The daughter of former University of Alabama athletic director Mal Moore recently filed a wrongful death lawsuit against Wyeth Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. alleging that the use of a dangerous drug connected to the companies caused his 2013 death.
In 1995, Wyeth Pharmaceutics received FDA approval to market and sell Cordarone, an antiarrhythmic heart medication, and Par Pharmaceutical Companies was approved to sell its generic equivalent, amiodarone, in 1999. Moore took amiodarone for 90 days in 2008 to treat an irregular heartbeat and five years later, was diagnosed with advanced pulmonary fibrosis.
What is Amiodarone?
Amiodarone is a medication used to treat irregular heartbeats or arrhythmias, sometimes in emergency situations. It is sold under the brand names Cordarone, Nexterone, and Pacerone and belongs to a group of drugs known as anti-arrhythmics, which work by:
- Blocking receptors that use adrenaline
- Slowing or preventing the passing of sodium out of heart cells
- Decreasing the electrical activity in the heart
- Increasing the activity time for contraction in the heart
Amiodarone has two FDA black box warnings regarding the drug’s potential to cause the risk of sudden death and potentially dangerous side effects including lung damage, liver damage, and irregular heartbeat, and recommending that it should be prescribed only for patients in situations where the benefits outweigh the drug’s risks.
The Moore lawsuit alleges that amiodarone caused Moore’s pulmonary fibrosis and subsequent death because the drug isn’t specifically meant to treat atrial fibrillation and the FDA has only approved it for that use as a last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia.
According to court documents, Wyeth and Par ignored the risks associated with the medication and instead aggressively marketed it as a first treatment choice for atrial fibrillation, not a last resort, a strategy known as off-label prescription and distribution.
Although the FDA requires the distribution of a Medication Guide detailing the uses and risks involved with the use of amiodarone whenever a prescription for the drug is filled, the complaint alleges that Par provided no such guide to distributors and pharmacists, and Moore was unaware of the dangers he faced from the medication when he filled his prescription in 2008. The suit alleges that had he known, he would never have taken the drug.