Doctors Who Would Have Prescribed Drug Even With More Specific Warnings Defeats Proximate Cause

While August is still viewed as a quieter one in legal circles, last month saw an important decision from the New Jersey Appellate Division on the vexsome issue of proximate cause in pharmaceutical failure-to-warn cases.  The opinion involved the claims of three Florida residents who sued Hoffman-La Roche in New Jersey over the anti-acne drug Accutane, alleging that they had developed severe cases of inflammatory bowel disease (IBD) after taking the drug and that the warnings as to the risks of IBD were insufficient.   Hoffman-La Roche argued that it was entitled to summary judgment because, among other reasons, the plaintiffs’ doctors testified that they would nevertheless have prescribed Accutane for the plaintiffs even in the face of a more robust warning regarding the possibility of IBD.  In other words, because the doctors ...
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New Jersey Replaces “Mass Torts” with “Multicounty Litigation”

In a move that will likely please defendants facing consolidated litigation in New Jersey, the New Jersey Supreme Court has approved changes to Rule 4:38A — the New Jersey Court Rule that authorizes the centralized management of similar cases — that will term such cases “multicounty litigation” instead of a “mass tort.”  (A complete copy of all forthcoming changes to the New Jersey Court Rules, including Rule 4:38A, is here.)  This change in nomenclature, which is effective as of September 4, 2012, does not provide any substantive change to the criteria and procedures under Rule 4:38A for designation of cases for centralized management.  Nevertheless, to the extent that defendants and their counsel have suggested over the years that the term “mass tort” may negatively imply that a product involved in such cases ...
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Warnings That Work: Pharmaceutical Manufacturer Secures Defendant’s Verdict

On Wednesday, May 30, 2011, a Connecticut federal jury held Pfizer not liable for damages resulting from a wrongful death, allegedly stemming from the decedent’s use of the product, Prempro. Prempro was approved by the FDA in 1994 and used to treat symptoms of menopause as well as prevent osteoporosis. In 2002 several studies raised concerns over the use of Prempro which was linked to unusually high instances of breast cancer. In this action, plaintiff alleged that the decedent’s six year use of the drug was a substantial factor in causing her to develop breast cancer, which ultimately resulted in her death. In issuing its verdict for the defendant, the jury stated that the product was “unavoidably unsafe.”  Fortunately for Pfizer, however, the drug contained sufficient warnings regarding the risks ...
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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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