Supreme Court Ruling Makes It Difficult To Sue Manufacturers

 Posted on December 29,2014 in Defective Prescription Drugs

Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

Mutual pointed to a 2011 ruling which determined that generic drugs were not required to change product labeling if alerted to side effects of which they were not previously aware.

In 2008, the Supreme Court decided in Reigel v. Medtronic that patients who suffered using an FDA-approved device had no legal grounds to sue the manufacturer, according to the Huffington Post. If the FDA approved the device, that is, regardless of whether it was recalled or declared unsafe, patients have no legal recourse against the manufacturer. Most critics of the ruling see this as especially troublesome as FDA-approval procedures have become more and more lax in in recent years. Premarket notifications are one such example of how FDA regulation has become questionable in some cases. Premarket approval, according to the FDA, requires that the manufacturer only need to demonstrate that the device seeking approval is similar to one already on the market, rather than conduct a series of well-vetted tests.

Regardless, if you have been injured by a defective medical product or device, the most important step is to seek the counsel of a legal professional. Contact a qualified Arlington Heights defective device attorney today.