Dilemma over Drug Safety
July 28, 2005
There is a newly urgent push from outside the pharmaceutical research and development community to get drug firms and the government to disclose the results of all tests conducted on new drugs and to immediately reveal information about problems that develop after those drugs go on the market. Consumers and health care providers say they're tired of finding out belatedly that negative information has come to light about the drugs they take or prescribe.
Improperly Attempting to Circumvent the Learned Intermediary Doctrine: Challenging the Adequacy of Warnings to Physicians
July 27, 2005
The learned intermediary doctrine is one of the most important doctrines for medical device and pharmaceutical drug defendants in product liability cases because under the doctrine, they are often able to obtain summary judgment on failure to warn claims. (The learned intermediary doctrine has been adopted and recognized in at least 45 states. <i>See Larkin v. Pfizer, Inc.</i>, 153 S.W.3d 758, 767 (Ky. 2005).) The learned intermediary doctrine provides that a manufacturer, designer or distributor of a medical device or pharmaceutical drug does not have a duty to directly warn patients of possible dangers associated with the use of the device or drug. <i>See Presto v. Sandoz Pharm. Corp.</i>, 487 S.E.2d 70 (Ga. Ct. App. 1997). Rather, "'a warning as to possible danger in its use to the prescribing physician is sufficient.'" <i>Id.</i> at 73.
Board of Immigration Appeals Break Rank
July 27, 2005
In a rather startling postscript to the two-part story on the marriage rights of transgendered persons that ran in the June and July issues of this newsletter, we now have this to report: A branch of the federal government has declared valid for the purpose of recognition of immigration status the marriage of a female-to-male postoperative transsexual to a woman.
The Future of Medical Trials in America
July 06, 2005
Four years have passed since the landmark Gelsinger case, in which attorney/modern-day crusader Alan Milstein of Sherman, Silverstein, Kohl, Rose & Podolsky, Pennsauken, NJ (and a member of this newsletter's Board of Editors) successfully brought suit on behalf of the family of Jesse Gelsinger, who died during a gene-therapy experiment at the University of Pennsylvania. From that point on, it became a brave new world. According to William Hirschborn, director of the office of Clinical Trials at Temple University School of Medicine in Philadelphia, who commented at the time: "Milstein opened the door for doctors to be held accountable."
Marriage and the Transgendered Person
June 30, 2005
In last month's newsletter, we discussed two 1970s New York decisions that held marriages between transsexuals and persons of their birth sex to be invalid. No recent cases on this issue have been brought in New York, so we are left to ponder what would be the outcomes of those cases in present-day New York. Recently, however, the Florida Court of Appeal relied on those old New York cases -- Frances B. v. Mark B.</i>, 78 Misc. 2d 112 (1974) and <i>Anonymous v. Anonymous</i>, 67 Misc. 2d 982 (1971) -- when it decided that marriage in Florida between a female-to-male transsexual and woman was invalid at its inception. In light of recent social trends in the State of New York, was that reliance justified?
Identifying Expert Witnesses
June 28, 2005
Anyone who has handled a custody or equitable distribution case knows that expert witness testimony may be necessary at trial with regard to the disputed custody or valuation issues. The Civil Practice Law and Rules require counsel to lay a preliminary foundation for the introduction of expert testimony at trial, if a proper demand is made. However, many attorneys never make such a demand, so their adversary is free to offer such testimony. Attorneys who serve a demand are often successful in precluding such testimony when their demand goes unanswered.
Using Daubert to Defeat Causation in the Delayed Diagnosis Claim
June 27, 2005
The old maxim, "the earlier the treatment, the better the outcome" has been a longtime staple in plaintiffs' collection of so-called "expert medical opinions." Let's face it -- the notion that earlier treatment is preferable, while imprecise, seems like a logical conclusion for most of us. However, the Eleventh Circuit's recent decision in <i>McDowell v. Brown</i>, 392 F.3d 1283 (11th Cir. 2004), establishes that such general medical principles, which are typically based on no more than the expert physician's common-sense and anecdotal experience, are far too speculative to overcome an evidentiary challenge pursuant to <i>Daubert v. Merrell Dow Pharmeceuticals, Inc.</i>, 509 U.S. 579 (1993) and therefore fail to establish causation in a medical negligence case. This is particularly so in those cases where the defendant medical provider maintains that the plaintiff's unavoidable and unpredictable underlying condition -- and not an alleged delay in treatment -- caused the plaintiff's injury, such that the plaintiff would have experienced the same level of injury despite any alleged delay.
Med Mal News
June 27, 2005
News from around the country for your review.
Verdicts
June 27, 2005
The latest rulings you need to know.
