Drug Safety Developments

Statement on Fosamax (alendronate sodium) Product Liability Trial in U.S. District Court

Quoted from http://www.medadnews.com/News/Index.cfm?articleid=644779

Statement on Fosamax (alendronate sodium) Product Liability Trial in U.S. District Court

WHITEHOUSE STATION, N.J., Aug.11,2009

Merck & Co., Inc. will vigorously defend itself in a jury trial set to begin today, in the United States District Court for the Southern District of New York. The company believes the evidence will show that FOSAMAX did not cause Shirley Boles to develop dental and jaw-related problems as she claims and that Merck provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities.

In Shirley Boles v. Merck & Co., Inc., the plaintiff alleges she used FOSAMAX from 1997 to 2006. Plaintiff further alleges that she suffered various jaw problems and complications following two tooth extractions in June 2002, including a several day hospitalization in 2004 to treat her condition.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX,” said Paul Strain of Venable LLP, outside counsel for Merck. “She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, which can result in poor wound healing. The evidence will show that Ms. Boles would have experienced dental and jaw-related problems whether she took FOSAMAX or not.”

Judge John F. Keenan of the U.S. District Court for the Southern District of New York will preside over the trial.

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Merck Faces First Trial of Claim That Fosamax Attacks Jawbone

Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=aN.O.OLorMnc

Merck Faces First Trial of Claim That Fosamax Attacks Jawbone

By Thom Weidlich and Margaret Cronin Fisk

Aug. 10 (Bloomberg) -- Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others.

The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements.

“In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it’s the first information about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University in New York and an expert on civil procedure.

Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said.

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Did Pfizer Intimidate a Key Plaintiffs Witness on the Eve of the Neurontin Trial?

Quoted from http://www.law.com/jsp/article.jsp?id=1202432898903

Did Pfizer Intimidate a Key Plaintiffs Witness on the Eve of the Neurontin Trial?

Susan Beck
The American Lawyer
August 10, 2009

Did Pfizer, the world's largest pharmaceutical company, cross the line on the eve of last month's crucial test trial involving its controversial anti-seizure medication Neurontin?

Two weeks after the trial abruptly ended with the plaintiffs agreeing to dismiss their case with prejudice, questions linger about why Pfizer sent a former CIA agent and private investigator to the home of a whisteblowing scientist the day before he was scheduled to testify. The scientist, David Franklin, told the Am Law Litigation Daily that he and his family felt harassed and intimidated by the Pfizer investigator's appearance at their home and are still shaken by the event. The judge overseeing the Neurontin multidistrict litigation, Boston federal district court judge Patti Saris, issued a restraining order instructing Pfizer and the investigator to stay away from Franklin and his family.

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Drug companies says there are bogus Digitek suits

Quoted from http://wvrecord.com/news/contentview.asp?c=220452

Drug companies says there are bogus Digitek suits

8/7/2009 8:00 AM By Steve Korris -Kanawha Bureau

CHARLESTON - Drug companies Actavis Totowa and Mylan Pharmaceuticals claim they have detected bogus lawsuits in national litigation over heart medicine Digitek.

"It is clear that many cases without any merit have been filed," Richard Dean of Cleveland wrote to U.S. District Judge Joseph Goodwin on July 14.

Goodwin presides over Digitek suits from around the nation by appointment of the U.S. Judicial Panel on Multi District Litigation.

Plaintiffs started suing Actavis Totowa and Mylan Pharmaceuticals last year, alleging injuries from adulterated and misbranded pills.

A Food and Drug Administration recall triggered the litigation.

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Mylan faces several product liability lawsuits over pain patches

Quoted from http://pittsburgh.bizjournals.com/pittsburgh/stories/2009/08/10/story3.html?b=1249876800%5e1896411

Mylan faces several product liability lawsuits over pain patches

Pittsburgh Business Times - by Kris Mamula

A Dallas law firm is targeting generic drug giant Mylan Inc., along with other pharmaceutical companies, in product liability lawsuits related to the manufacture of pain patches.

The lawsuits involve the powerful painkiller fentanyl, which is applied to the skin in a patch for the slow release of the medication. In the Mylan lawsuits, the plaintiffs attribute 28 deaths to the patches.

Mylan makes the patches at its plant in St. Albans, Vt., which is operated by Mylan subsidiary Mylan Technologies Inc.

“We think there was a manufacturer defect,” said Charles Miller, a lawyer with Heygood, Orr, & Pearson, which is representing the plaintiffs. “What we don’t know is the exact nature of the defect.”

Mylan has denied liability in court filings.

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Ghostwriters Paid by Wyeth Aided Its Drugs

Quoted from http://www.nytimes.com/2009/08/05/health/research/05ghost.html

Medical Papers by Ghostwriters Pushed Therapy

By NATASHA SINGER Published: August 4, 2009

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

Documents: A Case Study in Medical Writing

The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients.

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Arthritis Drugs to Carry Warning on Kids’ Cancer Risk

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aNB2zQF.rHdw

Arthritis Drugs to Carry Warning on Kids’ Cancer Risk

By David Olmos

Aug. 4 (Bloomberg) -- Anti-inflammatory drugs known as TNF blockers must carry stronger warnings about the increased risk of sometimes fatal cancer in children and adolescents, the U.S. Food and Drug Administration said today.

Drugs in that category include Abbott Laboratories’ Humira, Amgen Inc.’s Enbrel, Johnson & Johnson’s Remicade and Simponi, and UCB SA’s Cimzia, the FDA said in an e-mailed statement. The medicines are used to treat rheumatoid arthritis and the bowel ailment Crohn’s disease, along with other inflammatory diseases.

TNF blockers generated about $15 billion last year, according to IMS Health Inc., a Norwalk, Connecticut-based market researcher. Enbrel produced $3.6 billion in sales last year for Thousand Oaks, California-based Amgen, making it the biotechnology company’s biggest-selling drug. The stricter cancer-risk warning for the medicines stems from an investigation announced by the FDA in June 2008.

“An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average,” the FDA said. “About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.”

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Two More 'Iqbal' Dismissals Emerge in Product Liability Cases

Quoted from http://www.law.com/jsp/article.jsp?id=1202432738346

Two More 'Iqbal' Dismissals Emerge in Product Liability Cases

Alison Frankel
The American Lawyer
August 4, 2009

The Supreme Court's May 2009 ruling in Ashcroft v. Iqbal (pdf) is quickly becoming the best thing to happen to the products liability defense bar since Daubert. We told you a couple of weeks ago about the dismissal of a false-marketing suit involving AstraZeneca's anti-psychotic drug Seroquel because it didn't meet the new, tougher pleading standard the Court laid down in Iqbal. Now we have word of two other recent Iqbal dismissals involving controversial products. No wonder Sen. Arlen Specter is on the warpath against Iqbal.

On July 23, Judge Herman Weber tossed manufacturing and design defect claims in Frey v. Novartis Pharmaceuticals Corp., in which Amanda Frey sued Novartis when she developed multi-organ failure after taking an epilepsy drug called Trileptal. In his 13-page opinion (pdf), Weber concluded that Frey's lawyers at O'Connor Acciani & Levy "have failed to allege any facts that would permit the court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Amanda Frey’s alleged injuries." Lead counsel for Novartis was Michael Junk of Hollingsworth LLP, who didn't immediately return our call.

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