decided: July 10, 1989.
DOROTHY M. WHITE, EXECUTRIX OF THE ESTATE OF ALFRED S. WHITE, DECEASED, APPELLANT,
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
Appeal from the Order entered July 20, 1988 in the Court of Common Pleas of Delaware County, Civil Division, at No. 84-9355.
John M. Sheridan, Media, for appellant.
James M. Beck, Philadelphia, for Eli Lilly, appellees.
Brosky, McEwen and Hoffman, JJ.
[ 386 Pa. Super. Page 113]
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.*fn1 Upjohn had manufactured the prescription drug protamine sulfate that was administered to appellant's decedent and to which he allegedly had an adverse reaction.*fn2 Appellee filed its 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. Page 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. Page 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.
Appellant contends that in granting appellee's renewed motion for summary judgment, the lower court erred
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. Page 116]
Plaintiff's Statement of Matters Complained of on Appeal.*fn3 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.*fn4 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, 585-86,
[ 386 Pa. Super. Page 117508]
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).
It is axiomatic that the existence of a federal statute, such as that governing the manufacture, distribution, and sale of prescription drugs, see Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392 (1982) (hereinafter "the Federal Act"),*fn5 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. Page 118]
that the Federal Act did not preempt this Commonwealth's Dangerous Drug Act of 1955,*fn6 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., 397 Pa. at 231, 154 A.2d at 601. Hence, because the field of drug regulation is not exclusively within the federal domain, this Commonwealth may enter that field so long as its laws and regulations do not conflict with the federal provisions. Id., 397 Pa. at 234, 154 A.2d at 602.
The Commonwealth Act is a criminal statute, see 35 Pa.S. § 780-113 to 780-120 (prohibited acts, penalties), and does not establish a private right of action. Compare 21 U.S.C. §§ 331-337 (establishing penalties, providing that all actions shall be made in the name of the United States). The act, nevertheless, is instructive insofar as it is an expression of the legislature's policy on drug regulation, and it provides in pertinent part:
§ 780-108. Misbranding
[ 386 Pa. Super. Page 119]
A controlled substance, other drug or device or cosmetic shall be deemed to be misbranded:
(6) Unless its labeling bears (i) adequate directions for use, and (ii) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users: Provided, That where any requirement of subclause (i) of this clause as applied to any drug, device or cosmetic is not necessary for the protection of the public health, regulations shall be promulgated exempting such drug, device or cosmetic from such requirements.
35 Pa.S. § 780-108(6) (emphasis added).*fn7
With respect to the adequacy of the warning included on a label, the misbranding provision must be read in conjunction with the following section of the act:
§ 780-133. Conformity with federal law
No controlled substance, other drug, device or cosmetic shall be deemed to be adultered or misbranded under this act if it complies with the applicable Federal act and/or regulations and interpretations issued pursuant thereto, unless the secretary, after consultation with and upon the recommendation of the board, shall have previously promulgated a regulation stating that the applicable provision of the Federal act and/or regulations and interpretations thereof would not be followed.
35 Pa.S. § 780-133 (emphasis added).
As we read these sections, compliance with federal labeling requirements normally is sufficient to preclude criminal prosecution by the Commonwealth for misbranding. Id. Certainly the foregoing provisions do not control our disposition of appellant's claim in this civil action; they, nevertheless, do embody a legislative intent
[ 386 Pa. Super. Page 120]
that we cannot ignore. Our legislature unequivocally has expressed a policy of deference to the federal scheme in the area of drug labeling, id., and we can ascertain no reason not to extend that policy to civil cases raising misbranding claims.*fn8
[ 386 Pa. Super. Page 121]
The Federal Act requires pharmaceutical manufacturers to submit detailed drug applications, which include "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use." 21 U.S.C. § 355(b)(1)(A); see also 21 C.F.R. §§ 312.1 to 312.6. Additionally, after receiving approval, a manufacturer regularly must update its application with
data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may be general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination whether there is or may be ground for invoking subsection (e)*fn9 of this section.
21 U.S.C. § 355(j)(1) (renumbered to 21 U.S.C. § 355(k)(1) by 1984 amendment).
Moreover, under federal law, the prescription drug manufacturer,*fn10 packer, or distributor has the duty to label the prescription drugs that it respectively has manufactured, packed, or distributed. See 21 U.S.C. § 352(b); 21 C.F.R. § 201.100. In fact, "no person other than the manufacturer,
[ 386 Pa. Super. Page 122]
packer or distributor may be identified on the label of a drug or drug product." 21 C.F.R. § 201.1(h)(1); see also id. § 201.1(a). The label must bear the following information: "description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence, overdosage, dosage and administration, how supplied." 21 C.F.R. § 201.56. According to the Federal Act, similar to the Commonwealth Act, a prescription drug is misbranded if its labeling fails to include,
such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.
21 U.S.C. § 352(f). Compare 35 Pa.S. § 780-108(6)(ii).
There is no question that manufacturers of potentially dangerous drugs are held to a high degree of care. As this Court said in Henderson v. National Drug Company, 343 Pa. 601, 610, 23 A.2d 743, 748 (1942), '. . . the public interest requires the holding of companies which make and sell drugs and medicine for use in the human body to a high degree of responsibility under both the criminal and civil law for any failure to exercise vigilance commensurate with the harm which would be likely to result from relaxing it.'
Incollingo v. Ewing, 444 Pa. 263, 287, 282 A.2d 206, 219 (1971). Despite our imposition on manufacturers of finished prescription drugs*fn11 of this enhanced duty of care, we
[ 386 Pa. Super. Page 123]
have circumscribed the scope of their duty to warn. A manufacturer will be held liable "only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous." Baldino v. Castagna, 505 Pa. 239, 244, 478 A.2d 807, 810 (1984); see also Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 361 Pa. Super. 589, 596, 523 A.2d 374, 378 (1987); Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa. Super. 418, 432, 307 A.2d 449, 457 (1973) (equally divided court) (opinion in support of affirmance). In a line of cases beginning with Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971), our courts consistently have stated that a drug manufacturer's duty to warn extends only to the prescribing physician, and not to the ultimate consumer. See id., 444 Pa. at 288, 282 A.2d at 220; Baldino, 505 Pa. at 244, 478 A.2d at 810; Makripodis, 361 Pa. Super. at 596, 523 A.2d at 378; Leibowitz, 224 Pa. Super. at 431, 307 A.2d at 457 (opinion in support of affirmance).
On only two prior occasions has this Court evaluated the issue of the duty to warn with respect to entities other than the final manufacturer within the chain of distribution of a prescription drug. In both Coyle v. Richardson-Merrell, Inc., 372 Pa. Super. 118, 538 A.2d 1379 (1988), allocatur granted, 520 Pa. 588, 551 A.2d 215 (1988), and Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 361 Pa. Super. 589, 523 A.2d 374 (1987), we considered whether a pharmacist had a duty to furnish a warning with the drugs he or she dispensed, and we found no such duty. Coyle, 372 Pa. Super. at 121-22, 538 A.2d at 1381; Makripodis, 361 Pa. Super. at 597, 523 A.2d at 378. This general reluctance to expand tort liability within the distribution chain is consistent with our position that
[i]t is illusory to believe the public does not pay for tort recoveries, or that resources for such are limitless. As it is with everything, a balance must be struck -- certain
[ 386 Pa. Super. Page 124]
limits drawn . . . . A sound and viable tort system -- generally what we now have -- is a valuable incident of our free society, but we must protect it from excess lest it becomes unworkable.
Steiner v. Bell Telephone Co., 358 Pa. Super. 505, 522, 517 A.2d 1348, 1357 (1986) (en banc), aff'd without opinion, 518 Pa. 57, 540 A.2d 266 (1988).
In this case, we decline to impose on a bulk supplier of pharmaceutical chemicals the additional duties to warn suggested by appellant. The rigorous testing and reporting required of final manufacturers by federal law, see, e.g., 21 U.S.C. § 355(b)(1)(A), (k)(1), renders superfluous detailed warning by bulk suppliers to those same manufacturers. In a recent case the Washington Supreme Court addressed a similar issue of vertical liability:
We agree with Lilly that there should be no vertical liability in DES cases. DES is not inherently harmful, and is still prescribed today . . . . Furthermore, the United States [Food and] Drug Administration requires the tablet manufacturers . . . to account for and warn of a drug's properties. 21 U.S.C. § 355. It would therefore be anomalous to require the raw manufacturer to conduct separate tests to determine the adverse effects of the drug when by federal statute, the tablet manufacturer bears this responsibility.
George v. Parke-Davis, 107 Wash.2d 584, 599-600, 733 P.2d 507, 515 (1987) (emphasis added). We agree with the conclusion reached by the George court and decline to impose an additional common law duty to warn extending from a bulk supplier to a final manufacturer. Accordingly, we hold that beyond compliance with the labeling requirements of 21 U.S.C. § 353(a) and 21 C.F.R. § 201.122, appellee had no duty to provide a warning to Upjohn.
Like the testing requirements, the federal labeling requirements are extensive, see, e.g., 21 U.S.C. § 352(f); 21
[ 386 Pa. Super. Page 125]
C.F.R. § 201.56. Again, the onus is on the manufacturer to provide the labeling, see, e.g., 21 U.S.C. § 352, that reaches "those for whose use the article is supplied," namely the prescribing physician. Baldino, 505 Pa. at 244, 478 A.2d at 810. In light of federal law, we conclude that a separate warning from a bulk supplier to the medical community would be duplicative. We, therefore, hold that appellee had no duty to warn the prescribing physician of appellant's decedent.
We find further support for the foregoing conclusions in Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971), and its progeny, in which our courts declined to require separate warnings extending from prescription drug manufacturers and druggists to the general public. In Incollingo our Supreme Court concluded that the duty to warn the patient-consumer was one exclusively borne by the prescribing physician. Id., 444 Pa. at 288, 282 A.2d at 220. See also Baldino, 505 Pa. at 244-45, 478 A.2d at 810; Makripodis, 361 Pa. Super. at 596, 523 A.2d at 378. The rationale for this rule is obvious: It is the physician who has the superior knowledge in the circumstances because he or she is able to balance the risks associated with the prescription drug against its utility "in light of his [or her] personal knowledge of the patient's medical history." Leibowitz, 224 Pa. Super. at 431, 307 A.2d at 457 (opinion in support of affirmance); see also Makripodis, 361 Pa. Super. at 596, 523 A.2d at 378 ("the warnings which are required to be given by the manufacturer must be directed to the physician, not the patient-consumer. This is so because it is the duty of the prescribing physician to be fully aware of (1) the characteristics of the drug he is prescribing, (2) the amount of the drug which can be safely administered, and (3) the different medications the patient is taking. It is also the duty of the prescribing physician to advise the patient of any dangers or side effects associated with the use of the drug as well as how and when to take the drug."). Here, appellant does not argue that bulk suppliers of pharmaceutical chemicals
[ 386 Pa. Super. Page 126]
should be required to warn consumers, but rather that bulk suppliers have a duty to warn final manufacturers and the medical community. It is the final manufacturer and the medical community, however, who are in a better position to assess the risks associated with the administration of the prescription drug. As this Court noted in Wenrick v. Schloemann-Siemag Aktiengesellschaft, 361 Pa. Super. 137, 522 A.2d 52 (1987), allocatur granted, 518 Pa. 643, 542 A.2d 1371 (1988), "[a] component part manufacturer should not be burdened with the heavy duty of inquiring into every possible use of their part and warning of every possible danger that might be associated with the integration of their part into the completed product." Id., 361 Pa. Superior Ct. at 149 n. 1, 522 A.2d at 57-58 n. 1. Thus, our holding here, like that of our Supreme Court in Incollingo, places the duty on the party that is best able to ascertain and balance the risks associated with the final prescription drug. Hence, imposition of an additional common law duty to warn as between entities higher in the chain of distribution, would be in derogation of the policy considerations underlying the decisions in Incollingo and its progeny.
Accordingly, because appellee satisfied the federal labeling requirements imposed on a bulk supplier, 21 C.F.R. § 201.122, we conclude that the court below did not abuse its discretion in granting appellee's renewed motion for summary judgment. See Ackler, 380 Pa. Super. at 183, 551 A.2d at 292. For the foregoing reasons, we affirm the order below.