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Timothy Stahl, inf. by m/n/g Mary Ann Stahl v. Youchan Rhee, M.D.; Taik Yong Ban, M.D.; and Sterling Drug

Case Name

Timothy Stahl, inf. by m/n/g Mary Ann Stahl v. Youchan Rhee, M.D.; Taik Yong Ban, M.D.; and Sterling Drug

Type of Injury

INFANT SUFFERS MENTAL RETARDATION AND SEIZURE DISORDER

Location

Suffolk, NY

Verdict

Defense verdict (6/0)

Verdict Amount

$0.00

Case Details

XVII/11-18 PRODUCT LIABILITY PHISOHEX INFANT SUFFERS MENTAL RETARDATION AND SEIZURE DISORDER DEFENSE VERDICT

Timothy Stahl, inf. by m/n/g Mary Ann Stahl v. Youchan Rhee, M.D.; Taik Yong Ban, M.D.; and Sterling Drug 20633/85 3-month trial Verdict 6/3/99 Suffolk Supreme

Judge: Peter Fox Cohalan

Verdict: Defense verdict (6/0). Jury: 4 male, 2 female. A Notice of Appeal by Pltf. is likely.

Pltf. Atty: Roman M. Silberfeld of Robins, Kaplan, Miller & Ciresi, L.L.P., Los Angeles, California

Thomas J. Conlin of Robins, Kaplan, Miller & Ciresi, L.L. P., Minneapolis, Minnesota

Barry S. Huston of Huston & Schuller, P.C., Manhattan

Deft. Atty: Peter C. Kopff of Kopff, Nardelli & Dopf, L.L.P., Manhattan, for Rhee and Ban

George M. Newcombe and Jonathan K. Youngwood of Simpson Thacher & Bartlett, Manhattan, and James Ruger, Manhattan, for Sterling Drug (home counsel)

Facts: On 2/14/77, shortly after the infant Pltf. s birth, Deft. Dr. Rhee, the infant s treating pediatrician, prescribed pHisoHex antibacterial cleanser, manufactured by Deft. Sterling Drug, with Neosporin topical triple antibiotic as treatment for Pltf. s neonatal impetigo. Pltf. claimed that Hexachlorophene, an ingredient in pHisoHex, is dangerous to newborns with compromised skin, such as neonatal impetigo. Pltf. also contended that Deft. physicians improperly renewed the prescription on 2/23/77, without seeing the infant, permitting excessive application of the product, and failed to consider that pHisoHex could cause brain damage. Pltf. also claimed that pHisoHex is contraindicated for treatment of impetigo, and that in 1972, the FDA had found that it should only be used as a bacteriostatic skin cleanser or as treatment for staphylococcus infections in a hospital nursery. Pltf. contended that Deft. Sterling Drug sold a defective product, that it was negligent in the manufacture and marketing of pHisoHex, and that it negligently failed to adequately warn physicians of the danger of the product. Pltf. also claimed that the instructions in the Physicians Desk Reference ( PDR) were misleading to physicians and did not disclose the risks of pHisoHex or contain administration instructions.

Pltf. claimed that the Deft. physicians did not heed her complaints about the child, who suffered from episodes of crying, irritability, and stiffening on the changing table. These complaints were not in the infant s medical charts.

Pltf. contended that there was damage to the infant s white and gray matter and that the myelination process was disturbed. She claimed that pHisoHex will cause damage to the gray matter if the white matter is compromised. Pltf. sustained a permanent seizure disorder and is severely mentally retarded.

Defts. contended that pHisoHex with Neosporin was the standard of care in 1977 for a mild case of neonatal impetigo. They denied that the infant experienced any neurological manifestations of toxicity and that his developmental neurological condition manifested at 5 months of age. Defts. also contended that the onset of his seizures on 6/1/77, 4 months after the use of the product, ruled out pHisoHex as the cause of his seizure disorder.

Deft. Sterling Drug contended that pHisoHex was safe and effective when used as instructed. Deft. also claimed that the 1976 insert to the PDR fully disclosed the risks of Hexachlorophene intoxication. Deft. contended that Hexachlorophene can cause white matter problems, which are reversible and which, it claimed, the infant Pltf. did not have. Deft. also contended that Pltf. s MRI is normal, indicating that the cause of his mental retardation and seizure disorder was due to an event that occurred before he was born . Deft. contended that in over 50 years of use, pHisoHex has never caused mental retardation and permanent seizure disorder, which are gray matter conditions. Defts. also claimed that Pltf. s mother, who read the 1977 Physicians Desk Reference in 1983, thereafter gave the history that the child had all the symptoms of toxicity, including gastrointestinal injuries. Defts. denied that Pltf. reported these symptoms to them. Defts. also contended that gastrointestinal injuries could occur only with oral consumption. Defts. argued that the medication was given to Pltf. topically, not orally. Pltf. claimed that gastrointestinal problems can result from topical application as well as oral administration. Demonstrative evidence: bottle of pHisoHex; drawing of impetigo, diaper rash, and neonatal bran and myelination at 2 weeks of age; charts of brain cells; MRIs; enlargement of medical and hospital records; medical illustrations; articles; antimicrobial panel study by FDA. Specials: Medicaid lien of approximately $1,700,000; $2,300,000 in past medical expenses were stipulated. Amount asked of jury: $28,000,000. Jury deliberation: 2? hours. Carrier: MMIA and Medical Liability Mutual for Rhee and Ban.

Note: This case was settled in March 1994 before Honorable Lester E. Gerard, after Judge Gerard discharged Mrs. Stahl as the child s natural guardian and appointed Harvey Besunder, the president of the Suffolk County Bar Association, as guardian ad litem for the infant. Mr. Besunder accepted $575,000 in settlement from Sterling Drugs. The Appellate Division, Second Dept. reinstated Mrs. Stahl as the infant s natural guardian and vacated the settlement, and this trial ensued. The court found that [a] guardian [cannot be removed] solely to ensure approval of a settlement since the power of the court to approve a settlement does not confer a concomitant power to dictate the terms of the settlement. It cannot be said that the mother s judgment in this matter was unreasonable Rather the mother s refusal to accept the settlement offered was based upon an informed judgment that there was such a pronounced difference between the amount offered and her child s yearly and lifetime expenses, that the settlement would make no discernible difference in the child s life. Stahl v. Rhee, 220 A.D.2d 39, 643 N.Y.S.2d 148 (Second Dept., 5/13/96).

Pltf. Experts: Dr. Jean Lockhart, pediatrician, San Rafael, California; Dr. William P. Blackmore, research pharmacist (formerly with Sterling Drug), Delmar; William Guess, Ph.D., toxicologist, Oxford Mississippi; Dr. Sidney Baker, pediatrician, Hamden, Connecticut; Dr. Bruce Roseman, pediatric neurologist, White Plains; Richard Ruth, Ph.D., economist, New Jersey; Edmond Provder, life care planner, Manhattan.

Deft. Experts: Dr. Warren Rosenfeld, pediatrician, Mineola; Dr. Arthur Rose, pediatric neurologist, Brooklyn (both for Rhee and Ban); Dr. Alan Leviton, epidemiologist and pediatric neurologist, Boston, Massachusetts; Dr. Ira Bergman, pediatric neurologist, Pittsburgh, Pennsylvania.