Schneider Wallace Cottrell Konecky is tracking major pharmaceutical litigation news for clients and counsel. Recent litigation updates include:
- A Department of Justice False Claims Act complaint against Teva for kickbacks for Copaxone.
- Certification of a class against Merck for Zetia direct purchasers.
- Certification of a class against Bausch for Glumetza direct purchasers.
- Settlement by Actavis for Intuniv.
- Denial of a motion to dismiss by Mallinckrodt on Acthar.
To speak with a pharmaceutical litigation attorney, contact Schneider Wallace Cottrell Konecky LLP today.
Teva Copaxone False Claims Act Anti-Kickback Statute Violations
On August 18, 2020, the U.S. Department of Justice filed a False Claims Act complaint against Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. (“Teva”) alleging violations of the Anti-Kickback Statute by secretly paying Medicare co-pays for Teva’s multiple sclerosis drug, Copaxone. At its peak, Copaxone had over $4 billion per year in global sales.
In the case, the DOJ alleges that from 2007 through 2015 Teva funneled money to two purportedly independent patient assistance charities, The Patient Assistance Fund and the Chronic Disease Fund, with the intent and understanding that the two charities would use those funds to cover Medicare co-pays for Copaxone.
This case is one of a number of actions and investigations by the U.S. Attorney’s Office for the District of Massachusetts relating to abuse of patient assistance charities by pharmaceutical manufacturers.
United States v. Teva Pharmaceuticals, USA, Inc., et al., No. 20-cv-11548 (D. Mass)
Merck Zetia Direct Purchaser Class Certified
On August 24, 2020, the United States District Court for the Eastern District of Virginia certified a class of direct purchasers of Zetia. The magistrate judge has recommended certification of a class of end payors for Zetia and that recommendation is pending before the district judge. Zetia is used to treat high cholesterol and had global sales of $2.5 billion in 2016 (before generic entry).
The class plaintiffs allege that Glenmark delayed its generic version of Zetia by about five years and in exchange Merck dropped its patent infringement suit against Glenmark and agreed not to launch an authorized generic. The class period is November 2014 through June 2017.
In re: Zetia (Ezetimibe) Antitrust Litigation, No. 2:18-md-02836 (E.D. Va.)
Bausch Faces Class Action Certification for Glumetza
On August 15, 2020, the United States District Court for the Northern District of California certified a class of direct purchasers of Glumetza. The drug, estimated to have US sales of over one billion dollars in 2017, is a diabetic medication.
The direct purchasers allege Bausch engaged in a reverse-payment scheme to delay generic entry of metformin hydrochloride, and in doing so raised the price of the medication nearly 1000%. The generic manufacturer agreed to delay marketing a generic for four years until February 2016. Price of the medication remains elevated. The class period is May 2012 until the date of the class certification order.
In re Glumetza Antitrust Litigation, No. 3:19-cv-05822 (N.D. Cal.)
Actavis Intuniv Settlement
On August 19, 2020, attorneys for the direct purchaser class announced a settlement with Actavis over allegations that is entered a pay-for-delay agreement with Shire for Intuniv. Intuniv is used to treat attention deficit and hyperactivity disorder and had global sales of $330 million in 2014 (before generic entry). The amount of the settlement has not yet been made public. And the class’ claims against Shire are still pending.
The direct purchasers allege that Actavis delayed its generic version of Intuniv by over two years and in exchange Shire agreed not to launch an authorized generic. Furthermore, Actavis agreed to pay Shire 25% of its profits during the 180-day exclusivity period. The class period is October 19, 2012 through June 1, 2015. The court denied class certification to a class of indirect payors and that denial is currently on appeal.
FWK Holdings LLC v. Shire PLC et al., No. 1:16-cv-12653 (D. Mass.)
Mallinckrodt Acthar Motion to Dismiss Denied
On August 18, 2020, the United States District Court for the District of New Jersey denied a motion to dismiss by Acthar manufacturer Mallinckrodt ARD. The direct purchasers allege Mallinckrodt used an “orphan drug strategy” to relaunch the drug, misrepresented the safety and efficacy of the drug, and dramatically increased its price. The price for Acthar rose from $40 to $34,150 per dose.
Schneider Wallace Cottrell Konecky is pursuing a claim for a health care company involving similar allegations in the Superior Court of Alameda County, California.
United Association of Plumbers & Pipefitters Local 322 of Southern New Jersey v. Mallinckrodt ARD, LLC, et al, No. 1:20-cv-00188 (D.N.J)
Schneider Wallace has successfully represented nationwide insurance companies and other sophisticated institutional plaintiffs in recovering for overcharges due to branded and generic drug and medical device price manipulation. Schedule an appointment with our legal team to learn more about filing an antitrust lawsuit. Schneider Wallace has offices in California, Texas, North Carolina and Puerto Rico and litigates in jurisdictions throughout the country in state and federal administrative agencies and courts.