Product Liability

June 15, 2009

Accutane Lawsuits and Litigation

The acne remedy Accutane, a synthetic form of vitamin A used to treat serious forms of acne that can cause scarring, has been the subject of extensive litigation because of a long list of side effects including inflammatory bowel disease, suicide, and birth defects.

The U.S. manufacturer of Accutane, Hoffman La Roche, is part of the international conglomerate known as “The La Roche Group,” with affiliates in 150 countries. “The La Roche Group” is estimated to be the seventh largest pharmaceutical company in the world. Accutane is one of Hoffman La Roche’s top sellers with estimated annual sales of $1.2 billion. Accutane is also one of the 3 drugs on the market with the most reports of adverse side effects, and this has led to extensive litigation. Lawsuits have been brought against Hoffman La Roche for alleged adverse reactions caused by Accutane including gastrointestinal disorders, suicides, and birth defects.

June 13, 2009

F.D.A. Warns Against Use of Popular Cold Remedy

by Dr. Shezad Malik

Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

June 11, 2009

Wife of Congressman Loses Accutane Acne-Drug Suicide Case

by Dr. Shezad Malik

The Eleventh Circuit ruled on Wednesday on an interesting and provocative case. In an unpublished opinion, the Eleventh Circuit affirmed a trial court’s grant of summary judgment in a case in which the mother of a 17 year-old who committed suicide in 2000 sued Hoffman-La Roche, Inc. The plaintiff alleged that Accutane, an acne drug made by Hoffman-LaRoche caused the suicide. Click here for reports from BNET Pharma and the Drug and Device Blog, respectively.

June 8, 2009

Victoza for Diabetes: Better Than Byetta?

by Dr. Shezad Malik

A new diabetes drug — to be called Victoza if approved — works better than Byetta, a head-to-head clinical trial shows.

Byetta is the first of the class of type 2 diabetes drugs called GLP-1 analogs. The drug takes advantage of the body’s own signaling system to increase insulin output in response to meals.

Byetta is a popular drug, and it’s helped many patients. But liraglutide — soon to be called Victoza if approved by the FDA — works better, says Lawrence Blonde, MD, director of the diabetes clinical research unit at Ochsner Clinic Foundation, New Orleans.

“Our direct comparison study shows patients who took liraglutide once a day had a greater reduction in [average blood sugar levels] at the end of the 26-week study than did [Byetta] twice a day,” according to Blonde . “Obviously, once-a-day injections would be preferred by many patients because of the convenience — and it is not tied to meals. Liraglutide can be taken any time as long as you take it the same time each day.”

June 3, 2009

Defective Product: Kugel® Mesh Hernia Patch Recall

by Dr. Shezad Malik

The Bard® Composix® Kugel® Mesh Hernia Patch has been linked to serious, life-threatening side effects and has been voluntarily recalled by its manufacturer and in association with the U.S. Food & Drug Administration (FDA).

On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.”
In August 2001, Davol began receiving reports of complications and failures of its hernia mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. The reports also contain descriptions of problems other then memory recoil ring breakage including, “buckled mesh,” “patch shriveling” and “edges curled up,” as well as descriptions of the mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated” and “folded.”

June 2, 2009

Texas Mesothelioma Lawyers, How to File an Asbestos Lawsuit in Texas

by Dr. Shezad Malik

Asbestos is a naturally occurring fiber that, when released into the air, can be inhaled or swallowed. Asbestos fibers are so small that they are not visible to the naked eye. Once they are inhaled, asbestos fibers stay in the body and, over the course of decades, lead to the development of asbestos-related diseases like mesothelioma.

Mesothelioma is rare form of cancer caused by asbestos exposure. An estimated 3,000 Americans are diagnosed with mesothelioma each year, and because the disease takes decades to develop, the rate of new diagnoses is still climbing. The peak incidence of mesothelioma is predicted to occur around 2020.

May 29, 2009

Bausch & Lomb Settles 600 Fungus Law Suits

by Dr. Shezad Malik

Some eye doctors are still hoping that some of the lawsuits over a lens cleaner made by Bausch & Lomb will end up in court, so that the events that led to hundreds of fungal infection lawsuits will be aired publicly.

That has not happened. Over the past year, the company has quietly settled nearly 600 lawsuits, with dozens of individual claims still to be resolved. The cost so far is about $250 million.

May 29, 2009

March 2009 Drug Safety Update Newsletter Raises Emerging Safety Issue Of Kidney-Related Side Effects From Byetta Use

by Dr. Shezad Malik

We reported on Byetta (exenatide) in August 2008, when the FDA issued a MedWatch email alert about six new cases of hemorrhagic pancreatitis and necrotizing pancreatitis that had been reported to FDA since an October 2007 “Dear Doctor” letter about Byetta and acute pancreatitis was sent to doctors in the U.S.

The March 2009 Drug Safety Update newsletter — from drug regulators in the United Kingdom (UK) — included this article, “Exenatide (Byetta): risk of severe pancreatitis and renal failure”. We get some new information about two types of serious side effects associated with Byetta, pancreatitis and renal, or kidney, impairment.

May 28, 2009

Quadriplegic Musician Wins $18 M Verdict Against Ford Motor Co.

by Dr. Shezad Malik

An Oakland musician who was made a quadriplegic in a rollover crash four years ago won an $18.3 million verdict against Ford Motor Co. in federal court.

Dax Pierson, 38, suffered severe spinal injuries when a Ford passenger van that the band was traveling in ran off an icy highway in Iowa and rolled over in a ditch on Feb. 24, 2005.

Pierson sued Ford for creating a defective seat-latching mechanism that caused his seat to come loose, resulting in his head hitting the roof of the rolled-over van.

The $18.3 million jury award came after three weeks of trial in the court of U.S. District Judge Phyllis Hamilton. It includes $12.3 million for past and future medical expenses and lost earnings plus $6 million for pain and suffering.

May 24, 2009

Dangerous Drugs: Hydroxycut Class Actions Filed

by Dr. Shezad Malik

Two class action lawsuits have been filed in the wake of the recall of Hydroxycut, a popular weight-loss supplement that has been linked to liver damage and other life-threatening side effects.

The suits, filed in Canada and Tennessee, accuse Iovate Health Sciences, which manufactures Hydroxycut, of failing to warn of the drug’s dangers or take proper precautions to protect its users.