New Hampshire Jury Deliberates Federal Drug Liability Case

September 7, 2010

A New Hampshire woman is seeking more than $24 million in damages from the maker of a prescription drug she took to ease shoulder pain, but suffered a reaction so severe that she is now blind and scarred by internal and external burns.

A federal jury began deliberations Friday after a 14-day trial in the products liability lawsuit filed by Karen Bartlett, 51, of Plaistow against Philadelphia-based Mutual Pharmaceutical Co. Mutual manufactures and distributes a generic brand of Sulindac. Clinoril, which Bartlett’s doctor prescribed, is the brand name associated with Sulindac, an anti-inflammation drug.

The jury went home at 4 p.m., and is scheduled to resume deliberations today.

Bartlett’s lawyers called Sulindac a needless and useless drug that poses unreasonable risk to consumers. Lawyers for Mutual countered that sulindac has been marketed for 32 years and that all drugs carry risks of side effects.

Lawyers for Mutual vigorously cross-examined Bartlett’s witnesses, but did not call witnesses of their own.

Bartlett began taking Sulindac in January 2005 to treat shoulder pain. She was 45 and otherwise healthy. Two weeks later she noticed red spots on her face and irritation around her eyes. She was admitted to the hospital two days later, complaining of feeling like there were “pebbles” under her eyelids and in her throat, and suffering from a worsening rash.

She was diagnosed as having Stevens-Johnson Syndrome and Toxic Epideral Necrolysis (SJS/TEN) _ potentially fatal skin diseases that inflame the mucus membranes and eyes and are marked by a skin rash that burns off the outer layer of skin. She spent 112 days in five hospitals, including the Massachusetts General Hospital Burn Unit. The disease also seared her throat, stomach and lungs, causing permanent disabilities.

“It literally burned her alive,” Bartlett’s lawyer, Keith Jensen, told jurors during closing arguments Thursday. “It burned 65 percent of the skin off her body … It burned her inside and out. ”

Jensen said Sulindac has the highest reported incidents of SJS/TEN of any non-steroid, anti-inflammatory drug on the market _ 89 _ in arguing the drug’s dangers outweighed any benefit it offered that couldn’t have been derived from aspirin or many other drugs.

Joseph Thomas, arguing for Mutual, attacked the credibility of Bartlett’s experts.

“It is more than remarkable that two experts would come into this courtroom and tell you a drug approved by the FDA for 32 years should be removed from the market,” Thomas said. “A reality in society, and in the medical society, is there are risks associated with drugs. There are a lot of drugs on the market, and a lot of drugs have side effects.”

U.S. District Judge Joseph LaPlante told jurors that to hold Mutual liable, they had to find the drug was unreasonably dangerous and was the cause of Bartlett’s condition.

In 2005, Mutual changed the warning label accompanying Sulindac to elaborate on its possible side effects, including SJS/TEN.

Bartlett is seeking $4.5 million for past and future medical bills and lost earning capacity. Jensen displayed pictures contrasting Bartlett’s smiling face before her hospitalization with her disfigured face and eyes after her hospitalization in arguing for an additional $20 million to $30 million in damages to compensate for pain, suffering and loss of enjoyment of life.

Bartlett, who has undergone 12 eye operations, is legally blind. When the jury was not in the courtroom, her husband, Greg, escorted her to and from her seat alongside her lawyers.

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