For Medical Devices
"Two Roads Diverged": Current Issues for the Medical Device Industry
Discusses the Riegel vs. Medtronic Supreme Court case and the potential implications the court decision will have on U.S. medical device companies and the U.S. legal system itself.
Riegel vs. Medtronic
Donna Riegel, a New York resident, has sued Medtronic, a Minneapolis based medical device maker, on the grounds that a Medtronic catheter device exploded during her husband’s angioplasty procedure and seriously damaged both his kidneys and mental capacity. Though it was cancer that eventually claimed the life of Mr. Riegel, Donna Riegel’s attorney is suing for $5 million dollars on the grounds of inflicted injuries during the aforementioned procedure.
Reigel Vs. Medtronic: The Defense
Medtronic’s defense includes the allegation that the physician performing the angioplasty procedure performed the surgery inaccurately by using the catheter device to treat a condition for which it was considered inappropriate and/or unnecessary.
The Medtronic defense also claims preemption (or precedence by the federal government) to protect those companies (with products approved by the FDA) against state litigation. Legal rulings have in the past1 favorably supported federal preemption (especially for PMA approved Class III medical devices) based on standards legalized in 1976 by the Medical Device Amendments included as an addendum to the Food, Drug and Cosmetic Act.
Many supporters for preemption also bolster the idea that state litigation towards a federally “approved” medical device manufacturer could undermine confidence in the federal government itself.
High-Stakes for Medtronic
If Medtronic wins, medical device makers will likely save millions of dollars in legal defense costs and continue medical device innovation with immunity to state level litigation. The downside for medical device developers however, is that consumers may lose confidence in medical device innovation if no additional safety measures are eventually recommended to federal agencies by the Supreme Court.
High-Stakes for Consumers
If Riegel wins, consumers will have the power to levy state suits against medical device companies. A court decision for increased consumer power may ensure greater safety for consumers in the long run. However, consumers may eventually pay a greater price for procedures and products developed at costs inflated by increased litigation.
The Crux of the Riegel vs. Medtronic Debate for Medical Device Developers
In regards to the Riegel vs. Medtronic case, the crux of the issue for medical device companies is whether or not the court will (as many lower courts have done in the past) continue to support the federal “sanction” or preemption that medical device companies have enjoyed via PMA—or additional approvals---from the FDA or whether the consumer will be allowed to bring forth litigation (at the state level) against medical device companies reducing the power of the FDA and changing the way that medical device companies do business.
Regardless of the road taken by the supreme court regarding the Riegel vs. Medtronic case, the final judgment will be climactic for the medical device industry.
1 The following excerpt was found via the following URL:
Lohr left several questions unanswered, the most important of which is whether the rigorous PMA process imposes a specific requirement that preempts state tort claims. Since Lohr, the majority of cases have concluded that if consumer safety is the central concern, as it is with Class III devices, the PMA process imposes specific requirements that preempt state tort claims.”
“In 1996, the U.S. Supreme Court addressed the regulatory preemption of medical devices in the landmark decision of Medtronic, Inc. v. Lohr. The Court held that state claims regarding the negligent design of a Class III device marketed under 510(k) were not preempted. Central to the Court's holding was the fact that the device was marketed under the limited review of 510(k) as opposed to the more rigorous PMA process.
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