Product Liability

August 2, 2009

Defective Drugs: Levaquin Lawsuits and Tendon Rupture

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.

FDA agrees to Public Citizen’s request to issue a “black box” warning in the product label and a guide for patients warning of the dangers of tendinitis and tendon rupture with the fluoroquinolone antibiotics, but fails to send a letter to doctors warning of these dangers.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

August 2, 2009

FDA Warning: NJOY Firm Continues to Sell E-Cigarettes

by Dr. Shezad Malik

NJOY, the electronic cigarette brand based in Scottsdale, will continue to market the tobacco-less devices despite a warning from the Food and Drug Administration that it could pose health risks.

Public health officials said last week that electronic cigarettes, or “e-cigarettes,” may not be such a healthy alternative to traditional cigarettes.

The FDA tested NJOY and another brand. Results showed some of the samples in both brands contained human carcinogens and tobacco impurities suspected of being harmful to humans.

August 1, 2009

Arlington Texas Asbestos Litigation

by Dr. Shezad Malik

The asbestos lawsuits filed in the United States over the past fifty years constitute the longest running mass tort in the country’s history. A tort is defined as a civil action taken based on a negligent or intentional harm done that is not based on contract law.

A Rand Corporation research says that by the end of 2002, about 730,000 individuals claiming physical harm from asbestos exposure had filed suit against about 8,400 corporations and businesses. At that point, about seventy corporations had filed for bankruptcy protection over their asbestos liability.

Today, in 2009 the number of bankruptcy filings has reached one hundred. The number of lawsuits since 2002 are several hundred thousand in number and they have increased each year. Because the diseases caused by asbestos exposure have latency periods of up to fifty years, many people who were exposed to asbestos decades ago are just now getting sick.

August 1, 2009

Defective Drugs: Yaz and Yasmin Birth Control Lawsuits and Increased Risk of Strokes

by Dr. Shezad Malik

Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare. The generic brand Ocella is marketed and distributed by Barr Laboratories, Inc. Yasmin and Yaz contain the same estrogenic compound, ethinyl estradiol, that has been used in the Pill since the 1970s, but the progestin in Yasmin and Yaz is new.

Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin. No other birth control pills contain drospirenone, except for a recently approved generic version of Yasmin and Yaz, called Ocella.

July 31, 2009

Defective Drugs: Byetta Lawsuits and Acute Pancreatitiis

by Dr. Shezad Malik

Byetta which is used to treat Type 2 diabetes, has side effects that could increase the risk of serious and potentially life threatening pancreatitis.

Reports have found an association between Byetta and pancreatitis. Amylin Pharmaceuticals and Eli Lilly & Co., the manufacturers of the defective drug have failed to adequately warn about the risk of the serious and potentially fatal injury.

Byetta lawsuits are being investigated for users diagnosed with:

* Acute Pancreatitis
* Hemorrhagic Pancreatitis
* Necrotizing Pancreatitis
Potential cases are being evaluated throughout the United States.

July 29, 2009

Defective Drug: Yasmin Lawsuits

by Dr. Shezad Malik

Yasmin lawsuits are personal injury cases that seek settlements for women injured after taking Yasmin (drospirenone), a contraceptive pill also prescribed in the treatment of moderate acne and premenstrual dysphoric disorder (PMDD) for menstruating women. Yasmin may also be sold under the brand name Yaz, a form of drospirenone manufactured and distributed by Bayer.

Produced by Berlex Laboratories, Inc., Yasmin has been reported to cause a variety of serious side effects since its FDA approval in May 2001. Women injured after taking Yasmin will likely be entitled to compensation by pursuing a Yasmin lawsuit.

July 29, 2009

Baxter Contaminated Heparin Class Action Lawsuit Still Open

by Dr. Shezad Malik

Patients who were harmed because of heparin contamination still have time to bring claims against the makers of the heparin products. Patients may have been exposed to contaminated heparin through injections, pre-filled syringes or IV bags. It is important for people affected by contaminated heparin to hold those responsible accountable for what happened.

Heparin is a blood thinner, used in a variety of procedures, including dialysis and cardiac procedures. In early 2008, the US Food and Drug Administration (FDA) announced a recall of certain Baxter heparin products after the agency received reports of adverse reactions linked to the products. Within a month, hundreds of reports detailing severe reactions to heparin surfaced worldwide. The recall was later expanded to include more products and other companies.

The FDA discovered that the contaminant was oversulfated chondroitin sulphate (OSCS), the reactions to OSCS can be extreme; with large doses of heparin, it can result in death.

Injuries linked to contaminated heparin include nausea, vomiting and flu-like symptoms to anaphylactic shock, coma and even death.

July 29, 2009

FDA Warns Against Bodybuilding Products Containing Steroids

by Dr. Shezad Malik

Federal regulators warned consumers on Tuesday not to use body-building products that are sold as nutritional supplements but may contain steroids or steroidlike substances, citing reports of acute liver injury and kidney failure.

The Food and Drug Administration said it issued the warning because of increased reports of medical problems in men who had used such products.

But except for naming eight specific supplements sold by a single company, the Food and Drug Administration did not provide much clear guidance to consumers on what other products to avoid. The F.D.A. acknowledged that it did not know how many products its warning affect

July 28, 2009

Defective Drug: Accutane Lawsuits and Inflammatory Bowel Disease

by Dr. Shezad Malik

Accutane has been a controversial acne medication because of the serious risk of side effects and suicides attributed to it. The FDA warned physicians prescribing the acne medication to be aware of any signs of depression their patients might display. Accutane manufacturer Hoffman-LaRoche did not warn patients and healthcare professionals of the potential risks involved with Accutane until after the FDA made this advisement.

In October 2001, Congressman Bart Stupak expressed his concerns about Accutane following the suicide of his son who was taking Accutane. Accutane manufacturer has warned physicians that the acne drug can possibly cause “depression, psychotic symptoms, and rarely suicide attempts,” but still the company maintains they believe the drug is safe. In addition, Accutane carries high risk of serious birth defects, including deformed babies, miscarriage, premature birth, or death of the baby.

July 25, 2009

Fleet Phospate Class Action Lawsuits For Kidney Damage

by Dr. Shezad Malik

If you took an oral sodium phosphate (OSP) to clean your bowels prior to a colonoscopy and have developed kidney damage, there is a chance your health problems are linked to the use of the OSP. In 2008, certain oral sodium phosphates, including OsmoPrep and Visicol were given a black box warning, the highest warning required by the FDA, alerting patients to the risk of kidney damage.

The OsmoPrep and the Visicol are prescription drugs, and there is also an over-the-counter preparation called a Fleet enema. These also have been linked with acute kidney damage when used as bowel preparation for a colonoscopy but not when used as a laxative. In 2008, they were also given a black box warning that warns of the potential risks of renal failure.”

There are some people who are more susceptible to renal failure than others. Some factors that can affect a patient’s susceptibility include having pre-existing kidney damage, being dehydrated while taking the OSP, being on an angiotensin-converting enzyme (ACE) inhibitor while taking the OSP, being on an angiotensin receptor blocker (ARB) while taking the OSP, having increased bowel transit times (such as a bowel obstruction or colitis), or being on a non-steroidal anti-inflammatory drug (NSAID) while taking the OSP. A final risk factor is being 55 years of age or older at the time the OSP is taken.