Swisher v. Stryker Corporation et al

Filing 12

ORDER granting 7 defendants' motion to dismiss and plaintiff's negligence per se claim is dismissed...as it is possible plaintiff may be able to correct the pleading deficiencies he is granted leave to file an amended complaint by 04/04/2 014...otherwise this action will be dismissed; defendant Corin USA Limited noted in its motion that is was incorrectly sued as Corin USA Limited, Inc., the clerk is directed to correct the caption on the docket sheet to reflect the defendant's correct name. Signed by Honorable Joe Heaton on 03/14/2014. (lam)

IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF OKLAHOMA
KYLE M. SWISHER.
Plaintiff,
vs.
STRYKER CORPORATION,
CORIN GROUP PLC, and
CORIN USA LIMITED,
Defendants.

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NO. CIV-14-0028-HE

ORDER
Plaintiff Kyle M. Swisher filed this action in state court against defendants Stryker
Corporation, Corin Group PLC and Corin USA Limited, Inc., asserting a negligence per se
claim based on defendants’ alleged violations of various federal regulations and
specifications governing the design, manufacturing, marketing, sale and distribution of the
Cormet Hip Resurfacing System. Plaintiff essentially claims that he was injured as the result
of a defective Cormet System being surgically implanted into his right hip. Corin Group
PLC and Corin USA Limited, Inc. (collectively “Corin”) removed the action to federal court
and they have filed a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(6).1
When considering whether a plaintiff’s claims should be dismissed under
Fed.R.Civ.P. 12(b)(6), the court accepts all well-pleaded factual allegations as true and views
them in the light most favorable to the plaintiff as the nonmoving party. S.E.C. v. Shields,
___ F.3d ___, ___ (10th Cir. 2014). All that is required is “a short and plain statement of the

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Although it is titled a petition, because this action originated in state court, the court will
refer to the pleading as a complaint.

claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). The complaint
must, though, contain “enough facts to state a claim to relief that is plausible on its face” and
“raise a right to relief above the speculative level. Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 570, 555 (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.” Shields, ___ F.3d at ___ (quoting Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009)). As explained by the Tenth Circuit, the new Twombly/Iqbal pleading standard
“is a middle ground between heightened fact pleading, which is expressly rejected, and
allowing complaints that are no more than labels and conclusions or a formulaic recitation
of the elements of a cause of action, which the Court stated it will not do.” Id. at ___
(quoting Khalik v. United Air Lines, 671 F.3d 1188, 1191 (10th Cir.2012)). “‘Rule 8(a)(2)
still lives’” and under it “‘specific facts are not necessary; the statement need only give the
defendant fair notice of what the ... claim is and the grounds upon which it rests.’” Id.
(quoting Khalik, 671 F.3d at 1191-92). Context determines the “‘nature and specificity of
the allegations required to state a plausible claim.’” Id. (quoting Kan. Penn Gaming, LLC v.
Collins, 656 F.3d 1210, 1215 (10th Cir.2011)). Considering plaintiff’s negligence per se
claim under this standard, the court concludes defendants’ motion to dismiss should be
granted.
In the complaint plaintiff alleges that Corin designs, manufactures, markets, sells and
distributes implantable medical devices, including the Cormet Hip Resurfacing System, a

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Class III medical device,2 that the Cormet System was surgically implanted into his right hip
in December 2009, and that he experienced significant pain after the surgery and multiple,
varied health problems that seemed unconnected to the Cormet System. Physicians and other
medical professionals allegedly told plaintiff that his symptoms were part of the recovery
process from the surgery or were due to other causes. Plaintiff claims that, after his
symptoms continued to worsen and he was experiencing short-term memory loss, he
discovered through his own research that he could be suffering from “metallic blood
poisoning caused by the shedding of metal ions from the Cornet System he had received.”
Doc. #1-2, p. 5. A blood test performed in September 2013 revealed, plaintiff alleges, that
his “blood was contaminated with abnormally high levels of cobalt and chromium, both of
which are metals contained in the cup and cap components of the Cormet system.” Id.
Plaintiff alleges that his health problems, which have required additional surgeries, were
proximately caused by defendants’ violations of various regulations promulgated by the Food
and Drug Administration (“FDA”). Plaintiff lists in the complaint the regulations which he
claims Corin violated.
Although plaintiff asserts in his response brief that he also has alleged that “the FDA
has acknowledged the danger that metal-on-metal devices like the Cormet System might shed
metallic ions and cause numerous complications” such as those he suffered, Doc. #9, p. 20,

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Congress, by passing the Medical Device Amendments of 1976 (“MDA”), “swept back some
state obligations and imposed a regime of detailed federal oversight” for new medical devices.
Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). “The devices receiving the most federal
oversight are those in Class III.” Id. at 317. While the MDA includes a preemption clause, it does
“not prevent a State from providing a damages remedy for claims premised on a violation of FDA
regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.”
Id. at 330.

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those allegation are not in the complaint. Also missing from the complaint are allegations
showing “the defective nature of his Cormet System necessitates corrective surgery to
remove the device entirely and replace it with an entirely new design.” Id.3
The sole question raised by Corin’s motion to dismiss is whether plaintiff has pleaded
sufficient facts to state a negligence per se claim. Corin does not dispute that a parallel state
law claim for negligence per se based on a violation of federal regulations is allowed under
Oklahoma law. See Howard v. Zimmer, Inc., 718 F.3d 1209 (10th Cir. 2013).4 What is
missing, according to Corin, are facts demonstrating how specific FDA regulations were
violated. Corin essentially contends that, in light of the rigorous Pre-Market Approval
(“PMA”) process and the Food and Drug Administration’s continued strict oversight over
Class III devices, little short of an FDA warning letter or enforcement action or recall, will
suffice to state a parallel negligence per se claim against a Cormet manufacturer. While that
may be going too far, the court does agree with Corin that something more is needed for
plaintiff to get past a motion to dismiss.
The court realizes that individuals in the plaintiff’s position are handicapped because,
as several courts have noted,“[i]n the case of Class III medical devices, potentially valuable
information related to PMA is kept confidential as a matter of federal law and formal
discovery may be required before a plaintiff can fairly be expected to identify specific
defects.” Comella v. Smith & Nephew, Inc., 2013 WL 6504427, at *3 (N.D. Ill. Dec. 11,

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The court is not expressing an opinion as to whether such allegations, if included in the
complaint, would result in a different conclusion regarding its sufficiency.
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Plaintiff acknowledges in his response brief that he is not asserting a fraud claim, which
would be preempted.

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2013). However, more is required to make out a parallel claim than conclusory statements
that a defendant violated multiple regulations. Essentially all plaintiff alleges is that he was
diagnosed with abnormally high levels of chromium and cobalt in his bloodstream, that the
cup and cap components of the Cormet System are made of those two alloys, that
“microscopic metallic particles . . . have rubbed off from the metal surfaces of the cap and
cup components” and that the “shedding was the direct and proximate result of Defendants’
violation of the PMA specifications and the applicable GMPs,5 including but not limited to
those identified above.” Doc. #1-2, pp. 9-10.
Courts are not in agreement regarding how much must be pleaded by a plaintiff to
state a claim challenging a Class III medical device. Compare Comella, 2013 WL 6504427,
at *3-46 with Bass v. Styker Corp., 669 F.3d 501, 509-13 (5th Cir. 2012). However, the
approach taken by the Fifth Circuit in Bass appears to be more in line with Twombly. In
Bass the court contrasted allegations that it concluded were sufficient to plead a nonconclusory parallel claim based upon manufacturing defects resulting from violations of
federal regulations with those that were not. The court concluded a plaintiff had pleaded
enough to state a parallel claim when he alleged:
(1) he received a Shell implant; (2) the FDA had previously warned Stryker of
bioburden in excess of FDA regulations in its final rinse of the Shells; (3) after
Bass's surgery, Stryker ultimately voluntarily recalled those Shells, including
the Shell specifically used in Bass's implant; (4) Bass suffered from a loose

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“GMP” refers to “Good Manufacturing Practices”.

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Although the specific allegations in the complaint are not included in the opinion, the court
in Comella noted that “[a] post-operative report further revealed corrosion on the device at the
modular junction and lab results consistent with metallosis.” Comella, 2013 WL 6504427, at *1.
Similar allegations are not found in plaintiff’s complaint.

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Shell due to a lack of bony ingrowth; and (5) the lack of bony ingrowth is a
known effect of an excess of bioburden and manufacturing residuals on Shells.
Id. at 510. It found a complaint was “too conclusory to state a claim,” id. at 509, which did
not specify the manufacturing defect; nor d[id] it specify a causal connection
between the failure of the specific manufacturing process and the specific
defect in the process that caused the personal injury. Nor d[id] the complaint
tell us how the manufacturing process failed, or how it deviated from the FDA
approved manufacturing process.
Id. (quoting Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).
Plaintiff’s complaint has the same flaws as those rejected by the Fifth Circuit in Funk.
The court concludes plaintiff has failed to satisfy the Twombly/Iqbal pleading standard.
Accordingly, defendants’ motion [Doc. # 7] is GRANTED and plaintiff’s negligence per se
claim is DISMISSED. As it is possible plaintiff may be able to correct the pleading
deficiencies, he will be GRANTED leave to file an amended complaint by April 4, 2014.
Otherwise this action will be dismissed.
Defendant Corin USA Limited noted in its motion that it was incorrectly sued as
Corin USA Limited, Inc. The clerk is directed to correct the caption on the docket sheet to
reflect the defendant’s correct name.
IT IS SO ORDERED.
Dated this 14th day of March, 2013.

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