Posts Tagged ‘ GlaxoSmithKline ’

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.

Tags: Abbott Labs, Allergan, Bextra, Big Pharma, Botox, Celexa, Diovan, Drugs, Eil Lilly, Elan, Exforge, Forest Labs, Geodon, GlaxoSmithKline, GSK, J&J, Johnson & Johnson, Lilly, Lyrica, Merck, Novartis, Pfizer, Sandostatin, Sanofi Aventis, Seroquel, Tekturna, TriCor, Vytorin, Zelnorm, Zonegran, Zyprexa, Zyvox
Posted in Drugs/Medical | 3 Comments »

Avandia Study Conflicts – and Conflicts of Interest?

June 30th, 2010. By AbiK

So after the latest two Avandia studies came out earlier this week, we then see a third Avandia study—this one will also be debating fodder for the advisory panels at the FDA’s July meeting—the one that will determine Avandia‘s fate. The study was presented late Monday at the American Diabetes Association’s annual meeting by Dr. Richard Bach, associate professor of medicine at Washington University School of Medicine in St. Louis.

Here’s the thing though—the fist two studies basically added a few nails in Avandia’s ever-growing coffin. But this latest study to hit the airwaves actually digresses from the previous two in its findings—it states that there is no increased risk of heart attack, stroke or death associated with taking Avandia.

Hmm. Doesn’t that just make things a little…less definitive?

However, upon looking more deeply into this third study, some things about it just sort of pop out. For example, according to an article from healthfinder.gov, this third study if of a smaller sample size: 2,400 patients—compared to over 35,000 from the study done at the Cleveland Clinic.

There’s more..

• The third study was funded by the National Institutes of Health (NIH). Oh, and GlaxoSmithKline (GSK). Oh, and if you recall, GSK just happens to make Avandia. Conflict of interest? (just asking).
• While death, heart attack and stroke incidence rates were apparently 28 percent lower in the third study for those taking Avandia vs. those not taking a thiazolidinedione (TZD) medication, congestive heart failure was higher—just not at a rate “considered significant”. What was significant was a 45 percent increase in risk of fractures for those who took Avandia. (Ok—not heart-related, but 45 percent sounds more than significant to me).
• Apparently the ages of the participants in the third study were lower than that of the other studies. Translation: the other studies’ participants may have been more frail. Two things here: first, I don’t care what ages folks are who are affected by a drug–everyone’s well-being matters. So if an older population is more adversely affected, they’re still adversely affected. And second, so the tests are not comparing apples to apples–which should detract from the ability to make comparisons and draw conclusions.

Hard to say where the FDA advisory panel will net out in July. Will we still see Avandia on the market? Stay tuned.

Tags: Avandia, Glaxo, GlaxoSmithKline, GSK
Posted in Drugs/Medical | No Comments »

7 Game-Changing Settlements of 2009

December 15th, 2009. By Kristine B

We’re in the countdown to year-end and looking over some of the more impactful settlements LawyersAndSettlements.com has covered over the past year. When we’re talking impactful, everyone around here has an opinion—so we had to throw in some criteria. To get the nod for impact, a settlement had to be one of two things: 1. High dollar value; or 2. Precedent-setting—or at least have the potential to influence similar cases to follow. (Sounds simple, but you try getting Stephen, John, Jaime, Michelle and Ben to settle in on just 7 settlements with just those criteria…) So here we go…7 game-changing settlements for ’09…

1) Family takes on GlaxoSmithKline  

Michelle David filed a lawsuit against GlaxoSmithKline, alleging the company’s antidepressant, Paxil was responsible for her son’s birth defects. David said she had taken Paxil while pregnant and was not aware of the potential side effects. GlaxoSmithKline said that birth defects occur in between three and five percent of all live births, regardless of Paxil use. 

A jury found, in a 10-2 decision, that GlaxoSmithKline’s officials were negligent in failing to warn David’s doctor about the risks of Paxil. The jury also found that Paxil was a factual cause of the little boy’s heart problems. David was awarded $2.5 million.

Why it’s impactful:There are 600 or so lawsuits alleging Paxil caused birth defects waiting in Read the rest of this entry »

Tags: Asbestos, Eli Lilly, GlaxoSmithKline, Philip Morris, Wal-Mart, Wyeth
Posted in Settlement | No Comments »

Avandia and Alzheimer’s…What If?

September 24th, 2009. By LucyC

So here’s an interesting twist. Avandia, also known as rosiglitazone, once GlaxoSmithKline’s (GSK) blockbuster diabetes drug that turned out to be not so good for you after all, has failed to prove benefit in clinical trials as a treatment for Alzheimer’s disease. 

Why was GSK testing Avandia in Alzheimer’s, you ask? Well, sales of Avandia plummeted after the now infamous Nissen study was published in 2007 showing a link between the diabetes medication and heart attacks. In fact, one source puts 2008 sales down by 40 percent from 2007. So, GSK was looking for a new indication that would generate some cash—up to $300 million one estimate suggests. 

So GSK must look for new ailments for Avandia. After all—product recycling applies to the pharmaceutical industry just as it does in other industries. 

But what if Avandia had proven beneficial in treating Alzheimer’s—whatever ‘beneficial’ was defined as being? It is unlikely that the risk for heart attack would have disappeared or not been an issue in this population. So I find myself wondering about the ethics of testing a drug with an established link to potentially fatal adverse events, such as heart attack, in a population that may not be able to articulate their health problems. Not only that, had Avandia made the grade, would the FDA have approved the indication, despite the health risks? 

Perhaps the most worrying element of all this is why Avandia is being tested at all for any additional indications, when there are very real concerns about it remaining on the market in the first place.

Tags: Avandia, Glaxo, GlaxoSmithKline
Posted in Drugs/Medical | No Comments »

Rally in Denver for Ten Year Anniversary of Columbine

April 14th, 2009. By Evelyn Pringle

Ten years ago this month the violence and suicide caused by SSRI antidepressants gained international recognition in headlines all over the world when it became known that one of the teen shooters at the Columbine massacre, Eric Harris, had taken Zoloft in the past and was on Luvox at the time of the murder-suicide spree. Read the rest of this entry »

Tags: Columbine, GlaxoSmithKline, Luvox, paxil, Prozac, suicide, Zoloft
Posted in Emerging Issues | 3 Comments »