Posts Tagged ‘ GlaxoSmithKline ’

Whistle while you Work? Sad Reality in American Business

November 2nd, 2010. By Hunter West

Anyone who is aghast at the recent $750 million GlaxoSmithKline (Glaxo) whistleblower judgment to settle manufacturing deficiencies at a former plant in Puerto Rico shouldn’t be surprised that such things are going on. Happens all the time, it seems. And not just to Glaxo, either.

In actual fact, that $750 million—of which the whistleblower earns a share of the penalty totaling a whopping $96 million—pales in comparison to the $3.1 billion that the US Department of Justice has recovered under the federal False Claims Act so far in just this fiscal year alone.

Last year the haul was almost twice that—$5.6 billion.

Some will say that the whistleblower is an opportunist hoping for a big payday in the end, and will take any amount of criticism and crap en route to the pot at the end of the rainbow. Hell, I’d put up with a lot of grief to collect $96 million.

I would even eat liver.

But to those who view whistleblowers as ambulance chasers, consider the amount of fraud and wrongdoing that serves as a persistent blight on the business landscape. Somebody has to expose such misdeeds—and if the government can’t route out the evil-doers (sorry ‘W’…) on their own, then they have to provide incentive for those who can.

We would all wish that whistleblowers were not necessary. In a perfect world every business and corporate entity would operate with integrity and play by the rules.

Sadly, that’s not the case.

According to Taxpayers Against Fraud, a not-for-profit that supports whistleblower lawsuits, Read the rest of this entry »

Tags: Avandia, Eckard, GlaxoSmithKline, GSK, paxil, Qui Tam, Whistleblower
Posted in Whistleblower | 5518No Comments »2010-11-02+13%3A39%3A50Hunter+West

Week Adjourned: 10.29.10

October 29th, 2010. By LucyC

Top Class Actions

What’s the word de jour? Foreclosure—actually—make that Foreclosure Class Actions. This week saw several foreclosure lawsuits filed against big banks. Possibly the most recent, was filed against BAC Home Loans Servicing, which is a subsidiary of Bank of America Corporation, and successor in interest to Countrywide Home Loans Servicing; Deutsche Bank National Trust Company; and U.S. Bank National Association. The suit was filed on behalf of all those property owners who lost title to their property in foreclosure proceedings based on false and perjurious affidavits filed by the banks and their servicing companies.

Perjurious affidavits? What the heck are those, you ask? Well like everything, foreclosure is a business—a business that seemingly works on volume. Apparently, the banks have been hiring so-called “robo signers” or “affidavit slaves”—employees who literally sign hundreds of foreclosure documents a day, according to the Wall Street Journal, without carefully reviewing their contents. The Washington Post recently ran a story on a man who has signed as many as 10,000 foreclosure documents in one month.

Back to the lawsuit. The BAC suit alleges that the defendant banks obtained wrongful foreclosures by abusing the court process and submitting affidavits that were false, even though sworn to under penalty of perjury, as the basis for obtaining foreclosure judgments. They seek to restore title to the property owners.

Another foreclosure class action filed this week also named the omnipresent Bank of America (BoFA) as a defendant, not surprising since BoFA reportedly holds one in five mortgages in the Read the rest of this entry »

Tags: BAC Home Loans Servicing, Bank of America, Countrywide Home Loans, Deutsche Bank, Foreclosure, GlaxoSmithKline, GSK, Verizon Wireless
Posted in Week Adjourned | 5513No Comments »Week+Adjourned%3A+10.29.102010-10-29+20%3A58%3A28LucyC

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 | 5310No Comments »2010-10-25+12%3A33%3A39LucyC

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 | 4272No Comments »2010-06-30+22%3A45%3A51AbiK

Week Adjourned: 5.14.10

May 14th, 2010. By LucyC

gentiva logo2 Week Adjourned: 5.14.10 This week it’s all about bad employers and bad drugs…bad, bad, bad!

Top Class Actions

Whole New Meaning to Visitation Rights. A massive, nationwide class action lawsuit was filed this week by employees of one the largest healthcare service providers in the country—Gentiva Health Services, Inc. The employees are claiming the company violated the Fair Labor Standards Act (FLSA).

Apparently, Gentiva—which incidentally employs some 30,000 health care workers—treats visiting nurses and other health care providers as exempt from the overtime requirements of the FLSA and refuses to pay these employees for all hours worked. Sound familiar?

Instead, Gentiva pays nurses and other health care providers on a “per visit” basis for some work, an hourly rate for other work, and fails to pay anything at all for other hours worked. Plaintiffs allege that Gentiva’s rather creative take on employee compensation doesn’t quite meet the requirements of state or federal wage and hour law.

The lawsuit, if approved, seeks to represent all current and former Gentiva employees, including registered nurses, therapists, and other health care providers who are or were not paid for all hours worked.

You know these guys may end up rivalling Wal-Mart….