On May 6th, 2019, Martin, Harding & Mazzotti, LLP partner, Rosemarie Riddell Bogdan, was appointed to a leadership position on the Plaintiffs’ Personal Injury Steering Committee in the National Valsartan NDMA contamination litigation (IN RE: Valsartan Products Liability Litigation, MDL No. 2875) pending in federal court in New Jersey. Ms. Bogdan will serve as the Co-Science Chair on the Plaintiff’s Personal Injury Steering Committee.
The Re: Valsartan Products Liability Litigation, MDL No. 2875 centers around the FDA recalls of Valsartan which began in July of 2018 and have continued throughout 2019. The FDA recall came after 22 other countries issued recalls of over 2,300 Valsartan batches. Other batches of “sartan” medications, Losartan and Irbesartan, have been added to the FDA recall list. As of September, 2018, there have been 1,152 individual recalls making this the largest Class 1 drug recall to date.
The medications have been recalled because they contain nitrosamine impurities that don’t meet the FDA’s safety standards. Nitrosamines are organic chemical compounds that are comprised of a nitroso group bonded to an amine. The nitrosamine impurities that have been found are Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Most nitrosamines are carcinogenic. In particular, NDMA, NDEA and NMBA are recognized by the International Agency for Research on Cancer to be carcinogens. NDMA so reliably causes cancer that it is used to create cancer in rats for cancer research.
Over 2 million Americans have received notices in the mail alerting them of the recalls and their potential exposure to a probable carcinogen. Similar warnings have also been issued by the World Health Organization (WHO), Health Canada, the European Medical Association (EMA), and the Hong Kong Department of Health.
Many lawsuits have been filed by patients across the U.S., for strict products liability, manufacturing defect, negligence, fraud, violation of warranties, and other laws relating to the safe sale and distribution of prescription drugs. On February 14, 2019, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order consolidating valsartan products liability lawsuits in the District of New Jersey. This process is intended to serve the convenience of the parties, witnesses, and the judicial system, and to reduce duplicative discovery, and avoid conflicting pretrial schedules. Future cases filed by patients claiming injuries caused by the contaminated Valsartan will be transferred or sued directly into the MDL. This MDL is comprised of both personal injury cases, as well as class actions. The MDL includes all manufacturers of the recalled valsartan. A list of the medications that have been recalled can be found on the FDA’s website.
Martin, Harding & Mazzotti, LLP® is a personal injury law firm whose practice is limited to protecting the rights of those wrongfully injured as a result of negligence. If you or a loved one have been injured, you can call our experienced team of attorneys toll-free at 1.800.LAW.1010 (1-800-529-1010).