Navigation Links
U.S. Appeals Court Reinstates Claim That Controversial Diet Drug Redux Should Never Have Been Offered to American People

CINCINNATI, Ohio, Aug. 19 /PRNewswire-USNewswire/ -- An Ohio Federal Court of Appeals ruling issued yesterday is reinstating the late victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects. The Court, in remanding the case to the trial court, held that Federal drug regulations do not preempt Ohio 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.

Benjamin H. Anderson, Esq., of Anderson Law Offices, LLC of Cleveland, Ohio, counsel for the plaintiff, said, "Mary Buchanan, like so many others, turned to a drug to help her lose weight and as a result she lost her life. She and her surviving family members deserve justice; this is an important decision in her case and for the harms and losses she sustained, as well as the many millions of Americans taking prescription medications who have long been concerned about drug companies being shielded from appropriate state negligence laws. Significantly, the appeals court has also reinstated and remanded to the trial court our claim for punitive damages."

In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth, 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). Mrs. Buchanan, a hard-working and dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, lost her life to PPH in 2003 within a few months after filing the complaint. 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.

Though Redux was only on the market  for a relatively short period, to date 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 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.

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)."

In a footnote, it commented "...the overwhelming take-away from the Levine majority opinion is that state tort law has historically played a substantial role in the regulation of drug manufacturers and that Congress has never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there may be some state law claims that would conflict with the FDA's regulatory authority and function, the claim at issue in Levine was not one of them. We do not believe that Buchanan's pre-approval negligence claims are, either."

Attorney Anderson, commenting on the interpretation of the Levine ruling in the case, said, "Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process  and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan's case, death."

The Court affirmed the dismissal of the balance of the plaintiff's  claims, and Attorney Anderson said he will  evaluate with appellate counsel Paul Flowers, Esq., and Mrs. Buchanan's family all appropriate legal options.

SOURCE Anderson Law Firm
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. U.S. Court of Appeals Rules on Validity of Lillys Gemzar Method-of-Use Patent
2. Federal Appeals Court Rules Pharmaceutical Sales Reps Entitled to Overtime Pay
3. Watson Says Appeals Court Affirms Concerta(R) Patent Invalid
4. U.S. Court of Appeals Upholds AstraZeneca AWP Settlement
5. German District Court Finds RENASYS™ GO NPWT System Non-infringing
6. Appellate Court Sides With Terminally-Ill Medical Marijuana Patient
7. CRESTOR® Patent Upheld By US Court
8. Appellate Court Decides in Favor of Fenwal
9. Texas Court Asked to Appoint Receiver for Key Subsidiary of TSX Listed Northstar Healthcare, Inc. (TSX NHC) on Claims of Mismanagement and Breach of Fiduciary Duty
10. Pharma CI Conference Amy Yueh Pays $52,000 to Apaporis LLC to Satisfy Judgment Against Her In Superior Court Of New Jersey Case
11. Montana Supreme Court Decision Endangers Most Vulnerable Citizens
Post Your Comments:
(Date:11/24/2015)... FRANCISCO , Nov. 24, 2015  Thanks to ... Dignity Health St. Mary,s Medical Center,s Sister Diane Grassilli ... breast imaging capabilities in San Francisco ... an anonymous friend, stepped forward with a gift of ... for Breast Digital Mammography with Tomosynthesis and Whole Breast ...
(Date:11/24/2015)... Colo. , Nov. 24, 2015  Array ... that its Chief Executive Officer, Ron Squarer ... Healthcare Conference in New York.  The public is ... webcast on the Array BioPharma website.Event:Piper Jaffray Annual ... , Wednesday, December 2, 2015Time:1:30 p.m. Eastern Time ...
(Date:11/24/2015)... HOUSTON, TX and VANCOUVER, Nov. 24, 2015 /PRNewswire/ ... EPI; NASDAQ: EPIX ) announced today that the ... clinical study of EPI-506 as a treatment for metastatic ... States and Canada.  --> ... --> In the Phase 1/2 clinical trial, ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, I ... Bronx, N.Y. “I thought there had to be a convenient and comfortable way to ... The PROTECTOR enables disabled individuals to safely travel during cold or inclement weather. In ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible for advancing care ... disease. The Periwinkle Pioneers, nominated by the public, will receive special recognition throughout ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... philanthropic seniors, is resulting in a way for homeless people to have a ... have launched a new initiative whereby they are repurposing plastic bags into sleeping ...
(Date:11/25/2015)... ... November 25, 2015 , ... Since its launch in 2012, ... adult stem cell therapies to patients with chronic degenerative medical conditions. Now, the ... Registered Trademark (RTM). , Organizations are required to hold a registered trademark in ...
(Date:11/24/2015)... ... November 25, 2015 , ... Genesis Chiropractic Software ... software creates an agreement between the practice owner and the patient that automatically ... notification, and projections. Click here to learn more. , ...
Breaking Medicine News(10 mins):