Virginia woman among Suboxone whistleblowers

A Midlothian woman is among several former medical industry whistleblowers who expect to be rewarded from a record-setting settlement involving the marketing of a narcotic drug designed to ease withdrawal for opioid addicts.

The original maker of the medication Suboxone is paying $1.4 billion to avoid prosecution and resolve various claims that it oversold the safety and benefits of the drug.

The drug is well-known among those involved in the opioid crisis. It is designed to decrease opioid withdrawal symptoms. In its film format, it comes in thin strips that can easily be concealed.

Two Virginia lawyers have run afoul of authorities for trying to slip Suboxone strips to their jailed clients.

Whistleblowers say the drug is not as abuse-resistance or as safe as the companies claimed it was.

Unsupported claims

The allegations originated with former employees of drug maker Reckitt Benckiser PLC and its subsidiaries. Ann Marie Williams of Midlothian had worked in the pharmaceutical business for more than 30 years, her lawyers said.

She was in charge of Reckitt’s marketing to state government programs, a big part of the market.

Her lawsuit said Suboxone is an expensive drug for the consumer, with a wholesale price of more than $8 per tablet, and many patients – almost all drug addicts – were poor and often on Medicaid.

She sued in 2013 after talking to federal agents about her concerns that the company’s marketing posed a health risk to consumers, the lawyers said.

Williams and other accusers said the drug makers actively marketed off-label dosages and uses of Suboxone, engaged in unlawful kickback schemes and ignored laws intended to prevent over-prescription and abuse, according to Williams’ second amended complaint filed in Abingdon federal court in 2016.

Williams and other relators said the dissolvable strip version of Suboxone was inferior because it could be more easily diverted to illicit use and posed an increased risk to children who could accidentally put the film in their mouths.

“Perhaps most importantly, when faced with generic competition …, Defendants knowingly and falsely marketed Suboxone film, under which they had patent protected rights, as being less vulnerable to diversion and safer than Suboxone tablets. They made these false claims in order to extinguish competition from generic Suboxone tablets,” the complaint read.

Williams was represented by C. Thomas Turbeville and Kenneth R. Yoffy of Williamsburg and James H. Shoemaker Jr. and Scott L. Reichle of Newport News.

Government involvement

The U.S. Justice Department said it would intervene in Williams’ and three other False Claims Act cases in Abingdon federal court last summer.

Reckitt had spun off the Suboxone brand in 2014, leaving it to Indivior PLC, based in Chesterfield County.

The settlement of pre-2014 claims was announced July 11: Reckitt would forfeit $647 in proceeds, would pay $700 million in civil settlements to the federal government and the states, and would pay $50 million in an administrative resolution with the Federal Trade Commission.

The settlement resolved a total of six whistleblower claims, a Justice news release said.

“Today’s announcement demonstrates that this office will work tirelessly to address all facets of the opioid epidemic,” said Daniel P. Bubar, first assistant U.S. attorney in the Western District of Virginia.

The Virginia Medicaid Fraud Control Unit was among entities taking credit for the resolution.

“The settlement is another step towards holding the pharmaceutical industry accountable for their prominent part in the creation of the insidious and deadly opioid crisis,” Turbeville said.

Williams’ lawyers said terms of the settlement, including the amounts paid to the relators and their attorneys, were still to be determined.

They were united in praise for their client, who reportedly risked her career and personal life to report abuses in drug marketing.

The settlement “absolutely vindicates her decison to come forward back in 2012,” Shoemaker said.

“She was a central player in exposing the facts leading to this historic settlement,” said Reichle.

The post-2014 allegations directed at the Virginia-based Indivior Inc. are still unresolved. On April 9, an Abingdon federal grand jury indicted Indivior for an alleged nationwide scheme to boost Suboxone prescriptions. The criminal trial is scheduled to begin May 11, 2020.