What is Preemption? Preemption is legal concept that a number of medical device makers have used in liability lawsuits that have been filed over devices that received U.S. Food and Drug Administration (FDA) approval. While several device makers have sought preemption in liability lawsuits brought over alleged injuries associated with their medical devices, Medtronic, Inc. has very notably attempted to use preemption in much of its defense.
Our firm is pursuing lawsuits on behalf of individuals who have been injured by defective devices, including devices manufactured by Medtronic Inc. and Stryker, and who have had their lawsuits quashed over the legal device known as preemption.
Some Device Makers Continue to Utilize Preemption to Have Litigation Dismissed
Medtronic and Stryker attempted to have a lawsuit dismissed over their bone protein products and involved the off-label marketing of Stryker’s OP-1 Putty that was used with its Calstrux bone filler and Medtronic’s Infuse bone graft. In another case, Medtronic sought reconsideration of a ruling involving Infuse. In both cases, the justices ruled that preemption did not apply.
Most recently, the Supreme Court denied an order in a lawsuit brought against Medtronic that may help to stop the use of federal preemption in lawsuits brought over medical devices. The lawsuit involved was brought by a now-deceased man who allegedly became a paraplegic following surgery in which pain medication was infused into his spine. In this case, Medtronic was accused of neglecting to advise federal regulators about prior issues with its SynchroMed EL pump and catheter.
Medtronic argued that patients may not utilize state law to sue device makers for alleged violations of duty under federal law, according to Bloomberg News. The Appeals Court rejected the argument, which allowed the lawsuit to continue under Arizona state law.
Earlier Supreme Court decisions interpreted the federal law concerning medical device approval as limiting the types of lawsuits that may be brought, but a ruling in 2008 found that device makers may not be subject to “additional requirements under state product liability law,” Bloomberg News reported. In other words, individuals may sue under state rules deemed to be “parallel” to federal requirements. This most recent lawsuit, according to the Court of Appeals in San Francisco, found that the failure-to-warn claims were not preempted by the FDA’s supervision of medical devices and, therefore, met the requirements and is now able to proceed.
Medtronic has long sought to have a number of courts across the country stop the device maker from being sued over federal preemption in every claim that has involved devices that received Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA). Experts believe that Medtronic was seeking to resolve a gap in its litigation strategy by filing numerous preemption motions nationwide.
Preemption Attempts Met with Minimal Success
Medtronic had been using the preemption argument in a number of courts with minimal success and mounting lawsuits have rejected the review of applicable state law and statutes, including at least three other Circuit Courts of Appeal. The device maker also claimed the Court’s denial in two prior cases was meaningless in an attempt to skirt the views of the Solicitor General of the United States. The Supreme Court seeks out these views on these types of requests to review cases. Many see these moves as burdening the Court system with frivolous motions with no legal basis.
If the FDA does not specifically provide for a preemption of a medical device, then that device is not covered under legal preemption. If a device does have specific preemption from the FDA, state court actions may be maintained if device makers are just looking for restitution on state claims that are parallel to federal requirements and that do not seek to change federal requirements.