Solvay Pharma Must Face Bribery Claims

     HOUSTON (CN) – Solvay Pharmaceuticals cannot duck whistleblower claims that it bribed Medicaid doctors to prescribe its drugs for unapproved uses, a federal judge ruled.
     Two former Solvay managers, John King and Tammy Drummond, sued the company in 2006, alleging it violated the False Claims Act by paying doctors kickbacks in the form of “bogus speaker and research fees, resort weekends, cash payments, or Harley Davidson goods” to prescribe its drugs Aceon, Luvox and AndroGel for uses not approved by the Food and Drug Administration.
     Solvay is a Belgian chemical company. Its co-defendant subsidiary, Solvay America, is based in Houston. Another defendant is Solvay Pharmaceuticals, which was a Solvay subsidiary until Abbott Laboratories acquired it in 2009, and spun it off into a new entity called AbbVie Products.
     The whistleblower lawsuit was filed under seal and joined by 27 states, the District of Columbia and Chicago.
     The federal government declined to intervene in the lawsuit, but did file a statement of interest.
     Under the False Claims Act, a whistleblower, or qui tam plaintiff, with evidence of fraud against the United States can sue the perpetrator on Uncle Sam’s behalf.
     The law stipulates that whistleblowers can receive between 15 and 30 percent of the total recovery from the defendant.
     The lawsuit alleges that Solvay’s false marketing and kickbacks led the states’ Medicaid programs to pay millions of dollars in claims for Aceon, Luvox and AndroGel.
     Luvox is the brand name for fluvomaxine, a selective serotonin reuptake inhibitor, and a competitor of the blockbuster antidepressant Prozac.
     Solvay filed an application to sell Luvox with the FDA in 1991 to treat obsessive compulsive disorder. The FDA approved it for the disorder three years later.
     But Solvay soon realized that “OCD alone would not provide meaningful sales” and began pushing Luvox for off-label uses of treating depression and other anxiety-related disorders, according to the plaintiffs’ fifth amended complaint.
     The FDA issued a warning in 2004 stating the use of drugs such as Luvox by adolescents may increase the risk of suicidal thoughts and actions.
     Eric Harris, one of two teenagers who shot and killed 13 people at Columbine High School in 1999, before killing himself, was on Luvox, according to the complaint.
     Solvay downplayed the connection, telling doctors “that in Harris’s case Luvox had not been used appropriately,” according to the amended complaint.
     The marketing blitz paid off, the plaintiffs claim, as Luvox “was a top-selling drug for Solvay for years, with at least $6 million in Medicaid claims in the state of Texas alone. The majority of Luvox’s Medicaid sales were for indications other than for OCD.”
     The FDA approved Solvay’s drug Aceon in 1993 to treat high blood pressure, and with 11 similar drugs already available, the “market’s response to its launch was a collective sigh of indifference,” according to the complaint.
     But Solvay got creative with its marketing of Aceon, the whistleblowers say.
     “As part of Solvay’s 1999 launch of Aceon, Solvay promoted Aceon for ‘arterial wall compliance.’ Solvay stressed to doctors that Aceon delivered a structural change in all arteries by remodeling them, whereas other hypertension drugs merely lowered blood pressure,” the complaint states.
     Solvay also falsely marketed Aceon to treat strokes and kidney complications caused by diabetes, the whistleblowers claim.
     As for AndroGel, the plaintiffs claim, Solvay persuaded the FDA to approve the drug to treat men with hypogonadism, a condition in which the testicles do not produce testosterone.
     “Solvay launched AndroGel in 2000 touting the unsupported claim that four to five million American men suffered from hypogonadism. For this figure, Solvay cited the FDA’s own website as the source, when in fact the figure came from the manufacturer of Androderm, a testosterone skin patch,” the complaint states.
     By 2006, AndroGel was Solvay’s top-selling drug, with U.S. sales of more than $300 million, the plaintiffs say in their 277-page fifth amended complaint.
     Solvay sought partial dismissal of plaintiffs’ claims that it “actively targeted” and “wooed” doctors who were members of states’ Medicaid Pharmaceutical and Therapeutics Committees to place its drugs on states’ preferred drug lists (PDL) or formularies, which govern how state Medicaid programs pay for prescription drugs.
     The plaintiffs claim that Solvay’s deceptive marketing led to prescription filling by pharmacies that submitted claims to Medicaid for reimbursement.
     U.S. District Judge Gray Miller issued a 12-page ruling on Jan. 23.
     He granted Solvay’s unopposed motion to dismiss some claims involving several states because the plaintiffs “are no longer asserting a claim that [Solvay] improperly wooed P&T members into including its drugs on the state PDLs or formularies” in those states, the judge wrote.
     Miller left much of the Medicaid committee “wooing” claims intact, however.
     “The wooing claim is available, pursuant to the pleaded claims in the fifth amended complaint, for states that had a PDL or some type of formulary governed by a group called a P&T Committee during the relevant timeframe if the drugs at issue were on the list,” Miller wrote.
     The states and entities involved in the lawsuit are California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Massachusetts, Virginia, the District of Columbia and Chicago.

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