Legislators Take Aim at Popular Dietary Supplement

On January 22, 2013, Senator Jeffrey Klein of New York set forth proposed legislation which would ban the sale and use of products containing the popular dietary compound Dimethylhexaneamine (DMAA) in the state of New York. Over the past several years, the use of DMAA  has become a hot topic for legislators and plaintiffs’ lawyers following criticism that the compound is not a “natural compound,” as marketed, and that it has led to several serious consumer health issues. The criticism helped spark a string of…
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Labeling Inequality: FDA May Attempt To Overrule Mensing on Its Own

The Food and Drug Administration has indicated that it may allow generic drug manufacturers to alter their labeling.  The motivation for this change appears to be to address perceived inequalities stemming from the United States Supreme Court’s decision in Pilva v. Mensing, 131 S. Ct. 2567 (2011). In the Mensing decision, the Supreme Court held that patients who claim injury from generic drugs cannot sue the manufacturer for failure to warn because its labeling must match the labeling of the brand-name version of the…
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Stryker Hip Stem Claims Latest Multicounty Litigation in New Jersey

Earlier this month, the New Jersey Supreme Court granted an application to centralize all New Jersey state court claims involving Stryker Rejuvenate Hip Stems and ABG II Modular Hip Stems before the Hon. Brian Martinotti in Bergen County. Unlike the recent applications for centralizations of claims involving the Mirena contraceptive device and certain NexGen knee implant products — which were both denied (as we previously noted here and here) — the application for centralization of the Stryker Hip Stems claims was submitted by plaintiffs’…
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Football and Prescription Drugs – A Dangerous Combination

A former college football player for the University of Southern California, named Armond Armstead, has filed suit against the university founded upon allegations it improperly supplied players with painkillers to enable them to play in games.  Armstead, who played football for USC from 2008 to 2010, claims team doctors provided him with painkillers intended to be used for short-term treatment of post-operative pain in hospitals.  The use of these painkillers, according to Armstead, enabled him to play in games but also caused him to…
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Arguments Held on Roche Motion to Recuse

Last month, we noted that defendants Hoffman-La Roche Inc. and Roche Laboratories filed a motion seeking the recusal of Judge Carol Higbee, the New Jersey State Court judge before whom virtually all claims involving Accutane pending in New Jersey have been centralized since 2005.  As reported in Law360 (registration required), arguments were held yesterday before Judge Higbee with respect to Roche’s motion.   A decision from Judge Higbee continues to be awaited with great interest.…
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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…
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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…
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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”…
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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…
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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…
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