Pharmaceutical Drug Litigation Updates

Allergan Settles Oklahoma Botox Case During Trial

Quoted from http://www.bloomberg.com/news/2013-02-26/allergan-settles-oklahoma-botox-case-in-second-week-of-trial.html

Allergan Settles Oklahoma Botox Case During Trial

By Margaret Cronin Fisk - Feb 26, 2013 2:56 PM ET

Allergan Inc. (AGN) reached a confidential settlement during trial with the mother of a 6-year-old Oklahoma boy who wound up on a ventilator after he was injected with Botox.

The mother of Jackson Wells claimed the injection, given to treat spasticity in his legs, caused the boy to develop acute botulism, leaving him unable to breathe on his own. Jessica Wells also claimed Allergan promoted the drug for children despite a lack of regulatory approval for such use.

Allergan settled the lawsuit yesterday during trial while the boy’s treating doctor was testifying, said plaintiffs’ lawyer Ray Chester. The trial began Feb. 19 in Oklahoma City federal court.

“While the amount is confidential, young Jackson Wells will be well taken care of for life,” Chester said in an interview today. U.S. District Judge Robin J. Cauthron confirmed the settlement in a one-page order yesterday closing the case.

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Allergan wins new trial in big Botox damages case

Quoted from http://www.reuters.com/article/2012/06/01/allergan-botox-trial-idUSL1E8H1B1F20120601

Allergan wins new trial in big Botox damages case

By Nate Raymond

June 1 | Fri Jun 1, 2012 3:26pm EDT

June 1 (Reuters) - Allergan Inc has been granted a new trial in a case brought by a man who won a $212 million jury verdict last year after claiming he was disabled by taking Botox injections.

Douglas Ray Jr's jury award had already been slashed to less than $13 million total under Virginia state law, and now, after a federal judge's ruling on Friday, he will have to make his case all over again.

Ray accused Allergan of failing to warn doctors of the risk that Botox injections could cause autoimmune reactions that lead to brain damage. Ray alleged that he suffered a severe reaction that left him completely disabled after receiving Botox injections to treat a movement disorder in his right hand -- an off-label-use for the wrinkle-smoothing drug.

In April of last year, jurors in U.S. District Court in Richmond, Virginia, awarded Ray $12 million in compensatory damages, along with $200 million in punitive damages that were later reduced to $350,000 due to a cap under Virginia law.

But Judge Robert Payne ruled Friday that Allergan deserved a new trial because it should have been made clear to the jury that the company could not add a so-called "black-box" warning to Botox packing inserts on health dangers without prior approval from the U.S. Food and Drug Administration.

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Jury orders Allergan to pay $212 mln in Botox case

Quoted from http://www.reuters.com/article/2011/04/28/allergan-idUSN2812465820110428

Jury orders Allergan to pay $212 mln in Botox case

Thu Apr 28, 2011 7:05pm EDT

 

LOS ANGELES, April 28 (Reuters) - A Virginia U.S. District Court jury has ordered Allergan Inc (AGN.N) to pay $212 million to a man who claimed that injections of wrinkle-smoothing Botox left him with brain damage.

The jurors awarded 67-year-old Douglas Ray Jr $12 million in compensatory damages and $200 million in punitive damages, the company said on Thursday.

Ray said he was injured after getting Botox injections to relieve a hand tremor and writer's cramp, according to a report in the Richmond Times-Dispatch.

Allergan said in a statement that there was no evidence that the company failed to provide adequate information about the potential risks of the drug. It also said there was no proof that Botox caused his symptoms.

The company said it is evaluating the basis for an appeal, noting that Virginia state law caps punitive damages at $350,000.

Allergan agreed last year to plead guilty and pay $600 million to resolve a federal probe involving marketing Botox for unapproved non-cosmetic uses.

The Justice Department accused the company of paying kickbacks to doctors to prescribe Botox for unapproved uses -- such as treating headaches, pain and juvenile cerebral palsy -- and teaching doctors how to bill for such "off-label" uses. (Reporting by Deena Beasley; editing by Carol Bishopric)

What Allergan doesn't want to you know about Botox

Quoted from http://www.ocregister.com/news/botox-254083-allergan-company.html

What Allergan doesn't want to you know about Botox

Published: June 18, 2010
Updated: June 19, 2010 8:20 p.m.

By COLIN STEWART THE ORANGE COUNTY REGISTER

Allergan, manufacturer of the blockbuster cosmetic drug Botox, has downplayed information about the drug's dangers to avoid alarming consumers, according to public documents, court testimony and evidence revealed by recent lawsuits that allege severe or fatal reactions.

Botox is the world's most popular wrinkle-fighting drug, producing sales of $1.3 billion a year for Allergan. It is also an icon of social division in the United States. A person's attitude toward the drug is a litmus test that distinguishes people who are willing to go to great lengths to preserve their youthful looks from people who look down on artificial methods of fighting the effects of aging.

Dr. Sharla Helton, of Oklahoma City, won a $15 million lawsuit against Allergan over the side effects of Botox, which she says left her in constant pain and partially paralyzed. A jury agreed that Allergan had failed to disclose potential side effects. The company is appealing. JOHN CLANTON, SPECIAL TO THE ORANGE COUNTY REGISTER

In that social context, Irvine-based Allergan doesn't want consumers to focus on any possible ill effects of Botox or on the fact that it is derived from a toxin that causes paralysis.

"Botox Cosmetic is not a poison and is not botulism. It is a purified protein and a finished medical prescription product," Allergan's marketing materials state.

Yet Botox is a weakened version of what the Journal of the American Medical Association calls "the most poisonous substance known." Four-hundredths of an ounce of undiluted botulinum toxin is enough to kill a million people with the paralyzing nerve disease botulism.

Company officials say it's important that people not become so worried about the potential risks of Botox that they lose sight of its benefits.

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Botox maker is not liable in girl's death, O.C. jury says

Quoted from http://www.latimes.com/news/local/la-me-botox3-2010mar03,0,25189.story

Botox maker is not liable in girl's death, O.C. jury says

The case involving the 7-year-old cerebral palsy patient from Texas was believed to be the first of its kind to go to trial. The girl's family alleged that the product was responsible for her death.

By Lisa Girion

March 3, 2010

An Orange County jury Tuesday declined to hold Botox maker Allergan Inc. liable in the death of a 7-year-old Texas girl being treated for cerebral palsy because it found the company's warning labels adequate.

The closely watched case is believed to be the first to go to trial over allegations that the botulinum toxin-based drug contributed to a death. At issue was the safety of the blockbuster cosmetic drug in the higher dosages that are used in pediatric cerebral palsy cases and the adequacy of the Irvine manufacturer's warning labels.

Kristen Spears, who was born with severe cerebral palsy, began receiving large doses of Botox at age 6 in an effort to reduce debilitating limb spasticity. The girl died Nov. 24, 2007, at the age of 7.

Best known as a face-lift-in-a-syringe, Botox can relax contorted muscles and sometimes help young patients walk without surgery. U.S. regulators have not specifically approved the use of Botox in children, but doctors may legally prescribe it as an "off-label" use. Dosages used in such patients are many times those recommended for facial wrinkle injections.

Dee Spears alleged that her daughter died as a result of an overdose of Botox, which led to respiratory failure and pneumonia, and that Allergan failed to adequately warn the girl's pediatrician of the drug's risks.

The jury, which deliberated for several hours over two days, did not agree. The panel found that Botox posed risks of "a substantial danger" that "ordinary consumers" would not have recognized, according to the verdict form.

But jurors concluded that Allergan did not breach its duty to warn of those potential risks and therefore could not be held responsible for any potential adverse effect.

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Calif. jury deliberating in Botox death case

Quoted from http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2010/02/26/state/n080258S84.DTL

Calif. jury deliberating in Botox death case

Friday, February 26, 2010

Santa Ana, Calif. (AP) --

Jurors have started deliberating in the case of a mother who claims an overdose of the anti-wrinkle drug Botox killed her 7-year-old daughter with cerebral palsy.

Kristen Spears, of Amarillo, Texas, died in November 2007 of respiratory failure and pneumonia. Her mother, Dee, sued Botox maker Allergan Inc., alleging an overdose weakened muscles that controlled her daughter's breathing.

The family is seeking $20 million in actual damages and an additional $40 million in punitive damages from Irvine-based Allergan.

Kristen Spears, who was born with cerebral palsy, received Botox injections over a 17-month period to relax muscle spams in her legs.

While Botox is commonly used for cosmetic purposes to smooth wrinkles and frown lines, some doctors use the botulin-based drug at higher doses to treat muscle spasms in cerebral palsy patients.

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Orange County trial will focus on Botox's safety in children's cerebral palsy treatments

Quoted from http://www.latimes.com/news/local/la-me-botox27-2010jan27,0,1928030.story

Orange County trial will focus on Botox's safety in children's cerebral palsy treatments

The family of Kristen Spears alleges an overdose of the drug manufactured by Irvine-based Allergan Inc. killed her at age 7. The firm has said the family cannot prove the allegations.

By Lisa Girion

January 27, 2010

Kristen Spears started getting Botox injections at the age of 6 -- not to smooth furrows in her brow, but to calm spasms in her legs.

The girl was born with severe cerebral palsy, and Botox, best known as a face-lift-in-a-syringe, can relax contorted muscles and sometimes help young patients walk without surgery.

Instead, Kristen's mother alleges, an overdose of the drug killed her.

Opening arguments in a negligence lawsuit by Dee Spears against Botox manufacturer Allergan Inc. are set for today in Orange County.

At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.

It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.

The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker's own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

Allergan declined to comment on the trial. In a court motion, Allergan says that Kristen died of a bacterial infection and that her mother cannot prove Botox killed her.

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