Even after the U.S. Supreme Court ruled that injured patients were generally preempted from suing medical device makers, many in Congress believe that drug and medical device manufacturers should be held responsible for their actions – and they are considering legislation to make that happen.

Preemption 101

Preemption is a legal theory that generally relieves a company from liability if the federal government was ultimately responsible for approving a product before it could be released for public consumption or use. In the case of pharmaceutical companies and medical manufacturers, the U.S. Food and Drug Administration (FDA) is ultimately responsible for approving or denying a product. So, when one of those products injures someone, the victim generally has no recourse – even if the FDA was lax in its investigation or approval process. Preemption has become even more of a controversial issue as the U.S. Supreme Court decides two preemption cases this year.

U.S. Supreme Court cases

The Court recently ruled that medical device makers were generally not liable for injuries suffered as a result of a defective product if the FDA was ultimately responsible for approving the product. The Court will decide another case later this year on the same issue, but with regard to pharmaceuticals. While some legal analysts believe the Court will extend its first decision to drug companies, others aren’t so sure.

Regardless of how the Court rules, many in Congress say that drug and medical device manufacturers should be held responsible for their actions. They are considering legislation to make that happen in the wake of Presidential and Congressional elections in November – and it has medical device and pharmaceutical companies worried as the legislation may require them to do additional research and testing before seeking FDA approval.

Does that mean you can’t sue?

No. The recent U.S. Supreme Court ruling on preemption has certain limitations depending on the type of device or drug involved, the FDA’s level of involvement and the type of injury that was sustained. A qualified attorney will be able to determine whether you may have a cause of action.

If you’ve been injured due to a medical device or drug, contact an attorney to discuss your situation as you may be entitled to compensation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.