A Senate Bill To Unseal Secret Pharma Documents

posted on May 24, 2011

For all the intriguing evidence that emerges from product-liability litigation about potential hazards of different medicines, still more documents are often kept under wraps. Why? Drugmakers often succeed in convincing judges to issue protective orders so that certain info - sometimes labeled as trade secrets - remains sealed. And attorneys for plaintiffs generally agree in order to advance the cases.

However, the tactic has long riled critics who say select and crucial safety info may never reach the public. And so the US Senate Judiciary Committee today voted 12 to 6 to approve the “Sunshine in Litigation Act,” which would require judges to consider public health before granting a protective order or sealing court records and settlement agreements. You can read the text here.

“These court-sanctioned secrecy agreements prevent government officials or consumer groups from learning about defective and dangerous products that can stay on the market unchallenged,” says Herb Kohl, a Wisconsin Democrate who chairs the committee, in a statement. The bill is a “response to dozens of cases in which hazards and threats to public health were not disclosed during court settlements and subsequently resulted in additional fatalities, serious injuries or illnesses.”

He cites two examples. A federal judge in Orlando, Florida must decide whether AstraZeneca can keep under seal clinical trials about harmful side effects of its Seroquel antipsychotic. Lawyers for plaintiffs and Bloomberg News sued to force the drugmaker to make public documents that were discovered in dismissed lawsuits. Two years ago, Kohl says, the court unsealed some documents, but denied requests to release AstraZeneca’s submissions to foreign regulators and notes between sales reps and docs. Despite a recent $69 million settlement, “crucial documents,” he says, remain sealed.

Another example: In 2005, Eli Lilly settled 8,000 cases related to its Zyprexa schizophrenia pill and which alleged the drugmaker failed to disclose side effects such as weight gain and diabetes. Lilly was also accused of off-label promotion by urging docs to prescribe the med to elderly dementia patients. All settlements required plaintiffs “not to communicate, publish or cause to be published…any statement…concerning the specific events, facts or circumstances giving rise to (their) claims.” However, no one learned about the settlements or side effects until the documents, which were under a protective order, were later leaked to The New York Times (read here, here and here).

One critic of protective orders cheered the committee vote. “This is one of the ways to stop drug scandals. At this moment, there are tens of thousands of court documents under seal in various cases, including Glaxo and Paxil, that are important for knowing about the dangers of the drugs,” says Paul Thacker, an investigator with the Project on Government Oversight, a non-profit watchdog, and a former investigator for US Senator Chuck Grassley. “The judges keep these under seal and so they don’t become public. There are hundreds of pages of incriminating documents on the ghostwriting Glaxo had for Avandia. We released some of the documents in letters to the NIH, but we know there are more that are under seal.

“This bill would make important safety information public instead of remaining lost forever, which is what happens all the time. The problem has been that it’s not in the interest of anyone involved right now to have it unsealed. For the plaintiffs attorneys, there’s no incentive for them to make the stuff public, especially once their cases are settled, because then they’re done. And the companies want this hidden. And there’s no incentive for judges who just want to move their dockets along. But we’re talking about extermely broad protective orders that are issued.”

UPDATE: We sought a reaction from David Egilman, an expert witness in litigation filed against drugmakers and a clinical associate professor in the department of family medicine at Brown University, who leaked the Zyprexa documents. Here is what he said: “What’s sealed is often critical public health information that, when revealed, saved lives and could save lives in the future. The conduct of pharmaceutical companies has clearly not been changed by anything that’s happened. It’s never been clear to me, at all, why any of the information claimed as a trade secret is a trade secret. The drugs are patented. The method of making the drugs are also often patented, and thus are in the public domain. So the main things they claim as trade secrets are medical information that shows the companies know the drugs harm people and don’t want people to know. While it may hurt their business, the fact that the same information may be hurting patients using their drug or devices should take priority over their trade secrets.

“The other documents show how they conduct off label marketing, which is illegal, and induce the use of their drugs by paying bribes and kickbacks. These are not legitimate trade secrets in that all of the companies are aware of these methods and many of them use the same methods. Many made settlements or pled guilty to off-lablel marketing, so it’s hard to argue such methods are trade secrets, since these are well known to the industry.

“Essentially, they’re claiming the specific methods they use to lie, cheat or steal, are trade secrets, since the drugs and health studies they use to support their methods are public information. For example, many companies pled guilty to misrepresenting the benefits of their drugs. Those are lies. Many companies have been caught cheating in their marketing. And many companies have been caught stealing by overcharging federal and state entities for their drugs. It’s akin to a bank robber claiming that his technique for cracking locks on safes is a trade secret.”