Tuesday, September 18, 2007

TN Supreme Court holds that a child born alive has an independent cause of action for failure to obtain informed consent

In, Marissa Miller, a minor, by and through her mother, and next friend, Miranda Miller v. John Dacus, M.D. - M2006-02728-SC-R23-CQ View, the Tennessee Supreme Court held that child born alive does have an independent cause of action for injuries caused by the failure of a physician to obtain informed consent from the child’s mother during labor.

In 2003, the Plaintiff through her mother and next friend brought a medical malpractice suit in federal district court against the obstetrician for injuries sustained by the Plaintiff during her birth in 1993, alleging both medical negligence and lack of informed consent. The district court dismissed the lack of informed consent claim on summary judgment, ruling that a child born alive does not have an independent action for lack of informed consent. On appeal, the United States Court of Appeals for the Sixth Circuit certified two questions of law to this Court.
  1. Whether a child born alive has an independent cause of action for injuries allegedly caused by the failure of a physician to obtain informed consent from the child’s mother during labor and delivery.
  2. If the Answer to Question 1 is ‘Yes,’ whether the minority provision of Tennessee’s legal disability statute, Tenn. Code Ann. § 28-1-106, tolls the medical malpractice statute of repose, Tenn. Code Ann. § 29-26-116(a)(3), as applied to a fetus’s lack of informed consent claim.

TN SC holds that Tennessee Code Annotated section 28-1-106 tolls the three-year statute of repose for the Plaintiff’s lack of informed consent claim because the claim was commenced before December 9, 2005. See Calaway v. Schucker, 193 S.W.3d 509 (Tenn. 2005).

View case

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Note: TN's Callaway v. Schucker, 193 S.W.3d 509 (Tenn. 2005), case has held that TN's statute of repose is not tolled by child's minority. The court in Miller applied Callaway prospectively only.

NIH advisory panel says further testing needed to determine gene therapy's role in patient death.

[Source: Health and Life Sciences Law Daily, Sept. 18, 2007]

The Washington Post (918, A4, Weiss) reports that according to a National Institutes of Health panel, "tests on an Illinois woman who died mysteriously in July after getting an experimental gene treatment show no evidence that she was killed directly by the genetically altered viruses she was given" by Targeted Genetics, a Seattle biotechnology company, but "further tests will have to be done to see if the treatment somehow contributed to her death, perhaps by leaving her vulnerable to a runaway fungal infection." The FDA "has placed the experiment on hold, and the case is being watched closely by leaders of other gene-therapy experiments."

The New York Times (9/18, A22, Pollack) notes that the woman, Jolee Mohr, "died on July 24 at the University of Chicago Medical Center, three weeks after trillions of genetically engineered viruses were injected into her right knee as a test of an experimental treatment for rheumatoid arthritis. The type of virus used as a gene carrier has widely been considered safe and is being used in 35 other trials."

Insurance companies limiting coverage to drugs approved by FDA in order to control costs.

[Source: Health and Life Sciences Daily, Sept. 18, 2007]

The Wall Street Journal (9/18, A1, Anand) reports, "Doctors, particularly oncologists, rely on medicines approved for other diseases to try to save patients for whom all other treatments have failed. But as new medicines come to market at ever-higher prices, insurers are pushing back, limiting coverage of these drugs to only the disease for which they are specifically approved by the Food and Drug Administration -- or for which there is extensive evidence of efficacy in clinical trials." The Journal notes that insurers "have little leverage in negotiating the prices of many specialty drugs because they often extend lives and lack competition." And, according to many insurers, they must "limit use of the most expensive drugs to control healthcare costs, which are surging at a seven percent to eight percent annual rate and continue to outpace inflation." The insurers say it "makes sense" to require "proof that a drug works in a patient's particular disease before doling out tens or hundreds of thousands of dollars." Mohit Ghose, spokesman for America's Health Insurance Plans, an industry trade group, noted, "We're trying to bring new drugs to consumers, but trying to do it with employers getting the best value of every healthcare dollar spent in the system."

CMS report finds states differ widely in spending on healthcare.

[Source: Health and Life Science Daily, September 18, 2007]

The New York Times (9/18, A22, Pear) reports that according to a study appearing in the Web edition of the journal Health Affairs, a huge variation exists "in personal health spending among states, ranging from an average of nearly $6,700 a person in Massachusetts to less than $4,000 in Utah." The study "said that Massachusetts, Maine, New York, Alaska and Connecticut had the highest per capita spending on healthcare in 2004," while the "lowest-spending states were Utah, Arizona, Idaho, New Mexico and Nevada. Per capita spending in Utah was 59 percent of that in Massachusetts." The lead author of the report, Anne B. Martin, an economist at the CMS, "said the reasons for the differences included the age and incomes of the population, the concentration of doctors in a state, the generosity of public programs, the extent of private health-insurance coverage, and the mix of services used by state residents." The AP (9/18, Schmid) notes, "Nationally, per capita health spending increased on average 6.3 percent per year from 1998 to 2004, the report said."