Posts Tagged With: law and statistics

PhilStatLaw: “Let’s Require Health Claims to Be ‘Evidence Based'” (Schachtman)

I see that Nathan Schachtman has had many interesting posts during the time I was away.  His recent post endorses the idea of “a hierarchy of evidence”–but philosophers of “evidence-based” medicine generally question or oppose it, at least partly because of disagreement as to where to place RCTs in the hierarchy.  What do people think?

Litigation arising from the FDA’s refusal to approval “health claims” for foods and dietary supplements is a fertile area for disputes over the interpretation of statistical evidence.  A ‘‘health claim’’ is ‘‘any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication … characterizes the relationship of any substance to a disease or health-related condition.’’ 21 C.F.R. § 101.14(a)(1); see also 21 U.S.C. § 343(r)(1)(A)-(B).

Unlike the federal courts exercising their gatekeeping responsibility, the FDA has committed to pre-specified principles of interpretation and evaluation. By regulation, the FDA gives notice of standards for evaluating complex evidentiary displays for the ‘‘significant scientific agreement’’ required for approving a food or dietary supplement health claim.  21 C.F.R. § 101.14.  SeeFDA – Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final (2009).

If the FDA’s refusal to approve a health claim requires pre-specified criteria of evaluation, then we should be asking ourselves why have the federal courts failed to develop a set of criteria for evaluating health effects claims as part of its Rule 702 (“Daubert“) gatekeeping responsibilities.  Why, after close to 20 years after the Supreme Court decided Daubert, can lawyers make “health claims” without having to satisfy evidence-based criteria?

Read the rest.

Categories: philosophy of science, Statistics | Tags: , , , | Leave a comment

N. Schachtman: Judge Posner’s Digression on Regression

I am pleased to post Nathan Schactman’s most recent blog entry on statistics in the law: he has gratefully agreed to respond to comments and queries on this blog*.
April 6th, 2012

Cases that deal with linear regression are not particularly exciting except to a small brand of “quant” lawyers who see such things “differently.”  Judge Posner, the author of several books, including Economic Analysis of Law (8th ed. 2011), is a judge who sees things differently as well.

In a case decided late last year, Judge Posner took the occasion to chide the district court and the parties’ legal counsel for failing to assess critically a regression analysis offered by an expert witness on the quantum of damages in a contract case.  ATA Airlines Inc. (ATA), a subcontractor of Federal Express Corporation, sued FedEx for breaching an alleged contract to include ATA in a lucrative U.S. military deal.

Remarkably, the contract liability was a non-starter; the panel of the Seventh Circuit reversed and rendered the judgment in favor of the plaintiff.  There never was a contract, and so the case should never have gone to trial.  ATA Airlines, Inc. v. Federal Exp. Corp., 665 F.3d 882, 888-89 (2011).

End of Story?

In a diversity case, based upon state law, with no liability, you would think that the panel would and perhaps should stop once it reached the conclusion that there was no contract upon which to predicate liability.  Anything more would be, of course, pure obiter dictum, but Judge Posner could not resist the teaching moment, both for the trial judge below, the parties, their counsel, and the bar: Continue reading

Categories: Statistics | Tags: , , , , , | 2 Comments

The New York Times Goes to War Against Generic Drug Manufacturers: Schactman

Schachtman gives an interesting legal update today on his blog concerning the issue in my post Generic Drugs Resistant to Lawsuits” (Mar. 22, 2012).  I post it here:

The New York Times Goes to War Against Generic Drug Manufacturers

By: Nathan Schachtman, Esq., PC*

Last week marked the launch of a New York Times a rhetorically fevered, legally sophomoric campaign against generic drug preemption.  Saturday saw an editorial, “A Bizarre Outcome on Generic Drugs,” New York Times (March 24, 2012), which screamed, “Bizarre”!  “Outrageous”!

The New York Times editorialists have their knickers in a knot over the inability of people, who are allegedly harmed by adverse drug reactions from generic medications, to sue the generic manufacturers.  The editorial follows a front-page article, from earlier last week, which decried the inability to sue generic drug sellers. See Katie Thomas, “Generic Drugs Proving Resistant to Damage Suits,” New York Times (Mar. 21, 2012).

The Times‘ writers think that it is “bizarre” and “outrageous” that these people are out of court due to federal preemption of state court tort laws that might have provided a remedy.

In particular, the Times suggests that the law is irrational for allowing Ms. Diana Levine to recover against Wyeth for the loss of her arm to gangrene after receiving Phenergan by intravenous push, while another plaintiff, Ms. Schork, cannot recover for a similar injury, from a generic manufacturer of promethazine, the same medication.  Wyeth v. Levine, 555 U.S. 555 (2009).  See also Brief of Petitioner Wyeth, in Wyeth v. Levine (May 2008).

Of course, both Ms. Levine and Ms. Schork received compensation from their healthcare providers, who deviated from their standard of care when they carelessly injected the medication into arteries, contrary to clear instructions.   At the time that Levine received her treatment, the Phenergan package insert contained four separate warnings about the risk of gangrene from improper injection of the medication into an artery.  For instance, the “Adverse Reactions” section of the Phenergan label indicated: “INTRA-ARTERIAL INJECTION [CAN] RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.” Continue reading

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Guest Blogger: Interstitial Doubts About the Matrixx

By: Nathan Schachtman, Esq., PC*

When the Supreme Court decided this case, I knew that some people would try to claim that it was a decision about the irrelevance or unimportance of statistical significance in assessing epidemiologic data. Indeed, the defense lawyers invited this interpretation by trying to connect materiality with causation. Having rejected that connection, the Supreme Court’s holding could address only materiality because causation was never at issue. It is a fundamental mistake to include undecided, immaterial facts as part of a court’s holding or the ratio decidendi of its opinion.

Interstitial Doubts About the Matrixx 

Statistics professors are excited that the United States Supreme Court issued an opinion that ostensibly addressed statistical significance. One such example of the excitement is an article, in press, by Joseph B. Kadane, Professor in the Department of Statistics, in Carnegie Mellon University, Pittsburgh, Pennsylvania. See Joseph B. Kadane, “Matrixx v. Siracusano: what do courts mean by ‘statistical significance’?” 11[x] Law, Probability and Risk 1 (2011).

Professor Kadane makes the sensible point that the allegations of adverse events did not admit of an analysis that would imply statistical significance or its absence. Id. at 5. See Schachtman, “The Matrixx – A Comedy of Errors” (April 6, 2011)”; David Kaye, ” Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety and Liability Reporter 1007 (Sept. 12, 2011). Unfortunately, the excitement has obscured Professor Kadane’s interpretation of the Court’s holding, and has led him astray in assessing the importance of the case. Continue reading

Categories: Statistics | Tags: , , , , , , | 8 Comments

PhilStatLaw: Bad-Faith Assertions of Conflicts of Interest?*

In response to an indication that the FDA might need to loosen conflict-of-interest (COI) rules to get sufficient experts to serve on their advisory panels, a list has been proferred of “industry-free” experts capable of serving with “clean hands”  (See Oct 10 post: Junk Science ) But why not also seek “litigation-free” experts, asks lawyer, Nathan Schachtman on his interesting blog (Dec. 28) The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest:
Categories: Statistics | Tags: , , , | 5 Comments

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