Litigation Round-up

Settlements

The U.S. Department of Justice (DOJ) announced on Friday that it reached a nearly $5.5 million settlement with Abbott Laboratories to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products.  The alleged kickbacks included teaching assignments, speaking engagements and conferences with the expectation that these physicians would arrange for the hospitals with which they were affiliated to purchase Abbott’s products.  The settlement is a result of a qui tam whistleblower lawsuit filed by former Abbott employees Steven Peters and Douglas Gray.

As we told you about here, the DOJ announced that it had reached a global settlement with Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals and Scios Inc., for $2.2 billion to resolve criminal and civil liability relating to the prescription drugs Risperdal, Invega and Natrecor.    

Pfizer Inc. and Mylan Specialty LP reached settlements with the State Attorney General of Massachusetts related to a 60-second TV commercial that ran in April 2012 for EpiPen.  The state alleged that the commercial violated a 2008 consumer protection settlement because it misled consumers into believing that carrying the self-administered epinephrine injector alone was sufficient to protect against life-threatening reactions.  Pfizer as the EpiPen manufacturer agreed to pay $375,000 and Mylan as the exclusive licensee agreed to pay $250,000.  Pfizer also agreed to extend the term of its consumer protection settlement an additional 18 months for ads that run in Massachusetts. 

Genzyme Corp. reached a $22.3 million settlement to resolve two False Claims Act qui tam allegations that it marketed its Seprafilm adhesion barrier for uses not approved by the U.S. Food and Drug Administration (FDA).  The whistleblowers were former Genzyme manager Joseph Fuentes, former Genzyme surgery specialist Christopher Russo, and a physician and paid Genzyme speaker Scott Kelley. 

Investigations

AstraZeneca announced that it received a civil investigative demand from the DOJ related to the PLATO trial for its heart drug Brilinta and a subpoena duces tecum from the U.S. Attorney’s Office in Boston related to the safety of its antipsychotic drug Seroquel. 

The City of Chicago is conducting an investigation into Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, regarding whether the company deceptively marketed its narcotic pain medications Duragesic (fentanyl) patch and Nucynta (tapentadol) tablets. In a petition filed with the court for an order to enforce the subpoena issued to Janssen, the city alleges that Janssen may have violated Chicago’s False Claims Act when it “deceptively promoted opioids as safe and effective for long-term use to treat chronic pain . . . in order to expand the market for opioid sales despite lack of evidence (and the existence of contrary evidence) demonstrating the safety and efficacy of opioids for this purpose” and “minimizing the serious risk of addiction and overdose” from such drugs.

False Claims Act qui tam complaint was unsealed against Allergan that alleges that Allergan provided kickbacks to health care providers to boost sales of its eye care drugs.  The whistleblowers, ophthalmologists Herbert Neyvas and Anita Neyvas-Wallace, allege that Allergan offered illegal inducements such as business consulting services and expert billing advice to eye doctors and optometrists who prescribed Allergan products.  The Government previously declined to intervene in the suit in 2010.

Posted by Sarah K. diFrancesca

One Comment

  1. […] drug diversion.” This is notable because of government enforcement actions, such as the investigation and suit filed by the City of Chicago, which alleged that five pharmaceutical manufacturers […]

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