Critics blast feds' legal shields for manufacturers

By Amanda Erickson

WASHINGTON — Bridget Robb’s 6-year-old daughter watched fearfully one morning last December as her mother nearly passed out in pain.

A wire that connected a defibrillator in Robb’s chest had broken, causing it to send waves of powerful electric current to her heart.

The Medtronic device had been recalled almost two months before because of a defect. Robb, who needed two surgeries to replace the device, said she was never notified.

Now, she said at a Senate hearing this month, she would like to hold the company “accountable” by suing Medtronic for the medical fees she and her insurance company have had to pay.

But her lawyer told her that is probably not an option because of a clause the Food and Drug Administration has written into its policy on what kinds of standards medical devices like hers must meet. Because the defibrillator passed the FDA’s tests and was deemed safe, the company that made it may be immune from legal action.

Since 2005, lawsuit limits like the one protecting Medtronic and other manufacturers have been included in dozens of agency rules covering everything from drugs to car parts, shielding them from consumer suits if their products are approved by federal agencies. And it has often been done at the behest of the White House, critics say, with little input from Congress.

That has prompted a debate over whether the unprecedented increase in benefits granted to product makers is fair to consumers or even constitutional.

Manufacturers and some scholars say legal immunity encourages innovation and keeps costs low. Besides, they say, it’s only fair that if a company meets the government’s demanding standards, it should be shielded from legal action.

Medtronic officials say they took all the steps they reasonably could to keep users safe. Once the lead was recalled, the company sent letters and representatives to speak with patients and physicians, communicated with the FDA, held a news conference about the problem and posted information on its Web site.

Consumer advocates and some law professors argue that the anti-lawsuit clauses undermine consumers’ rights and make it difficult to hold businesses accountable for faulty products. And they say the federal government should not be blocking lawsuits that are permitted by individual states.

“I’ve been here since the second Reagan administration, and I’ve never seen anything like this,” said Michael Bird, federal affairs counsel for the National Conference of State Legislatures. “This is not what the framers of the Constitution had in mind.”

An example of this arose in 2006, when a Consumer Product Safety Commission regulation on flame-retardant mattresses limited the ability of consumers to win cases under state laws if their mattresses caught on fire.

Around that time, the FDA approved a rule on drug labeling that included a similar clause. That year, parents whose son killed himself while taking the antidepressant Paxil sued maker GlaxoSmithKline for failing to disclose that Paxil increases suicide risk. They lost their case because, the judge wrote, “federal law pre-empts plaintiffs’ instant action.”

Some complain that the Bush administration pushed these regulations through the federal agencies it controls instead of trying to move them through Congress. Passing a bill requires hearings and public debate, while an agency often can change its rules with little fanfare.

In 2007, the National Highway Traffic Safety Administration began including lawsuit-protection language in its rules on door locks, safety restraints and crash protection for cars. Now NHTSA may insert such a clause in proposed standards on how strong a car’s roof must be to prevent injuries from rollovers.

This most recent case has some lawmakers arguing that the threat of negligence suits is the only way to make sure manufacturers design safe devices and to provide justice in case of unnecessary injury.

“Liability puts a burden [on companies] to be very careful … and not cut corners,” said Joan Claybrook, a former head of NHTSA who now runs Public Citizen, a consumer advocacy group. “Without that, manufacturers will literally get away with murder.”

When she ran NHTSA, Claybrook said, the agency did not try to regulate for every situation. Instead, she said, it assumed companies also did their own testing to ensure the safety of their products. If they didn’t, they could pay the price in court.

“Federal standards are not all-encompassing,” she said. “Liability fills the gaps.”

But federal agencies and industry groups say lawsuits are out of control. More punitive damage verdicts of more than $100 million have been issued in the past 10 years than in the rest of U.S. history, said Ted Frank, a fellow at the conservative American Enterprise Institute.

He added that liability-happy lawyers have put companies and designers in a “damned if you do, damned if you don’t” situation. For example, he says, adding more weight to a car’s roof can protect riders in a rollover, but it also makes the car more likely to tip in the first place.

As for NHTSA, spokesman Rae Tyson said the agency is just putting something in writing that manufacturers and judges have always known to be true—that if manufacturers follow the law, they should be exempt from lawsuits.

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