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

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Message Lawrence Velvel

June 2, 2008

  Re:  Alexander Pekelis’ Jurisprudence Of Welfare And Drug Company Cases, Mainly In The Supreme Court, In Which Consumers Have Been Killed Or Injured By Defective Products.  


            On March 12th, a posting here discussed Alexander Pekelis, a great scholar killed in a plane crash at Shannon Airport in 1946, 62 years ago.  (Emails subsequently arrived from an Italian professor who is writing a paper on Pekelis and lamented that Pekelis’ work has been ignored, and from Pekelis’ daughter, a judge in the State of Washington.)  The posting spoke of Pekelis’ jurisprudence of welfare, which required judges to look at social science materials when determining what legal rule would best serve society.  It went on to discuss one recent Supreme Court case in which the welfare of society at large -- the welfare of the common man -- was trashed by the high Court’s screw-the-small-guy-five -- Scalia, Thomas, Roberts, Alito and Kennedy, who were joined, unbelievably enough, by Souter, Breyer and, partly, by Stevens.  Only Ginsburg had stood for decency.


            The question of the case was whether, under state law, suit for damages could be brought against the manufacturer of a defective catheter by a man who was injured when it ruptured in his heart during open heart surgery.  The screw-the-small-guy-five-plus-two-and-a-half-more said suit could not be brought under state law.  For state law supposedly was “preempted” as the lawyers say, i.e., was nullified because Congress had given the Food and Drug Administration the power to regulate medical “devices.”  The geniuses at the FDA, opined Justice Scalia, will make better decisions than juries on whether a defective device should have been saleable because it would help more people than it may harm, or should not have been saleable because it will cause more harm than benefit.


            The posting explained several reasons why Scalia and his pals basically were, as we used to say in Chicago, full of crap.  I will not reiterate those reasons, except for one:  the FDA had repeatedly been found to make horrendous mistakes and to be incompetent.  Let me now add that, in Pekelisian terms, the Supreme Court ignored the findings of science and social science with regard to the FDA’s incompetence and mistakes. Also, it  supported big business.  It did these things in service of its own speculation, which had no evidentiary basis whatsoever, that societal welfare would be benefited more by denying recovery to the injured under state law despite horrible mistakes and malperformance by the FDA and manufacturers than by permitting such recovery when defective devices injure or kill people.


            The catheter case, Riegel v. Medtronic, was decided on February 20th of this year.  Pending before the Supreme Court on that day was a similar case, Warner-Lambert v. Kent, where the question was whether recovery under state law was preempted because the drug Rezulin had been approved by the FDA.  Rezulin, as is now infamous, could cause serious liver damage.  Recovery was being sought under a state law that allowed it only when the FDA had, in effect, been defrauded because the drug manufacturer withheld information that would have caused the FDA not to approve the drug.


            Although the Rezulin case involved a drug and the Medtronic case involved a device, one would think that if FDA authority preempts state law in the one case, it would do so in the other as well.  The Rezulin drug case was argued orally to the Court on February 25, just five days after the Medtronic device decision.  Then, only a week after the oral argument in the drug case, a strange thing happened.  The Court in effect got rid of the drug case.  It issued an order saying merely that the judgment below “is affirmed by an equally divided Court,” with Justice Roberts not participating in the case.  The judgment below, contrary to the Supreme Court’s Medtronic decision, had been that state law was not preempted, so the affirmance meant the injured person in the Rezulin case could sue under state law. 


            Why did the Court issue a one line affirmance, much less one that at least on its face seems inconsistent with a case decided less than two weeks before.  One can only speculate, because there can be a number of different possible reasons.  But one reason necessarily jumps out.  The Court, less than two weeks after Medtronic, which had been 7½ to 1½ in favor of preemption, was now 4 to 4 on preemption in the absence of Roberts.  A one line affirmance of the decision below is common in such circumstances, if memory serves.  Moreover, on January 18th the Court had already agreed to hear another drug case, one involving a drug produced by Wyeth called Phenergan.  The FDA - approved label for this drug had not warned that use in a particular way could be disastrous; the drug’s injection had caused a musician to lose an arm; and the question is whether a recovery is precluded because state law is preempted by the FDA’s approval of the labeling.  The Court had even ordered an expedited briefing schedule in the case (though subsequently the schedule was lengthened, so that now the case will not be heard until this autumn). 


            What is especially interesting, nonetheless, is that, as said, in the Rezulin case the eight participating judges were divided 4 to 4, although in the prior Medtronic device case the count among the same eight (i.e., ignoring Roberts) was 6½ for preemption.  In less than two weeks -- between February 20th and March 3rd, the pro-preemption side, the screw-the-small-guy side, had lost 2½ votes.  How did that happen?


            Well, there are several possibilities, but the truth is I’m not smart enough to know.  Maybe some justices see differences in the federal statute when it comes to drugs as opposed to devices.  Also, though I’ve read the transcript of the oral argument on February 25th, a fair amount of it is legal gobbledygook to me.  The only thing that really stood out to me is that Justice Breyer, who has drunk the pro FDA Kool Aid, is really worried that juries will do wrong where the geniuses at FDA will do right.  But Breyer voted with the manufacturer, in favor of preemption, in Medtronic, with no sign of the slightest comprehension of the FDA’s terrible inadequacy.  So his concern for the FDA and distrust of juries represents no change in his position.


            Nor does the 4 to 4 division in the Court means the injured person is likely to win the Phenergan case when it is heard this fall.  In the fall, Roberts, who voted against the injured person in the catheter case, will be participating in the Phenergan case one presumes, and will likely provide the fifth vote to screw the small guy again, and to help the drug companies again, by finding preemption again so that the injured person again can’t sue.  (As written here previously, I regard Roberts as a bad person, a pro big business, pro unlimited executive power person who lied and unethically cheated his way onto the Supreme Court.  His dishonesty was expressed, dramatically and accurately, by the nation’s leading conservative court of appeals judge, Richard Posner, who said in his recent book, How Judges Think (p. 81), that “The tension between what he said at his confirmation hearing and what he is doing as a Justice is a blow to Roberts’ reputation for candor and a further debasement of the already debased currency of the testimony of nominees at judicial confirmation hearings.”) 


In addition to Roberts participating in the Phenergan case and likely voting for the drug company in favor of preemption, it is also quite possible -- even probable? -- that one of the (unknown) Justices who switched sides in the Rezulin case will switch back again in the Phenergan case because the latter involves labeling of drugs and because state law in the Phenergan litigation, unlike in the Rezulin case, does not limit recovery to situations in which a manufacturer defrauded the FDA.


            In any event, after the Medtronic decision of February 20th and the oral argument in the Rezulin case on February 25th, “a funny thing happened on the way to the forum,” so to speak.  The New York Times took out after both the FDA and the Supreme Court’s decision in the Medtronic case.  On February 26th, six days after Medtronic, and one day after the oral argument in the Rezulin case, the Times published an article (on P. A16) on what the Court was doing.  It cited and quoted Justices (like Breyer) who claimed to worry about whether jury decisions would gum up a situation which should be left to the geniuses at FDA.  But the very last paragraph of the article said this:

 The government argues that the F.D.A. competently oversees the drug and device markets, and should not be second-guessed by courts.  But the Institute of Medicine, the Government Accountability Office and the F.D.A.’s own science board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food. (Emphasis added.) 

            To return to a subject discussed above, as unlikely as the cognoscenti may claim an impact to be, one nonetheless cannot help wondering whether this short yet devastating paragraph, appearing just six days after Medtronic, and only one day after the oral argument in the Rezulin case, had an impact on one or more Justices that contributed to the switch manifested six days later, on March 3rd.  That was when an “equally divided” Court of 4 to 4 affirmed the lower court’s anti-preemption decision in the Rezulin matter less than two weeks after 7 ½ Justices were for preemption in the catheter case.  The New York Times’ paragraph, one notes, was worlds removed from the dry legalisms, from the legal abstractions and non-evidence-based judicial speculation, that had been the staple fare until then.  It was the beginning, or at least the start of the beginning -- pace Winston Churchill, who said that Allied victory in North Africa was at least the end of the beginning -- of the presentation of the kind of information that Alexander Pekelis so justly thought necessary in judicial cases, information about what is really happening in the world. 


            Five weeks after the Times article of February 26th, the Times published a long front page article on April 6th tellingly headlined Drug Makers Near Old Goal:  A Legal Shield, with the subheadline Court to Rule if F.D.A. Approval Bars Suits.  This article mentions the Medtronic decision and the fact that the Phenergan case would be heard by the Supreme Court in the fall, but was essentially about a case currently pending in a federal trial court in Ohio involving the Ortho Evra birth control patch made by Johnson & Johnson.  That patch is claimed to have caused disaster by releasing far more estrogen into the body than birth control pills do, while its FDA approved label wrongly described the amount of estrogen it released. 

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Lawrence R. Velvel is a cofounder and the Dean of the Massachusetts School of Law, and is the founder of the American College of History and Legal Studies.
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