With a growing number of lawsuits filed throughout the federal court system against Wyeth and other manufacturers of the heart drug amiodarone, involving allegations that side effects caused users to suffer severe lung damage, a motion filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeks to centralize the litigation before one judge for coordinated pretrial proceedings.
According to allegations raised in amiodarone toxicity lawsuits, the popular medication originally sold as Coradrone by Wyeth, and now widely available as a generic, has been promoted “off-label” for treatment of atrial fibrillation, without providing adequate warnings for consumers and the medical community.
In a motion to transfer (PDF) filed with the U.S. JPML on March 3, plaintiff Heather Moore Cook, as the executor of the estate of Mal M. Moore, requested that all amiodarone lawsuits filed in U.S. District Courts nationwide be consolidated to prevent duplicative discovery, avoid contradictory rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
All of the complaints raise common allegations that Wyeth, and the generic manufacturers that followed, promoted amiodarone as a first-line atrial fibrillation drug despite risks of amiodarone toxicity causing pulmonary fibrosis and other forms of lung damage, such as shortness of breath, wheezing, coughing, fatigue and depression.
Coradrone 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 Coradrone went off-patent in 1998, and a number of generic equivalents have been introduced, including medications manufactured by Sandoz, Eon and Novartis.
The motion to transfer and recent lawsuits indicate that the drug was provided without the required medication guide that would have warned patients about the potential lung damage risks and that the drug was not approved for atrial fibrillation.
“Defendant Wyeth’s campaigns were so pervasive and effective that for an entire generation of physicians, the drug wrongfully became a first line therapy for atrial fibrillation because physicians were not warned of many of the potential dangers of the drug,” the motion states. “Millions of atrial fibrillation heart patients, including each of the plaintiffs, have received amiodarone without the benefit of the Medication Guides and for off label purposes other than ventricular tachycardia.”
One of the more recent amiodarone toxicity lawsuits was filed in the Northern District of California on March 1, by Raymond J. Collette. According to the complaint (PDF), Collette was prescribed amiodarone for atrial fibrillation and never received a medication guide as mandated by FDA regulations. He was subsequently diagnosed with pulmonary fibrosis, a thickening of tissues in the lungs, which the lawsuit blames on amiodarone use.
“On personal knowledge, at the time Amiodarone was prescribed to him, Plaintiff was not aware that the FDA had not approved Amiodarone for the treatment of atrial fibrillation,” the lawsuit states. “Nor did Plaintiff receive the FDA-mandated Medication Guide to be distributed with each prescription of Amiodarone that warns the user of the extremely dangerous, potentially life-threatening complications associated with Amiodarone.”
The motion filed last week with the U.S. JPML recommends that all amiodarone toxicity lung damage lawsuits filed throughout the federal court system be transferred to the Western District of Texas, where a number of cases are already pending.