KILLEN v. STRYKER SPINE
Filing
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ORDER granting in part and denying in part 3 Motion to Dismiss for Failure to State a Claim; IT IS HEREBY ORDERED that the motion to dismiss is granted in part and denied in part as follows: COUNT I NEGLIGENCE. The motion to dismiss is denied with respect to Plaintiffs claim alleging negligence; COUNT II STRICT LIABILITY. The motion to dismiss is granted with respect to Plaintiffs strict liability design defect and failure to warn claims, but denied with respect to Plaintiffs strict liabili ty manufacturing defect claim; COUNT III FRAUD. The motion to dismiss is granted with respect to Plaintiffs fraud claims arising out of Defendants product literature and labeling, but denied with respect to claims arising out of Defendants alleged intentional misrepresentations concerning Killens medical care; COUNT IV NEGLIGENT MISREPRESENTATION. The motion to dismiss is granted with respect to Plaintiffs claim alleging negligent misrepresentations in product literature and labeling regardin g the testing, research, and inspection of the CerviCore implant, but denied with respect to Plaintiffs claim arising out of Defendants alleged negligent misrepresentations concerning Killens medical care; COUNT V BREACH OF IMPLIED WARRANTIES. The motion to dismiss is granted with respect to Plaintiffs claim for breach of implied warranty of fitness for a particular purpose, but denied with respect to Plaintiffs claim for breach of implied warranty of merchantability; COUNT VI BREACH OF EXPRE SS WARRANTIES. The motion to dismiss is granted with respect to Plaintiffs breach of express warranties claim, but the grant is without prejudice to Plaintiff being permitted to amend her complaint to allege sufficient detailed facts, if any, to sup port her claim of breach of express warranty; COUNT VII PUNTIVE DAMAGES. The motion to dismiss is denied with respect to Plaintiffs claim for punitive damages. IT IS FURTHER ORDERED that the Report and Recommendation 22 of Magistrate Judge Kelly, dated August 21, 2012, as supplemented or modified by this memorandum order, is adopted as the Opinion of the Court. Signed by Judge Joy Flowers Conti on 9/28/2012. (smc )
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
MELINDA KILLEN,
Plaintiff,
v.
STRYKER SPINE, an
unincorporated division of
Howmedica Osteonics
Corporation,
Defendant.
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Civil Action No. 11-1508
Judge Joy Flowers Conti
Magistrate Judge Maureen P. Kelly
MEMORANDUM ORDER
This action was removed from the Court of Common Pleas of Allegheny County to this
court on November 28, 2011. [ECF No. 1]. In the complaint, plaintiff Melinda Killen
(“Plaintiff”) asserts claims arising from the surgical implantation of the CerviCore Intervertebral
Device (“Cervicore”) and seeks damages for the injuries that she sustained as a result of the
artificial disc implant. The case was referred to a United States Magistrate Judge for pretrial
proceedings in accordance with the Magistrate Judges Act, 28 U.S.C. § 636(b)(1), and Local
Rules of Court 72.C and 72.D.
Defendant Stryker Spine (“Defendant”) filed a motion to dismiss. [ECF No. 3]. Plaintiff
filed a response in opposition. [ECF No. 11]. A reply and sur-reply were also filed. [ECF Nos.
14, 20].
The magistrate judge’s report and recommendation, filed on August 21, 2012,
recommended that the motion to dismiss filed by Defendant, and premised upon federal
preemption, be granted in part and denied in part [ECF No. 22]. Service of the Report and
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Recommendation was made upon all counsel of record. The parties were informed that in
accordance with the Magistrate Judge’s Act, 28 U.S.C. § 636(b)(1)(B) and (C), and Rule 72.D.2
of the Local Rules of Court, that they had fourteen days to file any objections. Defendant filed
objections to the Report and Recommendations (the “objections”) on September 7, 2012. [ECF
No. 23]. Plaintiff filed a reply to the pobjections (the “reply”) on September 21, 2012. [ECF
No. 27].
Defendant asserts five specific objections upon which it argues that this court should
reject the recommendations of the magistrate judge, grant the motion to dismiss, and dismiss
Plaintiff’s complaint in its entirety with prejudice. In her reply, Plaintiff requests that this court
adopt the Report and Recommendation and deny the motion to dismiss.
After review of the complaint, the objections, the reply, the filings related to the motion
to dismiss, applicable case law, and the Report and Recommendation, the court adopts the
Report and Recommendation. Each of the five objections are addressed seriatim.
I.
Objection that Plaintiff did not successfully pled parallel claims.
Defendant contends that Plaintiff did not successfully plead parallel claims on the ground
that Current Good Manufacturing Practices (“CGMPs”) are not applicable to investigational
devices (“IDE devices”) such as the CerviCore disc. Defendant is correct that CGMPs cannot
serve as the basis for Plaintiff’s state law claims because under 21 C.F.R. § 812.1, IDEs are
exempt from CGMPs’ requirements. See Martin v. Telectronics Pacing Sys., Inc., 105 F.3d
1090, 1096 (6th Cir. 1997). If Plaintiff asserted her claims based on Defendant’s violations of the
CGMPs, those claims would be preempted because they would be different from or in addition to
the requirements imposed by federal regulation. Id. at 1096. Plaintiff, however, does not rely on
the CGMPs in the manner that Defendant suggests. Plaintiff alleges that Defendant violated the
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requirements imposed on Defendant by the FDA in the IDE approval process and relies on the
CGMPs to set forth a plausible claim of what those requirements were. (ECF No. 28 at 4-5.)
Plaintiff alleges that before discovery, she cannot determine what requirements the FDA actually
imposed on defendant in the IDE approval process because that information is confidential. The
court finds that state law claims asserting parallel violations of the requirements imposed by the
FDA during the IDE approval process are not preempted because they are not different from or
in addition to federal requirements or regulations. Plaintiff’s claims, therefore, are not preempted
to the extent that requirements imposed by the FDA on Defendant during the IDE approval
process were the same as the requirements imposed by the CGMPs. To the extent the
requirements imposed by the FDA in the IDE approval process are different from or in addition
to the CGMP requirements, however, plaintiff’s claims referring to those CGMP requirements
will be preempted.
Defendant also argues that to the extent Plaintiff relies upon 21 C.F.R. § 812.5, the
regulation is not device specific and Plaintiff’s claim alleging the violation of § 812.5 is
preempted. Defendant further contends that specific parallel claims must be asserted at this
initial pleading stage. In response, Plaintiff argues that she sufficiently pled parallel claims to the
best of her ability at this initial stage of the case. She further contends that prior to discovery it is
impossible for her to access the device-specific requirements imposed by the Food and Drug
Administration (“FDA”). Based on this sufficiency of pleading, Plaintiff argues that her
negligence claims are not preempted. [ECF No. 28 at 2-5].
The court finds that the magistrate judge conducted a detailed and thorough review of this
evolving area of the law relating to parallel claims and preemption, including the arguments
raised again by Defendant in the objections. The magistrate judge also discussed the holding in
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Gross v. Stryker, Civil No. 11-1229, 2012 WL 876719 (W.D. Pa. Mar. 14, 2012). While
agreeing in substance with the legal rationale in Gross, the magistrate judge correctly recognized
that the facts of this case are distinguishable from the facts in Gross. Here, Plaintiff sufficiently
pled parallel claims at this initial stage of the proceedings.
Plaintiff specifically avers in her complaint that Defendant: (1) was negligent in its
record keeping and did not disclose manufacturing flaws that increased the risk of injury to
patients receiving the implant and argues that this activity violated the manufacturer’s duty to
establish and maintain procedures for implementing corrective and preventative action – which
are alleged requirements of the IDE approval process that are the same as those imposed under
21 C.F.R. § 800.100(a)(6)(7); (2) was negligent in compromising the integrity of the CerviCore
implant by utilizing titanium coating techniques – which is a violation of the alleged
requirements of the IDE approval process that are the same as those imposed under 21 C.F.R. §
820.70(e),(h)1; and, (3) failed to provide proper warnings concerning defects in the device,
including the use of nickel and the risks of metallosis, in violation of a manufacturer’s duty
outlined in 21 C.F.R. § 812.5(a) to describe “all relevant contradictions, hazards, adverse effects,
interfering substances or devices, warnings and precautions.” As recognized in the Report and
Recommendation, Plaintiff, in her sur-reply, refers to the allegation in the complaint that
Defendant was negligent in performing metal allergy testing prior to accepting patients into the
clinical trial, but admits that, without discovery, Plaintiff cannot identify specific requirements
imposing such testing.
The magistrate judge correctly found that these descriptions of purported regulatory
violations go beyond the rote conclusory pleadings that the Gross court found insufficient to
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The magistrate judge noted that this same regulation was construed in Howard v. Sulzer Orthopedics,
Inc., 382 F. App’x 436, 440–41 (6th Cir. 2010), as a sufficient basis on which to base a parallel claim.
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sustain parallel claim allegations.
As noted in the Report and Recommendation, it is disingenuous to identify the parallel
claim exception to the Medical Device Act Amendments of 1976 (“MDA”) exemption as
articulated in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) , but foreclose a plaintiff any
opportunity to prove the exception. As recognized in Burgos v. Satiety, No. 10-CV-2680, 2011
WL 1327684 (E.D.N.Y. Apr. 5, 2011):
[P]laintiffs alleging state-law parallel claims based on a violation of
a manufacturer's agreement with the FDA often suffer from a unique
disadvantage: the agreements (including IDEs) that would provide
the necessary factual specificity are confidential, and available only
to the defendants and the FDA. [A]plaintiff's pleading burden should
be commensurate with the amount of information available to them.
Other courts have similarly observed that it would be an injustice to
penalize a plaintiff for alleging, through no fault of her own, what
turned out to be insufficient facts about the manufacturing process
of a device that caused injury. See Hofts v. Howmedica Osteonics
Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009); see also Bausch v.
Stryker Corp., 630 F.3d 546 (7th Cir. 2010).
Id. at *4 (citing In re Medtronic, Inc., Spring Fidelis Leads Products Liability Litigation, 623
F.3d 1200, 1209 (8th Cir. 2010) (Melloy, J., concurring in part and dissenting in part and noting
injustice arising from court's decision to rigidly adhere to Twombly, rather than pragmatically
evaluate the complaint in context of plaintiff's informational limitations)). Given the specific
facts of this case where Plaintiff advanced factual allegations that plausibly suggest the existence
of parallel claims, but does not have access to the confidential information to plead more
specifically the alleged violation of FDA regulations, the court concludes the pleading standards
are satisfied.
II.
Objection that Plaintiff’s strict liability claim is prohibited under Pennsylvania law.
Defendant argues that the magistrate judge erred in finding that while Pennsylvania law
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prohibits strict liability claims in prescription medical device cases based on design defect and
failure to warn, Pennsylvania law does not preclude strict liability claims alleging a
manufacturing defect. Defendant contends that Plaintiff’s complaint does not contain allegations
sufficient to implicate manufacturing defect strict liability claims and, in any event, Pennsylvania
law prohibits all strict liability claims in a medical device case.
Plaintiff responds that she properly alleged manufacturing defect strict liability claims.
She contends that Pennsylvania law does not prohibit strict liability manufacturing defect claims
and breach of implied warranty of merchantability claims for defective devices.
At the outset, this court finds that the magistrate judge correctly considered that
Pennsylvania law recognizes three different strict liability claims: design defect, manufacturing
defect and failure to warn. Phillips v. A-Best Products Co., 665 A.2d 1167, 1170 (Pa. 1995).
The magistrate judge also recognized that in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), the
Pennsylvania Supreme Court decided that strict liability claims based upon a failure to warn
theory cannot be brought against prescription drug manufacturers. The Pennsylvania Supreme
Court relied upon and adopted comment k of Section 402A of the Restatement (Second) of Torts.
As both parties acknowledge, the Pennsylvania Supreme Court has not addressed whether
Hahn’s rationale applies to medical device manufacturers. As such, the magistrate judge
correctly identified the conflicting authority on this issue in decisions issued by panels of the
Pennsylvania Superior Court and federal district courts in Pennsylvania.
This court concludes that the magistrate judge properly relied upon the rationale set forth
in Dougherty v. C.R. Bard, Inc., C.A. No. 11-6048, 2012 WL 2940727 (E.D. Pa. July 18, 2012),
where, after a thorough analysis of Hahn, the district judge found that while Hahn instructs that
strict liability applies to failure warn claims, comment k’s exemption from strict liability does
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not extend to manufacturing defects. Id. at *6. At this preliminary stage of the litigation,
Plaintiff’s allegations in paragraph 48(a), (d), (i) and (j) of the complaint sufficiently allege a
manufacturing defect claim in strict liability. Accordingly, the motion to dismiss with respect to
the strict liability manufacturing claim in this case was properly denied.
III.
Objection that Plaintiff’s breach of implied warranty of merchantability claim is
prohibited under Pennsylvania law.
Defendant contends that, as with strict liability, Plaintiff’s breach of implied warranty of
merchantability is prohibited under Pennsylvania law. Defendant points to the same reasons it
asserts with respect to Objection II, as its basis to object to this recommendation. Defendant also
claims that the implied warranty of merchantability does not apply to IDE devices.
This court concludes that the magistrate judge conducted a thorough review of the
applicable case law and correctly relied on the rationale set forth in Dougherty, in determining
that to the extent that Plaintiff’s implied warranty claim is based on failure to warn or design
defect, it is not cognizable under Pennsylvania law and must be dismissed. Because Plaintiff,
however, alleged specific facts supporting a manufacturing defect in violation of FDA
requirements for the IDE approval process which are the same as other requirements of pertinent
federal regulations, Plaintiff will be permitted to amend her complaint as set forth in the
recommendation.
IV.
Objection that Plaintiff’s express warranty claim is preempted.
Defendant concedes that the magistrate judge correctly found that Plaintiff’s express
warranty claim was insufficiently pled. Defendant, however, takes issue with the
recommendation that Plaintiff should be allowed an opportunity to amend the complaint. It
contends that an amendment would be futile.
Plaintiff argues that she should be permitted to amend her complaint to allege additional
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details to support her breach of express warranty claim. Plaintiff points out that Pennsylvania
law does not preclude express warranty claims against manufacturers of medical devices.
Having considered the objections and reply with respect to this issue, this court concludes
that the magistrate judge conducted a detailed analysis about whether breach of express warranty
claims are cognizable in the medical device context. The magistrate judge recognized that
federal courts within Pennsylvania have split on this issue. As set forth in the Report and
Recommendation, some courts have implicitly recognized express warranty claims as viable
causes of action against manufacturers of prescription drugs and devices. See e.g. Kee v.
Zimmer, Inc., No. 11-7789, 2012 WL 1758618, at *3 (E.D. Pa. May 17, 2012); Horsman, 2011
WL 5509420, at *3-4; Kester v. Zimmer Holdings, Inc., No. 2:10–cv–00523, 2010 WL 2696467,
at *10–11 (W.D. Pa. June 16, 2010). Other courts, however, have held that Pennsylvania law
precludes such express warranty claims. See, e.g., Aaron v. Wyeth, No. 07–0927, 2010 WL
653984, at *11 (W.D. Pa. Feb.19, 2010); Kline v. Pfizer, Inc., No. 08–3238, 2008 WL 4787577,
at *3 (E.D. Pa. Oct. 31, 2008); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa.2006),
aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated 129 S. Ct. 1578 (2009). Based on
this review, and in the context of this case, the magistrate judge properly determined that
Pennsylvania law does not preclude express warranty claims against manufacturers of
prescription drugs and devices, such as Defendant.
The magistrate judge correctly recognized that, at this point, Plaintiff’s complaint does
not sufficiently allege how or by whom a promise was made or what exactly was promised.
Without factual allegations sufficient to describe a specific promise that became the basis of the
bargain, or to show that the promise was directed at her, Plaintiff’s express warranty claim may
not escape dismissal. See Kester v. Zimmer Holdings, Inc., No. 2:10–cv–00523, 2010 WL
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2696467, at *10–11 (W.D. Pa. June 16, 2010). Therefore, the motion to dismiss is granted with
respect to count VI of the complaint, but the grant is without prejudice to Plaintiff being
permitted to amend her complaint to allege sufficient detailed facts, if any, to support her breach
of express warranty claim.
V.
Objection that Plaintiff’s fraud and misrepresentation claims are preempted and
should be dismissed.
Defendant, in a brief objection, states that the magistrate judge correctly found that
Plaintiff’s claims of fraud misrepresentation are preempted to the extent that they take issue with
Defendant’s statements regarding testing, research, etc., as such claims challenge the sufficiency
of FDA oversight and investigation. Defendant, however, objects to the magistrate judge
allowing Plaintiff’s fraud and misrepresentation claims to survive preemption based on
Plaintiff’s allegation that Defendant falsely represented that she would receive appropriate
medical care. Defendant claims that representations regarding follow-up medical care fall within
the purview of FDA regulation and are preempted by federal law.
Plaintiff contends that the magistrate judge correctly found that the MDA does not
preempt Plaintiff’s fraud and negligent misrepresentation claims because Defendant’s false
representations concern matters beyond the scope of the FDA’s regulation of investigative
devices.
In the Report and Recommendation, the magistrate judge conducted a review of MDA
preemption and Pennsylvania law. The magistrate judge correctly recognized the distinction that
Plaintiff’s fraud and misrepresentation claims with respect to Defendant’s declarations about
testing, research and inspections are preempted in accordance with Riegel, 552 U.S. at 323.
Plaintiff’s claims with respect to representations of and fraud by Defendant with respect to
follow-up care, however, are not within the scope of the applicable federal regulations and are
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not preempted by the MDA, or by applicable Pennsylvania law.
Accordingly, the
recommendation with respect to count III is adopted.
AND NOW, this 28th day of September, 2012,
IT IS HEREBY ORDERED that the motion to dismiss is granted in part and denied in
part as follows:
a. COUNT I – NEGLIGENCE. The motion to dismiss is denied with respect to
Plaintiff’s claim alleging negligence;
b. COUNT II – STRICT LIABILITY. The motion to dismiss is granted with respect
to Plaintiff’s strict liability design defect and failure to warn claims, but denied
with respect to Plaintiff’s strict liability manufacturing defect claim;
c. COUNT III – FRAUD. The motion to dismiss is granted with respect to
Plaintiff’s fraud claims arising out of Defendant’s product literature and labeling,
but denied with respect to claims arising out of Defendants’ alleged intentional
misrepresentations concerning Killen’s medical care;
d. COUNT IV – NEGLIGENT MISREPRESENTATION. The motion to dismiss is
granted with respect to Plaintiff’s claim alleging negligent misrepresentations in
product literature and labeling regarding the testing, research, and inspection of
the CerviCore implant, but denied with respect to Plaintiff’s claim arising out of
Defendants’ alleged negligent misrepresentations concerning Killen’s medical
care;
e. COUNT V – BREACH OF IMPLIED WARRANTIES. The motion to dismiss is
granted with respect to Plaintiff’s claim for breach of implied warranty of fitness
for a particular purpose, but denied with respect to Plaintiff’s claim for breach of
implied warranty of merchantability;
f. COUNT VI – BREACH OF EXPRESS WARRANTIES. The motion to dismiss
is granted with respect to Plaintiff’s breach of express warranties claim, but the
grant is without prejudice to Plaintiff being permitted to amend her complaint to
allege sufficient detailed facts, if any, to support her claim of breach of express
warranty;
g. COUNT VII – PUNTIVE DAMAGES. The motion to dismiss is denied with
respect to Plaintiff’s claim for punitive damages.
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IT IS FURTHER ORDERED that the Report and Recommendation of Magistrate Judge
Kelly, dated August 21, 2012, as supplemented or modified by this memorandum order, is
adopted as the Opinion of the Court.
BY THE COURT,
/s/ Joy Flowers Conti
JOY FLOWERS CONTI
UNITED STATES DISTRICT JUDGE
cc:
Maureen P. Kelly
United States Magistrate Judge
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