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RIEGEL v. MEDTRONIC: What Claims are available post Riegel?
In the first of three significant cases that could have profound effects on the rights of patients and consumers of medical devices and pharmaceuticals, the Supreme Court has ruled to limit the types of claims that can be brought. Specifically, the court held: "The Medical Device Acts’s pre-emption clause bars common law claims challenging the safety or effectiveness of a medical device marketed in a form that received Pre-Market Approval from the FDA."
Riegel is a narrow holding and strives to balance an individual’s rights under state law with the federal health care demands.
The fundamental policy supporting pre-emption is that a company is required by federal law to take certain steps to obtain approval of a medical device. The PMA process is the strictest of all avenues for approval, and the underlying policy is that it would be unfair and inefficient for our society to allow manufactures to be subjected to liability, where they complied with all federal requirements. In Riegal the court addressed a unique case where the plaintiff’s claims were not based upon the company’s failure to comply with the federal duties. As such, the court interpreted the claims to create added and additional requirements to the manufacturer, where even though the company complied with federal law, it was also subject to additional state law issues. The court found that Congress added express language to the Act to prevent this kind of double standard to protect the industry and health care needs.
"Parallel" Common Law Claims Survived Riegel.
While the decision steered away from the policy that federal requirements are “minimal requirements”, the decision does not mean that a common law tort claim is bared, even in the light of PMA approvement. The decision is clear that the common law claim is viable provided it is consistent with the federal requirements and does not create added duties. In other words, the federal regulations and laws can serve as a basis for the state law causes of action. The practical effect is that each claim must be pled and evaluated with both federal and state law if the product was approved under the PMA.
Under federal law, the companies have duties to disclose all relevant information, update warnings, provide post market surveillance, manufacture the device according to approved specifications and conditions, and only market the product for purposes for which it was approved. The mass torts that come to fruition are always based upon a company’s failure to meet these federal duties. As such, though the defendants will certainly claim Reigel grant borad pre-emption, the language of the decision, and consensus of the judges (8-1) indicates that very few cases should fall under the narrow rational of Riegel.
Related Documents
Ketek Loses Approval Due To Safety Concerns
An FDA panel that met this December determined that the Sanofi-Avenits antibiotic Ketek should no longer be marketed to treat sinus and bronchial infections because the drug's safety risks outweigh the benefits. However, the drug will not be withdrawn from the market, and it remains indicated for more serious pneumonia, though the drug will carry a black box warning¯, the strongest warning. Ketek has been linked to liver damage.
Ketek has been the center of controversy since its approval by the FDA without a major safety study. The medical community and patient advocacy groups have pointed to Ketek as yet another example of a big business influence over the FDA.
Florida Supreme Court Upholds Right to Contract Between Plaintiff Counsel and Clients
The civil justice system won a pivotal case before the Florida Supreme Court on the issue of limiting Plaintiff counsel fees in medical malpractice cases. In 2004, the Florida Medical Association proposed an amendment to cap attorney fees in medical malpractice cases, which would effectively limit the ability of patients to find counsel to prosecute medical mistakes. By limiting the fees, the medical association attempted to make medical malpractice cases unprofitable for plaintiffs' attorneys who typically front the great expense of cases and are only compensated if they prevail.
The Florida Supreme Court agreed that the law, which was passed by voters, interfered with patients rights to seek and choose counsel. The Court approved the client's right to sign an informed waiver allowing the attorney to be compensated fairly. This ruling will allow clients to continue to seek and retain counsel in medical malpractice cases in a state that has been reported to have some of the worst health care in the country.
Voters should be aware that these limitations ultimately limit their rights and abilities to improve our health care system and will result in an inability to seek financial assistance if they are injured by a medical mistake. The insurance companies have spent billions of dollars on campaigns that blame lawsuits and runaway verdicts for health care cost. These arguments are self serving, baseless and ignore comprehensive federal and state reports that have found that nine out of ten jury trials result in favor of the physicians and that medical liability accounts for less than 3% of our health care costs.
