Supreme Court may ban lawsuits on FDA-approved drugs

Defective Medical Devices

The Supreme Court has yet to give a verdict in the case of Riegel v. Medtronic. In this case, the wife of a man who claims he was injured when a balloon catheter burst in his artery. The defense being used by Medtronic, the maker of the catheter, is that the catheter was approved by the FDA and therefore should be immune to liability under state laws. Essentially, this is another case of an industry attempting to use Federal preemption to protect itself from litigation. If this defense is granted, it could have grave implications for people seek restitution for injuries suffered as a result of defective pharmaceuticals or medical devices, including another Medtronic product, defective defibrillators and leads.

The industry charges that the FDA is responsible for making sure drugs are safe for marketing, and if an industry does its best to comply with FDA guidelines, it should not be held responsible for unforeseen side effects that become evident after the product comes into common use.

However, as I discussed in yesterday’s entry, the FDA works closely with drug companies, and actually allows drug companies to do most of the testing of their products. This testing, although expensive for drug companies, is worth it to them, because it gives them the opportunity to falsify data or use incomplete or poorly-recorded results to get their drugs approved. In fact, it is often only through litigation that the truth has come to light.

The outcome of this case, and another one on the docket for later this session, involving the drug Rezulin, might be bad news for people who are prescribed defective drugs by their doctors, as it might remove the last avenue for recompense they have: the courts. If you or someone you love has been injured by a defective drug or medical device, the time to act is now. Contact today to get in touch with a local defective pharmaceuticals lawyer to get your voice heard.

Related articles:

This law review article dealing with preemption and the ability of generic drug manufacturers to update their labels -

This article explores the scope of FDA jurisdiction and the relationship between the FDA and states -

This law review article explores whether the courts have given the FDA too much deference -

This article deals with the impact of the FDA's proposal to allow generic drug manufacturers to make label changes -