Friday, April 30, 2010

Book Review: Better

Title

Author

Publication Date
2007

Reason For Reading
I've heard good things about the author from a number of sources. Most recently, the professor of my Health Management and Policy class mentioned in class that he was reading the book (or possibly one of the other two books by this author) for the second time, and strongly recommended it. One other thing he mentioned was that an article Gawande wrote for the New Yorker on health care costs was one that made a strong impression on President Obama and recommended members of Congress to read it (cited below). As such, it was also a reading we did for the class.

Tuesday, April 13, 2010

Supreme Court Case of the Month: Daubert v. Merrell Dow Pharmaceuticals

Case
William Daubert, et ux., etc., et al., Petitioners v. Merrell Dow Pharmaceuticals, Inc (1993)

Chief Justice
William Rehnquist

Background
A couple children were born with birth defects, which their parents claimed was due to use of the drug Bendectin (used to treat nausea & morning sickness). Merrell Dow's expert witness showed that there were no studies linking Bendectin to birth defects. The plaintiffs' witness showed that there was evidence of birth defects in in vitro and in vivo animal studies, pharmacological studies, and reanalysis of other published studies. However, these apparently were not generally accepted within the scientific community at that time.

Two previous standards come into play. The older precedent is the Frye law, a common law standard from 1923. The second is the 1975 Federal Rules of Evidence. The Frye law held that in order to be admissible as evidence, the techniques must be "generally accepted by a meaningful segment of the associated scientific community." The Federal Rules of Evidence are a broad set of rules that apply to pretty much every aspect of evidence, not just scientific. This is where it gets a little tricky. I'm not sure how exactly these differed from the Frye law. I think they just didn't clearly articulate how expert opinion would be allowed in court and what would qualify as expert opinion.

Synopsis
Both the district court and the Circuit court found for Merrell Dow, so it wasn't a surprise that the Supreme Court found for the defendant as well, but the case established a new precedent for how scientific evidence is allowed. Frye appears to be quite similar to the Daubert Standard, and I think the significance of Daubert is just that it essentially overruled the Federal Rules of Evidence and established a Supreme Court precedent. More specifically, I think the FRE didn't clearly articulate what was permissible for expert opinions, and this case essentially clarified what would be, and it's similar to the original Frye Standard.

Two things were mentioned about the plaintiffs' evidence that bears mentioning. First, the evidence they submitted appeared to have been prepared specifically for litigation, which apparently made the Circuit Court skeptical. Also, the plaintiff's expert witness was later found to have falsifed research on the teratogenic effects of Bendectin, but that appears to have been after the case was heard by the Supreme Court.


Vote & Dissenting Opinions
Majority: 7 Concur/Dissent: 2

Notable on this is that Chief Justice Rehnquist is one of the two dissenters.

Further Discussion
I stumbled onto this case when it was mentioned in my Epidemiology text book. One of the first quotes I read was that this is the most important Supreme Court case you've never heard of.
It reminded me a bit of the Thimerosal vaccine discussion we had recently. How might this apply to potential cases involving Thimerosal? I would guess at this juncture, any cases with that would get thrown out pretty quickly or be an easy ruling for the defendants if the only evidence is one questionable research study that was later retracted by the journal that published it, so it's not exactly a valid comparison.


References and Further Reading


http://www.hcs.harvard.edu/~jus/0302/orofino.pdf

Federal Rules of Evidence as of 12/1/09: