The Supreme Court recently heard oral arguments in a case that could have profound implications on product liability for drug manufacturers. The case, Mutual Pharmaceutical Co. v. Bartlett, may open a new avenue for lawsuits against large drug companies. The decision centers on Karen Bartlett, a woman from New Hampshire that experienced serious side effects to her skin after being prescribed Mutual’s generic non-steroidal anti-inflammatory drug, Sulindac. In this case, Bartlett filed a lawsuit against Mutual under New Hampshire law, claiming that the drug was “unreasonably dangerous” and was too risky to remain on the market.
The case deals with complicated laws regarding federal preemption of drug companies from state tort claims. Essentially, the Supreme Court will decide whether generic drug companies, which are required under federal law to have the same design as their name-brand counterparts, are shielded from state lawsuits by plaintiffs. These drugs are approved by the FDA, but some plaintiff attorneys are advancing a novel legal theory that argues that despite federal approval, these drugs were unsafe from the outset and never should have been released to the market.
This case could have serious impacts on product liability, drug safety, and access to generic medications. The competing interests are affordability of medications (which generic drug manufacturers achieve by copying brand-name drugs) and drug safety. On the drug safety front, plaintiff attorneys are arguing that allowing state lawsuits to be filed against drug manufacturers would disincentivize companies from keeping dangerous products on the market. The FDA has acknowledged that it has difficulties regulating drugs once they are put on the market, as previously unknown latent defects often become apparent after approval. Therefore, some experts have suggested that the FDA’s mission to provide safe drugs would be significantly aided by imposing state tort liability on drug manufacturers.
As stressed by Forbes, this theory will likely carry on to branded drug companies. Therefore, even if this case against a generic manufacturer fails, the Obama administration filed an amicus brief in this case that details how plaintiff attorneys could still use this novel theory against larger branded drug manufacturers. If this theory wins against either generic or brand-name drug companies, or both, it could be an extremely positive result for any patients injured by defective drugs. If Bartlett wins, it is possible that those injured by defective generic drugs could sue the manufacturer seeking compensation under state laws, an opportunity previously foreclosed from plaintiffs.