The Bright Line Business Law Blog

Bendectin may be back

The March of Dimes announced recently that Bendectin was making a comeback.

You may remember Bendectin, a morning sickness drug widely administered to pregnant women from 1956 to 1983.

Bendectin treats the most common unpleasant pregnancy complication, nausea, affecting up to 80% of pregnant women. By 1980, between 10 and 25% of pregnant women were taking Bendectin.  In 1983, Merrill Dow Pharmaceuticals withdrew the drug from the market due to an overwhelming number of lawsuits claiming Bendectin caused birth defects. The most famous of these is unquestionably Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469.  In Daubert, plaintiffs alleged Bendectin caused birth defects. Merrell Dow moved for summary judgment, submitting an affidavit from an expert epidemiologist, Dr. Lamm, who stated that none of the 30 pertinent published studies had ever found Bendectin capable of causing malformations in fetuses. Rather than directly contest Dr. Lamm's factual statements, plaintiffs responded with their own experts' declarations to the effect that their unpublished studies, and reanalyses of published studies, indicated a link between Bendectin and fetal malformation.

Plaintiffs, in short, practiced Junk Science.

The motion was granted, and on appeal, the Ninth Circuit Court of Appeals ruled that expert opinion based on methodology diverging "significantly from the procedures accepted by recognized authorities in the field ... cannot be shown to be 'generally accepted as a reliable technique,' ..." (Id. at p. 1130.) The Court of Appeals rejected plaintiffs' reanalyses as "unpublished, not subjected to the normal peer review process and generated solely for use in litigation." (Id. at p. 1131, fn. omitted.) Emphasis added. I cannot imagine how an attorney could ethically prepare a “study” solely for use in litigation. Ultimately, the Supreme Court issued its landmark ruling, cited above, making federal judges "the gatekeepers" with aresponibility of keeping "junk sciecne' out of the courtroom.

Now, a Canadian Company plans to market a drug with the same ingredients as Bendectin, to be called Diclectin. By now, there is a large body of research showing that there is no connection between Bendectin and birth defects. Unfortunately, doctors are reluctant to invite lawsuits by prescribing a drug that even ahs the underserved reputation of causing birth defects. I don’t blame them, but, in the meantime we lose an important tool in improving our quality of life. Certainly, in this case, more harm than good was done.  I object to junk science because its use has harmful consequences that should have been avoided.

CDC backs off Mold Claim

The Canadian Occupational Safety magazine has an interesting article on mold exposure.  The typical mold related lawsuit will be careful to allege exposure to Stachybotrys, an allegedly harmful mold implicated in an outbreak of respiratory disorders among young children in Cleveland.  Now it seems the science behind that finding is questionable and the CDC has retracted its earlier report.  From the online article:

I realize that many who read this Newsletter make a good living in the search and destruction of mold in various indoor environments. As a toxicologist, however, I have real reservations about the science (or lack thereof) currently used to support the notion that molds may readily cause adverse health effects in humans.

Much of the concern about Stachybotrys relates to reports, dating back to 1994, of a cluster of infants in Cleveland, Ohio who were diagnosed with pulmonary hemorrhage or pulmonary hemosiderosis. Since these infants were found in homes with water damage and/or contamination with Stachybotrys strains capable of producing trichothecene mycotoxins, a causal association between these serious hemorrhagic lung disorders and this mold was made

What has happened is that moot clinical studies in humans combined with misinterpreted toxicological findings in animals have led to the creation of a "junk science" abetted by both the scientifically naive and unscrupulous opportunists. [emphais added]

The Centers for Disease Control (CDC) has recently announced a retraction of its earlier tentative support for a link between Stachybotrys and pulmonary hemorrhagic disorder.

Anti-Evolution Stickers invalidated

I wrote about the Cobb County evolution creation trial a few months ago. The Georgia District Court’s opinion is here.

The case arises from a decision by the school board to place a sticker in the front of biology textbooks that says:

“This textbook contains material on evolution. Evolution is a theory, not a fact, regarding the origin of living things. This material should be approached with a n open mind, studied carefully, and critically considered.”

The plaintiffs, parents of children in the school district, claimed that the sticker violated the First Amendment’s Establishment Clause.  The trial court held correctly but unfortunately, that there is no bright line for evaluating establishment clause claims.”  Although I am generally in favor of such bright line evaluations, in this case, I can’t think of a workable bright line Establishment Clause test.

The test the Court used was set out by the Supreme Court in Lemon v Kurtzman 403 U.S. 602. In Lemon, the Court held that a government sponsored message such as the sticker in this case violates the establishment clause if it fails one of these three prongs:

1.      It does not have a secular purpose.

2.      It’s principal or primary effect advances or inhibits religion.

3.      It creates excessive entanglement with religion.

In applying the first of the Lemon prongs, the court held that the sticker had a secular purpose—in fact two of them.  First, the school board intended to encourage student critical thinking. Second, the school board wanted to reduce offense to those whose personal religious beliefs might conflict with the teaching of evolution.

The court noted that the school district had refused to teach evolution for many years and was updating its biology curriculum in 1999.  Knowing there would be a significant objection from many families the school board sought to soften the blow by including the sticker. The court found that this was the main purpose of the sticker.

In applying the second Lemon prong, the court considered whether a disinterested reasonable person would conclude that the sticker contained an endorsement of religion.  This fortunately, is usually a legal question based more or less on judicial interpretation of social facts, and here the court concluded that a reasonable person would conclude the sticker conveyed and endorsement of a certain form of religion,  and that such persons were favored members of the political community so as to require a sticker to assuage their more privileged concerns.

The court did examone the social and historical background of the evolution creation conflicts routinely occrruing in public schools.  It also focused on the wording of the sticker itself “Evolution is a theory, not a fact.”  This language tqken directy from many religious creationist claims is essentially a “code phrase” routinely used by creationists opposed to evolution. Its use displays either a religious intent or a fundamental ignorance of science and the history surrounding the debate.  The court did not find the school board members to be ignorant and noted the historically loaded connotation of the “evolution is a theory not a fact” phrase. As the court observed, The Establishment Clause, at the very least, prohibits government from appearing to take a position on questions of religious belief and this is exactly what the School Board appears to have done.

            Although the governmental action is invalidated if any Lemon prong is violated, the court went on to hold that the school board had effectively entangled itself with religion by taking a position that agrees with and endorses fundamentalists and creationists but not necessarily all other religious beliefs. 

Mold Junk Science Information

Check here for  Junk Science Mold Info. Most of the mold litigation I've been involved with seems to involve junk science. I'm open to persuasion, but after attending a number of depositions of "mold experts," I put mold into the "junk science" category.  I'm glad to see that others agree.

Evolution and Creationism Collide in Federal Court (yet again)

Execpt for sex eduction, Evolution is probably the most controversial matter in school education. Ever since the 1925 Scopes trial, battles between evolution and creationism have raged.  Courts cannot ingnore the religious overtones of creationism. To determine whether an activty is Constituional, courts analyze the issues under the Lemon test.

The  Lemon Test is based the holding of  Lemon v. Kurtzman 403 US 602 (1971). In Lemon, the court held that state programs  supplementing the salaries of religious parochial school teachers who teach secular subjects violated the Establishment Clause.

The Lemon court set out a three prong test to analyze potential Establishment Clause violations. A statute will be upheld if all three are met.

1.                The statute must have a secular legislative purpose

2.                 Its principal or primary effect must be one that neither advances nor inhibits religion.

3.                 The statute must not foster "an excessive government entanglement with religion."

In Cobb County, the school board required placing a sticker in the high school biology textbook, which says:

This textbook contains material on evolution. Evolution is a theory, not a fact, regarding the origin of living things. This material should be approached with an open mind, studied carefully, and critically considered.

Since other textbooks, such as history and physics texts, don’t require this sticker and only a biology book discussing evolution was subject to the requirement, the very first prong of the test is at issue. School Board members testified at the trial  that the sticker was placed because of the concerns of Christian parents, suggesting that there is also an issue with the second prong, as well.

This case was a bench trial, so a decision will be rendered soon. I am interested in these cases because they frequently misuse experts and scientists.  Interestingly, this judge must have thought so, too, because he refused to hear expert testimony at trial. I'll discuss the implications for experts and Daubert in later posts.

Thoughts on State Medical Board proceedings

HealthLawBlog

The HealthlawBlog has several interesting articles on legal health issues and is definitely worth a read for anyone who is interested in medical/legal issues. This linked post discusses issues relating to quack medicine and also the proper role of state licensing boards. I've represented several health care professionals before the State Board of Medical Examiners. In those many instances I represented only one whose license should have been revoked--and the board did so. In all the other matters, the health care professional had the misfortune to settle a case above $30,000--not a large amount in medical malpractice circles. I don't think any disciplinary action should have been taken in those cases. In California, all settlements above $30,000 must be reported to the Medical Board, which then commences an action against the practictioner's license, using the evidence from the underlying case without a lot of thought and imagination. Many, but not all, of the Deputy Attorney Generals have a prosecutorial mindset that I think is not appropriate in most cases. I recognize the difficulties becasue you do want to swiftly move against dangerously incompetent individuals without steamrollering those who have made one mistake in a career.

HealthLawBlog makes the same good point in discussing the difficulties in dealing with medical quackery and innovative medical treatments