Confidentiality orders in drug, device lawsuits harm patients and the public

In 2001, West Virginia became the first state to sue Purdue Pharma, the maker of OxyContin (oxycodone ER). As part of the confidential exchange of documents during the litigation, Purdue disclosed something extraordinary: the company knew that OxyContin did not provide 12 hours of pain relief.

This disclosure was notable for two reasons: It contradicted the drug’s FDA-approved label, and Purdue had heavily promoted this supposed attribute of OxyContin to establish its competitive advantage over other pain relievers.

Other confidential documents showed how Purdue mobilized sales reps to tell doctors to prescribe stronger doses of the painkiller in hopes of disguising its lack of 12-hour effectiveness. This marketing strategy likely helped fuel the opioid epidemic, as these stronger doses put patients at greater risk for addiction and overdose.

Although the information was disclosed in litigation, Purdue worked to keep the company’s records secret by settling cases and ensuring evidence was sealed by judges’ confidentiality orders. The public only learned about the issue in 2016 after documents were leaked to the Los Angeles Times and STAT fought a long battle against Purdue to unseal secret records from a Kentucky case.

Unfortunately, there are many more examples like this one in which manufacturers used legal orders to keep hidden information that would have been important to public health and clinical decision-making.

There is growing consensus today that we need greater clinical research transparency. One area that deserves extra attention is the problem of secrecy in drug and medical device litigation. Lawsuits are common in the industry, and though they are sometimes unfounded, they have been an important source of information about medical products.

In lawsuits, manufacturers are compelled to produce otherwise secret information, including patient-level clinical trial data, serious adverse events, and internal documents like company emails. Any of these can reveal new information about drug or device risks, research misconduct, and illegal or unethical marketing practices. That information often does not see the light of day, sealed by a judge’s confidentiality order, even though under prevailing law this information should routinely be made publicly available.

U.S. law has long recognized that openness is fundamental to the judicial process. The First Amendment and common law protect the public’s right to access certain types of information in lawsuits, including court proceedings and records. Companies seeking to keep confidential information filed with a court have the burden of proving that specific documents should be held confidential, for example because they would impinge upon patient privacy or divulge a trade secret.

But as we wrote recently in JAMA Internal Medicine, secrecy is commonly the status quo in medical product lawsuits. Data and documents that emerge in litigation are often treated as confidential without regard for the legal standards.

We reported numerous examples in which important information was kept from public view, often for years — and these are only the cases we know about. In these cases, overly broad or unwarranted confidentiality orders prevented the public from accessing critical public health information, such as serious adverse events and illegal off-label marketing, and obscured patterns of injury and disease associated with the drugs and medical devices at issue.

From lawsuits against Wyeth Pharmaceuticals over the company’s drug Prempro (estrogen hormone therapy), for example, we belatedly learned how Wyeth hired ghostwriters to distort the medical literature, mischaracterizing hormone therapy as safe and effective, which contributed to its widespread use among millions of women who had no medical indication for the drug.

Similarly, in the cases against Merck about Vioxx (rofecoxib), the COX-2 inhibitor the company suddenly pulled from the market in 2004, we belatedly learned how the company misrepresented the safety of Vioxx in multiple clinical trials and coordinated clinical trials through its marketing department to promote the drug to high-prescribing physicians.

Though we cannot know precisely how often information is withheld that should be public, a Reuters analysis of court filings from 115 of the largest mass product liability cases over the past 20 years showed that the problem was extensive. In about half of the cases, health and safety information was sealed and, in 85% of those cases, judges improperly provided no explanation for granting the sealing order.

Secrecy in litigation continues today, including cases involving opioid manufacturers. Opioid manufacturers and distributors have produced millions of documents in the nearly 2,000 cases consolidated in multidistrict litigation in Ohio. Here, too, the judge presiding over the litigation has given the litigants broad authority to designate documents as confidential. Some of these records could likely shed light on the practices these pharmaceutical companies engaged in that contributed to the opioid crisis and help us better protect the public from such epidemics in the future.

Why does secrecy persist despite the harm to the public and the prevailing legal standards that favor more openness? Companies want confidentiality to prevent disclosure of information that may adversely affect sales or their reputations, such as data revealing previously unknown safety concerns or improper marketing practices. Perhaps more surprisingly, plaintiffs and their attorneys also often agree to secrecy to speed up litigation or facilitate settlement.

It also occurs because judges may view confidentiality orders as a means to promote settlements and the efficiency of litigation. Especially early on in litigation, all of the parties involved often prioritize the exchange of information, and circumvent or ignore the legal standards that are supposed to be applied.

Given the stakes for the public’s health, these practices need to change. It is possible to allow litigation to proceed at a reasonable pace, and to protect both legitimate interests in commercial confidentiality and privacy and the public’s interest in disclosure, if the appropriate legal standards are followed. Judges can and should rigorously investigate whether secrecy is warranted and ensure that the standards for secrecy are met before documents are protected or sealed.

Where it is necessary to protect information early on in litigation to facilitate discovery, we encourage the use of a model protective order that puts strict limits on this protection, to ensure that the burden of showing the need for confidentiality — particularly over time — remains with the defendants. Courts and judges should also adopt such model orders, as well as local rules that better reflect the prevailing legal standards.

Plaintiff attorneys and their clients should also challenge overly broad confidentiality. Many of those who feel they have been harmed by medicines want information about those harms to be shared, and they should be given the opportunity to refuse to agree to overly broad confidentiality. Medical experts involved in cases can also do much more to ensure that important documents are disclosed. Some of the best examples of public disclosure, such as those involving Vioxx, are the result of experts advocating for the release of data for the benefit of public health.

A more secure and ambitious route for reform would be through legislation or rule changes. For example, Congress and states can enact legislation, such as the Sunshine in Litigation Act, that make it harder to seal or protect health and safety information, building on steps that some jurisdictions have already taken.

Court secrecy poses a substantial risk to public health. Congress, judges, lawyers, and medical experts all have roles to play in ensuring that information that is important to public health and patient care is no longer kept hidden in litigation.

Alexander Egilman is a researcher at the Collaboration for Research Integrity and Transparency at Yale Law School. Joseph S. Ross, M.D., is a professor of medicine and of public health at the Yale School of Medicine and a member of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System. Amy Kapczynski, J.D., is a professor of law at Yale Law School and faculty co-director of the school’s Global Health Justice Partnership and the Collaboration for Research Integrity and Transparency.