Lieff Cabraser: Consumer Law Newsletter Issue No. 6

Consumer Law Newsletter:
Issue No. 6

October 9, 2001

Top News

Anti-Cholesterol Drug Linked To Life-Threatening Muscle Injury and Other Serious Side Effects
New Artificial Hip Implant Recall Announced
Lawsuit Claims Wal-Mart Compels Employees To Work "Off-The-Clock"

Introduction

The Consumer Law Newsletter is published quarterly by the national law firm of Lieff Cabraser Heimann & Bernstein, LLP. The Newsletter is sent to persons who have contacted our firm via the internet and provided their e-mail address. We hope you find the Newsletter of interest.

Top News

Anti-Cholesterol Drug Linked To Life-Threatening Muscle Injury and Other Serious Side Effects

On August 8, 2001, the Food and Drug Administration (FDA) announced that Bayer, the manufacturer of Baycol, was removing the drug from the market because of 31 reports of fatal rhabdomyolysis. Many of these victims were senior citizens. In Europe, it was reported that 21 additional persons died after ingesting Baycol.

Rhabdomyolysis is a potentially life-threatening condition that occurs when a large number of skeletal muscle cells die, resulting in the release of a massive amount of muscle protein (known as myogloblin) into the bloodstream. The muscle protein can become trapped in the kidneys, clogging up the filtering processes of the kidneys and leading to kidney or renal failure. In addition, potassium released from the damaged muscle cells can cause malignant heart rhythms resulting in cardiac arrest.

Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury.

Although fatal rhabdomyolysis is an extremely rare drug side effect, almost 11 million prescriptions of Baycol were written in the U.S. from its approval in 1997 to its 2001 withdrawal. The FDA recommends that all persons who were prescribed Baycol consult with their physician to discuss alternative cholesterol-reducing medications.

The recall of Baycol has led to questions and governmental inquiries worldwide as to when Bayer was first aware that fatal side effects were associated with Baycol, and whether it failed to timely inform public health authorities of these side effects. In the United States, the FDA does not provide any compensation to persons injured by recalled drugs. Thus, since the recall, many lawsuits have been filed against Bayer for strict liability for failure to warn, negligence and wrongful death.

The principal allegations in these lawsuits is that following Baycol's introduction, Bayer began receiving mounting clinical evidence and reports from physicians of serious side effects with the drug. Furthermore, Bayer allegedly pushed for FDA approval of higher dosages of Baycol despite clinical indications that adverse effects were linked to higher doses in clinical trials. At the same time, Bayer marketed Baycol as safe and highly effective. Presently, these lawsuits are at their initial stages, and Bayer has announced its intention to oppose any claims for damages.

Commenting on the Baycol litigation, Lieff Cabraser partner Donald C. Arbitblit stated, "We hope these actions, in addition to providing compensation for the injured patients' medical expenses and pain and suffering, will deter Bayer and other pharmaceutical manufacturers from aggressively promoting prescription drugs that pose grave risks, while offering no unique health benefits compared to other drugs on the market."

Lieff Cabraser is representing persons nationwide in individual lawsuits who were prescribed Baycol and suffered serious side effects.

New Artificial Hip Implant Recall Announced

On September 14, 2001, the FDA announced that eight U.S. firms will be recalling a component part of certain hip implants. The component, known as the zirconia ceramic femoral head, was recalled by its French manufacturer, St. Gobain Desmarquest, one month earlier because it was fracturing at a higher rate than expected.

It is not expected that all the recalled hips will break, and the FDA does not recommend surgery for patients whose implants have not failed. However, there is also no way to predict which hip implants will fracture. Symptoms of a fractured zirconia ceramic femoral head include hip pain, a sensation of grinding, or limitation of motion. The fracture is sometimes preceded by an audible pop. The at-risk hips tend to break between 19 and 28 months after they have been implanted. St. Gobain Desmarquest distributes zirconia heads worldwide to most of the orthopedic industry.

It is estimated that six percent of the approximately 200,000 persons that annually receive an artificial hip implant received one containing the recalled zirconia head. The recall applies to zirconia heads manufactured since January 1998.

The zirconia head recall is the second significant medical devices recall within one year, following the Sulzer Orthopedics hip recall announced in December 2000 that affected almost 32,000 patients, most in the United States. Lieff Cabraser is a leader in the Sulzer hip cases.

Lawsuit Claims Wal-Mart Compels Employees To Work "Off-The-Clock"

When Maria Gamble of Suffolk County, New York, worked at Wal-Mart Stores as a customer service manager, her supervisors locked her in the store with her co-employees after the store closed when all employees were "off-the-clock." "We were routinely expected to work at times when we were not paid," explained Gamble. "The worst part of this was we were locked in the store at night. Every week, I worked at least one shift that went from 2 p.m. to 10 p.m. or 3 p.m. to 11 p.m. When the store closed at the end of my shift, the manager or the person closing the store would lock the exterior doors while the hourly employees like me would have to remain in the store and restock merchandise and count out the cash registers, even though we had already clocked off and were not getting paid."

On August 9, 2001, Lieff Cabraser filed a class action lawsuit in New York state court charging that Wal-Mart Stores has engaged in unfair employment practices. The suit was filed on behalf of a proposed class of approximately 20,000 current and past Wal-Mart employees in New York State.

Among the allegations in the complaint are that Wal-Mart provides bonus and other incentives for managers to lower overhead costs, the largest component of which is employee payroll. Consequently, managers chronically under-staff projects and Wal-Mart stores in general. These efforts ultimately force employees to work off-the-clock and through lunch and rest breaks.

To read more about Ms. Gamble's experiences and this lawsuit, please visit our Wal-Mart case page. While the case was brought on behalf of New York Wal-Mart employees, similar allegations have been made against Wal-Mart in other states and we are investigating these claims.