The Bush Strategy For Pushing Preemption
8 CommentsBy Ed Silverman // October 15th, 2008 // 1:13 pm
Bush administration officials, in their last weeks in office, are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states, The Wall Street Journal reports.
The administration has written language aimed at preempting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain meds. The latest changes cap a multi-year effort that could be one of the Bush’s lasting legacies, the Journal writes, depending in part on how the underlying principle of preemption fares in a case the Supreme Court will hear next month (back story).
This year, lawsuit-protection language has been added to 10 new regulations, according to the Journal, including one issued October 8 at the Department of Transportation that limits the number of seatbelts car makers can be forced to install and prohibits suits by injured passengers who didn’t get to wear one.
These new rules can’t quickly be undone by order of the next president. Federal rules usually must go through lengthy review processes before they are changed. Rulemaking at the FDA, where most of the new preemption rules have appeared, can take a year or more, the Journal notes.
The Bush administration’s efforts to protect corporations that comply with federal rules from legal action have fueled a long-running power struggle between business interests, which support the efforts, and consumer groups and trial lawyers who have denounced the moves.
The US Chamber of Commerce’s Institute for Legal Reform supports preemption as part of its campaign to “neutralize plaintiff trial lawyers’ excessive influence over the legal and political systems,” according to its web site. “It’s exceedingly difficult for companies to comply with 50 different state standards,” the Institute’s president, Lisa Rickard, tells the Journal.
The American Association for Justice, the trial lawyers’ lobby, is trying to formulate a strategy to undo pre-emptive rules. “This is the gift that keeps on giving for corporations,” the AAJ’s chief executive, Jon Haber, tells the paper.
The use of rulemaking to protect corporations from product liability was discussed from early in the Bush administration, former Bush domestic-policy adviser Jay Lefkowitz, who was instrumental in the process, tells the Journal.
One administration concern was the spiraling number of multimillion-dollar product-liability lawsuits against corporations based on state “failure to warn” rules, according to Lefkowitz and other former administration officials. Some state consumer-safety laws on product warnings are tougher than, and conflict with, federal standards, particularly in the pharmaceutical area.
“You can’t ask companies to follow different standards,” Lefkowitz tells the Journal. PhRMA says that such inconsistencies on drug labels “may be, at best, confusing, or at worst, life-threatening.”
The Office of Management and Budget, which reviews regulations, has denied there has been a top-down plan in the administration to end lawsuits via regulatory changes. But in March, the OMB directed wording on railroad-tank-car safety, the Journal writes.
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 Journal reports. The rule hasn’t been finalized.
Lefkowitz tells the paper that the administration decided not to press its preemption agenda in Congress, where it might lose. “There was already authority within federal government statutes and regulations to start the reform process without legislation,” he tells the Journal. “Using that and legal briefs, we proceeded.”
The FDA began entering lawsuits and submitting briefs on the side of drugmakers and supporting federal preemption in 2001, though the agency previously supported the right to sue. The Supreme Court will hear arguments next month in a case called Wyeth vs. Levine that will be a big test of federal preemption authority.
Diana Levine, a musician, lost an arm to gangrene after receiving Phenergan, an antimigraine drug made by Wyeth in a hospital emergency room. She claims the company didn’t adequately warn about side effects under Vermont law. Wyeth says it followed federal warning-label standards and is protected from her claims. (Read an interview with Levine here).
The FDA, through the Justice Department, is defending preemption in that case, citing its own 2006 rule that says federal safety regulations trump state ones.
Preemption regulations are already affecting some pharmaceutical suits. The state of Alaska recently settled a case with Lilly to recoup medical costs for the Zyprexa antipsychotic for $15 million, a fraction of the original amount demanded, because of the Wyeth case, which could undo a large jury verdict, according to the state’s assistant attorney general Ed Sniffen (back story here and here ).
greg b
Just another clear example of poor leadership and failing to protect the public in favor of special interests.
Justice in MI
Mission accomplished.
Justice in MI
One more time, it is worth repeating that the “50 different standards” argument is pure horse hockey (if horse hockey can be pure).
The FDA and civil liability carried on for many years with no problems with over alleged “conflicting standards.” In the drug arena, that is because it remains the exclusive province of FDA to change labeling, approve or withdraw a drug, etc..
There are rare instances - and Levine may be one - in which a state court directly challenges FDA’s determinations. In the vast majority of instances, however, the issue is not what FDA did or did not do. It is whether a company acted such that FDA _could_ do its regulatory job and that FDA _did_ review the relevant risk at issue.
So it’s not about conflicting standards. It is about actual regulation on one side, and the presence of absence of negligence - from mild to felonious - on the other.
Dianne
The phrase (and caveat), “These new rules can’t quickly be undone by order of the next president …,” is worth noting.
Michigan has not been able to rescind its 1995 Drug Immunity Law that stripped citizens of their basic civil right of due process in claims against drug manufacturers, even though a 2007 House bill was passed to do so.
Justice in MI
Adding to Dianne’s commment, the key issue in Michigan is the state Senate which has a 1-2 vote majority against rescinding our law, and thus has been able to kill repeal in committee. As elsewhere conveyed, the state itself is about 70-30 against preemption.
The problem that Congress will have, should this cross-the-board preemption be upheld, has to do with the relationship between agency rule-making and Congressional oversight. Thus, even a very large majority in Congress against these directions would not have an easy time, as Ed’s summary suggests.
In my view, the most important first step of a President and Congress concerned with maintaining civil liability would be to replace the top management of every regulatory agency involved. This often happens with new administrations in any event.
I would then follow with hearings featuring representatives of those agencies, and some in industry, who have the experience and competence to describe what the realities of the regulatory process are.
Meg
I agree, Justice in MI. I don’t know how egregious the behavior has been in other regulatory agencies under President Bush, but having observed the FDA and studied it closely and testified before it, I am wont to say that its powers have been gutted and hundreds of thousands of individuals killed due to its “conflict of interest”.
Some have proposed Howard Dean as a follow up to Dr. Eschenbach’s charade. It will be interesting to see how quickly the FDA’s crooked culture can be turned around. And whether everyone there now in an appointed position gets off scott free.
Justice in MI
Meg - I concur with your overall assessment.
Whoever is Commish, there are a series of positions on down that will be harder to change. My limited study of FDA - like other large organizations - suggests that there is only so much a Commish can do to impact the organizational culture as a whole. But whatever that leader does, it has to be clear, definitive, and deadly serious. “Shmoozing around” will get us nowhere.
Sarah
Mr. Bush doesn’t know what he’s doing. All these drug companies are making people seriously ill instead of better. I have a friend that’s still waiting on a settlement from Eli Lilly,which lined Mr. Bush’s pockets. Mr. Bush does not care about anyone. He’s part of the zyprexa team that’s responsible for people getting diabetes and/or dying. Seriously people, look it up and see for yourselves who is on Eli Lilly so- called payroll (who’s getting money from that drug company and for what). OBAMA is our President now and things are going to get better for us all.