Monday, June 02, 2008

June 2, 2008


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


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.

The Times’ article did a real job on both the Ortho Evra patch and the FDA. Among its points were:

· “More than 3,000 women and their families have sued,” claiming “heart attacks, strokes and, in 40 cases, death.”

· “From 2003 to 2006” the FDA “received reports of at least 50 deaths associated with” the patch.

· Johnson & Johnson’s own internal documents showed that it knew the patch “delivered far more estrogen each day than low dose pills.”

· “The F.D.A. did not warn the public of the potential risks until November 2005 -- six years after the company’s own study showed high estrogen releases.” (Emphasis added.) Subsequent to the FDA’s warning, the sales of the patch dropped dramatically. (By February 2008 they had dropped to 187,000 from 900,000 in March 2004.)

· Plaintiffs’ lawyers and professors say that drug companies, on which the FDA necessarily relies to fully and honestly report test results, know and take advantage of the fact that the FDA is “overwhelmed,” “does not have the funding or the manpower to police” them, and rarely penalizes them even when they violate agency rules.

· Even the FDA’s own Commissioner has “acknowledged that the agency . . . may not be ‘adequate to regulate the food and drugs of the 21st century.’”

· “Last month, at a trial over schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.

‘“We at the F.D.A. know what we can obtain and we cannot obtain,’ Dr. Gueriguian said. ‘We have many, many problems, and we have a management system – what we can’t obtain we will not ask.”’

· In 1996 Johnson & Johnson promoted its patch to the FDA in part on the premise that “it would be likely to expose women to less estrogen than pills.” After all, “High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes.” But the patch was quickly found to apparently deliver a lot of estrogen -- more than pills. Yet the patch was marketed by Johnson & Johnson on the basis of statements falsely saying it released an amount of estrogen lower than was accurate, and “Clinical trials conducted before the patch was approved raised other red flags, as patients complained of breast soreness and nausea. ‘The side effects seem related’ to high estrogen doses, one company scientist wrote in an e-mail message.”

· “For years, top officials at the agency acknowledged that lawsuits could aid the agency’s oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.” But the FDA’s support for private lawsuits changed under the [pro big business] Bush Administration. “[N]ow the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines.”

· In late 2005 -- about six years too late, I would judge -- the FDA finally required a warning that the patch “exposes women to higher levels of estrogen than most birth control pills,” but “lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the F.D.A. approved the patch and its label”. [Many lawyers, of course, will defend any evil for a buck, and it is no surprise that drug company lawyers in the Supreme Court are among the most successful of such a (despicable) breed.]

The Times’ article, as said, did a (much deserved) job on the drug companies and the FDA. It was a continuation of presentation of the kind of information that would be called for by Pekelis’ jurisprudence of welfare, but not by the abstract legalisms and evidence-free speculations so often indulged by the Supreme Court.

A week later, on April 14th, the Times’ editorial page weighed in with an editorial entitled “The Dangers in Pre-emption.” Pointing out that the dangers of this doctrine were made clear in the April 6th article, the editorial said:

“The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices.”

“If this perverse legal doctrine, known as federal pre-emption, continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.”

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.’”

* * * * *

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.*



* This posting represents the personal views of Lawrence R. Velvel. If you wish to comment on the post, on the general topic of the post, or on the comments of others, you can, if you wish, post your comment on my website, VelvelOnNationalAffairs.com. All comments, of course, represent the views of their writers, not the views of Lawrence R. Velvel or of the Massachusetts School of Law. If you wish your comment to remain private, you can email me at Velvel@mslaw.edu.

VelvelOnNationalAffairs is now available as a podcast. To subscribe please visit VelvelOnNationalAffairs.com, and click on the link on the top left corner of the page. The podcasts can also be found on iTunes or at www.lrvelvel.libsyn.com

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