One issue in a recent decision by the District Court of New Hampshire was whether a generic manufacturer’s failure to comply with Food an Drug Administration (“FDA”) regulations constitutes a per se violation of its duty of care under New Hampshire law. Bartlett v. Mutual Pharm. Co., No. 08-CV-358-JL, 2010 WL 2765358 (D.N.H. Jul. 12, 2010). Judge Joseph N. Laplante answered in the negative, holding that the jury could consider the violation as evidence of a breach but it was not a per se breach of duty.
, Karen Bartlett sought medical treatment for right shoulder pain. Her physician prescribed a non-steroidal anti-inflammatory (“NSAID”) drug called Clinoril
. Bartlett’s pharmacist filled per prescription with Sulindac, the generic version of Clinoril, manufactured by Mutual Pharmaceutical Company (“Mutual”). Two weeks after taking Sulindac, Bartlett was diagnosed with Stevens-Johnson Syndrome
(“SJS”) progressing to toxic epidemal necrolysis
(“TEN”), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes.
As a result, Bartlett filed suit against Mutual asserting state law claims for strict products liability – failure to warn, strict products liability – defective design, fraud, and negligence. During discovery, it was found that the year prior to Bartlett’s physician prescribing Clinoril to her, an international medical journal found a link between NSAIDs and the conditions that Bartlett suffered from. It found 89 reported cases of SJS/TEN over a 17 year period in patients taking Clinoril, more than any other NSAID on the market. Also during discovery, Mutual admitted not being aware of the study and not monitoring medical literature for information on Sulindac’s safety risks. According to Mutual, the manufacturer of the brand named drug was responsible for monitoring safety risks.
On cross-motions for summary judgement, Bartlett argued that she was entitled to summary judgement on her negligence claim based on Mutual’s failure to survey medical literature for adverse events associated with Sulindac. Bartlett based this argument on the FDA requirement that generic manufacturers “develop written procedures for the surveillance . . . of post-marketing adverse drug experiences to the FDA.” 21 C.F.R. Section 314.80(b).
The Court interpreted this regulation to require generic manufacturers to develop procedures for surveying medical literature for information and studies on safety risks. Therefore, the question became whether Mutual’s admitted violation of this safety regulation versus violation of a statute could be a per se violation of its duty of care. The Court found that courts were split over whether plaintiffs could seek to enforce a FDA violation through a negligence per se action even thought the FDCA does not provide for a private right of action. Judge Laplante found no clear answer in New Hampshire but held that the New Hampshire Supreme Court would likely not treat the violation as negligence per se. Therefore, the court denied Bartlett’s motion for summary judgment and ruled that the jury could consider the violation as evidence of breach.
Drug manufacturers, generic and named-brand, must be aware of these FDA regulations governing surveillance of medical literature. Compliance with these regulations will be especially relevant in states that consider violations as negligence per se and not merely evidence of breach for the jury to consider.