Foster v. American Home Products Corp.
| Decision Date | 14 July 1994 |
| Docket Number | 93-1664,Nos. 93-1627,s. 93-1627 |
| Citation | 29 F.3d 165 |
| Parties | , Prod.Liab.Rep. (CCH) P 14,041 Craig FOSTER; Karen Foster, as parents and next friends, Guardians and/or Administrators of the Estate of Brandy Foster, Plaintiffs-Appellants, v. AMERICAN HOME PRODUCTS CORPORATION, Defendant-Appellee, and Barre-National Corporation, Defendant. Craig FOSTER; Karen Foster, as parents and next friends, Guardians and/or Administrators of the Estate of Brandy Foster, Plaintiffs-Appellees, v. AMERICAN HOME PRODUCTS CORPORATION, Defendant-Appellant, and Barre-National Corporation, Defendant. |
| Court | U.S. Court of Appeals — Fourth Circuit |
ARGUED: Richard L. Duncan, Gilreath & Associates, Knoxville, TN, for appellants. Deborah Sweet Byrnes, Whiteford, Taylor & Preston, Towson, MD, for appellee. ON BRIEF: Karl J. Nelson, Whiteford, Taylor & Preston, Towson, MD, for appellee.
Before NIEMEYER and HAMILTON, Circuit Judges, and CHAPMAN, Senior Circuit Judge.
Affirmed by published opinion. Senior Judge CHAPMAN wrote the opinion, in which Judge NIEMEYER and Judge HAMILTON joined.
American Home Products Corporation/Wyeth-Ayerst ("Wyeth") is a prescription drug manufacturer. Craig and Karen Foster brought suit against Wyeth when their daughter Brandy died after being given the generic equivalent of one of Wyeth's brand name prescription drugs. The district court granted summary judgment for Wyeth as to the Fosters' products liability counts because Wyeth did not manufacture the drug Brandy was given, but it allowed the Fosters to proceed on a negligent misrepresentation theory. It later granted Wyeth summary judgment on the negligent misrepresentation claim on the ground that the Fosters failed to show reliance.
This appeal presents two issues: whether the district court correctly held that a manufacturer of a brand name prescription drug may be held liable on a negligent misrepresentation theory for a death caused by another company's generically equivalent drug; and, if so, whether the district court correctly dismissed the Fosters' claim for failure to show reliance. We hold that a name brand manufacturer cannot be held liable on a negligent misrepresentation theory for injuries resulting from use of another manufacturer's product, and therefore do not reach the second question.
Phenergan is a brand name prescription drug manufactured and sold by Wyeth. On August 28, 1988 Dr. Martin Berger prescribed Phenergan Syrup Plain for infant twins Brandy and Bradley Foster, who were suffering from colic. The pharmacy substituted Promethazine Syrup Plain, a generic equivalent of Phenergan manufactured and sold by My-K Laboratories, Inc. The active ingredient in both Phenergan Syrup Plain and Promethazine Syrup Plain is promethazine hydrochloride.
The Foster twins were given the generic promethazine several times over the next few days, last on the night of September 10, 1988. The following morning, six-week-old Brandy was found dead in her crib. The autopsy report attributed Brandy's death to Sudden Infant Death Syndrome ("SIDS"). A pediatrician from the Maryland SIDS Center at the University of Maryland opined that Brandy's death was caused by the promethazine.
The Fosters brought suit in state court against Wyeth and Barre-National Corporation. At that time the Fosters thought Barre-National had manufactured the generic promethazine Brandy was given. Wyeth removed the case to federal court on grounds of diversity of citizenship, and the district court granted Barre-National summary judgment when it was determined that My-K Laboratories manufactured the generic promethazine Brandy took. The Fosters then brought suit against My-K, but agreed to a dismissal with prejudice for reasons not stated in the record.
The Fosters' complaint against Wyeth contained four counts: Negligence--Wrongful Death, Negligence--Survivorship, Strict Liability, and Breach of Warranty. Wyeth moved for summary judgment on all counts, arguing that it could not be liable for Brandy's death because it did not manufacture the promethazine Brandy ingested.
At the summary judgment hearing, the Fosters argued that their complaint also sounded in negligent misrepresentation, and the district court agreed. 1 The district court then granted Wyeth summary judgment on the negligence, strict liability and breach of warranty counts because Wyeth did not manufacture the promethazine at issue, however, it allowed the negligent misrepresentation claim to stand. The district court stated that it was assuming for summary judgment purposes that Wyeth was promoting the use of promethazine in general, as opposed to only its own product, Phenergan. It further stated that:
if Defendant Wyeth made a false representation concerning the safety of promethazine hydrochloride for use in infants and Dr. Berger relied on the representation in prescribing a promethazine hydrochloride-based product for Brandy Foster, then Wyeth may be liable for any harm caused to Brandy as a result of the ingestion of promethazine hydrochloride, even if the drug ingested was not Wyeth's product.
J.A. 68. It considered the negligent misrepresentation claim to be distinct from the Fosters' products liability claims and therefore unaffected by the fact that Wyeth did not manufacture the product alleged to have caused the injury.
Wyeth then filed a motion for summary judgment on the negligent misrepresentation claim, arguing that the Fosters had not shown reasonable reliance. With its motion Wyeth filed an affidavit signed by Dr. Berger stating that he prescribed Phenergan for Brandy based only on his own experience with the drug and did not rely on any representations made by Wyeth. The district court granted Wyeth's motion for summary judgment on the ground that the Fosters had not shown that Dr. Berger relied on representations made by Wyeth in his decision to prescribe Phenergan for Brandy and Bradley.
The Fosters now appeal the district court's dismissal of their negligent misrepresentation claim, and Wyeth cross-appeals the district court's initial determination that Wyeth could be held liable on a negligent misrepresentation theory for injuries caused by another manufacturer's product.
We review the district court's decision granting summary judgment de novo. Moore v. Winebrenner, 927 F.2d 1312, 1313 (4th Cir.), cert. denied, --- U.S. ----, 112 S.Ct. 97, 116 L.Ed.2d 68 (1991).
Although there is no recognized cause of action based on negligent misrepresentation against one manufacturer for injuries stemming from use of another manufacturer's product, the district court allowed the Fosters' negligent misrepresentation action to proceed because he viewed it as distinct from the Fosters' products liability claims. We are unable to see any validity in this distinction. Although actions for negligent misrepresentation arise in many contexts other than products liability, in this case the allegations of negligent misrepresentation are an effort to recover for injuries caused by a product without meeting the requirements the law imposes in products liability actions. Maryland law requires a plaintiff seeking to recover for an injury by a product to demonstrate that the defendant manufactured the product at issue. See Tidler v. Eli Lilly & Co., 851 F.2d 418, 424 (D.C.Cir.1988) (); Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156, 1163-64 (4th Cir.1986) (); Jensen v. American Motors Corp., 50 Md.App. 226, 437 A.2d 242, 247 (Md.Ct.Spec.App.1981) (). The Fosters are attempting to hold Wyeth liable for injuries caused by another manufacturer's product, and we are persuaded that the Maryland courts would reject this effort to circumvent the necessity that a defendant be shown to have manufactured the product that caused an injury prior to being held liable for such injury.
The Fosters insist, however, that the fact that Wyeth did not manufacture the promethazine should not shield Wyeth from an action for negligent misrepresentation. This argument, as well as the district court's assumption that Wyeth's representations regarding Phenergan encompassed other manufacturers' promethazine products, appears to stem from certain practices of the generic drug industry and from the federal regulatory scheme governing generic drug manufacturing and sales, which we now briefly examine. 2
The Food, Drug and Cosmetics Act requires that manufacturers obtain regulatory approval for drugs prior to marketing them. 21 U.S.C.A. Sec. 355(a) (West Supp.1994). For drugs that have never before been marketed, the approval process requires submission of a new drug application ("NDA"), which in turn mandates costly and time-consuming studies of the drug's safety and effectiveness. See 21 U.S.C.A. Sec. 355(b)(1) (West Supp.1994). As a result of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585, generic drugs can now gain approval pursuant to an abbreviated new drug application ("ANDA"), which permits the applicant to provide data demonstrating that the generic drug is the same as a previously approved drug in terms of its suggested usage, active ingredients, method of administration, dosage, strength, and bioequivalence 3 in lieu of the studies necessary for an initial NDA. 21 U.S.C.A. Sec. 355(j)(2)(A) (West Supp.1994). Thus, a...
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