Patients with Defective Defibrillator Leads Could Lose Their Right to Sue
Monday, January 28, 2008
On October 15, 2007, Medtronic recalled its Sprint Fidelis defibrillator leads, citing a fracture risk which can lead to unnecessary shocks and device failure. Concerned patients who turned to Medtronic for answers were told that with minor programming changes to the ICD, their leads would work properly. This answer was not satisfactory to many of these patients, and thousands of them sought the help of defective medical device attorneys.
There have been many successful settlements involving defective medical devices in recent years. However, the ability to receive just compensation from manufacturers of faulty medical devices is in serious jeopardy. A Supreme Court ruling expected in March or April could immunize Medtronic and other medical device manufacturers from product liability lawsuits. The case being decided is Rigel vs. Medtronic, and the issue which had been heavily debated is whether or not lawsuits in state courts are preempted by the Medical Device Act of 1979.
What is Preemption?
Preemption is the term used to describe the displacing effect that federal law will have on a conflicting or inconsistent state law. The Supremacy Clause (Article VI, section 2) of the United States Constitution states that The Laws of the United States, (which shall be made in Pursuance to the Constitution), shall be the supreme Law of the land. Thus, when there is a conflict between a state law and federal law, the federal law (subject to the Tenth Amendment and Fifth Amendment and other Constitutional Law) trumps – or "preempts" – the state law. This means that the state law cannot go into effect or be enforced.
History of Riegel vs. Medtronic
Donna Riegel sued Medtronic after a Medtronic catheter device exploded during her husband’s angioplasty procedure and seriously damaged both of his kidneys as well as his mental capacity. The Riegels’ claims alleged that the catheter had been negligently designed, labeled, and manufactured, that Medtronic was strictly liable for Riegel’s injuries, and that the company had breached express and implied warranties.
Medtronic moved for summary judgment (dismissal of the suit), claiming that the Riegels’ claims were preempted because the FDA had approved the catheter pursuant to its premarket approval, or "PMA" process. The district court granted summary judgment saying that the Riegels’ claims were preempted except for those based on negligent manufacturing and express warranty. Medtronic later moved for summary judgment of the remaining claims, which was granted by the district court.
The Riegels appealed the district court ruling to the Second Circuit. In a 2-1 decision, the Second Circuit affirmed the lower courts decision. The Riegels then filed a petition for certiorari or cert., which was granted on June 25, 2007. They urged the Court to grant cert. because the Second Circuit’s decision could not be reconciled with the Supreme Court’s 1996 decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which addressed the MDA and preemption of state law claims. On December 4, 2007, the Supreme Court heard oral arguments on this case, and a decision is expected in March or April.
Conclusion
Americans should be concerned that their right to seek compensation under the judicial system is in jeopardy. In addition to hearing the Riegel vs. Medtronic case, the Supreme Court also agreed to hear cases that could actually immunize pharmaceutical and tobacco manufacturers from litigation. Medical device litigation is the only hope for many victims and their families. These people have been greatly harmed by the negligence of large multi-billion dollar corporations. Taking away their right to file suit is the wrong message to send to medical device and pharmaceutical companies, which in recent years have been accused of being less than honest to the FDA and patients about the potential risks of their products.
Posted under: Medtronic Sprint Fidelis Defibrillation Leads