Last week, a federal judge in Texas ordered pharmaceutical giant Johnson & Johnson to pay nearly $5 billion to 29 mothers and children in their civil case against the company. J&J is also the largest contributor to the American Action Forum, a conservative think tank that works to decrease the burden of government regulation.
J&J is appealing the judgment, but the fact that the ruling is so high, and could result in a new era of corporate liability in the courts, raises serious concerns about the legal strategy employed against opioid manufacturers and distributors.
First, let’s consider the legal standard set forth in the ruling.
The mothers and children in the J&J case filed a legal theory called medical necessity. The mother of plaintiff David Dozier raised the claim that his overuse of opioid painkillers began when he was hit in the head with a log and suffered “serious brain damage, resulting in irreversible neurological deterioration.” He has now been addicted to opioids for 20 years. It’s the standard for medical necessity when a drug is designed to manage chronic pain and the patient’s condition has become so debilitated that standard therapies have no value.
The ruling holds that J&J failed to properly develop and market opioids for the patient population. It is the first such ruling in any state.
When J&J first introduced acetaminophen, its primary product and the active ingredient in Tylenol, it did so with consumer-safety in mind. With the addition of opiates, the company argued that the drug would manage minor pain and should not be widely used for patients suffering from moderate pain.
The case argued by the plaintiffs in their lawsuit might have been justifiable in 1968, when doctors were still just beginning to treat physical pain and no one considered addiction an ethical issue. And, as a result, patients had few rights in the eyes of the pharma industry.
But today, the opioid crisis threatens to usher in a new era of pharmaceutical liability. The scope of the problem has transformed well-intentioned marketing and sales efforts into a deadly epidemic.
The total number of opioid-related deaths reached 91,055 in 2016. In 2013, the last year for which data is available, 21,089 people died from overdoses.
The pace of opioid overdose deaths has continued to increase, with 4,133 opioid-related deaths recorded in 2017. There is also a disturbing association between drug addiction and the rate of new HIV cases, which has grown by 150 percent since 2013.
And the stigma of opioid addiction has become more pervasive. Reports now confirm that approximately 14 million Americans reported symptoms of drug abuse in 2016.
In response, the pharmaceutical industry has become a prime target of the anti-regulatory movement. But, as in the J&J case, it could become an economic victim of this legal onslaught.
The New York Times reported the other day that part of the reason the pharmaceutical industry has survived legal attacks so successfully for so long is because opioids are marketed in ways that confuse consumers about risks and reward.
It’s not a coincidence that sales of high-cost painkillers have declined. Opioid prescription use had been steadily rising since 1999, but fell 6 percent last year. The Centers for Disease Control and Prevention warned that there is a drug crisis taking place in America because of the overprescribing of opioids, and the Big Pharma companies are paying the price.
But pharmaceutical companies have begun to alter their practices in response to public pressure and regulatory action. And, as a result, the list of companies and industries the center for legal attacks against has grown, to include vitamin manufacturers, weight-loss companies, and opioid distributors.
While the drug companies and other companies have imposed voluntary restrictions on overprescribing and marketing their drugs, there are signs that their efforts are not working. A number of independent epidemiological studies have shown that opioid addiction has accelerated in the past three years.
Finally, the J&J case appears to show that the Federal Trade Commission and other government entities may be too lenient when interpreting the law. Let’s hope the court in Texas is more correct, which would raise some important questions for the legal community about how to proceed.
It’s unlikely that American consumers will achieve true legal fairness until the issue of opioid addiction is settled by the courts. The moral of the story is that the moral of the story, as much as the law, is about making sure the stakeholders—patients, physicians, health plans, governments, employers, and the pharmaceutical industry—share in the financial upside of meeting the needs of opioid patients. The market should be allowed to reward those who take that responsibility.
No one should make their financial livelihood from addiction. And that means patients