of negligence as product liability claims, which would have been barred on Mensing.

What It Means to You

The question before us is whether innovator liability will gain momentum in the courts. Prior to these decisions, theories based on innovator liability were routinely dismissed. Still too early to anticipate whether these decisions will be a true setback for the industry, more and more courts are forced to face the continuing barrage of novel theories to circumvent the Mensing decision.