Calif. Joins 35-State Suit Against Makers of Heroin Addiction Treatment Drug

California Attorney General Kamala Harris and 35 other attorneys general filed an antitrust lawsuit this week against the makers of Suboxone — buprenorphine/naloxone, a prescription drug used to treat heroin and other opioid addictions — over allegations that the companies engaged in a scheme to block generic competitors and cause purchasers to pay artificially high prices.

The lawsuit, filed Thursday in the U.S. District Court for the Eastern District of Pennsylvania, accuses the companies of violating the federal Sherman Act and state laws. Counts include conspiracy to monopolize and illegal restraint of trade. In the suit, the attorneys general ask the court to stop the companies from engaging in anti-competitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.

Reckitt Benckiser Pharmaceuticals, a British company now known as Indivior, is accused of conspiring with Indiana-based MonoSol Rx to switch Suboxone from a tablet version to a film (that dissolves in the mouth) in order to prevent or delay generic alternatives from coming onto the market and to maintain monopoly profits.

"When prescription drug companies unlawfully manipulate the marketplace to maximize profits, they put lives at risk and drive up the cost of healthcare for everyone," Harris said. "Indivior and Monosol flagrantly violated the law, deceiving doctors and patients and shutting down generic competition in order to rake in profits. These companies must be held accountable for this unlawful scheme that cost the public nearly a billion dollars and hampered fair competition in the marketplace."

The attorneys general claim that consumers and purchasers have paid artificially high monopoly prices for Suboxone, potentially since October 2009, when generic alternatives might otherwise have become available.

“Some people rely on this prescription drug to treat heroin addiction,” said Ohio Attorney General Mike DeWine, who was among those who filed the suit. “They shouldn’t be forced to pay higher prices or deprived of options because drug makers circumvent the law to maximize their profits. People deserve the benefits of fair market competition. When the product involved is used to treat addiction, the implications are even more significant.”

Indivior was granted FDA approval in 2002 for Suboxone tablets, along with exclusive rights to sell the drug for seven years based on representations that it was unlikely to recover its investment in the drug. During this time, Indivior generated over $1 billion in sales of the Suboxone tablets.

When its exclusive rights expired in 2009, the company was faced with potential competition expected to eliminate 80 percent of its profits from Suboxone tablets within a year. Indivior, with MonoSol’s assistance, thwarted that competition by switching the form of Suboxone from tablet to film. It allegedly falsely claimed the tablets presented pediatric safety issues, made unfounded claims to physicians that tablets were dangerous, and raised the price of its tablet while lowering the price of the film. Through these actions, Indivior was able to maintain artificially high prices for Suboxone, depriving the state and consumers of the benefits of lower prices that come with competition.

Harris says not only did the companies violate federal antitrust laws, they broke California's Cartwright Act and Unfair Competition Law. The complaint seeks to require Indivior to pay back any profits that resulted from the illegal conduct — disgorgement — and includes injunctive relief to ensure the conduct is not continued or repeated.

The other states involved in the lawsuit are: Alabama, Alaska, Arkansas, Colorado, District of Columbia, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington and Wisconsin.

— Chris Mosby (Patch Staff) contributed to this report.

Image via Jr de Barbosa, Wikimedia, used under Creative Commons