An important issue on the next Congress's policy agenda is to what extent US Food and Drug Administration regulation of a
drug or medical product shields manufacturers from liability challenges under state law. The Supreme Court recently heard
the high-profile Wyeth v. Levine case, and a decision is expected early next year. If the high court agrees with Wyeth Pharmaceuticals (Madison, NJ) that using
a drug according to its FDA-approved label protects the company from liability, the decision would bolster industry's position
in many lawsuits. Such a ruling, though, would prompt Rep. Henry Waxman (D-CA) to press for Congressional action to reverse
or modify the policy.
Waxman has been leading the antipreemption campaign, with support from many Democrats, consumer advocates, and plaintiffs'
attorneys. They believe that consumers should be able to seek redress through state courts for harm caused by drug use because
FDA makes mistakes and may fail to include sufficient warnings in product labels. They cite flaws in the drug-approval and
postmarket-surveillance systems, as seen in product recalls and serious adverse-event reports. And they consider the threat
of liability a powerful incentive for drug manufacturers to fully address product safety concerns. Juries frequently agree
with such arguments, especially when a case leads to genuine patient suffering, prompting manufacturers to settle many lawsuits
out of court.
The pharmaceutical industry and a broad coalition of business groups headed by the US Chamber of Commerce supports the Republican
position that state and local courts lack the expertise and authority to override decisions by FDA or other federal agencies
about appropriate product warnings. Bush administration officials added preemption clauses to many regulatory policies involving
consumer products, environmental protection, and transportation safety, in addition to FDAregulated drugs and medical devices.
So far, the high court has sided with industry arguments, as in a January 2008 ruling in favor of preemption in a medical-device
case involving Medtronic (Minneapolis, MN). But in questioning the attorneys on the Wyeth case in early November, several
justices challenged the manufacturer's contention that it had to adhere to FDA-approved labeling and could not strengthen
warnings on its own. There was considerable discussion about what safety information Wyeth provided FDA and whether the agency
assessed warnings sufficiently.
The general consensus is that individuals can sue drug companies that hide safety data or promote a drug for an unapproved
use. The issue in Levine is whether a manufacturer is liable for harm under state requirements even though the company followed FDA decisions on product
warnings and labeled indications. If Wyeth loses, pharmaceutical companies fear they will be open to unlimited claims. That
could prompt manufacturers to raise prices to cover added liabilities, or to pull products with any safety issues off the
market. Sponsors and FDA may decide to ratchet up label warnings, leading to overwarning that could inhibit the beneficial
uses of many medicines.
Eliminating preemption for manufacturers that follow FDA rules raises further questions about FDA's ability to balance risks
and benefits when making approval decisions. Internal agency staff documents released by Waxman showed that FDA officials
disagreed about whether agency regulation can address all possible safety issues. The high court could sidestep the larger
preemption controversy and issue a narrow decision that limits preemption to situations where the manufacturer follows all
FDA rules, including adverse-event reporting, and FDA specifically considers the safety issue in question. Industry would
like to see a strong ruling that preemption applies across the board, except in cases involving fraud or negligence, which
would be prosecuted as criminal cases.
The case highlights the importance of the new president's role in appointing members to the Supreme Court. Several long-term
members could retire during the next four years. A key test for Obama will be the criteria and expertise he looks for in new
appointees who will weigh in on critical medical issues in the years to come.
For more on this topic, see "Industry Changes and Challenges".