On July 24, 2013, GlaxoSmithKline (GSK) announced a settlement in principle with the Attorneys General of eight states related to the development and marketing of Avandia and a separate settlement with the Attorney General of Louisiana totaling $229 million. GSK previously paid $3 billion to settle civil and criminal allegations related to the marketing of Avandia and other company products.
In response to a False Claims Act qui tam complaint unsealed in March 2013, Warner Chilcott filed a motion to dismiss and memorandum of law in support in August 2013. Relying in part on United States ex rel. Rost v. Pfizer, 507 F.3d 720, 727(1st Cir. 2007), the memorandum of law argues that the complaint fails to state any factual allegations that Warner Chilcott’s alleged conduct caused “even a single physician” to write a prescription that was submitted for reimbursement to a federal health care program. The memorandum of law also argues that the relators failed to allege facts that the alleged conduct was a “substantial factor” in the submission of any false claim. Further, the memorandum of law argues that the following allegations should be dismissed: (i) allegations related to conduct prior to March 30, 2005 based on the statute of limitations because the alleged conduct occurred more than six years prior to the filing of the March 2011 original complaint; and (ii) allegations related to conduct prior to November 19, 2006 that are “materially different” than those alleged in the original complaint because they do not relate back to the filing of the original complaint. A response from the relators is expected.
Johnson & Johnson announced in a recent Securities and Exchange Commission (SEC) filing that its Janssen Pharmaceuticals, Inc. unit received a subpoena in May 2013 from the Atlanta Regional Office of the Department of Health and Human Services, Office of Inspector General, seeking production of documents and information regarding: (1) the sales, marketing and promotional practices, including remuneration to health care providers, related to Nucynta IR and Nucynta ER; and (2) any studies, reports and/or complaints regarding the safety and/or actual or potential side effects of Nucynta IR and Nucynta ER.