A Ohio Federal Court of Appeals Reaffirms that Diet-Drug Redux, commonly known as "Fen-Phen" Should Never Have Been Marketed to the American Public.
Why? The Court of Appeals indicated that the Plaintiff's death was due in part to Wyeth's pre-approval...
TIME MAGAZINE Cover re: Redux
In the same ruling, the Court held that Federal regulation does not preempt state consumer-protection law
In remanding the case to the trial court, the Court of Appeals held that Federal drug regulations do not preempt state law negligence claims, and indicated that the Supreme Court's 2009 landmark pharmaceutical manufacturer preemption decision (Wyeth v. Levine) may apply beyond inadequate warning-label claims.
Importance? This prevents drug companies being shielded from appropriate state neglignce claims from millions of Americans who get seriously injured taking these prescription medications that do not display adequate warnings due to misrepresentations about these serious lethal side effects to the FDA during the drug approval process.
In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."
The Court of Appeals also reinstated and remanded to the trial court Plaintiff's claim for punitive damages.
In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth et.al., 6th Cir. No. 09-3380, the three-judge appeals panel held that the trial judge erred in concluding that the U.S. Food and Drug Administration (FDA) preempted the Buchanan family's negligence claims that the drug should never have been made available to Americans given Wyeth-Redux's known health risks, particularly Primary Pulmonary Hypertension (PPH).
Redux/ Fen-Phen Causes Primary Pulmonary Hypertension
Although Redux was on the market for a relatively short period, it is estimated that Wyeth has paid thousands of victims of Redux and its predecessor, Pondimin – and/or their survivors – more than $20 billion in damages. In evaluating the potential side effects of Redux, researchers noted that Primary Pulmonary Hypertension (PPH) is a devastating pulmonary disease for which there is still no cure, and the associated heart-valve problems may and often did require high-risk heart surgery. The controversial, high-risk diet drug had previously been evaluated and pulled from pharmacies overseas and it was banned in some individual states before the total recall.
The drug company, which spent more than $50 million marketing the wildly popular and profitable drug after its launch in April 1996, pulled it on September 15, 1997 at the request of the FDA and under mounting criticism by independent researchers and reports in respected medical journals.
Mrs. Buchanan, the Plaintiff, was a dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, who lost her life to PPH in 2003 within a few months after filing her complaint.