HORSMON et al v. ZIMMER HOLDINGS, INC. et al
Filing
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ORDER granting 12 Motion to Dismiss, for the reasons set forth in the attached document. Plaintiff Mary Horsmon's claims for strict liability (Count II) and breach of implied warranties (Count III) are DISMISSED WITH PREJUDICE. Plaintiff Mary Horsmon's claim for breach of express warranties (Count IV) is DISMISSED WITHOUT PREJUDICE. Signed by Judge Cathy Bissoon on 11/10/2011. (rtt)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
MARY HORSMON and
FRED HORSMON
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Plaintiffs,
v.
ZIMMER HOLDINGS, INC., et al.,
Defendants.
Civil Action No. 11-1050
Judge Cathy Bissoon
MEMORANDUM AND ORDER
I.
MEMORANDUM
Pending before the Court is Defendants Zimmer Holdings, Inc., Zimmer Inc., and
Zimmer US, Inc.‟s Partial Motion to Dismiss Plaintiffs‟ Complaint (Doc. 12). For the reasons
stated herein, the Court will grant Defendants‟ motion to dismiss.
BACKGROUND
A. Factual Background
In May 2006, Plaintiff Mary Horsmon had a total hip replacement whereby her right hip
joint was replaced with implant components designed, manufactured, and sold by Defendants.
Compl. ¶¶ 11-12 (Doc. 1-2). Ms. Horsmon later began to experience pain in her right hip. Id. at
¶ 13. Sometime in 2009, an X-ray revealed that the screw holding Ms. Horsmon‟s hip prosthesis
in place was broken, and that the hip implant system had shifted from its original position. Id.
In September 2009, Ms. Horsmon underwent a revision of her total hip replacement, in which
her doctor removed the broken screw and replaced several components of the hip implant. Id. at
¶ 15. Post-operative X-rays indicated that a portion of the broken screw remained in Ms.
Horsmon‟s pelvis, and a subsequent pathology report revealed a 3.0 cm defect in the original
liner that was used during the May 2006 hip replacement. Id. at ¶ 16.
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Plaintiffs allege that Defendants‟ conduct caused Ms. Horsmon to suffer various injuries,
including being forced to undergo a second major surgical procedure, permanent injury to her
hip, and severe pain and discomfort. Id. at ¶ 17.
B. Procedural Background
Plaintiffs brought this action in the Court of Common Pleas of Allegheny County,
asserting five causes of action: negligence (Count I); strict liability (Count II); breach of implied
warranties (Count III); breach of express warranties (Count IV); and loss of consortium (Count
V).1 Defendants removed this action to this Court on the basis of diversity jurisdiction under 28
U.S.C. § 1332, and filed the currently pending motion to dismiss Counts II, III and IV of
Plaintiffs‟ complaint. Defendants assert that Counts II and III should be dismissed as barred by
Pennsylvania law, and that Count IV should be dismissed for failing to allege sufficient facts to
state a plausible claim.
ANALYSIS
A. Strict Liability (Count II)
Defendants assert that Plaintiff‟s claim for strict liability (Count II) is barred by
Pennsylvania law.2 Defs.‟ Br. 4-5 (Doc. 13). The Supreme Court of Pennsylvania in Hahn v.
Richter, 673 A.2d 888 (Pa. 1996), held that strict liability claims cannot be brought against
prescription drug manufacturers. The court relied on Comment k to the Restatement (Second) of
Torts § 402A. Comment k, titled “Unavoidably unsafe products” states:
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Plaintiff Fred Horsmon is Ms. Horsmon‟s husband. See Compl. ¶ 48. Counts I-IV are
brought by Ms. Horsmon, and Count V is brought by Mr. Horsmon. Because only Counts IIIV are at issue in Defendants‟ motion to dismiss, references to “Plaintiff” in this opinion refer
to Ms. Horsmon.
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The parties agree that Pennsylvania law applies to Plaintiffs‟ claims. See Defs.‟ Br. 4 n.1
(Doc. 13); Pl.‟s Br. 3, 8, 10 (Doc. 18).
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There are some products which, in the present state of human
knowledge, are quite incapable of being made safe for their
intended and ordinary use. These are especially common in the
field of drugs. . . . . Such a product, properly prepared, and
accompanied by proper directions and warning, is not defective,
nor is it unreasonably dangerous. The same is true of many other
drugs, vaccines, and the like, many of which for this very reason
cannot legally be sold except to physicians, or under the
prescription of a physician. . . . . The seller of such products, again
with the qualification that they are properly prepared and
marketed, and proper warning is given, where the situation calls
for it, is not to be held to strict liability for unfortunate
consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and
desirable product, attended with a known but apparently
reasonable risk.
Comment k does not mention medical devices and the Supreme Court of Pennsylvania
has not addressed whether Hahn applies to medical device manufacturers, but the Superior Court
of Pennsylvania and several United States District Courts applying Pennsylvania law have
extended Hahn to bar strict liability claims against medical device manufacturers. E.g., Creazzo
v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (“We find no reason why the same
rational [sic] applicable to prescription drugs [in Hahn] may not be applied to medical devices.”);
Parkinson v. Guidant Corp., 315 F. Supp. 2d 741, 747 (W.D. Pa. 2004) (Diamond, J.); Kester v.
Zimmer Holdings, Inc., 2:10-cv-523, 2010 WL 2696467, at *9 (W.D. Pa. June 16, 2010)
(McVerry, J.); Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 749-50 (E.D. Pa. 2007). This
Court agrees that the reasoning of Hahn extends to medical devices.
Plaintiff argues that even if Hahn applies to medical device manufacturers, numerous
commentators and courts have recognized the caveat in Comment k that a drug manufacturer is
shielded from strict liability claims only if its product is “properly prepared, and accompanied by
proper directions and warning.” Pl.‟s Br. 4-5 (Doc. 18). Plaintiff only cites law from other
jurisdictions. See id. But Hahn is the law of Pennsylvania, and the court in Hahn did not
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recognize this caveat in Comment k. See Hahn, 673 A.2d at 891 (“[W]here the adequacy of
warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise
reasonable care to warn of dangers, i.e., the manufacturer‟s negligence, is the only recognized
basis of liability.”). Other courts have interpreted Hahn as imposing an absolute bar to strict
liability claims against both prescription drug manufacturers and medical device manufacturers.
See Parkinson, 315 F. Supp. 2d at 747-48 (finding that while Comment k contains caveats, “the
Pennsylvania Supreme Court [in Hahn] ruled that § 402A strict liability is precluded entirely for
prescription drugs, and, presumably by extension, prescription medical devices”); Soufflas, 474
F. Supp. 2d at 749 n.8 ( “Under Pennsylvania law, . . . strict liability and § 402A are inapplicable
to prescription drugs.”); Bearden v. Wyeth, 482 F. Supp. 2d 614, 618 n.5 (E.D. Pa. 2006) (noting
that while Arkansas recognizes caveats in Comment k, Pennsylvania does not). While other
jurisdictions might recognize caveats to Comment k‟s exclusion of strict liability claims, this
Court must apply Pennsylvania law, which does not recognize such caveats. Plaintiff‟s claim for
strict liability is precluded by Pennsylvania law, and Count II of Plaintiffs‟ complaint is
dismissed for failure to state a claim.
B. Breach of Implied Warranties (Count III)
Defendants assert that Plaintiff‟s breach of implied warranties claim (Count III) also is
barred by Pennsylvania law. In a claim for breach of implied warranty of merchantability, “[t]he
essence of the warranty of merchantability is that the item sold is fit for the ordinary purposes for
which such goods are used.” Makripodis v. Merrell-Dow Pharms., Inc., 523 A.2d 374, 376 (Pa.
Super. Ct. 1987) (citing Wisniewski v. Great Atl. & Pac. Tea Co., 323 A.2d 744, 746-47 (Pa.
Super. Ct. 1974); 13 Pa.C.S. § 2314(b)(3)). Under Pennsylvania law, “the very nature of
prescription drugs themselves precludes the imposition of a warranty of fitness for „ordinary
purposes‟, as each individual for whom they are prescribed is a unique organism who must be
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examined by a physician who is aware of the nature of the patient‟s condition as well as the
medical history of the patient.” Id. at 377. Breach of implied warranty of merchantability
claims, therefore, are precluded for prescription drugs. Id.
Several courts have extended the reasoning of Makripodis to preclude claims against
medical device manufacturers for breach of implied warranties of merchantability and fitness for
a particular purpose. E.g., Parkinson, 315 F. Supp. 2d at 752-53 (finding that Pennsylvania law
precludes claims for breach of implied warranties of merchantability and fitness for particular
purpose for medical devices); Soufflas, 474 F. Supp. 2d at 751-52 (same); Kester, 2010 WL
2696467, at *11 (“As with strict products liability claims for failure-to-warn, Pennsylvania
courts have held that the nature of prescription drugs and prescription medical devices precludes
claims for breach of implied warranty.” (citing Parkinson, 315 F. Supp. 2d at 752-53)). Plaintiff
argues that such reasoning is flawed, because Makripodis involved a consumer‟s claim against a
retailer, not against a manufacturer. Pl.‟s Br. 8-9 (Doc. 18). But the rationale in Makripodis
relates to the nature of prescription drugs, not to the nature of the relationship between the
plaintiff and the defendant. See Makripodis, 523 A.2d at 377. The reasoning in Makripodis,
therefore, applies to manufacturers. This Court agrees with the various other courts that have
found that Makripodis applies to both prescription drugs and medical devices.
Plaintiff also argues that the court in Makripodis misapplied Comment k to the
Restatement (Second) of Torts § 402A in finding implied warranty claims precluded for
prescription drugs. Pl.‟s Br. 8-9 (Doc. 18). While the court in Makripodis cited Comment k in
support of its reasoning, the court found that the nature of prescription drugs, not Comment k,
precludes the imposition of a warranty of fitness for “ordinary purposes.” Makripodis, 523 A.2d
at 377. Further, the Restatement (Second) of Torts is not law. Plaintiff has not pointed to
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anything that would indicate that the Supreme Court of Pennsylvania would disagree with the
Superior Court‟s finding in Makripodis, and this Court cannot rely on the Restatement (Second)
of Torts to contradict a Pennsylvania state court decision. Finally, Plaintiff‟s reliance on law
from other states is similarly unavailing. See Pl.‟s Br. 10 (Doc. 18) (citing Illinois and New
Mexico law).
Because Pennsylvania law precludes breach of implied warranty claims for medical
devices, Count III of Plaintiffs‟ complaint is dismissed for failure to state a claim.
C. Breach of Express Warranties (Count IV)
Under Pennsylvania law, “[a]ny affirmation of fact or promise made by the seller to the
buyer which relates to the goods and becomes part of the basis of the bargain creates an express
warranty that the goods shall conform to the affirmation or promise.” 13 Pa.C.S. § 2313(a).
Defendants assert that Plaintiff‟s claim for breach of express warranty should be dismissed for
failing to allege any facts to suggest that her claim is plausible. See Defs.‟ Br. 6-9 (Doc. 13).
In deciding a motion to dismiss a complaint under Federal Rule of Civil Procedure
12(b)(6), the Court must accept as true all factual allegations in the complaint and draw all
inferences from the facts alleged in the light most favorable to the plaintiff. Phillips v. Cnty. of
Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). To survive a motion to dismiss, the factual
allegations in a complaint must “state a claim to relief that is plausible on its face.” Ashcroft v.
Iqbal, 556 U.S. 662, __, 129 S.Ct. 1937, 1949 (2009) (quoting Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 570 (2007)). “A claim has facial plausibility when the plaintiff pleads factual
content that allows the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556).
Plaintiff alleges that “Defendants expressly warranted in its written literature,
advertisements and representations of its representatives and agents that its acetabular systems,
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bone screws, liners and other related components were safe, effective, fit, and proper for the use
for which they were intended.” Compl. ¶ 43 (Doc. 1-2). But Plaintiff has not alleged any
particular “affirmation of fact or promise,” 13 Pa.C.S. § 2313(a), that would give rise to a
reasonable inference that Defendants “expressly warranted” that its products “were safe,
effective, fit, and proper for the use for which they were intended.” Compl. ¶ 43 (Doc. 1-2).3
Plaintiff‟s allegations also do not support a reasonable inference that any affirmation of
fact or promise by Defendants became “part of the basis of the bargain” in Plaintiff‟s purchase of
Defendants‟ goods. 13 Pa.C.S. § 2313(a). Plaintiff alleges that she “relied on the skill and
judgment and express warranties of Defendants that these products were safe, effective, fit and
proper for the use for which they were intended.” Compl. ¶ 44 (Doc. 1-2). Of course, Plaintiff
cannot allege that any particular affirmation of fact or promise became “part of the basis of the
bargain” without alleging any particular affirmation of fact or promise. But even assuming
Plaintiff sufficiently pled an affirmation of fact or promise, Plaintiff merely alleges that she
“relied on” Defendants‟ “express warranties.” Compl. ¶ 44 (Doc. 1-2). Plaintiff does not allege
for what purpose she “relied on” the alleged “express warranties.” See id. Plaintiff‟s factual
allegations do not indicate whether her alleged reliance was part of her decision to purchase
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Defendants argue that Plaintiff‟s allegations do not “sufficiently identify the actual source of
the alleged warranty as required to withstand a motion to dismiss under Pennylvania law.”
Defs.‟ Br. 7 (Doc. 13). Defendants rely on Simmons v. Stryker Corp., No. 08-3451, 2008
WL 4936982, at *2 (D.N.J. Nov. 17, 2008), a non-binding case applying New Jersey law
where the plaintiff identified “no source whatsoever of any alleged warranty.” Pennsylvania
law applies to this case, and Plaintiff alleges that “written literature, advertisements and
representations of [Defendants‟] representatives” are the source of the express warranty.
Simmons, therefore, is inapposite. As explained above, however, Plaintiff has failed to
allege that any particular “affirmation of fact or promise” was made in any of those sources.
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Defendants‟ products (i.e., that she relied on Defendants‟ promises as “part of the basis of the
bargain”).4
Because Plaintiff has not alleged sufficient facts to support a reasonable inference that
Defendants made “[a]ny affirmation of fact or promise . . . which relates to the goods,” and has
not alleged sufficient facts to support a reasonable inference that any such affirmation of fact or
promise became “part of the basis of the bargain,” Plaintiff has failed to state a plausible claim
for breach of express warranties under Pennsylvania law. 13 Pa.C.S. § 2313(a); See Kester,
2010 WL 2696467, at *11 (dismissing breach of express warranty claim where “Plaintiff neither
specifies any particular promise that formed the basis of her bargain with the Defendants, who
are generically and collectively named, nor does she demonstrate any promise was directed at
her, as a consumer, to induce her into purchasing the product”). Count IV of Plaintiffs‟
complaint is dismissed for failure to state a claim.
CONCLUSION
For all of the reasons stated above, Defendants Zimmer Holdings, Inc., Zimmer Inc., and
Zimmer US, Inc.‟s Partial Motion to Dismiss Plaintiffs‟ Complaint (Doc. 12) is granted.
Because Plaintiff‟s strict liability claim (Count II) and breach of implied warranties claim (Count
III) are barred by Pennsylvania law, amendment to Counts II and III of Plaintiffs‟ complaint
would be futile. Counts II and III, therefore, are dismissed with prejudice. See Phillips v. Cnty.
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Defendants argue that Count IV should be dismissed because Plaintiff has not alleged that
she actually saw, heard, or knew about a particular promise or representation made by
Defendants. Defs.‟ Br. 8 (Doc. 13). Plaintiff alleges that she “relied on the . . . express
warranties of Defendants . . . .” Compl. ¶ 44 (Doc. 1-2). Accepting this allegation as true,
Plaintiff, by implication, must have seen, heard, or known about the alleged express
warranties. The parties disagree as to whether a breach of express warranty claim under
Pennsylvania law requires reliance on the part of the buyer. Compare Defs.‟ Br. 6 (Doc. 13),
with Pl.‟s Br. 10 (Doc. 18). Because Plaintiff alleges that she relied on Defendants‟ alleged
express warranties, the Court need not determine at this time whether reliance is a required
element of a breach of express warranty claim.
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of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008) (“[I]n the event a complaint fails to state a claim,
unless amendment would be futile, the District Court must give a plaintiff the opportunity to
amend her complaint.” (citing Shane v. Fauver, 213 F.3d 113, 116 (3d Cir. 2000))). Plaintiff‟s
breach of express warranties claim (Count IV) is dismissed without prejudice.
II.
ORDER
For the reasons stated above, the Court hereby ORDERS that Defendants Zimmer
Holdings, Inc., Zimmer Inc., and Zimmer US, Inc.‟s Partial Motion to Dismiss Plaintiffs‟
Complaint (Doc. 12) is GRANTED. Plaintiff Mary Horsmon‟s claims for strict liability (Count
II) and breach of implied warranties (Count III) are DISMISSED WITH PREJUDICE.
Plaintiff Mary Horsmon‟s claim for breach of express warranties (Count IV) is DISMISSED
WITHOUT PREJUDICE. If appropriate and consistent with Federal Rule of Civil Procedure
11, Plaintiffs may file an amended complaint for the limited purpose of amending Plaintiff Mary
Horsmon‟s breach of express warranties claim (Count IV) no later than November 21, 2011. If
no amended complaint on Count IV is received by that date, it will be assumed that Plaintiff
acknowledges that she cannot state a breach of express warranty claim and the claim will be
deemed to have been dismissed with prejudice without further order of Court.
IT IS SO ORDERED.
s/ Cathy Bissoon
Cathy Bissoon
United States District Judge
November 10, 2011
cc (via e-mail):
All counsel of record.
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