Product Liability

November 23, 2009

FDA Orders Change to Pain Pump Warning Labels.

Federal regulators are demanding changes to labels on devices that deliver pain killers directly to joints after surgery, in response to numerous reports of irreversible cartilage damage.

The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement.

Companies making pain pumps include I-Flow Corp. and Stryker Corp. Makers of the anesthetics used in pain pumps, such as APP Pharmaceuticals Inc. and Hospira Inc., will also have to update their labels. The firms have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to the FDA.

November 17, 2009

Updated Findings from the Chinese Drywall Report

by Dr. Shezad Malik

The Chinese drywall product liability complaint is now nearly a year old. And while incidents of Chinese drywall being installed in homes have all but stopped, complaints of bloody noses, sinus infections and vomiting spells for pets and people, widespread corrosion and blackening of copper tubing and wiring and “rotten egg” smell continue to escalate. Last spring, the U.S. Consumer Product Safety Commission conducted 44 investigations into consumer complaints about drywall.

November 16, 2009

Study Confirms Increased Blood Clot Risks With Erythropoiesis-Stimulating Drugs

by Dr. Shezad Malik

Cancer patients who took drugs to cut the risk of anemia were twice as likely to develop blood clots in the lungs or legs as other patients, a decade-long study of more than 55,000 cancer patients has found.

The study adds to mounting evidence that the risks of the commonly used drugs — known as erythropoiesis-stimulating agents or ESAs — may outweigh the benefits.

ESAs stimulate bone marrow to increase the production of red blood cells. They were first approved in cancer patients in 1991 to reduce the number of blood transfusions needed during chemotherapy.

November 13, 2009

Dallas Yaz Lawsuit Plaintiffs’ Steering Committee Appointed

by Dr. Shezad Malik

There is progress to report in the Yaz and Yasmin multidistrict litigation (MDL No. 2100) currently underway in U.S. District Court for the Southern District of Illinois. Judge David Herndon, who is overseeing the Yaz and Yasmin MDL, has appointed members to the Plaintiffs’ Steering Committee.

The Plaintiffs’ Steering Committee was appointed by Judge Herndon in an Order dated November 10, 2009.

Dr Shezad Malik will be working closely with the members of the Plaintiffs’ Steering Committee.

November 13, 2009

KTLA: Yaz, Yasmin Birth Control Users Report Serious Problems

by Dr. Shezad Malik

KTLA TV in Los Angeles just ran an investigation and news article into Yaz and Yasmin side effects that folks may be interesting in watching.

Click here for the link.

Read the full article here.

November 13, 2009

Data From Studies of Pfizer Neurontin Drug May Have Been Altered

by Dr. Shezad Malik

Researchers say trials of Pfizer Inc.’s Neurontin epilepsy treatment for uses that were not yet approved may have been altered to emphasize favorable results.

Comparisons of internal company documents with published data from 12 clinical trials found inconsistencies between data that made it into the medical journals and findings from the original trials, according to a report in the New England Journal of Medicine. Discrepancies included reports of positive results from trials that were initially found to be negative, and primary study goals reported as secondary study goals.

November 11, 2009

Toyota Lawsuits by Consumers Over Sudden Acceleration of Vehicles

by Dr. Shezad Malik

– Toyota Motor Corp. has failed to correct a problem with the throttle control system on some of its vehicles, causing them to suddenly accelerate, lawyers for consumers said in a lawsuit.

Los Angeles residents Seong Bae Choi and Chris Chan Park, who claim they experienced multiple instances of unintended acceleration, filed the suit as a class action on Nov. 5, seeking to represent all U.S. owners of certain Toyota and Lexus models.

Toyota last month said it would recall as many as 3.8 million vehicles including Lexus ES luxury cars, Camry sedans and Prius hybrids over a potential flaw in which floor mats shifting out of position could jam the accelerator pedal. The mats aren’t the problem, according to the plaintiff’s lawyer.

November 10, 2009

Dallas Texas Yaz Update: Mass Tort Status for Suits Over Yaz, Yasmin

by Dr. Shezad Malik

The New Jersey judiciary is considering a request from Passaic County judge for mass tort status for suits alleging strokes and other serious health problems from the oral contraceptives Yaz, Yasmin and Ocella.

With 13 suits filed in his court, Assignment Judge Donald Volkert Jr. wrote to Acting Administrative Director of the Courts Glenn Grant on Oct. 22 that “the case management and potential trial of this particular litigation would place a fairly substantial strain on our already limited resources.”

There are 26 suits against the contraceptives’ manufacturers pending in other counties, and Volkert said plaintiffs lawyers have told him the number could reach 1,000.

In a notice to the bar, the Administrative Office of the Courts says it will accept public comments until Dec. 31 on the proposal to centralize the cases in Atlantic, Bergen or Middlesex counties, where mass torts are heard.

November 9, 2009

Light Cigarettes may not help Smokers Quit

by Dr. Shezad Malik

Smokers who want to quit and think a good first step is to switch to light or low-tar cigarettes are making a big mistake. A study has found that those smokers instead have about a 50% lower chance of giving up smoking.

The research, published in the November issue of Tobacco Control, analyzed survey data from about 31,000 smokers who were asked whether they had switched to a milder or low-tar brand of cigarettes and the reasons for the switch. They were queried about whether they had tried to give up smoking and if they could currently call themselves nonsmokers. Those who switched brands were 58% more likely to have attempted to give up smoking than those who stayed with one brand but were 60% less likely to successfully quit.

November 8, 2009

FDA: All-Natural Sex Pill Contains Viagra Chemical

by Dr. Shezad Malik

The US food and drug safety watchdog warned that an over-the-counter men’s sex aid, labeled as all-natural, contains a chemical similar to the active ingredient in Viagra and could be dangerous.

Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal,” the Food and Drug Administration (FDA) said in a statement. Read the full statement here.

The FDA began probing Stiff Nights after receiving a customer complaint about the product. The agency did not reveal the nature of the complaint.

The investigation found that rather than being all-natural, Stiff Nights contains sulfoaildenafil, a chemical similar to the ingredient in Viagra.