Purdue Pharma has filed a brief along with four other manufacturers of opiod painkillers seeking to halt a lawsuit by the City of Chicago, saying it would be impossible to decide the case without determining whether the addictive pills are safe and effective, a job for the Food and Drug Administration.
In their filing before U.S. District Judge Jorge L. Alonso, the drugmakers say the judge erred earlier this year when he rejected their so-called "primary jurisdiction" defense because the city was suing over alleged fraudulent marketing materials, not whether the drugs were in fact safe. In his May decision, Alonso dismissed claims against four manufacturers and left intact only the fraud claims against Purdue for statements on its own website. The other defendants are johnson & Johnson, Endo Pharmaceuticals, Allergan and Teva.
The lawsuit is an important test of a legal theory engineered by lawyers at Cohen Milstein, a Washington, D.C. firm that touts its focus on litigation with "a strong social and political component," including mortgage-backed securities cases and a successful suit against Apple over alleged price-fixing in the e-books business. Earlier this year, a federal judge in California threw out a similar lawsuit with Santa Clara County as the plaintiff, saying the “fundamental premise” of the case -- that it was about labeling, not the safety of opioid painkillers -- was “incorrect.”
Chicago would seem to have some of the elements of a good case since Purdue and three of its executives pled guilty and the company agreed to pay $600 million to settle federal claims they'd used misleading marketing materials to stimulate Oxycontin sales. But in their 300-page second amended complaint, Cohen Milstein and Chicago still fail to identify specific physicians who were misled into prescribing opioids for chronic pain, the manufacturers say.
The city "simply ignores" the necessity of proving the manufacturers caused drugs to be improperly prescribed when physicians are presumed to exercise their own informed judgment about which drugs to use. The city claims it covered 22,000 claims for opioids for chronic pain between 2007 and 2014, despite evidence such drugs are inappropriate for that use.
The manufacturers say Chicago didn't actually pay for the prescriptions, excess or not, since if pays a flat fee for prescription coverage each year regardless of how many claims are reimbursed. Either way, the city says, Chicago is still reimbursing for opioid painkillers, casting doubt on its claim it has uncovered a fraud against it.
The bigger question behind this litigation is whether courts or the FDA should regulate the use of prescription drugs. In their filing seeking dismissal, the manufacturers say "this is not a case where the underlying science is settled. Many of the alleged misrepresentations concern disputed scientific issues now under review at FDA."
Much of the pressure to stop the use of opioids comes from Physicians for Responsible Opiod Prescribing, an offshoot of Phoenix House, which petititioned the FDA in July 2012 to revise the labeling on Oxycontin and other drugs to discourage their use for chronic pain.
The FDA, in a 2013 response, said it was ordering drug manufacturers to add warnings and advice to labels encouraging doctors to consider alternatives, assess the risk of overdose and monitor their patients closely for abuse. The FDA rejected PROP’s claim that drug abusers with mental problems were more likely to be prescribed opiods, saying studies didn’t prove that relationship.
Chicago's complaint opens with the unarguable statement: “A pharmaceutical manufacturer should never place its desire for profits above the health and well-being of its customers.” It goes on to claim manufacturers promoted opioids for long-term treatment of chronic pain even though they knew they were addictive and had performed no studies longer than 90 days. It calls the marketing a “deceptive and unfair marketing campaign” because there was “no evidence” opioids were safer and more effective than alternatives like physical therapy and plenty of evidence they weren’t.
