Studies Show Need for Medical Device Accountability

Avery deGroh of McHenry, Illinois, was just three when the Medtronic lead to her implanted heart defibrillator fractured, sending nine shocks to her heart, similar to the sensation of being electrocuted nine times. When the episode occurred, Avery thought monsters were attacking her as her mother felt the shocks going through her little girl's body. Avery's lead was Medtronic's Sprint Fidelis model that was recalled by Medtronic and the FDA in October 2007, nine months after Avery's incident.

Even though the device was recalled, Avery has little recourse to hold the device manufacturer accountable for their faulty product because of a Supreme Court decision in 2008 in Riegel v. Medtronic. The Court held that device manufacturers have complete immunity from product liability because the product was approved by the Food and Drug Administration (FDA), even if the device is proven to be unsafe or defective, like Avery's.

Last week, two studies were released showing how the FDA lacks stringent scientific standards to evaluate cardiovascular medical devices. This underscores the need to pass the Medical Device Safety Act (MDSA), legislation that would help Avery and hundreds of thousands of others injured by faulty medical devices to hold the manufacturers accountable for their defective products.

One study in the Journal of the American Medical Association (JAMA) showed how premarket approval of several kinds of heart devices was based on small studies, about 300 patients on average, and two-thirds were approved with results from just one study. This is much less scrutiny than needed to approve pharmaceutical drugs, according to the study. The article also said cardiovascular device approval may be prone to bias.

As the JAMA article states, "The importance of FDA device approval is magnified as it preempts consumer lawsuits on device safety."

Another FDA-sponsored study published online in the American Journal of Therapeutics found about 40 percent of the heart and blood vessel studies examined lacked specific targets for how safety would be measured. The study also failed to follow all patients over the long-term enrolled in the research.

FDA approval plays an important role is ensuring that prescription drugs and medical devices are safe. However, the Courts also play an important role in product safety, especially if device manufacturers are potentially using flawed studies to gain FDA approval.

The Medical Device Safety Act (MDSA) (HR. 1346 / S. 540) would restore the right of victims to seek justice when injured by faulty medical devices, including heart defibrillators, artificial valves, and prosthetic knees and hips. This legislation would follow the Supreme Court's decision in Wyeth v. Levine, which held that federal law does not preempt state-law claims with regard to drug warning labels.

MDSA would restore this right to medical device patients like Avery. For more information about Avery's story and MDSA, view the video below.

 

Comments

[StephenHCassidy]

01:16 PM on 01/06/2010

In response to first comment, and in full disclosure I am a plaintiffs' attorney, the Medtronic patients who suffered multiple and devastating electrical shocks from their faulty device wish they had never been injured in the first place. Litigation is necessary because medical device manufacturers disown any legal responsibility to their patients for defects in their products. These corporations rely on the preemption doctrine to shield themselves from any accountability. Yes, if the attorney representing the patient is successful, he or she is compensated, just as we compensate other professionals for their services.

The preemption doctrine puts everyone at risk because the FDA alone can not insure patient safety. The New England Journal of Medicine endorsed the Medical Device Safety Act, stating: "Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides."
Source: http://content.nejm.org/cgi/content/full/NEJMe0902377

[nomoron]

03:18 PM on 01/05/2010

The FDA must insist on more extensive study of medical devices before approving them for use in clinical situations and manufacturers require close scrutinization before introducing equipment for use by the general public. At some point decisions regarding who is respon-sible for product failure need to be addressed. I'm not convinced MDSA is the answer. The argument made by the author might be more readily accepted if it was made by someone else. An attorney making the case to pass legislation clearly benefitting his profession deserves substantial scrutiny by the public at large.
While consequences are demanded for subjecting people to known flaws in technology I cringe at the idea of a select group of individuals profiting from the suffering of humanity.