August 8th, 2019
The realities of the opioid crisis call out to us, again and again. A sea of devastation drowns individual addicts, families, and communities. In response to lawsuits, government investigations and scathing press reports, the typical response from drug manufacturers and their defenders on social media argues: “The drug companies didn’t do anything wrong, they didn’t write the prescriptions, why are you saying this is their fault?”
Here’s a short video laying out some (not all) of the key federal laws that some drug manufacturers may have violated in their drive to sell more and more opioids – and thus reasons why some of them could be legally liable for the devastation that overuse and misuse of their products has wrought.
Full transcript below:
Drug Manufacturers and the Costs of the Opioid Crisis
Hi, this is Tim, from the whistleblower.com.
When discussing the opioid crisis, the question often comes up: Are the drug manufacturer’s liable for the crisis? Why? How?
Here’s a high level look at just some of the laws that apply.
An important caveat: Drug manufacturers are not liable for the opioid crisis just because they make opioids. But if they engaged in improper, illegal conduct in how they sold they drugs, they can, and in my view should, be held responsible.
The Four Key Federal Laws
There are four key federal laws at issue: (1) the Controlled Substances Act; (2) the Food, Drug and Cosmetics Act; (3) the Anti-Kickback Statute; and (4) the False Claims Act.
These aren’t only laws, just key federal ones. Many state laws could also come into play.
The Controlled Substances Act
21 U.S.C. §§ 801-904, and 21 C.F.R. §1301.7176
The CSA sets the overall framework for manufacture, sale and security of drugs like opioids. It imposes on manufacturers a duty to take steps to prevent theft and diversion.
So manufacturers can’t just ship tons and tons of pills to small communities or pharmacies that could not reasonably — legally — use that many pills. They have a legal duty to ask question and take steps to prevent overuse and abuse of opioids.
The Food, Drug and Cosmetics Act
21 USC § 502
The FDCA governs drug labeling. Basically, you can’t sell a drug unless the packaging is approved by the FDA, and accurately describes the proper use of the drug — including health and safety risks.
So if a manufacturer lied to the FDA to get the drug’s labeling approved, or if it sells the drug using false claims about risks or effectiveness, that could render the drug “misbranded” and thus illegal to sell.
There are numerous reports that manufacturers lied about how addictive opioids were, to the public, to doctors, and possibly to the FDA. That could be illegal.
The Anti-Kickback Statute
42 USC § 1320a-7b(b)
The AKS makes it a crime to pay a bribe to get a physician (or other health care provider) to prescribe or even recommend a prescription drug for patients covered by Medicare, Medicaid and other government-funded health care programs.
There are tons of reports of drug manufacturers, and others, paying doctors bribes, in the form of bogus speaking fees, sham research studies, all flavors of debauchery and sometimes, figuratively, just big piles of cash, to get them to write prescriptions for opioids.
If a manufacturer paid kickbacks to get doctors to prescribe their drugs, that is illegal.
The False Claims Act
31 U.S.C. §§ 3729 – 3733
The FCA makes it illegal to submit a false or fraudulent claim for payment to the government. Claims for opioids could be false for a variety of reasons:
- Were the pills medically necessary to treat that patient for a specific injury or disease? Was the patient really taking the drugs? Did they need as many as they got? If a prescription was not medically necessary, then the claim for payment is be false.
- If the doctor got a kickback to write the prescription, that makes the claim false.
- If the marketing material used to convince the doctor to write the prescription was misleading, that could make the claim false.
The Drug Companies’ Likely Excuse
Opioid manufacturers and their apologists will likely argue: “We didn’t submit any claims, how could we violate the False Claims Act?”
The easy answer: “It is also a violation to cause someone else to submit a false claim or to conspire with someone else to do it.”
How Could You Help Hold Companies Liable for Illegal Conduct?
Notably, of all of these laws, the False Claims Act is one where private individuals can take steps to hold manufacturers accountable.
The False Claims Act allows whistleblowers who know about a fraudulent scheme involving opioids – especially a whistleblower with insider, non-public information – to file a case in federal court, help the government hold the fraudsters accountable, and get a share of any money the company is made to repay.
Call Me if You’d Like More Information
So this has just been a quick overview, of some of the key federal laws about drug manufacturer’s legal duties with respect to the overuse and abuse of opioids.
If you have questions or want more information feel free to reach out to me at me at Contact or firstname.lastname@example.org, on Twitter @TimPMcCormack or at 207-747-7639.