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

            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.”

 1  |  2  |  3