Hearing Highlights Victims' Nightmares with Medical Devices

PA Patient Asks Congress to Restore Right to Hold Manufacturer Accountable through Civil Justice System

May 12, 2009, Washington, DC -- Two years ago 35-year-old Bridget Robb awoke from a sound sleep by what she describes as the feeling of "cannons repeatedly being shot at her chest at close range," followed by a strong electrical current racing through her body. The episode was not a dream, but a nightmare because the lead to Bridget's defibrillator fractured, sending 31 dangerous shocks to her heart and throughout her body.

Bridget has a heart condition and was implanted with a defibrillator five years ago to prevent her from dying from a fatal arrhythmia. The lead had been recalled by the manufacturer over two months before Bridget's incident. Bridget's nightmare continues today because she cannot hold the manufacturer of the faulty medial device accountable for her trauma.

Today, Bridget will testify before the U.S. House Energy and Commerce Subcommittee on Health, asking for Congress to pass the Medical Device Safety Act (MDSA), legislation that would restore the right of victims to hold manufacturers of hazardous medical devices accountable in state courts.

"The medical device left me demoralized, but the Supreme Court has left me discouraged," said Bridget Robb of Gwynedd, Pennsylvania. "Medical device companies should be held accountable for the safety of the products they produce. I am asking Congress to restore my right to seek justice for myself and medical device patients everywhere."

The Supreme Court ruled in Riegel v. Medtronic that because the Food and Drug Administration (FDA) had approved a medical device through the pre-market approval process, patients injured by medical devices do not have any recourse to hold the manufacturers accountable. The Supreme Court ruled a year later in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating a double standard between prescription drugs and medical devices.

MDSA, sponsored by Sen. Edward Kennedy (D-MA) and by Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), would restore the right to seek justice in state courts for victims of faulty medical devices like heart defibrillators, and prosthetic knees and hips.

Bridget Robb is just one of thousands of people that have been injured by faulty medical devices. Former Major League Baseball Umpire Mark Hirschbeck's hip replacement fractured while he was lying on the couch. The incident led to four additional hip surgeries, costing him his career.

A veteran of the U.S. Army, Nick Evola of Louisville, Kentucky was shocked 43 times by his faulty defibrillator, sending his body airborne every time. The surgery to replace the lead was paid with coverage from Medicare and insurance, and not by the manufacturer at fault. "Medtronic put profits ahead of patient safety. They were 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, Nick Evola's attorney with Lieff Cabraser Heimann & Bernstein, LLP. "Medtronic should not receive the benefit of a judicial doctrine granting the company immunity."

In 2008, Medtronic's revenue topped $13 billion and $10 billion in profits. Ranked first among "medical products and equipment companies" so far in 2009 Medtronic spent $1.2 million in lobbying, and $4.8 million last year.

Medtronic's Sprint Fidelis' lead 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 stated, "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."

"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 patients," said Linda Lipsen, Senior Vice President of Public Affairs for the American Association for Justice. "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."

For copy of Bridget's testimony, please contact kyle.murphy@justice.org.

Contact

Jen Fuson
202-965-3500, ext. 369
media.replies@justice.org