University of California, San Francisco.
Drug Industry Document Archives.
The Documents
The documents in DIDA were obtained from a number of court cases and investigations. Click on a specific lawsuit below to learn more about the case and to access the documents from that case.
 
Lawsuits
Cona v. Merck & Co.
Claimed Vioxx use increased risk of heart attacks.
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).

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Ernst v. Merck & Co.
Claimed Vioxx use increased risk of heart attacks.
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."

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Factor VIII or IX Concentrate Blood Products
The marketing and distribution of contaminated AHF (anti-hemophiliac factor) blood products.
In Re: "Factor VIII or IX Concentrate Blood Products," Product Liability Litigation, MDL No. 986, "Second Generation" Litigation:
Chang, Y. et al., v. Bayer Corp., et al., USDC, ND CA, No.: 3:04-cv-01925, MDL Case No. 04-c-4869

Bayer and its Cutter Laboratories manufactured AHF (anti-hemophiliac factor), a blood product used by hemophiliacs to treat uncontrolled bleeding. In the late 1960s the corporation began manufacturing AHF using pools of blood (plasma) from thousands of donors, often recruited from populations at high risk for hepatitis. In the early 1980s Cutter Laboratories realized that its AHF was contaminated with HIV but its financial investment in the product was considered too high to destroy the inventory. Cutter continued to sell the contaminated AHF to markets willing to accept it, including overseas markets in Asia and Latin America, without the recommended precaution of heat treating the product to eliminate the risk. Customers were not informed of the risk and as a consequence, hemophiliacs who infused the HIV-contaminated AHF tested positive for HIV and developed AIDS.

These documents are from class action litigation against Bayer from both US and Taiwanese plaintiffs. While "the hemo case" involved HIV-infected hemophiliacs in the United States and abroad, these documents focus on the marketing and distribution of contaminated blood products in Asia, the so-called "dumping" aspect of the larger body of cases litigated.

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Franklin v. Parke-Davis
Off-label marketing of Neurontin.
United States of America ex rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert/Pfizer, Case 96-11651-pbs.

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.htm

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Hermans v. Merck & Co.
Charged the makers of Vioxx with consumer fraud.
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.

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Humeston v. Merck & Co.
Claimed Vioxx use increased risk of heart attacks.
Humeston v. Merck & Co.

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.

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Neurontin Marketing and Sales Practices Litigation
Misrepresentation of Neurontin's effectiveness.
Neurontin Marketing and Sales Practices Litigation, MDL #1629, Docket #04-10981

A legal action, separate from Franklin v. Parke-Davis, involving the drug Neurontin (gabapentin) where consumers and third-party payers, including insurance companies and trade unions, sought repayment by Pfizer for billions of dollars of Neurontin prescriptions. The plaintiffs accused 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., argued 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.

Norvir Anti-Trust Litigation
Pricing of the HIV/AIDS drug Norvir.
Abbott Laboratories Norvir Anti-Trust Litigation; No. C 04-1511 CW

In 2003, Abbott Laboratories 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.

Prempro Products Liability Litigation
Continued marketing of HRT drugs despite knowledge of health risks.
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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Seroquel Products Liability Litigation
Continued marketing of an anti-psychotic drug despite health risks.
Seroquel Products Liability Litigation 06-MD-01769, US District Court, Middle District of Florida.

This Multi-District Litigation consolidates a number of pending actions against UK-based AstraZeneca Pharmaceuticals, the maker of Seroquel, an antipsychotic medication used to treat schizophrenia and bipolar disorder. The plaintiffs allege that AstraZeneca failed to test and to warn users of the drug's alleged harmful side effects, including the risk of diabetes and related medical complications.

The company has been sued in U.S. courts by thousands of individuals who allege that the growth in sales of Seroquel, from $66 million in 1998 to $2.75 billion in 2005, was spurred by "AstraZeneca's aggressive marketing of Seroquel," which "consisted chiefly of overstating the drug's uses and benefits (including massive off-label promotion), while understating and consciously concealing its life-threatening side effects."

The following are the names and job titles of the people giving the depositions from which the documents come:

  • Tony Zook - President and CEO of AstraZeneca US (2006 to present); Senior VP, Commercial Operations (2001-2006); VP Marketing & Sales (1997-2001)

  • Jack Schwartz - Executive Director, Seroquel Development

  • Athena Ruhl - Seroquel Senior Product Manager

  • Michael Reinstein - Key Opinion Leader

  • Claudia Piano - Parexel

  • Charles Peipher - Marketing

  • Alfred Paulson - Sales

  • Henry Nasrallah - Key Opinion Leader

  • Jamie Mullen - Senior Director, Clinical Research

  • Kevin McKenna - VP, Regulatory Affairs, Neuroscience Therapeutic Area

  • Wayne Macfadden - Former Director Clinical Research and U.S. Physician for Seroquel

  • Gerald Limp - U.S. Regulatory Affairs (Deceased)

  • Marianne Jackson - National Sales Director

  • Jeffrey Goldstein - Former Director of Clinical Science

  • Wayne Geller - Former Global Drug Safety Physician (GDSP) for Seroquel

  • Susanne Fors - Global Regulatory Affairs Director

  • Vikram Dev - VP of U.S. Drug Safety

  • David Brennan - Chief Executive Officer, Chairman of the Senior Executive Team (SET)

  • Martin Brecher - Former Medical Science Director

  • Geoffrey Birkett - Former Vice-President Global Marketing

  • Donald Beamish - Commercial Brand Executive Director

  • Barry Arnold - EU Qualified Person for Pharmacovigilance (January 2006 to present); VP Clinical Drug Safety (July 1999 - May 2006)

See all documents related to the Seroquel Products Liability Litigation.

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