Complete Warnings Are A Pharmaceutical Necessity

In 2010 the anticoagulant drug Pradaxa, otherwise known as dabigatran etexilate mesylate, was approved by the FDA and introduced to the US market, offering consumers a replacement to existing versions of blood thinning drugs such as Coumadin. Since Pradaxa’s release several dozen consumers from Tennessee, Louisiana, Kentucky, and Connecticut have filed lawsuits alleging injury from the use of the drug, claiming the manufacturer failed to adequately warn consumers of the possibility of the irreversibility of the drugs anticoagulation effects. As of December 2011, the FDA reportedly received over 500 reports of death in the US claimed to be linked to Pradaxa. Despite the product being on the market since late 2010, the manufacturer did not modify its labeling to include warnings of risk of bleeding until January 2012. According to ...
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Not So OraSure: First Over-the-Counter HIV Test Requires Enhanced Labeling

OraSure Technologies Inc. took a step forward in its bid to bring to market its OraQuick In-Home HIV Test.  If approved, OraQuick would be the first over-the-counter HIV test that lets people get results without using a doctor or laboratory.  The FDA Blood Products Advisory Committee unanimously determined that the benefits of the saliva test outweigh the risks.  The primary risk being false negative results.  Final-phase trials of the OraQuick home test are reported to have found 5,384 of 5,385 negative users resulting in one false positive, and 106 of 114 confirmed positive users resulting in eight false negatives.  Reports indicate that OraQuick would potentially produce one false negative result for every 13 true positive tests.  The FDA suggested that the product’s labeling be enhanced to ensure people understand the ...
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New Jersey Mass Tort Court Rejects Brand-Name Liability for Generic Drugs

In a long-awaited and important decision issued on June 26, 2012, New Jersey Superior Court Judge Carol E. Higbee joined dozens of other courts in dismissing pharmaceutical product liability claims against brand-name companies in cases in which plaintiffs had taken generic versions of the drug in question.  Judge Higbee is one of three judges presiding over cases in New Jersey’s Mass Tort Program, in which there are pending approximately one thousand cases where plaintiffs claim they were injured by ingestion of generic versions of the prescription drug metoclopramide, originally marketed under the brand name Reglan®.   In some cases, plaintiffs also ingested the branded version of the drug.  In all of the cases, plaintiffs joined the brand-name manufacturers as defendants.  The brand defendants moved to dismiss. As they have done in ...
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New Jersey Supreme Court Denies Centralized Management for NexGen Flex Products Claims

In a decision apparently made last month but only published at the end of last week, the New Jersey Supreme Court has denied an application for centralized management of all pending state court claims involving certain NexGen Flex knee replacement products.  We noted the pendency of this application earlier this year. Unlike many applications for centralized management or mass tort status in New Jersey that are submitted by plaintiffs — who often seek the procedural and other benefits of coordinated proceedings — the NexGen application was submitted on behalf of the defendants. In rejecting the application, the New Jersey Supreme Court provided no reasons for its decision.  As a result, practioners in this area can glean no guidance from the Court’s action that might inform future applications for centralization.
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Treating Physicians’ Right to Disagree With Their Patients

A recent appellate decision allowed defendants’ retention of experts who previously treated one or more of the hundreds of plaintiffs claiming damages in the pelvic mesh litigation against Johnson & Johnson. The decision in In Re Pelvic Mesh/Gynecare Litigation   should have a positive impact for the defense of mass litigation as well as the development of treating physician fact witness testimony in “ordinary” personal injury and products liability cases.  The Appellate Division rejected plaintiffs’ argument that treating physicians have a broad duty to “refuse affirmative assistance to the patient’s antagonist in litigation.”  Instead, the court “disavow[ed] any suggestion that a physician, or any witness for that matter, has a duty to support substantively a litigant’s claims or defenses.”  The Appellate Division reaffirmed that treating physicians can be compelled to testify as ...
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FDA Releases Guidance on Use of Nanotechnology in Food and Cosmetic Industries

On April 20, 2012 the Food & Drug Administration (FDA) issued for comment two draft guidance documents concerning the use of nanotechnology in food, food packaging and cosmetics. These documents were analyzed in a recent Law360 article (subscription or free trial required) in addition to other legal blogs such as the the FDA Law Blog. The first, entitled “Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives” (available here) “is intended to describe the factors you should consider when determining whether a significant change in manufacturing process for a food substance already in the market:  Affects the identity of the food substance; Affects the safety of the use ...
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New Jersey Court Backs Mensing Preemption

Several weeks ago, we discussed the issue of Mensing generic drug preemption and the anticipated decision from Judge Carol Higbee, who is presiding over the consolidated Reglan and metoclopramide litigation pending in Atlantic County.  As readers may recall, generic preemption is a battleground issue now in pharmaceutical litigation, as generic pharmaceutical defendants seek to take full advantage of the U.S. Supreme Court’s favorable ruling last year in Mensing, and plaintiffs’ attorneys try creatively to limit and narrow the scope of Mensing preemption. Judge Higbee has now ruled, and the result is a good one for defendants:  all counts of the plaintiffs’ complaints against the generic manufacturers are dismissed, with the exception of any claims made against any generic manufacturer of metoclopramide tablets that did not change its label to match ...
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Mensing Update

Recently, we posted about the awaited decision from Judge Carol Higbee in response to the generic defendants’ motion to dismiss the plaintiffs’ claims in the consolidated litigation involving metoclopramide on the basis of the U.S. Supreme Court’s ruling last year in Pliva v. Mensing.  While courts across the country continue to take up and decide this issue – including a very favorable opinion from Judge Danny Reeves in the multi-district litigation involving propoxyphene – generic pharmaceutical manufacturers continue to await a ruling from Judge Higbee.  Elsewhere, legislators such as Senator Leahy have proposed legislation to undo the preemptive effect of the Mensing decision. In the meantime, the growing body of case law from around the country continues to draw interest from commentators, including an interesting article written by M. Sean ...
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New Jersey Mass Tort Program Continues To Expand

New Jersey is known for many things, including an established state court mass tort program.  Currently, there are twenty litigations under centralized management in three different courts (Atlantic, Bergen, and Middlesex Counties) being managed by four separate judges (Hon. Carol Higbee, Hon. Brian Martinotti, Hon. Jessica Mayer, and Hon. Ann McCormick). New Jersey has a specific court rule – Rule 4:38A – that authorizes centralization of cases for coordinated management.  The New Jersey Supreme Court has also promulgated written guidelines for determining whether or not a litigation should receive centralized management. Under the so-called “Mass Tort Guidelines,” the Assignment Judge or any attorney involved in a case or cases may make a written application to the New Jersey Supreme Court, through the Administrative Director of the Courts, for a designation ...
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FDA-Approved Warnings Insufficient to Start Limitations Clock

In Kendall v. Hoffman-LaRoche, Inc., (February 27, 2012), the New Jersey Supreme Court rejected the argument that an FDA-approved warning – entitled to a “superpresumption” of adequacy under the New Jersey Product Liability Act (PLA) – is automatically sufficient to trigger the start of the statute of limitations.  Under New Jersey’s discovery rule, a person’s two-year time window to file a claim for personal injuries, including product liability claims, does not begin to run until s/he knows, or reasonably should know, of the alleged link between the product and the harm.     Kendall involved use of the anti-acne drug Accutane.  The plaintiff first was prescribed the drug in January 1997 when she was 12 years old and received three subsequent courses between July 1997 and September 1998.  In April 1999, while ...
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