Product Liability

July 14, 2009

Gadolinium MRI Dye Linked to Skin Disease

A Rhode Island woman has joined 516 other plaintiffs in a massive lawsuit against pharmaceutical companies that make certain dyes used for magnetic resonance imaging (MRI).

The woman, who did not want to be identified, was diagnosed with nephrogenic systemic fibrosis (NSF) in 2006 after being injected with a contrast-agent made with gadolinium . It’s a rare disease that affects people with renal failure, such as kidney disease.

The contrast-agent, or dye, is used during an MRI to help technicians and doctors examine tissue. Patients with healthy kidneys simply flush the gadolinium out. People diagnosed with NSF, however, describe their skin turning wood-like, eventually cracking. The disease can move to organs where it can be fatal.

July 14, 2009

Bayer Sued Over Safety of Birth Control Pills Yaz and Yasmin

by Dr. Shezad Malik

First came the warning letter from the U.S. Food and Drug Administration; now lawsuits.

Bayer HealthCare Pharmaceuticals has been hit with four individual federal lawsuits — three in Ohio, one in Wisconsin — involving the safety of its popular birth control pills Yaz and Yasmin.

The lawsuits — which were filed on July 7, 9 and 10 — come after Bayer reached an agreement with the Food and Drug Administration in 2008 to run a $20 million corrective ad campaign for overstating the benefits of Yaz and downplaying its risks. The FDA had issued Bayer a warning letter about the ads, noting that Yaz actually has additional risks compared to other birth control pills because it contains the progestin drospirenone, which can increase potassium levels.

July 13, 2009

Medtronic Paradigm Recall: Quick-Set Infusion Sets for MiniMed Insulin Pump

by Dr. Shezad Malik

Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death.

The Medtronic Paradigm recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse a diabetes patient from the Medtronic insulin pump. They are usually replaced after three days. Medtronic issued a press release on July 10 alerting users that approximately 2%, or about 60,000 units, from one lot of its infusion sets have a defect that could give too much insulin to the patient.

July 10, 2009

Zicam Lawsuit and the FDA

by Dr. Shezad Malik

Has a Zicam nasal cold remedy robbed you of your sense of smell, and possibly the ability to taste? If so you have probably been stricken with a condition called anosmia – loss of sense of smell, sometimes accompanied by loss of sense of taste – related to the presence of zinc gluconate in Zicam intranasal cold remedies. Like thousands of other people who have used Zicam nasal gel or swabs, you probably had no idea that these products could be so dangerous.

Matrixx Initiatives, Inc. has had to remove several varieties of Zicam nasal cold remedies from the market because of their association with anosmia. The lawyers at our firm are currently representing scores of people in personal injury lawsuits who lost their ability to smell, and in some cases taste, after using a Zicam nasal gel or swab to treat or prevent a cold.

July 8, 2009

Yasmin and Yaz Side Effects

by Dr. Shezad Malik

Yasmin was introduced in 2001 by Berlex Laboratories as a combined hormonal oral contraceptive. After Berlex was acquired by Bayer Healthcare in 2006, they marketed Yaz, which was an identical drug to Yasmin, except that Yasmin contained 30 mcg of ethinyl estradiol, while Yaz contained 20 mcg. Yasmin/Yaz was sold throughout the world but they are linked with problems and side effects.

Side effects such as Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), heart attack, stroke and death were prevalent among women who used Yasmin/Yaz. These problems were linked to drospirenone, which acts as a diuretic related to spironolactone. This causes high potassium levels, called hyperkalemia, which results in serious heart problems and other serious health issues.

July 8, 2009

Litigation Over Johnson & Johnson Antibiotic Levaquin Designated N.J. Mass Tort

by Dr. Shezad Malik

The New Jersey Supreme Court has designated mounting litigation over the Johnson & Johnson antibiotic Levaquin as a mass tort and has assigned it to an Atlantic County, N.J., judge. The suits charge that the drug, which is prescribed for bacterial infections of the lungs, urinary tract and skin, has caused Achilles’ tendon ruptures and other damage.

The plaintiffs law firm that sought mass-tort status, Douglas & London of New York, maintains that the litigation will likely involve thousands of cases with the same defendants, similar complex issues of law and fact, and plaintiffs with a high degree of commonality in their injuries and damages.

The firm, which has filed six Levaquin suits in New Jersey, also said Atlantic County is appropriate because its docket is less crowded than those in Bergen or Middlesex counties, the other venues hearing mass-tort cases.

July 7, 2009

Suicide Warnings for 2 Anti-Smoking Drugs

by Dr. Shezad Malik

Federal drug regulators warned that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users.

But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.

July 6, 2009

Zicam Lawsuit Filed

by Dr. Shezad Malik

Side effects of Zicam Nasal Gel and Nasal Swabs, marketed as an over-the-counter cold remedy, have been associated with the loss of sense of smell and taste, which can be an extremely devastating injury. In June 2009, the FDA required that three Zicam Cold Remedy products be pulled from the market due to reports of more than 130 users losing their sense of smell.

STATUS OF ZICAM LAWSUITS: Hundreds of Zicam lawsuits have been filed on behalf of individuals who lost their sense of taste or smell, and lawyers are continuing to review potential claims.

July 5, 2009

Defective Drugs: Chantix

by Dr. Shezad Malik

Side effects of Chantix could increase the risk of suicide or lead to a number of serious and life-threatening injuries.

The side effects of Chantix are being reviewed for potential lawsuits for individuals who suffered severe physical injury or death which may be related to the use of Chantix. The anti-smoking drug has been linked to a number of psychological side effects and other problems which could be caused by the effect the drug has on the brain.

July 2, 2009

Roche Pulls Accutane Off Market After Jury Verdicts

by Dr. Shezad Malik

Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.