Stanton v. Astra Pharmaceutical Products, Inc.

• Decision Date: 26 September 1983
• Docket Number: 82-3380,C,No. 82-3380,No. 82-3364,Nos. 82-3364,82-3364,s. 82-3364
• Citation: 718 F.2d 553
• Parties: 14 Fed. R. Evid. Serv. 257 Harrikah I. STANTON, a Minor, by Ruby BROOKS (nee Stanton), her Parent and Guardian, and Ruby Brooks, Appellees inross-Appellants in, v. ASTRA PHARMACEUTICAL PRODUCTS, INC., Appellant inross-Appellee in.
• Court: U.S. Court of Appeals — Third Circuit

Page 553

718 F.2d 553

14 Fed. R. Evid. Serv. 257

Harrikah I. STANTON, a Minor, by Ruby BROOKS (nee Stanton) her Parent and Guardian, and Ruby Brooks Appellees in No. 82-3364 Cross-Appellants in No. 82-3380, v. ASTRA PHARMACEUTICAL PRODUCTS, INC., Appellant in No 82-3364, Cross-Appellee in No. 82-3380.

Nos. 82-3364, 82-3380.

United States Court of Appeals, Third Circuit.

Argued Feb. 28, 1983.

Decided Sept. 26, 1983.

James W. Evans (argued), Goldberg, Evans & Katzman, P.C., William D. Boswell, Berman, Boswell & Tintner, Harrisburg, Pa., for Astra Pharmaceutical Products, Inc.

Frank M. McClellan (argued), Phoebe H. Northcross, Philadelphia, Pa., Allen T. Eaton, Allen T. Eaton & Associates, Washington, D.C., for Harrikah I. Stanton and Ruby Brooks.

Before ADAMS, WEIS and BECKER, Circuit Judges.

OPINION OF THE COURT

BECKER, Circuit Judge.

On December 2, 1971, Harrikah I. Stanton, then eight months old, suffered an adverse reaction to Xylocaine, a local anesthetic, and experienced cardiac and respiratory arrest, resulting in severe and irreversible brain damage. Ruby Brooks, Harrikah's mother, brought this diversity negligence and products liability action on behalf of herself and her daughter (the "plaintiffs") against Xylocaine's manufacturer, Astra Pharmaceutical Products, Inc. The suit alleged, inter alia, that Astra had been negligent in failing to file with the Food and Drug Administration (the "FDA") certain reports concerning Xylocaine, as required by federal statutes and regulations, and that the failure to file the reports also rendered Xylocaine a defective product within the meaning of Restatement (Second) of Torts Sec. 402A. Mrs. Brooks further asserted that the failure to file and the defective nature of the drug were substantial factors in causing her daughter's injuries. After an eight-week trial, the jury found Astra liable to plaintiffs on the above bases and awarded compensatory but not punitive damages. When the Pennsylvania Supreme Court subsequently changed the law regarding calculation of damages, however, the district court granted a new trial limited to computation of compensatory damages. Plaintiffs obtained a jury verdict of $2,367,032, on which judgment was entered.

Astra appeals from that judgment, claiming (a) that the federal statutes and regulations asserted as the basis for liability did not apply to Xylocaine and that, at all events, the evidence was insufficient to support the verdict on liability; (b) that the district court erred in resubmitting "special questions" on liability to the jury after the jury had returned the questionnaire containing answers inconsistent with its award of damages; (c) that the court abused its discretion in granting a new trial limited only to damages; and (d) that the court erred in denying Astra's motion for a mistrial based on prejudicial comments by plaintiffs' counsel in his opening statement during the retrial on damages. On cross-appeal, plaintiffs contend that several evidentiary rulings by the district court allegedly prejudiced their ability to prevail on their claim for punitive damages.

For the reasons that follow, we conclude that Astra did have an obligation to comply with the relevant statutes and regulations and that, although the question of causation is extremely close, plaintiffs introduced sufficient evidence to support the verdict in their favor. We also conclude that the district court acted within its discretion in resubmitting the "special questions" to the jury. However, because we hold that the court abused its discretion in granting a new trial limited only to damages, we will vacate the judgments as to liability and damages and remand for a new trial on both issues. Because several of the procedural and evidentiary questions raised in these appeals are likely to recur on retrial, we address those matters as well.

II. Factual and Procedural Background

Harrikah Stanton was an eight-month-old infant on December 2, 1971, when she entered Harrisburg Hospital and submitted to a bone-marrow test to determine the cause of the hemolytic anemia from which she had suffered since birth. In performing the test, the hematologist, Dr. Herbert S. Bowman, injected a two-percent solution of Xylocaine into Harrikah's right posterior iliac crest to anesthetize the area from which he would aspirate bone marrow. The Xylocaine, known generically as lidocaine hydrochloride, was a local anesthetic manufactured by Astra.

Shortly after the procedure, Harrikah began convulsing and experienced cardiac and respiratory arrest. Dr. Marita Fabian, a senior resident at the hospital, and other hospital employees attempted to resuscitate her, but to little avail. The cardiac arrest resulted in severe and irreversible brain damage. Harrikah cannot walk, talk, or stand; her development has not progressed beyond that of a three- to four-month old child. She will require constant care for the rest of her life.

On October 24, 1973, plaintiffs commenced this negligence and product-liability action against Astra, Harrisburg Hospital, and Drs. Bowman and Fabian. ¹ Plaintiffs pressed a host of claims against Astra, charging that the company had been negligent in (a) failing adequately to warn Dr. Bowman and the physician-employees at Harrisburg Hospital of a possible toxic reaction to Xylocaine, even in a proper pharmacological dose, when administered to a child of Harrikah's age; (b) failing adequately to warn Dr. Bowman and the Hospital's physician-employees of the need for immediate availability of resuscitative equipment and short-acting barbiturates when Xylocaine is administered; (c) "overpromoting" Dr. Bowman and the physician-employees so that they no longer heeded the warnings actually given; (d) failing adequately to warn Dr. Bowman and the physician-employees that Xylocaine should not be administered in a two-percent solution to an eight-month-old child; (e) failing to file annual reports and unexpected-adverse-reaction reports with the FDA, as required by 21 C.F.R. Sec. 130.35(e) and (f) (1972); ² (f) marketing a product that was defective because the manufacturer's failure to file the adverse-reaction reports pursuant to section 130.35(f) deprived the FDA of the information it needed to make an informed judgment concerning the conditions under which Xylocaine safely could be marketed; (g) failing to provide Dr. Bowman with adequate directions for computing a safe dosage of Xylocaine for an eight-month old infant; (h) failing to conduct studies adequate to determine what in fact would be a safe dosage for a child of Harrikah's age; and (i) failing to exercise reasonable care to monitor and investigate fully the adverse reactions associated with Xylocaine in order to determine the risks involved in the use of that drug.

After an eight-week trial, the case was submitted to the jury on "special questions." On January 10, 1980, the jury returned a verdict against Astra alone. ³ In response to the "special questions," see infra Part III, the jury found that Harrikah had suffered an adverse reaction to Xylocaine; that Astra had acted negligently in failing to file the annual and adverse-reaction reports required by subsections 130.35(e) and (f); that the failure to file these reports rendered Xylocaine a defective product; and that Astra's negligence and the product's defective nature were substantial factors in causing Harrikah's injury. The jury also found that Astra negligently had failed both to conduct adequate dosage studies and to monitor and investigate fully the clinical adverse-reaction experiences, but it did not deem this negligence to have been a substantial factor in causing the child's injuries. Finally, the jury rejected plaintiffs' claims that Astra had failed to issue adequate warnings to users of Xylocaine; that Astra had "overpromoted" those users; and that Astra had failed to provide adequate directions to the users. The jury awarded Mrs. Brooks $60,000 in her own right and $255,000 on behalf of her daughter but refused to award punitive damages, finding that Astra had not acted "with a bad motive or with reckless indifference to the interests of persons who might be administered the drug." The district court entered judgment on the verdict on January 11, 1980.

Before the district court had ruled on post-trial motions, the Pennsylvania Supreme Court decided the case of Kaczkowski v. Bolubasz, 491 Pa. 561, 421 A.2d 1027 (1980), which held that a jury may consider lost future productivity in awarding damages for future losses and that such losses should not be discounted to present value. In the wake of this change in Pennsylvania law, the district court granted plaintiffs' motion for a new trial on compensatory damages but denied it in all other respects. ⁴ Stanton v. Astra Pharmaceutical Products, Inc., Civ. No. 73-610 (M.D.Pa. Oct. 19, 1981) ("Stanton I "). The court denied Astra's motion in toto. Stanton v. Astra Pharmaceutical Products, Inc., Civ. No. 73-610 (M.D.Pa. Oct. 19, 1981) ("Stanton II "). ⁵

The new trial on compensatory damages resulted in a jury verdict awarding Mrs. Brooks $256,000 in her own right and $1,652,371 as Harrikah's parent and guardian. The court awarded damages for delay and molded the award to $2,367,032, pursuant to Pa.R.Civ.P. 238. ⁶ On April 14, 1982, Astra moved for a new trial, claiming that the district court had erred (a) in refusing to dismiss the panel of jurors after the court made allegedly improper remarks in its introductory statement to the panel, and (b) in refusing to declare a mistrial following allegedly improper and prejudicial statements by plaintiffs' counsel in his opening and closing arguments. ⁷ The court denied Astra's motion, Stanton v. Astra Pharmaceutical Products, Inc., Civ. No. 73-610 (M.D.Pa. June 28, 1982) ("Stanton III "), and Astra appealed. Plaintiffs filed a cross-appeal on August 6, 1982, challenging the court's denial of their motion for a new...