• Heart Device Makers' Short Cut On Patient Safety
  • April 16, 2014 | Author: Wendy R. Fleishman
  • Law Firm: Lieff, Cabraser, Heimann & Bernstein, LLP - San Francisco Office
  • Twice in the last seven years, tens of thousands of Americans implanted with cardiac defibrillators have had to make the agonizing decision of whether to undergo surgery to replace their recalled device.

    In 2010, the Food and Drug Administration announced a recall of certain St. Jude Medical Riata defibrillators due to faulty wiring. Three years earlier, Medtronic recalled its Sprint Fidelis cardiac devices also because of faulty wires. In both cases, deaths were linked to the defibrillators failing to send necessary electrical shocks to save the lives of patients.

    How could these companies have manufactured and sold defective defibrillators that purportedly passed FDA review? A new paper by Harvard researchers, using records recently made available by the FDA, offers one explanation.

    As reported in the New York Times, the researchers found that these companies changed the devices after initial approval -- making the electrical wire connecting the defibrillator to the heart thinner, for example -- without determining the safety and effectiveness of the altered devices in clinical trials with real patients under real-life conditions.

    While manufacturers say the process (called a premarket approval supplement application) allows manufacturers to get upgrades and improvements to patients faster, the problem is that a device can be modified over and over, even dozens of times, without ever being put through new trials in patients. As stated by Dr. Aaron S. Kesselheim to the New York Times, "Over time, the accumulation of changes may lead to a device that is substantially different than the original product." Most of top-selling devices sold today are "substantially different" from the versions originally approved, Dr. Kesselheim added.

    Doctors are often unaware which version of the device they are implanting, said Dr. Rita Redberg, a cardiologist and professor at University of California, San Francisco, who has written on the topic. "These supplements are not just flying under patients' radar screens, they're flying under doctors' radar screens," Dr. Redberg said.

    Lieff Cabraser represents patients who have been implanted with the recalled St. Jude Medical Riata heart lead. Some components in the Riata lead were clinically tested because they were components of an earlier model that was tested. However, the actual Riata device with the faulty electrical wiring that was implanted in patients and subsequently recalled was never clinically tested.