When an Oklahoma judge ordered Johnson & Johnson last year to pay half a billion dollars as compensation for the harm caused by abuse of prescription opioids, he relied on a definition of "public nuisance" so broad that it could cover nearly any product. Worse, as the Goldwater Institute notes in a brief supporting the company's appeal to the Oklahoma Supreme Court, his theory of liability was based on statements protected by the First Amendment.
Cleveland County District Court Judge Thad Balkman—who initially ordered Johnson & Johnson to pay Oklahoma $572 million, a judgment he later reduced to $465 million—concluded that Johnson & Johnson had exaggerated the benefits of its pain medications and underplayed their dangers. Yet several of the statements he deemed misleading, including the observation that patients typically do not become addicted to these drugs and rarely die from overdoses, are actually true.
Some claims about pain medication—concerning, for example, the extent of undertreatment, the long-term benefits of opioids for people with chronic pain, and the concept of "pseudoaddiction," which describes how bona fide patients desperate for pain relief can be mistaken for nonmedical "drug seekers"—are more controversial. Yet taking positions on these issues is not tantamount to commercial fraud. "The trial court characterized legitimate scientific discourse as deceptive," the Goldwater brief says.
Balkman dismissed the notion that he was punishing Johnson & Johnson for constitutionally protected speech. "I conclude that the speech at issue here is commercial in nature and that it is therefore not protected speech under the First Amendment," he wrote. That conclusion was doubly wrong, Goldwater says.
First, "commercial speech is protected by the First Amendment." Although the Supreme Court has said the government has more leeway to regulate commercial speech than it has to regulate other kinds of speech, the restrictions still must meet the test described in the 1980 case Central Hudson Gas & Electric v. Public Service Commission of New York. When speech is not misleading and concerns lawful activity, the Court said in that case, regulations must "directly advance" a substantial government interest, and they must be narrowly tailored, meaning they are "not more extensive than necessary." Balkman's conclusion that Johnson & Johnson's statements are "not protected speech under the First Amendment" therefore relies on his judgment that they were misleading, even when demonstrably true.
Second, the Supreme Court has defined commercial speech as expression that does "no more than propose a commercial transaction." That description plainly does not apply to general statements about, say, the addictive potential of prescription opioids or the extent to which patients who could benefit from them are denied medication. In the 1983 case Bolger v. Young Drug Products, Goldwater notes, the Court held that "informational pamphlets about medicines" did not qualify as commercial speech, even though "they were created with a commercial motive and addressed one specific product."
Having concluded that the First Amendment does not apply to Johnson & Johnson's statements about opioids, Balkman used them to find the company guilty of creating a public nuisance, a concept that no one has been able to satisfactorily define. "Nobody knows what a public nuisance is," Goldwater says, citing legal scholars who have described it as "vaguely defined," "poorly understood," "all things to all people," a "wilderness," an "impenetrable jungle," a "quagmire," and "a legal garbage can."
The nebulous nature of "public nuisance" is reflected in the Oklahoma statute that Balkman applied to Johnson & Johnson, which says it "consists in unlawfully doing an act, or omitting to perform a duty, which act or omission…annoys, injures or endangers the comfort, repose, health, or safety of others" or "in any way renders other persons insecure in life, or in the use of property." The breadth of such definitions poses obvious due process problems, since businesses are not given clear notice of which actions could expose them to massive liability.
The "public nuisance" concept has been deployed, for example, against companies that legally sold lead paint, which became a hazard years later as it flaked off surfaces in homes where it was used; gun manufacturers, because they legally sold firearms that were ultimately used in crimes; and General Motors, because its vehicles contribute to global warming. "Absent objective rules limiting liability," Goldwater says, "the concept can become a catch-all rule against whatever government officials, or even individual citizens, decide is bad behavior."
Making drug manufacturers liable for selling products in compliance with federal regulations is not merely unfair to them. It is part of a broader crackdown on pain medication that has denied treatment to legitimate patients while driving nonmedical users into a black market where the drugs are much more dangerous because their potency is highly variable and unpredictable.
The latter effect was apparent in the same trends that Balkman cited to justify his ruling against Johnson & Johnson. As the government succeeded in reducing opioid prescriptions, the upward trend in opioid-related deaths not only continued but accelerated. Illicit drugs now account for the vast majority of those deaths. Balkman, who erroneously claimed that the "current stage of the Opioid Crisis…still primarily involves prescription opioids," seemed oblivious to that fact.
Balkman likewise dismissed the suffering of legitimate patients who are unable to get the medication they need to relieve their pain. That problem has been aggravated in recent years by ham-handed efforts to reduce opioid prescriptions, as the Food and Drug Administration, the Centers for Disease Control and Prevention, and the American Medical Association have recognized. But in Balkman's view, any talk about undertreatment is inherently suspect, motivated by nothing but the desire to sell more pain medication. As Goldwater notes, "the trial court concludes that defendants and others broke the law by 'suggest[ing] pain is undertreated and doctors should prescribe more opioids'—without finding that these things were factually untrue or negligently stated."
Balkman's decision quotes Terrell Phillips, a physician who said this during an October 2016 presentation to the Oklahoma State Medical Association: "Everyone here knows how we got in this situation. They told us we were underprescribing. We need to prescribe more. It's the patient's rights to have pain medicine, so we all got on board. And when someone said they were hurting, we said, 'OK, we are going to give you something.' Now it's just the opposite. Not everyone deserves pain medicine."
In Balkman's view, that quotation reinforces the case that drug companies recklessly encouraged overprescription of opioids. But by implicitly endorsing the new message that "not everyone deserves pain medicine," Balkman shows a callous disregard for the patients who suffer because other people abuse the medication on which they rely to make their lives bearable.
Similarly, Balkman treats the concept of pain as "the fifth vital sign," which was intended to address undertreatment, as nothing more than a scheme to line the pockets of companies like Johnson & Johnson. "The phrase refers to the idea that physicians should be as focused on treating pain as they are on treating a patient's difficulty with breathing, cardiac problems, etc.," Goldwater notes. "This is a legitimate and humane attitude—quite the opposite of the shockingly inhumane, even cruel, idea expressed in the words the trial court quoted approvingly: 'Not everyone deserves pain medicine.'"
Some critics argue that the "fifth vital sign" concept contributed to excessive prescribing. But that does not mean the idea, which was backed by the Joint Commission on Accreditation of Healthcare Organizations as well as the American Pain Society, the Institute of Medicine, and the U.S. Veterans Administration, was simply a mercenary scam, as Balkman implies.
Likewise with pseudoaddiction, a concept that was endorsed by the Food and Drug Administration. "Although 'the concept may have fallen out of favor,'" Goldwater's brief notes, "it has not been squarely rejected, let alone proven to be a form of deceptive marketing….There is nothing deceptive or unlawful about the scientific community proposing, discussing, studying, and even later rejecting a medical or psychological hypothesis."
Balkman's understanding of the speech that can make a company guilty of creating a public nuisance is so broad that it could encompass any participation in scientific or public policy debates by businesses with a financial interest in the outcome. If the National Shooting Sports Foundation expresses skepticism about "assault weapon" bans, for instance, that would count as commercial speech in Balkman's view and, if deemed misleading, fall outside the scope of the First Amendment. Likewise if a natural gas producer defends fracking, if a carmaker criticizes new fuel efficiency standards, if a chemical company questions claims about pesticide residues on fruit and vegetables, or if a food manufacturer presents evidence that genetically modified ingredients pose no health threat to consumers.
Based on Balkman's logic, messages like those, which heretofore have been understood as constitutionally protected, could be punished for creating a public nuisance. If so, First Amendment rights will be tossed into "a legal garbage can," along with the fair notice required by due process.