Updated: July 3, 2019
Americans trust the pharmaceutical industry to create drugs that are safe and effective. When companies breach that trust, they can cause real harm to patients and their families. Large settlements from these drug companies provide restitution to the victims and deter those companies from making decisions that put people at risk.
Due partly to medical advances, Americans are taking more prescription drugs than ever before to treat various conditions. This increased dependence on pharmaceuticals could pose its own risks, however, especially if the drugs aren’t properly vetted or are taken in unapproved ways.
Pharmaceutical lawsuits have yielded some of the largest settlements in U.S. history. Many of these lawsuits have involved manufacturers’ use of deceptive practices to promote drug uses not approved by the Food and Drug Administration (FDA). Physicians can prescribe drugs for off-label, but pharmaceutical companies are prohibited from marketing them that way.
Top Pharmaceutical Lawsuit Settlements at a Glance
Here’s a quick look at some of the drug lawsuits with the highest payouts of all time:
- GlaxoSmithKline, $3 billion (2012)
- Pfizer, $2.3 billion (2009)
- Johnson & Johnson, $2.2 billion (2013)
- Abbot Labs, $1.5 billion (2012)
- Eli Lilly & Company, $1.415 billion (2009)
- TAP Pharmaceutical Products, $875 million (2001)
- Amgen, $762 million (2012)
- GlaxoSmithKline, $750 million (2010)
GlaxoSmithKline Fraud Case
The largest pharmaceutical lawsuit settlement of all time was reached in 2012 when GlaxoSmithKline agreed to pay $3 billion ($2 billion in civil penalties and $1 billion in criminal fines). The lawsuit involved the fraudulent sale of antidepressants for unapproved uses and failure to report safety information about a diabetes drug. The settlement also covered claims of improper marketing of several other drugs.
The drugs at the center of the suit were some of GlaxoSmithKline’s best sellers—Paxil, Wellbutrin, and Avandia, among others.
Former employees blew the whistle on wrongful practices like paying doctors to promote its antidepressants for use among children and for unapproved purposes. They also alleged concealment of data showing heart risks posed by the anti-diabetes drug Avandia.
The $3 billion settlement amount is only a small fraction of what GlaxoSmithKline made over the period covered by the lawsuit. Over roughly a decade, they made about $10.4 billion on Avandia, $11.6 billion on Paxil and $5.9 billion on Wellbutrin.
In early 2013, the Office of Fair Trading in the U.K. charged GlaxoSmithKline with paying competitors to delay manufacturing of generic versions of Paxil, violating competition laws. Later that year, the Chinese government fined them $500 million for offering kickbacks and laundering payments through travel agencies.
Pfizer Bextra Case
In 2009, Pfizer paid $2.3 billion to settle allegations that they illegally marketed the pain killer Bextra. The company pleaded guilty to promoting off-label uses for Bextra, including treatment of pain after knee surgery. It was only approved for arthritis and menstrual cramps.
The FDA pulled Bextra from the market in 2005, citing an elevated risk of heart attack and stroke, as well as possible fatal skin reactions.
In August 2016, Pfizer agreed to pay $486 million to settle accusations that they hid safety risks related to Bextra and Celebrex (another pain reliever), leading to major shareholder losses. They continue to deny wrongdoing.
Johnson & Johnson Risperdal Settlement
In 2009, Johnson & Johnson paid $2.2 billion to settle allegations that they promoted drugs like Risperdal for unapproved uses and paid kickbacks to doctors who recommended their drugs.
The case alleged that a Johnson & Johnson subsidiary promoted Risperdal to treat anxiety, agitation, confusion, and hostility in elderly dementia patients, despite only being approved for schizophrenia. Prosecutors argued that Risperdal put elderly patients at increased risk of stroke.
In October 2018, just days before a trial involving allegations that Risperdal caused a boy to develop breasts (a condition called gynecomastia), Johnson & Johnson decided to settle the case. As of early 2019, the settlement amount was still confidential.
Abbott Labs Depakote Case
In 2012, Abbott Labs paid $1.5 billion in civil and criminal penalties for promoting Depakote as a treatment for schizophrenia as well as agitation and aggression in elderly patients. In fact, it was only approved for use in patients with epileptic seizures, bipolar mania, and migraines.
Government prosecutors accused Abbott of marketing unapproved uses of Depakote from 1998 to 2006, particularly to nursing homes. The company was also accused of giving big rebates to pharmacy providers who promoted off-label use.
Depakote was found to be ineffective as a treatment for schizophrenia, and a medical trial involving dementia patients was canceled due to side effects. Despite this, Abbot Labs continued to push the drug for both uses.
Later in 2012, Abbott’s main pharmaceutical operations became a new company called AbbVie. In 2017, a federal jury awarded $15 million in the case of a birth defect caused by the mother’s prescribed use of Depakote during pregnancy. Hundreds of similar claims abound.
Eli Lilly & Company Zyprexa Case
Pharmaceutical titan Eli Lilly & Company paid $1.415 billion for marketing the anti-psychotic Zyprexa as an off-label treatment for aggression, Alzheimer’s disease, and other problems in elderly patients. They were accused of intentionally targeting nursing homes and assisted living facilities, as well as primary care physicians, though Zyprexa was not approved for use in primary care.
Since 2009, the Zyprexa case has not changed. Eli Lilly has faced other legal challenges, however; in 2011, the company agreed to pay a $337,500 fine after the Environmental Protection Agency charged them with releasing harmful airborne chemicals.
TAP Pharmaceutical Products Medicare Fraud Case
In 2001, TAP Pharmaceutical Products paid $875 million to settle charges that they defrauded Medicare and Medicaid by helping doctors get excessive payments for the drug Lupron. TAP was also accused of offering kickbacks for prescribing their drugs.
At the time of the settlement, a grand jury had indicted seven individuals on criminal charges. This number had grown to 12 TAP employees by 2003. In 2008, Abbot and Takeda—the companies who created TAP—decided to dissolve their partnership.
Amgen Aranesp Case
In another off-label marketing case, Amgen paid $762 million for inappropriate marketing of Aranesp. Although it was only approved for the treatment of anemia in cancer patients undergoing chemotherapy, Amgen was charged with marketing it for use in the absence of chemotherapy. They trained marketing reps to ask doctors leading questions that would allow them to push the drug for unapproved uses.
In 2015, Amgen settled another suit involving Aranesp and Enbrel for $71 million. They were accused of marketing both drugs for off-label uses and marketing Aranesp for unapproved dosing frequencies.
GlaxoSmithKline Poor Manufacturing Practices Case
GlaxoSmithKline paid $750 million in 2010 to settle charges that they knowingly sold contaminated products and an ineffective antidepressant for years. Bad-drug lawyers accused the company of selling about 20 brands manufactured at a Puerto Rico plant that had numerous known contamination problems. Whistleblowers from within the company alerted the government.
Further charges involving poor ethics and practices arose in 2016, leading to a settlement of $20 million for accounting violations involving the payment of foreign officials.
Have You Been Injured by a Drug? Saunders & Walker, P.A. Can Help
If you believe that you or a loved one have been injured by a drug, you may be owed compensation. At Saunders & Walker, P.A., we’ve successfully fought some of the nation’s largest drug and medical device companies and won substantial settlements for our clients. .
Call (727) 579-4500 to schedule your free consultation with an attorney.