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Fed Rules Protect Manufacturers From Injury Suits

Developing body of judicial opinion could place new limits on consumers' rights and insulate companies from billion-dollar product liability lawsuits.

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 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 proposals for stronger roofs.
Plaintiffs' attorneys call it ''silent tort reform.'' But it's part of tension existing since the nation's founding: conflict between state and federal law.
If they clash, state laws give way. That's in Article Six 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 may ''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 attorneys.
''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,'' Herrmann said in an interview.
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 Leahy, D-Vt., at hearings last fall, said 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 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 that 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' lawyer.
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 alleging 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.
U.S. District Judge Eldon Fallon in New Orleans called that argument ''entirely unpersuasive.'' Pre-emption would leave people without recourse when hurt by defective prescription drugs, he wrote. Fallon has since approved a $4.8 billion settlement.
Other courts have taken split positions, and cases now active could prove pivotal in setting judicial tone.
One is a case cited by Leahy -- Wyeth Pharmaceuticals' appeal of Vermont court rulings that it must pay $6.8 million to a musician whose arm had to be amputated because a Wyeth drug was dripped into an artery rather than a vein.
Diana Winn Levine of Marshfield, Vt., won a suit against Wyeth, contending the drug's label warning wasn't strong enough. Wyeth argued that FDA refused to let it strengthen its warning, but the Vermont Supreme Court upheld the award in a 4-1 decision.
The appeal is before the U.S. Supreme Court.
Regulatory power granted by Congress lets agencies set legal standards for manufacturers, said Alan Untereiner, a lawyer who represented the U.S. Chamber of Commerce at a Senate Judiciary Committee hearing last September.
''It's a 'get out of jail free' card for the manufacturer,'' said Allison Zieve of Public Citizen. The U.S. Supreme Court ruled 8-1 against her clients Charles and Donna Riegel of New York in a medical device case, saying federal law on medical devices takes precedence.
But there's an important difference between that case and the drug cases, Zieve said. When Congress gave FDA power to approve medical devices in 1976, some states already had their own laws. So Congress specifically stated its legislation superseded state laws.
Laws applying to other products make no such statement, Zieve said. Rather, she said, it is agency assertions that stake the claim.
Congress could have passed national product liability laws, but didn't, leaving it to federal agencies, where there is less political debate, said NYU's Sharkey.
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