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State’s lawsuit expands against opioid manufacturers, distributors

Opiods

An amended complaint in the civil lawsuit in South Dakota State Circuit Court against prescription drug manufacturers has been filed by the South Dakota Attorney General Office.

The originally-listed manufacturers were Purdue, Endo and Janssen. The amended complaint adds generic drug manufacturers Par Pharmaceutical Companies, Inc., Allergan PLC, and Mallinckrodt LLC, and distributors McKesson Corporation, Cardinal Health, Inc., Amerisourcebergen Drug Corporation, Walgreens Boots Alliance, Inc. and WalMart Inc.

An opioid is any controlled drug having an addiction-sustaining liability similar to morphine, or being capable of conversion. Opioids include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, morphine and many others.

“You will find lists of both the name brands and the generic brands made and prescribed, listed by each defendant named in the complaint,” said Tim Bormann, chief of staff with the Office of the Attorney General. There are 14 pages of lists in the suit.

“We are seeking to hold the pharmaceutical companies accountable for knowingly and deceptively harming South Dakotans,” said Attorney General Jason Ravnsborg. “The opioid crisis has been exacerbated by deceptive and misleading marketing and the failure to report suspicious orders as required by law.”

The lawsuit alleges that the drug companies and manufacturers violated South Dakota’s Deceptive Trade laws and gave false and misleading statements (false marketing) about the risks and benefits of opioids. Among other allegations, the distributors named failed to comply with their obligations under the law to report suspicious orders.

The numbers are staggering:

“From page 187 of the complaint, the Center for Disease Control statistics show that 54.8 out of every 100 South Dakotans had a prescription for opioids in 2016. In 2018, based on numbers from the SD Department of Health, there were 195 opioid overdoses and 27 opioid related deaths, 23 of which were from prescription opioids,” said Bormann.

The costs are staggering:

“On page 188 of the complaint, the Child Welfare League of America reports that in 2015 healthcare costs related to opioid abuse in South Dakota were $27,820,116. In 2017 the South Dakota Department of Social Services spent $20.2 million (about 2.4 percent of its total budget) on payments to providers for substance abuse and other related treatment,” said Bormann.

This epidemic is costing a difficult-to-determine amount for taxpayers.

“I have not broken it down to individual taxpayers because the round numbers I have all come from various dates, as not everyone finishes their reports at the same time. Plus there are parts of the equation that would have to be considered, i.e., what percentage of the gross cost to the state is paid out of pocket, what is paid by insurance, what is paid by Medicaid, what is paid by Medicare, etc. Each factor would have a different impact on the taxpayers of the state,” said Bormann.

How long could this lawsuit take?

“There is no answer for that, unfortunately. The original complaint was filed in March of 2018 under then Attorney General Marty Jackley. This is the amended complaint to expand the number of defendants,” said Bormann.

Under this lawsuit the state of South Dakota is seeking the following:

That the state recovers the costs and expenses of the lawsuit, pre- and post-judgment interest and reasonable attorneys’ fees

That the alleged acts be declared unlawful in violation of state statute and common law

That defendants be ordered to cease unlawful promotion, to correct misrepresentations and comply with legal obligations

That plaintiff (state) receive civil penalties.

That the state recovers damages allowable under state statutes, and judgment be entered against defendants.

That the defendants be ordered to pay punitive and treble damages as provided by law.

That the defendants be ordered to disgorge monies wrongfully retained by them.

Jill Courtney is with the Healthcare Distribution Alliance (HDA), a national trade association representing distributors — including AmerisourceBergen, Cardinal Health and McKesson, three pharmaceutical corporations added to the lawsuit by the state Attorney General’s Office.

HDA wanted to provide a distributors insight into the issue.

“The misuse and abuse of prescription opioids is a complex public health challenge that requires a collaborative and systemic response that engages all stakeholders,” Courtney said. “It’s also critical to understand the role of each stakeholder across the supply chain. Distributors do not conduct research, manufacture, market, or prescribe medications, nor do they influence prescribing patterns, the demand for specific products, or patient-benefit designs.”

“The idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated. Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation,” said John Parker, senior vice president of communications Healthcare Distribution Alliance.

According to HDA, distributors are logistics experts, tasked with the primary responsibility of delivering all medicines to licensed pharmacies and healthcare providers. In their role as wholesale distributors, HDA members are not healthcare providers or prescribing or dispensing practitioners.

The Drug Enforcement Administration (DEA) is responsible for setting the annual production of controlled substances in the market, approving and regulating the entities allowed to prescribe and handle opioids, and sharing data with entities in the supply chain regarding potential cases of diversion.

Distributors report every opioid sale to the DEA – whether it is suspicious or not. Greater communication and coordination with the DEA will help support real-time response against abuse and diversion where it occurs.

For more information from the HDA, Courtney suggested visiting https://www.hda.org/news/facts-about-rx-distributors-and-the-opioid-crisis.