L.A. Times reports on growth of patient reviews of doctors online

A recent L.A. Times article (“Doctor ratings: Is your healthcare hot or not?” Shari Roan 05/19/08) called attention to the issue of patients reviewing their physicians online via websites, such as www.rateMDs.com. This accelerating trend poses an emerging and serious challenge to physicians. As the article notes, this practice of online rating of physicians “shifts the balance of power.” It enables patients to do significant harm to physician’s reputations, without regard to the merits of the patient’s criticism. There is no system of verification of information.

In aftermath of Donda West case, California legislature considers legislation to raise cosmetic surgery requirements.

The highly publicized November 2007 death of Donda West, mother of rapper Kanye West, following a tummy tuck and breast reduction has prompted the introduction of legislation affecting cosmetic surgery in California. The coroner’s report found the death to be attributable to”coronary artery disease and multiple post-operative factors due to or as a consequence of liposuction and mammoplasty.” It was subsequently discovered that the physician who had performed the procedure had failed to require a pre-operative physical examination.

Adapting to Consumer-Directed Care

Professors Mark Hall and Carl Schneider examine legal challenges relating consumer-directed healthcare in the Michigan Law Review . What is consumer-directed healthcare? Traditionally, healthcare was doctor-directed: doctors administered care to patients by giving them limited options, as to which patients had limited access to information on which to base decisions and their respective risks or benefits. In the “consumer-directed” paradigm to which we are shifting, patient-consumers now exercise control over the range of options and the information on which to choose. As a consequence, control has shifted from healthcare provider to healthcare consumer.

Recommended Action: The trend presents wide ranging ramifications for providers to consider. Increasingly empowered patients will be a boon or bane for providers, depending on the success with which providers adapt to negotiating, rather than dictating, the delivery and management of caring for a new generation of patients. The trend toward consumer-directed care also presents new legal challenges: patient control over health care records, patient control over the patient-provider relationship, and issues of cost and pricing. Providers need to consider how to be respectful of patients without ceding their rightful role in the provider-patient relationship, how to engage patients most productively in sharing decision-making, and how to protect themselves from patients who abuse their increased power.

Supreme Court Ruling on FDA Approval Protects Device Makers

The New York Times reports on a Supreme Court ruling that federal law bars lawsuits “challenging the safety or effectiveness of a medical device,” as long as the device is marketed in a form that received premarket approval from the Food and Drug Administration (FDA). The case, In re Estate of Riegel v. Medtronic involved the bursting of a balloon catheter that injured a patient undergoing angioplasty. The patient and his wife sued Medtronic, maker of the catheter, on the theory that the patient had been injured by design, label, and manufacturing defects that violated New York state law. The Court ruled, however, that the FDA’s premarket approval prevented Medtronic from being sued over flaws.

The ruling applies only to medical devices that receive “premarket” approval, as opposed to the more common and streamlined process requiring a device maker only to prove substantial similarity to a device already on the market. Justice Scalia’s decision observed that the “premarket” approval process requires extensive review (1,200 hours on average) and grants approval only upon finding a “reasonable assurance” of the device’s “safety and effectiveness.”

The decision is expected to have a limiting effect on other cases involving FDA-approved medical devices.

Recommended Action: Providers can take little comfort from the protection extended to device makers as a result of the Riegel decision. FDA approval may protect providers from direct FDA action, but will not prevent patient suits if risks associated with a device are not fully disclosed. Fenton & Nelson encourages providers to review medical device usage to ensure appropriate risk disclosuresare being made .

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on FDA-related and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008