On Monday, the New York Times reported that the Supreme Court is considering protecting drug manufacturers from products liability lawsuits where the products have been approved by the FDA.
Justice Stephen G. Breyer said the fundamental question in the cases was who should make the decisions that will determine whether a drug is “on balance, going to save people or, on balance, going to hurt people?”
“An expert agency on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?” Justice Breyer asked.
Normally a member of the court’s liberal wing, Justice Breyer came down squarely on the industry’s side when he answered his own question, saying Congress left the role of policing the medicine market exclusively to the Food and Drug Administration.
“What worries me is, what happens if the jury is wrong?” he said.
Interesting question. Of course, Breyer's analysis assumes that the FDA has the resources and expertise to properly evaluate the products in question.
Today's Wall Street Journal casts some doubt on that assumption.
The FDA's leader, in an unusual public departure from Bush administration policy, says in an interview that he requested more than the 2.95% increase in overall agency appropriations proposed in the president's 2009 budget, though he declines to discuss specific figures. An outside advisory panel yesterday suggested the agency needs about 150% added to its appropriated base budget, phased in over five years, to cope with challenges such as inspecting a rising tide of imports.
"I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," Dr. von Eschenbach says. "This is a systemic overhaul that must go on over a period of years."
A recent report requested by Dr. von Eschenbach from an outside advisory group said the agency's "inability to keep up with scientific advances means that American lives are at risk." A series of earlier reports from government and independent organizations have faulted the FDA's handling of imports and drug safety, as well as the agency's habits and culture.
This is a fundamental problem with federal preemption of state tort claims based on the theory that regulatory agency approval is sufficient to provide an adequate level of safety for consumers - it assumes that the agency is fully funded and independent.
Industry trade associations will tell you that it's important to have a single standard, rather than "51" (as if a corporation would make 51 different products and not conform to the strictest level of safety). Reading between the lines, though, what the associations are saying is that it's easier to influence one federal agency chief than multiple agencies across the country.
The plaintiff's bar will tell you, on the other hand, that only in the "crucible of truth" can the proper level of safety be determined.
Of course, there's also the third way - split the difference and establish that regulatory approval creates a rebuttable presumption that the manufacturer has not committed a tort. But, again, that requires some assumption that the regulatory agency is acting in an independent manner and not advancing a particular ideology.