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Alex Sugerman-Brozan

Federal Judge Allows Zyprexa Class Action to Go Forward, Says Courts are “in the Strongest Position” to Protect Public from Fraudulent Drug Marketing

Cross-posted from Prescription Access Litigation blog:

BROOKLYN, NY – A U.S. District Court judge today issued a decision allowing to go forward a class action lawsuit that alleged that Eli Lilly & Co. (NYSE: LLY) fraudulently marketed the atypical antipsychotic drug, Zyprexa, for uses not approved by the FDA. Judge Jack B. Weinstein, of the U.S. District Court, Eastern District of NY, denied Eli Lilly’s motion for summary judgment, as well as a summary judgment motion filed by the plaintiffs.

The 14-page order highlighted the importance of the Courts in protecting the public in the arena of prescription drugs. The Judge stated:

“Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs’ bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs.” (Opinion, pp. 3-4)

The lawsuit, brought by the New York-based Sergeants Benevolent Association Health and Welfare Fund and others, alleged that Eli Lilly illegally marketed Zyprexa for “off-label” purposes (i.e. for uses not approved by the FDA), as well as withholding information about Zyprexa’s safety and efficacy. Doctors may prescribe prescription drugs for “off-label” uses but drug companies are prohibited from marketing or promoting drugs for such uses. A 2006 study in the Archives of Internal Medicine found that more than 1 in 7 prescriptions for commonly-used drugs were for off-label uses that lacked scientific support. A study released in January 2007 by the federal Agency for Healthcare Quality and Research found that there was little scientific evidence to support the off-label use of Zyprexa and other atypical antipsychotics.

The plaintiffs in this case alleged that Lilly’s marketing allowed it to charge a higher price than the drug would have been able to command. Lilly sold $4.4 billion worth of Zyprexa in the U.S. in 2006. According to a MarketWatch article, “While U.S. sales of Zyprexa rose 19% in the fourth quarter 2006, Lilly attributed this jump largely to higher prices.” (“Lilly CEO: 2007 Zyprexa sales seen flat,” Val Brickates Kennedy, MarketWatch, Mar 14, 2007)

The Court further said in its opinion:

“Allowing this and like suits to proceed may or may not increase the cost of pharmaceuticals and the efficacy of medical treatment in this country. It does, however, furnish backstop protection against under-regulated potentially dangerous activity by a market where caveat emptor largely rules.” (Opinion, p. 12)

“This ruling underscores the important role that Courts play in protecting patients from illegal drug company tactics,” said Alex Sugerman-Brozan, director of Prescription Access Litigation, a national coalition of which the Sergeants Benevolent Association Health and Welfare Fund is a member. “Unfortunately, the FDA has been trying to slam the courthouse doors in the public’s face by arguing that consumers’ legal claims are ‘preempted’ by the FDA’s authority.”

“We are very excited about this success and are grateful to all those who worked diligently defending the interests of our members,” said Ed Mullins, President of the Sergeants Benevolent Association. “We will continue to pursue any action of wrongdoing that impacts on a NYPD Sergeant or their family.”

The case is part of In re Zyprexa Products Liability Litigation, 04-MD-01596, E.D.N.Y. The Judge’s ruling can be found here.

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About the Sergeants Benevolent Association
The Sergeants Benevolent Association (www.sbanyc.org) is comprised of approximately 10,000 active and retired sergeants of the New York City Police Department. An independent union, it acts as the collective bargaining unit for those officers during contract negotiations with the City of New York, and manages a variety of other projects – including health and welfare programs, political outreach efforts and community service initiatives – for the benefit of its members and their families. The breadth of the association’s activities is wide, but above all else, the SBA is an advocate for New York’s police sergeants, the officers who stand at the Frontline of our nation’s largest metropolitan police department.

About Prescription Access Litigation
Prescription Access Litigation (PAL) (www.prescriptionaccess.org) is a nationwide coalition of over 130 state, local, and national senior, labor and consumer health advocacy groups in 35 states and the District of Columbia fighting to make prescription drugs affordable. The organizations in the PAL coalition have a combined membership of over 13 million people. PAL works to end illegal drug industry practices that increase the price of prescription drugs beyond the reach of the American consumer, using class action litigation and public education. Since 2001, PAL members have filed 28 sets of lawsuits targeting such practices. News about PAL’s cases and public education efforts is published regularly on the PAL Blog at www.prescriptionaccess.org/blog

Alex Sugerman-Brozan: Author Bio | Other Posts
Posted at 6:27 PM, Jun 28, 2007 in
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Comments

In my experiemce Zyprexa has been an wonderful molecule, not only because of its fast-acting nature , but also in old cases of agitated depression , dementia where other antipsychotics (like Haldol) simply failed . Any way being a congener of clozapine , the issue of obesity and Diabetes is a no brainer. The issue is the seriousness of the side effects. Although many of the psychiatrists , I know , were skirting the molecule , nonetheless used it for short-term purpose as an excellent choice for people with suicidal behavior. The fact of the matter is that you can see all the side effects in the black box warning of Zyprexa , and it is the job of the individual physician to sort that out for its patient. Now, which part of the marketing is seedy ? We already know the off lebel uses and it is not , that the off-label users didn’t get the effective drug they paid for. No body was cheated because of that and plesase explain, how come this off lebel use will increase the drug price? Granted they profited astronomically, but why should that be a concern for anybody, and be a case for class action , is beyond me.

Posted by: Anirban | June 29, 2007 2:21 PM

Anirban: You are actually trying to talk rationally to land pirates? They're land pirates, for Pete's sakes.

Posted by: Supremacy Claus | June 29, 2007 8:10 PM

There is no drug anywhere, of any kind, that is not harmful to someone somewhere. In fact there is no food to which some somewhere is not allergic.

My wife is a diabetic and two of the most effective medicines for her were scared off the market by bogus class action lawsuits. No medications available since then have proved as effective for her.

Most class action lawsuits are bogus; however, I can think of one that would be legitimate. All patients, such as my wife, should band together in a class action lawsuit against the former ATLA (I know they changed their name and initials, but the new name is a complete sham) and all its member attorneys. The measure of damages sought should be every penny of the fees ever received in pursuing class action litigation against pharmaceutical companies.

Is there any attorney with sufficient balls to take on such a case ??

Posted by: Paul W Dennis | July 1, 2007 2:12 AM

Paul,

I am so sorry to hear about your wife's situation. I don't think your assessment, that the unavailability of effective drugs is due to class action lawsuits, is accurate at all, though.

There is a certain level of risk that every person, every patient, deserves to know about. With that knowledge, s/he can then make a decision about whether to take the risk. The problem is not when there is a small tiny fraction of a one in a zillion risk (per your statement that every drug/food will harm at least one person somewhere); the problem is when a pharm company knows about a signficant adverse health risk and doesn't warn people. The problem is when people rely on the company's ads and believe that the drug will improve their health, and they actually end up dying or being severely injured.

Here's why our civil justice system is an important check against such disastrous results: companies by law must pursue the bottom line--pursue profits for their shareholders. Companies are not required by law to have a moral conscience, to be cautious when it comes to their consumers' well-being, etc. Class action lawsuits make it so that companies include in their calculation of the bottom line the consequences of reckless and deceptive advertising, or of improper testing or labeling of their drugs. In short, our civil justice system encourages corporations to practice good business, and not just business as usual.

Posted by: Kia | July 2, 2007 4:55 PM

If information were the goal, the lawyers would enjoin the drug companies to get candid. They would sue for the release of data.

They never do that. They only sue for huge sums. These sums take away the research budget for the next advance in medicine.

The totally, pro-lawyer rent biased cult criminals on the bench will not protect the public.

I see self-help as the remedy against this airtight rigged system. Not even the members of the class have any recourse against the plunder of clinical care by the lawyer. They often see little compensation.

In short, our civil justice system encourages corporations to practice going to other nations to do business, and not just hand over all assets to the land pirates. In short, our civil justice system deters corporations from innovations, from risk taking, from expanding the uses of medications to massive numbers of off label uses at little or no additional expense or effort.

I like Kia as a person. She is either heartless, or under 30. The relentless cascade of organ failure has yet to begin for her. Soon, her body will deter her enthusiasm for the all out attack on clinical care. Her body will deter her cheer leading for the criminal cult that indoctrinated her, and destroyed her independent mental ability.

Posted by: Supremacy Claus | July 2, 2007 7:35 PM

" I am so sorry to hear about your wife's situation. I don't think your assessment, that the unavailability of effective drugs is due to class action lawsuits, is accurate at all, though."

I am sorry that you are that naive. Both drugs came with adequate warnings; the problems with both came when either (1) the prescribing physician didn't do adequate monitoring or (2) the patient did not return for blood tests and monitoring at the proper intervals. Neither could be blamed on the pharmaceutical company, although both were the targets of class action lawsuits

Of course, I actually read and study the warnings and contraindictions in the literature of the drugs my wife, my mother, and I take. I don't have much sympathy for those who merely swallow whatever pills they are prescribed. Each of has the primary responsibility for our own well being

Posted by: Paul W Dennis | July 2, 2007 11:53 PM

Paul: As of 2007, there is almost no location in the US without internet access. It is now unreasonable if a patient has not done their own research on official sites, in chat rooms for similar patients, in Wikipedia.

The lack of informed consent is now an impossible claim. It is not frivolous, it is bad faith, per se. The claim of consumer fraud, misleading advertising, or cover up of side effects is an attempt to mislead the court. Any lawyer filing such a claim of lack of information should suffer severe sanctions out of personal assets, not out of law firm assets. Any judge permitting such a fraud on the court, should be summarily removed by the administrative judge. Failure to remove such a collaborator with lawyer fraud should result in an immediate impeachment of both.

All immunities of the court should end. Defendants subjected to such fraudulent claims should sue the owner of the court for its failure to prevent its judge criminality and collaboration with lawyer fraud. I would have no hesitation to subject a county with a bankrupting class action. To deter.

If the biased courts of the state dismiss such a claim, then wrack both with Section 1983 claims in Federal Court. Civil defendants now have substantive due process rights, since Morris v Williams, 2007.

Posted by: Supremacy Claus | July 3, 2007 8:08 PM

My only son , who had manic depression, was killed by Zyprexa in 2002. There was no warning on the label or by the doctor - a Medicaid doctor whose state formulary had probably been bribed. Having recently read his medical records for the first time, I think a share of the blame should go to Hipaa and possibly state mental health privacy laws. Had I known what I read in the files, I would have taken immediate action.

I hope Alex Sugarman-Brozan will consider this possibility for litigation. Most other litigation on Zyprexa has been a pathetic joke played on the plaintiffs or their surviving families. Even the state AG suits are miniscule compared to profits. And I don't know about shareholder suits.

To be mislead and misinformed by Hipaa and state mental illness privacy laws is wrong.

Posted by: Sorrowful | July 8, 2007 6:03 PM

Sorrowful: Please, tell us how Zyprexa killed your son, in 2002.

Posted by: Supremacy Claus | July 9, 2007 10:17 PM