Pharmaceutical Drug Litigation Updates

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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J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

Quoted from http://www.businessweek.com/news/2011-10-12/j-j-didn-t-warn-levaquin-riskier-than-rivals-lawyer-argues.html

J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

October 12, 2011, 4:30 PM EDT

By Jef Feeley

 

Oct. 12 (Bloomberg) -- A Johnson & Johnson unit never warned users of the Levaquin antibiotic that it posed a greater risk of tendon damage than rival medications, a lawyer for two men suing the company said today.

Executives of J&J’s Ortho-McNeil-Janssen Pharmaceutical unit sought to protect sales by omitting information about Levaquin’s “comparative risk” from its warning label, Andy Alonso, a lawyer for Paul Gaffney and Robert Beare, said in closing arguments in the trial of their lawsuits against the drugmaker.

“They should be held to account for not fully disclosing” that they knew Levaquin generated a higher number of reports of Achilles tendon injuries than competing antibiotics, Alonso told a state court jury in Atlantic City, New Jersey, today.

The case is the third over Levaquin tendon injuries to go to trial since November and the first to be tried in New Jersey state courts. J&J faces more than 2,600 claims in U.S. courts over the drug, court dockets show.

A lawyer for the J&J unit countered today that for more than a decade starting in 1996, Levaquin’s labels contained repeated warnings about the risk of tendon injuries associated with the drug.

 

Gaffney’s and Beare’s own doctors said “they were aware” of the tendon risk posed by the drug, Christy Jones, one of the drugmaker’s lawyers, told jurors in her closing argument today.

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J&J Failed to Warn About Drug’s Tendon Risks, Lawyer Says

Quoted from http://www.businessweek.com/news/2011-09-06/j-j-failed-to-warn-about-drug-s-tendon-risks-lawyer-says.html

J&J Failed to Warn About Drug’s Tendon Risks, Lawyer Says

September 06, 2011, 3:06 PM EDT

By Jef Feeley

Sept. 6 (Bloomberg) -- Johnson & Johnson officials failed to properly warn two New Jersey men the drugmaker’s antibiotic drug Levaquin could damage their tendons, a lawyer told a state jury.

 

Officials of New Brunswick, New Jersey-based J&J and its Ortho-McNeil-Janssen
Pharmaceutical unit downplayed Levaquin’s risks in warning labels even after receiving reports from Europe about tendon ruptures, said Andy Alonso, a lawyer for Paul Gaffney and Robert Beare. The two men contend they suffered Achilles-tendon injuries after taking the antibiotic.

 

“J&J officials knew there was a problem and did everything they could to hide it” to protect Levaquin’s sales, Alonzo told jurors in opening statements in state court in Atlantic City, New Jersey, today.

In her opening statement, Johnson & Johnson’s lawyer countered the drugmaker repeatedly warned doctors and patients about reports linking tendon ruptures to Levaquin starting when the drug was approved for sale in the U.S. in 1996.

“From the very first label, Johnson & Johnson included information about reports of ruptures of the shoulder, hand and Achilles tendon,” Christy Jones, the company’s lawyer, told jurors.

Gaffney’s and Beare’s case is the third over Levaquin tendon injuries to go to trial since November and the first to be tried in New Jersey state courts. J&J faces more than 2,600 claims in U.S. courts over the drug, court dockets show.

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J&J Wins Trial Over Claims Antibiotic Levaquin Caused Injuries

Quoted from http://www.bloomberg.com/news/2011-06-18/johnson-johnson-wins-second-trial-over-injury-claims-against-antibiotic.html

J&J Wins Trial Over Claims Antibiotic Levaquin Caused Injuries

By Margaret Cronin Fisk and Beth Hawkins - Jun 18, 2011 12:01 AM ET

Johnson & Johnson (JNJ) isn’t responsible for a tendon injury sustained by an 84-year-old man and properly warned of the risks posed by its antibiotic Levaquin, a Minneapolis jury decided.

Calvin Christensen, who said he ruptured the Achilles tendon in his right foot after taking the drug while hospitalized for pneumonia, sued the company and its Ortho- McNeil Pharmaceutical unit in 2007. Christensen said the companies downplayed the risks of Levaquin to boost sales of the drug.

Johnson & Johnson denied any failure to warn and contended Christensen needed Levaquin to treat the pneumonia. The Minneapolis federal court jury rejected his claim yesterday.

“The jury took a good, hard look at all the evidence and correctly concluded that Ortho-McNeil-Janssen Pharmaceuticals, Inc. acted responsibly and properly in disclosing the risks associated with this effective and life-saving medicine,” James B. Irwin, a lawyer for the company, said in a statement after the verdict.

Christensen’s case is the second of more than 2,500 pending claims in U.S. courts to go to trial over allegations that Levaquin caused tendon damage in patients and that the company failed to adequately disclose the risk. J&J and Ortho-McNeil lost the first trial when a separate Minneapolis jury awarded $1.8 million to an 82-year-old man who ruptured both Achilles tendons.

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Blockbuster drug kicks up a legal storm

Quoted from http://www.startribune.com/business/111420064.html

Blockbuster drug kicks up a legal storm

Johnson & Johnson faces thousands of suits over its antibiotic Levaquin.

 

By Janet Moore, Star Tribune

Last update: December 6, 2010 - 10:12 PM

 

When 76-year-old John Schedin was diagnosed with bronchitis five years ago, his doctor prescribed a popular antibiotic called Levaquin, plus a steroid, to lick the lingering chest infection once and for all.

But after taking the drugs for three days, Schedin ruptured both of his Achilles tendons, a bizarre injury he attributes to Levaquin. In 2008, the Edina resident sued the unit of pharmaceutical giant Johnson & Johnson that markets the drug, Ortho-McNeil-Janssen Pharmaceuticals.

Schedin's case is one of hundreds that have been consolidated in U.S. District Court in Minneapolis before Judge John Tunheim -- and is the first to go to trial. A jury of eight men and four women heard closing arguments Monday morning and began deliberating.

All told, more than 2,600 lawsuits have been filed by Levaquin patients with tendon injuries in state and federal courts nationwide. Schedin, a retired salesman, is seeking an unspecified amount in punitive and compensatory damages.

At issue is whether J&J adequately warned doctors and patients about the potential for Levaquin to cause tendon damage throughout the body.

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Johnson & Johnson Warned on Levaquin Risk, Lawyer Says [During Closing Argument of Schedin v. J&J Trial]

Quoted from http://www.bloomberg.com/news/2010-12-06/johnson-johnson-properly-warned-on-antibiotic-levaquin-lawyer-says.html

Johnson & Johnson Warned on Levaquin Risk, Lawyer Says

By Margaret Cronin Fisk and Beth Hawkins - Dec 6, 2010 12:48 PM ET

Johnson & Johnson didn’t hide the risk of tendon damage linked to its antibiotic Levaquin and properly warned doctors, a lawyer for the drugmaker told jurors at the end of a trial in Minnesota.

“The information was not concealed,” John Dames, a J&J attorney, said today in his closing argument in federal court in Minneapolis. “We provide warnings that give doctors the means to care adequately for their patients.”

John Schedin, 82, sued in 2008, claiming he ruptured the Achilles tendons in both feet after taking the drug. Schedin claims J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit failed to warn doctors and patients of Levaquin’s association with tendon damage.

Schedin’s case is the first trial on more than 2,600 claims in U.S. courts alleging that Levaquin caused tendon damage in patients taking the drug and J&J failed to adequately disclose the risk. The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs.

The plaintiffs claim the warning should have been enhanced earlier and remains inadequate. They also claim J&J and Ortho- McNeil-Janssen boosted sales by downplaying risks.

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Johnson & Johnson Hid Antibiotic’s Risk, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-15/johnson-johnson-hid-risks-of-antibiotic-levaquin-lawyer-says-in-trial.html

Johnson & Johnson Hid Antibiotic’s Risk, Lawyer Says

By Margaret Cronin Fisk and Beth Hawkins - Nov 15, 2010 7:58 PM ET

Johnson & Johnson knew its antibiotic Levaquin increased the risk of tendon damage and failed to properly warn patients or doctors, a lawyer said today at the start of a trial in Minnesota.

John Schedin, 82, who said he ruptured the Achilles tendons in both feet after taking the drug, sued the company and its Ortho-McNeil-Janssen Pharmaceutical unit in 2008. The companies downplayed the risks of Levaquin even after receiving adverse reports from Europe in 2001, Schedin’s lawyer, Mikal Watts, said in his opening statement at trial today.

“The decision they made was to add a single line to the 14-page package insert somewhere on page four or five,” Watts told the Minneapolis jury. “They did not tell the doctors that the use of Levaquin concomitant with corticosteroids will cause an Achilles tendon to rupture.”

Schedin’s case is the first trial on more than 2,600 claims in U.S. courts against Johnson & Johnson that Levaquin caused tendon damage in patients taking the drug and the company failed to adequately disclose the risk. The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs.

The plaintiffs claim the warning should have been enhanced earlier and remains inadequate. They also claim Johnson & Johnson and Ortho-McNeil-Janssen boosted sales by downplaying risks.

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Litigation Over Johnson & Johnson Antibiotic Levaquin Designated N.J. Mass Tort

Quoted from http://www.law.com/jsp/article.jsp?id=1202431984309&Litigation_Over_Johnson__Johnson_Antibiotic_Levaquin_Designated_NJ_Mass_Tort

Litigation Over Johnson & Johnson Antibiotic Levaquin Designated N.J. Mass Tort

Charles Toutant
New Jersey Law Journal
July 6, 2009

The New Jersey Supreme Court has designated mounting litigation over the Johnson & Johnson antibiotic Levaquin as a mass tort and has assigned it to an Atlantic County, N.J., judge. The suits charge that the drug, which is prescribed for bacterial infections of the lungs, urinary tract and skin, has caused Achilles' tendon ruptures and other damage....

Levaquin, made by J&J subsidiary Ortho-McNeil Pharmaceutical Inc., was approved by the Food and Drug Administration in 1996, but in July 2008, the FDA warned that Levaquin, and other drugs in the fluoroquinolone class of antibiotics, put users at heightened risk of developing tendonitis and tendon ruptures. The FDA ordered Ortho-McNeil to include on Levaquin's label a warning about the incidence of those injuries.

The most common injury associated with Levaquin, a ruptured Achilles' tendon, may require surgery to repair and frequently entails two months of immobility, then surgery and a rehabilitation period of six months or more....

Other reported injuries are ruptures of the rotator cuff, hand, biceps and thumb.

Most ailments occur during or soon after a course of Levaquin, although cases occurring several months after completion have been reported, and injuries are most frequent in users over age 60, people taking steroids, or persons who have had a kidney, heart or lung transplant, the plaintiffs allege.

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