(Avandia-Side-Effects-Video News) Sat, 31 Jan 2015 09:37:58 -0500 Sat, 31 Jan 2015 09:37:58 -0500 pixel-app en Glaxo Reaches Record $3 Billion Settlement to Resolve Paxil, Wellbutrin and Avandia Fraud Charges Tue, 03 Jul 2012 00:00:00 -0400 GlaxoSmithKline has agreed to pay a record settlement to resolve charges that it illegally marketed some of its drugs, including Paxil and Wellbutrin.  The $3 billion settlement with the U. S. Justice Department will also resolve charges that Glaxo failed to report important safety data to the U.S. Food & Drug Administration (FDA) about its diabetes drug Avandia.

According to the Justice Department, the $3 billion Glaxo settlement constitutes the largest healthcare-fraud settlement in U.S. history.

"Today's multibillion-dollar settlement is unprecedented in both scope and size. It underscores this administration's firm commitment to protecting the American people and holding accountable those who commit healthcare fraud," James Cole, U.S. deputy attorney general, said at a news conference in Washington, D.C.

According to a statement from the Justice Department, Glaxo agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia.  Under the terms of the plea agreement, the company will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.  The guilty plea and penalties must still be approved by the U.S. District Court. 

Glaxo has also agreed to pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states.   The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations, the Justice Department said.

The government had charged that Glaxo marketed Paxil to patients under 18, even though the FDA had not approved Paxil for use in children.  It further charged that the company promoted off-label uses of Wellbutrin, including for weight-loss and for the treatment of sexual dysfunction and substance abuse addictions.  According to the government, Glaxo paid doctors millions of dollars to promote these unapproved uses of Wellbutrin.

According to a report published by The Los Angeles Times, this is just the latest in a string of large settlements the Justice Department has reached with big pharmaceutical companies for illegally marketing their drugs.  In 2009, Pfizer plead guilty and agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including its now-recalled painkiller, Bextra; the anti-psychotic Geodon; and its anti-epileptic, Lyrica.  In 2009, Eli Lilly & Co. also agreed to pleaded guilty to a federal misdemeanor charge and pay $1.42 billion for unapproved uses of its schizophrenia drug Zyprexa.

Diabetic Macular Edema a Possible Avandia, Actos Side Effect Tue, 12 Jun 2012 00:00:00 -0400 A new study is raising more concerns about the possible side effects of thiazolidinediones, a group of drugs that includes Actos and Avandia.   The study, published in the Archives of Internal Medicine, found that type 2 diabetes who took either Actos or Avandia faced a higher risk of developing an eye disorder called macular edema compared to patients who did not take the drugs.

The study followed more than 100,000 people for a decade with type 2 diabetes who were listed in a U.K. database.  None of the patients had macular edema at the start of the study.  Just over 3,200 were using either Actos or Avandia. 

After one year, 1.3 percent of patients taking thiazolidinedione developed diabetic macular edema, compared with 0.2 percent of those not taking the drugs. The risk stayed the same whether patients were taking either Avandia or Actos.  When either drug was used with insulin, the risk increased to 4.4-fold.

The Archives of Internal Medicine study is the largest to ever investigate a possible connection between Actos or Avandia and macular edema. 

"Clinicians should be vigilant in the clinical screening for diabetic macular edema among those patients taking thiazolidinediones," the study authors wrote.

They advised that type 2 diabetics treated with Actos or Avandia have their vision checked on a regular basis, especially if they are using insulin or have pre-existing vision problems.   The study authors also called for additional studies to determine if thiazolidnenones cause diabetic macular edema.

Settlements Reported in 20,000 Avandia Heart Attack Lawwsuits Thu, 02 Feb 2012 00:00:00 -0500 GlaxoSmithKline has reportedly agreed to settle more than 20,000 Avandia heart attack lawsuits, according to a report from Bloomberg News.  The agreement to settle the Avandia lawsuits was reached in court-ordered mediation and comes just months after Glaxo said it would pay $3 billion to settle U.S. criminal and civil probes into whether it illegally marketed Avandia and other medications. 

Since November 2007, Avandia's U.S. label has included a black box warning detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increase in the risk of cardiovascular disease. Since 2007, more evidence of Avandia's heart risks has accumulated. Last year, the U.S. Food & Drug Administration (FDA) placed severe restrictions on sales of Avandia, after determining its heart risks outweighed its benefits.

The controversy surrounding Avandia sparked thousands of product liability lawsuits.  Previously, Glaxo had agreed to pay over $700 million to settle over 15,000 patient claims that Avandia caused heart attacks and strokes.  In November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiations for an unspecified number of Avandia cases that were consolidated before her in Philadelphia, and imposed a deadline for settling 75 percent of cases.  More than 2,500 cases are pending before Judge Rufe, Bloomberg said, while others have been filed in state courts around the country.

Now, a plaintiffs' attorney involved in that litigation has told Bloomberg that Glaxo has reached an agreement to settle 20,000 Avandia lawsuits.  However, it is still unclear if enough cases have been settled to meet the deadline.  If Judge Rufe's directive isn't been met by the deadline, she's promised to start scheduling cases for trial.

In a statement emailed to Bloomberg yesterday, a Glaxo spokesperson said the most-recent settlements of Avandia patients’ suits “are covered by existing provisions and those payments will be funded through existing cash resources.”

Avandia Side Effects, Heart Attack Lawsuit | Diabetes, Defective Drug | GlaxoSmithKline Thu, 02 Feb 2012 00:00:00 -0500 Avandia Side Effect linked to Heart Attacks

The diabetes drug, Avandia has been found to have side effects that may cause heart attacks in patients. Lawsuits are arising from the recall of the defective drug's side effects, if you have taken Avandia and suffered a heart attack, contact us now.

Contact Daniel Burke, attorney at the personal injury law firm of Parker Waichman LLP now or call us at 1-800-YOURLAWYER (1-800-968-7529) to see how we can protect your legal rights.