10. Protonix – $55 Million
In 2012, Pfizer agreed to pay $55 million for illegally promoting Protonix off-label. Wyeth, the company’s subsidiary, illegally introduced and promoted the drug between February 2000 and June 2001. The drug was used to treat various gastro-esophageal reflux diseases (GERD). Thus, Wyeth sought the FDA’s approval to promote Protonix as a short-term treatment for erosive esophagitis. The FDA approved the drug but later discovered that Wyeth promoted the use of Protonix for all forms of GERD. Consequently, Wyeth was accused of misbranding the drug because it marketed the drug for an unapproved use. Pfizer hence agreed to pay the $55 million, plus interests to settle the lawsuit.
9. Trovan – $75 Million
In 2009, Pfizer was in the spotlight because it had given 200 Nigerian children an experimental anti-meningitis drug, Trovan. The drug caused the death of 11 children while the rest were left with disabilities such as deafness blindness, paralysis, and brain damage. Even
when faced with the lawsuit, Pfizer was adamant that the deaths were due to meningitis, not their drug. However, Pfizer agreed to pay $75 million as compensation which the Kano state government agreed to, resulting in the dropping of the $6.5 billion-dollar suit filed by the Nigeria federal government. The Kano state had filed criminal and civil lawsuits against the drug company and demanded $2.75 billion in compensation. From the $75 million settlement, $35 million was for the victims, $30 million for rebuilding the Infectious Diseases Hospital where Pfizer conducted the trials, and the remaining $10 million for covering legal costs that the Kano state government incurred. In 2011, Pfizer started making a series of payments to the victims’ families by paying four families $175,000 each. It took two years before the payments were issued because DNA tests had to be carried out to determine which family was entitled to the payout.
8. Faulty Heart Valves- $215 Million
Pfizer, through its subsidiary, Shiley Inc., sold Bjork-Shiley Convexo-Concave heart valves between 1979 and 1986. Around 55,000 patients received the implant, and in the mid-1980s, the FDA forced their removal from the market. Unfortunately, the damage had already been done. In 1990, under pressure from the FDA and the Public Citizen Health Research Group, Pfizer sent letters to cardiologists who had implanted the devices. Pfizer wanted the surgeons to contact the patients who had the discontinued device. About 20,000 Americans were in danger of the faulty artificial heart valves, and Pfizer added they would follow up the letters with a $2 million campaign to track down each patient and warn them. Since its introduction, the valve had fractured at least 391 times and caused 250 deaths by the end of 1990. By 1991, 450 valve failures had been reported, resulting in 350 deaths. Pfizer dealt with multiple lawsuits and expected a settlement that would range from $155 million to $205 million. In August 1992, a judge wrapped up the suit with a $215 million settlement. Under the settlement terms, Pfizer would pay $90 million to $140 million for the recipients’ medical consultations. The company would also pay $75 million for research to identify any fracture risks and any valve replacement surgeries. Additionally, each valve recipient received $2,500. Pfizer’s then-CEO said the complaints regarding the valve lacked merit and only agreed to the settlements to end the lawsuit.
7. Chantix-$288 Million
Chantix is a drug designed to help smokers stop smoking and is meant for short-term use. The drug was linked with having psychological effects such as suicidal thoughts, depression, hostility, and agitation.
According to The Guardian, Timothy John committed suicide in April 2013 after taking the medication. He only took the drug for eight days before hanging himself, joining 24 more people who had committed suicide since its launch in 2006. As a result, around 2,700 lawsuits were filed against Pfizer. Consequently, sales of the drug fell from $848 million in 2008 to $648 million in 2013. In March 2013, Pfizer agreed to settle 80% of the 2,700 state and federal lawsuits against Chantix. The drug company took a $273 million charge to cover the costs and set aside an additional $15 million to wrap up the remaining 20% claims. Although the settlements were made, Chantix could still be a risky drug considering that on July 16, 2021, Pfizer announced that it was recalling two lots of the smoking cessation treatment. It discovered the presence of N-nitroso-varenicline that can potentially increase the risk of cancer in humans.
6. Rapamune – $490.9 Million
According to The New York Times, Pfizer agreed to pay $491 million to settle civil and criminal charges over the illegal marketing of Rapamune. The kidney-transplant drug helps prevent the rejection of a transplanted organ by the body’s immune system. Although FDA had approved the drug in 1999 for use by recipients of kidney transplants, Wyeth promoted the treatment for other organ transplants. It went as far as giving monetary incentives to push the sale of the drug. Wyeth pleaded guilty and was charged with the misbranding violation; hence, agreed to pay a criminal fine of $157.58 million and forfeit assets worth $ $76 million. The settlement increased because the Department of Justice joined the two whistleblowers in their lawsuit in 2010. The whistle-blowers’ lawyer predicted that with the government on their side, they could recover hundreds of millions of dollars in inappropriate billings. Since Rapamune had $376 million sales in 2008, the government was allowed to legally collect up to three times the amount it had been defrauded and pay whistleblowers 15-25% of the total. Of the $490.9 million, $257.4 million went to civil settlements, while the remaining was for criminal fines.
5. Medicaid Rebates- $784.6 Million
On April 27, 2016, the Department of Justice announced that Pfizer and its subsidiary Wyeth had agreed to pay $784.6 million to settle cases regarding Medicaid rebates calculation for a gastric drug. Fifteen US states filed complaints in Massachusetts federal court in 2009 claiming that Wyeth had failed to provide state Medicaid programs the same rebates it offered private hospitals. As per the allegations, Wyeth sold two of its PPI (proton pump inhibitor) drugs, Protonix IV and Protonix Oral, through bundled sales agreement such that a hospital earned steep discounts on the two drugs if it availed them within the hospital. The discounts incentivized hospitals to buy the drugs despite there being other competitively-priced and safe drugs readily available. It did not disclose the discounts to avoid paying hundreds of millions of dollars to Medicaid from 2001 to 2006. Wyeth was therefore charged with knowingly reporting to the government false and fraudulent prices of the two drugs. The settlement was divided such that Wyeth would pay $414,248,820 to the federal government, and the state Medicaid programs would receive $371,351,180.
4. Neurontin – $945 Million
In 2004, Pfizer’s subsidiary, Warner-Lambert, agreed to pay $430 million after pleading guilty to criminal charges and civil liabilities associated with the illegal and fraudulent promotion of Neurontin. The company marketed the drug as a treatment for an array of diseases that the FDA had not approved. Besides, scientific studies had proven that Neurontin was ineffective in treating such ailments. The lawsuit was far from over thus in April 2014, Pfizer agreed to pay another $190 million to settle a class-action lawsuit that alleged delayed market entry of the generic versions of Neurontin.
According to Reuters, buyers claimed that Pfizer forced them to pay inflated prices for the drug. As always, Pfizer denied any wrongdoing. They said they were happy with the results after the long and hard litigation process. They had spoken too soon because barely six weeks passed before Pfizer once again agreed to pay an additional $325 million to wrap up claims that the company’s Parke-Davis unit had touted Neurontin for non-approved FDA uses. Parke-Davis unit was a Warne-Lambert unit, and the off-label marketing labels went as far back as 1994. The total sum of settlements paled in comparison to the billions of dollars that Blue Cross Blue Shield Association was seeking in damages.
3. Prempro -$1.2 Billion
It seems that when Pfizer acquired Wyeth, it should have considered the lawsuits that came with it. Wyeth was the original defendant in personal liability cases revolving around the hormone replacement therapy drug Prempro. Pfizer took over and, in 2009, had to pay $6.3 million to a breast cancer survivor in compensatory damages because Prempro was among the drugs that caused cancer. The award was the largest then of the three dozen Prempro cases tried in Philadelphia. Unfortunately, the fight was just the beginning for the drug company. In 2012,
Fierce Pharma published that Pfizer had agreed to pay $896 million to settle 60% of the cases alleging that Prempro and Provera, also sold by Pfizer’s Pharmacia unit, caused breast cancer. About 4000 lawsuits were still pending, and Pfizer set aside $330 million to cover the settlements, bringing the total amount for the 10,000 cases to $1.226 billion. The pharmaceutical company added that the additional $330 million would likely not be enough to cover the remaining 4,000 claims, but they were still satisfied with the outcome.
2. Celebrex – $1.5 billion
When Pfizer bought out its rival, Pharmacia, it acquired Celebrex, a Cox-2 inhibitor. Investors accused Pfizer and former Pharmacia executives of violating securities laws and sued them, claiming the company and official misled investors regarding Celebrex trial data. In 2007, a judge certified the class action lawsuit and set a trial date. In October 2008, Pfizer reached an $894 million deal to end most of its lawsuits over Celebrex and Bextra; the company hoped to cover up to 92% of the claims through that settlement. However, that was not the end of the matter. In 2012, there was another $164 million deal to wrap up the lawsuit. Pfizer insisted they had not done anything wrong despite offering the settlements. Unfortunately, the matter was far from over.
According to Yahoo, Pfizer reached another $486 million settlement still involving Celebrex and Bextra. The amount was supposed to cover shareholders who bought Pfizer’s stock between October 31, 2000, and October 19, 2005. The company had already suffered enough financial damage because, in October 2004, it had lost $70 billion in market value when investors dumped their shares.
1. Bextra, Zyvox, Geodon, and Lyrica -$2.3 Billion
On September 3, 2009,
ABC News reported the largest healthcare fraud settlement in the history of the Justice Department. Pfizer and subsidiary, Pharmacia & Upjohn Company Inc., agreed to pay $2.3 billion after the subsidiary pleaded guilty to misbranding Bextra, purposing to defraud. Pfizer had pulled Bextra from the market in 2005 but still promoted the drug for uses and dosages that the FDA had previously declined to approve. As a result, Pfizer had to pay a fine of $1.195 billion- the amount was the highest criminal fine ever imposed in the US. Pharmacia & Upjohn Company Inc., on the other hand, had to forfeit $105 million. The punitive damages also included $billion that Pfizer agreed to pay to resolve claims of illegally promoting Geodon, Lyrica, Zyvox, and Bextra. The civil settlement was to resolve claims of Pfizer paying kickbacks. From the $1 billion, $331,458,170 went to the state Medicaid program, and $668,514,830 to the federal government. It was the largest fraud settlement in the litigation history of pharmaceutical companies.
Just an accusation of being someone called Kev. I'm totally happy to contact the Mods if needs be to prove I'm not (not even the right fucking gender JFC).
