For your delectation and delight, desultory dicta on the law of delicts.

Pharmacovigilantism – Avandia Litigation

November 27th, 2013

Six and one-half years ago, I gave a presentation on the then newly emerging controversy over Avandia (rosiglitazone).  Plaintiffs’ counsel Vance Andrus chaired the program, Mealey’s™ Avandia Litigation Conference, in Chicago on July 13, 2007.  Vance was a gracious host despite my skepticism about the potential for plaintiffs to cash in on their use of Avandia.

Despite Vance’s best efforts, the program was one of those lopsided affairs, and I was the only presenter who came prepared to address the scientific evidence from a skeptical perspective.  The remaining presenters were mostly cheerleaders for their declaration of war against GlaxoSmithKline over claims of heart attack and stroke from the use of Avandia.

This week, a Food and Drug Administration announcement sent me back to my presentation slides, which were provocatively titled “Pharmacovigilantism and Avandia.” Dr. Steven Nissen had published a meta-analysis in the New England Journal of Medicine in May 2007, and it had all the appearances of a contrived effort to embarrass GSK. See Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007).  A few weeks later, Dr. George Diamond published a thorough debunking of the Nissen meta-analysis, by showing that the statistically significant result in Nissen’s meta-analysis could be achieved only by choosing an inappropriate meta-analytic method.  Any other choice resulted in a result that lacked statistical significance for the rate of heart attack among patients taking Avandia.

Litigation, of course, followed and the Rule 702 hearings and decision resulted in a serious abridgement of the scientific process.  The federal MDL trial judge denied GSK’s motions to exclude plaintiffs’ causation witnesses in an opinion that has become a model for Rule 702 avoidance.  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.).  SeeLearning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011)

This week, without much fanfare, the FDA announced that maybe the evidence supporting the claims that Avandia causes heart attacks is not so strong, after all.  SeeFDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2011).  The Avandia MDL stands out as an expensive, negligent rush to judgment; a case more of phamacovigilantism than of pharmacovigilance.

Avoiding Nonsense About Science — Ask For The Evidence

November 25th, 2013

Sense about Science is a British charitable organization that is devoted to helping people understand scientific and medical claims. Sense about Science acknowledges that:

“Sharing scientific reasoning involves giving people the tools to question pseudoscience and misleading claims, to help cut through the noise around scientific or medical issues.”

To further its laudable goals, Sense about Science has launched an “Ask for Evidence Campaign”:

“We hear daily claims about what is good for our health, bad for the environment, how to improve education, cut crime, treat disease or improve agriculture. Some are based on reliable evidence and scientific rigour. Many are not.  How can we make companies, politicians, commentators and official bodies accountable for the claims they make? If they want us to vote for them, believe them or buy their products, then we should Ask for Evidence.”


Mr. Nicholas Kristof grew up on a cherry farm, and went on to a successful academic and writing career. For over a decade,  Kristof has written “columns” for The New York Times, a public platform that has helped him win two Pulitzer Prizes.  Sometimes, Kristof’s early experience in cherry picking has helped him with discussions of scientific issues, which seem more like “Nonsense about Science.”  Consider yesterday’s New York Times, in which, Kristof combines cherry picking with scare mongering.  SeeDanger Lurks in That Mickey Mouse Couch”:

“RESEARCHERS this summer purchased 42 children’s chairs, sofas and other furniture from major retailers and tested them for toxic flame retardants that have been linked to cancer, birth defects, diminished I.Q.’s and other problems.”

Besides the vague and conclusory language of “links,” Kristof does not cite a scintilla of evidence; instead he cites opinion from an environmentalist organization, Center for Environmental Health (CEH).  What is the CEH?  From its website, the CEH appears to be a group led by actors, community activists, politicians, self-styled “philanthropists,” advocates for “environmental justice.”  No serious scientists appear on the CEH’s board of directors, or on its staff, which is populated mostly by lawyers and activists.

Does the CEH, without the benefit of real scientific talent, marshal serious scientific evidence?  You should judge for yourself by reading the webpage that Kristof cites.  See CEH, “Playing on Poisons: Children’s Furniture Found with Harmful Flame Retardant Chemicals” (November 20, 2013).  If diligent readers of Kristof’s column were to read his “source,” they would find only hand waving and opinionated pronouncements without any reference to supporting scientific studies. Perhaps there is something to the accusations made by Kristof and his band of “environmental justice” advocates, but nothing in the column or its sources would shed any light on the matter. 

Mr. Kristof prefers to deal in vague, if not meaningless terms, such as “links” between chemical exposures and myriad dire outcomes.  He patronizes readers by giving them no understanding of the quantity or quality of the evidence that supports his innuendo.  Kristof repeats his bad, unscientific brand of journalism on his blog. See Nicholas Kristof, “Are You Sitting Down? On a Couch?” (Nov. 23, 2013).

Citing regulatory approval of the fire retardants at issue, the American Chemistry Council has taken Mr. Kristof to task.  SeeNew York Times columnist and new docudrama mislead public on importance of flame retardants, strong fire safety standards” (Nov. 23, 2013).  The Council’s webpage points to other sites that provide some additional evidence of regulatory approvals and efficacy testing of fireproofing chemicals, but it does not list the chemicals involved, and it does not address the biological causal claims made by Kristof and the CEH.  Nor does the American Chemistry Council mention that the litigation industry (a/k/a plaintiffs’ bar) has waged war against the use of companies for using natural, flammable fabrics and materials.

The Sense about Science organization focuses upon scientific nonsense mostly in the United Kingdom.  Kristof’s brand of hit-and-run journalism illustrates that we very much need a similar organization in the United States.  The discussion and debate over health issues should not take place by the trading of assertions and adjectives, without reference to the actual evidence at hand.  Interestingly, in the same issue of the New York Times, which carried Kristof’s column, two reporters, Walt Bodganich and Glenn Silber, covered a flawed forensics investigation in Florida.  Bodganich & Silber, “Two Gunshots on a Summer Night,” New York Times, A1 (Nov. 24, 2013).  In almost four full pages of coverage, these Times reporters analyze the circumstantial and forensic evidence in great detail to expose a flawed police investigation.  Although the death involved, and the police incompetence suggested by these journalists, is a tragedy, the inability of a newspaper to cover a story that alleges many thousands of deaths, with any attention to the actual evidence, is a much greater tragedy.


The aversion to reading and understanding the actual scientific evidence finds ample expression in the legal arena. In the recent case of Jackson v. Pollion, the Seventh Circuit chided the lawyers, and trial judges, for their failure to examine and understand the scientific evidence at issue in the merits of the case. Jackson v. Pollion, No. No. 12-2682 (7th Cir. Oct. 28, 2013) (Posner, J.).  Judge Posner argued the noteworthiness of the lapse by the advocates and the judges:

“This lapse is worth noting because it is indicative of a widespread, and increasingly troublesome, discomfort among lawyers and judges confronted by a scientific or other technological issue.”

Slip op. at 2.

And in more Kierkegaardian terms, Judge Posner admonishes the legal profession:

“The legal profession must get over its fear and loathing of science.”

Slip op. at 8.

Indeed!  Judge Posner’s admonition is undermined by the current Federal Rule of Evidence, which diminish the value of underlying data and evidence in expert witness opinion.  Rule 702 makes opinion admissible, and Rule 703 acknowledges that much of the bases for expert witness opinion will itself be inadmissible.  The structure of the Federal Rules of Evidence, however, undermines the importance of underlying evidence by not requiring that expert witnesses disclose the facts and data upon which they rely.

The evidence law of some states is to the contrary.  Consider Hansen v. Wyeth Inc., 77 Pa. D. & C.4th 501, 2005 WL 3068256 (Phila. Cty. Ct. Com.Pl. 2005) (Bernstein, J.).  The Hansen case focused on the testimony that was given by Dr. Harris Busch in a fenfluramine products liability case in Philadelphia.  Some may recall Busch as a veteran plaintiffs’ expert witness from the silicone gel breast implant litigation.  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans” and the litigation as largely based upon fraud). 

In Hansen, Busch testified that Wyeth had been negligent, but on post-trial motions, Judge Bernstein found that:

“The doctor’s opinion, however, was presented in conclusory form and was ‘generically’ predicated on voluminous materials.”

Hansen, 77 Pa. D. & C.4th at 501.

Applying Pennsylvania’s version of Rule 705, which incorporated the state’s traditional common-law approach, Judge Bernstein held that Dr. Busch’s failure to give a detailed accounting of the evidentiary basis for his opinion rendered his opinion inadmissible.  Pennsylvania Rule 705 provides:

Disclosure of facts or data underlying expert opinion.

The expert may testify in terms of opinion or inference and give reasons therefore; however the expert must testify as to the facts or data on which the opinion or inference is based.”

Hansen, 77 Pa. D. & C.4th at 504 (citing and quoting Rule 705).  The Pennsylvania version of Rule 705 differs significantly from the Federal Rule of Evidence 705 by requiring actual disclosure of the evidence upon which an expert witness opines.  In Pennsylvania state court, it is not sufficient for juries or judges to evaluate expert witness testimony upon looks, demeanor, apparent bias, and the like:

“While most rules of evidence concern the admission of facts, Rule 705 concerns itself not with admission but disclosure. Absent a clear disclosure of the factual basis of opinion testimony, an expert’s opinion does not so much assist the jury with their determination of the facts as replace the jury’s essential factfinding  role. Without a clear disclosure, the jury has no basis for determining whether the facts as understood or assumed by the expert are compatible with the facts as the jury finds them to be. Thus, Rule 705 was adopted to preserve the exclusive  factfinding function of the jury.”

Id. at 507 (internal citations omitted).  Pennsylvania Rule of Evidence 705 requires specificity by the testifying expert witness in identifying the actual basis for his or her opinion:

“The Rule 705 requirement of presenting the ‘facts and data’ which form the basis of the opinion may not be satisfied by a mere formalistic recitation of the material reviewed or considered. That pro forma routine absolutely obscures what Rule 705 intends to clarify and is tantamount to the clearly impermissible tactic of offering an opinion based on ‘all the evidence’.”

Id. at 511 -12 (internal citations omitted).

The omission of the Pennsylvania rule from federal practice and many other states’ practices illustrates our legal system’s failure to insist upon showing the factfinder the actual evidence.  We have a long way to go, in journalism, politics, and law, to become an evidence-based society.

Conflicted Public Interest Groups

November 3rd, 2013

The current “wisdom”:

“Conflict of interest in science is a very important issue, and it is a very big problem, because if uncontrolled, it can lead to biased, misleading and even false opinions about scientific evidence.” Dariusz Leszczynski, “Conflicting statements by the two experts of the Royal Society of Canada,” (Nov. 1, 2013)

This statement and the remainder of the blog post is an example of the current obsession and delusion over conflicts of interest (COIs).  COIs do not lead to false opinions (assuming an opinion can be false); fraud, misrepresentation, errors in data collection and analyses, fallacies, and inferential mistakes are what lead to misleading and false statements in science.  COIs may perhaps trigger greater scrutiny for error, but there is nothing in a COI disclosure, or lack of disclosure, that helps us ascertain the validity vel non of a study.

In a recent post, Celeste Monforton, of George Washington University School of Public Health & Health Services, wrote about conflicts of interest and the recent Georgia-Pacific decision out of the First Department of the New York Appellate Division, Weitz & Luxenberg P.C. v. Georgia–Pacific LLC, 2013 WL 2435565 (N.Y. App. Div., 1st Dep’t June 6, 2013).  Monforton, “Thou dost protest too much. Let the disclosure chips fall where they may” (Oct. 28, 2013).

The bashing of Georgia-Pacific is based upon rather dodgy factual and hypocritical ethical analyses. Historically, authors did not disclose their COIs.  In the polarized, political world of occupational safety, studies funded or sponsored by industry, labor unions, plaintiffs’ counsel, or their proxies were rarely or never accompanied by disclosures of COIs. To be sure, current ethical guidelines emphasize the importance of disclosure, but not limited to financial conflicts.  Committee on Publication Ethics.  If positional and political conflicts of interest were disclosed, we might actual shine light where it is needed, but I suspect Monforton would not be happy with that sort of illumination.

Georgia-Pacific has found itself in a controversy that is driven by one-sided emphasis on industry funding, without a balanced attention to sponsorship by advocacy groups, the litigation industry (a/k/a the “the trial bar”).  If Monforton is willing to let the chips fall where they may, she will welcome the attention to her own COIs and the COIs of her advocacy organization, The Project on Scientific Knowledge and Public Policy” (SKAPP).

Celeste Monforton is on the staff of SKAPP, which purports to support the examination of science and “how it is used and misused in government decision-making and legal proceedings.”  SKAPP funds scholarship and research designed to promote “transparent decision-making, based on the best available science, to protect public health.”  In other words, SKAPP supports “progressive,” pro-labor, anti-industry, science results, often without regard to the niceties of proper methodology.

The SKAPP website tells us that this organization is guided and supported by an advisory committee, consisting of:

Eula Bingham, PhD
Les Boden, PhD
Richard Clapp, DSc, MPH
Polly Hoppin, ScD
Sheldon Krimsky, PhD
David Michaels, PhD, MPH
David Ozonoff, MD, MPH
Anthony Robbins, MD, MPA

Clapp is a regular testifying witness for the litigation industry. Michaels testified for the litigation industry before President Obama appointed him to be the OSHA Administrator. Ozonoff and Bingham have also shown up in litigation, always on the plaintiffs’ side.  Krimsky has been unremitting scold of industry-sponsored science. Robbins was the physician invited to the American Law Institute meeting, where he criticized a draft of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm and accused the ALI of not understanding scientific principles or knowing what it was talking about. 79th Annual Meeting, 2002 A.L.I. PROC. at 294. See Michael D. Green, “Pessimism about Milward,” 3 Wake Forest J. L & Policy 41 (2013). Professor Green, however, has given a thorough rebuttal to Robbins’ partisan and ad hominem criticisms, which suggest that it was Robbins who did not know what he was talking about.  SeeMilward’s Singular Embrace of Comment C (May 4, 2013).

And whence comes the funding for SKAPP’s one-sided advocacy? At its inception, for some time afterwards, SKAPP was funded by the litigation industry, from a walking-around fund of the plaintiffs’ lawyers in the silicone gel breast implant litigation. SKAPP misleadingly continues to represent this funding as “a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation,” but the fund is nothing more than the fund that exists in virtually every multi-district litigation to allow plaintiffs’ counsel to find and pay expert witnesses, conduct studies, and engage in other activities for the common benefit of the plaintiff-litigants. SKAPP a Lot (April 30, 2010).

The funding ruse by SKAPP raises the question what other “public interest” groups are proxies for the litigation industry?  Consider for instance, Public Citizen, which describes itself, on its website, as follows:

“Public Citizen serves as the people’s voice in the nation’s capital. ***

For four decades, we have proudly championed citizen interests before Congress, the executive branch agencies and the courts. We have successfully challenged the abusive practices of the pharmaceutical, nuclear and automobile industries, and many others. We are leading the charge against undemocratic trade agreements that advance the interests of mega-corporations at the expense of citizens worldwide.
* * *
Public Citizen is a nonprofit organization that does not participate in partisan political activities or endorse any candidates for elected office. We accept no government or corporate money – we rely solely on foundation grants, publication sales and support from our 300,000 members.”

As it turns out, this group does take corporate money, but selectively from the litigation industry itself.  A recent newsletter from Public Citizen (May 2013) highlighted the prevalence of several magnates and trade organizations (AAJ) of the litigation industry among the names of large donors:

the Attorneys Information Exchange Group (one of the AAJ’s operating groups); Patrick Malone (plaintiffs’ personal injury lawyer);

I suspect that you will not find many publications or positions from Public Citizen that challenge “the abusive practices of the” litigation industry.

The point is, of course, that there are plenty of conflicts to go around, and so little valid data and analysis. The Monfortons of the world have used COI rhetoric to chill freedom of speech and to bias the discussion towards their preferred outcomes.