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Thursday, March 05, 2009

Courts - "No Legal Shield in Drug Labeling, Justices Rule"

Updating yesterday's brief ILB entry on the Wyeth decision, here are some quotes from Adam Liptak's front-page story today in the NY Times:

The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v. Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesday’s decision addressed implied pre-emption, a different legal standard.

Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish broader protections. They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies — in this case, from the drug agency’s authority to approve drug labels.

Producers of goods as different as antifreeze, fireworks, popcorn, cigarettes and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After Wednesday’s decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.

The Times also has a story in the business section, by Barry Meier and Natasha Singer, headed "Drug Ruling Puts Devices in Spotlight." It begins:
An injured consumer can sue a drug maker — but not a medical device maker?

That seemed to be the contradictory result of a decision Wednesday by the Supreme Court, ruling that federal law does not protect drug companies from product liability suits in state courts.

In contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.

The discrepancy reflects the different legal issues in the two cases. But the fallout from Wednesday’s decision, legal experts said, could be considerable for drug and device makers alike.

Drug makers, for their part, may now face a flood of new lawsuits. They may also feel compelled to settle current litigation that would have been dismissed if the Supreme Court decision had gone their way.

Meanwhile, influential members of Congress plan to introduce a bill soon that would supersede last year’s Supreme Court device ruling, their aides say. If that legislation became law, injured people or their survivors would have the same right to sue device makers that the Supreme Court on Wednesday gave to people claiming injury or death from unsafe drugs.

The ILB has had a number of early entries, such as this one, about federal agencies, by regulation, attempting to override or preempt state laws -- stealth pre-emption. I'm unclear, however, about how or if they fit into the picture of the current decisions.

[More] Okay, this is right on point, according to an article today in the WSJ by Avery Johnson, Alicia Mundy and Jess Bravin, headed "Ruling Ripples Beyond Drug Firms ." Some quotes:

One of Wyeth's strongest arguments drew on a 2006 regulation in which the Bush administration declared that permitting product-liability suits conflicted with the FDA's role "as the expert federal agency responsible for evaluating and regulating drugs."

But Justice John Paul Stevens wrote in his majority opinion that the Bush position "is entitled to no weight." He wrote that the 2006 regulation was "inherently suspect," because it provided no evidence to support its position and gave neither states nor the public an opportunity to comment before it was issued.

The White House strategy to pre-empt state laws, which got under way in 2001, used agency regulations as a way to sidestep Congress, according to former Bush domestic policy adviser Jay Lefkowitz, who was a leader of the strategy. The policy had strong backing from the U.S. Chamber of Commerce and its Institute for Legal Reform.

In early 2005, The Bush Consumer Product Safety Commission issued a regulation barring state product-liability suits against mattress makers whose products catch fire. By the end of 2008, the administration had inserted pre-emption language into 50 different regulations from agencies including the Federal Railroad Administration, the Pipeline and Hazardous Materials Safety Administration, and the National Highway Traffic Safety Administration.

Mr. Lefkowitz said he and other officials working for Mr. Bush had believed the rule changes would be hard to undo. But the move to adopt some pre-emption outside the formal rule-making process may have backfired. Justice Stevens's harsh criticism may hold "significant implications for areas other than the regulation of prescription drugs," Mr. Lefkowitz said. It will make certain pre-emption cases "far more difficult to maintain," he said. * * *

The impact on each industry will depend on the specific laws governing it. A year ago, for instance, an 8-1 Supreme Court found that medical devices were exempt from state product-defect lawsuits as long as the manufacturer had complied with the FDA approval process. In that case, Congress had specifically pre-empted state regulation of medical devices, and implied that private suits under state law were also barred.

Posted by Marcia Oddi on March 5, 2009 07:56 AM
Posted to Courts in general