Medtronic Sprint Fidelis Lawsuits in Minnesota State Court Dismissed
Published: October 26th, 2009 • Comments: 2
A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision follows a similar dismissal of the federal Sprint Fidelis litigation in January, based on the argument that the medical device manufacturer is immune from liability for injuries caused by their defective defibrillator leads since the FDA approved the devices.
In an order issued October 20, 2009, Minnesota District Court Judge Denise D. Reilly granted a motion by Medtronic to dismiss 600 Sprint Fidelis lawsuits. Reilly ruled that the plaintiffs’ claims are preempted under federal law, pursuant to a 2008 U.S. Surpeme Court decision in Riegel vs. Medtronic.
The lawsuits stem from an October 2007 Medtronic Sprint Fidelis recall that was issued after the defibrillator leads were found to be prone to fracture or break, which could result in unnecessary shocks or cause the defibrillator not to work if it is needed to deliver a life-saving jolt. More than 260,000 people had the defective leads implanted in their bodies at the time of the recall, and more than 100 Sprint Fidelis lead deaths have been reportedly linked to the problems.
Thousands of federal and state Medtronic Sprint Fidelis lawsuits have been filed on behalf of individuals throughout the country who had their leads fracture and by individuals who are now required to obtain additional medical monitoring.
On January 5, 2009, U.S. District Judge Richard H. Kyle dismissed the consolidated federal litigation, which was centralized in a multidistrict litigation (MDL) in the District of Minnesota. Judge Kyle cited the 2008 Supreme Court Riegel decision in finding that the product liability lawsuits were pre-empted, suggesting that the plaintiffs’ remedy lies with the legislator.
Attorneys representing plaintiffs in both the state and federal litigation indicate that they are appealing the dismissals.
Congress is considering new legislation which would, if passed, nullify the Supreme Court decision in Riegel by clarifying that the federal law regarding the FDA approval process does not make medical device manufacturers immune from liability for defective products.
Support for the Medical Device Safety Act of 2009 was buoyed this summer by a report from the Government Accountability Office (GAO), which determined that the FDA is not capable of ensuring medical device safety. The report cited deficiencies in the agency’s postmarket surveillance, and determined that FDA has been unable to keep up with regular inspections of medical device production facilities.
It is unclear, however, whether Congress will move on the proposed legislation in the near future. It is also uncertain whether any such legislation would be retroactively applied to cases still pending on appeal, such as the Sprint Fidelis lawsuits.
Comment by RBWILSSENS on 26 October 2009:
MEDTRONICS SENDS MILLONS TO THE LEGISATORS SO IN TURN THEY DO NOT A THING FOR THESE POOR PEOPLE WHO HAVE BEEN DAMAGED I DO NOT KNOW HOW THESE LEGISATOR SLEEP AT NIGHT 1600 PRODUCTS COVERED BY THIS LAW WHAT A BUNGE OF CROOKS VOTED THESE GUYS OUT
Comment by kenneth on 28 October 2009:
Always relevant to point out thar not all fda cases subject to dismissal as noted in both Reigel, and prior opinion of sct. in Lohr.