Drug Safety Developments

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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Heart attack risk seen with clot drug Pradaxa

Quoted from http://www.reuters.com/article/2012/01/09/us-heartattack-pradaxa-idUSTRE8082CX20120109

Heart attack risk seen with clot drug Pradaxa

 

By Bill Berkrot

Mon Jan 9, 2012 5:22pm EST   

(Reuters) - Boehringer Ingelheim's Pradaxa blood clot preventer has been associated with a slightly higher risk of heart attack or acute coronary syndrome, according to results of a meta-analysis of several studies reported in a major medical journal. 

The relative increase in risk to comparative medicines was found to range from 27 to 33 percent, however the absolute risk increase for suffering a heart attack was only 0.27 percent, the authors of the meta-analysis said in the study published on Monday in the Archives of Internal Medicine online edition. 

Pradaxa, known chemically as dabigatran, is approved in the United States for stroke prevention in patients suffering from an irregular heart beat known as atrial fibrillation, and in Europe to prevent strokes caused by blood clots in patients who have undergone hip and knee replacements.

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J&J Halts Study of Doribax Antibiotic on Higher Death Rate

Quoted from http://www.bloomberg.com/news/2012-01-05/j-j-halts-study-of-doribax-antibiotic-on-higher-death-rate.html

 

J&J Halts Study of Doribax Antibiotic on Higher Death Rate

By Alex Nussbaum - Jan 5, 2012 5:21 PM ET

Johnson & Johnson (JNJ) halted a clinical trial of its antibiotic Doribax after more pneumonia patients who took the product died and fewer were cured, regulators said.

Doribax, already approved for urinary and abdominal infections in the U.S., is still considered safe and effective for those uses, the Food and Drug Administration said today in a statement on its website. The trial tested the drug in pneumonia patients who were on ventilators, an indication for which it’s approved in Europe.

J&J, the world’s second-biggest seller of health-care products, stopped the study of 274 people in May on the advice of an independent monitoring committee, said Shaun Mickus, a company spokesman. He declined to say why Doribax failed and said the New Brunswick, New Jersey-based company isn’t changing its advice for doctors or patients.

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Bayer Judge Postpones First Yaz Trial to Have Cases Mediated

Quoted from http://www.businessweek.com/news/2012-01-05/bayer-judge-postpones-first-yaz-trial-to-have-cases-mediated.html

Bayer Judge Postpones First Yaz Trial to Have Cases Mediated

January 05, 2012, 11:26 AM EST

By Jef Feeley and Naomi Kresge

 

Jan. 5 (Bloomberg) -- Bayer AG, Germany’s largest drugmaker, won’t face the first trial next week over claims its birth-control pills caused blood clots after a judge appointed a mediator in hopes of settling the cases.

U.S. District Judge David Herndon in Illinois last week postponed the Jan. 9 trial of a lawsuit accusing Bayer and some of its units of misleading women about the health risks of its Yasmin family of birth-control pills. The case was the first of more than 10,000 suits over injuries allegedly caused by the drugs, which include the Yaz contraceptive.

Instead, Herndon ordered Bayer and lawyers for women suing the company to meet with mediator Stephen Saltzburg, a George Washington University law professor, to explore the possibility of “settlements in this litigation,” the judge said in a Dec. 31 order.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the company’s biggest-selling drugs after Betaseron, a multiple sclerosis medication. The contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.

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