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About POGO's Federal Contractor Misconduct Database (FCMD)
The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »
Wyeth
Wyeth, which changed its name from American Home Products in 2002, is one of the largest pharmaceutical companies in the world. Its biggest-selling products include the over-the-counter (OTC) drugs Robitussin and Advil and the prescription drugs Premarin and Effexor. In October 2009, Wyeth was acquired by Pfizer, Inc.
Federal Contract $: $ 0.0m
Total Number of Instances: 7
Total Misconduct dollar amount: $ 118.4m
Instances of Misconduct
1. Sandler et al. v. Wyeth Pharmaceuticals
The Justice Department, along with several states, joined a False Claims Act lawsuit accusing Wyeth Pharmaceuticals of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants. The lawsuit was filed in 2005 by two former Wyeth employees, Marlene Sandler and Scott Paris, who claimed they were encouraged to promote the drug for heart, lung, liver and pancreas transplants, even though the Food and Drug Administration had only approved it for kidney transplants. The lawsuit also claimed that Wyeth singled out two hospitals with a higher proportion of black patients – the SUNY Downstate Medical Center in New York and the Albert Einstein Medical Center in Philadelphia – for off-label promotions. In a financial statement filed with the Securities and Exchange Commission in November 2012, Pfizer (which acquired Wyeth in 2009) disclosed that it had taken a $491 million charge for an agreement in principle with the Justice Department to settle the lawsuit.... more»
2. Daniel v. Wyeth (Prempro)
In February 2011, the Superior Court of Pennsylvania reinstated a jury award of $1,681,650 in compensatory damages and an undisclosed award of punitive damages (reported to be $8.6 million) against Wyeth in a lawsuit filed in 2004 by Mary Daniel, who claimed the hormone replacement drug Prempro caused her to develop breast cancer.... more»
3. Diet Drug Litigation
Wyeth was named as a defendant in numerous legal actions relating to the diet drugs Pondimin (which in combination with phentermine, a product not manufactured, distributed or sold by Wyeth, was commonly referred to as “fen-phen”) and Redux, which were used in the United States, prior to their 1997 voluntary market withdrawal, by approximately 5.8 million people. These actions alleged that the use of Redux and/or Pondimin, independently or in combination with phentermine, caused certain serious medical conditions, including valvular heart disease and primary pulmonary hypertension. In October 1999, Wyeth entered into a nationwide class action settlement consisting of two settlement funds: Fund A (with a value at the time of settlement of $1 billion plus $200 million in legal fees) covered refunds, medical screening costs, additional medical services and cash payments, education and research costs, and administration costs. Fund B (to be funded by the company on an as-needed basis up to a total of $2.55 billion, plus interest) compensated claimants with significant heart valve disease. In addition, the company has incurred hundreds of millions of dollars more in damage awards and settlements with some of the approximately 63,000 individuals who opted out of the nationwide class action.... more»
4. Rowatt v. Wyeth (Hormone Therapy Litigation)
Pamela Forrester, Jeraldine Scofield and Arlene Rowatt claimed they developed breast cancer as a result of their use of Wyeth’s hormone replacement drugs, Prempro and Premarin. The jury found that Prempro and Premarin helped cause their cancers and that Wyeth misled the public about the drugs' health risks. The court ultimately awarded $22.8 million in compensatory damages and $35 million in punitive damages.... more»
5. Scroggin v. Wyeth (Hormone Therapy Litigation)
Donna Scroggin claimed she developed breast cancer as a result of using Wyeth’s and Upjohn’s hormone replacement drugs, Prempro, Premarin and Provera. The jury found that the drugs caused Scroggin’s breast cancer and ordered both companies to pay damages. Wyeth paid $2.75 million in compensatory damages and $19.36 million in punitive damages.... more»
6. GMP Deviations at PA and NY Facilities
Wyeth-Ayerst Laboratories Division of American Home Products Corporation, Wyeth-Ayerst Pharmaceuticals, and three Wyeth executives signed a consent decree of permanent injunction in which Wyeth agreed to a series of measures aimed at ensuring that the products manufactured at its Marietta, Pennsylvania and Pearl River, New York facilities are made in compliance with Food and Drug Administration's good manufacturing practice (GMP) regulations. FDA inspections of the Marietta and Pearl River facilities found deviations from GMP regulations, including issues related to quality control. Wyeth also agreed to pay $30 million.... more»
7. Levine v. Wyeth
Diana Levine claimed that, as a result of being injected with the Wyeth antinausea drug Phenergan as part of migraine treatment, she developed gangrene and had to have part of her arm amputated. A Vermont jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded $7.4 million in damages, which the court later reduced. Arguing that Levine’s claims were pre-empted by federal law because Phenergan’s labeling had been approved by the Food and Drug Administration (FDA), Wyeth appealed the case all the way to the U.S. Supreme Court, which affirmed the award in March 2009.... more»
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