Amiodarone Lawsuit MDL Rejected As Claims of Toxicity Continue To Be Filed

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has rejected a recent request to centralize and consolidate all amiodarone lawsuits pending throughout the federal court system, indicating that cases filed over severe lung damage and other side effects of Cordarone or generic equivalents of the heart drug do not warrant formal coordinated proceedings.

Earlier this year, a request was filed to establish a federal multidistrict litigation (MDL) for all amiodarone cases to prevent duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

At that time, there were at least nine amiodarone lung toxicity lawsuits pending throughout the federal court system, each involving similar allegations that the popular heart drug, which was originally sold by Wyeth under the brand name Cordarone, has been promoted “off-label” for treatment of atrial fibrillation, without providing adequate warnings for consumers and the medical community that the medication may cause pulmonary fibrosis and other forms of lung damage, such as shortness of breath, wheezing, coughing, fatigue and depression.

Cordarone and generic amiodarone has never been approved for treatment of atrial fibrillation, and the FDA has sent a number of warning letters to Wyeth ordering it to curb its advertisements. While doctors are able to prescribe approved medications for any purpose they see fit, drug makers are not allowed to promote such “off-label” uses until they have submitted sufficient data to establish that the medication is safe and effective for that indication.

Amiodarone was first approved in the 1980s, as a last-ditch emergency treatment of ventricular tachycardia. The brand name drug Cordarone went off-patent in 1998, and a number of generic equivalents have been introduced, including medications manufactured by Sandoz, Eon and Novartis.

Following arguments before the U.S. JPML on May 26, an order denying transfer (PDF) was issued on June 2, indicating that the claims were too few, and involved too many different generic manufacturers to make consolidation efficient. In addition, the judges said that the claims of missing medication guides, which have been reported in numerous cases, would require separate inquiries into each company’s actions, further reducing the usefulness of consolidated pretrial proceedings.

As a result, the cases will continue as individual claims for the time being.

Amiodarone Toxicity Lawsuits Continue To Be Filed

The decision comes as a growing number of lawsuits over amiodarone side effects continue to be filed by individuals nationwide.

In a complaint (PDF) filed against Wyeth and Zydus Pharmaceuticals in U.S. District Court for the Western District of Texas on May 19, one plaintiff indicates that problems with generic amiodarone caused her to suffer fatigue, weakness, nervousness, decreased concentration, and depression, as well as other neurological and physical problems, after she began taking the drug.

Like others filed against different manufacturers, the lawsuit neither the plaintiff, nor her doctor or pharmacist, received a medication guide outlining the drug’s risks.

The lawsuit also notes that the plaintiff was prescribed the drug for the treatment of atrial fibrillation, and accuses Wyeth of illegally marketing the drug so successfully that her doctor was unaware that it was only to be prescribed to adults suffering life-threatening heart rhythm problems called ventricular arrhythmias.

“Wyeth’s unlawful marketing campaign of amiodarone for off label uses never approved by FDA includes seminars and articles secretly and deceptively controlled by Wyeth, but presented to medical professionals as independent reliable scientific support for the safety and efficacy of unapproved uses,” the lawsuit indicates. “Defendants’ lengthy and pervasive unlawful marketing campaign of amiodarone for off label uses never approved by FDA has been effective: It has wrongly influenced an entire generation of medical professionals.”