I was going to say that $75 million is a bit of a ****ing, but that was awarded
in 2009. They're just sending out checks
now? And just a paltry $175,000?
(Googles)
Ah! Get in line, Nigeria!
Legislation and litigation
Pfizer is party to a number of suits stemming from its pharmaceutical products as well as practices of various companies it has acquired or merged with.
Kelo case
Pfizer's interest in obtaining property in
New London, Connecticut, for expanded facilities led to the
Kelo v. New London case before the
U.S. Supreme Court.
The Supreme Court's 2005 decision in Kelo v. City of New London handed local governments the right to seize private property for economic development,
[33] i. e., offices, a hotel to enhance Pfizer Inc.'s nearby corporate facility. However, following the completion of the aforementioned Wyeth merger, Pfizer announced it will close its research and development headquarters in New London, Connecticut, moving employees to nearby
Groton.
Quigley Co.
Pfizer acquired Quigley in 1968, and the division sold
asbestos-containing insulation products until the early 1970s.
[34] Asbestos victims and Pfizer have been negotiating a settlement deal which calls for Pfizer to pay $430 million to 80 percent of existing plaintiffs. It will also place an additional $535 million into an asbestos settlement trust that will compensate future plaintiffs as well as the remaining 20 percent of current plaintiffs with claims against Pfizer and Quigley. The compensation deal is worth $965 million all up. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million will come from insurance policies.
Bjork–Shiley heart valve
Pfizer purchased Shiley in 1979 at the onset of its Convexo-Concave valve ordeal, involving the
Bjork–Shiley heart valve. Approximately 500 people died when defective valves failed and, in 1994, the United States ruled against Pfizer for ~$200 million.
Political lobbying
Pfizer is a leading member of the
U.S. Global Leadership Coalition, a Washington D.C.-based coalition of over 400 major companies and NGOs that advocates for a larger International Affairs Budget, which funds American diplomatic, humanitarian, and development efforts abroad.
Pfizer is one of the single largest lobbying interests in United States politics. For example in the first 9 months of 2009 Pfizer spent over $16.3 million on lobbying US congressional lawmakers, making them the sixth largest lobbying interest in the US (following Pharmaceutical Research and Manufacturers of America (PhRMA), which ranked fourth but also represents many of their interests). A spokeswoman for Pfizer said the company “wanted to make sure our voice is heard in this conversation” in regards to the companies expenditure of $25 million in 2010 to lobby health care reform.
Pfizer's primary interests are opposition of Congressional efforts to attach a prescription drug benefit to Medicare and opposition to generic drugs entering US markets.
[39] Pfizer also purportedly proposed a ban on all
lawsuits against
manufacturers of
body implant parts which was proposed in the
United States Congress as part of
tort reform legislation.
According to
U.S. State Department cables released by the
whistle-blowing site
WikiLeaks, Pfizer "lobbied against New Zealand getting a
free trade agreement with the United States because it objected to New Zealand’s restrictive drug buying rules and tried to get rid of New Zealand’s former health minister,
Helen Clark, in 1990.
Off-label promotional practices
Access to pharmaceutical industry documents has revealed
marketing strategies used to promote
Neurontin for off-label use.
[43] In 1993, the
U.S. Food and Drug Administration (FDA) approved
gabapentin (Neurontin, Pfizer) only for treatment of
seizures.
Warner–Lambert, which merged with Pfizer in 2000, used activities not usually associated with sales promotion, including
continuing medical education and
research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within 5 years the drug was being widely used for the
off-label treatment of pain and psychiatric conditions. In 2004, Warner–Lambert admitted to charges that it violated FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses, and paid $430 million to resolve criminal and civil health care liability charges.
[44][45] Today it is a mainstay drug for migraines, even though it was not approved for such use in 2004.
Bextra settlement of off-label marketing investigation
In September 2009, the
United States Department of Justice announced that Pfizer had agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed four drugs:
Bextra,
Geodon,
Zyvox, and
Lyrica "with the intent to defraud or mislead" by promoting the drugs for non-approved uses[
examples needed]; this marks Pfizer's fourth such settlement in a decade.
[4][5][32] Pharmacia & Upjohn Company, Inc., a Pfizer subsidiary, agreed to plead guilty to mis-branded promotion of Bextra, a felony violation of the
Food, Drug and Cosmetic Act. The criminal fine accounts for $1.3 billion of the settlement, and is the largest criminal penalty ever imposed in American history.
[47] Pfizer has entered an extensive corporate integrity agreement (CIA) with the Office of Inspector General and will be required to make substantial structural reforms within the company, and maintain the Pfizer website (
PMC Redirect) to track the company's post marketing commitments. Pfizer must also put a searchable database of all payments to physicians the company has made on the Pfizer website by March 31, 2010.
[48] In addition, two former employees were separately indicted and sentenced for their role in marketing of Bextra. A former District Sales manager was found guilty of obstruction of justice for destroying documents pertinent to the investigation, and a Regional Sales Manager pled guilty to the distribution of a mis-branded product.
The case is the largest civil settlement against a pharmaceutical company as well.
[51] Pfizer paid a $1 billion civil fine to settle allegations it had illegally promoted the drugs for uses that were not approved by the
U.S. Food and Drug Administration (FDA) and caused
false claims to be submitted to Federal and State programs including but not limited to
Medicare and
Medicaid. Under the
False Claims Act, damages can be assessed for violations of the federal Anti-Kickback statute, 42 U.S.C. § 1320a–7b(b)
[52] and the off-label marketing provision within the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§301-97.
[53] Six
whistle-blowers will receive $102 million for their participation in the civil investigation, and John Kopchinski, a former sales representative, will receive $51.5 million for his allegations involving the marketing of Bextra.
CNN reported that Pharmacia & Upjohn, not Pfizer itself, pleaded guilty because prosecutors thought Pfizer was "too big to nail." Companies convicted of major health care fraud are automatically barred from billing Medicare and Medicaid for their products. Prosecutors feared that Pfizer would collapse if it pleaded guilty, and felt that the risk of harm to patients was too great. A CNN investigation revealed that Pharmacia & Upjohn Company is little more than a
shell corporation Pfizer uses to plead guilty; it was first created in 2007 as the defendant in a kickback case.
Nigeria
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to administer an experimental
antibiotic,
trovafloxacin, to approximately 200 children. Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities.
[56] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.
[57] Representing the government is Babatunde Irukera. According to news reports,
"[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[58]
The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee. The Nigerian government insisted that it was a fake and a panel of Nigerian medical experts agreed that the letter had been concocted and backdated by the company's lead researcher in Kano. They went on to conclude that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to children and infants.
In 2007, Pfizer published a Statement of Defense letter.
[60] The letter makes several claims, including that Pfizer donated 18 million in Nigerian Naira (NGN) (about $216,000 in 1996 US dollars (USD)) ,
[61] that the drug's oral form was presented as safer and easier to administer, that the administration of Trovan saved lives, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.
A more likely reason for Pfizer's insistence on the oral form is the result of testing trovafloxacin intravenously in 1995, which found that the drug precipitated in saline, making it ineffective in patients receiving IV fluids. This is inferred from an
FDA Warning Letter[62] to ex-CEO William C. Steere, regarding Trovan's compatibility with saline etc., which was omitted from Trovan's labeling until January 1999, shortly after Pfizer received the letter.
In June 1999, the FDA released a public health statement warning against the use of Trovan except in life-or-death situations, due to high risk of liver failure. In some cases, liver damage occurred after only two days of treatment.
In June 2010 the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.
[64]
In December 2010
WikiLeaks released
US diplomatic cables, which indicate that Pfizer had "used dirty tricks to avoid clinical trial payout". The company had hired investigators to find evidence of corruption against the Nigerian attorney general to persuade him to drop legal action.
[65] Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail."
[58] In response the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith.
Lawsuit over GMO virus
A scientist claims she was infected by a genetically modified virus while working for Pfizer. In her federal lawsuit she says she has been intermittently paralyzed by the Pfizer-designed virus. "McClain, of Deep River, suspects she was inadvertently exposed, through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the
lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS."
Blue Cross Blue Shield lawsuit
Health insurance company
Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for reportedly illegally marketing their drugs
Bextra,
Geodon and
Lyrica. BCBS is reporting that Pfizer used "kickbacks" and wrongly persuaded doctors to prescribe the drugs.
[68][69] FiercePharma reported that "According to the suit, the drugmaker not only handed out those "misleading" materials on off-label uses, but sent doctors on Caribbean junkets and paid them $2,000 honoraria in return for their listening to lectures about Bextra. More than 5,000 healthcare professionals were entertained at meetings in Bahamas, Virgin Islands and across the U.S., the suit alleges."
[70] Pfizer has had similar cases brought against it which it has settled with the US federal government and with more than 40 US states.
[71] Pfizer denies the allegations.
Wyeth's Rapamune
A "whistleblower suit" was filed in 2005 against
Wyeth, which was acquired by Pfizer, alleging that the company illegally marketed their drug
Rapamune. Wyeth is targeted in the suit for off-label marketing, targeting specific doctors and medical facilities to increased sales of Rapamune, trying to get current transplant patients to change from their current transplant drugs to Rapamune and for specifically targeting African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals with kickbacks to prescribe the drug in the form of grants, donations and other money.
[72][73] A US House of Representatives committee, led by Rep.
Edolphus Towns is currently investigating Pfizer for these abuses.
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