White v. Weiner

CourtSuperior Court of Pennsylvania
Writing for the CourtHOFFMAN
Citation386 Pa.Super. 111,562 A.2d 378
Parties, Prod.Liab.Rep. (CCH) P 12,214 Dorothy M. WHITE, Executrix of the Estate of Alfred S. White, Deceased, Appellant, v. Roger D. WEINER, M.D., Robb S. Seto, M.D., Gerard Voci, M.D., Episcopal Hospital, Eli Lilly and Company, Walter H. Beadling, Jr. and Dr. Baruch. 2493 PHILA. 1988
Decision Date10 July 1989

Page 378

562 A.2d 378
386 Pa.Super. 111, Prod.Liab.Rep. (CCH) P 12,214
Dorothy M. WHITE, Executrix of the Estate of Alfred S.
White, Deceased, Appellant,
v.
Roger D. WEINER, M.D., Robb S. Seto, M.D., Gerard Voci,
M.D., Episcopal Hospital, Eli Lilly and Company,
Walter H. Beadling, Jr. and Dr. Baruch.
2493 PHILA. 1988
Superior Court of Pennsylvania.
Argued April 4, 1989.
Decided July 10, 1989.

Page 379

[386 Pa.Super. 112] John M. Sheridan, Media, for appellant.

James M. Beck, Philadelphia, for Eli Lilly, appellees.

[386 Pa.Super. 113] Before BROSKY, McEWEN and HOFFMAN, JJ.

HOFFMAN, Judge:

This appeal is from an order granting appellee's renewed motion for summary judgment. Appellant contends that the lower court erred in entering its order. For the reasons that follow, we affirm the order below.

Appellant's husband died on August 14, 1982, allegedly from complications resulting from triple bypass surgery. On August 2, 1984, appellant instituted this action by writ of summons. Thereafter, on October 31, 1984, appellant filed a complaint alleging negligence on the part of several health care providers and negligence and strict liability of appellee, Eli Lilly and Company. This appeal concerns only the claims that appellant is pursuing against Eli Lilly.

According to appellant, appellee, a bulk supplier of pharmaceutical chemicals, had failed to provide an adequate warning on the packaging of the component chemical, bulk protamine sulfate, that it supplied to The Upjohn Company. 1 Upjohn had manufactured the prescription drug protamine sulfate that was administered to appellant's decedent and to which he allegedly had an adverse reaction. 2 Appellee filed its

Page 380

answer and new matter on March 6, 1985. On July 28, 1987, appellee filed a motion for summary judgment, and on September 9, the court below denied the motion without prejudice.

[386 Pa.Super. 114] After engaging in discovery, appellee renewed its motion for summary judgment, raising the following issues:

A. Lilly Is Entitled To Summary Judgment Because Plaintiff's Warning Claim Is Contrary To The Governing Federal Regulations.

* * *

B. Lilly Is Entitled To Summary Judgment Because Pennsylvania Law Does Not Impose A Duty To Warn End Users On A Supplier Of Bulk Component Chemicals.

* * *

C. Lilly Is Entitled To Summary Judgment Because Upjohn Would Not Have Changed Its Warnings In Response To Information From Lilly.

* * *

D. Lilly Is Entitled To Summary Judgment Because Dr. Seto Would Not Have Changed The Decedent's Treatment In Response To A Warning From Upjohn.

Memorandum of Law of Defendant Eli Lilly and Company in Support of Its Renewed Motion for Summary Judgment, May 25, 1988 at 8, 13, 18, 21. Appellant responded to appellee's motion, and on July 20, 1988, the court below entered an order granting the motion and dismissing appellant's complaint with prejudice. In the opinion accompanying its order, the lower court stated as follows:

As a matter of law Eli Lilly and Company as a bulk supplier of chemicals used in the making of prescription drugs had no duty to warn Plaintiff, Plaintiff's doctors or the manufacturer of the administered prescription drug of the allergic reaction that post vasectomized patients may have to Protamine Sulfate.

According to federal law all prescription drugs must be labeled according to Food, Drug and Cosmetic Act requirements, 21 U.S.C.S. § 825.

Suppliers of bulk drugs are specifically exempted from these labeling requirements of the Food, Drug and Cosmetic Act, 21 U.S.C. 353(a) (1982) provides in pertinent part.

[386 Pa.Super. 115] The secretary is directed to promulgate regulations exempting from any labeling or packaging requirements of this chapter drugs ... which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed.

As directed 21 C.F.R. § 201.122 (1982) specifically exempts from labeling requirements.

A drug in a bulk package, except tablets, capsules, or other dosage unit forms, intended for processing repacking, or use in the manufacture of another drug shall be exempt from Section 502(f)(1) of the act [if its label (sic) ] bears the statement "caution: (sic) For manufacturing, processing or repacking."

Lilly sold Protamine Sulfate to Upjohn in bulk packages not in tablet, capsule or dosage form. The packaging of the bulk Protamine Sulfate contained the warning required. Therefore, the Protamine Sulfate when supplied to the Upjohn [Company] by Lilly fell squarely in the exemption of 21 C.F.R. § 201.122 (1982). The duty of care owed by Lilly is to comply with the congressional statute and the Regulations of Food and Drug Administration. Eli Lilly and Company met this duty, and their renewed Motion for Summary Judgment must be granted.

Lower Court Opinion at 4-5. This timely appeal followed.

A.

Appellant contends that in granting appellee's renewed motion for summary judgment, the lower court erred

Page 381

in holding that the Defendant's compliance with the bulk product labeling requirements of the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. and the regulations promulgated thereunder at 21 C.F.R. § 201.122 is conclusive as a matter of law on the issue of whether its pharmaceutical product is unreasonably dangerous and therefore defective under the restatement (2d) of Tortes [sic] § 402A.

[386 Pa.Super. 116] Plaintiff's Statement of Matters Complained of on Appeal. 3 Appellant seemingly argues that satisfaction of federal labeling requirements does not insulate a bulk supplier from complying with the common law duty to warn, even though the manufacturer of the finished prescription drug has a federally-imposed duty to warn of the dangers of its product. Expanding on this theme, appellant claims that "at no time whatsoever did Eli Lilly and Company warn any party whatsoever of the known dangerous propensities of its drug. It did not warn the medical community; it did not warn the Food and Drug Administration and it did not warn the Upjohn Company." Brief for Appellant at 14.

As we interpret appellant's argument, she would have this Court impose a rather expansive duty on appellee. Appellant, however, stops short of seeking a separate warning from the bulk manufacturer to the ultimate consumer. 4 As a preliminary matter, we observe that it is not within the province of this Court to impose additional requirements on appellee vis a vis the FDA. Our task, therefore, is to determine whether, as a matter of Pennsylvania law, appellee had a duty to warn Upjohn and the medical community of the risks associated with bulk protamine sulfate.

At the outset, we note that an order granting a motion for summary judgment will not be reversed unless the court below has committed an error of law or clearly abused its discretion. See Ackler v. Raymark Indus., Inc., 380 Pa.Super. 183, 185-86, 551 A.2d 291, 292 (1988); Jones v. Keystone Ins. Co., 364 Pa.Super. 318, 323, 528 A.2d 177, 179 (1987), allocatur denied, 518 Pa. 613, 540 A.2d 535 (1988); Miller v. Federal Kemper Ins. Co., 352 Pa.Super. 581, [386 Pa.Super. 117] 585-86, 508 A.2d 1222, 1225 (1986). Further, the law on summary judgment is well-established. See Bowman v. Sears, Roebuck & Co., 245 Pa.Super. 530, 535, 369 A.2d 754, 756 (1976).

'Summary judgment is made available by Pa.R.Civ.P. 1035, 12 P.S. Appendix, when the pleadings, depositions, answers to interrogatories, admissions on file and supporting affidavits considered together reveal no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. This severe disposition should only be granted in cases where the right is clear and free from doubt. To determine the absence of a genuine issue of fact, the court must take the view of the evidence most favorable to the non-moving party, and any doubts must be resolved against the entry of the judgment.' Husak v. Berkel, Inc., 234 Pa.Super. 452, 458, 341 A.2d 174, 177 (1975). Thus, we need only determine whether there is a genuine issue of triable fact.

Id.; see also Bobb v. Kraybill, 354 Pa.Super. 361, 364, 511 A.2d 1379, 1380 (1986), allocatur denied, 513 Pa. 633, 520 A.2d 1384 (1987); Curry v. Thompson, 332 Pa.Super. 364, 368, 481 A.2d 658, 659 (1984).

B.

It is axiomatic that the existence of a federal statute, such as that governing the manufacture, distribution, and sale of

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prescription drugs, see Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 (1982) (hereinafter "the Federal Act"), 5 does not necessarily preempt state action in that field, see Controlled Substance, Drug, Device and Cosmetic Act, 35 Pa.S. § 780-101 to 780-144 (hereinafter "the Commonwealth Act"). In Whitehall Laboratories Division of American Home Products Corp. v. Wilbar, 397 Pa. 223, 154 A.2d 596 (1959), our Supreme Court specifically concluded [386 Pa.Super. 118] that the Federal Act did not preempt this Commonwealth's Dangerous Drug Act of 1955, 6 a predecessor statute to the current Commonwealth Act:

In determining whether the 'Dangerous Drug Act of 1955' and the regulations promulgated thereunder have been suspended by the 'Federal Food, Drug and Cosmetic Act' resort must be had to the language of the federal legislation for the purpose of ascertaining, if possible, the intent of Congress. An examination of the federal statute reveals neither an express or implicit exposition of any Congressional intent to preclude state action in the field of regulation of the sale and dispensing of drugs; there is, within the statute, 'no scheme of regulation' so 'pervasive' as to lead to the inference that the federal government by the passage of this legislation intended to pre-empt the field. The mere fact that Congress has taken action in this field does not justify the assumption that the federal system was thus intended to dominate that field.

Id. at 231, 154...

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22 practice notes
  • City of Philadelphia v. Lead Industries Ass'n, Inc., No. 92-1419
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • May 11, 1993
    ...in original). This passage is often quoted by Pennsylvania appellate courts refusing to expand tort law. See, e.g., White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 385 (1989) (no duty to warn for entities in distribution chain other than final drug manufacturer), aff'd, 525 Pa. 572, 583 A......
  • Lance v. Wyeth, Formerly Known Home Prods. Corp.
    • United States
    • United States State Supreme Court of Pennsylvania
    • January 21, 2014
    ...271 A.2d 265, 267 (1970)); accord Brief for Amicus Prod. Liab. Advisory Council, Inc. at 21. Additionally, Wyeth cites White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378 (1989), which referenced criminal statutes pertaining to adulteration and misbranding in support of the following pronounce......
  • Colacicco v. Apotex, Inc., Civil Action No. 05-5500.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • May 25, 2006
    ...the FDA is uniquely qualified to decide whether state law stands as an obstacle to the objectives of Congress. See White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 383 (1989) (stating that "our legislature unequivocally has expressed a policy of deference to the federal scheme in the area ......
  • Polt v. Sandoz, Inc., CIVIL ACTION NO. 16-2362
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • May 26, 2020
    ...has displayed a "general reluctance to expand tort liability within the [drug products] distribution chain." White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 385 (1989).7 Therefore, under the facts of this case, the Court will decline the invitation to alter Pennsylvania's social policy ca......
  • Request a trial to view additional results
22 cases
  • City of Philadelphia v. Lead Industries Ass'n, Inc., No. 92-1419
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • May 11, 1993
    ...in original). This passage is often quoted by Pennsylvania appellate courts refusing to expand tort law. See, e.g., White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 385 (1989) (no duty to warn for entities in distribution chain other than final drug manufacturer), aff'd, 525 Pa. 572, 583 A......
  • Lance v. Wyeth, Formerly Known Home Prods. Corp.
    • United States
    • United States State Supreme Court of Pennsylvania
    • January 21, 2014
    ...271 A.2d 265, 267 (1970)); accord Brief for Amicus Prod. Liab. Advisory Council, Inc. at 21. Additionally, Wyeth cites White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378 (1989), which referenced criminal statutes pertaining to adulteration and misbranding in support of the following pronounce......
  • Colacicco v. Apotex, Inc., Civil Action No. 05-5500.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • May 25, 2006
    ...the FDA is uniquely qualified to decide whether state law stands as an obstacle to the objectives of Congress. See White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 383 (1989) (stating that "our legislature unequivocally has expressed a policy of deference to the federal scheme in the area ......
  • Polt v. Sandoz, Inc., CIVIL ACTION NO. 16-2362
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • May 26, 2020
    ...has displayed a "general reluctance to expand tort liability within the [drug products] distribution chain." White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 385 (1989).7 Therefore, under the facts of this case, the Court will decline the invitation to alter Pennsylvania's social policy ca......
  • Request a trial to view additional results

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