Product Liability

July 20, 2009

Fleet Phospho-soda and Acute Phosphate Nephropathy Lawsuits

The use of oral sodium phosphate products, like Fleet Phospho-soda, Visicol and OsmoPrep, to clear out the bowels before a colonoscopy or other medical procedure, have been associated with the development of a rare but serious form of kidney injury known as acute phosphate nephropathy.

The Fleet Phospho-soda attorneys at Dr Shezad Malik Law Firm are investigating potential Acute Phosphate Nephropathy lawsuits for patients who have been diagnosed with the kidney condition after using an over-the-counter Fleet Phospho-soda laxative at high doses for colonoscopy prep.

July 19, 2009

Zicam Lawsuits and the FDA Complaint

by Dr. Shezad Malik

The Food and Drug Administration (FDA) has caught the manufacturers of Zicam and that should force it, to regulate homeopathic products.

FDA regulations require that drugs and treatments be “scientifically proven safe and effective.” Homeopathic remedies, except when people rely on them to treat serious conditions, are usually safe. So far, though, the FDA has ignored the multi-million dollar fraud. But now there is harm.

July 18, 2009

Zicam Matrixx Initiatives, Inc. Investor Class Action Lawsuit

by Dr. Shezad Malik

An investor with Matrixx Initiatives, Inc. the maker of Zicam, has filed a proposed securities class action lawsuit in the United States District Court for the District of Arizona on behalf of shareholders of Matrixx Initiatives, Inc., who purchased Matrixx stock between December 22, 2007 and June 15, 2009, in relation to Matrixx Initiatives alleged violations of FDA regulations involving the Zicam Cold Remedy products.

July 17, 2009

Accutane Lawsuits and Litigation

by Dr. Shezad Malik

Millions of people who have used the prescription acne medication call it a miracle. But the drug also has been the target of lawsuits, federal investigations and scientists who say the drug is overused and that its dangers outweigh its benefits.

But now Accutane is gone. Its maker, Swiss pharmaceutical giant Roche Holding, pulled it from the market last week. The company maintains the drug is safe but says it can’t compete with generic versions that flooded the U.S. market several years ago.

Others say Roche has had trouble shaking off the studies and lawsuits that link it to everything from birth defects to depression. Juries recently awarded at least $33 million in damages to users who blamed the drug for bowel disorders.

“We’ve never advocated this drug being taken off the market,” said Dr. Sidney Wolfe of Public Citizen, a consumer advocacy group that has been vocal about Accutane.

Click here for the Accutane Case List

July 15, 2009

Denture Cream Lawsuits

by Dr. Shezad Malik

U.S. District Judge Cecilia M. Altonaga, who is handling the consolidated Fixodent and Super PoliGrip lawsuits filed over zinc poisoning from denture creams, issued an order designating lawyers to serve in leadership positions in the MDL, or Multidistrict litigation. These denture cream lawyers will perform services that benefit all of the plaintiffs involved in the litigation during the pretrial proceedings.

On June 9, 2009, the Judicial Panel on Multidistrict Litigation centralized all federal denture cream lawsuits before Judge Altonaga in the U.S. District Court for the Southern District of Florida, for coordinated discovery and pretrial litigation.

July 15, 2009

FDA Safety Information and Adverse Event Reporting Program

by Dr. Shezad Malik

MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

July 15, 2009

Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements

by Dr. Shezad Malik

Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company’s five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

July 15, 2009

Rhabdomyolysis and Cholesterol Lowering Drugs

by Dr. Shezad Malik

A serious and potentially fatal muscle condition, known as Rhabdomyolysis, could be caused a number of different prescription medications.

The use of statin drugs, such as Baycol and Crestor, have been linked to side effects of Rhabdomyolysis, and the combination of drugs containing simvastatin, such as Zocor, Vytorin and Simcor, with heart drugs containing amiodarone, such as Cordarone and Pacerone, could increase the risk of the disorder. Recent reports also suggest that the dietary supplement Hydroxycut is associated with reports of rhabdomyolysis.

July 14, 2009

Shoulder Pain Pump Litigation

by Dr. Shezad Malik

The use of intra-articular pumps, also known as pain pumps or pain balls, to deliver medication to the shoulder following arthroscopic shoulder surgery has been linked to the development of a painful and debilitating condition which causes the loss of cartilage in the shoulder. The condition, known as Postarthroscopic Glenohumeral Chondrolysis or PAGCL, has no consistently successful treatment and often results in permanent shoulder pain.

STATUS OF SHOULDER PAIN PUMP LITIGATION: Lawsuits are currently pending and potential cases are still being reviewed by product liability lawyers. Motions have been filed to consolidate all Federal shoulder pain pump lawsuits and transfer the cases to one court for pre-trial proceedings.

July 14, 2009

Gadolinium MRI Dye Linked to Skin Disease

by Dr. Shezad Malik

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.