(May 13, 2012) – Concord, N.H. – A federal appeals court has upheld the largest ever verdict in a New Hampshire products liability case. A federal jury in September, 2010, awarded a Plaistow woman $21.6 million after determining that a prescription drug she took to relieve shoulder pain caused blindness and severe burning of her skin and mucus membranes.
The First Circuit Court of Appeals upheld the verdict against Philadelphia-based Mutual Pharmaceutical, manufacturer of the generic, anti-inflammatory drug sulindac. The pharmaceutical company challenged the verdict as excessive, in particular, targeting the $16.5 million the jury awarded for pain, suffering, and loss of enjoyment of life. But the appeals court upheld the award, stating in its ruling that the victim’s “injuries were truly horrific.”
The 51 year old woman sought treatment for right shoulder pain (bursitis). Her physician prescribed a non-steroidal anti-inflammatory (“NSAID”) drug called Clinoril. Her pharmacist filled her prescription with Sulindac, the generic version of Clinoril, manufactured by Mutual Pharmaceutical Company (“Mutual”). Two weeks after Sulindac, she was diagnosed with Stevens-Johnson Syndrome (“SJS”) progressing to toxic epidermal necrolysis (“TEN”), a serious and potentially fatal condition characterized by necrosis (death of tissue due to injury) of the skin and mucus membranes.
The victim’s lawsuit against Mutual included claims for strict products liability — specifically, failure to warn, defective design, fraud, and negligence. During discovery, it was learned that the year prior to the victim’s physician prescribing Clinoril to her, an international medical journal found a link between NSAIDs and the conditions the victim 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. In addition, 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, as Mutual is the generic brand manufacturer.
The victim filed for summary judgment on her negligence claim based on Mutual’s failure to survey medical literature for adverse events associated with Sulindac, but the court interpreted this regulation to require generic manufacturers develop procedures for surveying medical literature for information and studies on safety risks. Therefore, the question became whether Mutual 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 though the FDA does not provide for a private right of action. Since New Hampshire case law could not answer this question, the court denied the victim’s motion for summary judgment.
The victim spent almost two months in the burn unit of Massachusetts General Hospital, and additional months in a medically-induced coma, as doctors treated burns over almost 65 percent of her body. She has had more than a dozen operations on her eyes and is legally blind. During testimony at her trial, her burn surgeon described her experience as “hell on earth.”
First circuit judge Michael Boudin wrote in the court’s unanimous ruling that the permanent damage to the victim from her reaction to the drug is “severe.” “She cannot eat normally due to esophageal burns, cannot have sexual relations due to vaginal injuries, and cannot engage in aerobic activities due to lung injuries,” Boudin wrote. “She cannot read or drive to work. She is seriously disfigured in face and body.”
Sulinac is a non-steroidal, anti-inflammatory drug (NSAID). The victim’s doctor prescribed it in December 2004 for shoulder pain. The court noted that the consequences “were disastrous.” Evidence presented during the 14-day trial included graphic photographs of ulcerated burns on her body and her disfigured eyes.
The victim said at the time of her trial that she brought the lawsuit to help educate the public. “I never knew something like this could happen just from taking medication,” she said. Her symptoms began within weeks of going on this medication.
Lawyers for Mutual Pharmaceutical did not immediately return calls seeking comment. It is not known whether they plan further appeals. New Hampshire U.S. District Judge Joseph Laplante had instructed the jury that to hold Mutual liable, they had to find that the drug was unreasonably dangerous. The appeals court, in its May 2nd ruling, also rejected Mutual’s challenge to the qualifications of the victim’s expert witnesses.
Mutual cross-examined the victim’s witnesses, but did not put on witnesses of its own. One of the victim’s lawyers had stated that no one is more deserving of compensation than she, and that she faced this with courage and grace and is hopeful she will finally have justice in the near future.