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JEFFREY BLUM v. MERRELL DOW PHARMACEUTICALS INC. AND RITE-AID PHARMACY. APPEAL MERRELL DOW PHARMACEUTICALS (06/14/89)

filed: June 14, 1989.

JEFFREY BLUM, A MINOR BY HIS PARENTS AND NATURAL GUARDIANS, JOAN AND FRED BLUM AND JOAN AND FRED BLUM, IN THEIR OWN RIGHT, APPELLEES,
v.
MERRELL DOW PHARMACEUTICALS INC. AND RITE-AID PHARMACY. APPEAL OF MERRELL DOW PHARMACEUTICALS, INC. JEFFREY BLUM, A MINOR BY HIS PARENTS AND NATURAL GUARDIANS, JOAN AND FRED BLUM AND JOAN AND FRED BLUM, IN THEIR OWN RIGHT, APPELLANTS, V. MERRELL DOW PHARMACEUTICALS INC. AND RITE-AID PHARMACY, APPELLEES. JEFFREY BLUM, A MINOR BY HIS PARENTS AND NATURAL GUARDIANS, JOAN AND FRED BLUM AND JOAN AND FRED BLUM, IN THEIR OWN RIGHT, APPELLEES, V. MERRELL DOW PHARMACEUTICALS INC. AND RITE-AID PHARMACY. APPEAL OF MERRELL DOW PHARMACEUTICALS, INC. ("MERRELL DOW")



Appeal from the Judgment Entered May 16, 1988 in the Court of Common Pleas of Philadelphia County, Civil at No. 1027 September Term, 1982. Appeal from the Order dated June 8, 1988 in the Court of Common Pleas of Philadelphia County, Civil at No. 1027 September 1982. Appeal from the Order of June 10, 1988 in the Court of Common Pleas of Philadelphia County, Civil at No. 1027 September Term, 1982.

COUNSEL

Joseph E. Conley, Jr., Philadelphia, for appellant (at 1813, 2016) and appellees (at 1866, 1867).

Thomas R. Kline, Philadelphia, for appellees (at 1813, 2016) and appellants (at 1866, 1867).

Cavanaugh, Popovich and Hoffman, JJ.

Author: Popovich

[ 385 Pa. Super. Page 153]

This case involves cross-appeals from the orders of the Court of Common Pleas of Philadelphia County, all reduced to judgment, challenging the entry of delay damages (at Nos. 1866 & 2016 PHL 1988), the grant of Rite Aid Pharmacy's judgment n.o.v. (at No. 1867 PHL 1988), and the denial of a judgment n.o.v. and/or a new trial by Merrell Dow Pharmaceuticals, Inc. (at No. 1813 PHL 1988). We reverse in part and affirm in part.

Our inquiry starts with the judgment n.o.v. allegation, and, as a result, we must view the evidence in a light most favorable to the verdict-winner. McDevitt v. Terminal Warehouse Co., 304 Pa. Super. 438, 450 A.2d 991 (1982). Under such a standard, the evidence reveals that Joan Blum was prescribed Bendectin in February and March of 1980 by her obstetrician for treatment of nausea and vomiting ("morning sickness") during the first trimester of her pregnancy.

In September of 1980, Mrs. Blum gave birth to a son (Jeffrey) diagnosed as having a "severe" case of talus equinovarus (bilateral "clubbed feet"). Thereafter, a complaint in trespass was filed against the manufacturer (Merrell Dow) and distributor (Rite Aid) of the drug, asserted by

[ 385 Pa. Super. Page 154]

    the Blums to be the direct and proximate cause of Jeffrey's deformity. The theories of recovery encompassed claims based on, inter alia, negligence, strict liability, breach of express and implied warranties, and fraud and misrepresentation of the testing and marketing ("labeling") of the drug's efficacy.

The 44-day trial (which generated over 4,000 pages of testimony) began with the appearance of Doctor Alan Kimball Done, a specialist in the field of pediatrics. He testified to conducting an examination of Jeffrey, perusing all the medical records and the deposition testimony of the attending orthopedic surgeons. He testified to relying upon the structure/activity of the drug, as well as in vitro, animal and epidemiologic studies in reaching his conclusion that Bendectin is a teratogen (causes or increases the risk of birth anomalies) in humans, and, to a degree of reasonable medical certainty, was "capable of contributing to the formation of Jeffrey's limb malformation[;]" there "being no reasonable likelihood . . . that there could be any other basis for explaining it."

As for the Bendectin label, Doctor Done believed that it contained misinformation by citing the incidence of birth defects in offspring as being no higher in women who ingested the drug when compared to those who were not exposed. His review and interpretation of the studies indicated otherwise. Moreover, because Merrell Dow's Unisom label read that it was "contra-indicated in women who were pregnant or nursing", the same warning should have appeared in the Bendectin packaging since both drugs contained doxylamine succinate, thought by Doctor Done to be the teratogenic component. Accordingly, it was the witness' opinion that the standard of pharmaceutical care in 1980 required Merrell Dow to list the hazards associated with Bendectin, i.e., it should not have been used during pregnancy, on the labeling material. Merrell Dow's failure to warn of the "high degree of risk of harm", associated with the ingestion of Bendectin during pregnancy, was felt

[ 385 Pa. Super. Page 155]

    by the witness to be inconsistent with the information available on the drug's teratogenic qualities.

The next expert to testify was a Doctor Gross. He subjected Merrell Dow's data and animal studies to analysis to determine whether the results were statistically significant (had "power"), such that Bendectin could be considered the cause of the increase in birth defects; in other words, was the drug a teratogen? He decided it was, and he stated his position thusly;

Further, it was the contention of Doctor Gross that Bendectin was "clearly, without any question, a marked, significant teratogen" that should not have been marketed for use during pregnancy.

Doctor Gross also considered the 1980 Bendectin label to be "false" in discussing the absence of any "drug-induced fetal abnormalities" occurring at levels of up to ninety times the maximum human dose. His review of the evidence indicated, "unequivocally", that the drug should be branded a teratogen. Although the witness conceded he did not review any epidemiological studies on the subject, he was still able to "extrapolate" the risk Bendectin posed to humans from the animal studies performed. Similarly, he was unaware of any drug found to cause birth defects in animals, which, upon investigation, did not cause birth defects in humans.

Doctors Done and Gross held fast to their opinions -- despite the flaws which plagued some of the studies they relied upon and the existence of a body of contrary views

[ 385 Pa. Super. Page 156]

    held by others in the field as to Bendectin's teratogenic attributes -- that Bendectin caused Jeffrey's clubbed feet.

Other witnesses to testify on behalf of the plaintiffs included Mr. and Mrs. Blum, their obstetrician, the two orthopedic surgeons who operated on Jeffrey and the pharmacist who filled Mrs. Blum's prescription. Thereafter, the plaintiffs' case came to a close and the presentment of a motion for non-suit was denied.

The defense's side of the case started with the presentment of the deposition testimony of Doctor Herschel Jick, a clinical pharmacologist, who collected data on Bendectin and other drugs to see if they were producing any abnormalities in the children born to women who took the drug(s) during pregnancy.

The time-frame for Jick's study covered July of 1977 through December of 1979. The results, published in the Journal of the American Medical Society in July of 1981, were that there was no "strong" association between the use of any of the drugs and all congenital disorders.

To the extent that the study initially showed a statistically strong association between Bendectin and some of the deformities, it was discovered that this occurred as a result of a disorganization in the data, which, upon examination of additional (future) data, evidenced no nexus between Bendectin and the minor limb disorders that were excluded, correctly, from the study.

Doctor Jick did state, however, that:

In Jick's opinion, the data did not show Bendectin having an adverse effect on developing limbs. However, he did caution "one cannot rule ...


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