NH woman awaits U.S. Supreme Court appeal of $21M verdict against drug makerBy JASON SCHREIBER
Union Leader Correspondent
March 17. 2013 10:16PM
PLAISTOW - Karen Bartlett was living a normal life until Feb. 1, 2005.
That's when she began noticing a bad reaction to sulindac, a generic non-steroidal anti-inflammatory drug she'd started taking a few weeks earlier for shoulder pain.
Bartlett, now 53, discovered blisters on her face and other parts of her body. She had trouble breathing and experienced vision problems.
"It felt like I had sand in my eyes," she recalled.
Bartlett rushed to the emergency room for what she later learned was a drug reaction described as "hell on earth" by a burn surgeon. She was diagnosed with toxic epidermal necrolysis, a severe form of Stevens-Johnson Syndrome. It's a potentially fatal skin condition that can be caused by a reaction to taking drugs such as sulindac.
"Because of taking a generic drug, now my life is totally changed in all aspects," said Bartlett, who spent nearly two months in a medically induced coma in a burn unit. She said she suffered lung damage and burns over nearly two-thirds of her body, with her skin sloughing off. She also endured more than a dozen eye surgeries and is now legally blind.
Headed to high court
Bartlett sued the generic drug manufacturer, Mutual Pharmaceutical Company. After a two-week trial in 2009, a jury awarded her $21 million in damages.
Mutual appealed to the U.S. Court of Appeals of the First Circuit in Boston last year, arguing it's producing an FDA-approved drug and isn't liable, but the verdict was upheld.
On Tuesday, Mutual will take its appeal to the U.S. Supreme Court. Bartlett will be there as both sides argue a case that could decide whether the manufacturers of FDA-approved generic drugs can be held responsible and face lawsuits like the one Bartlett won.
Mutual argues that Bartlett's design defect claim is preempted by the federal Food, Drug and Cosmetic Act, which gives the Food and Drug Administration the authority to oversee the safety of food, drugs and cosmetics. The FDA approved sulindac in 1978 and Mutual's generic drug in 1991.
Federal law prohibits generic drug makers from altering the composition of brand-name drugs.
In this case, Bartlett's doctor prescribed sulindac under the brand name Clinoril, and her pharmacist dispensed generic sulindac.
In its brief filed in the Supreme Court case, the federal government urged the court to reverse last year's ruling that allowed the verdict to stand, writing in part, "Tort judgments second-guessing FDA's expert drug safety determination would undermine the federal regime to the extent that they forbade or significantly restricted the marketing of an FDA-approved drug."
It also states that the FDA conducted a "comprehensive review" of the risks and benefits of all NSAIDs and didn't conclude that sulindac should be removed from the market.
Keith Jensen, Bartlett's lawyer, argues that the risks outweigh sulindac's benefits and that there are more reports of reactions to the drug than to other similar drugs on the market.
"Two courts have concluded that sulindac is an unreasonably dangerous drug. Without suits like Karen's, blindness and death will result from people taking unreasonably dangerous drugs," he said, adding that generic drugs make up 75 percent of all drugs dispensed in the United States.
Jensen said that if the generic and brand name drug industry "get their way" in this case, lawsuits that could inform juries and the medical community of dangerous drugs "because of their changing risk benefit profiles will be abolished and there will be no mechanism to either, through lawsuits, alert the medical community of important issues, or to compensate victims like Karen who not only have been tragically injured but have also proven twice that the drug they took is an unreasonably dangerous drug."
Hell on earth
Eight years after suffering the reaction, Bartlett still sees numerous doctors on a regular basis and had to quit the job she loved with a local insurance company.
Bartlett said she can no longer drive and only walks to the mailbox because of her vision loss. She can't enjoy other things in life, like seeing her 28-year-old son, Matt, performing on stage.
"I go because I enjoy theater, but I just can't see him on stage," she said.
Like her burn surgeon, Bartlett said "hell on earth" is the only way to describe her experience.
"It's been terrible. I want people to be aware that drugs can do this. ... and I think they should be held accountable for the people that it harms," she said.