The alleged violations in the Pfizer lawsuit are complex and widespread. The company has agreed to an expansive corporate integrity agreement that includes procedures and reviews. The investigation stemmed from whistleblower lawsuits filed under the False Claims Act. The companies have agreed to pay over $102 million in compensation to the plaintiffs. The deal was reached after the court approved a proposed settlement. Meanwhile, the pharmaceutical giant faces other ongoing litigation.
One of the most prominent cases is the EpiPen.
The pharmaceutical company owns the EpiPen brand and manufactures the device. The drug epinephrine is an emergency treatment for severe allergies. A package of EpiPens costs $100 when Mylan first acquired rights to the brand in 2007. The company has since raised prices by more than 400 percent. The settlement comes three weeks after U.S. District Judge Daniel Crabtree dismissed most claims against the company. The alleged antitrust violations were dismissed, but the litigation has not been settled.
The alleged illegal marketing of the drug Neurontin by Pfizer has been resolved. The company paid a $430 million fine and entered into a corporate integrity agreement to resolve the allegations. The government’s Bextra case was a result of Kopchinski’s complaint. The former sales representative said that Pfizer executives dismissed his concerns when he approached them about the case. As a result, the government’s action was filed.
In addition to the Bextra case, another Pfizer-related lawsuit was settled last year for $430 million.
This settlement resulted from a $2.3 billion fine paid by Pfizer to settle lawsuits over the illegal marketing of coronavirus vaccines. Those allegations prompted the government to file the case in 2009. However, the lawsuit has been delayed because it did not resolve the cases brought by Kopchinski.
While Pfizer has faced legal problems with several of its medicines, the company has settled with cities like Chicago for millions of dollars. The agreement does not involve the city’s legal actions, however, and Pfizer is still required to follow the current drug marketing laws and regulations. Although the settlement may seem like a big win for plaintiffs, it breaks little new ground for the pharmaceutical industry. The government will continue to enforce the existing regulations.
The settlement also limits Pfizer’s illegal marketing practices.
The pharmaceutical giant has a contract with pharmaceutical firms that do not provide samples of opioids to physician offices. The agreement also prohibits Pfizer from funding organizations that make false claims about the effectiveness of opioids. In addition, the settlement requires the drug maker to disclose information about clinical trials and the promotion of the drug. In addition, it is unknown whether any of these actions were intentional.
In addition to settling the Pfizer lawsuit, a $2.3 billion criminal fine was also imposed on the pharmaceutical giant. The settlement also involves a corporate integrity agreement between Pfizer and the three other defendants. The terms of the agreement were not publicly disclosed, but both sides are cooperating in the settlement. The two lawsuits are based on similar facts but were filed in different courts. The large company has pleaded guilty to violating the law. The government has set aside millions of dollars in reserves to settle the cases.
According to the Pfizer lawsuit, the drug company has knowingly marketed several of its drugs without informing the public of their risks.
Despite the massive amounts of money spent on the settlement, Pfizer hasn’t yet settled any of the cases, despite the settlements. The drugmaker has also been sued for false advertising and marketing of their drugs. The companies have paid out $2.3 billion to settle the allegations.
A contract between Pfizer and the FDA prohibited Pfizer from providing free samples of its opioids to physicians and funding organizations that promoted these drugs illegally. It also required drug makers to disclose their clinical trials and their promotion of these drugs. Pfizer’s contract with the FDA may have an ulterior motive. If it did, then it may have a motive for settling the lawsuit. It’s worth considering the nuances of the Pfizer lawsuit.
there needs to be a lawsuit against Pfizer for knowingly pushing a covid-19 vaccine that they new had serious and deadly side-effects. The information on the 9 pages of reported effects dictate serious and continuing hazard. Blatant disregard for safety over the desire for profit.
Good Morning and Happy (almost) Father’s Day to you gentlemen. No, this will not be a homage to dads; rather, it will be a cautionary tale for everyone.
Most of you are well aware that I have an on-going, visceral loathing for how Big Pharma has come to dominate so much of our lives. The US is in a stranglehold to these companies. Ours is also one of the very few where advertisements and commercials are directed at the potential user or patient, not the physician or medical community. You are frequently told to ‘ask your physician about (insert drug here) for your treatment of (insert disease or condition here).’ Pay close attention because all of this is important. This is not a rant. Well, it is sort of but it’s real.
All of those slick commercials at some point have a rapid voice over recitation of possible side effects usually delivered in the same glowing manner as the pitch. The actors don’t fall down gasping for breath and clutching their hearts – they keep right on blowing bubbles and enjoying their best possible life all due to their use of this medical miracle.
Let me clue you in on reality and liability. This is from direct experience. Not too long ago, Bruce was prescribed hydralazine for chronic high blood pressure. Prior to that, he had been taking Lisinipril with some success, so I’m not entirely sure of the reason for the change. Neither is he.
At the time of the changed medication, his physician did not discuss the possibility of severe side effects incurred by a percentage of people taking this medication. As with most people, Bruce trusted his physician to prescribe medication that would help him – not cause irreparable damage.
You see, hydralazine – a drug that has known, serious side effects – is widely prescribed. I’m not entirely sure why it is prescribed so often when there are other drugs equally as effective that don’t have the possibility of horrible side effects. Bruce’s physician did not discuss possible side effects or what to look for in the event he might begin to experience side effects. You might think this is pretty basic stuff – providing information to your patient – but it isn’t.
Bruce began to experience a wide range of “symptoms” that could not be explained. They weren’t part of his usual medical history & seemed to come out of the clear blue. Repeated trips to his physician revealed nothing definitive but the symptoms remained, even intensified.
We were clueless and were grasping at medical straws trying to figure out why he was experiencing this odd cluster of symptoms of “something.” Heretofore he had been in reasonably good health with no chronic issues beyond high blood pressure & bladder stones. The high blood pressure could likely have been controlled effectively through weight maintenance, diet, and exercise – a regime we had begun following in the hope of getting him off blood pressure medication. I’m a big fan of the Mediterranean diet.
Eventually, blood work showed some dramatic changes. He was ordered to see various specialists including a rheumatologist to test for possible lupus. Lupus is one of the side effects of hydralazine, but no one told us that earlier. Shortly after this startling factoid, he was instructed to hie himself immediately to the ER because his hemoglobin was so low he must be bleeding internally.
We hustled to the ER which triggered a 9-day stay with all the medical resources brought to bear. No, he didn’t have lupus – what he did have was kidney failure – another side effect of hydralazine. I won’t go into the myriad of tests, treatments, and therapies conducted during those 9 days except to say they were exhaustive.
Medical bottom line is that he is in end stage renal disease due to hydralazine. He must have dialysis 3x a week, is on a highly specialized diet, and is also on a course of infusions. It is unlikely that his kidneys will heal much less return to normal function. All due to a prescribed drug. A drug that is known to have these side effects. A drug that is used frequently in the US without warning the patient. A drug that is far less often used in other countries due to the known risks.
Part B is almost as disturbing. Who is to “blame” – who is “responsible” in these cases? The drug manufacturer? The prescribing physician? You would logically think so. But that’s not the case. Nope.
There is a kind of chain of liability in the US. The drug manufacturer knows the drug can do more harm than good in a percentage of patients. The manufacturer informs the physician of this and, with those slick advertisements & commercials, “informs” the public and/or patient. They’ve exercised due diligence and have passed the buck to the physician and patient who may or may not have ever seen the commercial or paid attention.
The physician has no obligation to discuss this or inform the patient because one of two things happen that absolves the physician of liability. The drug may come with a very fine print, multi-page insert placed within the container. That’s one. The 2nd is that when the pharmacist staples your receipt to your little goodie bag they also staple the manufacturers drug information. Due diligence and ass covering.
The manufacturer isn’t held liable; the physician isn’t liable because he/she doesn’t dispense the drug; the pharmacist is a low man on the totem pole. Shit does indeed roll downhill.
Some pharmacists are wonders – they know their stuff like nobody’s business and will talk very candidly & thoroughly with you about the interactions & risks of specific drugs. They are also often overworked and much of the patient’s direct contact is with a pharmacy tech, not the pharmacist. So the skull & crossbones info may not get passed on except in the very fine print that few people ever read.
Yes, there are a few exceptions to this – the biggest recent one is oxycontin. The manufacturer failed to disclose how easily it was to become addicted to the drug and encouraged physicians to over-prescribe it. But that is the rarity. What I’ve related to you is more the norm.
In short, being safe and informed is on you. Truth is, my vet is more forthcoming than the medical community at large.
I have been forewarned regarding the MONUMENTAL BAR within our legal and governmentAl ‘system’ that ensures liability and responsibility lie at the bottom of the ‘food chain’.