Should previously undisclosed documents about side effects be kept hidden by a protective order? That was the issue in
the Zyprexa controversy more than a year ago. Going forward, such episodes may occur less frequently if the
Sunshine in Litigation Act becomes law. In
an editorial, The New York Times writes why the legislation is a good idea:
"When companies are sued for selling unsafe consumer products or creating environmental hazards, the cases too often end with court orders that keep vital health and safety dangers secret. This practice works out well for the wrongdoers, but it is bad for ordinary Americans, who need to know about these threats. The Senate Judiciary Committee last week approved a modest but potentially life-saving bill that would require federal judges to consider public health and safety before granting a protective order, sealing court records or approving a settlement agreement. The need for this bill is especially great right now when federal agencies charged with protecting Americans lack the resources and the will to exercise strong oversight.
"Under the bipartisan bill, judges will still have discretion about whether to grant a request for secrecy. First they will have to apply a sensible balancing test that takes into account both the public’s interest in learning of a potential hazard and the defendant’s legitimate interests in secrecy, say to protect trade secrets.
"The bill, sponsored by Senators Herb Kohl of Wisconsin and Patrick Leahy of Vermont, both Democrats, and Lindsey Graham, a Republican from South Carolina, is similar to laws already on the books in several states. Business interests opposed to the bill argue that it would discourage settlements, clog the courts with more trials and hurt plaintiffs by requiring lengthy fights over production of documents. Yet there has been no legal meltdown in jurisdictions that now have similar rules.
"Kohl first proposed the measure 15 years ago. Since then, there have been many cases involving prescription drugs, heart valves, defective tires and other products in which an untold number of injuries and deaths could have been prevented had the public not been blocked from learning about the dangers. The Senate should move quickly to approve this much-needed bill. And the House should move quickly to introduce the same legislation. When the courts have information about serious threats to health and safety, the public has a clear right and need to know." What do you think?
Do you think this bill should become law?
- Yes (78%, 32 Votes)
- No (22%, 9 Votes)
Total Voters: 41
16 Comments
Delayed justice is denied justice.
What variables determine at what point documents become unsealed?
What are the real reasons for such lengthy refusal to expose such things?
My opinion on the matter: If lives are potentially at risk, documents under seal should be removed for the benefit of the public.
To those voting 'No' - Why do you feel these documents should be kept under seal?
If you personally were impacted by an unsafe product, I think you might want to know all about it.
This is an enormous issue. One of the reasons commentaries in both JAMA and NEJM have been so forceful in opposing FDA preemption has to do with the discovery process in civil liability. As has been demonstrated several times, drug safety issues are often only uncovered in such contexts.
I can see a case for vetting some of the info so that it would be public health specific, and not place a company under unfair risk of would-be litigants "fishing" for information that has already been uncovered.
But, overall, this is why FDA preemption is as much a threat to public health as legal rights - probably more.
Since the post above, I have discussed this issue with friends. There have been a range of opinions, and so I would be interested to hear what people think here.
As we know, there are always "leaks" of one sort or another in the course of litigation (and later). These may not directly have to do with safety information, but rather about a company's thinking (or parts of a company's thinking) in response to potential problems. Thus we have emails about not "killing the drug" (Vioxx), about how "Hispanics are easy to intimidate" (Rezulin), about reps not being "proactice" in raising certain issues (Zyprexa, et. al.), etc. etc.
Beyond public health info, is it your view that _all_ such communications should become public, whatever the results of litigation (including settlement)?
Justice,
FDA, Industry and Plaintiffs attorney's, have known for more than 12 years that antidepressants can and will cause children and adolescents to become violent and suicidal. Do secret setllements save lives?,... absolutely not.
Blood was shed,.. and lives were lost. Why?
Greed?.. Lack of respect for human life?.. Its probably both.
I really have a hard time with the argument that knowledge of the potential for any given drug to inflict harm be withheld for any reason. Patients need and deserve full disclosure. This isn't easy, but every time we do something that withholds information from the patient, then we diminish and I would say violate, the patients right to informed consent. Some will argue that a patient can never be truly informed because they cannot possibly know and understand all that their trained, highly skilled physician knows. But we cannot and must not allow this way of thinking interfere with the patients right and ability to make their decision.
Each time we withhold information to either the patient or the doctor we find that the only thing the patient is free to do is to do exactly what we want them to do.
Is it any wonder when, after the fact, the data is finally released with an attitude of "well we did have some indication that this could have happened" that everyone especially the patient is so upset?
I think there has to be some way to provide this information up front so that full risks and benefits can be analyzed for any given patient. Doing so will reduce sales, but probably save lives and help to start to rebuild pharma's reputation with the public. This is an important trust issue.
Pharma needs to trust that patients and doctors can and will handle the information correctly. Patients and doctors will be given something to help them restore their trust.
Former Pharma,
Beautifully,. Stated. Thank You
I don't think anyone has argued (here) that safety-related info should be sealed.
The question is whether all the "thinking" behind the decision-making process that discovery reveals should all be public = for example, that at least one of Warner-Lambert's email senders used racism as part of their Rezulin marketing strategy to Latinos.
Personally, I am glad that we have learned that. But what I would _really_ like to see is the _range_ of arguments within company decision-making - the obviously gross stuff, the emails of others that may or may not counter that, etc. etc. Again, that is what I have enormous interest in, and it would certainly serve us if, in general, we all knew more about how these processes really work. It is probably the greatest "black box" for people outside the industry, and perhaps for a certain number within it.
However, whether all that info should be public, for all companies in all industries in all such situations, is a tougher question.
And that is the tougher question I raised, and which no one tried to answer.
To say the above even more specifically - it would serve us to learn more about how the "cowboys" win in some situations; how they may not win in others; the strategies, power plays, internal politics, etc. involved; and the various permutations of the ways all that plays out.
That is still not to me a full answer to the legal policy question though.
Justice,
Whatever happened to the truth,.. the whole truth,... and nothing but the truth.
Attorneys benefit, as does Industry, when it comes to secret settlements,..
JIM:
This is a tough question. When it comes to health care and patients lives as well as doctors ability to provide care, then yes, this information needs to be disclosed. If someone decides that information cannot be shared publicly then we need to understand the rationale. Patients are not consumers in the true sense of the word. Whatever "background" information can be provided so that we understand the rationale for any given decision certainly helps in the overall decision making process.
Does it need to be so transparent in other industries. I personally am leaning towards a big Maybe. I am specifically thinking about food and cosmetics. We need to keep our eye on these areas. Food can do much harm as well as good to our bodies. Ingredients in cosmetics can and do enter our blood system. Each of these areas should require better education to the end users. We need to know what the risks are and weigh them to the benefits. Think about the breast implant fiasco. Think of the lead in the toys issue.
This is critically important to the end consumer (non health care sector).
Think about the airline industry - why didn't the pilots say something, or were they even told anything regarding the FAA concerns with the equipment. If it is happening at Southwest, could it be happening somewhere else.
There are risks in everything, but as a consumer (non healthcare) I want to make sure that I am weighing the right risks with the right benefits. Why would this be different for patients, for Doctors and other health care workers?
FME - Thanks for your thoughtful response. I would lean the same way, but - as you recognize - it is, indeed, challenging as policy, particularly when one considers a full range of industries involved.
I was imaginging going something wrong at a health food company in my area that does Corporate Social Responsibility on steroids (so to speak). They contribute as much to our community, and beyond, as any business I can imagine. They also treat their employees superlatively.
Still, S happens. Would full transparency be in the greatest interest if, in the process, a company like this - its reputation, etc. - was permanently damaged (as is certainly conceivable). Or should there be some criteria for screening what is genuinely in the public interest to unseal, and what may be "titillating," and a great service to their far more scuzzy competitors, but not serve the the rest of us.
I have no definitive answer.
Why shouldn't pharma companies have the threat of permanent damage over their behaviors? Conversely, we are supposed to support the fact that they shouldn't incur any permanent damage? This only serves to give them the chance to do it again if they can sweep it all under the rug with a settlement.
My primary concern is with documents that truly can be taken out of context; if it weren't so time consuming, it would be great to look at a document and hear/read both sides of the story.
It's hard not to respond to this issue one-dimensionally. Those of us who have activists for a long time re: pharma-related problems obviously push toward every means that provides rightful accountability - whether that means criminal penalities, civil liability, etc. etc.
For me, it also means understanding the differences between companies and how to support the folks within each who are as committed to right action as anyone on this blog, and who have been willing to take significant risks (unlike many of us) to ensure it. Without those people, we are all toast; and no amount of external sanctions will counter-balance their importance.
In any case, the question here is not solely about pharma but about any company, anywhere, doing anything.
In the example of the food company I gave above - as excellent and ethical a business as any on the planet - they would probably themselves move toward full transparency and make everything available short of what could _unfairly_ hurt a particular employee and that had nothing to do with whatever went wrong. Their reputation and history are solid enough to withstand any scrutiny, and they would support transparency in principle.
So, in general, would I. But it ain't entirely simple.
If a legal case, such as one against a pharma company, is filed and kept under seal by the DOJ, this can be harmful to others. Depending on the contents of the case, what if it involved such matters as unnecessary, as well as threatening diagnostic testing? What if the case involves mistreatment of subjects involved in clinical trials. The discretion should not be left solely with the courts, but an entire team of professionals that include doctors who specialize on matters such as these.