Centralized Management Denied for Bayer’s Mirena Claims

In a decision reached earlier this month and posted last week, the New Jersey Supreme Court has denied an application submitted by Bayer HealthCare Pharmaceuticals, Inc. for centralized management of all pending state court actions involving its Mirena contraceptive device.  No reasons for the denial are provided in the notice, so practitioners in this area are left without any guidance as to why the Supreme Court rejected the application.  This is similar to the Supreme Court’s previous denial of centralization of the litigation involving NexGen Flex knee replacement products, as we discussed previously. While the nomenclature for centralized management of cases in New Jersey recently changed, the guidelines have not.  However, in the absence of any explanation from the Supreme Court outlining the basis for its terse decision, it is ...
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The High Risk Game of False Advertising

In today’s ultra-competitive market economy, businesses are not only encouraged to aggressively compete for market share, but must do so if they are going to survive and prosper in the market place.  In the pursuit of economic dominance, manufacturers are sometimes tempted to make unfounded product claims to achieve supremacy in a market industry.  Ironically, making unfounded claims of product superiority and performance may result in market dominance, but in many instances can be financially devastating to the manufacturer.  Particularly in recent years, regulators, courts and lawmakers have been cracking down on false and deceptive product advertising.  Such is the case with the popular diet supplement, Hydroxycut. Hydroxycut has been embroiled in a series of legal battles for the past three years.  In the late 2000’s, Hydroxycut enjoyed a whopping ...
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Pain Pump Marketing Pains Stryker (and others)

A False Claims Act complaint against Stryker Corp., and others, alleges the firms’ marketed pain pumps for off label use that the U.S. Food and Drug Administration had specifically denied.  The False Claims Act dates back to the Civil War and imposes liability on companies (or persons) that defraud government programs.  Stryker and the others are accused of submitting payment claims to federal programs, including Medicare, for unapproved uses of their pain pumps. The orthopedic surgeon that brought the case, as the “relator” or “whistleblower”, worked as a consultant to Stryker at one time.  He claims that he raised concerns about improper product testing before marketing pumps for in-joint use.  He had seen marketing presentations by the various defendants at industry trade shows in which they were marketed for off ...
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Recusal Motion Filed Against Multicounty Litigation Judge

Earlier this week, defendants Hoffman-La Roche Inc. and Roche Laboratories Inc. filed a motion before the Hon. Carol E. Higbee, J.S.C. – the judge to whom virtually all of the Accutane litigation pending in New Jersey state court has been assigned since 2005 – asking Judge Higbee to disqualify herself from further oversight of the Accutane litigation pending before her.  Not surprisingly, this filing has drawn immediate attention from commentators such as the New Jersey Law Journal (registration required) and Law360 (same).   Roche’s brief details a number of examples of what it believes to be indicative of both apparent and actual bias on the part of Judge Higbee in favor of plaintiffs and against Roche.  Given the number of Accutane cases pending before Judge Higbee in Atlantic County (in excess ...
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Energy Crisis: Scrutiny Over the Safety of the Energy Drink Industry Continues

On the heels of an investigation into the possible link between Monster energy drinks and five deaths, the energy drink industry as a whole has been under the legal, administrative and legislative microscope.  Most recently, Senators Dick Durbin and Richard Blumenthal have requested a meeting with the Food and Drug Administration FDA following the reports that 5-Hour Energy may be linked to thirteen deaths in the past four years 5-Hour Energy. Senators Durbin and Blumenthal are no strangers to this issue. In September of 2012, United States Senators Richard Blumenthal and Dick Durbin requested the FDA investigate the ingredients in energy drinks and the potential health effects of caffeine on children and adolescents.  As a result, on October 22, 2012, the FDA stated it was launching an investigation regarding the five ...
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Stay Where You Are: Ruling in Eastern District of New York Keeps State-Law Claims against Generic Drug Manufacturers in Federal Court

In a decision that was seen as a victory for pharmaceutical companies, U.S. District Court Judge William Kuntz denied a remand motion made by a group of plaintiffs suing a number of manufacturers of generic anti-seizure drugs.  The plaintiffs in Bowdrie, et al v. Sun Pharmaceutical Industries, Ltd., et al, 1:12-CV-00853 in the U.S. District Court for the Eastern District of New York, claim that they suffered tissue damage from taking generic anti-seizure drugs manufactured by Sun Pharmaceutical Industries, Inc., Taro Pharmaceuticals USA Inc., and Caraco Pharmaceutical Laboratories Ltd.  The plaintiffs alleged that the defendants neglected their duty to match their products’ labeling with that of their brand-name counterpart.  In denying the plaintiffs’ application to remand the actions to state court, Judge Kuntz found that even though the claims were ...
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Turning the Heat Up on the Energy Drink Industry: Monster Faces New California Class Action Lawsuit

Once again, energy drink industry leader, Monster, finds itself under heightened scrutiny and encumbered with ongoing legal challenges regarding its diverse line of energy drink products Monster.  The most recently filed, Jennifer Wooding vs. Monster Energy Company, Monster Beverage Corporation is a class action suit filed in the California Orange County Superior Court alleging that Monster has failed to warn consumers regarding the ingredient, epigallocatechin-3-gallate (ECGC) which, per the Complaint, is noted as being a   “toxic and potentially lethal ingredient”.  This latest product liability lawsuit against Monster alleges violation of the Unfair Competition Law, violations of Consumers Legal Remedies Act, breach of express warranty, breach of implied warranty and unjust enrichment. The suit is seeking restitution and damages, including punitive damages, as well as an order requiring Monster to launch ...
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Energy Drinks Take Center Stage: Risk Of Litigation For Beverage Manufacturers Heightens Under Scrutiny

Energy drinks are again under the legal microscope.  On the heels of the highly publicized wrongful death suit filed against energy drink titan Monster, involving the death of 14-year old Anais Fournier, a class action was launched in Florida against Vital Pharmaceutical Inc., manufacturer of the energy supplement drink, Redline.  In recent years the caffeine content of energy drinks has caused many to scrutinize the potential affiliated health risks associated with consuming high quantities of caffeine and the necessity for heightened FDA regulations.  Under current FDA regulations, the amount of caffeine found in soda-type beverages does not have to be included on the labeling when it is at concentrations below 02%.  At such levels, the FDA considers the ingredients to be “generally recognized as safe” or GRAS.  However, energy drinks are exempt from this ...
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Another Centralized Pharmaceutical Litigation in New Jersey?

As we have posted about before, New Jersey has an established system for coordinated, centralized litigation involving claims against pharmaceuticals and medical devices.  While the nomenclature has recently changed from “mass tort” to “multicounty litigation” the process and procedures remain the same. A new addition to New Jersey’s lineup of centralized pharmaceutical and medical device litigation may be in the offing:  this week, the New Jersey Judiciary posted an application submitted by Weitz & Luxenberg to formally centralize litigation involving two different hip stems manufactured by New Jersey’s Howmedica Osteonics Corporation d/b/a Stryker Orthopaedics.  Comments to the application are due by November 30, 2012, after which a decision on whether to not to grant the application will be made. According to the application, there are currently 10 filed cases, and ...
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Warning: Liability For Deficient Labels May Extend Beyond Your Own Products

Generally, the duty of care of a manufacturer for product liability is limited to consumers who use the manufacturer’s product.  This duty is based on the theory of strict liability in torts, which requires a plaintiff to prove that the defendant actually manufactured the injurious product.  However, in the pharmaceutical industry, courts are beginning to apply negligence principles to extend liability to persons who did not use the manufacturer’s product. In the 2009 case of Conte v. Wyeth, Inc., the California Court of Appeals held that an individual who suffered injury from a drug produced by a generic drug manufacturer could sue the manufacturer of the name-brand version, even though the individual never used the name-brand manufacturer’s product.  In reaching this conclusion, the court applied the theory of negligent misrepresentation, ...
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