–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
2 Comments
Mike Bryant
To sit with a person who has a letter in their hand that says that the product that was placed in their heart is no good and can't be taken out and has shocked them repeatedly, but they have no remedy is just sickening. This is important information that you have here that needs to keep getting out.
msc
While the pre-emption covers PMA device safety/effectiveness, I was under the impression that it does not cover events such as negligence, manufacturing defects, fraud on the FDA or failure to warn. Has anyone tried suing on any of these theories? What was the result?
The Medtronic recall (and several other recent recalls) are truly egregious, in that the manufacturer knew there was a problem, and chose not to report it, or if they did report it, did so in a manner that minimized the effects. It's somewhat surprising that FDA did not take it upon themselves to be more proactive in the recalls.
The vast majority of medical products are not covered by the PMA (approval) process; most are subject to the 510(k) requirements, which are NOT covered by the pre-emption provisions.
The idea that a product can be approved by FDA based on a (relatively) small study may be somewhat misstated. In the case of a PMA supplement, that study may have been in addition to the original, larger scale study. Furthermore, one study may have multiple sites with different investigators, different staff and different patient demographics. It is difficult to create a multi-site trial in which the data is poolable and can anticipate every possible adverse outcome.
This is an important topic and it will be interesting as event progress.
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