Monday, March 31, 2008

NEW ORLEANS (AP)— If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can’t sue the maker for injury if it met agency standards.

The Consumer Product Safety Commission (CPSC) says you can’t sue a mattress maker if your mattress bursts into flame despite meeting CPSC standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration (NHTSA) proposals for stronger roofs.

Plaintiffs’ attorneys call it “silent tort reform.” But it’s part of the tension that’s existed since the nation’s founding: conflict between state and federal law.

If they clash, state laws give way. That’s in Article 6 of the Constitution. But in areas where there is no federal law, federal courts must defer to laws of the state where a lawsuit is heard. That includes product liability.

A developing body of judicial opinion could place new limits on the rights of those who buy or use products, consumer advocates say. It also could mean the savings of billions of dollars by companies insulated from lawsuits.

What’s riling plaintiffs’ lawyers, consumer groups and some regulators is agencies’ assertions their rules override state product-liability laws. Most such claims are rooted in statements in the introductions to their rules, not the rules themselves.

“These pre-emption preambles may be only the beginning,” New York University law professor Catherine Sharkey wrote in the DePaul Law Review.

She projected preambles might “displace competing or conflicting state regulations or common law as a matter of course.”

The practice varies by agency but is spreading. “It’s absolutely a trend,” said Deepak Gupta, staff lawyer for Ralph Nader’s Public Citizen Litigation Group.

It also delights corporate defense lawyers.

“Pre-emption is an extraordinarily powerful defense,” Mark Herrmann and James Beck wrote in their Drug and Device Law blog.

The argument is that federal agencies are the rule-makers. Period. “As long as the expert FDA weighs the risks and benefits, lay juries shouldn’t be second-guessing it,” Mr. Herrmann said.

One example of what this means to the average person is found in NHTSA proposals for new SUV-rollover rules.

Attorneys general from 26 states asked the organization in 2005 to drop lawsuit protection from the rules, which could go into effect as early as July 1.

“State governments and the federal government will have to cover millions of dollars in health care costs, which they will pass along to taxpayers — costs that, by all rights, should be the responsibility of manufacturers,” the attorneys general wrote.

NHTSA hasn’t dropped the pre-emption provision, agency spokesman Rae Tyson said.

Sen. Patrick J. Leahy, Vermont Democrat, said at hearings last fall that agencies have issued at least a dozen rules to shield drug and other product manufacturers from liability.

Indeed, plaintiffs’ lawyers say “pre-emption by preamble” has been coming in waves during the Bush administration.

When CPSC approved new mattress-flammability standards in 2006, member Thomas Moore objected to its claim that states cannot order stricter standards, and courts cannot rule a mattress caught fire because it wasn’t safe enough.

“The consumer’s right to sue a manufacturer, potentially any manufacturer of a regulated consumer product, for injuries from that product, may be seriously curtailed. That surely is not without consequence,” he said.

Actor Dennis Quaid and his wife are preparing to fight such a contention — this one made by the FDA — in a suit accusing Deerfield, Ill.-based Baxter Healthcare Corp. of putting vastly different doses of a blood-thinner into confusingly similar packages.

The Quaids went to court in November 2007, after their infant twins were given 1,000 times more heparin than babies should get. Their suit contends Baxter should have changed the packaging after three babies died in 2006 at an Indianapolis hospital.

No trial date has been set in the Quaids’ case.

A “foremost authority in drug labeling” will testify “because she feels mislabeling issues are going to be an epidemic in the United States,” said Susan Loggans, the Quaids’ attorney.

Baxter spokeswoman Erin Gardiner noted the label was approved by the FDA, but she would not comment on the company’s litigation strategy.

Such FDA claims have been used before.

In suits claiming the painkiller Vioxx caused heart attacks or strokes, manufacturer Merck & Co.’s defense included the FDA’s claim that its approval of the label warning protected the company. A federal judge rejected that defense and has since approved a $4.8 billion settlement.

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