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On April 20, 2012 the Food & Drug Administration (FDA) issued for comment two draft guidance documents concerning the use of nanotechnology in food, food packaging and cosmetics.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 ...
Continue Reading...


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 ...
Continue Reading...

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 ...
Continue Reading...

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 ...
Continue Reading...

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 ...
Continue Reading...

Mensing Generic Preemption Decision Awaited in New Jersey

In 2011, the US Supreme Court’s landmark decision in PLIVA v. Mensing altered the world of pharmaceutical product liability litigation, holding that claims challenging the adequacy of warnings provided by generic drug makers were preempted.  The basic underpinning of the Supreme Court’s opinion was that, under federal law, a generic pharmaceutical had to be the same — and provide the same warnings — as the branded drug, and that any deviation by a generic manufacturer would run afoul of federal law.  Mensing involved claims against makers of metoclopramide – the generic version of Reglan – that the plaintiffs allege caused them to develop tardive dyskinesia, a disorder characterized by involuntary, repetitive facial grimaces and tongue and limb movements. In the months that have followed since Mensing was decided, many courts around ...
Continue Reading...