Big Pharma Lawsuits – Who Got Hit with the Biggest Settlement?

October 25th, 2010. By LucyC

It seems that every month practically, one pharmaceutical company or another makes the news for bending rules around marketing. Mis-marketing, which could also be called consumer fraud, can  result in serious, if not life-changing consequences for people making decisions about their health. 

Recently, I came across a list of the largest settlements paid by 11 pharmaceutical companies for bending the rules. The fines total a staggering $6 billion. The more frequent offender, according to the company that compiled the list, is Eli Lilly. They paid more than $1.4 billion in fines all for various violations for just one drug—Zyprexa.  

And then there’s Pfizer, who paid $2.3 billion for ‘mis-marketing’ a number of drugs including Bextra, Geodon, Lyrica and Zyvox. 

These drugs are used to treat everything from schizophrenia to epilepsy to diabetes, and the consequences of not having the correct information may have resulted in serious adverse health events, possibly even death for some. 

Not surprisingly, people tend to be very interested when the big boys get caught behaving badly, for a variety of reasons, not the least of which being that we feel our trust has been betrayed. We trust drug companies, and the medical profession in general, to give us the straight goods because it’s a matter of life and death. Why would you not be straight about that? Well, the answer is, not surprisingly, money. And lots of it. But eventually the offenders do get caught. And that leads to drug lawsuits, criminal investigations and ultimately, very large fines. 

So, without further ado—here’s a list of the big offenders—who took them on, what for and how much they paid, with acknowledgement to FiercePharma.com who actually did the homework on this. 

Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: 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. (oh, and ps, Novartis is recruiting for a Senior Brand Manager for Prevacid…)

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

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The 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
Why: Elan received a $203.5 million fine for its marketing of Zonegran, an epilepsy drug.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why: Though J&J is most recently famous or a rash of 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
Why: In the same week as the J&J settlement, AstraZeneca was fined $520 million misleading doctors and patients about the safety of its antipsychotic drug Seroquel.  

Abbott
With: Twenty-three states
When: Jan. 7, 2010
Why: 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. (btw, Abbott Labs is the one who brought you beetle parts in Similac, causing the recent Similac recall…)

Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Why: A total of 13 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
Why: In another Zyprexa case, West Virginia Attorney General Darrell McGraw levied $2 billion in fines against Eli Lilly. In the end, the company agreed to $22.5 million in fines.

Merck
With: 35 states’ attorney offices
When: July 15, 2009
Why: Following a 35 state investigations into the Enhance study of Vytorin, Merck paid $5.4 million in fines, without admitting fault in the cases.

Sanofi-Aventis
With: Department of Justice
When: May 28, 2009
Why: In an agreement with the federal government, Sanofi paid $95.5 million total, to the federal government, 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
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (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
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.

Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Why: 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.

Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down. 

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner. 

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel. 

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy? 

Oh…my…God… 

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval. 

It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »

Asbestos Residents in Denial?

October 21st, 2010. By janem

The bid to buy the Jeffrey Mine in Asbestos, Quebec is the talk of the town. Apparently the mine owners, who are faced with bankruptcy, are close to sealing the deal with some interested Indian financiers. Trouble is, will the deal seal the fate of countless asbestos workers in India?

Hugues Grimard , the mayor of Asbestos, was harping on about how its asbestos won’t be dangerous if it is used properly on the CBC radio this morning. By ‘properly’,  I guess he means you must wear full-on safety gear, including respirators. Maybe he should take a trip to India and pay for asbestos awareness education and the cost of kitting out asbestos workers in safety equipment. And while he’s at it, stamp a few warning signs on those cargo boxes exporting the deadly cargo to India. To date, Canada is not legally obliged to do so.

Organizations worldwide–including health experts in India–want asbestos banned! (Read Ban Asbestos Network of India (BANI) letter to Quebec’s Chief Minister)

A resident of Asbestos was also interviewed on the radio show. The last thing she wants is the mine shut down because it is her family’s livelihood. She described growing up in Asbestos and how people would sweep asbestos fibers from the streets, how the kids used to make asbestos snowballs from the fibers with their bare hands. “I’m 62 years old and perfectly healthy,” she said. “My husband has been working the mine for years and he’s still alive and kicking—and I mean kicking,” she laughed. But she won’t be laughing if asbestosis or mesothelioma rears their ugly heads a decade or so from now (latency period typically takes 20-30 years.) She also claimed that she knows no one who has died from asbestos disease.

Try telling that to thousands upon thousands of asbestos victims. By 1984, 154 people had been killed from asbestos in Ontario, Quebec’s next-door neighbor. And about 454 asbestos victims were collecting workers’ compensation at that time. They worked at the John Manville Plant in Toronto (the name was later changed to Manville Corporation when lawsuits started to pour in, and thereby saved themselves millions of dollars at the expense of former workers). What’s going on with the workers at the Jeffrey mine—are they in denial? Have they been paid to keep quiet? OK, I’m not going into a conspiracy theory now but it makes you wonder…

Amazingly, Asbestos, Quebec had scheduled the Canadian Cancer Society’s (CCS) “Relay for Life”, a fund raising event to take place within the town’s streets—where asbestos fibers were swept up decades ago. Not surprisingly it was cancelled, apparently as a result of political differences arising between the town’s and the Canadian Cancer Society’s positions on the production of asbestos.

Meanwhile citizens of Asbestos are pressuring Quebec’s Premier, Jean Charest, for loans that will keep the floundering asbestos mine open but the CCS is urging Quebec’s Premier to “let [the mine] die.”

“Our mandate is really public health,” says a spokesmen for the CCS, André Beaulieu, “and right now, obviously, the community’s looking from an economic point of view and we understand.” How polite. Isn’t it about time Canadians rallied together and stormed the mayor’s office, barricaded the Jeffrey Mine?

Check out these videos from the CBC archives–where do I sign up to stop the Jeffrey Mine from churning out any more asbestos?

Asbestos News Roundup: 10.21.10

October 21st, 2010. By LucyC

A roundup of recent asbestos-related news and information that you should be aware of.

Veterans and Asbestos

Montpelier, VT: The federal government is implementing a plan to ensure that the state’s Veterans are not put at risk for mesothelioma and other asbestos-related illnesses. A $3.1 million grant from the Department of Veterans Affairs has been earmarked to help prevent mold and asbestos from contaminating the state’s Veterans’ Home in Bennington. 

The estimated cost of renovations to the aging building is $5 million, 65 percent of which will come from the VA. This grant is part of over $360 million the VA expects to spend helping Vermont’s 55,000 veterans this year. (wcax.com) 

Asbestos Law

Bloomfield, NM: Advantage Asphalt Seal & Coating LLC has been served with an administrative compliance order issued by the New Mexico Environment Department, in the amount of $817,000.

The company is facing allegations that it improperly handled, labeled, contained, transported and disposed of more than 1,000 cubic yards of material containing asbestos waste.

According to a report in the New Mexico Business Weekly, The Environment Department claims Advantage dumped the toxic waste at numerous sites, “including a dumpster at a high school, in a dumpster at another waste hauler’s operations yard, and on the ground at an auction yard in Bloomfield frequented by the public.”

In 2009, Advantage contracted with the city of Bloomfield to perform utilities work in the North Read the rest of this entry »

Job Alert: Novartis Seeks Sr. Brand Manager – Prevacid

October 21st, 2010. By AbiK

Need a job? If you’ve got 5+ years experience in CPG marketing with prior healthcare industry experience and knowledge of regulatory issues, well, get that resume submitted over at Novartis pronto! They’re apparently looking for a Senior Brand Manager for Prevacid—the prescription and OTC proton pump inhibitor med used to treat gastroesophogeal reflux disease (aka GERD).

No, I’m not getting a “finder’s fee”, though all donations gratefully received.

The interesting thing about such a job post, if you step back for a moment and really think about it, is what level of soul-searching goes into accepting the role of marketer for a big pharma drug? Does conscience even enter into the equation at any time?

It did for me a while back when I was recruited for a job at a pharma ad agency. The role entailed repositioning a contraceptive (manufacturer and brand need not be mentioned here). But here’s the thing—when I researched it, I found there were a number of adverse events Read the rest of this entry »