Recently the American Association for Justice (AAJ) issued a letter explaining the latest developments in a case with implications for all those working on matters involving defective medical devices. The issue of preemption is invovled in the case related to state and federal rules for off-label promotion of the devices. In other words, this is a matter of a company violating rules in order to get its products used in ways that were not approved by regulators.
The Latest Case
The AAJ letter explains that the case, Sandager v. Medtronic, Inc. stems from complaints by a plaintiff that she was harmed by a bone-graft product as a result of that product’s illegal promotion. The device was not approved by the U.S. FDA for the use in the way that the plaintiff received it. These illegal marketing issues are quite common in many settings, including medical devices and pharmaceuticals.
Expectedly, the plaintiff in this case filed a lawsuit against Medtronic seeking recovery for her losses. However, Medtronic recently filed a motion to dismiss the case, claiming that federal law preempts the state product liability claim where, as in this case, the plaintiff claims harm as a result of illegal promotion for unapproved FDA uses. It doesn’t take much to realize how misguided this argument seems on its face. It is a suggestion that federal regulators intended that these manufacturers to be immune for claims against it by those harmed by their illegal marketing actions.
The defendant’s argument in the case is rooted in the U.S. Supreme Court case Riegel v. Medtronic, Inc. (2008). In Riegel that Court unfortunately ruled that those who make certain medical devices (Class III) and receive “pre-market” FDA approval, are free from basic state law claims. However, importantly, in issuing that ruling the Court noted an exception. That exception included cases where the state law requirements are the same as the federal requirements.
The letter, written by AAJ President Mary Alice McLarty explains that, “there is substantial precedent against a finding of express preemption in cases that involve injury caused by illegal off-label promotion of medical devices.” As such, the defendant’s attempt to get this state law cause of action thrown out should be beaten back, allowing the plaintiff and her family to continue to puruse fairness and justice for the harm caused by the illegal marketing practices.
It is critical that all advocates for legal fairness stand up against this latest effort to immunize large companies for harm caused by their dangerous devices and practices. As the AAJ article notes, this particular case is just another reminder of situations where profits are prioritized over patients.
Legal Help in Chicago
From defective hips implant products like DePuy and Stryker to problems with heart stent, defibrilators, and more, our attorneys are proud to work on behalf of all those harmed by inadequate medical devices. It is critical that fair legal rules remain in place such that affected parties are afforded a full slate of options to ensure accountability and redress. Few matters are as important as ensuring the safety of our medical products, and accountability for poor care via the civil justice system remains one of the key ways that companies are encouraged to act prudently at all times and prevent unnecessary harm.
See Our Related Blog Posts:
The Intersection of Medical Malpractice & Product Liability — The Meningitis Outbreak Example