Real Life David v. Goliath: Parents of Injured Five-Year-Old Girl v. Medical Device Manufacturers

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Real Life David v. Goliath: Parents of Injured Five-Year-Old Girl v. Medical Device Manufacturers 

For Immediate Release: March 5, 2009

Contact: Jennifer Fuson
202.965.3500 ext. 8369

Real Life David v. Goliath:  Parents of Injured Five-Year-Old Girl v. Medical Device Manufacturers

Congress Introduces MDSA to Restore Rights Held in Wyeth v. Levine to Medical Device Victims 

Parents of Five-Year-Old Girl Among Patients Seeking Justice for Faulty Medical Devices

Washington, DCPatients, including parents of a five-year-old girl that suffered injuries from a defective medical device, will be able to hold manufacturers accountable in state courts through new legislation introduced today, according to the American Association for Justice. 

The Medical Device Safety Act, sponsored by Senator Edward Kennedy (MA-D) and by Rep. Frank Pallone (NJ- D) and House Energy and Commerce Committee Chairman Henry Waxman (CA-D) would restore the right to seek justice for victims of faulty medical devices like heart defibrillators, artificial valves, and prosthetic knees and hips.  This legislation follows yesterday’s Supreme Court’s decision in Wyeth v. Levine that held that federal law does not preempt state-law claims with regard to drug warning labels.  The Medical Device Safety Act would restore this right to medical device patients. 

Prompted by the United States Supreme Court decision last year in Riegel v. Medtronic, the legislation would re-establish that federal law governing medical device approvals does not “modify or otherwise affect” lawsuits brought in state courts.   The Riegel decision held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration’s (FDA) pre-market approval process are essentially immune from liability.  The immunity could apply even in instances when a company knows a device is defective and dangerous, and has even been recalled.

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 the 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.  

“Medtronic was aware the device was failing at abnormally high rates but continued to market it as alleged in lawsuits filed against the company,” according to Wendy Fleishman, Avery’s attorney with Lieff Cabraser Heimann & Bernstein, LLP. “Medtronic put profits ahead of patient safety.  It should not receive the benefit of a judicial doctrine granting the company immunity.”

Medtronic’s Sprint Fidelis’ model, like Avery’s, is the subject of multidistrict litigation in U.S. District Court in Minnesota.   In January, U.S. District Court Judge Richard Kyle dismissed over 1,400 patients’ cases, citing the Supreme Court decision in Riegel v. Medtronic.  The ruling said, “The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. … Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court.”  Without Congressional legislation these individuals as well as countless others will be left without justice and negligent manufacturers will continue to profit from faulty and sometimes deadly medical devices.

“You only have to look at these 1,496 individuals to see the real life effects of allowing negligent manufacturers to receive complete immunity for their hazardous products,” said Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice.  “The Medical Device Safety Act is an important step in restoring accountability to device manufacturers and protecting patients from defective devices that can harm and even kill consumers.”     

The Government Accountability Office (GAO) reported in January that the FDA has failed for decades to comply with a Congressional mandate and rigorously review class III devices as covered in Riegel, the riskiest class of medical devices.  In a recent five year period, the FDA required only minimal testing before approving 228 class III, high-risk medical devices, including metal hip joints, defibrillators, and electrodes for pacemakers.  Based on findings from their report, the GAO recommended the FDA either issue regulations to reclassify some medical devices or require the more stringent premarket review process. 

“From peanut butter to unsterile syringes, we know the FDA alone cannot adequately police all drugs and medical devices on the market,” added Lipsen.  “That is why it is essential the civil justice system provide an added check and balance to strong federal regulations and oversight authority.  People who have suffered like little Avery deserve as much.”

In 2008, Medtronic had $13.5 billion dollars in revenues and $10 billion dollars in profits.  Medtronic spent $4.8 million on lobbying last year and ranks #1 among “medical products and equipment” companies rated by Fortune, and ranks 217th in the Fortune 500. 

Supreme Court Justice Stevens wrote in Wyeth v. Levine, “In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. …State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. …Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”

“Congress is just restoring the right the Supreme Court held for Diana Levine to victims of faulty medical devices,” added Lipsen. “The Supreme Court affirmed state law offers an important layer of consumer protection, and Congress is just reaffirming this applies not just in cases of pharmaceutical drugs, but also medical devices approved by the FDA.”     

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