Oops, They Did It Again! Dangerous Drugs and Preemption

Brenda Fulmer

Attorney
(866) 735-1102 Ext 703

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On October 16, 2008, the FDA announced the recall of dextroamphetamine sulfate tablets manufactured by ETHEX Corporation. Apparently, these tablets were sold for more than a year (from January 2007 through May of 2008) before the public was alerted to this inexcusable manufacturing defect. Patients who have suffered an overdose of this medication may experience tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, and stomach upset.

Apparently, this latest recall is the second strike this year against ETHEX Corporation. In June of 2008, a similar incident occurred leading to the recall of some of the company’s morphine sulfate tablets. The morphine recall covered medications that were sold for a 23 month time period – which leads one to question whether there are any quality control safeguards whatsoever in place.

It is incomprehensible that a drug company could manufacture a medication at twice its normal thickness and not have anyone notice – apparently not for days, months, or even years. Recently, the FDA announced yet another recall of medications that were manufactured at twice their normal size (and strength). Patients are still reeling from the Digitek recall in April and the mounting reports of deaths and serious injuries associated with Actavis Totowa’s negligence in that case.

The public should find this situation particularly disturbing since they occurred before the ongoing efforts to immunize manufacturers through federal preemption have been completed. It is safe to assume, however, that if these efforts are successful that such manufacturing blunders should become expected, since there would be no recourse for victims and little oversight from the government. One of the fallacies underpinning federal preemption is that our government is capable of ensuring drug safety, such that there is no longer a role for our tort system. Sadly, however, this latest chapter only confirms what we have known for years -- that the civil justice system is a powerful protector of patient safety and should be embraced as the safety net so desperately needed by the FDA to ensure that the drugs designed, manufactured, and sold in this country are truly safe.