More on the Medical Device Safety Act from the AAJ

The American Association for Justice reports about the hearing on the Medical Device Safety Act held last week:

Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife across the Midwest to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking and thought it was from hitting road debris. He soon realized his heart defibrillator was malfunctioning and sending electrical shocks throughout his body while he was driving on the interstate.

His nightmare continues because he cannot hold the manufacturer of his faulty medical device accountable for their faulty product because of a U.S. Supreme Court decision last year that gave the manufacturer complete immunity. Today, Mulvihill will testify before the U.S. Senate Health, Education, Labor, and Pensions Committee, asking for Congress to pass the Medical Device Safety Act (MDSA), legislation that would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices have malfunctioned.

Mulvihill had an irregular heartbeat, and was implanted with a defibrillator in 2006 to control his heart rhythm and pulse. The device intended to save his life nearly killed him and his wife when it malfunctioned while he was driving. The anxiety from the episode led Mulvihill into taking early retirement because his job required so much interstate travel.

A representative from Medtronic confirmed the device had shocked Mulvihill 22 times in 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA). However, because of a U.S. Supreme Court ruling last year, Mulvihill does not have any recourse to hold the manufacturer accountable.

In February 2008, the U.S. 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 earlier this year 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.

"I relied on this medical device to save my life. Instead, the trauma I experienced because the device was not safe cost me my career and crippled my lifestyle," said Mulvihill. "Medical device companies should be held accountable for the safety of the products they produce and profit from. I am asking Congress to restore my right to seek justice for myself and medical device patients everywhere."

"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, Mulvihill's attorney with Lieff Cabraser Heimann & Bernstein, LLP. "Medtronic should not receive the benefit of a judicial doctrine granting the company immunity."

Medtronic's Sprint Fidelis' lead, like Mulvihill'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 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."

MDSA, sponsored by Sen. Edward Kennedy (D-MA), 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, prosthetic knees, and hips.

"The Medical Device Safety Act is necessary to protect patients from defective devices and make sure manufacturers are held accountable," said Linda Lipsen, Senior Vice President of Public Affairs at the American Association for Justice. "The Supreme Court has affirmed that state law offers an important layer of consumer protection, and Congress should make clear that this applies not just in cases of pharmaceutical drugs, but also medical devices approved by the FDA that are later faulty or malfunction."