Drugmaker Cleared Over Woman's 'Horrific' Injury

[The Straight Story]

Drugmaker Cleared Over Woman's 'Horrific' Injury


WASHINGTON (CN) - A drugmaker does not owe $21 million to a woman whose skin was burned off by a rare side effect associated with pain relievers, the Supreme Court ruled Monday.

Karen Bartlett's doctor prescribed her sundilac, a nonsteroidal anti-inflammatory drug (NSAID), in 2004 when she complained of shoulder pain. Though the doctor prescribed the name-brand Clinoril, her pharmacist dispensed a generic by Mutual Pharmaceutical and other companies.

A rare side effect of sulindac is a hypersensitivity reaction called Stevens-Johnson Syndrome or the more etreme toxic epidermal necrolysis (SJS/TEN).

Bartlett ultimately developed SJS/TEN in 2005 and lost 60 to 65 percent of the outer layer of her skin.

She was hospitalized for 70 days, nearly two-thirds of which were spent in the burn unit, and she became permanently near blind.

A federal jury in New Hampshire ordered Mutual Pharmaceutical to pay Bartlett $21.06 million for design defect, the largest award in New Hampshire's history, and the 1st Circuit affirmed in May 2012.


"She spent almost two months in MGH's burn unit, spent months in a medically-induced coma, and suffered burns over nearly two-thirds of her body," the judges continued. "Her burn surgeon described the experience as 'hell on earth.' She spent a year being tube fed and endured two major septic shock episodes. She suffered through 12 eye surgeries and has many more ahead of her. ...

....

Though the Supreme Court also expressed sympathy for the tragedy that befell Bartlett, a five-justice majority concluded Monday that federal pre-emption warrants reversal.

"New Hampshire law imposes a duty on manufacturers to en­sure that the drugs they market are not unreasonably unsafe, and a drug's safety is evaluated by reference to both its chemical properties and the adequacy of its warn­ings," Justice Antonin Scalia wrote for the court. "Because Mutual was unable to change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings. But, as this court recog­nized just two Terms ago in PLIVA, Inc. v. Mensing , ... federal law prohibits generic drug manu­facturers from independently changing their drugs' labels. Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are 'without effect.'

http://www.courthousenews.com/2013/06/24/58783.htm

[mhatrw]

1. SCOTUS: All Corporate, All the TIme

[Archae]

2. How many actual cases of these burns are there?

Just that poor woman?
I do feel for her, I have a sister who had a horrendous reaction to 'The Pill.'
Nearly killed her too.

A few people, (VERY few in nearly all cases,) have bad reactions to drugs.

Sometimes drug makers will OVER-react to a few bad reactions, like when Darvon was yanked off the market.

[nomorenomore08]

3. Darvon killed (or helped kill) Lester Bangs. That's enough for me, damn it!

Granted, he wasn't exactly using the stuff as directed...

[Archae]

5. And it wasn't just Darvon.

"Bangs died in New York City on April 30, 1982, of an accidental overdose of Darvon, Valium, and NyQuil."

Yeep.

[nomorenomore08]

6. An OD is always a sad, rather pointless way to go. But that combo is honestly kind of pathetic.

I mean, he could've at least mixed the Valium and NyQuil with a stronger opiate.

[nomorenomore08]

4. Disfigured and nearly blind. Talk about a fate worse than death.

Though it seems the drug company was ultimately not responsible for her very rare allergic reaction.