When Mal Moore, the former athletic director for the University of Alabama, died two years ago, he was in the advanced stages of pulmonary fibrosis. It was the ailment that caused him to step down. He was soon after hospitalized and died in March 2013.
Now, his daughter alleges that the condition was caused by a drug he was prescribed in 2008 for treatment of an irregular heartbeat.
In its generic form, the drug is called amiodarone, and it’s used to treat life-threatening heart rhythm problems (known as arrhythmias) in individuals who have already taken other similar forms of medication. Moore only took the medication for three months to treat his condition, but his daughter alleges this exposure to the drug caused him to develop the pulmonary fibrosis.
Her federal lawsuit, Cook v. Wyeth Pharmaceuticals, Inc., was filed in the U.S. District Court, Northern District of Alabama, Southern Division.
The company received approval from the U.S. Food and Drug Administration to market and sell the brand name drug, Cordarone, in 1995. Nearly 15 years later, a firm called Par Pharmaceutical Companies, Inc. was given the rights to sell generic amiodarone.
Complaint asserts the FDA did not approve use of the drug for atrial fibrillation, which is what more suffered. Rather, it was intended as a last resort for those suffering from recurring, life-threatening ventricular fibrillation and ventricular tachycardia – and only when patients with these conditions did not respond positively to other kinds of drugs and therapies.
Rather than market it this way, the lawsuit alleges, defendants flouted these risks and aggressively marketed the drug as a first-choice treatment for patients like Moore. The drug companies reportedly failed to notify prescribing physicians of the possible dangers associated with drug toxicity.
This off-label use, plaintiff alleges, was deceitful, egregious and resulted in catastrophic injury and death to patients, including her father. This is the basis for her product liability lawsuit.
Although the FDA sometimes allows for off-label marketing, this kind of action must adhere to strict requirements. For example, the manufacturer has to submit an application to the FDA for approval of off-label use, and it has to provide its marketing materials to federal regulators in unabridged form. Any deviation from these requirements would be a violation of federal law.
The FDA requires that anytime a prescription for this drug is filled, patients are supposed to receive a guide that detailed the drug’s uses and also the risks. However, plaintiff asserts Par never provided pharmacists or distributors with such a guide, and her father didn’t receive one when he had his prescription filled in 2008. Further, his condition was not life-threatening, so he was not in a position to need this “last resort” drug in the first place.
Plaintiff alleges defendants’ actions were not only negligent but also illegal, in flagrant violation of federal law regarding promotion of off-label uses. The practice has allegedly been so pervasive that an “entire generation of medical professionals” has been wrongly influenced about the drug’s dangers.
Call Allred & Allred P.C. at 1-866-942-9315 to speak with a Montgomery personal injury lawyer.
Late Alabama athletic director Mal Moore’s family sues over ‘very dangerous’ drug they say killed him, April 6, 2015, By Stephen Dethrage, Al.com
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