Failure-to-Warn Generic Drug Claims to Move Forward in Court

Dangerous drug lawyers at Pintas & Mullins Law Firm report on a recent ruling by the Pennsylvania Supreme Court allowing all claims brought against makers of the generic Reglan to move forward. This is a substantial win for drug injury plaintiffs, who were devastated by the ruling of Mutual Pharmaceuticals vs Bartlett, which shielded generic manufacturers from liability.

Defendants in this case, the manufacturers of generic Reglan (an acid reflux and heartburn medication), attempted to have all injury claims dismissed based on the recent SCOTUS ruling. The case, Mutual Pharmaceuticals vs Bartlett, revolved around a woman who was permanently and catastrophically injured after taking the painkiller sundilac, which is the generic of Clinoril. Bartlett successfully sued Mutual Pharmaceuticals for her injuries, winning $21 million on design defect claims.

In an upsetting decision, the Supreme Court ruled that Bartlett had no ground to sue the generic manufacturer for selling her a defectively designed drug because sundilac was merely an exact replica of Clinoril, which was approved by the FDA and not designed by the generic manufacturers.SCOTUS reasoned that since Mutual was unable to change sundilac’s labeling, it could not be held liable for its inherent dangers and consequent injuries.

Similarly, plaintiffs in Pennsylvania are attempting to sue the companies that manufacture metoclopramide, the generic version of Reglan, for causing them to develop tardive dyskinesia, which is a neurological disorder. The plaintiffs allege that the generic companies, PLIVA Inc., Hospira Inc., and Teva Pharmaceuticals, failed to warn them about the risks of serious injury.

The defendants appealed, claiming that the case was preempted by PLIVA vs Mensing, wherein SCOTUS ruled that generic manufacturers could not be held liable for consumers’ injuries because they were required under federal law to maintain the same ingredients and labels as brand-names.

Plaintiffs are now attempting to argue that their claims are not simply of failure to warn, but of strict liability and negligence for selling and marketing a drug the companies knew was unreasonably dangerous and defective. The Pennsylvania court agreed with them, at least for now. The court ruled that plaintiff’s allegations against metoclopramide did not necessarily implicate labeling, but suggest that the companies should be liable based on their sales of a defective product. The ability to relabel or redesign a drug, the court observed, was not an element of the plaintiffs’ action.

Pennsylvania supported the plaintiff’s notion that strict liability, negligence, and breach of warranty claims were not necessarily the same as failure-to-warn claims. Additionally, while federal labeling statutes do preempt state laws, they do not preempt claims based on selling and marketing defective products, lack of due care in testing, or a product’s failure to conform to warranties.

By suing the manufacturers for breach of implied and expressed warranty, plaintiffs are seeking to impose liability for failing to deliver a product that conformed to its labels and promotional materials. They claim, and the court agrees, that their cases are not premised on the inadequacy of the label, but on the drugs’ failure to live up to its advertising.

Plaintiffs are also seeking to expel the profits Hospira, Teva and PLIVA made from metoclopramide because they stemmed from deceptive practices and concealment and withholding of information. The court affirmed that this claim was not preempted, as it applied to state remedies for fraudulent and tortious business practices.

Pennsylvania’s assertion that state negligence claims based on misbranding of drugs were preempted neither by Mensing nor Bartlett is a huge step forward for those injured by generic medications. Defective drug lawyers at Pintas & Mullins Law Firm will continue to report on this case, as well as any others directly relating to generic drug litigation throughout the country. If you or a loved one was seriously injured by a defective or recalled drug, you may be entitled to compensation for past and future medical bills, lost wages, and pain and suffering.