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Cerna v. South Florida Bioavailability Clinic


An appeal from the Circuit Court of Dade County, Paul Siegel, Judge.

Hector Conrado Cerna has appealed an order which excludes his expert witness from testifying and grants final summary judgment for the appellees. We affirm the exclusion and the judgment.

Cerna alleged that he became legally blind as a result of his ingestion of two pharmaceuticals, erythromycin and cetirizine, while participating in a 1992 Pfizer-sponsored study. In 1996, Cerna initiated this product liability and negligence action in which the sole basis for his theory of causation is predicated upon the opinion of ophthalmologist Dr. Harry Hamburger, whose testimony the defendants moved to exclude.

Cerna claims that his blindness was the result of the onset of a specific hereditary disease, Leber's hereditary optic neuropathy [Leber's]. Dr. Hamburger's opinion is that the onset of Leber's in Cerna was caused by Cerna's ingestion of erythromycin and cetirizine. To reach this opinion, Dr. Hamburger first focused on the temporal proximity between Cerna's ingestion of the pharmaceutical drugs and the onset of Cerna's blindness. That is, Dr. Hamburger opined that since Cerna's alleged blindness manifested itself after he ingested the drugs then the drugs must have caused the blindness. Second, Dr. Hamburger relied on (1) a number of scientific articles linking the onset of Leber's to environmental toxins; and (2) extrapolation from two separate and distinct articles dealing with in vitro experiments using high doses of erythromycin under altered pH conditions. From these he developed his opinion as to the effect of the lower doses of erythromycin given to Cerna, with no evidence of an altered pH level.

Dr. Hamburger admitted, however, that there exist no epidemiological studies linking either erythromycin or cetirizine to Leber's or any other optic nerve problem; that he has never had peer reviewed articles published regarding erythromycin or the onset of Leber's; that he formulated his opinion solely as a result of this litigation; that he did not know at what dosage erythromycin becomes toxic; that he did not determine the effect a normal dosage would have on a human being; and that he did not rule out other potential causes of Cerna's alleged injury. Additionally, Dr. Hamburger (who is not a pharmacologist) admitted that he has done no testing or experimentation as to the onset or causes of Leber's, has never before this case opined on Leber's or the causes of Leber's, and did not diagnose the onset of Leber's in Cerna. His prior experience with Leber's consisted largely of seeing a few Leber's patients years ago while in medical school. In none of those cases did Dr. Hamburger independently diagnose the onset of Leber's. After finishing his medical fellowship in 1986, he may have seen perhaps two or three additional patients with Leber's. In none of these cases did he diagnose the cause of the onset of Leber's.

Dr. Hamburger could point to no scientific evidence relating cetirizine to Cerna's condition. The only two scientific articles Dr. Hamburger obtained involving erythromycin dealt with in vitro experiments, that is, petri dish experiments on cells. The articles dealt with high dosages of erythromycin under altered pH (acid/base) conditions under which (these articles implied) erythromycin affected the mitochondria. Because, Dr. Hamburger stated, other medical articles associated the onset of Leber's with a mitochondrial problem, he concluded that Cerna's ingestion of erythromycin caused the onset of Leber's.

In short, Dr. Hamburger's methodology consisted of an extrapolation from (1) the temporal relationship between the ingestion of the drugs at issue and the al

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