Ken Julian of Manatt, Phelps & Phillips LLP in California is a well-known white-collar criminal defense attorney and expert on the subject of opioids and the law. Recently, we asked him how pharmaceutical companies should respond to the opioid epidemic going forward in light of the litigation and actions taken by various state and federal agencies.
Q: How should pharmaceutical companies respond to the opioid epidemic in the future?
A: That is a complex question with many facets. The crisis of prescription drug abuse over the past 12 years has claimed thousands of lives and devastated communities across the country, including my own.
Currently, each state’s attorney-general is providing guidance on how companies should respond. For example, a recent statement by the Massachusetts Attorney General indicates that requests for documents and information from pharmaceutical manufacturers will be “the most immediate focus” of the investigation. The Pennsylvania Attorney General has been more aggressive in targeting specific drug makers whose opioids have hit specific geographic regions of the state hard. In a few of these cases, the drug makers have already paid significant judgments to plaintiffs.
Individual states may also guide what types of information manufacturers should be produced in light of ongoing investigations and potential litigation. There are likely going to be a wide variety of approaches by individual attorneys-general across the country.
Q: What do you think we’ll see from the big pharmaceutical companies in response to the opioid epidemic?
A: While practicing white-collar defense, I have never known a company not to take an aggressive and proactive approach to responding to government investigations and litigation. Big Pharma is no different. Therefore, look for those companies under investigation and targets of lawsuits to be providing substantial information and cooperation.
In addition, I expect we will see some significant changes in the way pharmaceutical companies respond to potential opioid abuse going forward. These changes may include more careful assessment of a drug’s risk-benefit profile before release, tighter monitoring of sales reps, so they don’t overpromote potentially dangerous products, and aggressive monitoring of the internet to identify potential cases of abuse.
The opioid epidemic has caused wide-ranging social, economic, political, and personal devastation across all strata of society. There is no question that pharmaceutical companies must play their part in addressing the problem. I am confident we will see significant changes in how drug makers deal with pain management medications going forward. It is unfair to say that, as a class, pharma hasn’t been aggressive in this area. However, the opioid epidemic has clearly shown that many companies must do more.
Q: Can you provide any insights into where big pharmaceutical companies might focus regarding the potential abuse of prescription opioids? Do you think they’ll go after the mass-marketing of opioids or focus more on so-called “pill mills”?
A: While no company likes to have a dangerous product, the opioid crisis is not a one-product problem. When it comes to pain management products, many types of drugs can be abused and potentially lead to addiction. In addition, the opioid epidemic has shown that there are far more non-opioid drugs being used, including sedatives and stimulants.
As mentioned above, we will likely see significant changes in the way pharmaceutical companies respond to potential opioid abuse going forward. These changes may include more careful assessment of a drug’s risk-benefit profile before release, tighter monitoring of sales reps, and aggressive monitoring of the internet to identify potential cases of abuse.