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Woman Receives $21M In Side Effect Suit

By Drug Discovery Trends Editor | September 9, 2010

CONCORD, N.H. (AP) – A federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain.

Karen Bartlett, 51, of Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac. After three days of deliberations, the jury found Wednesday that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers.

Bartlett’s attorneys said it was the largest award in a New Hampshire product liability case. The largest previous award was $13 million in a 1993 case involving a construction site accident.

Pierre Chabot, one of Mutual Pharmaceutical’s attorneys, declined to comment on the verdict.

Bartlett said her goal in filing the lawsuit was to educate others about the dangers of prescription drugs.

“That was my biggest thing – getting the word out,” Bartlett said. “Before this happened to me, I never knew something like this could happen just from taking medication.”

Bartlett wept as she hugged her lead attorney, Keith Jensen. She said the verdict was a source of consolation, and that the road to reach it has been “very nerve-racking, very emotional and very long.”

Bartlett began taking Sulindac in January 2005 to treat shoulder pain. Two weeks later, she noticed red spots on her face and irritation around her eyes. She was admitted to the hospital on Feb. 2, 2005, 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 epidermal 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 last week. “It burned 65 percent of the skin off her body … It burned her inside and out. “

Bartlett has undergone 12 eye operations and is legally blind. Her husband, Greg, would escort her to and from her seat beside her lawyers while the jury was out of the courtroom.

Bartlett sought $4.5 million for past and future medical bills and lost earning capacity. Jensen asked jurors to award her an additional $20 million to $30 million to compensate for pain, suffering and loss of enjoyment of life.

Evidence presented during the 14-day trial included graphic photographs of ulcerated burns on her body and of her disfigured eyes.

Jensen said Sulindac has the highest reported incidents of SJS/TEN of any non-steroidal anti-inflammatory drug on the market in arguing the drug’s dangers outweighed any benefit it offered.

“This drug should not have been on the market when it was prescribed for Mrs. Bartlett and it shouldn’t be on the market now,” Jensen said after the verdict.

Joseph Thomas, arguing for Mutual, had attacked the credibility of Bartlett’s experts and said the drug has been approved by the Federal Drug Administration for 32 years. Lawyers for the pharmaceutical company cross-examined Bartlett’s witnesses but called no witnesses of their own.

“A reality in society, and in the medical society, is there are risks associated with drugs,” Thomas said, in his final argument. “There are a lot of drugs on the market, and a lot of drugs have side effects.

U.S. District Judge Joseph LaPlante had instructed 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.

Clinoril, which Bartlett’s doctor prescribed, is the brand name commonly associated with Sulindac.

Date: September 8, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

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