Pharmaceutical Drug Litigation Updates

J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says

Quoted from http://www.businessweek.com/news/2012-02-02/j-j-hid-risperdal-studies-to-boost-drug-sales-lawyer-says.html

J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says

February 02, 2012, 4:41 PM EST

By Jef Feeley

 

Feb. 2 (Bloomberg) -- Johnson & Johnson hid studies showing its Risperdal anti-psychotic drug caused diabetes to protect billions of dollars in sales, a lawyer said in the first personal-injury claim over the medication to go to trial.

Researchers at J&J’s Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators probing links between the disease and anti-psychotic medicines, Fletch Trammell, a lawyer for a former Risperdal user, told a New Jersey jury today in opening statements.

“The evidence will show Janssen buried studies for a competitive advantage,” Trammell told jurors in state court in New Brunswick, New Jersey. J&J, the world’s second-largest health-products maker, is based in the city.

The trial of Gary Skala’s claims that his 14 years’ worth of Risperdal use caused his diabetes began two weeks after J&J agreed to pay $158 million to settle Texas officials’ claims that it fraudulently marketed the drug.

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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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Experts want suicide risk warning on ADHD drug

Quoted from http://www.foxnews.com/health/2012/01/31/experts-want-suicide-risk-warning-on-adhd-drug/

Experts want suicide risk warning on ADHD drug

Published January 31, 2012

Reuters

Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S. pediatric health advisers said on Monday.

Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older.

The FDA often follows the advice of its committees, although it is not required to.

The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.

"The suicidal ideation seems to be pretty serious," said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children's Hospital.

But the FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.

"I'm somewhat puzzled by the focus of suicidal ideation," said Tom Laughren, head of the FDA's psychiatric products division, in response to the panel's recommendation.

"These drugs are very widely used. And what you're seeing here are a handful of reports that are difficult to interpret with regard to causality," he said.

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Roche Denies Settling Claims Over Genentech’s Raptiva Psoriasis Drug

Quoted from http://mobile.bloomberg.com/news/2012-01-24/roche-settles-raptiva-claims-plaintiffs-lawyer-says

Roche Denies Settling Claims Over Genentech’s Raptiva Psoriasis Drug

By Laurence Viele Davidson and Jef Feeley
January 24, 2012 2:23 PM EST

Roche Holdings AG (ROG) denied settling lawsuits that say its Raptiva psoriasis drug caused lethal infections and said it’s proceeding to the first trial of the claims in June.

Mark Lanier, a lawyer for the plaintiffs, earlier said Roche’s Genentech unit had settled. He later called that statement “in error and wishful thinking.”

Genentech was sued in state court in California over allegations that Raptiva caused Stephen Johnson’s death. The 46- year-old Louisiana businessman took the drug to treat a skin condition. The Johnson family is seeking $15 million in compensatory damages along with “several hundred million dollars” in punitive damages, according to plaintiffs’ lawyers.

“Genentech has not settled the Stephen Johnson lawsuit,” Nadine Pinell, a spokeswoman for the South San Francisco, California-based company, said today in an e-mailed statement. “The trial in this matter is set to begin on June 4, 2012.”

Genentech began taking Raptiva off the U.S. and European markets in April 2009 after three psoriasis patients were diagnosed with progressive multifocal leukoencephalopathy, or PML, a rare, incurable brain infection. The month before the withdrawal, Basel, Switzerland-based Roche completed a $46.8 billion buyout of the biotech company.

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Johnson & Johnson Wins Jury Verdict Over Levaquin Warning

Quoted from http://www.businessweek.com/news/2012-01-26/johnson-johnson-wins-jury-verdict-over-levaquin-warning.html

Johnson & Johnson Wins Jury Verdict Over Levaquin Warning

January 26, 2012, 10:29 PM EST

By Margaret Cronin Fisk and Beth Hawkins

Jan. 26 (Bloomberg) -- Johnson & Johnson can’t be held liable for the tendon injuries to a 78-year-old man who said the company didn’t properly warn of the risks of its antibiotic Levaquin, a Minnesota jury said.

Clifford Straka, who blew out two Achilles tendons after taking the drug for pneumonia, sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

Johnson & Johnson, based in New Brunswick, New Jersey, has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia. The Minneapolis federal jury today found that J&J and its unit failed to provide reasonably adequate warnings, while also ruling that this wasn’t the cause of Straka’s injuries. The verdict is the companies’ third straight trial win.

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J&J Unit Didn’t Hide Levaquin Risks, Company Lawyer Says

Quoted from http://www.businessweek.com/news/2012-01-24/j-j-unit-didn-t-hide-levaquin-risks-company-lawyer-says.html

J&J Unit Didn’t Hide Levaquin Risks, Company Lawyer Says

January 24, 2012, 12:49 PM EST

By Margaret Cronin Fisk and Beth Hawkins

Jan. 24 (Bloomberg) -- Johnson & Johnson properly warned of the risks of its antibiotic Levaquin and shouldn’t be held liable for tendon injuries sustained by a 78-year-old man, a company lawyer said at the end of a trial in Minneapolis.

Clifford Straka, who blew out two Achilles tendons after taking the drug for pneumonia, sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

Johnson & Johnson, based in New Brunswick, New Jersey, has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia.

“The label from day one in 1996 was adequate,” James Irwin, J&J’s lawyer, said in closing arguments today. “The information was out there and available to the doctors and everyone else.”

The lawsuit is the third federal case to go to trial in Minnesota alleging the unit, now known as Janssen Pharmaceuticals, downplayed the risks of the antibiotic to boost sales. J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year. The company also won the first state case in October, when a New Jersey jury rejected the claims of two plaintiffs.

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Roche Settles Raptiva Claims, Plaintiffs’ Lawyer Says

Quoted from http://www.businessweek.com/news/2012-01-24/roche-settles-raptiva-claims-plaintiffs-lawyer-says.html

Roche Settles Raptiva Claims, Plaintiffs’ Lawyer Says

January 24, 2012, 10:03 AM EST

By Laurence Viele Davidson and Jef Feeley

 

Jan. 24 (Bloomberg) -- Roche Holdings AG settled lawsuits claiming its Raptiva psoriasis drug caused infections, according to a lawyer for the plaintiffs.

The lawyer, Mark Lanier, wouldn’t disclose the terms of the settlement today. Genentech withdrew the medication from the market almost three years ago.

Genentech, a unit of Basel, Switzerland-based drugmaker Roche, was sued in state court in California over allegations that Raptiva caused Stephen Johnson’s death. The 46-year-old Louisiana businessman took the drug to treat a skin condition. That trial had been set to begin this month and was postponed last week to June, according to the case docket.

The Johnson family was seeking $15 million in compensatory damages along with “several hundred million dollars” in punitive damages, according to plaintiffs’ lawyers.

Nadine O’Campo, a spokeswoman for South San Francisco, California-based Genentech, couldn’t be reached immediately before regular business hours to comment on any settlement.

Genentech began taking Raptiva off the U.S. and European markets in April 2009 after three psoriasis patients were diagnosed with progressive multifocal leukoencephalopathy, or PML, a rare, incurable brain infection. The month before the withdrawal, Roche completed a $46.8 billion buyout of the biotech company.

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Pfizer Seeks MDL for Zoloft Birth Defect Cases

Quoted from http://www.law.com/jsp/pa/PubArticlePA.jsp?id=1202539031562

Pfizer Seeks MDL for Zoloft Birth Defect Cases

Majority of Cases Were Filed in Pa. State Court, Removed to Eastern District

Amaris Elliott-EngelThe Legal Intelligencer

January 20, 2012

Mark S. Cheffo
Photo by Rick Kopstein

 

In the latest volley by pharmaceutical defendants seeking alternative forums to Pennsylvania state court, drugmaker Pfizer on Wednesday asked that almost 50 cases that have been removed to the U.S. District Court for the Eastern District of Pennsylvania be consolidated into one multidistrict litigation.

Pfizer counsel Mark S. Cheffo and Katherine Armstrong of Skadden Arps Slate Meagher & Flom in New York filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate 59 cases filed in Pennsylvania, New York, Illinois, Mississippi, Missouri and Ohio for pretrial proceedings.

The plaintiffs allege that birth defects were caused in children whose mothers took Zoloft during their pregnancies, according to court papers.

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Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths

Quoted from http://www.businessweek.com/news/2012-01-20/novartis-s-gilenya-pill-reviewed-by-eu-u-s-after-11-deaths.html

Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths

January 20, 2012, 12:27 PM EST

By Simeon Bennett

 

Jan. 20 (Bloomberg) -- European and U.S. regulators are reviewing Novartis AG’s Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.

The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it’s also reviewing data on the medicine.

Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.

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Group seeks re-vote on birth control clot risk

Quoted from http://www.reuters.com/article/2012/01/13/us-fda-bayer-idUSTRE80C03320120113

By Anna Yukhananov

WASHINGTON | Thu Jan 12, 2012 7:51pm EST

WASHINGTON (Reuters) - A watchdog group on Thursday urged the Food and Drug Administration to hold a new vote about blood clot risks from popular birth control pills, after advisers to the agency were shown to have ties to the pillmakers.

The FDA asked outside experts in December to discuss the safety of birth control that contains the compound drospirenone, including Bayer's Yaz and Yasmin.

The panel decided by a four-vote margin that the benefit of pregnancy prevention from these pills outweighed their risk of dangerous blood clots.

But according to court and public documents, three of the FDA's 26 advisers had research or financial ties to Bayer. A fourth adviser had a connection to a manufacturer of generic copies of Yaz, Barr Laboratories, now part of Teva Pharmaceuticals.

All four of these advisers voted that the drugs' benefits outweighed risks, meaning the pills could stay on the market, according to the Project on Government Oversight (POGO).

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