Desabio v. Howmedica Osteonics Corp. et al
DECISION AND DENYING Plaintiff's 14 Motion to Amend/Correct Amended Complaint; GRANTING Defendants' 10 Motion to Dismiss Amended Complaint; DIRECTING the Clerk of the Court to close this case. Signed by William M. Skretny, Chief Judge on 9/11/2011. (Attachments: # 1 PMA) (MEAL)
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NEW YORK
DECISION AND ORDER
HOWMEDICA OSTEONICS CORP. and
Plaintiff Desabio commenced this action in New York State Supreme Court, County
of Erie, on or about February 20, 2009, alleging claims for breach of express warranty,
carelessness and negligence, and breach of implied warranty relating to an allegedly
defective hip prosthesis he received. Defendants, the alleged manufacturers and sellers
of the prosthesis, removed the action to this Court, and subsequently moved for partial
dismissal and for a more definite statement. In response, Plaintiff amended his Complaint,
asserting claims for negligent design and/or manufacture, breach of warranty, and res ipsa
loquitur. (Docket No. 12.)
Now before the Court are Defendants’ Motion to Dismiss the Amended Complaint
in its entirety (Docket No. 10), and Plaintiff’s Motion to Amend/Correct Amended Complaint
(Docket No. 14). Plaintiff seeks to revise his negligence claim to allege a failure to comply
with Food and Drug Administration (“FDA”) standards in the manufacturing process. The
motions are fully briefed,1 and the Court finds that no oral argument is necessary. For the
reasons discussed below, Plaintiff’s motion is denied, and Defendants’ motion is granted.
This case involves an artificial hip prosthesis, known as the Trident™ System,2
which has been classified by the FDA as a Class III medical device. According to Plaintiff,
after the Trident System was implanted, in or about April 12, 2005, the device squeaked
and he “suffered severe grinding and pain.” (Docket No. 12 ¶¶ 9, 12.) In his Amended
Complaint, Plaintiff asserts claims for negligent design and/or manufacture, breach of
warranty, and res ipsa loquitur.
Defendants urge that these common law claims must be dismissed because they
are preempted by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360k,
to the Federal Food, Drug and Cosmetics Act (“FDCA”), and also because Plaintiff has
failed to adequately plead them.
In response, Plaintiff contends that his negligence and res ipsa loquitur claims
implicitly assert violations of FDA standards, and that his breach of warranty claim survives
as a “parallel claim.” Alternatively, Plaintiff seeks leave to amend his negligence claim to
specifically reference the FDA and thereby purportedly cure any pleading defect.
Defendants argue that Plaintiff has not presented any “parallel claim” and that his
Defendants included their opposition to Plaintiff’s m otion in their Reply in further support of their
m otion to dism iss.
Plaintiff refers to the device, upon inform ation and belief, as a “Styrker [sic] Ceram ic Hip
Replacem ent.” (Docket No. 12 ¶ 10.) Defendants state the device is a “Trident™ Ceram ic on Ceram ic
Acetabular System .” (Docket No. 10-2 at 7.) For purposes of this m otion, the at-issue hip prosthesis will
be referred to as “the Trident System .”
proposed second amended pleading is insufficient to salvage his negligence claim.
Applicable Standards of Review
Motion to Dismiss
Federal pleading standards are generally not stringent. Rule 8 requires only a short
and plain statement of a claim. FED . R. CIV. P. 8(a)(2). But the plain statement must
“possess enough heft to show that the pleader is entitled to relief.” Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 557, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) (internal quotation
When determining whether a complaint states a claim, the court must construe it
liberally, accept all factual allegations as true, and draw all reasonable inferences in the
plaintiff’s favor. ATSI Commc’ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d Cir. 2007);
Goldstein v. Pataki, 516 F.3d 50, 56 (2d Cir. 2008). Legal conclusions, however, are not
afforded the same presumption of truthfulness. See Ashcroft v. Iqbal, __ U.S. __, 129
S.Ct. 1937, 1949, 173 L. Ed. 2d 868 (2009) (“the tenet that a court must accept as true all
of the allegations contained in a complaint is inapplicable to legal conclusions”).
“To survive a motion to dismiss, a complaint must contain sufficient factual matter,
accepted as true, to ‘state a claim to relief that is plausible on its face.’” Iqbal, 129 S.Ct.
at 1945 (quoting Twombly, 550 U.S. at 570). Labels, conclusions, or “a formulaic recitation
of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. Facial
plausibility is present when the factual content of the complaint allows for a reasonable
inference that the defendant is liable for the misconduct alleged. Iqbal, 129 S.Ct. at 1949.
The plausibility standard is not, however, a probability requirement; the pleading must
show, not merely allege, that the pleader is entitled to relief. Id. at 1950; FED . R. CIV. P.
8(a)(2). Well-pleaded allegations in the complaint must nudge the claim “across the line
from conceivable to plausible.” Twombly, 550 U.S. at 570.
A two-pronged approach is thus used to examine the sufficiency of a complaint.
First, statements that are not entitled to the assumption of truth — such as conclusory
allegations, labels, and legal conclusions — are identified and stripped away. See Iqbal,
129 S.Ct. at 1950. Second, well-pleaded, non-conclusory factual allegations are presumed
true and examined to determine whether they “plausibly give rise to an entitlement to
Motion to Amend
Pursuant to Rule 15(a) of the Federal Rules of Civil Procedure, leave to amend a
pleading shall be freely given when justice so requires. See Livingston v. Piskor, 215
F.R.D. 84, 85 (W.D.N.Y. 2003). “Absent evidence of undue delay, bad faith or dilatory
motive on the part of the movant, undue prejudice to the opposing party, or futility, Rule
15's mandate must be obeyed.” Monahan v. New York City Department of Corrections,
214 F.3d 275, 283 (2d Cir. 2000) (citing Foman v. Davis, 371 U.S. 178, 182, 83 S. Ct. 227,
9 L. Ed. 2d 222 (1962)), cert. denied, 531 U.S. 1035 (2000).
The FDA’s Premarket Approval (PMA) of the Trident System
The FDA’s regulatory regime under the MDA establishes three levels of oversight
for medical devices, depending on the risks they present. Riegel v. Medtronic, Inc., 552
U.S. 312, 316, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008). Devices receiving the most
federal oversight are those in Class III. Id. at 317. The Trident System is classified as a
Class III device, which includes devices “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 “presents a potential unreasonable risk of
illness or injury,” and for which it cannot be established that a less stringent (Class I or
Class II) classification would provide reasonable assurance of safety and effectiveness.
21 U.S.C. § 360c(a)(1)(C).
A new Class III device must undergo a premarket approval process (“PMA”), unless
the FDA finds it is “substantially equivalent” to a device that already was on the market
prior to the MDA’s effective date and was “grandfathered” in under the statute. Id. §
360c(f)(1). Most new devices enter the market through this “substantially equivalent”
process, also known as the § 501k process. For example, in 2005, the FDA authorized the
marketing of 3,148 devices under § 510(k), while just 32 devices were granted premarket
approval. Riegel, 552 U.S. at 317. The PMA process is a “rigorous” one, and this is the
process the FDA required for the Trident System.3 Gelber v. Stryker Corp., 752 F. Supp.
2d 328, 331 (S.D.N.Y. 2010).
As more fully discussed in Riegel, the PMA process involves the submission of
voluminous, comprehensive information on the device—including, among other things, full
reports of all studies and investigations, a full description of the methods used in, and the
W hen Defendants filed their m otion, in 2009, they cited web addresses for, inter alia, the FDA’s
approval letter relative to the PMA application for the Trident System . Those addresses, assum ing they
were once correct, no longer lead to inform ation on the Trident System .
The Court was able to confirm , through a search of the FDA’s website conducted on Septem ber
7, 2011, that the Trident System was assigned PMA Num ber P000013, and the application was approved
on February 3, 2003. See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pm a.cfm ?id=19609.
The Court takes judicial notice of this fact.
facilities and controls used for, the manufacture and processing of the device, samples of
the device components, and a specimen of the proposed labeling—and the FDA spends
an average of 1,200 hours reviewing each application. 552 U.S. at 18-19 (citing Medtronic,
Inc. v. Lohr, 518 U.S. 470, 477, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996)). The FDA may
choose to refer an application to a panel of outside experts, 21 C.F.R. § 814.44(a), and
may request that the manufacturer provide additional data, 21 U.S.C. § 360e(c)(1)(G).
Premarket approval is granted only if the FDA finds there is a reasonable assurance of the
device’s safety and effectiveness. 21 U.S.C. § 360e(d).
Upon completion of the PMA process for the Trident System, the FDA approved the
device as safe and effective for its intended use. Supra, fn. 3. After approving a Class III
device, the FDA retains regulatory control and the manufacturer is prohibited from
changing design specifications, manufacturing processes, labeling, or any other attribute
that would affect its safety or effectiveness. Riegel, 552 U.S. at 319 (citing 21 U.S.C. §
The MDA contains a preemption clause, which states that:
Except as provided in subsection (b)4 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.
The exception contained in subsection (b) perm its the FDA to exem pt som e state and local
requirem ents from preem ption. 21 U.S.C. § 360k(b). There is no allegation that any such exem ption has
been granted in New York state with regard to the Trident System .
21 U.S.C. § 360k(a).
In Riegel, the Supreme Court interpreted this clause as preempting state law claims
when (a) the federal government has established specific requirements applicable to the
device, and (b) the state law claims are based on requirements that are "different from, or
in addition to the federal ones" and relate to the safety and effectiveness of the device.
552 U.S. at 321-22; see also 21 U.S.C. § 360k(a)(1). The Court found that, because a
PMA is specific to the particular device in question and is entirely concerned with the safety
and effectiveness of the device, it imposes "specific requirements" and thus meets the first
preemption requirement. Riegel, 552 U.S. at 322-23. The Court further concluded that
common law claims involving a medical device are premised on the existence of a legal
duty, and therefore impose state “requirements” that would be preempted by devicespecific federal requirements. Id. at 323-324 (citing Lohr, 518 U.S. at 512). The majority
specifically noted that, although the dissenting member had difficulty believing that
Congress would remove all means of judicial recourse for consumers injured by Class III
PMA devices, “this is exactly what a preemption clause for medical devices does by its
terms.” Id. at 326.
Riegel went on to explain that not all state-law claims relating to approved devices
are foreclosed. “[Section] 360k 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." 552 U.S. at 330 (citing Lohr, 518
U.S. at 495). But the Court declined to provide further guidance on this issue because the
plaintiffs had not raised their “parallel claims” argument below or in their petition for
certiorari. That has left post-Riegel courts with the task of determining the circumstances
in which state law claims remain available as “parallel” to federal requirements. Plaintiff’s
claims, in both his Amended Complaint and proposed second amended complaint, are
considered in light of Riegel and subsequent relevant decisions.
Plaintiff’s Negligence Claim
The Amended Complaint’s First and Third Causes of Action
Plaintiff claims in his Amended Complaint that the Trident components he received
were “improperly, carelessly and negligently manufactured and/or inadequately improperly
and carelessly designed.” (Docket No. 12 ¶ 11.) He goes on to assert that, even absent
evidence of negligence, “the component parts were developed and manufactured by the
Defendants and/or others who were solely in the control of the Defendants” such that
negligence is presumed under the doctrine of res ipsa loquitur. (Id. ¶¶ 20-21.) In short,
Plaintiff’s first and third claims for relief are based squarely on Defendants’ purported
breach of state tort duties of care. Common law negligence claims are precisely the type
of claims Riegel held are preempted by the MDA. 552 U.S. 320-21, 330 (affirming holding
that strict liability, negligence, and breach of implied warranty claims under New York’s
common law were expressly preempted).
Indeed, since Riegel, a number of courts have dismissed negligence and other tort
claims in actions involving the Trident System based on the MDA’s preemption clause.
See, e.g., Funk v. Stryker, 673 F. Supp.2d 522 (S.D. Tex. 2009), aff’d, 631 F.3d 777 (5th
Cir. 2011) (finding claims for strict liability, negligence, and breach of implied warranty
preempted, and rejecting doctrine of res ipsa loquitur on ground that PMA process
amounts to federal declaration that product, while not risk-free, is not unreasonably
dangerous in light of potential benefits, and it follows that negligence cannot be inferred
solely from negative side effect); Lemelle v. Stryker Orthopaedics, 698 F. Supp. 2d 668
(W.D. La. 2010) (breach of implied warranty preempted); Anthony v. Stryker Corp., No. 09CV-2343, 2010 U.S. Dist. LEXIS 31031 (N.D. Ohio Mar. 31, 2010) (dismissing with
prejudice claims for strict liability, negligence, breach of implied warranty, breach of
express warranty, and misrepresentation); Delaney v. Stryker Orthopaedics, No. 08-03210,
2009 U.S. Dist. LEXIS 16865 (D. N.J. Mar. 5, 2009) (dismissing claims for failure to warn,
strict liability, negligence and recklessness, and breach of implied warranties as preempted
by MDA); Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y. 2009) (dismissing
claims for strict liability, negligence and recklessness, and breach of express and implied
In opposition to Defendants’ motion, Plaintiff argues that his first and third claims
adequately plead a violation of FDA regulations, and therefore are parallel claims that
cannot be preempted. But the only fact allegations on which Plaintiff’s negligence claim
rests is that, after implantation, the Trident System squeaked with severity and Plaintiff
suffered severe grinding and pain. These allegations simply do not implicate a violation
of federal law. Accordingly, as pleaded in Plaintiff’s Amended Complaint, his first and third
claims are preempted and must be dismissed.
The Proposed Second Amended Complaint
Plaintiff next argues that, in the event the Court finds his negligence claim
preempted—as it has—he should be granted leave to file the proposed second amended
complaint that he submitted in response to Defendants’ motion to dismiss. As previously
noted, Rule 15(a) of the Federal Rules of Civil Procedure provides that leave to amend
should be freely given when justice so requires. In this instance, however, leave to amend
Plaintiffs’ proposed second amended complaint is identical to the Amended
Complaint but for the addition of four paragraphs to the first cause of action, only three of
which refer to federal law. They state, in pertinent part, that:
The Defendants were negligent in that the aforesaid components were
unreasonably dangerous and defective as the manufacturing process for
said components were not in compliance with the [FDA’s] [PMA] standards
for Class III devices in general and this device in particular
[T]he implanted components were defectively manufactured and not in
compliance with the requirements approved by the FDA and had an impurity,
imperfection and/or other product defects allowed to be created, contained
or placed within the product in the Defendant’s manufacturing process
[T]his impurity, imperfection and or other product defects were a deviation
from the Defendants’ design and quality manufacturing standards for the
[Trident System] approved by the FDA
(Docket No. 14-2 ¶¶ 11-13.) These new allegations of a manufacturing defect resulting
from Defendants’ violation of unspecified “general” and “particular” federal standards are
supported by precisely the same facts as appear in the Amended Complaint—i.e., that
Plaintiff experienced squeaking, grinding, and pain after receiving a Trident System
implant. Plaintiff urges that he should be permitted to conduct discovery so he can
determine “how the plaintiff [sic] violated FDA standards” and “where exactly the
negligence occurred.” (Docket No. 15-3 at 7.)
The new allegations appear to be drawn directly from Hofts v. Howmedica Osteonics
Corp., the sole case on which Plaintiff relies in opposition to Defendants’ motion and in
support of the viability of his proposed second amended complaint. 597 F. Supp. 2d 830
(S.D. Ind. 2009). In Hofts, the district court allowed the plaintiff’s claims for defective
manufacture to proceed as a “parallel claim” on substantially similar and conclusory
allegations, reasoning that to hold otherwise would amount to “an unusually stringent
application of Twombly and Rule 8 of the Federal Rules of Civil Procedure at the motion
to dismiss stage.” 597 F. Supp. 2d at 838. This Court respectfully disagrees.
In Twombly, the Supreme Court explained that “something beyond the mere
possibility of [a federal violation] must be alleged, lest a plaintiff with a largely groundless
claim be allowed to take up the time of a number of other people, with the right to do so
representing an in terrorem increment of the settlement value.” 550 U.S. at 557-58 (citing
Dura Pharms., Inc. v. Broudo, 544 U.S. 336, 347, 125 S. Ct. 1627, 161 L. Ed. 2d 577)
(2005). Thus, “a district court must retain the power to insist upon some specificity in
pleading before allowing a potentially massive factual controversy to proceed [to
discovery].” Id. The operative word in the prior sentence is “some.” Neither Rule 8 nor
Twombly require that a plaintiff plead facts in support of each element of a claim.
Nevertheless, the complaint must have enough factual content to allow for a reasonable
inference that the defendant is liable for the misconduct alleged. Iqbal, 129 S.Ct. at 1949.
Plaintiff’s allegation that the Trident System did not resolve his pain and mobility problems
in the manner he anticipated, without more, does not reasonably allow for the inference
that Defendants violated federal law.
“In line with the majority of courts who have addressed pleading standards in this
context, the Court agrees that ‘Plaintiffs cannot simply incant the magic words [Stryker]
violated FDA regulations in order to avoid preemption.’” Gelber, 752 F. Supp. 2d at 334
(quoting In re Medtronic, 592 F. Supp. 2d 1147, 1158 (D. Minn. 2009)) (alteration in
Gelber). “‘To properly allege parallel claims, the complaint must set forth facts' pointing to
specific PMA requirements that have been violated.” Wolicki-Gables v. Arrow Int’l, Inc.,
634 F.3d 1296, 1301 (11th Cir. 2011) (quoting Parker v. Stryker Corp., 584 F. Supp. 2d
1298, 1301 (D.Colo. 2008))). Plaintiffs must also allege a link between the failure to
comply and the alleged injury. Wolicki-Gables, 634 F.3d at 1301-02 (citing Ilarraza v.
Medtronic. Inc., 677 F. Supp. 2d 582, 589 (E.D.N.Y. 2009)).
Plaintiff’s vague, proposed amendments are readily distinguished from pleadings
that have been found to state parallel claims. For example, in Purcel v. Advanced Bionics,
the court determined plaintiff successfully stated a parallel claim where he alleged that a
particular malfunction causing his injury was due to a supplier's unapproved modification
of a component part of the regulated device. No. 07-CV-1777, 2008 U.S. Dist. LEXIS
62131, at *3 (N.D. Tex. Aug. 13, 2008). Unlike the pleading here, the pleading with respect
to the modification in Purcel identified a particular federal specification referring to the
device at issue that the defendant allegedly violated. Similarly, in Rollins v. St. Jude
Medical, the plaintiff was found to have stated a parallel claim where he was able to point
to an alleged violation of premarketing packing requirements applicable to the particular
medical device at issue. 583 F. Supp.2d 790, 800-01 (W.D. La. 2008). And, in Bausch
v. Stryker Corp., the Seventh Circuit reversed the district court’s dismissal of the plaintiff’s
parallel claim where her original complaint alleged that, prior to her surgery, defendants
had received complaints their product was failing, they had recalled some components for
“dimensional anomalies,” and the FDA had informed defendants of “numerous
deficiencies” in the manufacturing and inspection processes and had later issued a warning
letter to them. 630 F.3d 546, 559 (7th Cir. 2010). The Court acknowledged that the
complaint would have been stronger had the plaintiff specified the precise product defect
or the specific federal requirements violated, but found she had pled with enough
specificity to satisfy Rule 8 and Twombly. Id. at 559-60.
Here, in an effort to avoid dismissal, Plaintiff seeks to amend what was a
straightforward common law negligence claim to plead a claim premised on the violation
of federal law. Because his factually unsupported legal conclusions are insufficient to
satisfy the notice pleading and plausibility standards for stating a parallel claim, Plaintiff’s
motion for leave to file his proposed second amended complaint is futile, and is denied.
The Second Cause of Action—Breach of Express Warranty
The claims for breach of express warranty, as set forth in the Amended complaint
and proposed second amended complaint, are identical. Plaintiff alleges his physicians
advised him that Defendants warranted the Trident System as being “of good and
merchantable quality and fit for the purposed [sic] for which they were intended, to wit:
replace a defective hip in Plaintiff’s body.” (Docket No. 12 ¶¶ 14-15.) He claims that
Defendants breached that warranty because the Trident System he received was not of
merchantable quality nor fit for its intended purpose. (Id. ¶ 19.)
Defendants contend that this claim,5 too, is preempted by the MDA. Plaintiff, again
relying on Hofts, contends that it must survive as a parallel claim.
Riegel did not address an express warranty claim. Nevertheless, numerous cases
since have applied Riegel’s analysis and concluded that claims for breach of express
Defendants argue that this is so regardless of whether Plaintiff is alleging a claim for breach of
im plied warranty or breach of express warranty. Plaintiff m akes clear in his opposing m em orandum that
he is claim ing breach of express warranty only.
warranty are preempted by the MDA. Quite recently, the District Court for the Northern
District of Georgia reasoned that, in order to prove breach of an express warranty, a
plaintiff would need to show that the device was not fit for its intended use, and such a
finding “would directly conflict with the FDA’s premarket approval of the device as
reasonably safe and effective,” such that preemption applies. Leonard v. Medtronic, Inc.,
No. 10-CV-03787, 2011 U.S. Dist. LEXIS 93176, at *30 (N.D. Ga. Aug. 19, 2011). As in
the instant case, the plaintiffs in Leonard argued that they were not challenging the FDAapproved product labeling as defective, but rather, were alleging that the device did not live
up to the FDA-approved promises in the label.6 Id. at *31. The district court concluded,
and this Court agrees, that a finding that a defendant violated state law by not living up to
FDA-approved promises would necessarily conflict with the FDA’s determination that the
label was not false or misleading. Id. at *32. In other words, it would impose additional
and different requirements that would necessarily disrupt the federal scheme, and
preemption applies. See also, In re Medtronic, Inc., 592 F. Supp. 2d at 1164 (to find in
favor of a plaintiff on express warranty claims, a jury would be required to conclude the
device was unsafe, and safety and effectiveness of device is matter solely for the FDA);
Wheeler v. DePuy Spine, Inc., 706 F. Supp. 2d 1264, 1271 (S.D. Fla. 2010) (allowing claim
that defendant breached warranty in FDA-approved document to proceed under state law
would impose a requirement on device that was different from or in addition to federal
requirements); Horowitz, 613 F. Supp. 2d at 285 (citing Parker, 584 F. Supp. 2d at 1303
(express warranty claim would contradict FDA’s determination that label was adequate and
Plaintiff m akes precisely this argum ent in his opposing m em orandum . (Docket No. 15-3 at 8.)
Based on the foregoing, this Court finds Plaintiff’s reliance on Hofts is misplaced.
Because his express warranty claim would disrupt the federal scheme by imposing
additional or different requirements on Defendants, the second cause of action is
For the reasons stated, Plaintiff’s motion for leave to file his proposed amended
complaint is denied as futile, and Defendants’ motion to dismiss the Amended Complaint
is granted in its entirety.
IT HEREBY IS ORDERED that Plaintiff’s Motion to Amend/Correct Amended
Complaint (Docket No. 14) is DENIED.
FURTHER that Defendants’ Motion to Dismiss Amended Complaint (Docket No. 10)
FURTHER that the Clerk of Court is directed to close this case.
Dated: September 11, 2011
Buffalo, New York
/s/William M. Skretny
WILLIAM M. SKRETNY
United States District Court
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