Pharmaceutical Drug Litigation Updates

Glaxo Settles Almost 25,000 Avandia Cases Under Mediation

Quoted from http://www.businessweek.com/news/2012-02-15/glaxo-settles-almost-25-000-avandia-cases-under-mediation.html

Glaxo Settles Almost 25,000 Avandia Cases Under Mediation

February 15, 2012, 12:46 AM EST

By Sophia Pearson

 

Feb. 14 (Bloomberg) -- GlaxoSmithKline Plc settled almost 25,000 cases over its Avandia diabetes drug in mediation as multidistrict litigation begins to wind down, lawyers told a federal judge in Philadelphia.

In November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiations. She also set a 75-day deadline to resolve 85 percent of the remaining cases. While it was unclear in a court hearing today whether lawyers met the threshold, Rufe called the effort “a major success.”

“Mediation will no longer be the focus of this court’s effort,” Rufe said. “We will resolve the remaining cases through litigation.”

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Glaxo Settles 20,000 Lawsuits Over Avandia, Lawyer Says

Quoted from http://www.businessweek.com/news/2012-02-01/glaxo-settles-20-000-lawsuits-over-avandia-lawyer-says.html

Glaxo Settles 20,000 Lawsuits Over Avandia, Lawyer Says

February 01, 2012, 3:16 PM EST

By Jef Feeley

 

Feb. 1 (Bloomberg) -- GlaxoSmithKline Plc, which is paying $3 billion to resolve government claims that it illegally marketed drugs such as the Avandia diabetes medication, agreed to settle more lawsuits over the pills, a lawyer said.

Glaxo, the U.K.’s biggest drugmaker, agreed last month to resolve more than 20,000 cases alleging Avandia causes heart attacks, said Paul Kiesel, a lawyer for former users. The accord, reached in court-ordered mediation, included a case that was set for trial in state court in Los Angeles, he said.

“We are pleased the mediation has successfully resulted in the settlement of a significant number of the remaining cases,” Kiesel, one of the lead lawyers for plaintiffs in the Avandia litigation, said yesterday in a telephone interview.

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Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

Quoted from http://www.bloomberg.com/news/2011-11-08/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1-.html

Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

By Jef Feeley - Nov 8, 2011 3:34 PM ET

GlaxoSmithKline Plc (GSK), which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication.

U.S. District Judge Cynthia Rufe said yesterday she appointed a mediator to “preside over settlement negotiations” for an unspecified number of Avandia cases consolidated before her in Philadelphia. Rufe set a 75-day deadline to resolve 85 percent of the remaining cases, according to court filings.

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Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

Quoted from http://www.bloomberg.com/news/2011-06-24/takeda-s-actos-glaxo-s-avandia-raise-risk-of-eye-disease.html

Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

By Elizabeth Lopatto - Jun 24, 2011 5:00 PM ET

Takeda Pharmaceutical Co.’s Actos, the world’s best-selling diabetes treatment, and GlaxoSmithKline Plc. (GSK)’s Avandia raise the risk of an eye disease that can lead to blindness, a study shows.

People taking the drugs have a 3 to 6 times increased risk of developing diabetic macular edema, a condition in which the retina thickens and swells, according to a study of more than 100,000 people to be presented Sunday at the American Diabetes Association’s annual meeting in San Diego.

Diabetic eye disease is the most common cause of blindness in working-age Americans, according to the National Eye Institute. Macular edema damages the retina and can eventually cause blindness. The best way to prevent the side-effect of diabetes is to keep blood sugar under control, according to the National Eye Institute.

“Patients at high risk of sight-threatening DME should avoid” the class of drugs including Actos and Avandia, the study authors, led by Richard Donnelly at the University of Nottingham, wrote in their study abstract. High-risk patients include those who have poor control of their blood sugar and those with a previous history of macular edema.

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Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies

Quoted from http://www.bloomberg.com/news/2011-05-18/glaxo-s-diabetes-drug-avandia-pulled-from-u-s-pharmacies.html

Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies

By Michelle Fay Cortez - May 18, 2011 5:45 PM ET

GlaxoSmithKline Plc (GSK)’s diabetes drug Avandia will be pulled from U.S. pharmacies in November and available only through a special program, the Food and Drug Administration said.

The restrictions are part of a risk mitigation strategy established in September with a medication guide to limit the use of Avandia after data suggested patients had a higher chance of heart attacks. The drug and combination therapies containing it will no longer be available in retail pharmacies starting Nov. 18, according to the FDA, which is requiring doctors and patients to enroll in a program to prescribe or take them.

Avandia, once the world’s best-selling diabetes bill at $3 billion in annual revenue, generated $680 million in sales last year for London-based Glaxo. About 460,500 patients filled a prescription for Avandia, Avandamet or Avandaryl at a retail pharmacy from January to October 2010, the FDA said in a safety announcement posted today on its website.

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Glaxo May Settle 1,000 More Lawsuits Over Avandia, Patients’ Lawyer Says

Quoted from http://www.bloomberg.com/news/2011-05-04/glaxo-is-poised-to-settle-about-1-000-suits-over-avandia-drug-lawyer-says.html

Glaxo May Settle 1,000 More Lawsuits Over Avandia, Patients’ Lawyer Says

By Jef Feeley - May 5, 2011 5:22 AM ET

GlaxoSmithKline Plc (GSK), after setting aside more than $6 billion to help settle lawsuits over medicines including its Avandia diabetes drug, is poised to resolve 1,000 more cases, a lawyer for patients said.

Glaxo, the U.K.’s biggest drugmaker, is in settlement talks with lawyers for an estimated 1,000 former Avandia users who sued the company in state courts in Pennsylvania, California and Illinois, Dianne Nast, a plaintiffs’ attorney who serves on a group helping to oversee cases consolidated in federal court in Philadelphia, said in an interview yesterday.

“There are a total of about 5,300 state-court cases pending” around the country, Nast told U.S. District Judge Cynthia Rufe at a hearing in Philadelphia. “I expect a multiple number of them probably will be resolved.” After the hearing, Nast declined to comment on the amount of any settlements.

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Suspended diabetes drug Avandia 'raises heart disease risk by a quarter'

Quoted from http://www.telegraph.co.uk/health/healthnews/8388096/Suspended-diabetes-drug-Avandia-raises-heart-disease-risk-by-a-quarter.html

Suspended diabetes drug Avandia 'raises heart disease risk by a quarter'

A diabetes drug which was used by at least 50,000 people in Britain increases the risk of heart disease while on it by almost a quarter and the risk of death by almost a sixth, according to research.

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• Widely-used diabetes drug 'increases risk of heart disease and death', warn experts

  21 Feb 2010

 

By Stephen Adams 6:30AM GMT 18 Mar 2011

A study of 810,000 people, published today online in the British Medical Journal, found that those taking Avandia were 23 per cent more likely to suffer congestive heart failure and 14 per cent more likely to die while on it, compared to a similar medication. In addition, they were 16 per cent more likely to have a heart attack.

Last September the European Medicines Agency (EMA) suspended the licence for the drug, after 10 years on the market, saying the evidence of its harmful effects had tipped the balance against it being prescribed.

Today's study is further evidence supporting that decision. It analysed the results of 16 separate studies in 810,000 patients, of which 429,000 were on Avandia (also known by its generic name rosiglitazone) and 381,000 were on Actos (also known as pioglitazone). Most were over 60.

The drugs both belong to a class that help control blood sugar levels in patients with Type 2 diabetes.

It found that Avandia could have led to an extra 431 deaths per 100,000 people on Avandia, an extra 170 heart attacks and an extra 649 cases of heart failure.

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Glaxo Said to Pay $250 Million to Resolve Avandia Suits

Quoted from http://www.businessweek.com/news/2011-02-07/glaxo-said-to-pay-250-million-to-resolve-avandia-suits-update1.html

Glaxo Said to Pay $250 Million to Resolve Avandia Suits

February 07, 2011, 12:52 PM EST

By Jef Feeley

Feb. 7 (Bloomberg) -- GlaxoSmithKline Plc agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia diabetes drug and avoid the first trial over claims it can kill users, two people familiar with the accords said.

Glaxo, the U.K.’s biggest drugmaker, agreed to settle the lawsuits claiming the drug causes heart attacks and strokes for an average of at least $46,000 each, said the people, who declined to be identified because they weren’t authorized to speak publicly.

The accords included a previously reported settlement of an undisclosed amount for the family of James Burford, an Avandia user who died in 2006. The Burford family’s case, filed in federal court in Philadelphia, was set for trial last week.

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GlaxoSmithKline Settles Avandia Heart Attack Death Litigation on Trial Eve

Quoted from http://www.bloomberg.com/news/2011-01-31/glaxosmithkline-settles-suit-on-avandia-diabetes-drug-heart-attack-death.html

GlaxoSmithKline Settles Avandia Heart Attack Death Litigation on Trial Eve

By Jef Feeley - Jan 31, 2011 12:22 PM ET

GlaxoSmithKline Plc said it settled on the eve of trial a lawsuit alleging its Avandia diabetes drug caused a North Carolina man to die of a heart attack, avoiding a jury determination over risks associated with the medicine.

The U.K.’s biggest drugmaker resolved the suit by the family of James Burford, an Avandia user who died in 2006. The company declined to provide details of the accord’s terms. The resolution eliminates the risk Glaxo would face a large jury award, said Navid Malik, a drug-industry analyst at Matrix Corporate Capital in London.

Investors worried it “could lead to substantial punitive damages,” Malik said in a Jan. 25 interview. The company has already agreed to pay almost half a billion dollars to resolve claims it hid the drug’s health risks. “GSK needs to successfully settle as many of these cases as possible.”

The lawsuit, scheduled for trial this week in Philadelphia federal court, was the first of 2,000 heading to court alleging London-based Glaxo hid Avandia’s health risks. Regulators in Europe had the drug withdrawn from the market and U.S. sales were limited because of heart attack risks. Glaxo had also said it was setting aside money to address federal prosecutor probes of its marketing of at least nine drugs, including Avandia.

Mary Anne Rhyne, a U.S.-based spokeswoman for Glaxo, said in an e-mailed statement yesterday that the company settled the Burford case to avoid the risks and costs of litigation.

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In Avandia Case, Motion Hearing Delayed as Attorneys Huddle With Judge

Quoted from http://thelegalintelligencer.typepad.com/tli/2011/01/in-avandia-case-motion-hearing-delayed-as-attorneys-huddle-with-judge.html

 

In Avandia Case, Motion Hearing Delayed as Attorneys Huddle With Judge

By Shannon P. Duffy
U.S. Courthouse Correspondent

Monday, January 24, 2011

Global settlement talks just might be underway in the massive federal multi-district litigation of thousands of products liability suits filed by diabetics who took the drug Avandia, but for now the lawyers are saying nothing.

On Monday, a team of defense lawyers for GlaxoSmithKline and the lead plaintiffs lawyers in the MDL assembled in the courtroom of U.S. District Judge Cynthia M. Rufe for a final round of pretrial hearings.

Rufe was expected to hear arguments about how to conduct the first “bellwether” trial, and court records show that the lawyers were arguing over whether to empanel an “advisory” jury that would focus only on causation.

But those hearings never took place.

Instead, throughout the morning and most of the afternoon, a sizable group of spectators waited in the courtroom for the hearings to begin only to watch groups of lawyers shuttling back and forth between Rufe’s chambers and private conference rooms.

Rufe was on the bench only briefly for a few minutes in the morning and again at the end of the day when she announced that she was continuing the proceedings until next Monday.

GSK said earlier this month that it expects to record a legal charge of $3.4 billion for the fourth quarter of 2010, primarily related to Avandia. The company said the charge is related primarily to the investigation by the U.S. Attorney's Office for the District of Colorado into the sales and promotional practices of Avandia, as well as Avandia products liability cases.