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Bush Rule Changes Might Hinder Product-Safety Suits

Oct 15, 2008 | Parker Waichman LLP

In their final weeks in office, Bush administration officials, are working hard to rewrite a wide variety of federal rules with changes or additions that could prevent product safety lawsuits by consumers and states.  As part of the multi-year endeavor, the officials have written language aimed at pre-empting product-liability litigation into 50 rules that govern everything from consumer products to medications.  Many feel that this represents another example of the Bush administration's efforts to protect corporations in the long-running power struggle between business interests, which support such efforts, and consumer groups and trial lawyers who reject them.

Here are some of the examples of rules created to protect industry:  The Mattress Flammability rule requires mattresses that burn more slowly; however it prevents suits if a consumer is injured in a fire.  The Drug Labeling rule makes the FDA responsible for the wording of label warnings; however, those companies that comply receive protection.  The Railroad Safety rule requires stronger construction for rail cars carrying hazardous materials; however suits are prohibited if cars catch fire.

This year, lawsuit-protection language was added to 10 new regulations, including one issued early this month at the Department of Transportation limiting the number of seatbelts car makers can be forced to install while prohibiting suits by injured passengers who did not get to wear a seat belt.  Because federal rules must go through lengthy review processes, new rules cannot be readily reversed by order of the next president.  For instance, rulemaking at the Food and Drug Administration (FDA), where most new pre-emption rules appear, can take at least a year.

The U.S. Chamber of Commerce's Institute for Legal Reform supports pre-emption. "It's exceedingly difficult for companies to comply with 50 different state standards," said Institute president Lisa Rickard.  Meanwhile, the American Association for Justice, the trial lawyers' lobby, is strategizing to undo pre-emptive rules.  "This is the gift that keeps on giving for corporations," said the association's chief executive, Jon Haber.

Such rulemaking, intended to protect corporations from liability, has long been a topic in the Bush administration, said former Bush domestic-policy adviser Jay Lefkowitz, who was instrumental in the process.  Meanwhile, the Office of Management and Budget (OMB), which reviews regulations, has denied there is a plan to end lawsuits via regulatory changes; however, recently, the OMB directed wording on railroad-tank-car safety.  According to an email titled, "Preemption language for the preamble in the tank car rule," the Federal Railroad Administration and the Pipeline Hazardous Materials Safety Administration, part of the Department of Transportation, were asked to use OMB's pre-emption wording.  The rule is pending finalization.

The FDA began entering lawsuits and submitting briefs on the side of drug makers and supporting federal pre-emption in 2001.  For instance, next month the Supreme Court will hear arguments in Wyeth v. Levine, in which Diana Levine lost an arm to gangrene after receiving an anti-migraine drug made by Wyeth in a hospital emergency room.  Levine claims Wyeth did not sufficiently warn about side effects under Vermont law; Wyeth says it followed federal warning-label standards and is protected from Levine's claims; and the FDA, through the Justice Department, defends Wyeth, citing its own 2006 rule indicating federal safety regulations override the state.

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