Wednesday, April 14, 2021 12:49:53 PM
Case in point: Eli Lilly
10 Biggest Pharmaceutical Settlements in History
Contributor: Enjuris Editor
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pharmaceutical lawsuit settlements amounts
You sometimes hear about lawsuits that result in damage awards with enough zeros to make your mind spin. Millions. Billions.
Despite what some people think, filing a lawsuit is never a get-rich-quick scheme. A single lawsuit can take years to get through the courts, the litigation process is expensive and time-consuming. But in some situations, it’s the only way to get what you deserve if you’ve been injured, whether in a car accident, truck accident, slip and fall, workplace accident, toxic exposure, by a defective product or medical device, or by a pharmaceutical drug.
Prescription drugs are a great relief to many of us because they treat everything from minor infections to serious, life-threatening conditions. Sometimes the risks outweigh the benefits, and that’s a conversation each person needs to have with their doctor before beginning a new drug or treatment.
Often, when a drug is recalled or when lawsuits are filed, it’s because the manufacturer failed to warn doctors and patients about dangerous side-effects or long-term issues. When the manufacturer doesn’t share important risk information with doctors, the doctors can’t provide their patients with a clear picture of the risks and benefits. As a result, patients use a drug that they think will help them, but they can end up having serious health problems in the long term.
The subject of many of the largest drug lawsuit settlements to date is how companies have misrepresented the drugs and their uses to physicians. In many of these cases, the lawsuits were filed because drug manufacturers promoted their products for uses outside of the scope of FDA approval.
Why do pharmaceutical companies misrepresent drugs?
Put simply: money.
When a company can claim that a drug is used for more purposes than it’s actually approved for, it can sell more product. And, in some cases, these uses aren’t inherently unsafe — they’re just not approved by the FDA.
But sometimes they are unsafe.
Some of the cases involve drugs being prescribed at higher doses than recommended, and in other cases the drugs have yet to be tested in clinical trials.
This is like Big Pharma playing roulette with your health. Your doctor is acting in good faith and prescribing medications according to what the manufacturer specifies is correct. That’s why the manufacturers are the ones being sued — they’re misleading doctors and the public about how these drugs function and what they can do.
When it comes to prescription drugs, Big Pharma often plays roulette with consumers’ health. Tweet this
Fortunately, in recent years the negligent actions of pharmaceutical companies are being called into question and lawsuits have been filed. These settlements are huge, even for some of the largest pharmaceutical manufacturers in the world.
Pharmaceutical company settlement amounts
Let’s take a look at the top 10 pharmaceutical settlements, in order of dollar amounts (highest to lowest). These can include a combination of criminal fines and civil settlements:
Company Amount of penalties Year
GlaxoSmithKline $3 billion 2012
Pfizer $2.3 billion 2009
Johnson & Johnson $2.2 billion 2013
Abbott $1.5 billion 2012
Eli Lilly $1.42 billion 2009
Merck $950 million 2011
Amgen $762 million 2012
AstraZeneca $520 million 2010
Actelion $360 million 2018
Purdue Pharma $270 million 2019
1. GlaxoSmithKline, $3 billion
Drugs: Paxil, Wellbutrin, Avandia
GlaxoSmithKline holds the dubious distinction of being forced to pay the largest health care fraud settlement in U.S. history. The criminal fine was $956,814,400 with a forfeiture of $43,185,600. $2 billion was paid to resolve civil liabilities under the False Claims Act.
The penalties are related to deceptive marketing, including off-label promotion and kickbacks, and failure to report safety data.
GSK agreed to pay based on:
Promoting Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label and non-covered uses, in addition to paying kickbacks to physicians for prescribing those drugs.
Giving kickbacks to physicians for prescribing Imitrex, Lotronex, Flovent, and Valtrex.
Making false and misleading statements about Avandia’s safety.
False reporting to the Medicaid Drug Rebate Program.
2. Pfizer, $2.3 billion
Drugs: Bextra, Geodon, Zyvox, Lyrica
The criminal fine was $1.3 billion, and the additional $1 billion was for civil allegations under the False Claims Act. Pfizer falsely promoted Bextra, antipsychotic drug Geodon, antibiotic Zyvox, and antiepileptic Lyrica. The company was also accused of paying kickbacks related to these drugs and submitting false claims to government health care programs based on uses that weren’t medically accepted.
Bextra was pulled from the market in 2005 after it was deemed unsafe.
3. Johnson & Johnson, $2.2 billion
Drugs: Risperdal, Invega, Natrecor
Criminal fines and forfeiture totaled $485 million, and civil settlements amounted to $1.72 billion.
In the early 2000s, Risperdal was approved to treat schizophrenia. However, the company’s sales representatives were promoting the drug to physicians as a treatment for elderly dementia patients for anxiety, agitation, depression, hostility, and confusion. There were also allegations that Risperdal was marketed for other unapproved uses, such as prescription to children and individuals with mental disabilities.
Invega and Natrecor were also included in these lawsuits as having been illegally marketed for off-label and unapproved uses.
4. Abbott, $1.5 billion
Drug: Depakote
Criminal fines in this action were $700 million and civil settlements were $800 million. Abbott promoted Depakote as a drug to control agitation and aggression in elderly dementia patients, and for schizophrenia. The FDA hadn’t approved the drug for either of these uses. For 8 years, the manufacturer marketed Depakote for this purpose in nursing homes, even though there wasn’t any evidence that the drug was safe and effective when used that way.
In fact, the FDA had approved Depakote for epileptic seizures, bipolar mania, and migraine treatment. The manufacturer had actually discontinued clinical trials of Depakote for dementia treatment in 1999 because of adverse events, yet they still continued to market it publicly.
Eli Lilly, $1.42 billion
Drug: Zyprexa (generic: olanzapine)
Eli Lilly promoted antipsychotic drug Zyprexa for uses outside the FDA’s approval, which resulted in criminal fines of $515 million and civil settlements of $800 million.
The FDA approved olanzapine in 1996 for treating psychotic disorders. It was later approved for treatment of manic episodes of bipolar disorder, and then for short-term treatment of schizophrenia. It was not approved for treatment of dementia or Alzheimer’s Disease.
However, Eli Lilly was marketing Zyprexa to primary care physicians even though it wasn’t a drug intended for the primary care market. As a result, physicians were prescribing it for patients of all ages for anxiety, irritability, depression, nausea, Alzheimer’s, and other issues.
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