Fwd: Psych Rights Sues Alaska to Stop Harmful Psych Drugs of Kids

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"VERACARE" <veracareSeptember 7, 2008 8:55:52 AM HST"Infomail1 (AT) ahrp (DOT) org" <Infomail1Psych Rights Sues Alaska to Stop Harmful Psych Drugs of Kids ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIOn Sept. 2, 2008, Psych Rights Law Project, headed by Jim Gottstein, Esq,filed an important, potentially landmark lawsuit against the State of Alaskato Stop the massive use of harmful brain-altering psychiatric drugs onAlaskan children.The suit seeks Declaratory and Injunctive Relief for the administration ofpsychotropic medication to children and youth in the custody of, or paid forby, the State of Alaska. See:http://psychrights.org/states/Alaska/PsychRightsvAlaska/PsychRightsvAlaskaKidDruggingComplaint.pdf The suit lays out the scientific evidence of harm produced by psychotropicdrugs in children. The documented evidence about these drugs' hazards hasbeen collated by Critical Risk Rx, a curriculum for mental healthprofessionals designed by Dr. David Cohen, Professor at FloridaInternational University--who is an officer of the Alliance of HumanResearch Protection (AHRP). The purpose of Critical Risk Rx is to promote critical thinking skills aboutpsychiatric medication issues. http://www.criticalthinkrx.org/CriticalThinkRx offers an alternative perspective to the drugging ofchildren based on empirical evidence. Its goal is to stimulate "criticalthinking" and a more balanced evaluation of the "prescription situation"based on ethical codes of practice of medical and non-medical helpingprofessions. The curriculum aims to sharpen critical skills of mental healthand child welfare professionals assessing and practicing with children andadolescents who may be medicated with psychiatric drugs. Two days later, on Sept. 4, federal Judge Jack Weinstein reiterated his Julystatement:``There is sufficient evidence of fraud'' by Lilly in selling the drug tojustify a jury trial in a 294-page decision.Indeed, tens of thousands of Zyprexa users, investors and third-party payorsfiled suits, including: 30,000 personal injury claims; civil and criminalcases filed by attorneys general. A securities class action recentlydismissed as time barred by Weinstein; and the present class action,initiated on behalf of tens of thousands of insurers and unions. In his latest ruling, Judge Weinstein gave class-action status to a casebrought by insurance companies, pension funds and unions that seek billionsof dollars from Lilly for overpayment for the drug. The judge certified thecase as a class action on the RICO claims for all plaintiffs exceptindividual patients who bought the drug, rejecting Lilly arguments that thepension funds, union and insurance companies had claims too different to betried together. These plaintiffs, so-called ``third-party payors,'' boughtthe drug for members or customers.Furthermore, Judge Weinstein ordered Eli Lilly's Zyprexa documents to beunsealed and made publicly available, stating: "Lilly's legitimate interest in confidentiality does not outweigh the publicinterest in disclosure at this stage...the health of hundreds of thousandsof people, fundamental questions about our system of approval and monitoringof pharmaceutical products, and the funding for many health and insurancebenefit plans."Until the unsealing of these documents, AHRP board members, Dr. David Cohen(Secretary) and Vera Sharav (President) were enjoined by Judge Weinsteinfrom disseminating the Zyprexa documents.  On August 20, 2008, Attorney,Alan Millstein filed an order on behalf of Dr. Cohen and Mrs. Sharav,requesting a Hearing on the Motion of the Alliance for Human ResearchProtection requesting publication of a limited number of confidentialdocuments.Fifteen law firms are involved, contending that Lilly hid the side effectsof Zyprexa and marketed it for unapproved uses. The 350 sealed Zyprexa documents are significant in providing (partial)evidence of the company's illegal marketing tactics. The documents show thatLilly promoted a drug they knew was toxic----their experts warned about itstoxic effects, in particular Zyprexa's propensity to induce acute weightgain triggering metabolic syndrome and diabetes. Yet, the company embarkedon an aggressive marketing campaign--Viva Zyprexa--for off-label unapproveduses of the drug.     However, Judge Weinstein immediately stayed the unsealing order to giveLilly a chance to appeal it.  The count so far, in State lawsuits against Eli Lilly charging the companywith illegal marketing of Zyprexa (olanzapine) is 11: Alaska, Connecticut, Idaho, Louisiana, Mississippi, Montana, New Mexico,Pennsylvania, South Carolina, Utah and West Virginia.6 State suits have been filed against Johnson & Johnson/ Jansen overmarketing of Risperdal (risperidone): Arkansas, Louisiana, Montana, Pennsylvania, South Carolina and Texas 4 State suits against  AstraZeneca over the marketing of Seroquel(quetiapine): Arkansas, Montana, Pennsylvania, South Carolina  Contact: Vera Hassner Sharavveracare212-595-8974Psychiatric Rights, Inc.406 G Street, Suite 206, Anchorage, AK 99501 ~ psychrights.org ~contactNEWS RELEASEFOR IMMEDIATE RELEASESeptember 2, 2008PsychRights Sues State of Alaska to Stop Its Massive, Harmful PsychiatricDrugging of Alaskan ChildrenToday the Law Project for Psychiatric Rights (PsychRights) announced thatdue to the State of Alaska's unwillingness, or inability, to enter intosubstantive talks, it has filed its lawsuit against the State of Alaska andofficials responsible for the excessive, ineffective, and extremely harmfulpsychiatric drugging of Alaskan children and youth. The lawsuit seeks aninjunction stopping the practice of Alaska authorizing or paying forpsychotropic drugs to be given children without safeguards being in place tomake sure proper decision making occurs.Jim Gottstein, the president of PsychRights and the attorney bringing thelawsuit, said, "The corrupt influence of the pharmaceutical industry inillegally promoting much of this psychiatric drugging of children has beenwell established, yet the State of Alaska continues to inflict great harm onthe children it has taken away from their families by giving them thesedrugs." It is ludicrous that the State sued a drug company for fraud inhiding the harm caused by one of these drugs and still gives that same drugand other toxic drugs like it, to children.Dr. Karen Effrem, pediatrician and board member of the Alliance for HumanResearch Protection (AHRP) and the International Center for the Study ofPsychiatry and Psychology (ICSPP), said, "These dangerous and ineffectivedrugs are tragically overused to merely control behavior of children who aredistraught about being taken away from their families. Missing one's familyor reacting to trauma are wrongly labeled as biological brain disorders thatneed treatment with powerful medications. Drugs will not put their familiesback together or help them overcome their trauma and grief. These brain andbody damaging pharmaceuticals compound the abuse and trauma. To paraphrase apopular motivational saying, what these kids truly need are 'hugs, notdrugs; hope not dope,' (even legal dope)"Governor Palin is one of the defendants because, as governor, she isultimately responsible for the protection of the children of Alaska, but Mr.Gottstein noted, "I doubt anyone on Governor Palin's staff has even let herknow about the problem of the State harming Alaskan children throughexcessive psychiatric drugging despite my trying to bring it to herattention ever since she came into office.I know Governor Palin has beenfocused on the very pressing issue of freeing Alaska, and the nation forthat matter, from Big Oil's stranglehold on the trillions of cubic feet ofNorth Slope natural gas the nation needs from reaching the people that needit," Mr. Gottstein continued, "but Alaska's children also deserve herattention. We know that Governor Palin is very compassionate about the needsof children with problems and it is hard to imagine she would turn her backon them if she knew about it."CONTACT:Jim Gottstein907-274-7686jim.gottstein (604) 936-8940 Vancouver Phone ~ (907) 274-7686 Anchorage Phone ~ (907)274-9493 Fax~~~~~~~~~~~  THE NEW YORK TIMESSeptember 6, 2008Judge to Unseal Documents on the Eli Lilly Drug ZyprexaBy MARY WILLIAMS WALSHA federal judge in Brooklyn decided on Friday to unseal confidentialmaterials about Eli Lilly's top-selling antipsychotic drug Zyprexa, citing"the health of hundreds of thousands of people" and "fundamental questions"about the way drugs are approved for new uses.The decision by Judge Jack B. Weinstein of Federal District Court came aspart of a ruling that gave class-action status to a case brought byinsurance companies, pension funds and unions that want Lilly to repay thembillions of dollars they spent on the drug. They contend that Lilly hid theside effects of the drug and marketed it for unapproved uses.The confidential documents were produced by Lilly in response to a relatedlawsuit filed by patients who said that Zyprexa had caused excessive weightgain and diabetes. The papers were placed under a protective court ordersoon after the suit was filed in 2004."Lilly's legitimate interest in confidentiality does not outweigh the publicinterest in disclosure at this stage," Judge Weinstein wrote.A spokeswoman for Lilly, Marni Lemons, said the company would not appeal thedecision to make the documents public but that it would appeal the judge'scertification of a class action.The issue of confidential information arose in 2006, when some of theZyprexa papers were provided to a reporter for The New York Times, AlexBerenson. He wrote front-page articles based on evidence they contained thatLilly executives had kept information from doctors about Zyprexa's links toobesity and high blood sugar.Eli Lilly denied having withheld such information and said that thedocuments Mr. Berenson had seen were "cherry-picked" to give a one-sidedview.The publication of sealed information led Judge Weinstein to issue a sharplyworded ruling last year, stating that Mr. Berenson had engaged in aconspiracy with a doctor and a lawyer and that they had used others "astheir agents in crime."The judge said the sealed documents belonged to Lilly and ordered thedoctor, David S. Egilman, and the lawyer, James B. Gottstein, to returnthem. Dr. Egilman had been serving as an expert consultant for theplaintiffs at the time, and Mr. Gottstein was working on Zyprexa litigationin Alaska.Since then, insurance companies, unions, medical researchers and otherpublications have filed formal requests for copies of the documents. Many ofthe papers were entered into open court proceedings in Alaska, and copies ofsome have been posted on the Internet.In his ruling on Friday, Judge Weinstein repeated that the information hadbeen "obtained illegally" by The Times but also cited "this country'sgeneral policy of accessibility of court records."Dr. Egilman said on Friday that he felt vindicated."The public can now decide for itself what these documents stand for," hesaid.Mr. Gottstein said he still disputed Judge Weinstein's rulings that he hadobtained the documents illegally."I think I did get them properly," he said, adding that the new orderunsealed only a small number of the Zyprexa documents that Lilly hasprovided to the court. "There are a lot of other documents that are hidden."Copyright 2008 The New York Times Company  ~~~~~~~~~~~~~~~~http://www.bloomberg.com/apps/news?pid=newsarchive & sid=a1xvxgo48su0 BloombergLilly Zyprexa Group Buyers Win Class Action StatusHurtado P, Van Voris B2008 Sep 5A U.S. judge ruled that pension funds, labor unions and insurance companiesthat bought Eli Lilly & Co. 's Zyprexa drug could sue as a group and wereentitled to a jury trial of claims the medicine was overpriced.Zyprexa is approved to treat schizophrenia and bipolar disorder. Theplaintiffs claim Lilly, based in Indianapolis, Indiana, urged doctors toprescribe Zyprexa for uses not approved by the U.S. Food and DrugAdministration.The institutional buyers, who sought $6.8 billion in damages, claim Lillyoverpriced the drug by making excessive claims about Zyprexa's usefulness,violating the Racketeer- Influenced and Corrupt Organizations Act, or RICO.Zyprexa was the company's top-selling drug last year, with $4.76 billion insales.``There is sufficient evidence of fraud'' by Lilly in selling the drug tojustify a jury trial, said U.S. District Judge Jack Weinstein, in a 294-pagedecision issued today in Brooklyn, New York.The judge certified the case as a class action on the RICO claims for allplaintiffs except individual patients who bought the drug, rejecting Lillyarguments that the pension funds, union and insurance companies had claimstoo different to be tried together. These plaintiffs, so-called``third-party payors,'' bought the drug for members or customers.Today's ruling is nearly identical to a draft of the decision that Weinsteinissued July 2, as part of an attempt to persuade both sides to settle. Classcertification gives the plaintiffs more leverage to settle the dispute.Damages SoughtAll the plaintiffs were initially seeking as much as $7.7 billion in damagescovering a 10-year period. The ruling limits the time frame for damages tofour years, from June 20, 2001 until June 20, 2005 when the suit was filed.The third-party payors had claimed damages for as far back as 1996.Without the individual patients who paid for Zyprexa themselves, damagessought by the other plaintiffs were as high as $6.8 billion over theten-year period, Weinstein said.Weinstein said the third-party payors include: the United Federation ofTeachers Welfare Fund , or UFCW, a Philadelphia- based fund representing20,000 food and commercial workers; Mid- West Life Insurance and theSergeant Benevolent Association Health and Welfare Fund, which representscurrent and retired New York City Police sergeants and their families --33,000 people.The judge denied class-action status to individuals with claims because hefound their proposed leaders can't properly represent the proposed class.``They have a conflict of interest since they are suing Lilly for personalinjury,'' he said.350 DocumentsWeinstein permitted the parties to make an immediate appeal of his classcertification to a U.S. appeals court in New York. In April, that courtreversed Weinstein's decision to certify a nationwide class of lightcigarette smokers in a case claiming as much as $800 billion from U.S.tobacco companies.The judge also granted the plaintiffs' motion for an order to unseal about350 documents previously designated as confidential in the case. Heimmediately stayed that order too to give Lilly a chance to appeal it.``Lilly's legitimate interest in confidentiality does not outweigh thepublic interest in disclosure at this stage of the litigation,'' Weinsteinsaid. ``The documents are now so outdated that unsealing will notsignificantly harm Lilly.''He said access to the documents was warranted, ``because this litigationinvolves issues of great public interest, the health of hundreds ofthousands of people, fundamental questions about our system of approval andmonitoring of pharmaceutical products, and the funding for many health andinsurance benefit plans.''Lilly CommentLilly spokeswoman Marni Lemons said the company will appeal the classcertification ruling which it regards as being ``in error.'' The companywon't contest the document order, she said.Lemons said the judge recognized in his opinion that Zyprexa is a valuableand effective medicine that has reduced hospital costs for many patients.The information that has become public in recent years hasn't convincedinsurers to remove Zyprexa from their lists of approved drugs, she said.Lilly fell 65 cents to $45.44 in New York Stock Exchange composite trading.The case is: UFCW Local 1776 and Participating Employers Health and WelfareFund v. Eli Lilly and Co., No. 05-CV-4115, U.S. District Court, EasternDistrict of New York (Brooklyn).~~~~~~~~~~ NEW YORK LAW JOURNALNarrow Zyprexa Class Certified, Sealed Files ReleasedMark Fass09-08-2008A federal judge in Brooklyn, N.Y., has certified a class of "third-partypayors," such as pension funds, labor unions and insurance companies, intheir claim that the drug giant Eli Lilly committed fraud by overpricing itsanti-psychotic drug Zyprexa while overstating the drug's utility andunderstating its drawbacks.The decision was a partial victory for both sides, as Eastern District ofNew York Judge Jack B. Weinstein certified only the plaintiffs' RacketeerInfluenced and Corrupt Organizations Act claims and not their state-lawones, and on a narrower basis than the plaintiffs sought. The judge alsodeclined to certify a class of individual-payor claims."Total denial of certification would constitute the death knell of theaction," Weinstein wrote in Zyprexa Products Liability Litigation,04-MD-1596. "Almost all plaintiffs' claims would be too small toindividually support this costly litigation. Under such circumstances,absent an unusual situation, the rule to be applied in deciding to denycertification is essentially that for summary judgment."Weinstein's 295-page decision also marks the apparent end of the controversysurrounding approximately 350 sealed documents that were obtained in a legalend-run by New York Times reporter Alex Berenson.Eighteen months after Weinstein derided the "conspiracy" orchestrated byBerenson and two sympathetic attorneys to obtain the documents -- primarilyinternal Lilly documents and e-mails between its top managers -- the judgeordered the documents unsealed."Public access is now advisable because this litigation involves issues ofgreat public interest, the health of hundreds of thousands of people,fundamental questions about our system of approval and monitoring ofpharmaceutical products, and the funding for many health and insurancebenefit plans," Weinstein wrote."Public and private agencies and organizations have a right to be informed.At this stage public disclosure, congruent with our long tradition of opencourts, is desirable."As summarized by Weinstein in a 78-page decision in February 2007, theTimes' Berenson obtained documents, which he knew were subject to aprotective order, by convincing an Alaska attorney involved in an"unconnected" case to subpoena them. After that attorney, James B.Gottstein, obtained the documents, he released them to Berenson and others,and they quickly found their way into Times articles and onto the Internet.In his 2007 decision, Weinstein enjoined a number of the individualconspirators from further disseminating the documents and ordered them toreturn any in their possession.Weinstein has now ordered the seal removed, though he referred the unsealingto a special master to "avoid any unnecessary embarrassment" to any party."Based on this country's long-standing tradition of open access to thecourts and court records, the enormous number of people who have taken orwill take Zyprexa, the involvement of government regulatory bodies, absentclass members' interest in the proceeding, and the age of the documents, themotions to unseal are granted," Weinstein wrote."NARROW LIABILITY WINDOWThe present class action is one of the larger suits in the mass of claimswaged against Lilly over the last five years regarding Zyprexa, which thecompany began marketing in 1996 as a wonder drug for schizophrenia andlater, bipolar disorder.Zyprexa quickly became one of Lilly's top sellers, with more than 12 millionusers and billions of dollars in annual sales.However, beginning in 2000, a number of studies linked Zyprexa to serioushealth concerns. In 2006, the Times published the first of its reports onthe drug, which alleged that Lilly and its officers misrepresented or failedto disclose Zyprexa's link to diabetes, obesity and heightened blood sugar.Tens of thousands of Zyprexa users, investors and third-party payors filedsuits, including: 30,000 personal injury claims; civil and criminal casesfiled by attorneys general; a securities class action recently dismissed astime barred by Weinstein; and the present class action, initiated on behalfof tens of thousands of insurers and unions.In Friday's decision, Weinstein certified the class of third-party payors,though on a more limited basis than sought by the plaintiffs. The judgedefined the class as U.S. entities "at risk ... to pay or reimburse all orpart of the cost of Zyprexa prescribed, provided, or administered ... fromJune 20, 2001 to June 20, 2005."The four-year window, based on RICO's statute of limitations, provides amuch shorter period of potential liability than the one sought by theplaintiffs, whose claims date back to 1996.Weinstein also declined to certify a class of individual-payor claims. "It will be difficult to obtain the necessary reliable payment data in mostcases," the judge reasoned. "More important, the individual plaintiffsproposed as representatives cannot properly represent the proposed class ofindividual persons."Weinstein also took the unusual step Friday of certifying an interlocutoryappeal within the decision itself."[T]he court continues to be of the opinion that its Order of June 28, 2007,denying Lilly's motion for summary judgment, involves a controlling questionof law as to which there is substantial ground for difference of opinion andthat an immediate appeal from the Order may materially advance the ultimatetermination of the litigation," the judge wrote. "Primarily that question iswhether Lilly is entitled to summary judgment on the ground that plaintiffscannot satisfy essential elements of their RICO and state law claims,particularly computation of damages."Fifteen different firms represent the various plaintiffs. A call for commentto Hanly Conroy Bierstein Sheridan Fisher & Hayes, the only New York-basedfirm among the plaintiff firms, was not returned.The Philadelphia firm Pepper Hamilton represents Lilly. New York-basedpartner Samuel J. Abate Jr. could not be reached for comment. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.