Pharmaceutical Drug Litigation Updates

J&J Wins Reversal of $1.1 Million Levaquin Punitive Award

Quoted from http://www.bloomberg.com/news/2012-11-30/j-j-wins-reversal-of-1-1-million-levaquin-punitive-award.html

J&J Wins Reversal of $1.1 Million Levaquin Punitive Award

By Margaret Cronin Fisk - Nov 30, 2012 2:38 PM ET

Johnson & Johnson won a reversal of $1.1 million in punitive damages awarded to a man who claimed the company failed to properly warn of the risks of tendon damage linked to its antibiotic Levaquin.

While erasing the punitive award, the U.S. Court of Appeals in St. Louis sustained a Minnesota jury’s 2010 finding that J&J failed to warn plaintiff John Schedin. The court also upheld an award of $630,000 in compensatory damages to Schedin, who sued J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit in 2008.

“The evidence is neither clear nor convincing, as a matter of law, that OMJP deliberately disregarded the safety of the users of Levaquin,” U.S. Circuit Judge William Jay Riley said today. Proving deliberate disregard is “required for punitive damages under Minnesota law,” Riley said.

J&J has faced more than 3,400 state and federal lawsuits alleging tendon injuries from Levaquin, according to court filings. The company had settled about 845 of them by last month, according to an Oct. 30 filing in federal court in Minneapolis, where a judge is overseeing about 1,900 Levaquin lawsuits.

The New Brunswick, New Jersey-based company has won three of the four Levaquin cases that have gone to trial. Schedin’s case was the only such victory for the plaintiffs.

[Article continues at original source]

Johnson & Johnson Settles 845 Levaquin Lawsuits

Quoted from http://www.bloomberg.com/news/2012-11-01/johnson-johnson-reaches-settlement-in-845-levaquin-cases.html

Johnson & Johnson Settles 845 Levaquin Lawsuits

By Margaret Cronin Fisk and Beth Hawkins - Nov 1, 2012 4:44 PM ET

Johnson & Johnson (JNJ) settled lawsuits with about 845 plaintiffs who claimed the drugmaker didn’t properly warn of the risks of tendon damage from its antibiotic Levaquin.

The settlements were disclosed in an Oct. 30 filing in federal court in Minneapolis, where a judge is overseeing about 1,900 Levaquin lawsuits. The initial agreements will be completed in the next two weeks, the plaintiffs said in the filing, which didn’t say how much Johnson & Johnson would pay.

According to the filing, Johnson & Johnson faces more than 3,400 state and federal lawsuits alleging tendon injuries from the drug, including about 1,500 cases in New Jersey state court.

Johnson & Johnson has won three of the four Levaquin cases that have gone to trial. It lost the first, a jury verdict for $1.8 million in 2010. Settlement discussions are under way with about 190 other plaintiffs, according to the filing.

[Article continues at original source]

Popular Antibiotics May Carry Serious Side Effects

Quoted from http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/

Popular Antibiotics May Carry Serious Side Effects

By JANE E. BRODY

September 10, 2012

Antibiotics are important drugs, often restoring health and even saving lives. But like all drugs, they can have unwanted and serious side effects, some of which may not become apparent until many thousands of patients have been treated.

Such is the case with an important class of antibiotics known as fluoroquinolones. The best known are Cipro (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin). In 2010, Levaquin was the best-selling antibiotic in the United States.

But by last year it was also the subject of more than 2,000 lawsuits from patients who had suffered severe reactions after taking it.

Part of the problem is that fluoroquinolones are often inappropriately prescribed. Instead of being reserved for use against serious, perhaps life-threatening bacterial infections like hospital-acquired pneumonia, these antibiotics are frequently prescribed for sinusitis, bronchitis, earaches and other ailments that may resolve on their own or can be treated with less potent drugs or nondrug remedies — or are caused by viruses, which are not susceptible to antibiotics.

In an interview, Mahyar Etminan, a pharmacological epidemiologist at the University of British Columbia, said the drugs were overused “by lazy doctors who are trying to kill a fly with an automatic weapon.”

Dr. Etminan directed a study published in April in The Journal of the American Medical Association showing that the risk of suffering a potentially blinding retinal detachment was nearly fivefold higher among current users of fluoroquinolones, compared with nonusers. In another study submitted for publication, he documented a significantly increased risk of acute kidney failure among users of these drugs.

[Article continues at original source]

Two Antibiotics Linked to Liver Injury in Elderly

Quoted from http://health.usnews.com/health-news/news/articles/2012/08/13/two-antibiotics-linked-to-liver-injury-in-elderly

Two Antibiotics Linked to Liver Injury in Elderly

But while serious, these cases are relatively rare, study says

August 13, 2012

MONDAY, Aug. 13 (HealthDay News) -- A new study finds that two antibiotics commonly used to treat respiratory and sinus infections -- moxifloxacin (Avelox) and levofloxacin (Levaquin) -- may boost the risk of severe liver injury in seniors.

The two drugs belong to a class of antibiotics called fluoroquinolones.

For the study, published Aug. 13 in CMAJ (the Canadian Medical Association Journal), Canadian researchers examined the medical records of 144 patients in Ontario who were over 65 and admitted to the hospital to treat liver injury within a month of receiving moxifloxacin or other antibiotics commonly used to treat respiratory infections. The patients had no history of liver disease, and 88 of them died.

[Article continues at original source]

Drugs most frequently reported for adverse reactions

Quoted from http://www.philly.com/philly/blogs/healthcare/157042255.html

Drugs most frequently reported for adverse reactions

by Michael R. Cohen, R.Ph.

You may be surprised to learn that in 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions. This was an increase of 15,386 reports (9.4 percent) from the 2010 total. Reports reached the FDA through two mechanisms. Voluntary reports from health professionals and consumers and reports from manufacturers. There were 21, 002 voluntary reports and 158,853 from manufacturers. Manufacturers must report serious events within 15 days of becoming aware.

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. Keep in mind that this is not a scientific study of the frequency of adverse drug events in clinical practice. These are the medications that health professionals and consumers told the FDA were causing serious and fatal side effects during 2011. It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs.

Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure. Coumadin has been prominent in the rankings for many years. It accounted for 1,106 reported ADEs overall, including 731 reports of hemorrhage and 72 deaths.

[Article continues at original source]

Common antibiotics tied to eye emergencies: study

Quoted from http://www.reuters.com/article/2012/04/03/us-common-antibiotics-idUSBRE83210420120403

Common antibiotics tied to eye emergencies: study

By Genevra Pittman

NEW YORK | Tue Apr 3, 2012 4:25pm EDT

NEW YORK (Reuters Health) - A common class of antibiotics was linked to a higher risk of so-called retinal detachment -- when the light-sensitive tissue in the eye separates from gel that fills the eyeball, in a new Canadian study.

People treated by ophthalmologists for the emergency condition were five times more likely to be taking drugs known as fluoroquinolones, which include ciprofloxacin (marketed under names including Zoxan, Proquin and Cipro) and levofloxacin (Levaquin, Cravit), than those who didn't have retinal detachment.

"We know that these drugs are toxic to connective tissue and cartilage," said Mahyar Etminan, the study's lead author, noting past studies linking fluoroquinolones with damage to Achilles and shoulder tendons.

"We wanted to see whether this damage also may translate in the eye, because there's lots of connective tissue in the eye," Etminan, from the Child and Family Research Institute of British Columbia in Vancouver, told Reuters Health.

Retinal detachment, which starts as the appearance of lines, dots or "floaters" across the eye, can cause permanent blindness in some cases if it's not surgically treated within a few days.

[Article continues at original source]

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.

[Article continues at original source]

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.

[Article continues at original source]

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.

[Article continues at original source]

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.

[Article continues at original source]