Part 2 in a series of guest blogs about pharmaceutical litigation and medical devices

from James McHugh Jr., Esq.
Lopez McHugh LLP, Attorneys and Counselors at Law

In 2006, Glaxo recalled Paxil, an antidepressant, because some of the pills lacked an active ingredient—meaning the pills were useless.  Problem is, Glaxo did not bother to warn patients who might have been taking them, even though abruptly stopping the drug can lead to thoughts of suicide; many patients were successful.  And this was even after the FDA seized some lots of Paxil in 2005 for the very same reason.[1] But hey, they managed to sell $11.7 billion worth of the drug in the U.S. alone, so they still turned a profit.[2]

In July 2010, the FDA held hearings concerning the diabetes drug Avandia. The FDA accused Glaxo of repeatedly submitting sloppy data and failing to follow up on reports of problems among patients, including stroke and premature death.  Glaxo had ignored (or covered up) this information even though the drug had been on the market since 1999.[3]

Today’s corporate bigwigs have no reason to care what happens to the end users of their products, because they rarely face civil or criminal penalties.  Obviously, it is more difficult to impose criminal liability on a large corporation when the decision making process is divided among a number of individuals.

CEOs don’t even have to worry about angering their own shareholders.  So what if the company will wind up having to pay millions of dollars years from now?  The president of Evil Drugs, Inc. isn’t planning on sticking around that long.  He’ll make his millions, then at the first opportunity jump ship to another corporation.  Corporate America just keeps putting the same people in charge.  That’s why, after the recent government bailouts of the banks, the same people who put us in the mess in the first place wound up keeping their jobs.  Evil protects itself.

Federal and state attorneys general should consider more criminal litigation; the FDA has recently indicated a desire to prosecute corporate executives at drug companies that repeatedly violate good manufacturing practices.[4] In the meantime, as there is no real potential for criminal punishment, our civil system is really the last line of defense against corporate America.

We do our part to bring some form of justice to the system, but let’s face it: the best we can do is provide for our clients’ needs, provide for their families, and hope that one day big pharma will finally stop putting profit motive before patient safety.

Learn more about unsafe drugs like Avandia and Fosamax or faulty medical devices such as Medtronic defibrillator leads at LegalView.

[1] Justin Blum, David Voreacos and Andrew Harris. Glaxo Agrees to Pay $750 Million to Settle Defective Drug Suit.  The Bloomberg News. Oct 27, 2010

[2] Jef Feeley and Margaret Cronin Fisk. “Glaxo Said to Have Paid $1 Billion in Paxil Suits.”  The Bloomberg News. December 14, 2009.

[3] CNN Wire Staff, “FDA researcher blasts manufacturer’s tests on diabetes drug.” July 12, 2010.

[4] Parija Kavilanz , “Recall fallout: FDA puts execs on notice.” CNN Money, August 24, 2010.

Swiss researchers recently concluded that Avandia, a type 2 diabetes drug, nearly doubles the chances of osteoporosis and bone fracture among patients who take the drug and is increased for patients taking the drug for more than a year. The results of the study come on heels of controversy surrounding the drug’s link to increased heart disease and various studies warning of potential risks related to bone degradation.

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The U.S. Food and Drug Administration recently voted to keep Avandia on the market. Avandia is a drug manufactured by GlaxoSmithKline and it is used to treat type 2 diabetes. However, though the news would seem positive for GlaxoSmithKline, the FDA’s treatment of the situation has called into question the FDA’s ability to manage situations such as these and the review likely will damage Avandia sales.

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A U.S. Food and Drug Administration panel has concluded that diabetes patients taking the drug Avandia to treat their condition have a greater risk of heart attack than those taking other drugs to treat their conditions. While the panel did not advise removing the drug from the market, they did say that Avandia needs a stricter warning on its label.
Warning Label Urged for Avandia

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The side effects noted by patients taking diabetes drug Avandia tripled in the months after a study linked the drug to increased rates of heart attacks. A report from the U.S. Food and Drug Administration says: “In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped… Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet.”
Reports of Avandia-Related Heart Attacks Jump, Highlight Flawed FDA Monitoring

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A class action lawsuit has been filed against GlaxoSmithKline, saying that the drug company did not do enough to alert those taking the drug of the drug’s risk. The lawsuit was filed at the Court of Queen’s Bench in Regina on the behalf of a 75-year-old woman who died in May after having taken Avandia.
Class Action Suit Launched Over Avandia

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A memorandum acquired by the Senate Finance Committee shows that Food and Drug Administration knew that there were dangerous side effects associated with GlaxoSmithKline drug Avandia. The memo shows that Dr. David Ross, a FDA reviewer, recommended that there be a highlighted boxed warning on Avandia packaging about an increased risk of CHF. CHF is a life-threatening condition that occurs when fluid builds in the lungs and causes a shortness of breath.
FDA Gave Glaxo Extra Year to Profit Off Avandia(more…)

The U.S. Food and Drug Administration decided this week that GlaxoSmithKline’s diabetes drug Avandia shall remain on the market, but will carry more warnings on its label. Avandia recently was linked to increased heart and kidney problems in those who take the drug to manage their diabetes. Shares of GlaxoSmithKline had their biggest gain in two years after the FDA advisory panel decided not to withdraw Avandia from the market.
Glaxo Avandia FDA Adversity Fuels Doubts of Comeback

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A month after a study found a possible link between heart attacks and GlaxoSmithKline’s diabetes drug Avandia, the number of reported side effects tripled. Dr. Ronald Goldberg from the University of Miami Diabetes Research Institute says that diabetes patients are excited to switch medications. Goldberg says that when he explains the risks possibly associated with Avandia to patients, they “tend to feel more comfortable going off to a different medicine, a different oral medicine.”
Popular Diabetes Drug May Cause Heart Problems

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A majority of the recent federal drug panel has voted to keep Avandia on the market. Data from recent studies have linked Avandia to increased risk of heart and kidney problems. The panel advises that Avandia remain on the market, but with more warnings on its labeling.
Is Avandia Safe? Depends Who You Talk To?

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