On mission to sue med-tech makers

  • Article by: JANET MOORE , Star Tribune
  • Updated: August 17, 2009 - 2:42 PM

A bill to make it easier to sue makers of faulty medical devices is personal for some Minnesotans.

Doctors fastened leads to a heart defibrillator. The industry says the Medical Device Safety Act would hamper innovation and treatment.

Photo: Glen Stubbe, Star Tribune

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As Michele Meyer navigated the hallways of Congress earlier this month, meeting lawmakers and telling her story, she felt as though her daughter Katie was beside her, urging her on.

"She would have been right there," said Meyer, of Cambridge, Minn. "She was very outgoing, exuberant, true to herself and her own beliefs."

But Katie, 30, died in 2008 after surgery to remove a heart defibrillator wire made by Medtronic Inc. that had been recalled for safety reasons. She was joined in Washington by Mark and Janice Baird of Oakdale, who lost their 16-year-old son Robert after his Medtronic pacemaker malfunctioned.

The families want to restore the right to sue manufacturers of faulty medical devices, such as pacemakers and heart defibrillators.

In 2008, the Supreme Court ruled in a Medtronic case that makers of certain devices -- those that require the most stringent kind of regulatory review before approval -- were largely immune from product liability claims.

The medical technology industry, hampered by hundreds of such claims, supported the decision, saying the millions of dollars used to defend these lawsuits would be better deployed to develop new technologies to treat patients.

However, a bill in Congress called the Medical Device Safety Act would restore the right to sue for some patients who were harmed by a device that malfunctioned.

The medical technology industry opposes the legislation. "Its passage would be stifling and destructive to innovation, with the biggest losers being the patients who would increasingly find themselves with a limited range of therapy options as a result," said Medtronic spokesman Steve Cragle.

On Aug. 4, Meyer and the Bairds attended a hearing before the Senate Health, Education, Labor and Pensions Committee. Later, they met with Sen. Al Franken, D-Minn. In March, Meyer attended a House committee hearing on the bill, as well.

Meyer admits she's an unlikely activist, but says she was spurred on by the circumstances surrounding her daughter's untimely death. Katie developed a heart condition as a result of cancer treatment, and was treated with an implantable cardioverter defibrillator made by Medtronic.

When these stopwatch-sized devices sense an irregular heartbeat, they shock the heart back into rhythm. Surgically implanted in the chest, the device is connected to the heart with an insulated wire.

In 2007, Medtronic's Sprint Fidelis lead was recalled because some had fractured. The company does not recommend that the lead be replaced in most cases because the surgery can be dangerous.

Katie Meyer's lead fractured, and following extraction surgery to remove it -- recommended by her doctor -- she bled out and died.

Robert Baird's case involved a different Medtronic device, the Sigma SDR 303 pacemaker. The device was recalled in June because wires that connect the electronic circuit to other components, such as the battery, may separate and cause the device to fail.

"Our condolences go out to the Baird family," Medtronic said in a statement. "It is important to note that Medtronic has conducted an inspection of the explanted pacemaker, including exchanging information with the medical examiner assigned to this matter. We shared the results with the patient's physician and immediate family, and the public statements made by the Baird's lawyers are incorrect. We take our obligations to maintain the privacy of patient health information very seriously, and without the consent of Mr. and Mrs. Baird or a court order, we cannot share further details of the outcome of our investigation."

The Supreme Court decision "makes it very difficult, if not impossible, to pursue legal remedies in cases like Michele's and the Bairds," said Michael Johnson, their Minneapolis-based attorney. The families have not filed suit, but would have if the Supreme Court had decided differently, he said.

Following the Sprint Fidelis recall, hundreds of lawsuits were filed against Medtronic in state and federal courts. The federal cases, which were consolidated in Minnesota, were dismissed, according to Medtronic spokesman Christopher Garland. The only cases remaining are about 400 state court cases, approximately 380 of which have been consolidated in Hennepin County District Court. Medtronic has filed a motion to dismiss those cases.

Meanwhile, despite the Supreme Court decision, lawsuits related to the Sprint Fidelis recall continue to trickle into the legal system. On Aug. 7, 29 cases were filed in Hennepin County District Court by aggrieved patients (none from Minnesota) with faulty Sprint Fidelis leads.

Texas personal injury attorney John David Hart said filing deadlines are approaching because the statute of limitations will expire on Oct. 15 in several states but not in Minnesota. Hart filed suit on behalf of clients from seven states, including Texas, Florida, Michigan, Ohio and Pennsylvania.

Hart's lawsuits claim Medtronic concealed "known defects" of the Fidelis lead from patients, regulators and doctors, among other charges. Medtronic had no comment on the latest round of litigation.

It's unclear what Congress will do. Meyer worries that the Medical Device Safety Act may get lost as Congress debates behemoth health care reform legislation. Despite that, she says she'll continue to lobby on behalf of the bill as she grieves her daughter's death. "It helps me keep focused," she said.

Janet Moore • 612-673-7752

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