- In the United States, the pharmaceutical companies used their clout to be free from liability even if they knowingly caused death in a certain class of patient. The act says that for a “vaccine-related injury or death”, people have to file a claim with an administrative program – the National Vaccine Injury Compensation Program (NVICP or VICP, sometimes called the Vaccine Court) before they can sue either a manufacturer or a provider. (42 U.S.C. 300aa-11(2)(A)). Only after such a petition is filed, petitioners (claimants in the program are referred to as “petitioners”) have two ways of getting to regular courts, if that is what they want. First, they can go through the program until there is a judgment, and then reject the judgment and go to court – whether or not they were compensated. Can you imagine that a car manufacturer knows that their car blows up under certain conditions so they bribe politicians to prevent being sued?
- 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|
|Johnson & Johnson||$2.2 billion||2013|
|Eli Lilly||$1.42 billion||2009|
|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.