• 07
  • May
    2012

Our Houston readers are used to seeing news about injury cases involving awards or settlements against brand name drug companies which manufacture dangerous drugs, and there is good reason for that. As we've written previously, generic drug manufacturers cannot be held liable for failing to provide warnings which aren't provided by the brand-name pharmaceuticals on which the generics are based.

As a recent case shows, however, there is still some question as to whether federal law permits claims against generic drug companies for design defects.

The case at issue involves a New Hampshire woman who had suffered a severe skin reaction after taking the generic anti-inflammatory drug sulindac for shoulder pain. As a result of taking the drug, she suffered burns on two-thirds of her body and permanent near-blindness.

According to the 1st U.S. Circuit Court of Appeals, who upheld the woman's $21 million jury award, the drug was unreasonably dangerous due to its risk of causing Stevens Johnson syndrome, a life-threatening skin reaction.

Referring to the 2011 case that insulated generics from liability for label warnings not provided by brand name pharmaceuticals, the court said that the Supreme Court would have to issue a separate ruling in order to extend that decision to design defects and that generics are liable for them until then.

Attorneys for the generic drug company in the case were upset by the decision, pointing to FDA approval of the drug, but the plaintiff's attorney noted that the drug's risks outweigh its benefits, and generic drug makers should be responsible for injuries occurring in the sale of the product.

Source: Thomson Reuters News & Insight, "1st Circuit affirms $21 mln award in generic drug suit," Terry Baynes, May 4, 2012.