Alexander Pekelis And Drug Company Cases In Which Consumers Have Been Killed Or Injured

            The editorial added that “the disturbing element is that the company seems to have done its best to mislead the F.D.A., as revealed in company documents made public as a result of the lawsuits.”  It closed with the following:

                        “Whatever the merits of this case, it would be a mistake to rely solely on the F.D.A.’s judgment.  The agency is short of skilled scientists.  If a company buries important information deep in the bowels of a report, the agency may not detect it or appreciate its significance.  Injured patients should not lose the right to sue if they are harmed by duplicitous manufacturers.”

            Two days later, on April 16th, the Times had an article on an April 15th hearing at which ranking Senators said the F.D.A. is seriously underfunded.  The article (on page A15)added that “A report last year by a panel of outside advisers to the agency said American lives were in danger because the F.D.A. did not have the money, the staff or the scientific expertise to protect them.  And in a speech last month, Dr. von Eschenbach [the head of the F.D.A.] acknowledged that the F.D.A. ‘may fail in its mission to protect and promote the health of every American’ and that ‘peril exists.’” 

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            So. . . . where are we with regard to preemption of lawsuits against drug companies?  Where should we be?  These questions involve ideas that have been presented here before, plus other ideas.

            We know that thousands of people have been killed or injured because of defective and dangerous drugs and devices or inadequate warnings on labels.  Unless everything the Times has written is a lie, we know that this disaster is in part due to the F.D.A.’s incompetence and its insufficient staff and money.  We know that drug companies take advantage of the F.D.A.’s inadequacies to put defective products on the market, or products with insufficient warnings on their labels, and thereby also cause the deaths and injuries.  We know that the Supreme Court’s statements about the relative danger of the F.D.A. and juries are speculations pure and simple, with no evidentiary basis whatever -- in this regard, justices like Breyer, who was an expert on regulation before becoming a judge, have drunk the Democratic left’s Kool Aid about the glories of regulation in protecting people, while reactionaries like Scalia are pro big business and to hell with the small guy.  We know that the Medtronic case, unless reversed by Congress, or unless lower courts deliberately choose to and do find ways to ignore it because it is so vicious, will screw the small guy who is harmed by devices that are defective or  defectively labeled.  We don’t know yet what the Supreme Court will do with the upcoming Phenergan drug case, where it could impose the same vicious, anti-small –man, pro big business ruling of Medtronic, or could, even if inconsistently, break with Medtronic to rule that state law suits against defective, or defectively labeled, drugs are not preempted even if suits over defective devices are preempted.

            We can expect the drug companies’ lawyers, and their buddies in the Bush Administration, to continue to make the same kind of legalistic, often completely abstract arguments favoring preemption that they have made in cases like Medtronic, the Rezulin proceeding, and so on.  Lawyers for injured plaintiffs, however, would be well advised to go beyond legalistics and abstractions to one of two Pekelisian positions.  Using the outside and internal reports, and already existing testimony before Congress, that find the FDA inadequate and overwhelmed, they can argue there already is ample scientific and social science evidence that state law lawsuits are essential to protect consumers by discouraging drug companies from marketing products that have serious problems or whose labels do not describe possible problems.  That is, they can argue that the evidence already shows that the FDA cannot do and has not been doing the job. 

As a secondary position they should argue that, if the Court does not accept the conclusiveness of the evidence that already exists in reports, testimonies, etc., then there should be trials in which plaintiffs put on evidence on the question of the adequacy of the FDA’s conduct, and the honesty of drug manufacturers’ conduct, in specific cases.  If a manufacturer and the FDA acted honestly and fully competently, and did all that could be done at the time, then a state law lawsuit would be preempted.  If there was, as there so often has been, inadequate testing, inadequate disclosure, withholding of information by the manufacturer, or other derelictions by the manufacturer, or incompetence or sloth by the FDA, then state law lawsuits should be permitted -- they will not be preempted. 

The Supreme Court has expressed concern that such judicial inquiries into FDA conduct will tie up some agency personnel. My reaction is, “big deal.”  Is it better for the FDA and the drug manufacturers to get away with conduct that kills and maims people than for some FDA officials to have to devote some time to lawsuits because courts, ala Pekelis, are trying to get the evidence of how things happened in the real world?  The question answers itself, does it not?  Moreover, I frankly suspect that a few multibillion dollar recoveries in large class action cases against drug or device companies that lied or cheated or withheld information, or against companies that did much less than they could have to try to insure safe products and full disclosure of possible danger on labels, will work wonders in causing the drug companies to clean up their act and in providing greater safety to the public.

            The kind of evidentiary hearings discussed here combine Pekelis’ call for evidence of what is happening in the real world with an analog to ideas previously bruited here that the Supreme Court should find ways of allowing greater protection from states when the states exceed the protections of the federal government, and the Court should look at the thoroughness and competence with which governmental bodies have acted.  All of this – Pekelis’ ideas and mine – are far superior to the crapola, to the dry legalisms and baseless speculations, that the courts otherwise indulge in order to feed evidence-free decisions that simply accord with judges’ prejudices and result in harm to the average guy.*

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