Pharmaceutical Drug Litigation Updates

AstraZeneca Resolves Most Seroquel Suits for $647 Million

Quoted from http://www.businessweek.com/news/2011-07-28/astrazeneca-resolves-most-seroquel-suits-for-647-million.html

AstraZeneca Resolves Most Seroquel Suits for $647 Million

July 28, 2011, 4:46 AM EDT

By Jef Feeley

July 28 (Bloomberg) -- AstraZeneca Plc has settled almost all lawsuits that claimed its antipsychotic drug Seroquel causes diabetes in some users for a total of $647 million.

AstraZeneca, the U.K.’s second-biggest drugmaker, has set aside the $647 million to resolve 28,461 suits alleging it knew Seroquel could cause diabetes in some users, the company said in its second-quarter earnings report. The settlements provide an average payout of more than $20,000 per case.

AstraZeneca’s ability to settle the Seroquel liability for less than $1 billion “may well be a positive surprise for investors,” Les Funtleyder, a health strategist and portfolio manager at Miller Tabak & Co. in New York, said in a telephone interview. “That’s a real bargain when you look at what competitors such as Lilly have paid in settlements over a similar drug.”

Eli Lilly & Co, maker of the antipsychotic drug Zyprexa, has paid at least $1.2 billion to resolve lawsuits alleging the drug caused diabetes in some users. That’s on top of $1.42 billion in fines the drugmaker paid the U.S. government to resolve claims that it illegally marketed Zyprexa.

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Heart Warning Added to Label on Popular Antipsychotic Drug

Quoted from http://www.nytimes.com/2011/07/19/health/19drug.html

Heart Warning Added to Label on Popular Antipsychotic Drug

By DUFF WILSON

Published: July 18, 2011

AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.

 

The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.

Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.

Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.

The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.

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AstraZeneca Said to Pay $150 Million to Settle Additional Seroquel Suits

Quoted from http://www.bloomberg.com/news/2010-09-01/astrazeneca-won-t-face-immediate-trials-of-seroquel-cases-amid-mediation.html

AstraZeneca Said to Pay $150 Million to Settle Additional Seroquel Suits

By Jef Feeley - Feb 17, 2011 1:24 AM ET

 

AstraZeneca Plc agreed to pay $150 million to settle more lawsuits claiming its antipsychotic drug Seroquel causes diabetes, pushing the amount the drugmaker has paid to resolve cases over the medicine to almost $350 million, people familiar with the accords said.

AstraZeneca, the U.K.’s second-biggest drugmaker, will resolve about 6,000 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, two people familiar with the settlements said. They spoke on the condition of anonymity because they weren’t authorized to speak publicly about the accords. The cases settled for an average of about $25,000, the people said.

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UK study links antipsychotic drugs to clot risk

Quoted from http://www.reuters.com/article/idCNLDE68K0XS20100921

UK study links antipsychotic drugs to clot risk

Tue Sep 21, 2010 7:01pm EDT

 

By Ben Hirschler

LONDON, Sept 22 (Reuters) - Modern antipsychotic drugs, especially AstraZeneca's (AZN.L) blockbuster Seroquel, may increase the risk of patients developing life-threatening blood clots, British researchers said on Wednesday.

The finding, from a trawl of tens of thousands of patient records, adds to a growing body of evidence linking so-called atypical antipsychotics to adverse side effects.

Atypicals -- which also include Eli Lilly's (LLY.N) Zyprexa, Johnson & Johnson's (JNJ.N) Risperdal and Bristol-Myers Squibb's (BMY.N) Abilify -- dominate the antipsychotic market, which had sales of $16 billion in 2009, according to Thomson Reuters data.

First introduced more than 20 years ago, such drugs cause fewer of the involuntary-movement problems associated with older medicines but have been linked to diabetes and increased mortality in people with dementia.

There has also been limited evidence linking them with dangerous blood clots, such as deep vein thrombosis and pulmonary embolism, although previous studies have been small.

The large British study, which compared 25,000 cases of patients with venous thromboembolism (VTE) against 89,000 controls, found people prescribed antipsychotics had a 32 percent greater risk of serious blood clots, after adjusting for other potential risk factors.

 

The risk was greater for people on atypical drugs, rather than older ones, and the highest risk was seen with Seroquel, which showed a nearly three times increase on an adjusted basis.

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AstraZeneca Given More Time to Settle 6,000 Seroquel Lawsuits

Quoted from http://www.businessweek.com/news/2010-09-01/astrazeneca-given-more-time-to-settle-6-000-seroquel-lawsuits.htm

AstraZeneca Given More Time to Settle 6,000 Seroquel Lawsuits

September 01, 2010, 12:04 AM EDT

By Jef Feeley

Sept. 1 (Bloomberg) -- AstraZeneca Plc was given more time to settle 6,000 lawsuits claiming its antipsychotic drug Seroquel causes diabetes after a group of judges decided not to send the cases back to their home courts for trials.

The U.S. Judicial Panel on Multidistrict Litigation yesterday vacated orders sending the cases, consolidated in federal court in Florida, in courts across the U.S. after a judge said the move might hinder settlement negotiations. London-based AstraZeneca has settled about two-thirds of the 26,000 Seroquel cases pending against it.

“A remand at this juncture would likely disrupt the settlement dialog,” U.S. District Judge Anne Conway, based in Orlando, Florida, said in an Aug. 30 order asking the judicial panel to forgo remands. Returning the cases could “stall negotiations altogether,” Conway said.

AstraZeneca officials said they would continue to work with a mediator to resolve the remaining lawsuits over Seroquel.

“We remain committed to a strong defense effort, but will continue to participate in the court-ordered mediation process,” Tony Jewell, a U.S. spokesman for the drugmaker, said in an interview yesterday.

AstraZeneca, the U.K.’s second-biggest drugmaker, still faces at least 8,000 cases in both state and federal courts alleging Seroquel causes diabetes in some users. The drugmaker won the first jury trial over those claims in state court in New Jersey in March.

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AstraZeneca Pays $198M To Settle US Seroquel Claims

Quoted from http://online.wsj.com/article/BT-CO-20100809-702486.html

AstraZeneca Pays $198M To Settle US Seroquel Claims

AUGUST 9, 2010

By Simon Zekaria Of DOW JONES NEWSWIRES

LONDON (Dow Jones)--U.K. pharmaceutical group AstraZeneca PLC (AZN.LN) said Monday it has reached a $198 million settlement over claims regarding its best-selling antipsychotic drug Seroquel in the U.S.

AstraZeneca has faced thousands of product-liability lawsuits alleging that the use of Seroquel caused diabetes and other injuries, and that the company failed to adequately warn of the drug's risks.

 

The group has also faced long-running allegations it improperly promoted the drug, which is approved to treat schizophrenia, bipolar disorder and depression.

 

The settlement relates to 17,500 product liability claims, and the company said the mediation process over claims is ongoing in both federal and state jurisdictions.

 

"We remain committed to a strong defense effort, but will also continue to participate in good faith in court-ordered mediation," the company said in a statement.

 

Federal prosecutors and authorities from several U.S. states have been probing allegations AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. In April, the company announced a settlement of $520 million with the U.S. Justice Department over the matter.

 

Astrazeneca Monday said that, as of June 29, approximately 2,900 additional claims had been dismissed by order or agreement.

 

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AstraZeneca Said to Pay $55 Million to Settle 5,500 Lawsuits Over Seroquel

Quoted from http://www.bloomberg.com/news/2010-08-04/astrazeneca-said-to-pay-55-million-to-settle-5-500-lawsuits-over-seroquel.html

AstraZeneca Said to Pay $55 Million to Settle 5,500 Lawsuits Over Seroquel

By Jef Feeley and Phil Milford

Aug 4, 2010

AstraZeneca Plc, the U.K.’s second- biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel, people familiar with the accords said.

The settlements, with an average payout of about $10,000 per case, resulted from mediation involving 26,000 suits filed over Seroquel, the people said. The London-based company previously agreed to pay $2 million to resolve more than 200 allegations that Seroquel causes diabetes in some users, people familiar with those accords said last month.

AstraZeneca is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium in the next four years. Seroquel, the company’s second- biggest seller after Nexium, generated sales of $4.87 billion last year, or 15 percent of AstraZeneca’s total revenue.

The 5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing, the people said. The company hasn’t disclosed terms of the accords and wouldn’t comment on them yesterday. The settlements stemmed from mediation ordered by the judge in Orlando, Florida, who was overseeing all federal-court litigation over the drug.

AstraZeneca “continues to participate in good faith in the mediation process, with multiple mediation sessions scheduled throughout the summer,” Tony Jewell, a company spokesman in Wilmington, Delaware, said in an e-mailed statement. He declined to comment further, citing the mediator’s request for confidentiality.

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AstraZeneca Settlement Terms in Almost 4,000 Seroquel Cases to Stay Secret

Quoted from http://www.bloomberg.com/news/2010-07-30/astrazeneca-says-almost-4-000-seroquel-claims-settled-through-mediation.html

AstraZeneca Settlement Terms in Almost 4,000 Seroquel Cases to Stay Secret

By Phil Milford and Jef Feeley - Jul 31, 2010

AstraZeneca Plc, which tentatively settled almost 4,000 product-liability cases this month involving its antipsychotic drug Seroquel through mediation, said it will keep terms of the agreements confidential.

“AstraZeneca remains committed to a strong defense effort, but will also continue to participate in good faith in the court-ordered mediation process,” Tony Jewell, an AstraZeneca U.S. spokesman in Wilmington, Delaware, said yesterday in an e-mailed statement.

The London-based company, the U.K.’s second-biggest drugmaker, said in a regulatory filing that by the end of March, it was defending more than 10,000 cases involving 22,500 plaintiff groups. Some of the cases were previously dismissed because plaintiffs lacked sufficient evidence to support allegations that Seroquel causes diabetes.

The company, with $32.8 billion in sales last year, said in the July 29 filing that by March, it had spent about $688 million defending Seroquel-related cases.

AstraZeneca agreed earlier to pay $2 million to settle more than 200 Seroquel cases, averaging about $10,000 each, people familiar with the agreements said. Those settlements were part of the same federal-court-ordered mediation.

Some of the cases were filed in state courts, including New Jersey and Delaware. Others have been consolidated on the federal level with U.S. District Judge Anne Conway in Orlando, Florida.

In the first Seroquel case to be tried, AstraZeneca won a jury verdict that the company properly warned doctors of a Vietnam War veteran of the drug’s diabetes risk. A judge in Delaware dismissed three more cases saying there wasn’t enough proof of a diabetes link.

The consolidated Seroquel case is In re Seroquel Products Litigation, 06-MD-01769, U.S. District Court, Middle District of Florida (Orlando).

AstraZeneca Said to Pay $2 Million to Settle Lawsuits Over Seroquel Drug

Quoted from http://www.bloomberg.com/news/2010-07-22/astrazeneca-said-to-pay-2-million-in-first-settlements-of-seroquel-suits.html

AstraZeneca Said to Pay $2 Million to Settle Lawsuits Over Seroquel Drug

By Jef Feeley - Jul 22, 2010

AstraZeneca Plc is said to have agreed to pay $2 million to settle more than 200 cases over its drug Seroquel.   Photographer: JB Reed/Bloomberg

 

AstraZeneca Plc agreed to pay $2 million to settle more than 200 cases over its antipsychotic drug Seroquel in the first resolution of lawsuits alleging the medicine causes diabetes, people familiar with the accords said.

The settlement, which provides an average payout of more than $10,000 per case, came as the result of a U.S. court-ordered mediation involving 26,000 cases filed against London-based AstraZeneca over Seroquel, the people said.

“It should come as no surprise to investors and we’ve seen Eli Lilly settle on the very same issue with their competitor product, Zyprexa,” Gbola Amusa, an analyst at UBS AG, said yesterday in an interview. “The amount of the settlement implies a very low liability, much lower than the $1 billion to $2 billion range we expected a couple years ago.”

AstraZeneca’s decision to begin settling Seroquel claims comes as the U.K.’s second-largest drugmaker’s London shares surged to a three-year high last month after a judge upheld a patent on the company’s Crestor cholesterol pill. U.S. District Judge Joseph Farnan in Delaware concluded June 30 the patent on Crestor’s active ingredient is valid and enforceable until 2016.

AstraZeneca officials declined to comment on the settlement of the 200 Seroquel cases or the mediation ordered by a federal judge in Florida who was overseeing all federal-court litigation over the antipsychotic drug.

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Federal court upholds ruling for AstraZeneca

Quoted from http://finance.yahoo.com/news/Federal-court-upholds-ruling-apf-1667931978.html

Federal court upholds ruling for AstraZeneca

Appeals court upholds dismissal of lawsuit alleging AstraZeneca drug Seroquel caused diabetes

Linda A. Johnson, AP Business Writer, On Tuesday April 6, 2010, 5:53 pm EDT

TRENTON, N.J. (AP) -- A federal appellate court has upheld a lower court ruling dismissing the first product liability lawsuit among thousands alleging British drugmaker AstraZeneca PLC's antipsychotic drug Seroquel triggered a patient's diabetes.

A three-judge panel of the 11th Circuit Court of Appeals ruled Tuesday that the U.S. District Court for the Middle District of Florida had correctly dismissed the case brought by Linda Guinn, a former legal secretary from Palm Bay, Fla., in her early 60s.

Before that case was to go to trial, AstraZeneca successfully argued in January 2009, before District Judge Anne Conway, that Guinn's doctor did not qualify as an expert under federal court rules and so her testimony should be excluded. The drugmaker also persuaded the judge to grant a summary judgment motion in its favor, arguing that Guinn failed to establish that Seroquel caused her diabetes.

The 11th Circuit Court, based in Atlanta, upheld those decisions.

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