Even I did not know the extent of their profit before patient

October 13, 2010

Big Pharma Behaving Badly: A Timeline of Settlements
Tuesday October 5th, 2010

Erica Teichert
Fierce Pharma

Sometimes pharma companies bend the rules. And increasingly, they’re getting caught. After Novartis’ recent $422.5 million settlement with the U.S. Attorney’s office and reader requests, we looked back at other Department of Justice and government fines levied against Big Pharma for improper marketing and other infractions. Those fines range from a relatively light slap on the wrists to multi-billion dollar charges in addition to criminal penalties. 

Eleven companies have paid a total of over $6 billion to the government in 22 months. The biggest offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all for Zyprexa. But those three settlements pale in comparison to Pfizer’s massive $2.3 billion charge for mis-marketing a host of drugs, including Bextra, Geodon, Lyrica and Zyvox.

Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest’s off-label use of Celexa for children’s use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan’s $600 million DoJ settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney’s Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company’s U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J’s more infamous woes stem from its phantom recalls, two of the troubled drugmaker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney’s office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug’s safety.

Abbott
With: Twenty-three states
When: Jan. 7, 2010
Scoop: In a case involving 23 different states, Abbott Laboratories and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million for blocking the states from obtaining a cheaper alternative for its cholesterol drug, TriCor.

Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Scoop: Thirteen states total had filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay $25 million to Connecticut in this ruling.

Eli Lilly
With: West Virginia Attorney General
When: August 21, 2009
Scoop: In another Zyprexa case, West Virginia Attorney General Darrell McGraw levied $2 billion in fines against Eli Lilly. As the motion put it, “At $5,000 per violation, therefore, the State is attempting to fine Lilly approximately $2 billion for use of a product label that was approved by the FDA.” In the end, the company agreed to $22.5 million in fines.

Merck
With: 35 states’ attorney offices
When: July 15, 2009
Scoop: Merck escaped relatively unscathed from 35 state investigations against the Enhance study of Vytorin, only paying $5.4 million without admitting fault in the cases.

Sanofi-aventis
With: Department of Justice
When: May 28, 2009
Scoop: In an agreement with the federal government, Sanofi paid $95.5 million total, doled out to the feds, state Medicaid agencies and other public health service agencies, all for its subsidiary Aventis’ nasal spray price inflation between 1995 and 2000.

GlaxoSmithKline
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Scoop: After seven years of off-label promotion on nine of its best-selling drugs, GSK was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.

Pfizer
With: Department of Justice
When: Jan. 26, 2009
Scoop: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion, the largest fine levied on our list, for off-label promotions of its COX-2 drugs. That settlement lowered the company’s 2008 net income by 90 percent.

Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Scoop: In the first Zyprexa settlement (and one of three on our list), the Department of Justice levied $1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.