The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and may have been too quick to seal from the public information that would have warned of painkillers’ addictive and lethal characteristics.
Makers’ false claims about opioids and their problematic practices in promoting, selling, and distributing the drugs were hidden, too, in the “pervasive and deadly secrecy that shrouds product-liability cases in U.S. courts, enabled by judges who routinely allow the makers of those products to keep information pertinent to public health and safety under wraps,” Reuters reported.
The news agency dug deep into the judicial practices, finding:
“[J]udges sealed evidence relevant to public health and safety in about half of the 115 biggest defective-product cases consolidated before federal judges in so-called multidistrict litigation, or MDLs. Those cases comprised nearly 250,000 individual death and injury lawsuits, involving dozens of products used by millions of consumers: drugs, cars, medical devices and other products. And the numbers don’t convey the full extent of information locked away because they don’t include thousands of product-liability cases heard in state courts. The impact is broad. Although secrecy makes complete analysis impossible, Reuters found that hundreds of thousands of people were killed or seriously injured by allegedly defective products after judges in just a handful of cases allowed litigants to file under seal, beyond public view, evidence that could have alerted consumers and regulators to potential danger.”
Besides affecting opioids, the judicial discretion that permitted records to be sealed failed to protect 200 users killed by a Remington rifle with a defective trigger, Reuters reported. It may have contributed to thousands of deaths by drivers and passengers in General Motors cars and trucks with roofs the company knew would be safer if reinforced.
Secret settlements have been a personal bugaboo of mine for the past decade. I’ve campaigned nationally to persuade my fellow plaintiffs’ lawyers to resist and refuse these hush agreements and narrow them if there is no other option. You can read about our stand on secret settlements on our website.
Blocking case information from public view goes against a fundamental idea in U.S. courts, calling for them and their processes and actions to be as transparent and open as possible. Exceptions have been carved out for privacy concerns, notably for medical records and companies’ trade secrets. But judges have grown so accustomed to sealing shut product defect cases that they fail to provide explanations why they do so, as the law requires them, Reuters reported. Here’s why the news agency said jurists act this way:
“It makes things easier for everyone involved. Corporate lawyers want to protect their clients’ reputations. Plaintiffs’ lawyers want to avoid miring their clients’ cases in lengthy courtroom wrangling over requests that filings be sealed or redacted. And judges want to keep the business of justice moving. Secrecy is amplified by the growing practice of consolidating similar lawsuits under a single judge. MDLs, which now cover as much as 40% of all lawsuits filed in federal courts, are meant to promote efficient resolutions. Each decision the judge makes applies to all of the consolidated lawsuits. Thus, with one sealing order, a judge can impose secrecy in thousands of cases.”
The reporters also explain that changes in the law, starting in the early 2000s, altered a key part of the process for litigating product defect cases. Important information deemed necessary to even figure out the bones of a case — dug up and exchanged in “discovery” — moved less and less from the purview of courts. Instead, lawyers for the various parties exchange the information among themselves. That kept judges, their clerks, and their courts freer from handling mountains of paperwork and possible exhibits. But it also meant that the information no longer was logged and visible to the public with at least some sight lines into accumulating evidence.
Reuters pointed to the federal judge in Ohio who has been assigned the challenge of potentially striking a “global” resolution to 2,000 or so opioid suits — from states, cities, Indian tribes, and many others. The news agency reported that he has imposed strict secrecy on all involved in his court in “draconian” fashion, with litigants — including Big Pharma — given by the judge “broad discretion to determine what records remain secret. As a result, entire lawsuits have been filed under seal in his court, including supporting evidence drawn from millions of records that detail the industry’s conduct over two decades.”
The investigative journalists make the case with Purdue Pharmaceuticals that the court handling its litigation let the firm skate on a false and key claim about the 12-hour duration of its OxyContin product’s pain killing strength. The company hyped that notion to doctors and hospitals, which also accepted — with too great gullibility, experience would show — that if the drug lasted longer patients would take less of it, making it safer. The claim proved to be false, but not before OxyContin had become a lucrative best-seller, addicting thousands and, experts say, opening the way to the opioid-drug overdose crisis.
Purdue also persuaded a federal judge that she should not even allow information about its increasingly problematic product with regulators from the federal Food and Drug Administration. The FDA, in contrast to the National Highway Traffic Safety Administration, also has not issued a federal guidance to jurists about creating legal exemptions so that records with pertinent health and safety data may be shared with regulators.
Reuters said that courts have made clear, too, to parties involved in product defect cases — notably a matter involving Big Pharma — that they may be taking high legal risks by disclosing information that courts have sealed and may not have explained why. The journalists cite the case of a medical faculty member who shared with the New York Times records he had as an expert witness. The drug maker threatened him with the prospect it would seek criminal sanctions against him in court. He paid the company $100,000 to resolve the matter, and the drug maker later paid $1.4 billion to resolve claims against it over its product marketing.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the uncomfortable twists and turns they may experience when they seek justice for themselves and their loved ones in the civil justice system for damage that may have been inflicted on them by defective and dangerous products.
Secrecy in our courts is a less than optimal condition. An ugly truth about medical malpractice lawsuits is that some of the most indefensible violations of patient safety are covered up by hospitals, clinics and doctors with the complicity of the lawyers representing the injured patients. This happens when settlements are struck that require the patient to keep confidential everything that happened, and sometimes to even pretend it never happened. USA Today reported in detail a particularly egregious example: the prestigious Cleveland Clinic covered up a rape allegation against one of its surgeons by settling the patient’s claim and requiring the patient to sign a settlement document promising to remain silent about the episode. Eventually the surgeon resigned quietly and moved onto another health care institution, which of course knew nothing about the allegations until informed recently by the newspaper.
Everybody is familiar by now, too, with how secret settlements have allowed sex abusers in the entertainment and media world – Harvey Weinstein, Bill Cosby, Bill O’Reilly and the rest of the gallery of shame – to buy off their accusers and go onto perpetrate harms against others.
Meantime, Politico, the politics and policy focused web site, reported that doctors, nurses, and other medical personnel, as well as hospitals, may be hard-pressed to tell each other and, more important, patients and the public about the many and growing woes of proprietary electronic health records systems. That’s because the giant EHR-tech companies, which burgeoned after the Obama Administration sought to improve medical care by providing billions of dollars to boost the systems’ use, have gagged medical staff and hospitals with nondisclosure agreements (NDAs). The NDAs, Politico says, effectively bar “health care providers from talking about glitches that slow their work and potentially jeopardize patients.”
Reuters deserves credit for raising in the opioid-drug overdose crisis questions about courts’ role, quoting one legal scholar’s observation that it was “bananas” that a jurist made key decisions in Purdue litigation with an abundance of crucial documents under seal and with no explanation why this was so.
Court practices can be tricky and difficult for parties involved to question or criticize. Secret settlements, nondisclosure agreements, and the unexplained shutting off from public view of information that may be pertinent to the collective health and safety — these all sound like suitable issues for congressional hearing and consideration, especially if the FDA is letting dangers lurk, hidden in files that it may have perfect legal standing to seek and which Americans may regret if the agency or someone else fails to dig into.