The Opioid Crisis, Lobbying, and the Amicus Brief

The Opioid Crisis, Lobbying, and the Amicus Brief

Definition of opiate: a drug (such as morphine or codeine) containing or derived from opium and tending to induce sleep and alleviate pain. We are having an opioid crisis in America.

One of the most powerful lobbying groups in Washington is the U.S. Chamber of Commerce. Last year the Chamber spent over $100 million on federal lobbying.  However, the Chamber's influence does not stop at lobbying congress. The Chamber also lobbies the courts through Amicus briefs. The goal is to avoid responsibility for the opioid crisis. Amicus briefs have become a favorite tool for lobbying groups across the country.  

Ohio was one of the first states to initiate lawsuits against major opioid manufacturers to combat the opioid crisis. Against Ohio, the manufacturers argued every defense under the sun to prevent themselves from taking responsibility for the opioid crisis in America. The amicus brief argued Primary jurisdiction, Preemption, and First and Fifth Amendment principles. The Primary jurisdiction argument is that the court does not have the authority to adjudicate the lawsuit. The Preemption argument is based on a hypothetical ending with the manufacturers being forced to commit heinous acts. And finally, the First and Fifth Amendment arguments proposed that drug manufacturers cannot be forbidden from fraudulently marketing. They want to be able to continue to fraudulently market to continue to push the opioid crisis.

Most of these arguments don't pass the sniff test but that's not really the point. Preemption was based on the FDA forcing manufacturer conduct.  The Chamber simultaneously argued that the FDA has limited powers and cannot oversee the manufacturers. The focus of these Amicus briefs is persistence. By persistence, I mean the same way a river is persistent against a rock. The arguments don’t need to make sense, they just need to muddy the waters. The goal of their Amicus brief is to make it impossible to sue drug manufacturers.

Opioid manufactures are persistent, in fact, so persistent that they've had a chilling affect on one case in particular.  Mr. Caltagirone is a man who was prescribed a fentanyl laced lollipop for migraines, but unfortunately, Mr. Caltagirone  became addicted. He went in and out of treatment, and eventually died from an accidental methadone toxicity. Prescribing fentanyl for migraines is a bit overzealous, it also sounds insane, and that's because it is insane. Fentanyl is designed to provide relief for cancer patients in around the clock pain, not for migraines.

Mr. Caltagirone’s estate sued the manufacturer of Actiq for continuing to illegally conduct off-label promotion and in 2008, the manufacturer of the fentanyl laced lollopop  paid the government $425 million dollars as a settlement for off-label marketing. Unfortunately, this is business as usual, no one was forced to stop selling a product, and no one went to jail. The only punishment was a drop in the bucket fine. I'm not sure why, but the government doesn't understand Economics. When someone makes a billion dollars profit, and only has to pay 40% of the profits back in fines, than there is no incentive to stop the immoral conduct.

According to the DEA, more than 6 million fentanyl prescriptions are dispensed each year. There are not 6 million cancer patients who meet the criteria for fentanyl. Most experts  estimate the need being closer to 3 million.  The trial court dismissed Mr. Caltagirone's case and it is now on appeal.  The Chamber filed an amicus brief for the appeal in Pennsylvania. The Chamber's amicus brief argued that Plaintiff’s attempt to enforce the FDCA through a state law tort claim stands as an obstacle to the FDA’s discretion and is preempted.  That precise argument is also being made by the opioid manufacturers in Ohio. The opioid manufacturers are attempting to stretch Buckman's precedent into an all encompassing force field.  They want Buckman to protect all drug and medical device manufacturers from state tort claims, but so far it is not working. It’s no coincidence that the U.S. Chamber of Commerce is filing a brief in an individual drug death lawsuit that happens to support other arguments they are making across the country.   This isn't the first time the Chamber has used this strategy to fight the opioid crisis. For years, the Chamber has filed amicus briefs with the purpose of narrowing the law. Their goal is to make it impossible to sue drug manufacturers responsible for this opioid crisis.  The last few years has seen a ramped up effort by the chamber. Now the Chamber seems particularly focused on thwarting arguments against opioid manufacturers. Most of the opioid lawsuits out there haven’t made it far enough to have these issues decided but If the drug industry is able to  use individual cases to stack the legal deck in their favor, governmental entities, and other individuals may never get a fair day in court.