Lederman v. Howmedica Osteonics Corp. et al

Filing 34

ORDER: Defendant Howmedica Osteonics Corp.'s Motion to Dismiss Amended Complaint 31 is granted without prejudice to Plaintiff to amend his complaint. Plaintiff shall file his second amended complaint within 14 days. Failure to file a second amended complaint by this time shall result in the closure of this case without further notice. Signed by Judge James S. Moody, Jr on 6/19/2013. (LN)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION

PAUL E. LEDERMAN,
Plaintiff,
v.

Case No. 8:13-cv-506-T-30AEP

HOWMEDICA OSTEONICS CORP., and
STRYKER ORTHOPAEDICS CORP.,
Defendants.
_____________________________________/

ORDER
THIS CAUSE comes before the Court upon Defendant Howmedica Osteonics Corp.’s
Motion to Dismiss Amended Complaint (Dkt. 31), Defendant Howmedica Osteonics Corp.’s
Notice of Supplemental Authority (Dkt. 32), and Plaintiff Paul E. Lederman’s Response in
Opposition (Dkt. 33). The Court, having reviewed the motion, response, supplemental
authority, and being otherwise advised in the premises, concludes that the motion should be
granted without prejudice to Plaintiff to amend his complaint a final time.
DISCUSSION
This removed case is a medical device product liability action filed on January 15,
2013, in the Twelfth Judicial Circuit, in and for Manatee County, Florida. Plaintiff Paul E.
Lederman alleges he sustained injuries from the implantation of a Stryker Trident artificial
hip prosthesis designed, manufactured, and sold by Defendant Howmedica Osteonics Corp.
(“HOC”).

On March 7, 2013, HOC filed a motion to dismiss the complaint on the grounds that
the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. §360k, to the Federal Food,
Drug and Cosmetics Act (“FDCA”) preempts all of Plaintiff’s claims. On March 19, 2013,
Plaintiff filed a motion to remand, which this Court denied because Defendant Dr. Alan L.
Valadie was fraudulently joined. The Court accordingly dismissed the claims against
Defendant Dr. Alan L. Valadie without prejudice. The Court ordered Plaintiff to file a
response to HOC’s motion to dismiss on or before April 22, 2013.
Plaintiff did not file a response on April 22, 2013. Accordingly, the Court entered an
order to show cause and directed Plaintiff to file his response within fourteen days (by May
8, 2013). On May 7, 2013, Plaintiff filed a motion to amend the complaint, which the Court
granted. On May 9, 2013, Plaintiff filed his amended complaint (Dkt. 30). Plaintiff alleges
a single claim for negligent manufacturing (Dkt. 30 at ¶ 54). HOC now seeks to dismiss
Plaintiff’s amended complaint. Like its first motion to dismiss, HOC argues, in relevant part,
that Plaintiff’s negligent manufacturing claim is expressly preempted by the MDA to the
FDCA. For the reasons discussed below, the Court grants HOC’s motion without prejudice
to Plaintiff to amend his complaint a final time.
MOTION TO DISMISS STANDARD
Federal Rule of Civil Procedure 12(b)(6) allows a complaint to be dismissed for
failure to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). When
reviewing a motion to dismiss, a court must accept all factual allegations contained in the
complaint as true, and view the facts in a light most favorable to the plaintiff. See Erickson

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v. Pardus, 551 U.S. 89, 93-94 (2007). However, unlike factual allegations, conclusions in
a pleading “are not entitled to the assumption of truth.” Ashcroft v. Iqbal, 129 S. Ct. 1937,
1950 (2009). On the contrary, legal conclusions “must be supported by factual allegations.”
Id. Indeed, “conclusory allegations, unwarranted factual deductions or legal conclusions
masquerading as facts will not prevent dismissal.” Davila v. Delta Air Lines, Inc., 326 F.3d
1183, 1185 (11th Cir. 2003).
DISCUSSION
Plaintiff alleges a claim for negligent manufacturing. As a result, Plaintiff must plead
a manufacturing defect. See Citizens Prop. Ins. Corp. v. Simkar LLC, 813 F. Supp. 2d 1356,
1362 (M.D. Fla. 2011).
The parties do not dispute the underlying legal framework. Specifically, the United
States Food and Drug Administration (“FDA”) approved the medical device implanted in
Plaintiff through the Premarket Approval (“PMA”) process. As a result of that “rigorous
process” for approval, a category of express preemption applies to protect such medical
devices from state-law claims seeking to impose liability. See Riegel v. Medtronic, 552 U.S.
312, 317 (2008). As summarized in Riegel, the MDA contains an express-preemption
provision. See id. at 316-19 (applying 21 U.S.C. §360c et seq.). That provision states as
follows:
[N]o 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

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(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.
Id. at 316 (quoting 21 U.S.C. § 360k(a)). Thus, state-law claims against PMA medical
devices are preempted when they seek to impose requirements that are “different from, or in
addition to” the “detailed federal oversight” involved in PMA. Id.
The Eleventh Circuit has applied this form of express preemption to a Florida law
manufacturing defect claim. See Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1301
(11th Cir. 2011). In Wolicki-Gables, the Eleventh Circuit held that a claim that the
manufacturer “fail[ed] to reasonably manufacture the [PMA medical device] in a reasonable
manner” was preempted under Riegel and section 360k(a). Id. The Eleventh Circuit noted
that such a claim “could [impose] liability even if the manufacturer had completely complied
with the” federal requirements for the medical device. Id. Thus, like any claim that would
require the medical device to be manufactured other than in the manner approved and
required by the PMA, the claim imposed a requirement “different from, or in addition to” the
PMA requirements. Id.; see Stokes v. I-Flow Corp., 2013 WL 1715427, at *6 (M.D. Fla.
Apr. 8, 2013) (“Florida laws . . . for negligent [] manufacture . . . imposed requirements that
were ‘different from, or in addition to’ the federal requirements established for the premarket
approval of the device at issue”).
A limited exception to the rule of express preemption may apply for “parallel claims”
in which the state-law requirement matches the federal requirement. See Riegel, 552 U.S.
at 330; Wolicki-Gables, 634 F.3d at 1300-01. The parties dispute whether Plaintiff alleges

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a parallel claim. Although Plaintiff argues standards set forth by other Circuits, the Court
will not ignore the binding and specific requirements for alleging a parallel claim set forth
in Wolicki-Gables. See 634 F. 3d at 1300-01.
Under Wolicki-Gables, “for a state requirement to be parallel to a federal requirement,
and thus not expressly preempted under § 360k(a), the plaintiff must show that the
requirements are ‘genuinely equivalent.’” Id. at 1300 (quoting McMullen v. Medtronic, Inc.,
421 F.3d 482, 489 (7th Cir. 2005)) (emphasis in original). To allege a “genuinely
equivalent” parallel claim:
Plaintiffs cannot simply incant the magic words “[Appellees] violated
FDA regulations” in order to avoid preemption. Parallel claims must
be specifically stated in the initial pleadings. A plaintiff must allege
that [the] defendant violated a particular federal specification referring
to the device at issue. To properly allege parallel claims, the complaint
must set forth facts pointing to specific PMA requirements that have
been violated.
...
The[] allegations [must] set forth [a] specific problem, or failure to
comply with any FDA regulation that can be linked to the injury
alleged.
Id. at 1301-02 (internal citations and quotation omitted). In other words, a plaintiff must
“identify [a] particular specification or specific PMA requirement or FDA regulation that
[d]efendant violated” regarding the plaintiff’s medical device and that caused the plaintiff’s
injury. Kaiser v. DePuy Spine, Inc., 2013 WL 2006122, at *4 (M.D. Fla. May 14, 2013)
(dismissing claims under PMA preemption).
Plaintiff attempts to allege a parallel claim by asserting that HOC violated several
federal regulations. Plaintiff alleges that the FDA sent a warning letter to HOC in March
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2007 regarding an inspection of HOC’s manufacturing plant in Ireland, and sent another
warning letter to HOC in November 2007 regarding an inspection of HOC’s manufacturing
plant in New Jersey. Plaintiff alleges that the warning letters addressed violations of Current
Good Manufacturing Practice (“CGMP”) requirements at both plants. Plaintiff further
alleges that the medical device implanted in his hip was manufactured at one of those two
plants.
Under certain circumstances, an FDA warning letter may support a parallel claim,
including under the Wolicki-Gables standard. See Cline v. Advanced Neuromodulation Sys.,
Inc., 2012 WL 7009687, at *6 (N.D. Ga. Nov. 7, 2012) (plaintiff used warning letter to
“allege[] specific facts about when and how these violations occurred in the manufacture of
the specific device at issue”); see also Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 156
(S.D.N.Y. 2011) (plaintiff used warning letter to support allegations that her medical device
“was adulterated because some of the components, as a result of the manufacturing process,
contained excess levels of manufacturing residue”). The violations stated in the warning
letter must, however, relate to the plaintiff’s medical device and alleged injury. See Anthony
v. Stryker Corp., 2010 WL 1387790, at *4 (N.D. Ohio Mar. 31, 2010) (plaintiff did not allege
“that his injuries were caused by any act of noncompliance specified in the [] warning
letters”); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 283 (E.D.N.Y. 2009) (“Plaintiff
has failed to demonstrate that the injuries she sustained resulted from the federal violations
spelled out in the warning letters.”). This requirement is consistent with the specific

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requirements for alleging “genuine equivalence” from Wolicki-Gables. See 634 F.3d at
1300-01.
Here, Plaintiff fails to plead the necessary nexus between the warning letters, his
device, and his injuries. For example, Plaintiff fails to allege how warning letters issued in
2007, regarding inspections in 2006 and 2007, and referencing complaints dating back to
2005, could relate to his medical device implanted in 2004. Plaintiff alleges generally that
his medical device was defectively manufactured because it “contained dimensional
mismatches . . . [that] resulted in altered articulating surface geometries,” which “led to
unanticipated backside wear of the device and the introduction of an unreasonable amount
of wear particles into [his] body.” (Dkt. 30 at ¶ 54). Plaintiff fails to allege, though, which
“particular federal specification” or “specific PMA requirements” that HOC violated for his
medical device and how those violations caused the alleged defect and injuries. Instead,
Plaintiff misapplies the standard and alleges that, due to a defect, HOC violated conditions
set forth in the PMA.
In sum, in order to state a parallel claim based on the warning letters, Plaintiff must
allege the specific federal requirements applicable to his medical device that are identified
in the warning letters, along with the violations of those requirements set forth in the warning
letters, and how those violations caused his claimed defect and injury. See Wolicki-Gables,
634 F.3d at 1301-02 (plaintiff must allege the “specific problem, or failure to comply with
any FDA regulation that can be linked in the injury alleged”); Llado-Carreno v. Guidant
Corp., 2011 WL 6223409, at *5-*6 (S.D. Fla. May 16, 2011) (granting motion to dismiss

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because “general allegations are insufficient to satisfy the requisite elements of a parallel
claim”).
Notably, although HOC deems the warning letters “irrelevant,” HOC fails to show
that the warning letters are inapplicable to Plaintiff’s claims. Neither Plaintiff nor HOC
provided the warning letters to the Court, even though the Court may take judicial notice of
them at the pleadings stage. See Rounds v. Genzyme Corp., 440 Fed. Appx. 753, 754-56
(11th Cir. 2011) (relying upon FDA-related documents filed in support of a motion to
dismiss); Kaiser, 2013 WL 2006122, at *5 n.2 (“tak[ing] judicial notice of public records of
the FDA relating to the medical device involved in this case” on a motion to dismiss).
Accordingly, although HOC’s motion should be granted, the dismissal is without
prejudice. The Court will provide Plaintiff a final opportunity to plead a parallel claim based
upon the warning letters, provided that Plaintiff can do so consistent with his Rule 11
obligations.
The Court also concludes that the other issues raised by the parties are premature
given that Plaintiff has not pled a parallel claim.1

1

HOC’s argument that Plaintiff’s amended complaint must be dismissed even if he can plead
a parallel claim because Florida law does not recognize a claim to enforce violations of FDA
regulations is well-taken. See Kaiser, 2013 WL 2006122, at *5 (noting that “district courts in this
Circuit have consistently held that [parallel claims] that seek to enforce violations of FDA
regulations are barred because Florida does not recognize such causes of action”). However, the
Court declines to reach this issue until it becomes relevant, that is, until the Court concludes that
Plaintiff has pled a parallel claim.
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It is therefore ORDERED AND ADJUDGED that:
1.

Defendant Howmedica Osteonics Corp.’s Motion to Dismiss Amended
Complaint (Dkt. 31) is granted without prejudice to Plaintiff to amend his
complaint.

2.

Plaintiff shall file his second amended complaint within fourteen (14) days of
this Order. Failure to file a second amended complaint by this time shall result
in the closure of this case without further notice.

DONE and ORDERED in Tampa, Florida on June 19, 2013.

Copies furnished to:
Counsel/Parties of Record
S:\Even\2013\13-cv-506.mtdismiss31.wpd

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