(CN) – The 6th Circuit revived a negligence lawsuit against Wyeth Pharmaceuticals over its recalled Redux diet pill, which caused some users to develop a fatal hypertension disorder.
A Redux user named Mary Buchanan sued the company after she was diagnosed with primary pulmonary hypertension, or abnormally high blood pressure in the arteries of the lungs. There is no known cure, and the condition can be fatal.
In Buchanan’s case, she died in December 2003 — about two years after her diagnosis and only two months after she filed suit.
Redux was approved by the Food and Drug Administration in April 1996, but was recalled in September 1997 based on its link to the hypertension disorder.
While Wyeth sold Redux, it warned doctors that “a small risk of a serious, potentially life-threatening cardiovascular condition, primary pulmonary hypertension (PPH)” was “associated with the use of all types of prescription weight-loss drugs.”
A few months later, Wyeth allegedly notified doctors that the risk of PPH was actually much greater – “about 23 times higher for patients using [appetite suppressants] for three or more months compared to non-users.”
It also cautioned that “PPH is a serious disorder with an estimated 4-year mortality rate of 45%.”
New warning labels were issued, but the drug was ultimately pulled off the market.
Buchanan’s estate accused Wyeth of wrongful death, design defect, product liability, and negligence, and demanded punitive damages.
A federal judge dismissed all claims, explaining that the strict product liability and negligence claims were pre-empted by the FDA’s approval of the diet pill.
The judge then dismissed as moot the demand for punitive damages.
The federal appeals court in Cincinnati reinstated the negligence claims, ruling that “FDA approval does not automatically pre-empt state law tort claims for negligence.”
And because the negligence claims survived, the court also revived the estate’s punitive damages demand and remanded.