The Supreme Court under Chief Justice John Roberts has made it difficult for consumers to seek redress from corporations in many ways. This decidedly anti-consumer court has even upheld laws shielding makers of medical devices from claims of negligence and fraud. The New Jersey injury lawyers at Gersowitz, Libo & Korek P.C. are dedicated to upholding the rights of consumers and we know how damaging this ruling can be.
In Riegel v. Medtronic, Inc. (2008), the Court held that manufacturers of certain medical devices that received pre-market approval from the FDA were shielded from most causes of action under state law. However, the Court did recognize one exception—when state requirements parallel federal requirements. This exception has led to testing post-Riegel claims by two Florida law firms in the case of Sandager v. Medtronic, Inc.
Testing Post-Riegel Parallel Claims
Medtronic, the defendant, claims that federal law preempts product liability claims in cases where the manufacturer illegally promoted its medical device for uses not approved by the FDA, and a plaintiff was harmed as a result. In other words, Medtronic denies it should be held responsible for illegally promoting a device for non-approved uses.
The FDA gave premarket approval to Medtronic for a bone graft product called InFUSE, but only when used with another product called the LT-CAGE, and only when used for a specific type of surgery. The FDA approved these products to be used together as a system. However, Medtronic promoted InFUSE for off-label uses. Medtronic claims that its product is a Class III medical device and is therefore not subject to state law remedies. However, there is a parallel claim because federal law also prohibits this kind of promotion.
For more information about testing post-Riegel parallel claims and how your consumer rights are affected, contact the New Jersey injury attorneys at Gersowitz, Libo & Korek, P.C. by calling (800) 529-9997.