Policy & Medicine Compliance Update
Don’t have a subscription yet? Subscribe Here ?rid=m4O2wt.
OCTOBER 2019 Issue
Issue Summary:
Our focus for this month’s issue is on opioids. To start things off, we feature a discussion on the need for any court-imposed resolutions include effective compliance controls to prevent a resurgence of the behaviors, decisions and actions that fueled the current opioid public health crisis. Next, as promised in September, we have an in-depth review of the Oklahoma opioid verdict against Johnson and Johnson. Finally, we round out our opioid coverage with a look at the recent $1.4 billion settlement by the Reckitt Benckiser Group to resolve its potential liability surrounding the marketing of Suboxone for the treatment of opioid dependence, and a brief look at some Opioid MDL Defendants attempt to disqualify the judge presiding over the Opioid MDL before the upcoming first trial.
Rounding out the October issue, we also feature an article from Deloitte Insights on using digital technologies to improve pharmaceutical compliance. The article not only provides insights but gives practical pointers on increasing compliance’s digital maturity.
FEATURE
When Money and Doritos Don’t Suffice – The Crucial Imperative for Integrating Effective Compliance Controls in the Ongoing Opioid Settlements
By Dr. Seth B. Whitelaw
Summary: The mass of opioid litigation is far from over, but the results of Oklahoma’s settlements with and trial verdict against various pharmaceutical manufacturers reveal that money alone will not suffice. Therefore, any court-imposed resolutions need to include effective compliance controls to prevent a resurgence of the behaviors, decisions and actions that fueled the current public health crisis.
TAGS: Opioids, Oklahoma, J&J, Purdue, Opioid MDL, Effective Compliance, Corporate Behavior
OPIOIDS
Oklahoma, J&J and the “Mutant Poppy Strain” – The Settlement
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In what is considered by many legal observers as a “landmark case” Oklahoma State Judge Thad Balkman on August 26, 2019, by way of a 42-page legal opinion, determined that J&J engaged in a widespread illicit marketing scheme to push opioids into the market including creating in 1994, a “mutant” poppy strain of opioids that effectuated a state-wide opioid epidemic and violated Oklahoma state nuisance laws. The Court in rendering its decision ordered J&J to pay $572 million to remedy the devastation wrought by the opioid epidemic in the state and its residents and is expected to have widespread legal implications for opioid-related pharmaceutical companies, among others, as it relates to liability under the legal theory of public nuisance.
TAGS: Opioids, Public Nuisance, Oklahoma, J&J, API
Parental Liability – Reckitt Benckiser Group Settles Its Suboxone Case with the Justice Department
By Carolyn Greene, Staff Writer
Summary: With months of its subsidiary being indicted for alleged wrongdoing relating to its Suboxone marketing, the Reckitt Benckiser Group agreed to a settlement that includes a record-setting monetary component. The case sends a clear signal neither complex corporate structures nor foreign ownership will shield a company from liability for its noncompliance.
TAGS: Opioids, Indivior, Suboxone
UPDATE: On the Eve of Trial Opioid MDL Defendants Seek to Disqualify the Judge
By Nicodemo Fiorentino, Esq.
Summary: A motion by various defendants in the National Prescription Opiate Litigation to disqualify the presiding judge is the latest effort to either derail or postpone the upcoming trial, which is scheduled to begin on October 21, 2019.
TAGS: Opioids, Disqualification, Opioid MDL
Operations
Maintaining Value in Pharmaceutical Compliance How can companies modernize programs through digital to deliver strategic value?
By John Conrad, Paul Silver, and Natasha Elsner
Summary: Rapid changes in the pharmaceutical industry call for a compliance upgrade. Adoption of digital technologies such as automation and machine learning can help compliance maintain its position as a strategic partner to the business.
TAGS: Digital Technology, Digital Maturity, Pharmaceuticals
