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Injured By A Medical Device? You're Still Out of Options

Posted by Jane Akre
Monday, March 08, 2010 1:16 PM EST
Category: Major Medical
Tags: Medical Devices, Riegel, Medtronic, Supreme Court, Sprint Fidelis, Surgical mesh, AAJ

Ever since the Riegel decision by the Supreme Court two years ago, patients injured by medical devices have had no recourse and today they still don't .

Riegel Decision Still Reverberates Today 


IMAGE SOURCE: Katie Meyer, Alliance For Justice- Faces of Preemption / iStockPhoto/ courtroom gavel

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). #


Anonymous User
Posted by Suzanne McClain
Tuesday, March 09, 2010 11:56 PM EST

Let me first offer my condolences to the family of Katie Meyer. The Supreme Court decision that favor’s medical devices makers over their constituents are appalling. This young woman’s death was a tragedy, and Katie’s family is further being punished by not being allowed to hold accountable the company who manufactured this faulty device. This truly saddens me.

Devices that are to be implanted in ones body, whether it is a Class II or Class III Device should never be cleared to go to market under the 510K process. As Jane Akre stated above, surgical mesh, a Class II device has received clearance using this method, and thousands have been injured. I am merely one of these statistics.

As a result of suffering these injuries, I began researching many surgical mesh devices cleared by the FDA. I have linked more than sixty of theses clearances, (as late as 2009) to Boston Scientific’s ProteGen Sling that was recalled by its own manufacturer in a letter to the FDA on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
These devices are all predicated upon one another, and even though the newer devices had not specifically used the recalled device as their predicate, I was able to link them through devices they used as predicates that were predicated by the ProteGen Sling. Following the FDA mesh clearance merry-go-round is not an easy task; it took me quite some time to master the research process of their website.

One thing of interest I found was the clearance of the IN-SLING, manufactured by Influence Inc., and cleared by the FDA on September 19, 1997. The approval number is K972651. Within Influence Inc.’s document, under the subheading “Performance Standards” it was clearly stated “No performance standards applicable to surgical mesh have been established by the FDA” yet the FDA approved this device and has subsequently cleared many more surgical mesh devices over the last decade. If, as this document states, no performance standards had been established, neither this device nor its predecessor the ProteGen Sling should have received FDA clearance. Had these clearances not been issued, it would have saved thousands from being injured. The FDA is clearing these devices in a negligent and irresponsible manner predicated on greed.

We must do away with the pharmaceutical lobbyist and get the pharmaceutical companies, the FDA, the doctors and our elected officials out of bed with each other. Until regulatory agencies in the United States can recognize and rectify these problems, we as a society are doomed to poor health care that’s cost is exorbitant; both in injuries and monetarily, and we as patients are paying the price.

Anonymous User
Posted by Joan Petty
Wednesday, March 10, 2010 9:33 PM EST

What gives Congress the right to discriminate against the law? There is NO remedy for any prescription drugs or Medical Devises that cause injury or death by a defected prescription drug or defected medical devise. How can Congress give half a law that has been completly deleted from the Product Liability Fairness Act, a part remedy for causing death or injury? In 1962 Congress omitted Product Liability from Prescription drugs and Medical Devises when they amended the FDA Act to the FDCA Act. There is NO law, Congress preempted the law and now they want to Half Amend this law? There is No Law, No State Law or Federal Law. In 1970 they deleted Product Liability for Prescription drugs and Medical Devises from the Product Liability Fairness Act. Where is the Law? Show me the Law.

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