Tuesday, March 04, 2008

A SLAPP Against Clinical Research?

Posts on the Wall Street Journal Health Blog, the Clinical Psychology and Psychiatry Blog, and by Dr Aubrey Blumsohn on the Scientific Misconduct Blog all picked up on a brief story in the Harvard Crimson about a lawsuit apparently claiming that a clinical research article, and a randomized controlled trial no less, was defamatory. Here is the gist from that news article,



Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).

In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.

HipSaver’s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel’s study to be applied to hip protectors in general.

Robert L. Hernandez, who is representing HipSaver, described Kiel’s article as 'disparaging' and 'grandiose.'


Actually, as quoted by Dr Blumsohn, the JAMA article's conclusions were framed in the typically measured terms of clinical research reports.



In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

[See Kiel DP, Magaziner J, Zimmerman S et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298: 413-422. Link here.]

Of course, if these conclusions were libelous, than practically any scientific article could be considered libelous.

Equally obviously, HipSaver leadership have a perfect right to criticize the Kiel article. But to sue the authors because the company disagrees with their conclusions could have a chilling effect on science. This lawsuit seems to be a deliberate effort to intimidate clinical scientists who dared to collect and publish data which suggesting that commercial products may not be as wonderful as their marketers claim.

If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe.

Furthermore, this lawsuit can be construed as an attack on basic human rights in the US context. In this context, it appears to be a SLAPP, that is, Selective Litigation Against Public Participation. This term was coined to describe lawsuits designed to intimidate people from speaking out about issues of public interest (but in a way that might threaten vested interests.) For more information about SLAPPs, see the SLAPP Resource Center. Also see this article from the First Amendment Center.

Most US states, including Massachusetts, have laws that allow SLAPPs to be countered. For example, in Massachusetts, the law provides (see the SLAPP Resource Center), ]


Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys’ fees shall be awarded to a victim prevailing on the motion to dismiss.


I don't think it is too much of a stretch to apply the SLAPP concept to a lawsuit aimed at the free discussion of the effectiveness of treatments in health care, given that the government indirectly or directly pays for many of these treatments, and that determining the effectiveness of treatments is clearly a public health policy issue.

I fervently hope HipSavers withdraws this ill-conceived lawsuit. If the company persists, I fervently hoped its attempted SLAPP gets slapped down.

Here is another sorry example of how health care, particularly clinical research, is under seige by those with vested interests and private agendas.

13 comments:

Anonymous said...

You write "If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe" and I absolutely agree. I would rather know than be left in the dark. A second opinion can always be sought after if you are not happy with the conclusions that you read.

Ian Furst said...

Absolutely chilling. I'm going to post the link as well. The tought that you can be sued for making a scientific observation is scaring. www.waittimes.blogspot.com

Anonymous said...

"Follow the money"

Steve Lucas

somas said...

In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

Daniel Goldberg said...

As a lawyer, I'd like to remind the readers that anyone can sue anybody for anything. That doesn't mean it is likely to be successful. This lawsuit has, IMO, absolutely no chance at success, and is essentially an attempt to save a business that has been severely undermined by the evidence.

Thus, while the lawsuit is certainly ridiculous, I doubt there will be significant consequence from this, other than fanning the flames of fears of tort liability. As I mentioned to Scot in a different thread, there is hardly a robust plaintiffs' bar suing for transgressions in clinical research.

Anonymous said...

Yeah, but Mr. Goldberg, I think you may be underestimating the degree of doctors' paranoia about lawsuits. Even if this doesn't have a prayer of succeeding, the psychological effect alone may be worth other companies following suit (not to make a bad pun). After all, they have the $$ to throw away on it; the poor defendants don't. This is scary news; thanks to Dr. Poses for shining a light on it.

Anonymous said...

My guess is that Dr. Kiel's counsel will file motions for summary judgment and requesting an award of costs and attorneys' fees. I have no opinion as to whether these motions will succeed. (I'm a lawyer, but this is totally outside my area of expertise.) Whether the case goes to trial or not, I agree with Daniel Goldberg that it seems unlikely that HipSaver will ultimately prevail. I just think HipSaver will have a difficult time proving falsity and intent.

I looked at the Massachusetts anti-SLAPP law and just based on the statutory language (what Dr. Poses quotes is actually a paraphrase or summary, not the statutory language itself) it did not sound like it would apply to this situation. However, it is possible that there is some Massachusetts case law that supports his view. I have not researched it. My reasoning is that no one is "petitioning the government" here or even talking about petitioning the government. However, I have no expertise in this area either so my opinion isn't worth much. If someone else does, I would be interested in their views.

Marilyn

Anonymous said...

Via today's BBC (3/6/08) we find that the British government is going to require stricter reporting of trial date. It seems drug companies have not been reporting negative outcomes of some trials.

It seems GSK escaped criminal prosecution over not releasing negative information regarding suicidal tendencies in those under 18 taking Seroxat. This is driving this legislation.

Steve Lucas

Anonymous said...

Although I still don't have any answers, I want to at least do a better job of framing the issue:

The Massachusetts anti-SLAPP statute, in pertinent part, provides:

"In any case in which a party asserts that the civil claims, counterclaims, or cross claims against said party are based on said party's exercise of its right of petition under the constitution of the United States or of the commonwealth, said party may bring a special motion to dismiss."

The statute then defines "a party's exercise of its right of petition" as:

"[A]ny written or oral statement made before or submitted to a legislative, executive, or judicial body, or any other governmental proceeding; any written or oral statement made in connection with an issue under consideration or review by a legislative, executive, or judicial body, or any other governmental proceeding; any statement reasonably likely to encourage consideration or review of an issue by a legislative, executive, or judicial body or any other governmental proceeding; any statement reasonably likely to enlist public participation in an effort to effect such consideration; or any other statement falling within constitutional protection of the right to petition government."

The key question appears to be whether the researchers' statements regarding hip protectors were "reasonably likely to encourage consideration or review of an issue by a legislative, executive, or judicial body or any other governmental proceeding" or "reasonably likely to enlist public participation in an effort to effect such consideration." As Dr. Poses points out, one could argue that the researchers' discussion regarding hip protectors was reasonably likely to encourage review by some governmental body of issues related to the use of hip protectors, such as whether government money should be used to pay for them. One could also argue that members of the public, after reading or hearing about the researchers' statements, might be reasonably likely to petition the government not to spend taxpayer money on hip protectors (for example).
Whether there is any support in the case law for this broad interpretation of the statute is something I do not know, because I haven't had time to look into it yet.

Marilyn Mann

Radagast said...

My fellow students really struggled with tort, because there were so many cases to remember, discussing various minute points of interpretation. I didn't have the same problem, because the stories (sorry: facts), were fascinating to me. I never ceased to be entertained by the bloody ridiculous situations that people got themselves into.

Anyway, as I wrote on the WSJ blog: this is bollox. The Law was never conceived for the purpose of silencing critics, but with the objective of upholding basic standards of conduct. Regrettably, any system will end up looking like those who run it.

Matt

Anonymous said...

This manufactured science to benefit the sponsors may be worse than the other forms of corruption that exist in the health care system presently. Too many rely on sound scientific judgement. Sponsorship of such studies should be strictly prohibited, and a specific government entity, monitored by others, should be the ones only allowed to participate in science, especially if it involves the health of others. Taxpayers would pay the price for this, but they would rather pay for something like this instead of paying for the corruption of corporations, if they had thier choice, I believe

Anonymous said...

Even if the anti-SLAPP statute does not apply, there is another option Dr. Kiel could pursue if he prevails against HipSaver: a malicious prosecution lawsuit against counsel for HipSaver.

Malicious prosecution actions tend to be disfavored by the courts, because of the potential chilling effect on a citizen's right to bring a civil dispute to court.
The elements of a malicious prosecution case are (1) that the defendant filed and/or prosecuted the underlying civil action; (2) a favorable termination of the prior case, in which the innocence of the former defendant was established; (3) the absence of probable cause, meaning that no reasonable attorney would have considered it to be tenable; (4) malice, which can be implied from a conscious disregard for the consequences, from a lack of probable cause, and from inadequate investigation and research, and (5) damages.

Plaintiff's counsel (i.e., counsel for Dr. Kiel) might bring in an expert witness to try to prove "malice" by comparing what research and investigation a reasonable attorney would have done with what counsel for HipSaver did before filing the case. Counsel for the defendant would argue that the defendant was only representing his client zealously.

With respect to damages, there would be Dr. Kiel's attorneys' fees, any detriment or harm to his reputation and social standing, emotional or mental suffering. Here I think damages to Dr. Kiel's professional reputation and social standing would be hard to prove because it seems unlikely that any of his friends and colleagues view HipSaver's action as anything other than a nuisance lawsuit. If called as witnesses, they would be unlikely to testify that they shunned Dr. Kiel as a result of HipSaver's lawsuit.

Of course, it is quite possible that Dr. Kiel would not think it was worth the time and trouble to bring such an action. He would probably also want to first be reasonably certain that HipSaver's counsel would be able to pay any resulting judgment.

Marilyn

Anonymous said...

When a court decided that SLAPP statues should be "considered broadly" they opened up a can of worms the legislature never would have condoned. If the SLAPP mover was the initiator of a "frivolous" claim in a bifurcated case, he can effectively swim out of whatever difficulty he wants leaving an orginal defendant with no recourse. this is a ridiculous statute allowing one individual to file against another individual. Where does right of one stop and right of another start????