Myrl’s terrific post about what we learned about product liability law suits from the breast implant litigation prompts me to sound the alarm for what’s happening today. The Supreme Court is poised to make a decision with far-reaching consequences for consumers and could very well affect you someday.

This spring, the Court will hand down its decision on Riegel v. Medtronic. Charles Riegel underwent coronary angioplasty in 1996. During the procedure, the balloon ruptured, and advanced cardiac life support and emergency coronary bypass surgery were needed. He and his wife are suing Medtronic, claiming that the device was defective and the labeling inadequate, but Medtronic is arguing the because the FDA approved the product, it can’t be held responsible or culpable for injuries, even if the product is faulty.

We know that FDA made a big mistake in putting silicone implants back on the market in late 2006, when they decided to go for “safety later” instead of “safety now.” We know that, as Myrl said, science in the court room has an agenda, and we can’t reasonably assume that FDA approval is a guarantee that any approved device is safe. Can you imagine what would happen to all the women who are running to get implants after the FDA approved them? They would not be able to sue the manufacturer for injuries. The manufacturers would never need to cover any medical bills or pay any restitution for the harm they’re causing. The manufacturer would never be held responsible for permanent injury!

The Riegel v. Medtronic ruling will cover anything the FDA approves. The FDA would provide the basic standard for any laws passed by individual states.

The Supreme Court is considering the arguments presented by different interested parties. Of course pharmaceutical companies have put a lot of money into presenting their case — they have very deep pockets for “buying” the science to support their arguments. The other side of the issue is being presented by public interest attorneys.

We will just have to wait to see if the Supreme Court is a corporate court.

TAGS: product liability, Supreme Court, medical devices, Medtronic