Posts Tagged ‘ GSK ’

Whistleblower Lawsuit Pays Off Big For Former GSK Employee

November 22nd, 2010. By Kristine B

Talk about your big payouts. A woman who acted as a whistleblower against GlaxoSmithKline will receive a whopping $96 million for her role in bringing the company to justice. Who knows, maybe eventually an Erin Brockovich-style movie will be made about her, too. This week, Pleading Ignorance looks into the story behind the whistleblower who helped officials in their case against GlaxoSmithKline—and what qui tam is all about.

The woman who acted as whistleblower in this case was Cheryl Eckard, who worked at GlaxoSmithKline from 1992 through 2003. When she was asked to visit the now-closed plant at Cidra, Puerto Rico, following citations for violations at the plant, Eckard was a manager of global quality assurance for GlaxoSmithKline.

According to The Wall Street Journal (10/28/10), Eckard found massive problems at the Cidra plant, leading her to make recommendations to her superiors about how to fix things up. Those recommendations included to stop shipping all products from the plant and to notify the FDA about product problems, such as problems where drugs of different types were mixed up in the same bottle.

But, according to the lawsuit, Eckard’s superiors ignored her, leading to her eventually telling them she would not be part of a cover-up. In 2003, Eckard was reportedly fired. Despite the firing, she says she continued to try to convince GlaxoSmithKline to make changes to the Cidra plant. It’s a screenplay waiting to happen: Woman sent to investigate plant, woman makes recommendations, woman is fired after following up on recommendations, woman is repeatedly ignored, woman files lawsuit against large corporation…

Eventually, Eckard called the FDA, which led to the FDA investigation. Meanwhile, Eckard filed a lawsuit against GlaxoSmithKline under the US False Claims Act. Then, in 2010, GlaxoSmithKline agreed to pay $750 million to settle charges of allowing adulterated drugs onto the market. Of that, Eckard will receive $96 million, reportedly the largest award given to a single whistleblower in US history.

A provision of the False Claims Act, also known as the Qui Tam Statute, allows private citizens to sue a person or company that knowingly submits false bills to the federal government. Although the qui tam lawsuit is filed by a private citizen, it is done on behalf of the federal government. Furthermore, it protects plaintiffs who are demoted, suspended or discriminated against because they have filed a claim under the False Claims Act. If a qui tam suit is successful, as was the case here, the whistleblower is entitled to between 15 and 30 percent of the money the government recovers. The whistleblower is also eligible for between $5,000 and $10,000 per false claim.

A lawsuit filed under the False Claims Act is first served on the government and is not served on the defendant until the court orders it be served. The whistleblower is not allowed to discuss the lawsuit while the government investigates the allegations detailed in the complaint.

The sad thing is that if GlaxoSmithKline had done the right thing from the start and listened to Eckard’s concerns, the lawsuit could have been avoided. Unfortunately, many companies see little or no benefit in doing the right thing, until doing the wrong thing costs them a lot of money.

Pleading Ignorance cheers Ms. Eckard, who continued to fight to ensure the right thing was done, even when it meant she lost her job. Sometimes, good things happen to people who fight for them.

Tags: GlaxoSmithKline, GSK, Qui Tam Lawsuit, Whistleblower
Posted in Emerging Issues, Pleading Ignorance, Whistleblower | 57721 Comment »2010-11-22+19%3A22%3A42Kristine+B

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

Is Your Doctor Getting Cash from Big Pharma? Find Out

October 20th, 2010. By AbiK

It’s been a good year for Dr. Firhaad Ismail. Indeed! Financially speaking, that is. See, according to the info over at ProPublica, in their Dollars for Docs report, Dr. Ismail took in no less than $303,558 from big pharmaceutical companies GlaxoSmithKline (GSK…the folks who brought you Avandia and Paxil), Eli LIlly, and Merck.

Now, Dr. Ismail is just one of 384 doctors nationwide who’ve received payment from big pharma. Ismail is based in Vegas (clearly, if ProPublica’s involved, what goes on in Vegas is not staying in Vegas) and his specialty is Endocrinology and Metabolism. And he appears to do a fair amount of consulting on the topic. On big pharma’s dime.

Dr. Ismail may be the best damn doctor there is in his specialty. I don’t know. But what I do know is that the ProPublica report indicates that Dr. Ismail received a total of $209,400 from GSK alone. Recall what area of practice Dr. Ismail is in…Endocrinology. What does Endocrinology deal with? Well, diabetes for one. And last I checked, Avandia is a type 2 diabetes drug made by GSK.

I’m just putting on the table what’s already out there. I’m not saying there’s any unsavory relationship here…but I the jaded skeptic in me does raise a little eyebrow…

Needless to say, I’ve been checking out my own doctors over at ProPublica.com. You can, too. Just hop over to Dollars for Docs and do a search for your doctor’s name, by state. You can also find a full list there of all the doctors nationwide.

Let us know what you find…and if you think doctors receiving funds from big pharma presents a conflict of interest.

Tags: Dollars for Docs, Dr. Firhaad Ismail, Eli Lilly, GSK, Merck, ProPublica
Posted in Drugs/Medical | 5290No Comments »2010-10-20+12%3A25%3A27AbiK