Archive for the ‘pharmaceutical litigation’ Category

Tysabri, a drug made by Biogen Idec Inc., to treat multiple sclerosis, has been linked to progressive multifocal leukoencephalopathy (PML), a rare and often lethal brain infection.  The new case of PML linked to Tysabri was reported on June 23rd, and is the ninth such case reported since the drug was put back on the market in July 2006.  Biogen stated it will no longer report individual cases of Tysabri PML infections, but will keep a weekly update on its website.

Tysabri was approved by the Food and Drug Administration (”FDA”) in 2004 to treat multiple sclerosis. It was recalled in 2005 after three patients suffered PML infections; two of those infections were fatal.  The FDA reintroduced Tysabri in July 2006 with stronger warnings about side effects, and doctors were warned to use strict guidelines to limit the risk of infections.

PML is a brain infection that causes inflammation to the white matter of the brain.  Certain brain functions disintegrate, and the patient can die.  Even if the infection is discovered early, it could still lead to impaired speech, loss of vision, paralysis, and cognitive decline.

The psoriasis drug Raptiva was recalled in April due to PML infections, and the cancer drug Rituxan has been linked to 57 cases of the infection.

For more information on Raptiva lawsuits or a Tysabri lawyer, contact Bernstein Liebhard for a free and confidential consultation.

The Associated Press (“AP”) is reporting that over 800 homeopathic ingredients have been linked to health problems in the past year.  Homeopathic ingredients are highly diluted drugs made from natural ingredients, and are sold as treatments for various ailments.  Due to the recent Food and Drug Administration Zicam warning, a homeopathic cold remedy that has been named a possible cause of a permanent loss of smell in users, the FDA’s lax regulation over homeopathic remedies has been questioned.

Because homeopathic remedies are diluted and natural, they don’t require FDA safety checks.  FDA safety checks are essential for monitoring product concentration, the presence of alcohol in remedies, and the use of any dangerous ingredients.  The recent problems discovered in homeopathic remedies like Zicam and Hydroxycut, a weight-loss supplement that triggered an FDA warning this year, possibly could have been discovered through FDA safety checks.

Investigators are also examining the marketing practices used for drugs such as Zicam and Hydroxycut.  Even before the FDA took action, the Federal Trade Commission began an investigation on whether Zicam was deceptively marketed, and the Better Business Bureau took similar action for both Zicam and Hydroxycut.

Homeopathic drugs are often marketed for vague, broad symptoms, and as such it is difficult to establish their effectiveness. Still, some people swear by the remedies, and the homeopathic drug market brought in over $830 million last year in sales to almost 4 million Americans.

If you have been harmed after using a homeopathic remedy, you may be entitled to file a claim.  Contact an experienced Zicam lawyer or Hydroxycut lawyer today for a free claim evaluation.

Approximately 58 billion dollars worth of privately funded prescription drug research is currently being conducted, which makes it nearly impossible for medical journals to assess and publish the clincial tests or their findings. For this reason, there are a large amount of clinical tests that are never made publically available, and clinical tests results that are unpublished may be the result of deals struck between the medical journals and pharmaceutical companies.

Medical experts at UCSF and the University of Washington have discovered that only slightly more than fifty percent of Food and Drug Administration (”FDA”) filings involving new drugs are published, and only 20% of clinical trials for cancer drugs are ever disclosed in a medical journal.  While all of the clinical trial data must be submitted to and read by the FDA, some medical policy analysts worry that failure to publish cinical trial results could lead to dangerous situations in which the public does not have adequate information about new drug side effects.

Also, researchers reviewing the FDA’s paperwork have discovered that in some clinical trials submitted for publication, results were changed and outcomes altered to make the drugs look more effective.  In 75% of the cases in which clinical trials were altered before publication, the published version of the study was more favorable and side effects were not accurately described.

But those concerned about seeing the accurate and complete results of clinical tests now have the option to do so. The FDA has imposed more stringent reporting requirements, and researchers will be forced to publish their basic results on a federal online registry maintained by the National Library of Medicine. That registry can be found at www.ClinicalTrials.gov and has already logged 65,000 studies to help create transparency between researchers and the public.

On June 22, lawyers filed a Zicam lawsuit in Arizona on behalf of 117 people who suffered adverse reactions to Zicam cold remedies, including Zicam nasal spray and Zicam swabs.  Zicam was recently recalled after the Food and Drug Administration warned that the cold remedy could lead to anosmia, or loss of smell, and that the side effects could be permanent.  The lawsuit was filed against Matrixx Initiatives, and among those suing the company is an upscale Las Vegas chef who can no longer smell or taste food.
     Matrixx has already settled 340 Zicam lawsuits for $12 million dollars to avoid the cost of defending each individual lawsuit.  While Matrixx maintains that Zicam does not cause anosmia, William Hemelt, Matrixx’s active president, recognized that the company is particularly vulnerable to lawsuits.
     If you or someone you love has suffered a loss of smell after using Zicam, you may be entitled to file a Zicam lawsuit.  Contact a Bernstein Liebhard Zicam lawyer for a free claim evaluation.

The Wall Street Journal and other news outlets are reporting that on June 19, Zicam manufacturer Matrixx Inc. received an informal inquiry from the Securities and Exchange Commission regarding its line of recently recalled Zicam cold remedy products.  As we reported previously, Matrixx recalled Zicam nasal spray and swabs after the Food and Drug Administration (“FDA”) received over 30 reports that the products could lead to anosmia, or loss of smell, and that these side effects could be permanent. 

According to the Wall Street Journal, the SEC is asking for documents related to the FDA warning letter sent on June 16.  This letter contained the FDA’s concerns that Zicam could lead to anosmia.  The product was recalled the next day.  A Matrixx spokesperson says that the company will fully comply with the SEC request.

Zicam lawyers are currently investigating potential Zicam lawsuits and some Zicam lawsuits have already been filed.  Bernstein Liebhard lawyers are available for a free legal consultation about potential Zicam claims.

     Matrixx Initiatives Inc., manufacturer of Zicam brand cold remedies, failed to turn over 800 consumer complaints of serious side effects to the Food and Drug Administration (“FDA”) over a period of two years.  The FDA recently issued a Zicam warning after it received 130 complaints directly from doctors and consumers linking Zicam swabs and nasal sprays to anosmia, or loss of smell.  The FDA does not know whether these Zicam side effects are permanent, and the side effects can occur after just one use of Zicam products.
     A 2007 mandate from the FDA required all companies to turn over any consumer complaints linking food or drug products to serious side effects.  However, Matrixx maintains that the 2007 regulation does not apply to it because Zicam is a cold remedy, not a drug, and therefore not subject to FDA regulation.  FDA spokespeople have asserted that Matrixx was bound by the 2007 government directive.
     Several Zicam lawsuits have already been filed, and that number is expected to grow in the upcoming months.  If you or someone you love has suffered a loss of smell after using Zicam nasal sprays or swabs, you may be entitled to compensation.  Contact an experienced Zicam lawyer.

By order dated June 9, 2009, the Judicial Panel on Multidistrict Litigation (JPML) centralized In re: Denture Cream Product Liability Litigation, MDL-2051, in the Southern District of Florida before Judge Cecilia M. Altonaga, who the JPML said “has the time and experience to steer this litigation on a prudent course.”  The transfer order and MDL denture cream updates are available in the ConsumerInjuryLawyers news section.

The JPML concluded that transfer under “Section 1407 will eliminate duplicative discovery; prevent inconsistent pretrial rulings; conserve the resources of the parties, their counsel and the judiciary.”  The court highlighted that “[t]hese actions share questions of fact arising out of the allegation that the levels of zinc contained in certain brands of denture cream can cause copper deficiency and neurological injuries.”

Bernstein Liebhard’s denture cream lawyers are pursuing denture cream lawsuits against the manufacturers of Poligrip and Fixodent.  We are also actively accepting denture cream case referrals and co-counsel relationships.  Our work on the denture cream litiagion has been the focus of media coverage, including Good Morning America.

The Hydroxycut litigation is starting to heat up with the filing of class actions, personal injury actions, claims against the distributors of Hydroxycut and the issuance of product codes by the manufacturer.

Hydroxycut Class Actions

One of the first filed Hydroxycut class actions over the Hydroxycut recall was in Canada (even though Hydroxycut reportedly was not even sold in Canada).  More recently, a Hydroxycut class action lawsuitwas filed in federal court in the Middle District of Tennessee on behalf of six people who purchased Hydroxycut prior to the recall on May 1, 2009.  The lawsuit was filed on May 20, 2009 and and claims that the six plaintiffs, all of whom are residents of Tennessee, spent between $20 and $5,000 on Hydroxycut supplements before they were removed from the market.

The Tennessee consumer class action seeks economic and personal injury damages (e.g., return of the money consumers spent on Hydroxycut).  The complaint alleges that the manufacturer and distributor, Iovate, knew or reasonably should have known, of the potential Hydroxycut side effects and should be prevented from profiting on the sale of the defective and dangerous supplements.  While the class action names various personal injury causes of actions, those claims are rarely, if ever these days, certified as a class action.

Hydroxycut Personal Injury Actions

Individual Hydroxycut lawsuitsallegeging personal injuries are now being filed by Hydroxycut lawyers.  A lawsuit was filed on behalf of a 28-year old Wisconsin man who suffered acute hepatitis with necrosis of the liver, allegedly from Hydroxycut.  The lawsuit alleges failure to warn and other state law claims.  The range of injuries in these types of lawsuits over Hydroxycut include claims of liver damage, cardiovascular injuries such as heart attacks and strokes, and rhabdomyolysis, an acute muscle tissue breakdown that can trigger liver and kidney damage.

Hydroxycut Product Code Labels

The company has now disclosed the specific product labels for the recalled products.  Unused products can be returned to most wholesalers, including GNC.  The list of recalled Hydroxycut products by Universal Product Codes include:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2×60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets

The JPML has denied the request by a number of plaintiffs counsel in the Reglan litigation to centralize the federal cases before a single district court judge for pretrial litigation purposes.  This means that at least for now, the cases will continue to be litigated in various courts around the country.  During oral argument before the JPML in Louisville, Kentucky in late May, moving counsel argued that a flood gate of Reglan (and generic version) cases were coming.  The court apparently decided to wait to centralize the cases to see if that claim proves true.  Click here to view the order.