The 5 Largest Drug Lawsuit Settlements in U.S. History
Creating new medications is big business, but it can also be costly if emerging drugs and medical devices are rushed to market without a full explanation of the side effects.
Many name brand pharmaceutical companies have found this out the hard way, being on the receiving end of the largest drug lawsuit settlements in American history.
Historic U.S. Drug Lawsuit Settlements
From 1991 to 2012, the United States Department of Justice ordered pharmaceutical companies to pay some of the biggest settlements in United States history. The settlement amounts include both civil and criminal fines.
Many of the pharmaceutical companies violated the False Claims Act resulting in large amounts of civil settlements. The largest settlement on record to violate the False Claims Act occurred in 2012. In 2009, another pharmaceutical company paid a record-breaking criminal fine.
In ascending order, these are the five largest drug lawsuit settlements in the United States:
5. Eli Lilly – $1.4 Billion
In 2009, the pharmaceutical company Eli Lilly settled with the United States Department of Justice for the total amount of $1.4 billion dollars. The U.S. Department of Justice found Eli Lilly to be in violation of off-label promotion. The plaintiff’s allegation of off-label promotion of a pharmaceutical drug specifically dealt with Zyprexa.
By promoting off-label use of the drug Zyprexa, Eli Lilly was found guilty of violating the False Claims Act and the Federal Food, Drug and Cosmetic Act (FDCA).
4. Abbott Laboratories – $1.5 Billion
The United States Department of Justice found Abbott Laboratories to be in violation of the off-label promotion of the pharmaceutical drug Depakote. Using Depakote for off-label promotion was found to violate the False Claims Act and the Federal Food, Drug and Cosmetic Act (FDCA).
A settlement was reached between the U.S. Department of Justice and Abbott Laboratories for the overall amount of $1.5 billion dollars in 2012.
3. Johnson & Johnson – $2.2 Billion
The pharmaceutical company Johnson & Johnson was ordered to pay a total of $2.2 billion dollars in 2013. The main allegation from the U.S. Department of Justice was the use of off-label promotion of three different drugs produced from Johnson & Johnson. The three drugs used for off-label promotion by Johnson & Johnson included Risperdal, Invega and Nesiritide.
Another allegation made by the U.S. Department of Justice included the use of kickbacks. Kickbacks are a form of negotiated bribery where a commission is exchanged for services. The pharmaceutical company was found to have violated the False Claims Act and the Federal Food, Drug and Cosmetic Act (FDCA).
2. Pfizer – $2.3 Billion
Since 2009, the settlement against the pharmaceutical giant Pfizer remains the largest criminal fine on record today.
Pfizer was ordered to pay a total of $2.3 billion dollars. The United States Department of Justice found that Pfizer promoted the off-label use of four different pharmaceutical drugs: Bextra, Geodon, Zyvox and Lyrica.
Along with the allegation of off-label promotion, Pfizer was found using kickbacks, a form of negotiated bribery. Pfizer was found to violate the False Claims Act and the Federal Food, Drug and Cosmetic Act (FDCA).
1. GlaxoSmithKline – $3 Billion
Holding the record for the largest civil, False Claims Act settlement, the pharmaceutical company of GlaxoSmithKline paid a gross amount of $3 billion dollars.
Of the total $3 billion dollars, $1 billion went toward criminal fines and $2 billion paid toward civil settlement. Allegations against GlaxoSmithKline included criminal violations of off-label promotion and a failure to disclose safety data.
Violations of the civil settlement included bribery to physicians (kickbacks), false and misleading claims about the safety of Avandia, reporting false best prices and underpaying rebates to the Medicaid Drug Rebate Program. The drugs involved in the violations included Paxil, Avandia, Wellbutrin, Advair, Zofran, Lamictal, Lotronex, Imitrex, Flovent and Valtrex. The U.S. Department of Justice alleged the pharmaceutical company violated the False Claims Act and the Federal Food, Drug and Cosmetic Act (FDCA).
Even with such enormous expenses in their recent history, the biggest names in the pharmaceutical sector know that a well-marketed drug can make far more money than it might lose in drug lawsuit settlements. Patients need to be aware of this and make informed decisions about medications they take.
In situations where negligence or false claims are evident by these companies, patients should also feel empowered to seek a case evaluation and pursue legal action where appropriate.
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