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 ...