Justices Make It Harder to Sue Medical Device Makers


The Supreme Court on Wednesday made it harder for consumers to sue manufacturers of federally approved medical devices.

In an 8-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure.

The case has significant implications for the $75 billion-a-year health care technology industry, whose products range from heart valves to toothbrushes. In a recent three-month span, federal regulators responded to over 100 safety problems regarding medical devices.

Supreme Court Decisions

In a separate case, the High Court invalidated parts of Maine's law barring Internet tobacco sales to minors.

In a unanimous decision, the court said Maine cannot impose a regulatory scheme on transportation companies delivering tobacco products directly to consumers. The justices said federal transportation law blocks the states from doing so.

The ruling could provide the impetus for the transportation industry to get out from under state laws regulating cigarette deliveries in the Internet age.

Federal Regulators Cleared Medical Device

At issue in the medical device case before the Supreme Court was whether the estate of Charles Riegel could sue a company under state law over a device previously cleared for sale by federal regulators.

Under federal law, a company must substantiate the safety and effectiveness of a medical device before the U.S. Food and Drug Administration will approve it for the marketplace.

State lawsuits are barred to the extent they would impose requirements that are different from federal requirements, said the ruling by Justice Antonin Scalia.

In dissent, Justice Ruth Bader Ginsburg said that Congress never intended "a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Seven federal appeals courts including the one in Riegel's case have interpreted federal law on medical devices as prohibiting state lawsuits. The 11th U.S. Circuit Court of Appeals in Atlanta and the Illinois Supreme Court have ruled otherwise.

Charles Riegel's family alleged that the catheter produced by Medtronic had a design defect and an inadequate warning label.

Riegel survived the procedure to unclog an artery, though he had permanent disabilities, his family says. He died in 2004.

The Bush administration sided with industry, saying unfavorable state jury verdicts would compel companies to alter product designs or labels that had already gotten FDA approval.

Lawyers for Riegel's estate argued that a manufacturer can use FDA approval as a legal defense, but cannot use the law to block state lawsuits altogether.

Lawyers for Riegel's estate said that FDA procedures are far less rigorous than Medtronic says.

No Exception for Public Health Goals

Meanwhile, in the tobacco case, Justice Stephen Breyer said he could not agree withe Maine's approach even though there was an important public health objective behind it.

Breyer wrote that federal law "says nothing about a public health exception" enabling state regulation.

Federal law bars states from regulating prices, routes or services of shipping companies.

Because of Maine's regulation, companies will have to offer tobacco delivery services "that differ significantly" from what the market might dictate, Breyer wrote.

Thirty-one states besides Maine have cigarette delivery laws targeting the problem of underage smokers.

Maine's law requires delivery companies to intercept packages from unlicensed tobacco sellers and to verify the age of buyers, hitting delivery companies with huge additional costs, the industry says.

Maine passed the law to ensure state tax collections and to keep cigarettes out of the hands of youths under the age of 18.

The state of Maine argued that federal law does not pre-empt state regulation for public health and safety. The 1st U.S. Circuit Court of Appeals in Boston disagreed, rejecting Maine's argument that the federal law trumps state law only when it comes to traditional economic regulation of carriers.

The Bush administration sided with the delivery companies, declaring that when Congress deregulated the transportation industry, it determined that states should not step in to fill the void.

Congress deregulated truckers to put them on the same competitive footing with the deregulated airline industry.

The delivery companies are fighting Maine's law at the same time the industry's biggest players have stopped shipping cigarettes directly to consumers from illegal Internet sellers. The largest companies agreed to do so in the face of an aggressive campaign by the state of New York.

The ruling against Maine's law could enable the industry to argue that similar laws in other states are invalid. The decision could clear the way for companies to challenge the New York law and the agreements.

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