Archive for the ‘mass torts’ Category

A class action lawsuit has been filed in federal court in California on behalf of individuals who used Hydroxycut products that were recalled by the FDA on May 1. The recall encouraged consumers to discontinue use of at least 14 different versions of Hydroxycut due to its adverse effects on the body, including liver damage, seizures, heart problems, blood toxicity and various other conditions, including a rare form of muscle damage known as rhabdomyolysis. Effects of Hydroxycut, which accounts for 90% in sales of weight loss products, are not only severe, but have already resulted in one fatality.

The lawsuit is the second Hydroxycut class action suit filed in the U.S. The claim alleges that the makers, Iovate, made fraudulent, false and misleading statements, violated trade practice laws and profited off of the sale of a product about which they made unsupported claims of its safety and effectiveness. If you or a loved one has used Hydroxycut, you may be entitled to file a Hydroxycut lawsuit. For more information contact us.

Medication adherence, which is really the extent to which patients take medication as prescribed by their doctors, is important to the medication’s effectiveness to cure and treat the particular illness.  Poor medication adherence can have a particularly negative impact on the medication’s ability to treat many diseases, causing more severe complications from the illness and decreased quality of life for patients.   Many factors cause poor adherence; the most common ones being the inability to pay for medications, lack of belief that the treatment is necessary or helping, busy schedules, forgetfulness, and confusion about how and when to take the medication.

The Food Drug Administration recently published an article on its website, which discusses the importance of medication adherence and provides tips on how to take different types of medication correctly.  For example, when taking antibiotics, the FDA warns strict medication adherence is vital.  If antibiotics are not taken as prescribed by the doctor, a small number of bacteria is likely to survive and continue to replicate and become resistant to the antibiotics.  The same reasoning goes for the HIV virus.  When patients with AIDS skip or stop taking their prescribed medication, they might develop strains of HIV that are more resistant to the prescribed medication and even some medications that patients aren’t currently on.

The FDA advises people to communicate with their doctors or pharmacists if they are experiencing side effects of their prescribed medication and understand how long they need to take the medication.  Setting a daily routine to take medication, keeping medications in noticeable places, using daily dosing containers, and keeping written or computerized schedules are all good ways to help people remember to take their medication.

Ultimately, if there is ever an issue of negligence, consumers want to make sure it is medical negligence outside of their control and not negligence of their own.  Making sure you properly take medications, at least according to the FDA, is an important consumer health issue.

Several skin care products, marketed under various brand names, have been recalled after inspections revealed high levels of bacterial contamination. Clarcon Biological Chemistry Lab Inc., of Roy, Utah, recalled several of its skin sanitizer and skin protectant products which were discovered to contain bacteria capable of causing opportunistic infections of the skin and underlying tissue. On June 8, the U.S. Food and Drug Administration issued a Clarcon warning to all consumers to refrain from using any Clarcon products.

The results of the inspection contradict what Clarcon Labs promises its consumers.  The company promises its users skin care products that will safely protect and enhance the skin. Even more alarming, results of the inspection proved the existence of high levels of bacteria within products marketed as antimicrobial agents that claim “to treat open wounds, damaged skin, and protect against various infectious diseases,” the FDA’s statement reported. Use of these products should be discontinued and the products thrown away. Read more for a list of Clarcon products affected by the recall.

Six weeks after the US Food and Drug Administration recalled units of Hydroxycut products, the UK’s Food Standards Agency (FSA) issued warnings against use of the weight loss supplements. The US recall brought to light the loose standards applied to the dietary supplements industry, an industry often accused of being unregulated and providing unsafe products for consumers. Hydroxycut, a highly popular and commercialized weight loss product within the US, was recalled after studies showed ingredients within the supplement cause severe liver damage and other potentially fatal health complications.

The ingredient directly responsible for these adverse effects is still unknown. The UK delay on issuing warnings on the product was a result of investigations of the two different formulas sold in the US and the UK.  However, concerns about the Hydroxycut products increased since both formulas are available for sale in the UK. Retailers contacted Tropicana Health & Fitness, distributor of Hydroxycut within the UK, concerning the adverse side effects associated with use of the product once the US warning was issued. Tropicana, however, did not directly address these concerns and said it was in talks with Iovate Health Sciences, the North American distributor. Although Tropicana does not sell the US formula, it eventually acknowledged customer confusion among the two products and voluntarily agreed to suspend sales after the FSA issued its warning.

The FSA ultimately decided to take precautionary action and issued warnings against the use of 14 products in the Hydroxycut line.  The FSA warning covers the same 14 products recalled in the US, Finland, Canada, and Ireland. Read more for Hydroxycut lawsuits.

If you’re like me, you probably assume that vitamin and herbal supplements are good for you and don’t think there are any risks involved with these so-called “natural” products.  However, testing over the past decade has shown that we’re both wrong.  We recently reported on quality problems in the supplements market.  The most recent controversy over supplements was the recall of Hydroxycut, a popular diet supplement.

ConsumerLab.com, an independent company that tests pills for manufacturers that want its seal of approval, and publishes ratings for subscribers, has found that one quarter of the supplements tested have had some form of quality problem.  Sometimes the supplements contained ingredients that did not match what the label stated, ranging from contaminants that were not listed to ingredients that either fell short of the amount claimed or exceeded safe limits.  Other “natural” supplements in reality contained hidden prescription drugs, which can sometimes pose significant health risks. 

Diet pills have been frequently used supplements in our society over the past decade or so, but these do not come without risk either.  A popular diet drug called ephedra was banned by the FDA in 2004 after it was found to cause serious heart problems, seizures, and even deaths.  On May 1, 2009, the FDA warned consumers to stop using Hydroxycut diet pills after receiving 23 reports of Hydroxycut side effects, including liver damage, jaundice, seizures, cardiovascular disorders, and rhabdomyolisis, a type of muscle damage that can lead to other serious health problems such as kidney failure. 

Consumers should be careful in choosing their dietary supplements to avoid these quality problems, and be aware of their options if they have suffered the ill effects of these hidden dangers.  Some harmful side effects may give rise to legal action, such as Hydroxycut lawsuits.  For more information, contact a Hydroxycut lawyer today.

Pharmaceutical companies pay $995 a pop to send employees to a course to help their employees avoid the attention of Food and Drug Administration (FDA) investigators, prosecutors, and products liabilities attorneys.  The course, entitled “Dangerous Documents: Avoiding Land Mines in your FDA Records and Emails,” is apparently offered by the Medical Technology Learning Institute and Compliance Alliance, and has been attended by Allegan, Inc., Sepracor, Inc., Varian Medical Systems, Inc., Siemens AG, and Medtronic, Inc., the manufacturer of the InFuse Bone Graft, which has been the subject of off-labeling marketing inquiries.

Nancy Singer of the Compliance Alliance developed the course while working as counsel for a device firm. “I noticed that employees at the firm did not understand how a plaintiff’s lawyer could use their emails and other documents to the firm’s detriment if the firm was ever sued in a products liability action,” she said.  The “Dangerous Documents” seminar teaches companies to avoid any written communications whenever possible, and to use vague language that cannot be connected to any potentially illegal activity that the company is conducting.  The seminar also teaches what FDA investigators search when reviewing documents, words that attract the attention of prosecutors, the kind of information that should never be included in written documents, and practices that are likely to alert the attention of investigators.  By attending the seminar, corporate drug manufacturers learn how to placate government officials, and in the process, avoid lawsuits.

One example of such a lawsuit resulting from careless documentation is the Microsoft antitrust lawsuit of 1996.  Government lawyers found a memo from an AOL executive recounting a meeting in which Bill Gates said, “How much do we need to pay you to screw Netscape.”  The memo was used in the antitrust case against the company, which Microsoft eventually lost. 

As companies become aware of the tactics of prosecutors and plaintiff’s attorneys, whistleblowers will become invaluable to uncovering corporate fraud.  If you have knowledge of corporate activity that violates an FDA policy or any governmental regulation, you could bring a civil lawsuit on behalf of the government and collect a portion of the damages.  These are called whistleblower lawsuits, and are authorized by the False Claims Act (“FCA”).  FCA whistleblower lawsuits could lead to a reward for the whistleblower of up to 15-30% of the damages awarded by a judge.

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.

On Monday, five Oregon Army National Guard soldiers filed lawsuits in federal court in Oregon against a war contractor, Kellogg, Brown & Root (KBR), alleging that KBR knowingly exposed them to a cancer-causing chemical, chromium, during their tours in Iraq. 

The soldiers allege that they were exposed to chromium at the Qarmat Ali water treatment plant in Iraq in May 2003.  The soldiers were charged with protecting civilian employees working at the treatment plant, which was a key part of the Iraqi oil production. 

The lawsuits allege that KBR of Houston knew the site was contaminated by hexavalent chromium, a highly toxic and long-identified carcinogen, before the solders arrived.  The lawsuits claim that KBR either failed to do the required testing at the treatment plant or destroyed the records regarding treatment and further discounted soldiers’ and civilians’ bloody noses and other symptoms of chromium exposure as sand allergies.

In addition to the cases filed in Oregon, cases are expected to be brought by soldiers from West Virginia who have been exposed to chromium.  Last year, 15 Indiana National Guard members who replaced the Oregon troops at the water planed filed similar lawsuits.  Various KBR employees also brought cases, but their cases are being handled in arbitration.

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.