The civil justice system, by regularly closing off and keeping secret key parts of lawsuits involving medical devices and prescription drugs, may contribute to patients’ serious injuries and deaths, according to a “special communication” published in a noted medical journal.
The online article in JAMA Internal Medicine argues for greater transparency and disclosures, with a table of examples that includes how:
- With the Prempro hormone therapy drug for women, the “Manufacturer hired vendors to publish ghost written reviews and commentaries that promoted estrogen replacement for several off-label uses, including prevention of dementia, Parkinson disease, and visual impairment, and downplayed risks of hormone-associated breast cancer.”
- With the potent psychiatric drugs Celexa (citalopram) and Lexapro (escitalopram) and young people, “Results of a ghost written pediatric trial for citalopram were misrepresented as positive in a key published article and to the federal [Food and Drug Administration], contributing to the promotion of citalopram for pediatric use and FDA’s approval of escitalopram in adolescents.”
- With one type of hip implant, “Manufacturer initiated a seeding trial to promote use of the Pinnacle Hip System and to generate survivorship data for marketing purposes and also misrepresented study results.”
- With the painkilling drug Vioxx (rofecoxib), the “Manufacturer minimized the cardiovascular risks of rofecoxib in marketing materials and published clinical trials; contracted with medical publishing companies to ghost write manuscripts related to rofecoxib; and used seeding trials [a form of marketing, not science] to promote prescriptions.”
Of course, the opioid crisis is cited in this work. It was — and is — one of the most lethal cases involving information that had to be pried loose by news organizations and involving Big Pharma and harmful practices. Hundreds of thousands of Americans have died, victims of opioids and overdoses in a mess that has involved too many elements of the health care system, including doctors, hospitals, insurers, and of course, Big Pharma. The nation is reckoning still with the carnage caused by addiction and abuse tied to the potent painkillers and the illicit drugs they paved the way for.
The JAMA article underscores points also made recently by Reuters journalists about the opioid nightmare and lawsuit confidentiality. But the medical journal authors, including the two who penned an accompanying commentary, come to the issue with a mix of legal, clinical, and personal backgrounds. The lead author of the special communication is Alexander C. Egilman, a bachelor’s degree-holder doing work at Yale. He’s also the son of David Egilman, a doctor and professor of family medicine at Brown University. Egilman senior has been a lifetime crusader against what his research has found to be problematic conduct by medical device makers and prescription drug manufacturers. As “Science” recently reported of Egilman senior:
“In 35 years as an expert witness, he has given depositions and testimony in more than 600 cases of occupational or environmental disease. He has helped win billions of dollars for injured or sick workers or consumers, or for the families of those who have died. By his reckoning, he has earned more than $5 million for such legal work; he says he has donated some of his fees to charities, including a nonprofit he founded to improve health in developing countries. Specializing in occupational lung disease, Egilman diagnoses patients and marshals data. But he also digs into corporate records uncovered during litigation, invariably finding memos and studies showing that companies knew about industrial hazards long before warning employees or the public.”
Young Egilman, joined by esteemed members of the medical school and law faculties at Harvard and Yale, urges judges to weigh carefully requests from defendants and plaintiffs in medical device and drug cases to withhold from the public documents and other materials “discovered” and exchanged as part of lawsuits. If key information must be kept secret, parties should defend why, and judges should consider limiting the time when materials may not be disclosed. The authors say that courts should “Expressly allow litigants and experts to contest confidentiality for the purpose of disclosing public health and safety information to regulators and, if appropriate, to the general public.” The authors also decry the hasty destruction or return of litigation materials, further keeping them out of public view.
In a counterpoint editorial, two well-known Harvard Law professors offer a dose of realism about the call for greater transparency in medical device and drug lawsuits. They point out that lawyers and judges may be captive of their fundamental duties to clients and litigants, not necessarily to the public. Claimants may come to court as an extreme step and when their needs are staggering. They may be disinclined to see their cases slammed by delays and burdened by costs as their lawyers battle big companies over disclosures from which plaintiffs may not see immediate and speedy benefit. Attorneys may be loath to hang up a negotiated settlement favorable to their clients, bickering over making public documents from a case.
The legal counterpoint in the JAMA commentary also takes a stance worth reading:
“If Egilman [and colleagues] are right that excessive secrecy poses a threat to public health—and we think they have offered strong arguments to this effect — more ambitious interventions (perhaps not directed at the courts at all) may be needed. Those interventions might include laws requiring additional disclosures from drug and medical device manufacturers, enabling the U.S. Food and Drug Administration to more assiduously review marketing and detailing practices, and providing the U.S. Justice Department and state attorneys general with the resources to more zealously enforce laws against fraud and abuse. None of the additional interventions that we suggest may be politically feasible. They may also not be sufficient. But they deserve consideration alongside the argument of Egilman that protecting the public health requires rethinking the rules governing disclosure in civil litigation.”
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the extreme stress that legal cases can put on them and their loved ones when they go to court, injured by dangerous drugs or defective and dangerous products, particularly of the medical kind. Contrary to what doctors and hospitals may contend, scrupulous lawyers and damaged patients don’t file malpractice and other actions without great care and certainly not in frivolous fashion. Lawsuits can take time and they can be financially and emotionally draining, especially because most Americans rarely step in court and feel the gravity of a legal action in which they are involved.
Patients in lawsuits not only seek to be made whole for injuries they have suffered or to ensure they and their loved ones can access and afford what may be a lifetime of extensive and demanding medical care. They also seek a sense of closure and justice — seeing that wrongs committed against them are admitted and that steps will be taken to ensure they never reoccur. Many plaintiffs hope their voice can be heard to protect others.
But when it comes to resolving cases, particularly those where defendants bid to keep them secret as part of tough negotiations, the choices get tough. 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 and why we oppose them mostly. Here’s a key opt-out we discuss with clients:
“We make one exception – if secrecy benefits an injured person who wants to keep the amount of a settlement from prying eyes, or who wants to keep embarrassing facts about them quiet, then we will agree to confidentiality of specific terms, such as the dollar amount or the name of the injured client. But we don’t agree to keep the facts of the case or the name of the defendant confidential.”
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. And it’s an ugly truth about medical malpractice lawsuits 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. 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 on to perpetrate harms against others.
We’ve got a lot of work to do to ensure the civil justice system stays as open, transparent, and public as possible, protecting parties involved in it and the public, too.