Healthy Skepticism Library item: 14019
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Sharav VH.
Zyprexa Litigation: Federal Judge Blasts FDA
Alliance for Human Research Protection 2008 Jul 19
http://ahrp.blogspot.com/2008/07/zyprexa-litigation-federal-judge-blasts.html
Full text:
On Thursday, July 17, Judge Jack Weinstein held a hearing on his discussion-only draft certification of a third-party payer RICO class against Eli Lilly.
Judge Weinstein refused defendant Lilly’s request that he withdraw his draft opinion because two state government plaintiffs have already cited it. The judge said he kind of likes the First Amendment and the free marketplace of ideas. And he rebuffed a plaintiffs request to change the proposed class period from 2001-2005 to 1996-2005, but said that might be a good idea if there were a settlement…
Judge Weinstein’s Statement is here (http://www.thejabberwock.org/blog/pdf/20080717weinstein.pdf)
He then read a Statement of the Court which in effect is a sweeping indictment of the entire US federal and state protective agencies “upon which users of pharmaceuticals primarily depend to protect against overpricing and misuse, and, in particular, the FDA’s lack of adequate research and control over marketing; failure of third-party payers, pharmacy benefit managers, and their consultants to exercise control over drug pricing and use; failure of what should be impartial and timely research by governmental and non-governmental organizations; inadequate steps by governmental and non-governmental organizations to promptly publicize efficacy and dangers; and, to some extent, failure of prescribing doctors and other medical personnel to limit appropriately usage and costs.”
“Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation. This congeries of conflicting considerations would tend to minimize a jury’s finding of damages and preclude punitive damages.”
He knocked down most of plaintiffs’ arguments—even as he once again acknowledged that there is “some merit” to the claim that Eli “Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.”
Judge Weinstein undercut the arguments of FDA officials who pretended not to know about Zyprexa’s hazards and the illegal off-label marketing: “Information about Zyprexa’s alleged deficiencies and overpricing has been available for years. Food and drug agencies in other countries were not misled. The third-party payers, with their professional consultants and pharmacy benefit managers, arguably should not have been gulled.”
He further undercut the case made by third-party payers by reminding them of their “fiduciary duty to ensure that their members were not overusing or overpaying for a medication.”
Judge Weinstein makes a persuasive argument when he says: “Strong evidence that they were not defrauded is provided by the fact that most of the third-party plaintiff representatives still maintain Zyprexa on their formularies and continue to pay for the drug, as they have in the past.”
“By contrast, the Veterans Health Administration in Los Angeles dropped Zyprexa as a first line drug in 1998 because of its known high costs and adverse side effects…”
He also notes that state Attorneys General, who have made overpricing and off-label claims based primarily on state Medicaid payments for Zyprexa, “[have] all already received substantial payments in the form of liens and hold-backs on personal injury settlements obtained by individuals who used Zyprexa when they were covered by Medicaid.”
Indeed, the victims of Zyprexa’s debilitating effects whose attorneys won $2.2 billion judgments never did get just compensation: those who survived Zyprexa-induced life-threatening effects and were awarded $50,000, never saw that money. They were made to pay the state for past care received.
Judge Weinstein’ harshest criticism is directed at the U.S. Food and Drug Administration: “The federal government’s claims may well be viewed by juries as especially anomalous. A large part of the legal problems attributed to Zyprexa, if they exist, are arguably due to the failure of the responsible federal agencies to prevent abuse.”
“Compared to its peer agencies in other parts of the world, the United States Food and Drug Administration (“FDA”) has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”
Finally, Judge Weinstein points to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173 prohibiting the government from negotiating with drug companies over the price of pharmaceuticals as contributing to the problems.
Judge Weinstein’s Statement is here (http://www.thejabberwock.org/blog/pdf/20080717weinstein.pdf)
