On Sunday, the Washington Post published a detailed investigative report about how the drug industry snuck through Congress a bill that ruined one of the Drug Enforcement Agency’s key tools in the fight against the opioid epidemic. The DEA’s own chief administrative judge, John Mulrooney, has a forthcoming law review article about how the new law made it “all but logically impossible” for the DEA to stop drug manufacturers and distributors from dumping opioids out onto the streets, even when they are doing so in obvious violation of federal law.
That outrageous bill is just one part of the war that the drug companies are fighting to keep bringing in massive profits from the opioid epidemic that they created. Today we’re going to talk about the pharmaceutical industry’s lobbying of courts, which they do through amicus briefs filed by groups like the “Pharmaceutical Research and Manufacturers of America” (also known as “PhRMA”), the “Medical Information Working Group,” and the U.S. Chamber of Commerce.The U.S. Chamber of Commerce is “the premier voice for corporate power in Washington.” Last year the Chamber spent over $100 million on federal lobbying. I’ve written many times before about the Chamber and its odious attacks on the rights of consumers, the disabled, and even veterans, like with H.R. 985. Just last month, the Chamber sued the Consumer Financial Protection Bureau to make it easier for banks to cheat customers.
Less well-known outside the legal field, however, are the ways that groups like the Chamber and “PhRMA” lobby courts and try to sway the courts. That brings us to the most recent wave of lawsuits against opioid manufacturers and to the tragic case of Joseph Caltagirone. We’ll return to Mr. Caltagirone in a minute.
The State of Ohio was one of the first governmental agencies to begin the recent round of opioid lawsuits, and last month, the major opioid manufacturers — Purdue Pharma, Teva Pharmaceuticals, Cephalon Inc., Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeal, Endo, Allergan, and Actavis — filed motions to halt and to dismiss the Ohio Attorney General’s lawsuit against them. As expected, the companies raised every defense they could think of, including three arguments that drug companies have been pushing for years:
- “Primary jurisdiction,” by which the drug companies mean that the courts should stop deciding cases just in case a federal agency might someday take some action that relates in some way to the same societal issue.
- “Preemption,” by which the drug companies mean that the courts should entertain various hypothetical scenarios in which the FDA could theoretically require the drug companies to do harmful things.
- “First and Fifth Amendment principles,” by which the drug companies mean that the Constitution forbids the FDA or any other governmental agency from making it illegal to fraudulently market or sell drugs and medical devices.
These arguments are all contradictory — the drug company is dreaming up ways that the FDA could force them to do something ridiculous while simultaneously claiming the FDA doesn’t have the power to force them to do anything — but the point of these amicus briefs isn’t consistency, it’s repetition. They don’t need to make sense, they just need to muddy the waters enough to make it impossible to hold drug companies accountable for their misdeeds.
I know a bit about these topics; I’ve dealt with them numerous times, and here’s a video of me debating a drug company lawyer about them on Capitol Hill. In the Ohio case, the opioid manufacturers cite Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to support their argument that it’s impossible to sue a drug company even for breaking federal law by promoting the drugs for unapproved or off-label uses. Buckman was an unusual case: as part of a larger litigation against many companies, the plaintiffs tried to sue a regulatory consultant to a medical device company despite the absence of any traditional state law claims against the consultant, and the Supreme Court said they couldn’t do so by making a claim “solely” out of regulatory violations. But we’ll come back to Buckman.
For now, back to Mr. Caltagirone. Mr. Caltagirone suffered from migraine headaches, for which he was prescribed Actiq, which is a lollipop laced with fentanyl. Mr. Caltagirone became addicted, went in and out of treatment, and eventually died from an accidental methadone toxicity.
If prescribing a fentanyl lollipop for migraines sounds insane, that’s because it is insane: fentanyl is far deadlier than heroin. Actiq is approved by the FDA for a single use: “the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.”
So how did Mr. Caltagirone end up getting prescribed a fentanyl lollipop for migraines?
In 2008, the manufacturer of Actiq paid the government $425 million for off-label marketing of Actiq and other drugs, but nobody went to jail, of course, and no company was forced to stop selling it, of course, so the drug industry just kept business going as usual. According to the DEA, more than 6 million fentanyl prescriptions (including Actiq, the Fentora tablets, the Duragesic patch, and the Subsys spray) are dispensed each year — a number far greater than the number of cancer patients who meet the criteria for fentanyl prescriptions.
Mr. Caltagirone’s estate sued the manufacturer of Actiq for a variety of claims, and as part of those claims alleged that the company was still illegally conducting off-label promotion. The case was dismissed by a trial court in Philadelphia and is now on appeal in the Pennsylvania Superior Court, and in that appeal the Chamber of Commerce showed up with an amicus brief to make this argument:
The gravamen of Plaintiff’s claims is that Cephalon and Teva violated the federal Food, Drug, and Cosmetics Act (“FDCA”) by marketing ACTIQ, which is approved to treat breakthrough pain in opioid-tolerant adult patients with cancer, for off-label use. However, Plaintiff’s attempt to enforce the FDCA through a state law tort claim necessarily “stands as an obstacle” to the FDA’s administrative discretion and is preempted under the Supreme Court’s reasoning in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
That is precisely the same argument the opioid manufacturers are making in Ohio and elsewhere, an effort to stretch Buckman into a shield that protects all drug and medical device manufacturers. It’s no coincidence that the U.S. Chamber of Commerce is filing a brief in an individual drug death lawsuit that just so happens to support the arguments that opioid manufacturers are making across the country.
This strategy isn’t new. For years, the Chamber of Commerce has been filing briefs with the purpose of narrowing the law to make it impossible to sue drug manufacturers even when they have clearly broken federal law. But in the past few years they’ve ramped up matters considerably, and now they seem particularly keen on thwarting arguments that could be used against the opioid manufacturers.
In June of this year, the Chamber joined with the Pharmaceutical Research and Manufacturers of America to file an amicus brief in a Seventh Circuit case (Sidney Hillman Health Center of Rochester v. Abbott Laboratories, Inc.) where healthcare plans were suing the manufacturer of Depakote for money wrongly spent while the company was aggressively marketing the drug off-label. The company eventually plead guilty to violating federal law — but successfully avoided the civil racketeering lawsuit brought against it. In August, the Chamber filed an amicus brief (in U.S. ex rel. Campie v. Gilead Sciences, Inc.) that tried to convince the Ninth Circuit to absolve a drug company from a False Claims Act case in which alleged, in the Court’s words, the company “made false statements about its compliance with Food and Drug Administration regulations regarding certain HIV drugs, resulting in the receipt of billions of dollars from the government.”
The Chamber and the pharmaceutical industry has been doing this sort of court lobbying work for years. Last September, the Medical Information Working Group, which includes Amgen, Bayer, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, GlaxoSmithKline, Novartis, Novo Nordisk, and Pfizer, filed an amicus brief in a criminal case (United States v. Facteau) in which two executives had been convicted of selling “adulterated and misbranded” medical devices after the FDA had specifically rejected approval. The Group argued that the laws prohibiting selling misbranded and adulterated drugs and medical devices were “unclear” and unconstitutional.
The United States Supreme Court flattened most of these “blame the FDA” arguments back in 2009 with Wyeth v. Levine, 555 U.S. 555, and flattened them again in January 2016 by refusing to grant certiorari in Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015), cert. denied, 136 S. Ct. 896 (2016), despite the Chamber of Commerce and collection of Big Pharma advocacy groups begging the Supreme Court to take the case. The Buckman argument has been repeatedly rejected, like in Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), in which Judge Watford wrote a concurrence noting, “There is no question that state law has an important and legitimate role to play in regulating the adequacy of post-sale warnings for products already on the market.” Id. at 1235. Yet, these zombie arguments keep coming back and, occasionally, courts are swayed by them (not least because the Chamber spent over $25 million on U.S. Senate candidates last year), which is why the Chamber, PhRMA, and other lobbying arms of the pharmaceutical industry keep pushing them on courts.
Most of the opioid lawsuits out there brought by states, counties, and municipalities haven’t made it far enough along to have these issues decided, although a federal court in Illinois was wholly unimpressed by them and denied the drug manufacturers’ motions. That said, if the drug industry and the U.S. Chamber of Commerce are able to use individual cases like Mr. Caltagirone’s to stack the legal deck in their favor, those governmental entities, as well as other individuals and health benefit plans also bringing suit, may never get a fair day in court.