We must reform the law to force corporate documents into the public
Companies continue to hide evidence of product dangers by sealing off records behind corrupt court protective orders.
15 minute read
Hey guys. I was gone last week on a trip to give a talk at a conference in Toronto. I’ve been working for the last several years with an international group of academics and journalists on a program to address ghostwriting in science and medicine, and we were meeting to present papers at an academic conference in Toronto.
It was a hellish trip.
I got stuck for a couple days in the Newark airport—actually slept on the airport floor when I couldn’t stay awake any longer. I was so angry, I pushed out a 4 a.m. tweet thread one morning about the craziness happening in the airport, and CNN picked it up for their TV broadcast.
Realizing I wasn’t going to make it to Toronto on time, I gave my talk from a quiet corner of Newark’s airport. So crazy. I flew from Madrid, for a talk at a conference in Toronto, that I gave while seated on the concrete floor of Newark’s airport.
I eventually took a 12-hour bus trip to meet everyone in Toronto, and finally got back home on Saturday. United Airlines said that the weather on the Eastern seaboard forced them to cancel hundreds of flights, but I don’t think they are being honest. They’re hiding the fact that they’re having labor problems as well.
Anyways, here’s the talk.
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Records entered into public courts belong to the public
Pretty much any day of the week, lawyers locked in litigation exchange documents in a process called “discovery.” These documents are only released to people who have signed a protective order that maintains the documents’ secrecy, but that allows each side in the lawsuit to explore if their legal opponent is being honest.
During discovery, lawyers for a mother in Iowa, who claims she was harmed by a bad drug, can comb through the pharmaceutical company’s documents to see if there is evidence that the drug was actually bad. Meanwhile, the company can look through the woman’s medical records to see if she actually got sick.
At times, this process can uncover evidence that a company’s product is dangerous—maybe even signs that company executives knew this and hid these dangers. Making these documents public can have a dramatic impact on public health.
The importance of court documents is best captured by the release of 43 million pages of internal tobacco documents as part of several settlements and the tobacco Master Settlement in the 1990s. These documents are now archived at the University of California—San Francisco (UCSF) and provide a wealth of information for public health researchers and policy experts. In short, the archive exposed how tobacco engaged in a decades-long conspiracy to deny the dangers of smoking—a strategy they implemented by buying off university professors.
These documents have been critical for helping me to understand how industry operates behind the scenes to affect public policy. Back in late 2005, I was trolling through the tobacco documents and discovered that Steven J. Milloy—then a FoxNews.com science columnist—was on the payroll of a tobacco company. Milloy had written several articles downplaying the dangers of second-hand smoke, and I profiled Milloy’s pay-for-play journalism in The New Republic.
In a second example, attorneys suing GlaxoSmithKline (GSK) passed me dozens of documents they uncovered in discovery while suing GSK over the dangers of Paxil. These documents showed several examples of GSK paying a PR firm to write scientific studies that were then passed off to academics at Stanford and Emory University to put their names on as authors—a process known as ghostwriting.
I wrote a couple blogs posts about this and then passed the documents to reporters at the New York Times who then covered the scandal (Drug Maker Hired Writing Company for Doctors’ Book, Documents Say).
I also sent the documents to UCSF and they added them to their Drug Industry Documents Archive. Today, the UCSF Documents Archive contains litigation records from the following industries: tobacco, chemicals, drugs, food, fossil fuels, pharmaceuticals, and opioids. These documents are critical to exposing harms caused by corporate products and the strategies companies use to fool people.
Litigation is critical to uncovering evidence of dangerous products, but discovery documents are seldom made public, and are often sealed as part of settlements. Because of this secrecy, legal experts and members of Congress have proposed legal reforms that would require discovery documents be made public when they show products cause harm. Three incidents, which I will discuss, make this need for reform clear.
Since a 1984 Supreme Court decision on rules of discovery, the courts have become more secretive and willing to keep documents hidden under seal, even if those documents show a product is dangerous. In response, Congress has introduced legislation called the “Sunshine in Litigation Act” and states such as Florida and Texas have passed sunshine rules and laws that limit courts from sealing health and safety records finding public hazard.
Since that 1984 ruling, an increasing number of experts have spoken up about secrecy in the courts. “When the courts have information about serious threats to health and safety, the public has a clear right and need to know,” reads a 2008 New York Times editorial, discussing a Senate bill designed to stop courts from sealing documents. The Sunshine in Litigation Act was introduced for several decades but was never passed. (FYI: While a Senate staffer, I worked briefly on the Sunshine in Litigation Act.)
In a 2019 series, Reuters documented several examples of court secrecy where discovery documents were sealed even though the they showed proof of product harm. That same year, historians advocated that documents found in litigation against Purdue Pharma for causing the opioid crisis should be made public and housed in an online database.
“[C]ourts and litigants operate in a manner that often improperly impose the burden on those who seek disclosure, or impose secrecy without meeting the proper legal standard, thus favoring confidentiality over public access,” noted Yale public health experts, in a 2019 JAMA editorial calling for legal reforms to stop court secrecy and protect the public from product harm.
II. Ghostwriting and Ghost Management in Science
Failing to disclose input and study authorship can be considered a type of plagiarism in academic research. For example, the Health and Human Services Office of Research Integrity defines plagiarism as “the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.” When corporations secretly write or manage studies without disclosure of their input, others define this as ghostwriting or ghost management.
Ghost management of research has been defined as instances where companies and their agents are secretly involved in the research without proper disclosure but “control or shape multiple steps in the research, analysis, writing, and publication of articles.” As explained:
Such articles are “ghostly” because signs of their actual production are largely invisible—academic authors whose names appear at the tops of ghost-managed articles give corporate research a veneer of independence and credibility. They are “managed” because those companies shape the eventual message conveyed by the article or by a suite of articles.
Peer review has obviously not stopped ghost management, as corporate control is done in secret and is not disclosed by authors. The solution involves sanctions for this unethical behavior.
Universities and academic health centers should prohibit contracts that allow sponsors to draft, edit, or suppress articles, or that allow sponsors to keep data from authors; they should even prohibit sponsors from facilitating publication. Universities should also take disciplinary action against investigators who serve as authors on ghost-managed articles. Meanwhile, investigators need to be aware of the mechanisms of ghost management of work that goes under their names, and to refuse to participate.
III. Secrecy in the Courts
Reuters produced a four-part series in 2019 on secrecy in American courts and how this hurts consumers. The first part covered opioids, while succeeding investigations looked at the pharmaceutical company Merck, plaintiffs’ firms, and business interests. Increased court secrecy began in 1984, when Seattle Times v Rhinehart came before the Supreme Court and the justices examined how broadly courts should interpret protective orders. The Supreme Court’s decision upheld a judge’s order blocking discovery documents from public disclosure.
This Supreme Court decision set off changes in discovery during the 1980s and 90s that allowed attorneys to directly exchange information instead of entering it into the court. This benefitted companies wanting to keep documents secret, as well as judges dealing with complex cases and large discoveries. For example, Reuters reviewed 155 large federal product-liability cases and found 31 where judges sealed arguments that dealt directly with evidence for possible harm. In most cases, judges did not explain why they allowed this secrecy.
Jeremy Fogel of the Berkeley Judicial Institute at the University of California, told Reuters that judges do not have time for confidentiality battles, “You’re overburdened. You’ve got limited bandwidth. You have lawyers fighting about everything. And so, when they finally agree on something, you’re all too happy to accept that.”
Citing the 1984 Supreme Court’s decision, the defense bar’s leading trade group, the Defense Research Institute, published a 1987 guide that urged corporate litigators to seek protective orders “even where defense counsel can make no special claim of confidentiality.” This helped transform the taxpayer-funded courts into a more closed system.
In the early 1990s, Congress responded with what corporate lawyers called “the perennial Kohl bill,” proposed legislation introduced several times by Senator Herb Kohl. A precursor to the Sunshine in Litigation Act, Kohl’s bill sought to limit protective orders in cases where discovery documents point to problems with public health and safety.
Purdue Pharma and opioids
Documents showing that Purdue Pharma duped doctors into widely prescribing Oxycontin by minimizing addiction risk were entered into a West Virginia Circuit Court as part of pretrial discovery in 2001. The judge later rejected Purdue’s 2004 motion to dismiss the lawsuit, forcing the company to settle for $10 million that year with the state. However, the judge sealed the documents forcing this settlement.
Purdue managed to keep their incriminating internal documents under seal in dozens of other cases in succeeding years,. But 12 years and 245,000 overdoses later, Purdue’s documents were leaked to the Los Angeles Times in 2016. After the Times article, the judge in the West Virginia Circuit Court began releasing documents he had sealed in 2004.
Congresswoman Katherine Clark, told Reuters that, had judge had released the documents sooner, few doctors would have written Oxycontin prescriptions. “We don’t know how many lives we could have saved.” Reuters also reported:
In an unprecedented analysis, Reuters found that over the past 20 years, judges 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.
In 85 percent of the cases where Reuters found health and safety information under seal, judges gave no explanation for keeping the documents secret.
Reuters also reviewed confidential documents that accused Merck of exaggerating Propecia’s safety record. Legal briefs filed by plaintiffs’ lawyers cited company communications and alleged that, in revisions to the drug’s original 1997 label, Merck understated side effects they found in clinical trials. Other documents show that Merck knew two decades back that sales would drop if people knew about the side effects.
One sealed document cites a sworn deposition.
Lawyer: So you knew internally that if these sexual adverse events were prolonged or lengthened or never went away, that that would be something that would impact sales in a negative way. Right?
Merck executive: Yes.
The drug remains on the market.
GM and Plaintiffs firms
While preparing for a case in 2000 involving a Chevrolet Blazer that flipped, paralyzing someone, a legal researcher discovered a 1980s test results showing that people wearing seatbelts in vehicles with stronger roofs were less likely to suffer severe injuries in a rollover. This evidence helped persuade a jury to award the paralyzed plaintiff $15.4 million. However, the majority of the documents remained sealed. In the years after that settlement, more than 5,000 seatbelt-wearing passengers died in GM rollover accidents, many more were injured, and the company continued pumping out vehicles with similar roofs.
In another example, a former GM engineer served as expert witness in the 1990s to analyze the company’s safety data in a GM roof-crush case. The jury later awarded the plaintiff $8.8 million. A lawyer in the case challenged the sealing of documents, but the judge refused to lift the protective order.
"GM has shown that the testing information is of value to GM's competitors," the judge said in his 1993 decision. Among the records the judge kept under seal were about 10 exhibits that had been cited openly in the trial.
Because current law allows judges to seal documents, interested parties have been forced to take action to make discovery documents public. In the following three incidents, we find that such action is costly.
IV. Disclosing court documents can be costly
Three recent examples show that disclosing court documents to the public can be costly. In all three cases, the documents should have been made public to protect public health, but the courts keep siding with secrecy.
Zyprexa documents leaked to the New York Times
In a first example, documents showing Eli Lilly had hidden dangers of Zyprexa, forced the leaker to pay $100,000 to the company. The New York Times first reported on the documents, which were under seal in litigation, on December 17, 2006. As reported:
The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.
The judge in the case later ordered two expert witnesses to return all documents produced in litigation and a physician paid $100,000 to Eli Lilly for leaking the documents. Two years after the New York Times article, the judge decided to dedesignate the Eli Lilly documents “citing 'the health of hundreds of thousands of people' and 'fundamental questions' about the way drugs are approved for new uses.”
In effect, if one of the expert witnesses had not defied the protective order and leaked the documents, the public and physicians would have been in the dark for two years without knowing what Eli Lilly knew: Zyprexas was dangerous to children.
Monsanto disclosures led to attorney sanctions
Lawyers can also face sanctions for making important documents public. In 2015, the World Health Organization's International Agency for Research on Cancer (IARC) found glyphosate, the main ingredient in Monsanto's herbicide Roundup, to be a probable human carcinogen. Around this same time, multiple law firms filed thousands of cases against the company, alleging glyphosate had harmed users. During litigation, one of the law firms began publishing discovery documents on a website called “Monsanto Papers.”
These documents, obtained via Discovery (pre-trial civil procedure allowing the parties to obtain evidence from each other) allow people to see what is happening “behind the curtain” of secrecy that normally shrouds ongoing litigation. You will find links to internal Monsanto emails, text messages, company reports, studies and other memoranda.
Documents published on the website exposed a host of corrupt activity by Monsanto, including the company ghostwriting a series of studies to downplay the dangers and dismiss the carcinogenicity of glyphosate.
Releasing the documents applied pressure to Monsanto, exposing their process to deny glyphosate’s dangers, but this was not without cost. The law firm publishing these documents was sanctioned for making them public after Monsanto claimed that some of the documents were subject to a protective order in the case.
Attorneys needed to access Wyeth documents
In a third incident, documents that show the pharmaceutical company Wyeth was ghostwriting studies were only made public after the New York Times and PLoS Medicine hired attorneys and sued. In this particular case, the two publications worked with attorneys at Public Justice to act as “intervenors” in litigation against menopausal hormone manufacturers who had been sued by women who had suffered stroke, heart attack, blood clots, cardiovascular disease, and cancer.
The publications argued that documents showing ghostwriting should be unsealed. PLoS Medicine Chief Editor Ginny Barbour stated in a motion that ghostwriting “gives corporate research a veneer of independence and credibility” and may “substantially distort the scientific record”; “threaten[ing] the validity and credibility of medical knowledge.”
The judge granted the motion, leading to publications in both PLOS and the New York Times that alerted the public about the drugs’ dangers. As the New York Times reported:
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
Yet, none of this would have happened unless PLOS and the New York Times had convinced attorneys with Public Justice to sue on their behalf to make the documents public.
V. Reform Required
The president of the American Association for Justice, the plaintiff bar’s main lobbying group, has said, “Whether it’s dangerous cribs, defective drugs or exploding tires, court secrecy endangers consumers and allows corporations to hide wrongdoing. Americans have a right to know about hazardous and defective products.”
Some federal agencies have responded. The National Highway Traffic Safety Administration (NHTSA) issued guidance in 2016 for judges on allowing exemptions in secrecy orders so that lawyers can share health and safety records with the agency. Meanwhile, Public Justice maintains a program to fight excessive secrecy in the courts.
An academic physician and plaintiff’s lawyer wrote an analysis of legal cases involving ghostwriting in the academic literature and found that plaintiffs' lawyers have begun naming ghostwriting firms and ghost authors as defendants. If ghostwriting involves fraud against the government, then the guest author may be held liable as a conspirator under the federal False Claims Act (FCA).
Academics involved in ghostwriting should not expect safety under the First Amendment:
[G]uest authors and pharmaceutical defendants may try to argue they have a First Amendment right to participate in ghostwriting. The US has a rich history of protecting anonymous speech, especially in the area of political speech. However, the same level of protection does not apply to commercial speech, i.e., speech promoting the safety/sale of a drug. Moreover, the US Supreme Court has firmly held that “the First Amendment does not shield fraud.”
The authors conclude that since complaints about ghostwriting in the science have fallen on deaf ears, the courts have the task of restoring integrity to the scientific literature.
Texas and Florida have “sunshine” rules and laws that limit the sealing of health and safety records, but corporate lobbying has stymied federal sunshine legislation for decades. While pursuing a federal law to limit court secrecy, reformers should consider advancing similar state laws to ensure court documents, once entered into public courts, remain public.
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