Several lawsuits on behalf of thousands of patients with Medtronic heart-defibrillator wires that have been known to fracture and dispatch potentially lethal shocks to the patient, have been dismissed by a federal judge.
Medtronic recalled the Sprint Fidelis lead in October 2007 because of the relatively high risk of fractures in the wire, which could result in patients receiving a painful series of unnecessary shocks or other malfunctions.
U.S. District Judge Richard H. Kyle in Minneapolis dismissed the lawsuits, citing a February decision that federal law “preempts” product-liability lawsuits under state law, effectively precluding such cases. That decision has triggered Congress to change the law which is likely to intensify under new Democratic Congress.
In February of last year, the Supreme Court affirmed a lower court ruling in Riegel v. Medtronic, finding that the preemption clause of the Medical Device Amendments of 1976 bars common-law claims challenging the safety of an FDA-approved medical device. Charles and Donna Riegel had sued Medtronic when one of their balloon catheter devices burst during angioplasty, requiring advanced life support and emergency coronary bypass surgery. The Supreme Court set important precedent by siding with the medical device industry in this case.
Another landmark case, Wyeth v. Levine went before the Supreme Court in November; the Justices will decide on her case later this year.
Diana Levine, a professional musician, sued Wyeth after losing her arm to amputation following an injection of Phenergan, an anti-nausea medication, into her arm.
The justices will decide - whether Wyeth, the maker of the drug, Phenergan, should have included in the label an explicit warning against the method of delivery into Levine’s arm – an IV push, a more aggressive method of drug delivery that quickly sends the medication into the blood stream, but also potentially causes gangrene when it misses the artery.
In a decision upheld by the Vermont Supreme Court, a Vermont jury ruled in Levine’s favor, awarding Levine $6.8M in damages. Wyeth appealed on the basis that the FDA’s approval of Phenergan preempted any product liability claims brought under state law.
If the Court sides with Wyeth, the implications are far-reaching and could potentially impact anyone who takes prescription medication, but also anyone who suffers an injury from any product – whether automobile, industrial chemicals, or drugs – and then seeks a remedy in court.
On the whole, federal preemption is a broad and complicated area of law, and years of intense study would be required to fully grasp its complexities. But, in its simplest form, preemption is the idea that federal approval should prohibit state lawsuits challenging defective products or warnings.
“The power to make it easier for injured patients to sue device maker’s lies not with the courts, but with Congress,” suggested Judge Richard H. Kyle, citing the following:
Congress has decided to limit medical-device manufacturers’ liability in order to spur innovation, although individuals are sometimes injured while using medical devices. Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court (or any other court).
Congressional intervention is possible. President-elect Barack Obama was co-sponsor of a Senate Bill introduced last year that would make it easier for plaintiffs’ to file liability lawsuits against device makers. #