From “childrenshealthdefense.org”
“Discovery,” a process by which evidence is uncovered during lawsuits, has often succeeded in exposing corporate malfeasance to the public, including evidence of hazards from a wide range of products.
But too often, evidence unearthed through the discovery process is sealed away for years, even decades, posing unnecessary and avoidable public harm.
According to investigative journalist and former congressional staffer Paul D. Thacker, the discovery process is broken and in need of reform.
In a Substack post last week, Thacker cited several instances where discovery brought vital information about drugs and other harmful products to the public’s attention — in some cases after that information had been concealed for years.
“Pretty much any day of the week, lawyers locked in litigation exchange documents in a process called ‘discovery,’” Thacker wrote. “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.”
Part of the reason for this, Thacker said, stems from a 1984 U.S. Supreme Court ruling that a protective order prohibiting a newspaper from publishing information it acquired through discovery did not violate the First Amendment.
Thacker also highlighted corporate practices, such as the ghostwriting and corporate management of “scientific research,” as factors that contribute to limiting the public’s knowledge about corporate malfeasance.
In an exclusive interview with The Defender, Thacker also described how special interests have hampered proposed federal legislation intended to make it easier to publicize discovery documents:
“There’s no one really wanting that [disclosure of discovery] to happen. There are only a few small interests even aware that this stuff is going on, [so] this stuff remains secret. There’s no constituency lining up in D.C. to make court documents public.”
Litigation is critical to uncovering evidence of “dangerous products,” Thacker said, because discovery “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,” he said.
Thacker told The Defender this is typically a slow process, during which the products under investigation remain on the market. He described the typical timeline as follows:
“A product comes on the market. Within 5-6 years, we find out that there’s problems with it. Lawyers sue. Another 3-4 years later — with the product now on the market for at least eight years — we find out through the court documents that the product’s bad. That’s the typical, classic timeline we deal with.
“What often happens is, these documents are sealed. Lawyers for the plaintiffs are simply trying to get money for their clients and then move on. Another lawsuit follows 3-4 years later, and then the documents are finally made public.”
‘What happens in the American court system has global significance’
According to Thacker, several large-scale settlements in lawsuits against Big Pharma, Big Tobacco and major corporations illustrate the importance of court documents.
Thacker cited the example of the 2014 revelation that glyphosate, the key active ingredient in Monsanto’s herbicide Roundup, was a probable human carcinogen. Through lawsuits filed against Monsanto, discovery documents were published online in what became known as the “Monsanto Papers.”
“Documents published on the website exposed a host of corrupt activities by Monsanto, including ghostwriting a series of studies to downplay the dangers and dismiss the carcinogenicity of glyphosate,” Thacker wrote.
“If you go back to look at the documents in the lawsuit against Monsanto, documents that were made public from a lawsuit in San Francisco ended up all the way in Brussels, in European parliamentary hearings on what the pesticide companies knew about their products,” Thacker said.
Thacker noted that Robert F. Kennedy Jr., chairman on leave from Children’s Health Defense, testified at those hearings in 2018.
“Those hearings in Brussels were spurred by the lawsuit,” Thacker said. “What happens in the American court system has global significance in terms of regulations.”
Ghostwriting scientific papers to drive the narrative
Thacker also cited “the release of 43 million pages of internal tobacco documents” as part of the tobacco Master Settlement and other settlements in the 1990s.
Those documents revealed “how tobacco engaged in a decades-long conspiracy to deny the dangers of smoking,” including via “buying off university professors,” he said. They are now stored at the University of California, San Francisco (UCSF), providing “a wealth of information for public health researchers and policy experts.”
Ghostwriting has not been limited to academics. Thacker referred to information he uncovered in 2005 and later published exposing that then-Fox News science columnist Steven J. Milloy was on the payroll of a tobacco company and publishing articles downplaying the dangers of second-hand cigarette smoke.
In another example, documents uncovered by The New York Times and PLoS Medicine as part of a lawsuit they filed against drugmaker Wyeth revealed that it “played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women” while deemphasizing health risks.
Thacker noted that in such ghostwritten articles, “companies shape the eventual message conveyed,” and that the peer-review process has “not stopped ghost management, as corporate control [of research efforts] is done in secret and is not disclosed by authors.”
Thacker also cited documents he previously received from attorneys suing GlaxoSmithKline (GSK) over the dangers posed by Paxil, an antidepressant.
“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,” Thacker said.
Evidence of these tactics was ultimately exposed by the Times and was later added to the UCSF Industry Documents Library, which Thacker said also contains litigation records “from the tobacco, chemicals, drugs, food, fossil fuels, pharmaceuticals, and opioids” industries.
Thacker said such examples were “critical for helping me to understand how industry operates behind the scenes to affect public policy” and are also “critical to exposing harms caused by corporate products and the strategies companies use to fool people.”
Supreme Court ruling limited public disclosure of discovery evidence
The 1984 U.S. Supreme Court decision, Seattle Times v. Rhinehart, significantly curtailed the public release of documents uncovered during the discovery process.
Courts have since “become more secretive and willing to keep documents hidden under seal, even if those documents show a product is dangerous,” Thacker said.
According to Thacker, the 1984 ruling “set off changes in discovery during the 1980s and 90s that allowed attorneys to directly exchange information instead of entering it into the court.”
These changes “benefitted companies wanting to keep documents secret, as well as judges dealing with complex cases and large discoveries.”
“This helped transform the taxpayer-funded courts into a more closed system,” Thacker said, citing a 2019 Reuters investigation that examined 155 major federal product liability cases. In 31 of the cases, “judges sealed arguments that dealt directly with evidence for possible harm,” usually without explanation, Thacker said.
Citing the Reuters investigation, Thacker wrote 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,” comprising “nearly 250,000 individual death and injury lawsuits.”
In one example, documents showing that Purdue Pharma misled doctors into widely prescribing Oxycontin by downplaying the risk of addiction posed by the drug, leading to a $10 million settlement with West Virginia. Despite this, the judge sealed the documents.
It was only “12 years and 245,000 overdoses later” that Purdue’s documents reached the public — via a leak to the Los Angeles Times in 2016. This leak finally prompted the West Virginia judge to begin releasing sealed documents from the 2004 lawsuit.
In another example from the Reuters investigation, documents accusing Merck of exaggerating the safety record of Propecia, a male pattern baldness medication, showed that the company downplayed side effects (which included sexual dysfunction and suicidal ideation) found during clinical trials. Once again the documents were sealed and the product remains on the market.
Cost of discovery, revealing documents often prohibitive
Another obstacle to the disclosure of discovery evidence found is the significant financial costs, Thacker said. This is primarily due to two factors: court rulings against whistleblowers and leakers, and often prohibitive expenses of examining thousands or millions of pages of documents.
For law firms representing plaintiffs “to find these ‘hot docs’ that show bad behavior,” the process is costly. “They’ve got to hire people to go through them, read them, understand what they mean,” Thacker said, adding that the process may involve locating a few hundred pages out of millions.
In the example involving Monsanto and glyphosate, Thacker wrote, “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.”
In another example involving drugmaker Eli Lilly and Zyprexa, its schizophrenia medication, documents showed that the company “engaged in a decade-long effort to play down” its health risks, according to Thacker. Nevertheless, the two expert witnesses who revealed the documents were ordered by a court to pay $100,000 to the company.
It took two years for the same judge to “de-designate” the documents. “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,” Thacker said.
‘Follow the documents, follow the money’
Thacker told The Defender that such practices may extend to COVID-19-related examples, including the concealment of information regarding potential harms caused by COVID-19 vaccines.
However, he said, “It’s still hard to tell … We haven’t seen any lawsuits that I’m aware of yet against these manufacturers.”
Nevertheless, Thacker told The Defender, “My mantra with COVID-19 has been, do not follow the ‘science.’ Follow the documents, follow the money.”
Despite revelatory investigations by establishment media outlets like the Times and Reuters against drugmakers, Thacker noted that they were only published after years of positive coverage for the drugs and the companies involved:
“What we know from uncovering these court documents is, by the time they come out, the media has been flooded with and promoted corporate messages for years, on every product out there … and we only find out later through court documents what the companies were doing.
“We have example after example of corporations that have gamed the science. Where it’s at its most devious is in biopharmaceuticals.”
Thacker noted that when COVID-19 vaccines came on the market, “the companies had not submitted their findings to the U.S. Food and Drug Administration. They released interim results on their own websites, that ended up on the front page of The New York Times.”
“I don’t know what other industry out there gets to use its own inside research that hasn’t been vetted by experts and gets it on the front page of the Times,” he said.
‘Powerful interests do not want to see change’
Thacker told The Defender that there are “some very powerful interests that do not want to see change” to the status quo, naming three actors: judges, defendants and law firms representing plaintiffs.
“On the plaintiffs’ side, it’s not always in their interest to make the documents public,” he said. “They can use that possibility as leverage against the companies to settle.”
In turn, defendants have a vested interest in keeping the documents concealed, while judges are typically eager to avoid further rounds of hearings, Thacker said.
As a result, efforts to pass legislation at the federal level that would facilitate the disclosure of discovery documents have been stymied, Thacker said.
Following the 1984 Supreme Court ruling, the “Sunshine in Litigation Act” was repeatedly introduced in Congress but was never passed. Thacker noted that he had worked briefly on the Sunshine in Litigation Act as a congressional staffer.
However, there have been some positive developments. According to Thacker, “states such as Florida and Texas have passed sunshine rules and laws that limit courts from sealing health and safety records finding public hazard.”
There have also occasionally been other calls to increase such disclosure. A 2008 Times editorial said that “When the courts have information about serious threats to health and safety, the public has a clear right and need to know,” while a 2019 editorial in JAMA Internal Medicine called for legal reforms to stop court secrecy.
A few federal agencies have enacted measures of their own, Thacker said, citing the National Highway Traffic Safety Administration, which in 2016 issued guidance for judges so that health and safety records could be shared with the agency.
Thacker said “sunshine” litigation differs from the Freedom of Information Act (FOIA) adding:
“FOIA is critical for uncovering examples of corporate fraud in products, but the problem is that things are being hidden all the time in FOIA. We sometimes find out things through FOIA requests, but the documents that come to light through litigation are so much more important. They really show what’s happening inside a company.
“You’re never going to find internal corporate documents through FOIA. 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. The timeline for how quickly this should happen needs to be worked out by the judicial branch.”
Thacker also said that “Academics involved in ghostwriting should not expect safety under the First Amendment,” which the Supreme Court has held “does not shield fraud”:
“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.
“What we need is to take the issue out of the hands of those special interests — plaintiffs, defendants and judges — and make it so that such legislation has to happen. Defense firms aren’t going to do it, the plaintiffs’ bar isn’t going to do it, and judges just want to clear their docket.”