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THE 5TH CIRCUIT COURT REJECTS DRUG MAKER?S (REGLAN) ARGUMENTS OF PRE-EMPTION
January 15, 2010

The Fifth Circuit Court of Appeals announced in its recent decision, Demahy v. Actavis, Inc.(5th Cir. 2010), that the federal regulatory regime governing pharmaceuticals is without preemptive effect over state-law failure-to-warn claims against manufacturers of generic drugs. Translated, this means that simply because a manufacturer of generic drugs obtains FDA approval for the manufacturing and marketing of its drugs, the manufacturer can still be held liable for its failure to warn consumers of dangerous side effects that it knew or should have known about. This opinion follows the trend of last year's landmark decision by the Supreme Court in Wyeth v. Levine, that such claims are not preempted against name brand drug manufacturers.

Actavis, Inc., the manufacturer of Reglan, a drug widely prescribed for gastroesophageal reflux, was sued by Julie Demahy because after taking Reglan for 4 years she alleges she developed tardive dyskinesia, a neurological movement disorder that causes the body to shake and tremor violently and uncontrollably.

At the time her doctor prescribed the medication, the Food and Drug Administration (FDA) had approved Actavis' manufacture of Reglan. In 1985, the FDA required that Reglan's label be updated to include a warning regarding the risk of developing tardive dyskinesia. Actavis revised its labeling to comport with these changes to the Reglan label. In February 2009, the FDA issued another labeling revision for metoclopramide meant to warn of the risk of prolonged use, defined as use for more than 12 weeks

Demahy asserted a failure to warn claim under the Louisiana Products Liability Act because Actavis did not warn of the risks of neurological disorder after long-term use of metoclopramide. Specifically, Demahy alleges that Actavis ignored scientific and medical literature establishing a higher risk of developing tardive dyskinesia, failed to request a labeling revision from the FDA, failed to change the label itself even though no prior FDA approval was required, and failed to report safety information directly to the medical community.

Actavis moved to dismiss Demahy's claims, arguing the claims were "pre-empted" - that since the FDA did not originally require this disclosure, state laws could not impose such an obligation. The Fifth Circuit disagreed.

The issue of adequate warnings on labels of generic drugs is an important issue because so many people are purchasing generic forms of drugs either because their health insurance plans require it, or simply because of the cost savings. However, the labeling requirements of the FDA are significantly less stringent for generic drugs than they are for the original drug.

The FDA Process for Approval of Marketing New Drugs

All prescription drugs marketed in this country must first receive FDA approval. Manufacturers of new drugs must submit a new drug application (NDA) to the FDA that demonstrates the drug's effectiveness and safety for its intended use. The 1962 Food, Drug and Cosmetics Act (FDCA) established this avenue for pioneer drugs, with the core objective of ensuring that drugs are both safe and effective; the FDA has codified the NDA regulations at 21 C.F.R. Part 314. New drug approval requires, among other deliverables, the results of successful clinical trials and labeling that accurately portrays the benefits and risks of the drug, as indicated by those trials and other data. "Before approving an NDA . . . [the] FDA undertakes a detailed review of the proposed labeling, allowing only information for which there is a scientific basis to be included in the FDA-approved labeling." The FDA will reject the proposed labeling if "based on a fair evaluation of all material facts, such labeling is false or misleading in any particular."

The FDA Process for Marketing Generic Drugs

Contrast this with the simpler, less demanding approval process required of generic drugs. In 1984, Congress passed the Hatch-Waxman Amendments to the FDCA, which altered the federal regulatory regime governing generics. Thanks to these Amendments, once a pioneer drug loses patent protection, a drug company may seek permission to market a generic version through a significantly simplified process, known as the abbreviated new drug application procedure, or ANDA. ANDA drugs must be the "same as" a name brand drug that has already been approved by the FDA as to active ingredients, route of administration, dosage form, strength, and conditions of use recommended in the labeling. Under Hatch-Waxman, generic drug manufacturers need not repeat the clinical work of their name brand counterparts, but instead must only establish the generic drug's bioequivalence with the name brand drug. By avoiding "unnecessary," "wasteful," and "unethical" duplication of previously-performed human clinical trials, Congress meant "to provide a careful balance between promoting competition among pioneer . . . and generic drugs, and encouraging research and innovation." In turn, this increased competition, coupled with the elimination of "retesting" of a drug that has already been determined to be safe and effective, would result in significant cost savings to the American public. Indeed, the Congressional Budget Office estimated that generic drugs save American consumers between $8 billion and $10 billion each year. Generic drugs now account for seven out of ten prescriptions filled in the United States.

In their application, generic manufacturers must also show "that the labeling proposed for the new drug is the same as the labeling approved for the listed drug. Applying to market a generic drug, then, requires "[a] statement that the applicant's proposed labeling is the same as the labeling of the reference listed drug except for" enumerated differences irrelevant here; without such a statement, the FDA will deny the application.

Actavis' Argument

Despite the Supreme Court's decision in Wyeth v. Levine finding the failure to warn cases agains the original drug manufacture are not pre-empted, Actavis claimed that failure to warn cases against the manufacturer of generic drugs should be pre-empted because the manufacturer of a name brand drug may change its label unilaterally-through the FDA's "changes being effected" (CBE) process-while seeking the FDA's approval of the change, but that a generic drug manufacturer must produce the same drug and use the same label as the name brand drug manufacturer.

Here, as in every preemption case, "[t]he purpose of Congress is the ultimate touchstone." Congressional intent to preempt state law can either be expressed in statutory language or implied in the aim and structure of federal law. Implied preemption comes in two forms: field and conflict preemption. Field preemption is inferred where federal law is so pervasive that it leaves no room for state supplementation. When Congress has not completely displaced the possibility of state regulation, preemption may nonetheless occur when state law "actually conflicts" with federal law. This conflict might be with a federal statute or an "agency regulation with the force of law." Actavis claimed that under the Supreme Court's decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) it was impossible to comply with both the federal regulatory regime governing generic drugs and the state laws which imposed more a more complete disclosure on its warning labels, and that Louisiana law obstructs the goals of the FDCA, as amended by the HatchWaxman Amendments and implemented by FDA regulation.

Courts have been particularly reluctant to find preemption in such cases without an unambiguous signal of congressional intent. This is especially true in cases that involve health and safety concerns, because "[s]tates traditionally have had greater latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons."

Demahy's case seeks to hold Actavis liable for failing to take steps to change its warning label after approval in order to provide adequate warning once additional risks emerged. Generic manufacturers are subject to the requirement that their labeling "be revised . . . as soon as there is reasonable evidence of an association of a serious hazard with a drug." Demahy claims that Actavis failed to comply with this requirement despite reasonable evidence that long-term use of metoclopramide poses a serious hazard.

As one court stated, "the purpose of [the] regulation was not to prevent a generic manufacturer from improving or strengthening its warnings. It was, instead, to ensure that the FDA could require a generic manufacturer to modify its labeling to match labeling changes in the reference listed drug." In Levine, the Supreme Court found it "difficult to accept" that "the FDA would bring an enforcement action against a manufacturer for strengthening a warning." Nor is "a drug . . . misbranded simply because the manufacturer has altered an FDA-approved label"; rather, the misbranding provisions concern the accuracy of the label's substance and the adequacy of its warnings and the FDA "contemplates that federal juries will resolve most misbranding claims."

In addition to the CBE and prior approval processes, Demahy claims that Actavis could have satisfied its state-law duty to warn by communicating directly with doctors, through a "Dear Doctor" letter. These letters are used in the industry to advise medical professionals of the risks associated with prolonged use of metoclopramide-would also be subject to FDA regulation because they fall within the agency's broad definition of "labeling." The FDA made clear that its labeling requirements "do not prohibit a manufacturer . . . from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered."

Thus, though generic manufacturers cannot send "Dear Doctor" letters without prior FDA approval, they can suggest that the FDA send such letters on their behalf; the FDA will then send letters out if it determines that they are a necessary part of a risk evaluation and mitigation strategy.

This decision is clearly a victory for consumers. This decision encourages manufacturers of generic drugs to promptly update its warning labels to properly and timely advise consumers of the dangers associated with their drugs and discourages drug manufacturers from hiding the risks of their drugs from doctors and consumers. At Montes Herald Law Group, L.L.P., we believe drug manufacturers should be held accountable for the products they design, and distribute and for the warnings that need to be given for their product so that doctors and patients can make informed medical decisions about whether or not to prescribe or to take a drug. The FDA was correct when it advised the Supreme Court these lawsuits against drug manufacturers are beneficial not only to compensate individuals for the injuries they have sustained, but that these lawsuits also serve an important role in our society to ensure that manufacturers are held accountable to develop and to distribute safe products.

If you or a loved one has been injured because of the use of Reglan or other dangerous drug, contact Rachel Montes or Tom Herald to discuss your case. Visit our website at www.MontesHerald.com or call us at (214) 522-9401 for a free, no obligation case consultation. Our office is located in Irving, Texas near Dallas and Fort Worth however, we handle cases all across Texas and the United States.

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Hypertension Medication Contaminated with Metal
December 31, 2009

Medicines Co. has issued a warning and a recall to users of the hypertension medication Cleviprex. So far, the warning and recall extends to 11 lots of the intravenous hypertension drug Cleviprex because it has been found to be contaminated with bits of stainless steel. The cause and scope of the contamination are still unclear. The company has not determined how many vials of the drug were affected by the problem because the lots vary by size.

The Food and Drug Administration said in a notice Thursday that the particles could potentially disrupt blood flow to the brain, kidney, liver heart and lungs. Cleviprex is used to lower excessively high blood pressure in patients who cannot take pills. It is distributed to doctors for injection in patients who are undergoing surgery. In a letter to health care professionals, the company recommends doctors inspect vials of the drug for possible contamination before using them.

If you are scheduled for surgery and if you suffer from hypertension, be sure to discuss whether your doctor intends to use this medication in connection with your surgery. In addition, stayed tuned to our blog at http://www.montesheraldblog.com/ for additional updates on this story as well as other news and information.

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Federal Judge Orders Seroquel Cases To Trial
November 25, 2009

AstraZeneca Plc may face as many 6,000 trials of lawsuits claiming its antipsychotic drug Seroquel causes diabetes after a judge said she will recommend sending the cases back to their home courts. U.S. District Judge Anne Conway in Orlando, Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said yesterday she'll urge a panel of judges to return all of the cases to courts across the U.S. for possible trials. In Re Seroquel Products Litigation, 06-MD- 01769, U.S. District Court, Middle District of Florida.

The company faces more than 14,000 suits in U.S. state and federal courts alleging Seroquel caused diabetes in some users. Seroquel, which generated sales of $4.45 billion in 2008, is AstraZeneca's second-biggest seller after the ulcer treatment Nexium. AstraZeneca officials noted in regulatory filings last month that the drugmaker could face the first trials of Seroquel suits in state courts in Delaware and New Jersey in January. The company also disclosed it has spent $623 million in "legal defense costs" for Seroquel litigation so far.

AstraZeneca, the U.K.'s second-largest drugmaker, wanted Judge Conway to send as many as 60 suits back to their home courts for trial as test cases. Lawyers for former users contended they were ready to press forward on their claims that the London- based company downplayed Seroquel's diabetes risk.

"While providing the prospect of lifetime employment for AstraZeneca's attorneys, AstraZeneca's plan is also plainly designed to permit AstraZeneca to prolong resolution of this litigation," Camp Bailey, a Houston-based lawyer for Seroquel users, said in a Nov. 6 court filing.

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Medical Journal Accuses Pfizer of Skewing Test Data
November 13, 2009

A report in the New England Journal of Medicine is expected to show that the drug manufactuer Pzifer, skewed test data to make its test results on Neurontin look more favorable. Neurontin is primarily used to treat epilepsy, and is being marketed by Pfizer for treatment for uses that have not yet been approved. The Journal is reporting that comparisons of internal company documents with published data from 12 clinical trials found inconsistencies between data that made it into the medical journals and findings from the original trials. Discrepancies included reports of positive results from trials that were initially found to be negative, and primary study goals reported as secondary study goals. The internal company documents were obtained as a result of lawsuits filed against Pfizer and a subsidiary for promoting Neurontin, or gabapentin, for "off-label uses",uses which are not approved by the U.S. Food & Drug Administration.

The New England Journal of Medicine reports that of 21 primary study objectives of off-label uses of Neurontin described in original documents:

•1. six weren't included in published reports;

•2. four were reported as secondary goals, according to tomorrow's study in the journal;

•3. For eight of the 12 published trials, the definition of the primary study goal differed between the original and published documents;

•4. Seven of the nine trials published as full-length research articles reported statistically significant results for the study's main goal, and

•5. In more than half of those, the outcome differed between the published account and the original documents.

Pfizer has already paid $430 million in criminal fines and civil penalties in 2004 for urging doctors to prescribe Neurontin for off-label uses.

This report emphasizes how important it is for drug manufacturers to be held accountable for their actions and for the truth of their statements to the FDA and in their research results as doctors are forced to rely on the accuracy of the findings in published literature when deciding which drugs to prescribe for patients.

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Utah Settles Zyprexa Claims Against Eli Lilly for $24 Million
November 13, 2009

The State of Utah has agreed to a $24 million dollar settlement agreement with Eli Lilly for marketing of Zyprexa for "off label" uses. The Food and Drug Administration had approved Zyprexa's use for treating schizophrenia and bipolar disorders. But, Utah investigators say, Eli Lilly's sales force had been encouraging, since 1999, doctors to prescribe the drug for dementia, Alzheimer's, agitation, aggression, hostility, depression and generalized sleep disorders. Zyprexa's side effects include significant weight gain and obesity -- part of a metabolic syndrome, and can lead to diabetes, hypertension and stroke.

"The thing that was remarkable was how vigorously it was promoted and how much we spent in our Utah Medicaid program" -- the state's Zyprexa tab totaled $11 million since 2007, said David Sundwall, executive director of Utah's Department of Health.

"This isn't just about money," Utah Attorney General Mark Shurtleff said Wednesday. "The victims were those who could least afford health care." Shurtleff said, besides the settlement money, the state "wanted [Eli Lilly's] bad conduct to stop." According to Utah's investigation, 1,769 Utah Medicaid patients over age 65 took Zyprexa without the proper diagnosis.

While Eli Lilly representatives claim, "We have always lived by the highest standards in promoting our drugs," the company has battled Zyprexa litigation since 2003.

•· In 2008, Eli Lilly settled a lawsuit filed by 32 states for $62 million;

•· Utah was one of 13 states that chose to file separately;

•· Eli Lilly also settled with Alaska in 2008 for $15 million;

•· In January, 2009 Eli Lilly settled with the federal government for $1.42 billion in criminal and civil fines and Medicaid restitution in more than 30 states;

•· In 2009, Eli Lilly settled with Connecticut for $25.1 million;

•· In 2009, Eli Lilly settled with Idaho for $13 million;

•· In 2009, Eli Lilly settled with South Carolina for $45 million; and

•· In 2009, Eli Lilly settled with West Virginia for $22.5 million

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Philadelphia Jury Holds Pfizer Accountable for Marketing Prempro Drug That Causes Cancer
November 09, 2009

A jury determined that Pfizer Inc. must pay about $75 million in punitive damages to an Illinois woman who developed cancer after taking the drug Prempro, one of the drugmaker's menopause treatments. A Philadelphia jury ordered Pfizer's Wyeth unit on Oct. 26 to pay the bad-conduct award, which is about 20 times larger than the $3.7 million in actual damages the panel awarded to Connie Barton over her use of Wyeth's Prempro menopause drug. Barton, a retired records clerk from Peoria, Illinois, took Prempro for five years before developing breast cancer in 2002. Jurors in Philadelphia concluded Prempro helped cause the illness and the manufacturer failed to warn Barton and her doctors adequately about the drug's risks.

More than 6 million women have taken hormone-replacement medicines to treat menopause symptoms including hot flashes, night sweats and mood swings. Until 1995, many patients combined Premarin, Wyeth's estrogen-based drug, with progestin-laden Provera, made by Upjohn, another Pfizer unit.

Wyeth, which hasn't reserved funds to cover losses in the litigation, later combined the two hormones in Prempro. The drugs are still on the market. New York-based Pfizer completed its $68 billion purchase of Wyeth Oct. 15.

Annual sales of Wyeth's hormone-replacement drugs topped $2 billion before the 2002 Women's Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested women using the medicines had a higher breast-cancer risk.

Pfizer rose 20 cents, or 1.2 percent, to $16.93 in New York Stock Exchange composite trading yesterday.

The jury found Wyeth's conduct in marketing and selling the drug was "willful and wanton," opening the company up to punitive damages under Pennsylvania law. Barton's lawyers presented evidence during the trial about Wyeth officials' efforts to "deflect" criticism of the company's handling of the drug and its use of ghostwritten articles in medical journals to market the medicine. They also alleged executives hid Prempro's cancer risks to pump up the drug's sales.

Third Award

Barton's punitive award of about $75 million is the third surviving verdict in Prempro cases since juries began deciding them in 2006.

•· The largest award was handed down to three women who blamed the drugs for their breast cancers in 2007. Jurors in state court in Reno, Nevada awarded the trio a total of $99 million in punitive damages. That figure was later reduced to $35 million and is being appealed.

•· A federal appeals court earlier this week ordered a new trial on punitive damages for an Arkansas woman's claims that Wyeth's mishandling of Prempro caused her breast cancer.

Philadelphia Common Pleas Court Judge Sandra Moss, who oversees all the court's product-liability cases, said last week that she agreed to seal Barton's punitive award to protect the rights of other litigants involved in an ongoing trial in the same courthouse over the drug.

Pfizers Wyeth unit has now lost five of eight trials, including the last three in a row, over the drugs since cases began reaching juries in 2006. Thirty-three Prempro cases have been set for trial so far, and 19 have been thrown out by judges or withdrawn by plaintiffs, according to Pfizer officials. The company has won three defense verdicts and two losses were thrown out at the post-trial stage. The remaining verdicts are being appealed. Wyeth also has settled at least five cases over the drugs.

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Pfizer Agrees to Pay $2.3 Billion for Unlawful Drug Promotions
September 02, 2009

Pfizer has agreed to pay a record high civil penalty of $2,300,000,000.00 in connection with charges that it was engaged in unlawful prescription drug promotions. The announcement of the agreement came from the U.S. Justice Department, who in conjunction with the FBI, federal prosecutors, and Health and Human Services Department officials have been investigating this case.

Pfizer is the world's largest drug manufacter and is accused of recommending and promoting its drugs for so-called "off-label" uses that have not been approved by the Food and Drug Administration.

Although the penalty is the largest penalty ever, the penalty does not appear to have phased Pzier. When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival drug manufacturer Wyeth for $68 billion. That deal is expected to close before year's end. Also, despite the news release of the $2.3 billion penalty, shares of Pfizer were up 9 cents at $16.47 in early trading Wednesday.

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FDA Issues Zicam Warning & Manufacturer Recalls Zicam
June 23, 2009

Company officials are bracing for additional lawsuits after the Last week the Food and Drug Administration (FDA) issued a warning letter linking Zicam nasal gel and swabs to loss of smell. Matrixx Initiatives Inc, the manufacturer of Zicam initially declined a recall of the product, but has since responded by voluntarily recalling its Zicam Cold Remedy nasal gels and swabs from retailers nationwide. The company has more than a dozen oral Zicam products that were not targeted by the FDA and remain in stores nationwide. William Hemelt, Matrixx's acting president and chief operating officer, last week said the FDA's warning letter and following publicity "undoubtedly" leaves the company vulnerable to additional lawsuits.

Monday, a lawsuit was filed on behalf of 117 people who claim they have suffered loss of smell or a loss of the ability to taste food after using the popular nasal spray.

Matrixx is certainly aware that people claim to have lost a sense of smell after using Zicam. The company has already faced more than 400 lawsuits over the past decade from people who claimed that Zicam's Cold Remedy gel has caused anosmia, or loss of smell. In 2006, the company settled a batch of lawsuits with 340 plaintiffs for $12 million. Among the plaintiffs in the lawsuit filed Monday include Richard Kennedy, 62, of Glendale.

If you have taken Zicam and believe that you suffer from a loss of a sense of smell or the loss of the ability to taste food, contact Montes Herald Law Group, LLP for a no obligation, free consultation to discuss your case.

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Eli Lilly Sold Drug for Dementia Knowing It Didn?t Help
June 15, 2009

Court documents reveal a story of a drugmaker's efforts to push for billions in profits by marketing Zyprexa, a drug to people that its own studies had shown was not effective, and that subject the targeted patients to a significantly increased risk of death. Unsealed court documents show that Eli Lilly & Co. urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn't work for such patients, according to unsealed internal company documents. A 1995 study conducted by the drugmaker, patients taking between 1 to 8 milligrams of Zyprexa "did not show efficacy in alleviating the psychotic symptoms and behavioral disturbances in elderly" patients suffering from "primary degenerative dementia of the Alzheimer's type," according to a study summary that was unsealed. The company also noted that three patients taking Zyprexa died during a study or within 30 days of its completion, while only one control-group patient expired, according to the unsealed court documents.

Nevertheless, drugmaker Eli Lilly sought to expand its customer base in 1999 by selling Zyprexa as part of a marketing campaign that focused on long term-care facilities, particularly nursing homes, according to the unsealed documents. In 1999, four years after Eli Lilly sent study results to the U.S. Food and Drug Administration showing Zyprexa didn't alleviate dementia symptoms in older patients, it began marketing the drug to those very people, according to documents which a judge ordered to be unsealed in a lawsuit filed by an insurance company against the drugmaker for overpayment. Zyprexa was initially approved in 1996 for use with patients suffering from schizophrenia. In 2000, Eli Lilly received the FDA's approval to sell Zyprexa to those dealing with the mania stage of bipolar disorder. However, the drug has never been approved for use with dementia patients, according to the FDAs Web site.

One of the documents showed that the drugmaker viewed dementia as the "key" to the elderly and PCP markets, "Elderly - PCP Sales Aid. In that paper, executives urged salespeople to "utilize dementia and symptoms as entry." In 1999, when Lilly began its marketing push, Zyprexa's only approved use was for patients suffering from schizophrenia, according to the FDA. In 2008, Zyprexa was Lilly's best-selling drug, with $4.7 billion in annual sales, while antipsychotics as a group topped U.S. drug sales last year, with $14.6 billion.

Seven Studies

In a request for a December 2003 meeting over a proposed label change, drug manufacturer Eli Lilly told the FDA that data from seven studies showed Zyprexa didn't alleviate symptoms of Alzheimer's or other dementia. The studies found death rates among older dementia patients taking Zyprexa were "significantly greater" than those who didn't get the medicine, the company said, according to the unsealed documents.

Eli Lilly Pleads Guilty

Eli Lilly pleaded guilty in January to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

The Indianapolis-based drugmaker agreed in January to pay $1.42 billion to the U.S. government and more than 30 states to settle off-label marketing allegations over Zyprexa. The agreement included a $615 million penalty for the federal criminal charge. Lilly has paid $1.2 billion so far to settle more than 32,000 individual claims by patients, the company said in an April 30 securities filing.

$6.8 Billion in Damages

Meanwhile health insurers, along with some states and other third-party payers have filed lawsuits against the drugmaker contending that Eli Lilly should pay as much as $6.8 billion in damages for downplaying Zyprexa's health risks, including excessive weight gain and the risk of contracting diabetes, and for marketing the drug for unapproved uses to pump up profits.

U.S. District Judge Jack Weinstein in Brooklyn, New York, ordered the release of the Eli Lilly documents on May 1, 2009 in the case of UFCW Local 1776 and Participating Employers Health and Welfare Fund v. Eli Lilly and Co., No. 05-CV-04115, U.S. District Court, Eastern District of New York (Brooklyn). In September, Judge Weinstein allowed insurers and other payers to sue Lilly as a group after finding "sufficient evidence of fraud" to let the case go to trial. Eli Lilly is appealing that ruling.

12 States File Lawsuit Against the Drugmaker 

Currently, Eli Lilly is facing lawsuits filed by at least 12 states over its Zyprexa marketing practices. Cases brought by South Carolina and Connecticut officials are set for trial later this year.

Regulators required Eli Lilly and other antipsychotic drug- makers in April 2005 to warn that the products posed an increased risk to elderly patients with dementia. The documents show the health dangers in marketing a drug for an unapproved use, called off-label promotion. As Sidney Wolfe of Public Citizen explains, "By definition, off-label means there is no clear evidence that the benefits of a drug outweigh the risks. The reason why off-label promotion is illegal is that you can greatly magnify the number of people who will be harmed."

Medical Journals

The documents also revealed Eli Lilly officials wrote medical journal studies about Zyprexa and then asked doctors to put their names on the articles written by the drug manufactuer, a practice called "ghostwriting." Eli Lilly employees compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to the documents. Eli Lilly's own internal documents were unsealed as part of law suits against the drugmaker by health insurers and pension plans seeking to recoup monies spent on Zyprexa. The insurance plans contend the papers indicate that Lilly promoted the antipsychotic to doctors treating elderly patients even after March 2001.

Eli Lilly's documents include a 2002 business plan calling for expanding prescriptions in off-label use. They also point to notes from Lilly sales representatives through 2003 recording efforts to press doctors to prescribe elderly patients Zyprexa for mood symptoms, irritability and insomnia.

Even before the drug was on the market, Lilly researchers were eyeing whether elderly dementia patients could benefit from taking the antipsychotic, according to the unsealed documents.

Failed Efforts to Get FDA Approval 

In 1998, Lilly went back to the FDA seeking approval to market Zyprexa to those battling Alzheimer's, the most common form of dementia, the company said in its 2003 request for a meeting on a proposed label change. Lilly withdrew its bid to promote Zyprexa for Alzheimer's cases in 1999, according to the document.

After two failed attempts to get a labeling change to allow marketing of the drug to patients with dementia, a November 2000 memo sent by company executives to Eli Lilly salespeople, said the dementia marketing initiative was abandoned because the FDA questioned Zyprexa's effectiveness in treating the ailment. In a 2003 memo to FDA regulators citing the clinical studies, Eli Lilly researchers acknowledged the death rates among older dementia patients on Zyprexa in the reviews were two times higher than their counterparts taking placebos.

Patient Deaths

• Deaths among the patients taking Zyprexa in the studies were "significantly greater than placebo-treated patients (3.5 percent v. 1.5 percent, respectively)," Lilly officials said, according to the unsealed documents.
• The studies didn't find Zyprexa was effective in treating dementia, the company acknowledged in this document.
• Eli Lilly recognized this earlier, according to a 2002 document entitled "Zyprexa in serious mental illness (65 plus years) -- A Strategy Review." "The treatment of serious mental illness for people over the age of 65 has been identified as a growing opportunity for Zyprexa," the authors wrote. "Unfortunately, attempts to gain the data to support an application for an indication in the treatment of dementia have to date been unsuccessful."

Marketing to Primary Care Physicians

Eli Lilly then began targeting primary care physicians, known as PCPs, as another potentially lucrative Zyprexa market. Such physicians frequently deal with dementia patients, according to the unsealed files. Another benefit to the strategy was that many of those practitioners were "unaware of Zyprexa weight gain issue," according to a December 1999 Lilly sales memo, referring to one of the drug's possible side-effects.

Lilly marketing executives envisioned expanding "Zyprexa's market by redefining how primary care physicians treat mood, thought and behavioral disturbances," according to the December 1999 memo. The strategy included: "Focus message patients; symptoms and behaviors (rather than diagnoses)," according to the unsealed internal company documents.

Zyprexa Sales

• Eli Lilly officials in 2002 reported Zyprexa sales grew due to "an expanding prescriber base in primary care, off-label use including PTSD and sleep," according to a document called Zyprexa Business Summary," referring to post-traumatic stress disorder.
• The company's goal was to reach $6 billion in annual sales by 2006, according to a July 2002 Zyprexa marketing plan.
• Lilly's long-term care unit also saw Zyprexa sales rise 2.9 percent in the second quarter of 2002 as sales of Risperdal, Johnson & Johnson's rival antipsychotic, fell, according to the 2002 marketing plan.
• At that time, long-term care sales made up about 20 percent of Zyprexa prescriptions, according to the summary. Of that number, 65 percent were written for nursing-home patients.
• Overall, prescriptions for older patients were the "2nd biggest money-producing segment" for Zyprexa in the U.S., according to a Feb. 15, 2002, e-mail from Lilly researcher Peter Feldman to Denice Torres, the company's global marketing director.

Internal Memos from Eli Lilly 

In a Feb. 15, 2002, e-mail from Lilly researcher Peter Feldman to Denice Torres, the company's global marketing director, Feldman said company officials were saying in internal memos that they were going to stop studying Zyprexa's potential health benefits for elderly consumers.

That would risk "killing the goose that lays the golden eggs to save on poultry feed costs," Feldman said in the unsealed messages. Torres assured him older consumers would continue to be a prime target for Zyprexa sales, according to the e-mail. Elderly remains an important aspect of target PT and affiliate focus," she said in the message.

Eli Lilly Knew Its Sales People Urged Off Label Use

Unsealed documents also showed Lilly salespeople prodded doctors to prescribe the drug for off-label uses, according to "call notes" Lilly turned over in lawsuits against the drugmaker. Portions of some call notes, which record sales visits to doctors, are cited in a recently unsealed June 15, 2007, filing by the insurance plans. One sales representative wrote in a March 7, 2003, note she'd persuaded a doctor to write Zyprexa prescriptions for use in "elderly pts, help sleep and irritability." Another asked a doctor to try Zyprexa "in elderly who are not thinking clearly and are suspicious and hostile," according to an Aug. 31, 2001, note.

Common Adverse Effects

In June 2004, Paula Rochon, a senior scientist at the Institute for Clinical Evaluative Sciences in Toronto, published a literature review in the British Medical Journal showing there were only five trials available analyzing antipsychotics' effect on the elderly.

• In those trials, adverse effects were common.
• In May 2008, Rochon found that atypical antipsychotics triple the risk of a patient's death or hospitalization within a month of starting therapy, according to research published in the Archives of Internal Medicine.
• About 17 percent of nursing home patients suffering from dementia are prescribed an antipsychotic within 100 days of their admission, according to her study

Failure to Warn to Risks

The insurance plans, states and former Zyprexa patients suing Lilly also claim company officials hid the drug's health risks and failed to properly warn patients they could develop diabetes by taking the medicine. Former users contend the drug leads to increased weight gain, which can spark the disease. In 2001, marketing executives advised salespeople not to duck questions about whether Zyprexa caused some users to gain weight, according to an internal memo. Acknowledge weight gain but present it as a manageable side effect," Lilly advised its sales force, according to the documents. With most customers, we will continue to address the diabetes concern only when it arises," the December 2001 document said. "Get back to selling!"

A copy of the Bloomberg.com article on this chilling case of corporate greed is attached for you to read even more details of this case. At Montes Herald Law Group, LLP, we pursue claims against large corporations such as drug manufacturers who put profits ahead of safety. These lawsuits show that all of us pay when manufacturers design, manufacturer and market dangerous products. This case shows that it is not just the people that take these dangerous drugs have been effected by corporate greed. When a drug manufacturer markets a drug to doctors for unapproved uses, that affects the overall cost of medicine and everyone's insurance rates. It affects not only the rates that health insurers charge us, but it also affects our tax dollars as states have billions of dollars in health care costs for ineffective and dangerous drugs. In the end, those costs are paid by everyone, even people that do not take these drugs. At Montes Herald Law Group, LLP, we believe it is critical to stop these practices to protect not only the patient, but to stop fraud at a corporate level. If you or a loved one has been prescribed a drug that you believe is dangerous, contact our law firm now. We handle cases throughout the country.

Attachments:
ZyprexaMarketedByDrugmakerKnowingItDidntHelp.pdf

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Texas Court Allows Prempo Lawsuits Against Pfizer, Inc. For Menopause Drug
May 26, 2009

Susan Brockert, who claims that she developed breast cancer as a result of her taking the drug Prempo for menopause has been granted the right by the Texas Court of Appeals in Houston to proceed with her lawsuit against Pzizer, Inc. The Court of Appeals, citing the United States Supreme Court holding in Wyeth, held that Susan Brockert's "failure-to-warn" claims are not preempted by federal drug-labeling regulations. This ruling is expected to allow other related lawsuits over Prempro that had been on hold pending the decision to move forward. According to Bloomberg.com, as many as 6 million women took the hormone-replacement therapies to ease menopause symptoms, such as hot flashes and mood swings, before a 2002 study revealed links between the drug and cancer. If you or someone in your family took Prempo and subsequently developed cancer, please contact Montes Herald Law Group, LLP immediately to discuss your case and your rights.

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