Kaiser Foundation Health Plan, Inc. successfully finalized a $142.1 damages verdict against Pfizer for off-label promotion of the anti-seizure medication Neurontin. The case was part of a multidistrict litigation (MDL) in the U.S. District Court for the District of Massachusetts (In re Neurontin Marketing, Sales Practice and Product Liability Litigation, MDL-1629) which included third-party payer suits and personal injury lawsuits alleging suicide, attempted suicide and other personal injuries as a result of use of Neurontin. The verdict was affirmed by the U.S. Court of Appeals for the First Circuit in April. This month, the U.S. Supreme Court denied Pfizer's petition for certiorari, effectively finalizing the verdict.
According to a Case Management Order issued on December 17th, Stryker Corp. has settled four lawsuits in New Jersey state court, where more than 500 lawsuits have been consolidated for pretrial proceedings. The settlements were made for an undisclosed amount of money. A recall on Stryker Rejuvenate and ABG II hip implants was announced in July 2012, affecting 20,000 patients worldwide. In addition to the 500+ lawsuits in New Jersey, Stryker faces an additional 400+ lawsuits in federal multi district litigation in U.S. District Court, District of Minnesota.
 In Re Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem Litigation, No. 296 (Bergen County Superior Court, New Jersey)
 In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL No. 2441 (U.S. District Court, District of Minnesota)
On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. Gardasil® is a vaccine recommended for 11-12 year olds in order to prevent human papillomavirus (HPV), a virus that causes cervical cancer. If a person received a vaccine containing glass particles, mild reactions such as swelling at the injection site may occur. The effectiveness of the vaccine is not affected by this problem. The affected vials were distributed between August 20, 2013, and October 9, 2013.
 CDC, "Voluntary Recall of One Lot of Gardasil HPV Vaccine" (December 20, 2013).
Last week Merck & Co., the manufacturer of Gardasil, recalled one lot of the vaccine because a limited number of the vials in the lot may contain glass particles. Gardasil is a vaccine that protects against the human papillomavirus (HPV), a sexually transmitted disease that causes about 70% of cervical cancer cases and 90% of genital warts cases. The affected vials were distributed between Aug. 20 - Oct. 9, 2013. If a patient received a vaccine containing glass, he or she may experience mild redness or swelling near the injection site.
 FDA Biologics Recall of GARDASIL [Dec. 19, 2013]
Novartis Vaccines has implemented a voluntary market recall of one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. This action is being taken following the observation of higher-than-specified levels of residual moisture within a vial in the lot. This residual moisture content is not expected to impact product quality, but constitutes a deviation of the required quality standards and the vaccine is being recalled as a precaution.
 FDA Biologics Recall [Dec. 2, 2013].