–crossposted from The Huffington Post—
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, see