PENNSYLVANIA RECORD

Weeks after one drug company filed an antitrust suit against the makers of the opioid

blocker Suboxone, another plaintiff has taken the same step, asserting in a federal class action complaint that Reckitt Benckiser Group engaged in an overarching anticompetitive scheme to exclude competition from the market for the drug combination typically used to treat heroin addiction.

Lawyers representing Meridian Plan of Michigan Inc. filed suit on behalf of their client and others similarly situated against Reckitt Benckiser Group and Reckitt Benckiser Pharmaceuticals over allegations that the defendants used various acts and practices as part of an overall scheme to improperly maintain and extend its monopoly power in the market for co-formulated buprenorphine/naloxone to the detriment of the class.

The drug combination is used as opioid replacement therapy for the treatment of opioid dependence, which typically comes in the form of addiction to heroin or prescription painkillers.

“Not satisfied with 7 years of government-bestowed exclusivity for a drug largely developed and reimbursed by taxpayer money, Reckitt concocted a multifaceted anticompetitive scheme, executed over the course of several years, to maintain and extend its monopoly power over co-formulated buprenorphine/naloxone, by illegally preventing generic manufacturers from effectively competing with Suboxone,” the lawsuit reads. “Reckitt’s scheme was executed through a purposeful and planned manipulation of the complex distribution and regulatory approval systems for pharmaceutical products in the United States.”

According to the complaint, the defendants started their scheme by developing and marketing a sublingual film version of Suboxone two years before their orphan drug exclusivity with the Food and Drug Administration had expired.

While the film was equivalent to Suboxone tablets from a medical standpoint, the suit states, the defendants knew pharmacists could not substitute less-expensive generic versions of the film when presented with prescriptions for Suboxone.

“Disrupting this competitive mechanism was Reckitt’s entire reason for introducing Suboxone film: to the extent it could introduce its film version of Suboxone and cause the prescription base of branded Suboxone tablets to disappear before generic competition arrived, Reckitt could cripple generic Suboxone tablet competition before it even began, thus maintaining its monopoly stranglehold on the co-formulated buprenorphine/naloxone market,” the complaint states.

The lawsuit claims that Reckitt’s motives for introducing the Suboxone film were predatory, and that the company engaged in anticompetitive actions to block and delay would-be generic Suboxone tablet sellers from obtaining FDA approval of their Abbreviated New Drug Applications for generic Suboxone tablets, in violation of an express statutory mandate.

“Reckitt’s scheme, as a whole and in its individual parts, was intended to, and has, blocked and delayed generic Suboxone competition, disrupted the normal channels, and the statutory and regulatory mechanisms, by which generic competition takes place and was prescribed by Congress to take place, and excluded would-be generic competitors from the most efficient means of distributing their products,” the complaint states.

The suit contains counts of monopolization and monopolistic scheme, attempted monopolization, unfair and deceptive trade practices, and unjust enrichment.

In addition to seeking class certification, the plaintiff is looking for a declaration that the defendants committed unlawful acts.

The suit also seeks equitable relief in the form of disgorgement of profits, restitution, and the creation of a constructive trust to remedy Reckitt’s unjust enrichment.

The class also seeks treble and punitive damages, along with attorneys’ fees and costs.

The suit was jointly filed by attorneys with Philadelphia-based Spector, Roseman, Kodroff & Willis, lawyers with Detroit-based Milberg LLP, and attorneys from Chicago-based Wexler Wallace LLP.

 

The federal case number is 2:13-cv-01594-MSG.