Are medical device makers protected from lawsuits by the government approval process? A decision is expected in 2008.
In a case that could give patients the right to pursue product-liability lawsuits against medical device companies, the U.S. Supreme Court on Monday agreed to hear an appeal involving Medtronic Inc.
If the high court decides against the Fridley-based medical technology giant, the ruling would have broad implications for the med-tech industry in Minnesota, home to hundreds of device companies, including St. Jude Medical and major operations of Boston Scientific Corp.
The appeal stems from a New York case that began as an angioplasty procedure gone awry in 1996.
After Charles Riegel suffered a heart attack, a doctor inserted a Medtronic catheter into his badly blocked right coronary artery. But when the catheter's balloon was expanded to restore blood flow to the heart, it burst. Riegel suffered "severe complications," according to his lawyer.
With almost any other consumer product, an injured party could sue the manufacturer for damages in state court. But that's not the case with many medical devices.
Medtronic argues that it is pre-empted from being sued because the device was first cleared for sale by the Food and Drug Administration (FDA). Lower courts have agreed.
Should the Supreme Court rule against Medtronic, "It could really change the legal landscape for med-tech companies," said Sarah Brew, an attorney with the Minneapolis law firm Greene Espel, which has represented Medtronic and other device firms in the past.
Facing a lot of risk
"These companies will be caught between a rock and a hard place -- they have to do what the government says for premarket [FDA] approval in a very involved and costly process," Brew said. "But to think that later a jury can say, 'No, you didn't design the device correctly or failed to warn us properly on the label,' puts them at a lot of risk."
But if patients injured by a medical device can't sue under state law, "there's no means of getting any compensation for an injury that wasn't the patient's fault," said Riegel's attorney, Allison Zieve, of the Public Citizen Litigation Group in Washington, D.C.
A lawsuit holding manufacturers accountable for injuries caused by their products "provides a very powerful incentive for companies to make their products as safe as possible," Zieve said.
The Medtronic device used in Riegel's angioplasty procedure, the Evergreen balloon catheter, was approved for use by the FDA after an extensive "premarket" review, a process that involves submission of detailed information regarding the device's safety and effectiveness. (The product is no longer made by the company.)
Patient required surgery
Once the angioplasty balloon burst during Riegel's May 1996 procedure, he lost consciousness and required emergency bypass surgery.
In a statement Monday, Medtronic said that Riegel's doctor inflated the device's balloon beyond limits spelled out on its FDA- approved product labeling and that Riegel was not a proper candidate for the procedure involving the device.
Riegel and his wife, Donna, sued the company, but a trial court in Albany, N.Y., dismissed the case. That decision was upheld by the Second Circuit Court of Appeals. The high court will hear arguments in the case late this year, with a decision in 2008.
St. Jude Medical of Little Canada said in a statement Monday that "the FDA is in the best position to regulate medical devices and their appropriate labeling." Boston Scientific, which is based in Natick, Mass., and employs about 6,500 in the Twin Cities area, declined to comment.
Medtronic used the pre-emption argument in another high-profile case that stems from its February 2005 recall of heart defibrillators. Several hundred lawsuits against the company have been joined in a single case in U.S. District Court in Minneapolis.
In November, U.S. District Judge James Rosenbaum denied the company's motion to dismiss the case, writing that it "defies logic" to contend that Congress meant to preempt device makers from lawsuits after they received FDA approval for a product.