Tag Archive > Mass Tort

Montana reaches $5.9M settlement in pharmaceutical case

admin » 12 March 2014 » In Legal News, Mass Tort » No Comments

HELENA – Montana Attorney General Tim Fox announced Thursday that a $5.9 settlement has been reached in a lawsuit filed against a large pharmaceutical company, and money will be used to pay for a new prescription drug abuse prevention program, mental health services and ongoing consumer protection services.

The Attorney General’s Office filed a lawsuit in 2008 against Janssen Ortho LLC and Janssen Pharmaceuticals, Inc. The lawsuit alleged the company employed illegal, unfair and deceptive practices in the marketing of Risperdal, an antipsychotic drug used to treat certain psychological disorders in adults.

The lawsuit alleged Janssen deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, but was aware that research showed dangers associated with its use and hid that research from the public.

Janssen’s own studies of Risperdal demonstrated it had the potential to cause weight gain and diabetes, cerebrovascular complications in the elderly, as well as other severe adverse side effects.

Janssen agreed to settle the lawsuit for $5.9 million last month. The settlement also restricts Janssen from making misleading claims in the promotion of its drugs, and present information about the benefits and risks of its product in promotional materials.

Janssen did not admit wrongdoing through the settlement.

Fox said about $1.5 million of the settlement will be used to bolster the state’s Prescription Drug Abuse Prevention Program. A public education specialist will be hired to create a student education program, look for ways to expand prescription drug drop box locations across the state, and create a public awareness campaign about the dangers of prescription drug addiction.

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Bard Loses $2 Million Verdict in Vaginal-Mesh Trial

admin » 19 August 2013 » In Defective Products, FDA, Legal News, Verdicts » No Comments

C.R. Bard Inc. was told by a jury to pay $2 million to a woman who alleged the company hid flaws within some of its vaginal-mesh implants in the first federal trial of claims over the devices.

Jurors in Charleston, West Virginia, deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable for injuries Donna Cisson blamed on its Avaulta line of devices. The jury awarded $250,000 in compensatory damages for Cisson’s injuries plus $1.75 million in punitive damages.

Bard, based in Murray Hill, New Jersey, still faces more than 8,000 other claims over its Avaulta devices, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP) and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through vaginal incisions, shrink over time.

“This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.”

Bard officials said they dispute the jury’s finding that Cisson’s injuries were caused by the vaginal implant and will appeal.

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Avaulta Transvaginal Mesh Lawsuit Trial Begins Today

admin » 09 July 2013 » In Legal News, Mass Tort » No Comments

The first of four bellwether trials regarding C.R. Bard transvaginal mesh lawsuits began today in the U.S. District Court in the Southern District of West Virginia, with the plaintiff of the first transvaginal mesh multi-district litigation trial alleging to have suffered injuries from C.R. Bard’s Avaulta transvaginal mesh device. The woman claims that the transvaginal mesh device was made from a resin-based plastic not suitable to be implanted in the human body.

Transvaginal mesh has been commonly used to treat urinary incontinence and pelvic organ prolapse in women. However, transvaginal mesh devices are currently facing scrutiny for the numerous health problems associated with the implantation of the transvaginal mesh device in the body. Shrinkage of the transvaginal mesh device due to the body’s natural foreign body response after implantation can ultimately lead to the destruction of nerves, tissue, and organs surrounding the transvaginal mesh device.

“Multi-district litigation trials are important in encouraging defendants to recognize the damage and harm that their products have caused and compensate all victims of their defective devices accordingly. If C.R. Bard should learn anything from the past, it would be the need for their company to have performed adequate testing and to convey proper warnings. In the absence of an effort to protect public safety, they should be found liable for the harm that they produce” said Robert Price, a transvaginal mesh attorney with the law firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.

Thousands of women implanted with faulty transvaginal mesh devices have filed lawsuits against C.R. Bard and other manufacturers of defective transvaginal mesh products. In June 2012, a woman was awarded a $5.5 million verdict by a California jury for injuries she suffered from an Avaulta transvaginal mesh device.

An Atlantic County, New Jersey jury ruled against Johnson & Johnson with an $11.11 million verdict, in which the plaintiff was awarded $3.35 million in compensatory and $7.76 million in punitive damages from injuries she suffered from ProLift, a recalled transvaginal mesh device manufactured by Ethicon, a subsidiary of Johnson & Johnson.

“Often times, the manufacturers of these faulty transvaginal mesh devices are aware of the serious health risks associated with their products,” commented Daniel Nigh, a transvaginal mesh attorney also with the law firm of Levin, Papantonio. “However, companies such as C.R. Bard and Johnson and Johnson failed to warn consumers of the risks and continued to market their products as safe and effective. Now, they are being held accountable for their negligence.”

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Blood-thinner Pradaxa target of mass-claims suit

admin » 09 November 2012 » In Defective Products, FDA, Legal News, Mass Tort » No Comments

After taking the blood-thinning drug Pradaxa for three weeks, Charles Jackson experienced intestinal bleeding. His doctor told him to get off the drug, which he began taking after suffering a stroke last September.

Months later, Jackson, 75, a retired truck driver from the rural railroad community of Hohenwald, saw a television advertisement imploring patients who had complications with Pradaxa to dial 1-800-BAD-DRUG to learn more about joining a lawsuit against the drug company.

Now Jackson is among hundreds of other patients around the country who are teaming against an anti-stroke drug whose sales eclipsed $1 billion last year. Joining the suit thrusts Jackson into the high-dollar stream of product liability lawsuits, a burgeoning world of mass claims in which specialty law firms cast a wide net for injured consumers who represent the pitfalls of marketing risky products.

Spearheading the Pradaxa litigation is the San Antonio-based law firm of attorney Mikal Watts, a prominent product liability attorney and deep-pocketed Democratic fundraiser.

Watts, who recently hosted President Barack Obama at his home for a private fundraiser, filed tens of thousands of claims for redress after a $20 billion fund was set up to handle claims from the 2010 Gulf oil spill. He was responsible for an $800 million settlement after winning a case against Ford and Firestone alleging defective tires and vehicle parts, one of the country’s largest product liability payouts.

Pradaxa, Watts wagers, could be the country’s next blockbuster civil settlement.

Emily Baier, a spokeswoman for Pradaxa’s company, Boehringer Ingelheim, declined to comment on the lawsuit, though she said safety is the company’s chief priority.

The drug has been under attack by physicians groups and patient advocates since 3,781 adverse effects and 542 deaths associated with Pradaxa were reported last year to the Food and Drug Administration. Its adverse reports and deaths surpassed all other monitored drugs. The FDA is now conducting a safety review of the drug, which millions of people around the country take twice a day.

Yet some legal observers say the case exposes the seams of mass litigation: Clients like Jackson are treated as no more than a claim number. And the fairest outcome for Jackson and numerous others, experts say, will not result from a collective suit in which cherry-picked examples stand-in for hundreds of individual stories.

“It’s going to be one of the larger mass torts in the history of the United States,” said Ryan L. Thompson, attorney with Watts Guerra Craft, who is working on scores of cases including Jackson’s, with a team of 70 employees dedicated to the Pradaxa suit.

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Pfizer Jury Awards $72 Million After Finding Prempro Caused Breast Cancer

admin » 06 December 2011 » In FDA, Legal News, Mass Tort, Verdicts » No Comments

Pfizer Jury Awards $72 Million After Finding Prempro Caused Breast Cancer

Pfizer Inc. (PFE) must pay $72.6 million in damages to three women who contended they developed breast cancer after taking the company’s menopause drugs, a Philadelphia jury decided.

Jurors in state court deliberated over two days before finding today that hormone-replacement drugs made by Pfizer’s Wyeth and Pharmacia Upjohn units were responsible for cancer in Susan Elfont, Bernadette Kalenkoski and Judy Mulderig. The panel awarded Elfont $20 million; Kalenkoski, $27.85 million; and Mulderig, $24.75 million.

“We are obviously disappointed with the verdict in this case, Chris Loder, a Pfizer spokesman, said in a written statement. “Once the verdict is finalized, the company will weigh its legal options to determine how it will continue with the case.”

More than 6 million women took Prempro and related menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the release of the Women’s Health Initiative, a National Institutes of Health-sponsored study.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill.

Prempro Accords

Pfizer announced in May it had settled a third of the pending Prempro cases filed against it and had set aside $772 million to help resolve the claims.

Elfont, 66, is a former teacher who once lived in Northeast Philadelphia, Tobi Millrood, a lawyer for the three women, said during the trial. She took Premarin and Provera for more than two years before being diagnosed with breast cancer in 1997, Millrood said.

Kalenkoski, 68, is a former nursing home aide who took Prempro for more than four years and was diagnosed with cancer in 2002, Millrood said.

Mulderig, 68, a retired teacher from Carlisle, Pennsylvania, took Premarin and Provera for 11 years starting in 1988.
Millrood told jurors that none of the three women had a family history of breast cancer and experts concluded the women’s use of menopause drugs helped lead to the development of the disease. Millrood today declined to comment immediately.

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Chantix: Smoking-pill suicides overlooked in missing reports

admin » 27 May 2011 » In FDA, Legal News, Mass Tort » No Comments

Chantix: Smoking-pill suicides overlooked in missing reports

Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through “improper channels.”

Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.

“We’ve had a major breakdown in safety surveillance,” said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of completed suicides, suicide attempts, aggression and hostility and depression — had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved.

They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts.

“It’s really chilling,” said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. “This seems to unleash something in people. It can be violence to anything around.”

Moore’s case studies describe “inexplicable and unprovoked” reactions in Chantix patients with no previous history of violence or mental illness, including:

A 24-year-old woman who started beating her boyfriend in bed because “he looked so peaceful” and later attempted suicide;
A 42-year-old man who punched a stranger at a bowling alley;
A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

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J&J, Hip Makers Asked by FDA for Data on Metal in Patients

admin » 12 May 2011 » In Defective Products, FDA, Mass Tort, Recall » No Comments

J&J, Hip Makers Asked by FDA for Data on Metal in Patients

The U.S. Food and Drug Administration asked Johnson & Johnson, which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.

The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. and Zimmer Holdings Inc., asking them to study the levels of cobalt and chromium in patients for at least eight years after implantation. The request focuses on all-metal devices whose failure rates have prompted recalls and increased scrutiny from regulators.

The agency “is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems,” Karen Riley, an FDA spokeswoman, said in an e-mail to Bloomberg News. “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip- replacement system that had been implanted in 93,000 patients worldwide. DePuy cited unpublished data from the U.K. national joint registry that indicated a failure rate of 12 percent within five years of implantation.

DePuy “is seeking further clarification from the FDA and considering how to best meet the agency’s requirements,” Lorie Gawreluk, a spokeswoman, said in an e-mail.

Scope of Request

Garry Clark, a spokesman for Warsaw, Indiana-based Zimmer, said in an e-mail that his company was “working to understand the scope of the agency’s request.”

Stryker doesn’t make metal-on-metal implants, Russell Weigandt, a spokesman for the Kalamazoo, Michigan-based company, said in an e-mail. He declined to comment further.

The leading hip makers behind J&J are Zimmer and Stryker, according to a BMO Capital Markets report in February that said the worldwide hip replacement market would grow 3.2 percent this year from $5.28 billion in 2010.

J&J rose 81 cents, or 1.2 percent, to $66.57 at 4 p.m. in New York Stock Exchange composite trading. Zimmer fell 54 cents to $69.15 and Stryker rose 84 cents, or 1.4 percent, to $61.84.

The American Academy of Orthopaedic Surgeons and the leading makers of hip and knee implants last year started a pilot program designed to duplicate joint registries that track patients’ health in the U.K., Australia and other countries.

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Despite FDA Warning, Avandia Use Varies Across U.S.

admin » 30 November 2010 » In Defective Products, FDA, Legal News » No Comments

Despite FDA Warning, Avandia Use Varies Across U.S.

Using the controversial diabetes drug Avandia as an example, new research finds that doctors’ prescribing patterns vary across the country in response to warnings about medications from the U.S. Food and Drug Administration.

The result is that patients may be exposed to different levels of risk depending on where they live, the researchers said.

“We were looking at the impact black-box warnings for drugs have at a national level, and, more specifically, at a geographical level, and how these warnings are incorporated into practice,” said study lead researcher Nilay D. Shah, an assistant professor of health services research at the Mayo Clinic in Rochester, Minn.

In 2007, the FDA required that Avandia come with a “black-box warning” — the strongest warning possible — alerting consumers that the drug was associated with an increased risk of heart attack.

Before the warning, Avandia was widely prescribed throughout the United States, although regional differences existed. “There was about a two-fold difference in use before the warning — around 15.5 percent use in Oklahoma versus about 8 percent in North Dakota,” Shah said.

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Bausch & Lomb beats back lens-cleaner lawsuits

admin » 31 August 2009 » In Defective Products, Mass Tort, Verdicts » No Comments

Bausch & Lomb beats back lens-cleaner lawsuits

Bausch & Lomb Inc., rocked by the worldwide recall of its flagship contact lens solution in 2006, has beaten back scientific claims blaming ReNu with MoistureLoc cleaner for a flurry of non-fungal eye infections.

The optical products maker has already paid out more than $250 million to settle roughly 600 lawsuits linking MoistureLoc to a potentially blinding fungal infection known as Fusarium keratitis.

But after a hearing in New York in June on the admissibility of expert evidence, a federal judge in South Carolina said there’s no reliable scientific basis for arguing that MoistureLoc caused another 1,024 lens wearers across the United States to contract assorted bacterial, viral and parasitic infections.

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Levaquin Cipro Tendon Ruptures

admin » 03 August 2009 » In Levaquin, Mass Tort » No Comments

Levaquin Cipro Tendon Ruptures

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