Prescription drugs are often beneficial--treating maladies from minor to life-threatening. Sadly--often driven by money as the bottom line--pharmaceutical companies sometimes engage in fraud, thereby risking public health and costing consumers and the government billions of dollars. Bad actions abound: some companies promote products untested in clinical trials or for uses beyond the scope of governmental approval; some encourage prescriptions at higher doses than recommended; and some push medicines that are just plain dangerous. In a great many cases, manufacturers fail to warn doctors and patients about dangerous side-effects or associated long-term issues. When that happens, doctors cannot transparently inform patients. Beyond morality and justice, often the only check (pun intended) on these companies can be to their pocketbooks. Below are some of the top pharmaceutical litigation settlements of all time.
$8.344 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2020
- Defendant: Purdue Pharma
- Drugs: OxyContin, Butrans, Hysingla
- Allegations: Marketing and selling dangerous opioids to healthcare providers with knowledge of diversion to abusers; kickbacks to physicians and to a health records company; facilitating dispensing of opioids without a legitimate medical purpose, and thus without lawful prescriptions; impeding the Drug Enforcement Administration; and reporting misleading information to boost manufacturing quotas.
- Disposition: $5.544 billion criminal fines and forfeiture; $2.8 billion civil liabilities under the False Claims Act.
- More info: https://www.justice.gov/opa/pr/opioid-manufacturer-purdue-pharma-pleads-guilty-fraud-and-kickback-conspiracies
$3 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2012
- Defendant: GlaxoSmithKline
- Drugs: Paxil, Wellbutrin, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex
- Allegations: Misbranding and unlawful promotion; deceptive marketing, including off-label promotion and kickbacks to physicians for prescriptions; failing to report safety data; and reporting false drug prices to underpay rebates owed under the Medicaid Drug Rebate Program.
- Disposition: $2 billion civil liabilities under the False Claims Act; $1 billion criminal fines and forfeiture.
- More info: https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report
$2.4 BILLION IN SETTLEMENTS
- Settlement Year: 2015
- Defendant: Takeda Pharmaceutical
- Drug: Actos
- Allegations: Concealing associated bladder cancer risks; and deceptive marketing.
- Disposition: $2.4 billion to settle approximately 8,000 lawsuits.
- More info: https://www.drugwatch.com/news/2015/04/29/takeda-actos-settlement-2-billion/
$2.3 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2009
- Defendant: Pfizer
- Drugs: Bextra, Geodon, Zyvox, Lyrica
- Allegations: Unlawful promotion; deceptive marketing, including off-label promotion and kickbacks to physicians for prescriptions; and submitting false claims to government healthcare programs based on non-medically accepted uses.
- Disposition: $1.3 billion criminal fine; $1 billion civil liabilities under the False Claims Act (including more than $102 million to six whistleblowers).
- More info: https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history
$2.205 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2013
- Defendant: Johnson & Johnson
- Drugs: Risperdal, Invega, Natrecor
- Allegations: Unlawful promotion; and deceptive marketing, including off-label promotion and kickbacks to healthcare providers.
- Disposition: $1.72 billion civil liabilities under the False Claims Act; $485 million criminal fines and forfeiture.
- More info: https://www.justice.gov/usao-ndca/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations
$1.5 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2012
- Defendants: Abbott Laboratories
- Drug: Depakote
- Allegations: Unlawful promotion; deceptive marketing, including off-label promotion and kickbacks to healthcare providers and nursing home employees; and submitting false claims to government healthcare programs.
- Disposition: $800 million in civil liabilities under the False Claims Act; $700 million criminal fines and forfeiture.
- More info: https://www.justice.gov/opa/pr/abbott-labs-pay-15-billion-resolve-criminal-civil-investigations-label-promotion-depakote
$1.415 BILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2009
- Defendant: Eli Lilly and Company
- Drug: Zyprexa
- Allegations: Misbranding and unlawful promotion; deceptive marketing, including off-label promotion and kickbacks to physicians and nursing home employees; and submitting false claims to government healthcare programs.
- Disposition: $800 million civil liabilities under the False Claims Act; $615 million criminal fines and forfeiture.
- More info: https://www.justice.gov/opa/pr/eli-lilly-and-company-agrees-pay-1415-billion-resolve-allegations-label-promotion-zyprexa
$950 MILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2011
- Defendant: Merck
- Drug: Vioxx
- Allegations: Misbranding and unlawful promotion; and deceptive marketing, including off-label promotion impacting payment decisions of state agencies.
- Disposition: $628 million civil liabilities; $322 million criminal fines.
- More info: https://www.justice.gov/opa/pr/us-pharmaceutical-company-merck-sharp-dohme-pay-nearly-one-billion-dollars-over-promotion
$875 MILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2001
- Defendant: TAP Pharmaceutical
- Drug: Lupron
- Allegations: False pricing and fraudulent marketing practices; kickbacks to healthcare providers and other customers; and violating the Prescription Drug Marketing Act by charging government healthcare beneficiaries and the government for free samples.
- Disposition: $585 million civil liabilities; $290 million criminal fines.
- More info: https://www.nytimes.com/2001/10/04/business/2-drug-makers-to-pay-875-million-to-settle-fraud-case.html
$762 MILLION IN CRIMINAL PENALTIES AND LIABILITIES
- Settlement Year: 2012
- Defendant: Amgen
- Drugs: Aranesp, Enbrel, Neulasta
- Allegations: Unlawful promotion; deceptive marketing, including off-label promotion and kickbacks to healthcare providers; and reporting false prices.
- Disposition: $612 million civil liabilities under the False Claims Act; $150 million criminal fines and forfeiture.
- More info: https://www.justice.gov/opa/pr/amgen-inc-pleads-guilty-federal-charge-brooklyn-ny-pays-762-million-resolve-criminal
$775 MILLION IN SETTLEMENTS
- Settlement Year: 2019
- Defendants: Bayer and Johnson & Johnson
- Drug: Xarelto
- Allegations: Downplaying associated risks; and deceptive marketing.
- Disposition: $775 million to settle approximately 25,000 lawsuits.
- More info: https://www.nytimes.com/2019/03/25/health/xarelto-blood-thinner-lawsuit-settlement.html
$520 MILLION IN SETTLEMENTS
- Settlement Year: 2010
- Defendant: AstraZeneca
- Drug: Seroquel
- Allegations: Unlawful promotion; and deceptive marketing, including off-label promotion and kickbacks to physicians.
- Disposition: $520 million civil liabilities.
- More info: https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing
$360 MILLION IN SETTLEMENTS
- Settlement Year: 2018
- Defendant: Actelion
- Drugs: Tracleer, Ventavis, Veletri, Opsumit
- Allegations: Using a foundation to illegally pay copays for thousands of government healthcare program patients, which induced patients to buy the drugs at artificially low prices. By undermining the program’s copay structure designed to prevent drug price inflation, it was then able to raise Tracleer’s drug price by nearly 30 times the overall rate of inflation.
- Disposition: $360 million civil liabilities under the False Claims Act.
- More info: https://www.justice.gov/opa/pr/drug-maker-actelion-agrees-pay-360-million-resolve-false-claims-act-liability-paying
Cotchett Pitre and McCarthy has been a leader in prosecuting cases against pharmaceutical and medical device companies in complex litigation involving the manufacture, marketing and sales of drugs and medical treatments. CPM has served as lead trial counsel or co-lead counsel in major multidistrict litigation against companies such as Pfizer and Merck. CPM has brought cases involving claims for product defect, deceptive advertisement and encouraging off-label use, amongst others. Few law firms possess the resources, skill and tenacity to litigate these difficult cases against powerful and well-funded pharmaceutical and medical device companies. For general information about CPM’s Pharmaceutical Litigation practice, see this link.