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United States of America ex rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert/Pfizer Filed by former Parke-Davis employee David Franklin, the lawsuit alleged that the company violated federal regulations by engaging in systematic efforts to promote the drug gabapentin (Neurontin) for uses not approved by the US FDA. The case was concluded in May 2004 with a $430 million settlement and an agreement by Parke-Davis to plead guilty to resolve civil liabilities and criminal charges pertaining to the case. The U.S. Department of Justice press release is available at: http://www.usdoj.gov/opa/pr/2004/May/04_civ_322.htmSee all documents related to Franklin vs. Parke-Davis, Case 96-11651-pbs |
Prempro Products Liability Litigation, MDL Docket No 4:03CV1507 WRW (W.D. Arkansas) These documents were produced in litigation against manufacturers of hormone replacement therapy (HRT) by women who developed breast cancer while taking these drugs. They show how Wyeth contracted with "medical communication" companies to market the Premarin product line under the guise of scientific endeavor. The documents expose marketing campaigns that included the publication of ghostwritten articles published by leading peer-reviewed journals, presentation of ghost-authored posters at professional association conferences and involvement in academically-sponsored continuing medical education events.This group of documents was made available to the public by a United States Federal judge in response to a request by PloS Medicine and The New York Times. In a document submitted to the court, Virginia Barbour, PloS Medicine’s Chief Editor, asserted "ghostwriting has the potential to substantially distort the scientific record, and hence threaten the validity and credibility of medical knowledge." In unsealing the documents the court agreed that uncovering ghostwriting and related practices is in the interest of public health.
See all documents related to Prempro Products Liability Litigation.
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Thomas Cona et. al. v. Merck & Co., Inc.; Docket Number ATL-L-3553-05MT in the Superior Court of New Jersey, Atlantic County John McDarby, age 77, and Thomas Cona, age 60, sued Merck & Co. claiming that the Vioxx arthritis medication manufactured and sold to them was defective and unreasonably dangerous and, as a direct result, they suffered heart attacks after taking the drug. They claimed that Merck knew that the drug increased the risk of heart attack but failed to warn of the risk. Merck asserted a causation defense claiming that taking the drug did not cause the heart attacks. The case concluded with a plaintiffs' verdict of $4.5 million for McDarby and only $45 for Cona (the cost of his medication).
See all documents related to Cona, et al vs. Merck |
Humeston v. Merck & Co., Inc. This 2005 personal injury case, known as "The New Jersey Vioxx Case," was brought by Mr. and Mrs. Humeston against Merck & Co. Humeston claimed in his suit that taking VIOXX for knee pain caused him to suffer a heart attack in 2001. During the original trial, Merck was cleared of any wrongdoing. The Atlantic City jury, relying on medical professional testimony, decided that Merck had provided enough warning to doctors and voted unanimously on three counts that Merck did not mislead doctors about the drug's safety. A re-trial took place in 2007 where New Jersey Superior Court Judge Carol E. Higbee vacated the November 2005 verdict on various grounds, including findings by the New England Journal of Medicine that Merck had failed to report material cardiovascular safety data in connection with the publication of its landmark 2000 Vioxx clinical study known as VIGOR. In March 2007, a jury in Atlantic County, N.J. returned a verdict awarding a total of $20 million in compensatory damages to plaintiff Frederick "Mike" Humeston and his wife Mary against defendant Merck & Co.
See All Documents Connected to Humeston v. Merck |
Estate of Brian Hermans et. al. v. Merck & Co., Inc.; Docket Number ATL-L-5520-05MT in the Superior Court of New Jersey, Atlantic County Frederick "Mike" Humeston and the widow of Brian Hermans sued Merck & Co. on a products liability theory claiming that the Vioxx that Humeston and Hermans took was defective and unreasonably dangerous and that Merck failed to provide warnings about the risk of heart attack. Brian Hermans of Waupaca, Wisconsin, died at age 44 after having a heart attack. Plaintiffs claimed that Merck committed consumer fraud by misleading doctors and patients and by intentionally suppressing, concealing or omitting information about the risks of Vioxx, which was withdrawn from the market in September 2004.
See all documents related to Hermans vs. Merck |
Carol Ernst et. al. v. Merck & Co., Inc.; Cause number 19961*BH02 in the 23rd District Court of Brazoria County, Texas The first of many cases against Merck in the Vioxx scandal, this suit involved the widow of a user of the drug. Represented by Vioxx attorney, Mark Lanier, Ms. Ernst filed the first Vioxx claim, which went to court in August 2005. The Texas jury found Merck to be negligent in the death of 59-year-old Robert Ernst and ordered the company to pay $253.4 million. In 2008, a Texas appeals court reversed the judgment in that suit finding the evidence to be "legally insufficient on the issue of causation."See all documents related to Ernst vs. Merck |
United States Senate Finance Committee - Charles Grassley Several studies over the years have shown that researchers who receive money from drug companies are more likely to report positive results from clinical trials. The Senate Finance Committee, spearheaded by Sen. Chuck Grassley (R-Iowa), has been conducting a far reaching investigation into the issues of transparency, conflict of interest and violations of federal research rules by some 30 academic researchers nationwide. In conjunction with this investigation, Grassley is promoting a bill called the Physician Payment Sunshine Act that would require pharmaceutical companies and medical device manufacturers to disclose all payments over $500 made to physicians. Dr. Charles Nemeroff, psychiatry department chair at Emory University, is one of a number of researchers being investigated by the committee. Nemeroff was found to have earned more than $2.8 million in consulting arrangements with various drugmakers between 2000 and 2007, but had failed to report at least one-third of this income to his university. See the New York Times article on the committee's investigation into Nemeroff and Emory University.See all documents related to the Senate Finance Committee inquiry. |
United States Congressional Committee on Government Reform - Henry A. Waxman A select set of documents, obtained from the public records of the Minority Office of the Congressional Committee on Government Reform, which detail the marketing of Vioxx (rofecoxib) to physicians. In his report to the Committee, Representative Waxman concluded, "a review of over 20,000 pages of Merck documents suggests that the company used its sales force of thousands to counter growing evidence of concern over the safety of Vioxx. These efforts involved providing highly questionable information to physicians and pursuing aggressive marketing strategies."
See all documents related to the Goverment Reform Committee inquiry. |
Neurontin Marketing and Sales Practices Litigation, MDL #1629, Docket #04-10981 A separate legal action involving the drug Neurontin (gabapentin) is still pending in Boston, where consumers and third-party payers including insurance companies and trade unions want Pfizer to repay billions of dollars for Neurontin prescriptions. The plaintiffs accuse Pfizer of fraudulently misrepresenting the drug's benefits. Thomas Greene, a lawyer for the plaintiffs, and attorney on the previous case, Franklin vs Parke-Davis, et al., said the documents in this case revealed that even after the Neurontin settlement, Pfizer "continued with the medical marketing firms and planted marketing messages in journal articles (saying) that Neurontin was effective while they knew that their own clinical trials had failed to demonstrate it was effective." Read the New York Times article Experts Conclude Pfizer Manipulated Studies by Stephanie Saul.
See all documents related to the Neurontin Marketing and Sales Practices Litigation. |
Abbott Laboratories Norvir Anti-Trust Litigation; No. C 04-1511 CW In 2003, Abbott Laboratories (NYSE:ABT) raised the price of its HIV/AIDS drug Norvir (ritonavir) by 400% overnight. Norvir is used in combination with other "protease inhibitors", (PIs) and it "boosts" the effectiveness of the PI it’s used with. Abbott also makes a combination pill called Kaletra that includes both Norvir and its own PI. When Abbott Labs raised the price of Norvir, they did not raise the price of Kaletra. The SEIU Health & Welfare Fund filed a national class action lawsuit against Abbott, claiming the company violated federal anti-trust laws. The plaintiffs charged that Abbott effectively raised the price of its competitors' products, forcing patients to either pay much more for their medications or to switch to Kaletra. The suit argued that Abbott tried to "leverage" its patent-protected monopoly over Norvir into a monopoly over the market for protease inhibitors. In August 2008, SEIU Health & Welfare Fund, two individual plaintiffs, and Abbott agreed to a proposed settlement of the case. Abbott has agreed to pay between $10 Million and $27.5 Million, depending upon court rulings to come, to settle the nationwide claims by consumers who were overcharged for the medication. Read more about the case on the Prescription Access Litigation Project blog.
See all documents related to the Norvir Anti-Trust Litigation. |
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