Posts Tagged With: Supreme Court

Generic Drugs Resistant to Lawsuits

Waiting for my plane at La Guardia, I see that the NYT has an article on page one about the disparity between suing brand name vs. generic drug makers for failure to adequately warn of serious side effects on their drug labels. Can it be that no one is responsible for monitoring/updating drug label warnings once a drug becomes generic?

Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall.

That result stands in sharp contrast to the highly publicized case of Diana Levine, a professional musician from Vermont. Her hand and forearm were amputated because of gangrene after a physician assistant at a health clinic injected her with the same drug. She sued the drug maker, Wyeth, and won $6.8 million.

The financial outcomes were radically different for one reason: Ms. Schork had received the generic version of the drug, known as promethazine, while Ms. Levine had been given the brand name, Phenergan.

“Explain the difference between the generic and the real one — it’s just a different company making the same thing,” Ms. Schork said.

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Categories: Statistics | Tags: , , , , | 4 Comments

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

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