Tennessee drug injury liability lawsuits, drug injury lawyers, and those injured by prescription drug side-effects across the U.S. received surprising support with last week’s Supreme Court decision ruling against drug manufacturer Wyeth. The 6-3 decision in Wyeth v. Levine marks a sea change in the Court’s stance on liability law and has many pharmaceutical drug manufacturers sweating.
Since a 2006 executive order, pharmaceutical companies have been avoiding injury lawsuits for dangerous medical products by absurdly asserting that FDA approval means that a defective medical device or drug has been deemed safe. This, despite the public misconception that the FDA performs its own safety studies before approving prescription and OTC drugs; this, despite FDA officials admitting publicly that the agency lacks the resources to protect the public from dangerous drugs (and, I’m inferring, salmonella).
The pharmaceutical manufacturer’s appeal of a drug injury lawsuit won by Diana Levine, a Vermont musician, was what brought this drug injury lawsuit to the Supreme Court. Levine went to a clinic for migraine treatment where she was given Phenergan, a Wyeth-brand antinausea drug, via a IV-push. The injection went into Levine’s artery instead of her vein, which reduced the blood supply and led to gangrene that led to a two-stage amputation of her gangrened (which, despite how it sounds, rotted to a black color) right arm.
Although the package’s warnings were approved by the FDA, Levine’s drug injury attorneys argued that Wyeth, like many drug companies looking to maximize sells, diluted the wording of this warning. A Vermont jury (and, in 2006, the state supreme court) agreed and awarded the musician $6.7 million in damages for loss of her music and livelihood.
Because the drug label, as approved by the FDA, stated “extreme care” was required to avoid hitting an artery that would “likely” affect complications, including “gangrene requiring amputation,” Wyeth argued Levine had no right to sue. The Supreme Court announced, rightly, that state liability laws acted as a further check to the safety of drugs.
Wyeth Company may be extremely sensitive to this decision as rival pharmaceutical company Pfizer Inc. is expected to buy out Wyeth for $68 billion later this year. And there are at least 20 other cases of amputation due to gangrene from Phenergan since FDA approval for IV-push administration.
This decision is not, as both Wyeth and the Pharmaceutical Research and Manufacturers of America (PhRMA) have said, a matter of a jury deciding science or pharmaceutical drug safety. This is not a matter of drug injury lawsuits second guessing the educated guesses of an understaffed, interest-conflicted FDA. This Court decision is about justice for those injured by pharmaceutical drugs and making these drug manufacturer’s liable for the injury their products cause. When any company makes obscene profits and has undue influence over its regulators (including drug company sales reps over doctors’ prescription choices), then those injured by its dubious business practices or hidden side effects must be allowed justice, though I am at a loss for how to compensate for a lost limb. I know of no amount of money my own dominant arm would be worth–and I’m not even an amateur musician.