Riegel Decision Still Reverberates Today
Two years after a Supreme Court decision that favored medical device makers over those patients injured from them, and thousands of patients still have no legal recourse.
The Riegel decision gave immunity to manufacturers of Class III medical devices that undergo pre-market approval by the Food and Drug Administration (FDA).
That means patients such as Katie Meyer had no recourse. Katie had cancer, which she eventually beat, but she did not survive the three shocks from a malfunctioning Medtronic Sprint Fidelis lead attached to her defibrillator.
She died three days before her 31st birthday.
The Riegel Decision
As a result of the Riegel decision, issued by the U.S. Supreme Court on February 20, 2008, consumers injured by FDA approved medical devices cannot hold the device maker accountable, reports AAJ.
The case law was established by Donna and Charles Riegel who brought a lawsuit against medical device maker, Medtronic, when its Evergreen Balloon Catheter ruptured in Charles Riegel’s coronary artery during heart surgery.
A Class III medical device, the catheter had received FDA premarket approval, but the Riegels argued that it was defective in its design and label and violated New York law.
In losing their decision to the high court, it was established that federal safety oversight for medical devices, established by the Medical Device Amendment of 1976, trumped state authority.
Consumers injured by a defective device would be pre-empted from filing a lawsuit against a manufacturer of a medical device approved by the FDA.
Judge Antonin Scalia noted the FDA spends about 1,200 hours reviewing each application for a medical device and will grant approval if there is a “reasonable assurance” or its safety and effectiveness.
As a result, the Riegel decision largely leaves consumers unprotected, while medical device makers, even if their device is later found to be defective and removed from the market, enjoy protection from pre-market surveillance and costly litigation.
In fact, several lawsuits on behalf of thousands of patients with the Medtronic heart-defibrillator wires were dismissed by a federal judge last year.
The Riegel ruling applies to medical devices that receive FDA premarket approval.
The majority do not.
510K System - No Pre-Market Approval
Americans may not be aware that some Class III devices, those considered to carry the highest risk, do not even undergo pre-market approval or PMA.
Most Class I and Class II devices, considered less risky, are approved for marketing only under a little known clause in the FDA known as the 510 (k) that allows manufacturers to obtain approval to market the device, bypassing the more stringent PMA review. In an exchange of paperwork, the manufacturer must claim their device is substantially equivalent to one already on the market, known as a predicate device.
Even some Class III devices are approved under 510 (k).
Under 510 (k), about 8 % to 10% of device makers include clinical data required for high-risk device approval. The rest do not.
The FDA’s own Web site says “Only a small percentage of 510 (k) s require clinical data to support a marketing clearance by the Food and Drug Administration.”
Last year, IB News reported on the synthetic surgical mesh, a Class II device that is approved under 510 (k) for marketing, yet is causing problems for thousands of patients who had the devices implanted to correct hernias and urinary incontinence.
In January, the GAO concludes the FDA inadequately tests many Class III medical devices. The American Association for Justice reports that in a five-year period, the FDA approved 228 high-risk medical devices with minimal testing. Some of the devices are implanted in patients.
Congress has introduced the Medical Device Safety Act to allow injured patients injured by medical devices to seek a remedy in court. Consumers may want to inquire whether the medical device they are slated to receive has undergone premarket approval by the FDA or was approved for marketing under 510 (k). #