Haffner v. Stryker Corporation et al

Filing 36

ORDER re 28 Motion to Dismiss. Parties have 21 days to file the briefs requested. by Judge R. Brooke Jackson on 8/1/14.(jdyne, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Judge R. Brooke Jackson
Civil Action No 14-cv-00186-RBJ
EDWARD HAFFNER,
Plaintiff,
v.
STRYKER CORPORATION, a Michigan corporation,
STRYKER SALES CORPORATION, a Michigan corporation, and
HOWMEDICA OSTEONICS CORPORATION, d/b/a STRYKER ORTHOPAEDICS, a
Michigan corporation,
Defendants.

ORDER

This matter is before the Court on Defendant’s Motion to Dismiss [ECF No. 28] for
failure to state a claim upon which relief may be granted. The Court exercises jurisdiction over
this action pursuant to 28 U.S.C. § 1332. The motion became ripe for review on May 30, 2014
upon the filing of the defendant’s Reply [ECF No. 33]. For the reasons discussed below, instead
of ruling on the motion at this time, the Court requests briefs from the parties as to whether the
case should be dismissed for a different reason not discussed in the briefs on the pending motion.
BACKGROUND
For purposes of a motion to dismiss, the Court must accept all factual assertions
contained in the pleadings as true. On or about September 27, 2011 plaintiff Edward Haffner
underwent a total knee arthroplasty in which Dr. Roger Greenberg surgically removed his left
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knee and replaced it with a Stryker Triathlon Total Knee System (“the Knee System”). The
Knee System contained cobalt and nickel. At the time of the surgery, Mr. Haffner was
personally unaware that the Knee System contained these metals. It also appears he was
unaware that he was allergic to either of these metals, one or both of which caused him to suffer
an allergic reaction resulting in pain, inflammation, swelling, bone loss, and limited mobility. As
a result, Mr. Haffner underwent a total knee arthroplasty revision surgery on August 7, 2012 to
remove and replace the Knee System.
Mr. Haffner filed a tort action in the district court in Weld County, Colorado on October
14, 2013. The defendants Stryker Corporation, Stryker Sales Corporation, and Howmedica
Osteonics Corporation d/b/a Stryker Orthopaedics (collectively “Stryker”) removed the case to
this Court on the basis of diversity jurisdiction on January 22, 2014 [ECF No. 1] and filed their
original motion to dismiss on February 3, 2014 [ECF No 11]. Mr. Haffner filed his First
Amended Complaint on February 24, 2014 [ECF No. 13] and subsequently filed his Second
Amended Complaint on April 1, 2014 [ECF No. 24]. He asserts four different theories of
products liability in the Second Amended Complaint: (1) strict products liability; (2) negligence;
(3) breach of implied warranties of merchantability and fitness; and (4) breach of express
warranty. [ECF No. 24 at 5–15]. On April 22, 2014 the defendants filed the pending motion to
dismiss for failure to state a claim upon which relief can be granted [ECF No. 28].
ANALYSIS
In 2008 the Supreme Court decided Riegel v. Medtronic, Inc., 552 U.S. 312.

In that

case the Court considered whether the preemption clause included in the Medical Device

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Amendments of 1976 (MDA) 1, 21 U.S.C. § 360c et seq., bars “common-law claims challenging
the safety and effectiveness of a medical device given premarket approval by the Food and Drug
Administration (FDA).” 552 U.S. at 315. Before the provisions of the MDA were enacted, the
States were largely left to supervise the introduction of new medical devices as they saw fit. Id.
However, the regulatory landscape began to change in the 1960’s and 1970’s as complex
medical devices entered the market. Id. As certain devices became linked to serious infections
and deaths, the public saw “the inability of the common-law tort system to manage the risks
associated with dangerous devices.” Id. In turn, Congress passed the MDA in 1976, sweeping
“back some state obligations and impos[ing] a regime of detailed federal oversight.” Id. at 316.
The MDA’s preemption provision reads as follows:
Except as provided in subsection (b) of this section, no State or political subdivision of a
State may establish or continue in effect with respect to a device intended for human use
any requirement—
(1) which is different from, or in addition to, any requirement applicable under
this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter
included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). 2 The regulatory regime established three classes of medical devices with
varying levels of oversight based on class. Class III medical devices receive the most federal
oversight as they are “purported or represented to be for a use in supporting or sustaining human
life or for a use which is of substantial importance in preventing impairment of human health,”
or they “present[] a potential unreasonable risk of illness or injury.” 21 U.S.C.A. §
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The MDA amended the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.

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The exception discussed in subsection (b) concerns the right of the FDA to exempt some state and local
requirements from preemption in specific circumstances, and only by regulation promulgated after notice
and a hearing. See 21 U.S.C. § 360k(b).

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360c(a)(1)(C)(ii).
The MDA “established a rigorous regime of premarket approval for new Class III
devices.” Riegel, 552 U.S. at 317. The FDA only grants premarket approval if it finds there is
“a ‘reasonable assurance’ of the device’s ‘safety and effectiveness’” after weighing “‘any
probable benefit to health from the use of the device against any probable risk of injury or illness
from such use.’” Id. at 318 (citations omitted). The premarket approval process also “includes
review of the device’s proposed labeling.” Id. at 319. Once a device receives premarket
approval, “the MDA forbids the manufacturer to make, without FDA permission, changes in
design specifications, manufacturing processes, labeling, or any other attribute, that would affect
safety or effectiveness.” Id. (citation omitted).
Based on the foregoing, the Court held that “[s]tate requirements are pre-empted under
the MDA . . . to the extent that they are ‘different from, or in addition to’ the requirements
imposed by federal law.” Id. at 330 (quoting 21 U.S.C. § 360(k)(a)(1)). In particular, the
plaintiff’s claims that Medtronic’s Evergreen Balloon Catheter was designed, labeled, and
manufactured in a manner that violated New York common law were preempted by the MDA.
Id. The Court further noted that the plaintiff had failed to put forward any argument that the
state duties were “parallel” to the FDA regulations, rather than in addition to them, in her
previous filings. See id.
Soon after the Riegel decision came out, Judge Blackburn of this district had a case
similar to the present case, also against Stryker: Parker v. Stryker, No. 08-CV-01093-REBMEH. The plaintiff brought seven common-law causes of action against Stryker regarding a hip
replacement device: (1) strict liability for failure to warn; (2) strict liability for defective
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manufacture; (3) strict liability for defective design; (4) negligence and recklessness; (5) breach
of express and implied warranties; (6) breach of implied warranty of fitness; and (7) breach of
implied warranty of merchantability. Stryker moved to dismiss on the grounds that the claims
were preempted, with other arguments presented in the alternative. The court concluded that all
of the claims were preempted under Riegel and dismissed the case. Parker v. Stryker, 584 F.
Supp. 2d 1298, 1303 (D. Colo. 2008).
The Court is uncertain as to why Stryker neither cited Parker nor discussed preemption in
the pending motion. There may well be a distinction that has not occurred to me, and at a
minimum, I do not want to analyze preemption here without giving plaintiff (or Stryker) an
opportunity to explain the distinction to me. The Court therefore requests briefs from the parties
of no more than fifteen (15) pages stating their respective positions on the preemption issue. The
parties will each have twenty-one (21) days from the date of this Order to file their respective
supplements.
ORDER
For the foregoing reasons, the Court will abstain from ruling on Defendant’s Motion to
Dismiss [ECF No. 28] until it receives further briefing consistent with this Order.
DATED this 1st day of August, 2014.
BY THE COURT:

___________________________________
R. Brooke Jackson
United States District Judge

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