Elliott et al v. Smith & Nephew, Inc. et al

Filing 39

AMENDED MEMORANDUM DECISION AND ORDER re: 36 Memorandum Decision and Order,. Signed by Judge Edward J. Lodge. (caused to be mailed to non Registered Participants at the addresses listed on the Notice of Electronic Filing (NEF) by (jp)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF IDAHO

L. WAYNE ELLIOTT & NORMA
ELLIOTT, husband and wife,
Plaintiffs,

Case No. 1:12-CV-0070-EJL-MHW
AMENDED MEMORANDUM
DECISION AND ORDER

v.
SMITH & NEPHEW, INC., an entity
incorporated under the laws of Delaware,
and ABC CORPORATIONS, 1 – 5,
Defendants.

As a preliminary matter, a factual error within this Court’s Memorandum Decision
and Order (Dkt. 36) has been brought to the Court’s staff attorney’s attention by Plaintiff’s
counsel. The Court issues this Amended Order to correct the factual error contained
within the original Memorandum Decision and Order. The factual error (located on page
15 of the original Memorandum Decision and Order) noted that the specific recall notice
Defendant sent to Plaintiff after recalling the device at issue in this case was attached to the
Complaint. However, the recall notice attached to the Complaint (as Exhibit D) was the
notice used in the United Kingdom, and was not sent to either Plaintiff or his physician.
AMENDED MEMORANDUM DECISION AND ORDER - 1

The Court accordingly omits the portion of the sentence referencing Exhibit D from the
Memorandum Decision. This correction does not alter either the Court’s Order or the
substantive analysis included within the Court’s Memorandum Decision.
Plaintiffs L. Wayne and Norma Elliott, husband and wife, (the “Elliotts” or
“Plaintiffs”) bring this products liability action against Defendant Smith & Nephew
(“Defendant”). Defendant is the manufacturer and seller of the PLUS Promos Shoulder
Inclination Set (“Promos Inclination Set”). The Elliotts allege nine causes of action
related to Defendant’s allegedly defective and unsafe design and manufacture of the
Promos Inclination Set. Pending before the Court is Defendant’s Motion to Dismiss (Dkt.
16) for failure to state a claim.
Having fully reviewed the record, the Court finds that the facts and legal arguments
are adequately presented in the briefs and record. Accordingly, in the interest of avoiding
further delay, and because the Court conclusively finds that the decisional process would
not be significantly aided by oral argument, this matter shall be decided on the record
before this Court without oral argument.
FACTUAL BACKGROUND
Plaintiff L. Wayne Elliott (“Mr. Elliott”) underwent a total left shoulder
replacement on January 21, 2009, wherein the Promos Inclination Set was implanted in his
shoulder. (Dkt. 1-3, p. 3, ¶11.) The Promos Inclination Set implanted in Mr. Elliott’s
shoulder was manufactured by Defendant. (Id., ¶9.) On February 3, 2010, Defendant
recalled the Promos Inclination Set, including that implanted in Mr. Elliott’s shoulder.
AMENDED MEMORANDUM DECISION AND ORDER - 2

(Id., ¶14, Exs. A, B and C.) The Promos Inclination Set was recalled due to eight
complaints of set screws fracturing, both intra- and post-operatively. (Id., Ex. B.)
Mr. Elliott underwent a revision of his shoulder replacement on January 12, 2011
because the set screws within his implanted Promos Inclination Set had fractured. (Dkt.
1-3, p. 5, ¶16.) Mr. Elliott’s revision surgery required removal of the Promos Inclination
Set and replacement with a competitor’s implant. (Id., ¶17.) Mr. Elliott claims he has
suffered and will continue to suffer significant pain and disability as a result of the
malfunction of the Promos Inclination Set. (Id. at p. 6, ¶24.)
The Elliotts filed a complaint in state court against Defendant, and unknown
defendants ABC Corporations 1-5, alleging violation of Idaho’s Products Liability Reform
Act Idaho Code §6-1401 et. seq., as well as several other common law causes of action
associated with Defendant’s allegedly defective design and manufacture of the Promos
Inclination Set. Defendant removed the case to federal court and, following denial of
Plaintiffs’ Motion to Remand, moved to dismiss each of Plaintiffs’ claims under Federal
Rule of Civil Procedure 12(b)(6). (Dkt. 16.)
Defendant argues in the Motion to Dismiss that all of the Elliotts’ claims are
preempted by the Medical Device Amendments (“MDA”) to the federal Food, Drug and
Cosmetics Act (“FDCA”) 21 U.S.C. § 360c et. seq., which preempts certain product
liability claims in the case of medical devices approved by the Food and Drug
Administration’s (“FDA”) premarket approval process. Defendant also maintains that
Plaintiffs have failed to meet their pleading obligations under the Federal Rules. The
AMENDED MEMORANDUM DECISION AND ORDER - 3

Elliotts argue that, because the Promos Inclination Set was approved via the FDA’s less
rigorous § 510(k) process, rather than the extensive premarket approval process, their
claims are not preempted.
The Elliotts also maintain that additional discovery is needed before the Court
should dismiss their case for failure to state a claim. Although this matter is before the
Court on Defendant’s Motion to Dismiss, the Elliotts have sought to convert Defendant’s
motion into one for summary judgment, and have submitted a Motion for Permission to
Conduct Limited Discovery under Rule Fed. R. Civ. P. 56(d) (Dkt. 21), in conjunction with
their Opposition to Defendant’s Motion to Dismiss. (Dkt. 22.)

STANDARD OF REVIEW
A motion to dismiss for failure to state a claim challenges the legal sufficiency of
the claims stated in the complaint. Conservation Force v. Salazar, 646 F.3d 1240, 1242
(9th Cir. 2011). Because a primary objective of the legal system “is to obtain a judgment
on the merits, rather than a dismissal based on the pleadings,” motions to dismiss for failure
to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6) are generally viewed
with disfavor. Cabo Distrib. Co., Inc. v. Brady, 821 F.Supp. 601, 608 (N.D.Cal. 1992).
To sufficiently state a claim to relief and survive a 12(b)(6) motion, the pleading
“does not need detailed factual allegations,” however, the “[f]actual allegations must be
enough to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly,
550 U.S. 544, 555 (2007). Mere “labels and conclusions” or a “formulaic recitation of the
AMENDED MEMORANDUM DECISION AND ORDER - 4

elements of a cause of action will not do.” Id. Rather, there must be “enough facts to
state a claim to relief that is plausible on its face.” Id. at 570. In other words, the
complaint must contain sufficient factual matter, accepted as true, to state a claim to relief
that is plausible on its face. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
In light of Twombly and Iqbal, the Ninth Circuit summarized the governing standard
as follows: “In sum, for a complaint to survive a motion to dismiss, the nonconclusory
factual content, and reasonable inferences from that content, must be plausibly suggestive
of a claim entitling the plaintiff to relief.” Moss v. U.S. Secret Serv., 572 F.3d 962, 969
(9th Cir. 2009). Apart from factual insufficiency, a complaint is also subject to dismissal
under Rule 12(b)(6) where it lacks a cognizable legal theory, Balistreri v. Pacifica Police
Dept., 901 F.2d 696, 699 (9th Cir. 1990), or where the allegations on their face “show that
relief is barred for some legal reason.” Jones v. Bock, 549 U.S. 199, 215 (2007).
In deciding whether to grant a motion to dismiss, the court must accept as true all
well-pleaded factual allegations in the pleading under attack. Iqbal, 556 U.S. at 663. A
court is not, however, “required to accept as true allegations that are merely conclusory,
unwarranted deductions of fact, or unreasonable inferences.” Sprewell v. Golden State
Warriors, 266 F.3d 979, 988 (9th Cir. 2001).
When ruling on a motion to dismiss, the court must normally convert a Rule
12(b)(6) motion into one for summary judgment under Rule 56 if the court considers
evidence outside of the pleadings. United States v. Ritchie, 342 F.3d 903, 907 (9th Cir.
2003). However, a court may consider certain materials, such as documents attached to
AMENDED MEMORANDUM DECISION AND ORDER - 5

the complaint, documents incorporated by reference in the complaint, or matters of judicial
notice, without converting the motion to dismiss into a motion for summary judgment. Id.
at 908.

ANALYSIS
1.

Preemption
Congress enacted the MDA in 1976 to regulate the safety and effectiveness of

medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). The MDA
contains an express preemption clause which provides:
…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).
In 1996, the Supreme Court determined that lawsuits brought under state law
against medical device manufacturers who undergo the FDA’s § 510(k) “premarket
notification” process are not preempted by 21 U.S.C. § 360k(a) when liability is premised
on theories that the device was defective and unreasonably dangerous and that the
manufacturer failed to use reasonable care in the device’s design, manufacture, assembly,
and sale. Medtronic, Inc., v. Lohr, 518 U.S. 470, 481, 494-95 (1996).
In 2008, the Supreme Court held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),
that lawsuits brought under state law against medical device manufacturers who instead
AMENDED MEMORANDUM DECISION AND ORDER - 6

undergo the FDA’s rigorous “premarket approval” process are expressly preempted by
§360k(a) of the MDA when liability is premised on violations of state law requirements
that are “in addition to or different from” federal requirements regulating the device. Id.
at 321-323.
To understand the holdings of Lohr and Riegel, an explanation of the difference
between “premarket notification” to the FDA and the “premarket approval” process is
necessary. The MDA delineates three classes for medical devices depending on the risks
the device presents. Class I devices pose the least risk, and are subject to only “general”
federal control such as labeling requirements. 21 U.S.C. § 360c(a)(1)(A); Riegel, 552
U.S. at 316. Class II devices are potentially more harmful. Manufacturers of Class II
devices must comply with federal performance regulations known as “special controls.”
21 U.S.C. § 360c(a)(1)(B); Riegel, 552 U.S. at 317. However, Class I and Class II
medical devices may be marketed without receiving premarket approval from the FDA.
21 U.S.C. § 360(a)(1)(A)-(B).
Finally, devices that either “presen[t] a potential unreasonable risk of illness or
injury,” or which 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,” are designated as Class III. 21 U.S.C. § 360c(a)(1)(C)(ii). Class III
devices are generally subject to the FDA’s rigorous “premarket approval,” or “PMA”

AMENDED MEMORANDUM DECISION AND ORDER - 7

process.1 Lohr, 518 U.S. at 477; see also 21 U.S.C. § 360e . If a product is approved via
the PMA process, 21 U.S.C. § 360k(a) expressly preempts state law claims that are
different from, or in addition to, the federal requirements because the medical devices have
undergone a rigorous federal safety review.2 Riegel, 522 U.S. at 323.
The Promos Inclination Set at issue in this case is a Class II device. As such, the
Promos Inclination Set was not subject to the PMA process, but did undergo the § 510(k)
premarket notification process. The § 510(k) review process is not “specific to the device
in question” and instead reflects “entirely generic concerns about device regulation
generally.” Id. at 322, citing Lohr, 518 U.S. at 501. As the Supreme Court has
explained, the § 510(k) process “is by no means comparable to the PMA process; in
contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is
completed in an average of only 20 hours.” Lohr, 518 U.S. at 478-79.
Since the § 510(k) process does not impose specific federal requirements on a
device, state law claims against devices subject only to premarket notification, rather than
premarket approval, are not expressly preempted under the MDA. Cornwell v. Stryker

1 

  Not all Class III devices are subject to premarket approval due to two important exceptions to

the PMA requirement. First, the MDA allows for “grandfathering” of pre-1976 devices. Such
devices are allowed to remain on the market without FDA approval until the FDA initiates and
completes the requisite PMA. 21 U.S.C. § 360e(b)(1)(A). Second, “to prevent manufacturers of
grandfathered devices from monopolizing the market while new devices clear the PMA hurdle,
and to ensure that improvements to existing devices can be rapidly introduced into the market, the
Act also permits devices that are ‘substantially equivalent’ to pre-existing devices to avoid the
PMA process.” Lohr, 518 U.S. at 478 (citing 21 U.S.C. § 360e(b)(1)(B)).
2  However, “§ 360k(a) 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.” Riegel, 552 U.S. at 330 (citing Lohr, 518 U.S. at 495).     
AMENDED MEMORANDUM DECISION AND ORDER - 8

Corp., 2010 WL 4641112 (1:10-cv-00066-EJL), at *3; see also Lohr 518 U.S. at 502,
explaining, “given the critical importance of device specificity in our (and the FDA’s)
construction of § 360k(a), it is apparent that few, if any, common law duties have been
pre-empted by this statute.”). Plaintiffs’ state law claims are not expressly preempted
under the MDA.
Defendant argues that Plaintiffs’ claims are instead impliedly preempted. Before
turning to Defendant’s implied preemption theory, it is important to note that there is “a
presumption against federal preemption of state laws that operate in traditional state
domains.” Stengel v. Medtronic Incorp., 704 F.3d 1224, 1227 (9th Cir. 2013) (“Stengel
II”). The states have traditionally had “great latitude under their police powers to legislate
as to the protection of the lives, limbs, health, comfort and quiet of all persons.” Lohr, 518
U.S. at 475 (citation omitted). Regulation of public health and safety through protection
from defective products is “primarily and historically” a matter of local concern. Stengel
II, 704 F.3d at 1228 (citing Lohr, 518 U.S. at 475). Given the presumption against
preemption, parties seeking to challenge state law claims based on preemption “bear the
considerable burden of overcoming ‘the starting presumption that Congress does not
intend to supplant state law.’” Stengel II, 794 F.3d at 1227 (citation omitted).
The Supreme Court has determined state law claims are impliedly preempted by the
MDA when such claims are based on a “fraud-on-the-FDA” theory. Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). Plaintiffs in Buckman brought a
state-law negligence suit for damages resulting from orthopedic bone screws, a Class III
AMENDED MEMORANDUM DECISION AND ORDER - 9

medical device. Id. at 343-44. Defendant in Buckman was not the manufacturer of the
screws, but was instead a consulting company that plaintiffs alleged had made fraudulent
misrepresentations to the FDA in the course of obtaining premarket approval for its client,
the bone screw manufacturer. The Supreme Court determined such claims were impliedly
preempted by the MDA. In so holding, the Court explained:
The conflict stems from the fact that the federal statutory scheme amply empowers
the FDA to punish and deter fraud against the Administration, and that this authority
is used by the Administration to achieve a somewhat delicate balance of statutory
objectives. The balance sought by the Administration can be skewed by allowing
fraud-on-the-FDA claims under state tort law.
Id. at 348.
The Buckman Court distinguished plaintiffs’ claims in Lohr because in Lohr
plaintiffs’ claims arose from the manufacturer’s “alleged failure to use reasonable care in
the production of the product,” rather than from any wrongdoing during the FDA’s
premarket approval process. Id. at 352. The claims in Lohr escaped preemption, while
those in Buckman were impliedly preempted. The Ninth Circuit initially extended the
Buckman holding to plaintiffs’ state law claims in Stengal v. Medtronic Incorp., 676 F.3d
1159 (9th Cir. 2012) (“Stengel I”).
In Stengel I, a divided three-judge appeals panel held plaintiffs’ negligence, breach
of warranty and strict liability claims were expressly preempted under § 360k(a) because
they “generally challenged the safety and effectiveness of [Medtronic’s Class III pain
pump] without any hint of an allegation that Medtronic’s conduct violated FDA
regulations.” Id. at 1162. As such, plaintiffs’ state law claims could not be considered
AMENDED MEMORANDUM DECISION AND ORDER - 10

parallel to, rather than in addition to, FDA regulations. The panel also held that plaintiffs’
proposed failure to warn claims were impliedly preempted because Medtronic’s duty to
warn was regulated by the FDA, and any further duty to warn under Arizona law would be
in addition to, rather than parallel to, the federal requirements. Id. (stating, “[w]here a
federal requirement permits a course of conduct and the state makes it obligatory, the
state’s requirement is in addition to the federal requirement and is thus preempted.”)
(citation omitted)
The Stengal I panel held there was no “meaningful distinction” between plaintiffs’
failure to warn claim and the “fraud-on-the-FDA” claim held to be preempted in Buckman,
as Medtronic’s duty to warn was regulated by the FDA, and recognizing a state cause of
action based on such conduct “would conflict with the statutory scheme established by
Congress.” Id. at 1164. In this case, Defendant argues the Elliotts’ state law claims are
impliedly preempted under Buckman and Stengel I because they clearly seek “to establish
failure to comply with FDA regulations in failure-to-warn, failure-to-monitor, and other
so-called ‘fraud-on-the-FDA’ claims.” (Dkt. 32, p. 6.)
Defendant’s argument regarding implied preemption may have succeeded were it
not for a significant recent change in the law. After Defendant’s Motion to Dismiss and
Reply brief were filed, the Ninth Circuit decided to rehear Stengel I en banc. Upon
rehearing, the appeals court reversed. In Stengal II, 704 F.3d 1224 (9th Cir. 2013), the
Ninth Circuit held Buckman did not impliedly preempt plaintiffs’ proposed state-law

AMENDED MEMORANDUM DECISION AND ORDER - 11

failure to warn claim predicated on alleged regulatory violations. The Stengel II decision
appears to limit implied preemption to the FDA’s premarket approval process, noting:
Our sister circuits have uniformly held that, in cases dealing with violations of the
MDA outside the pre-market approval process, the MDA does not preempt
state-law causes of action for damages in which the state-law duty ‘parallels’ the
federal-law duty under the MDA.
Id. at 1231.
In deciding plaintiffs’ proposed failure to warn claim was not preempted under the
MDA, the Stengel II Court further explained:
We do not decide whether plaintiffs can prevail on their state-law failure to warn
claim. That question is not before us. But we do hold, under Lohr, Buckman, and
Riegel, that this claim is not preempted, either expressly or impliedly, by the MDA.
It is a state-law claim that is independent of the FDA’s premarket approval process
that was at issue in Buckman. The claim rests on a state-law duty that parallels a
federal-law duty under the MDA, as in Lohr. In holding that the Stengels’
failure-to-warn claim is not preempted, we join the Fifth and Seventh Circuits,
which reached the same conclusion with respect to comparable state-law claims….
(citing Hughes v. Boston Scientific Corp., 631 F.3d 762,765 (5th Cir. 2011) and
Bausch v. Stryker Corp., 630 F.3d 546, 549 (7th Cir. 2010).
Id. at 1233.
In Hughes v. Boston Scientific Corp., 631 F.3d 762, 765 (5th Cir. 2011), plaintiff
suffered severe burns when hot liquid leaked from a Class III medical device manufactured
by Boston Scientific. Plaintiff brought suit under Mississippi law, claiming violation of a
state-law duty to warn. The Fifth Circuit held plaintiff’s state-law duty to warn claim was
not preempted, and specifically extended its holding to both express and implied
preemption, “[w]e conclude that [plaintiff’s] failure to warn claim is neither expressly nor
impliedly preempted by the MDA to the extent that this claim is premised on Boston
AMENDED MEMORANDUM DECISION AND ORDER - 12

Scientific’s violation of FDA regulations with respect to reporting burns caused by the
[device].” Id. at 776.
Similarly, in Bausch v. Stryker Corp., 630 F.3d 546, 549 (7th Cir. 2010), plaintiff
brought suit under Illinois tort law, alleging violation of various state-law duties premised
upon a violation of parallel federal-law duties, when she was injured by a Class III ceramic
hip replacement device. The Seventh Circuit concluded plaintiff’s state-law claims were
neither expressly nor impliedly preempted, stating, “federal law does not preempt parallel
claims under state law based on a medical device manufacturer’s violation of federal law.”
Id. at 558. Like Hughes and Bausch, the Stengel II Court specifically held that state-law
duties which parallel federal-law duties are not impliedly preempted under the MDA.
Thus, to the extent the Elliotts can establish Defendant violated Idaho state-law
requirements which parallel federal-law requirements, their claims are not impliedly
preempted under the MDA.3
2.

Pleading Requirements

Defendants also suggest the Elliotts’ claims must be dismissed because they cannot
satisfy the pleading requirements established under Bell Atlantic Corp. v. Twombly, 550
3  Although Defendant argues it is impossible to analyze whether the Elliotts’ claims are based on

state-law requirements that are parallel to federal-law requirements given the generality of the
Complaint, the Court need not determine at this stage whether the Elliotts’ claim that Defendant
failed to comply “with applicable design, manufacturing and/or testing standards,” refers to state
standards that are different from or in addition to the federal regulatory standards (and which
would thus be preempted under § 360k(a)). Complaints “that combine legally valid and invalid
claims are common. When a complaint asserts claims that are legally valid and those that are not,
the correct judicial response is not to dismiss the complaint… The case may proceed…with the
understanding…as to the proper scope of claims that can survive the legal challenge.” Bausch,
630 F.3d 546, 559. 
AMENDED MEMORANDUM DECISION AND ORDER - 13

U.S. 544, 555 (2007) and Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In White v. Stryker
Corp., 818 F.Supp. 2d 1032, 1037 (E.D.Ky. 2011), a federal district court considered the
pleading specificity required in the context of MDA preemption, explaining:
In the context of MDA preemption, Twombly and Iqbal make a plaintiff’s job more
difficult than it would be in a typical products liability case. When facing MDA
preemption, a plausible cause of action requires, among other things, a showing that
the alleged violation of state law parallels a violation of federal law. This
additional step requires some greater specificity in the pleadings.
Id. at 1037.
Although the Elliotts’ Complaint is rather threadbare, the Seventh Circuit in Bausch
v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010), an opinion specifically referenced with
approval and applied by the Stengel II en banc Ninth Circuit panel, held there are no
special pleading requirements for product liability claims in general, nor for claims
involving preemption under the MDA in particular. As such, the “federal standard of
notice pleading applies, so long as the plaintiff alleges facts sufficient to meet the new
‘plausibility’ standard applied in Iqbal and Twombly.” Id. In applying this standard to
claims for defective manufacture of a medical device in violation of federal law, the
Bausch Court directed that district courts, “must keep in mind that much of the
product-specific information about manufacturing needed to investigate such a claim fully
is kept confidential by federal law.” Id. As such, “formal discovery is necessary before a

AMENDED MEMORANDUM DECISION AND ORDER - 14

plaintiff can fairly be expected to provide a detailed statement of the specific bases for her
claim.” 4

Id.

Significantly, in Bausch, the Seventh Circuit determined plaintiff’s original
complaint satisfied Twombly and Iqbal where the complaint, like that here, failed to
reference particular federal regulations violated by a medical device manufacturer. Id.
Plaintiff in Bausch included several key factors in her original complaint, including: that
the FDA investigated the medical device at issue prior to plaintiff’s surgery and issued a
letter warning to the defendant that the manufacturing methods were not in conformity
with regulatory standards; that the FDA’s warning was for a medical device model number
bearing the same catalogue number as the one implanted in the plaintiff; and that the
medical device implanted in the plaintiff was later recalled by defendant. The Bausch
Court held that such facts made the plaintiff’s claim for strict liability and negligence
“plausible on its face as required by Iqbal and Twombly.” Id. at 559.
Like plaintiff’s original complaint in Bausch, the Elliotts’ Complaint references
Defendant’s recall of the medical device implanted in Mr. Elliott, and includes documents
identifying that the recall was for a medical device model number bearing the same
catalogue number as the Promos Inclination Set implanted in Mr. Elliott’s shoulder. The
Complaint also attaches Defendant’s recall notice to the FDA, stating the Promos
Inclination Set was recalled due to reports of intra- and post-operative set screws

4  At this early stage of the proceedings, the Elliotts have not had any opportunity to conduct
discovery. 

AMENDED MEMORANDUM DECISION AND ORDER - 15

fracturing, and alleges that Mr. Elliott required revision surgery when set screws, contained
within the Promos Inclination Set implanted in his shoulder, fractured. The Complaint
also includes the FDA letter agreeing with Defendant’s decision to recall the Promos
Inclination Set.
With respect to the Elliotts’ claims for violation of the Idaho Products Liability
Reform Act, strict liability, negligence and loss of consortium (Counts I, II, III and VIII)
the Court determines the complaint satisfies the purposes of Federal Rule Civil Procedure 8
of giving Defendant fair notice of the nature of the claims against it and of stating claims
for relief that are facially plausible as required by Iqbal and Twombly.5 Under Bausch, the
Elliotts need not “specify the precise defect or the specific federal regulatory requirements
that were allegedly violated.” Id. at 560. Although “the complaint would be stronger
with such detail,” the absence of such details does not show “a failure to comply with Rule
8 of the Federal Rules of Civil Procedure,” nor can it “support a dismissal under Rule
12(b)(6).” Id.
Federal Rule of Civil Procedure 9(b) does not impose any special requirement that a
products liability claim (even in the context of MDA preemption) be plead with
particularity. Id. Moreover, victims of defective products, like Mr. Elliott, may not be
able to determine without discovery and further investigation the specific source of the
defect (such as whether it was caused by a design or manufacturing defect). Id. Indeed,
5 In so holding, the Court is not ruling on Plaintiffs’ likelihood of success with respect to Counts

I-III, and Count VIII. Indeed, to the extent such claims impose state requirements that are
different from or in addition to federal regulatory standards, they will be preempted under 21
U.S.C. § 360k(a).
AMENDED MEMORANDUM DECISION AND ORDER - 16

if a plaintiff were required to allege that defendant violated a particular FDA-approved
specification before discovery, “then it is difficult to appreciate how any plaintiff [would]
ever be able to defeat a Rule 12(b)(6) motion.” Id. at 561 (citing In re Medtronic, Inc.
Sprint Fidelis Leads Products Liability Litig., 592 F.Supp.2d 1147, 1212 (D.Minn. 2009)
(Melloy, J., dissent)). The Court accordingly denies Defendant’s Motion to Dismiss with
respect to Counts I, II, III and VIII.

3. Negligent Misrepresentation-Count IV
Count IV of the Complaint alleges Defendant made representations to Mr. Elliott,
his physician, other recipients and their healthcare providers that the Promos Inclination
Set was safe for use in shoulder replacement surgery, and that Defendant knew or should
have known that it did not have sufficient information to determine whether the Promos
Inclination Set was, in fact, safe. (Dkt. 1-3, p. 8-9.) However, Idaho law does not
recognize a tort claim for negligent misrepresentation outside of a professional relationship
with an accountant. Mannos v. Moss, 155 P.3d 1166, 1174 (Idaho 2007); Duffin v. Idaho
Crop Imp. Ass’n, 895 P.2d 1195, 1203 (Idaho 1995) (tort of negligent misrepresentation is
strictly limited in Idaho to the “narrow confines of a professional relationship involving an

AMENDED MEMORANDUM DECISION AND ORDER - 17

accountant.”).6 Accordingly, the Elliotts cannot state a claim for negligent
misrepresentation against Defendant. Count IV is dismissed with prejudice.7
4.

Breach of Implied or Express Warranty-Counts V and VI
Count V of the Complaint alleges Defendant impliedly warranted that the Promos

Inclination Set was of merchantable quality and safe for the use for which it was intended.
(Dkt. 1-3, pp. 9-10.) Count VI claims Defendant expressly warranted the Promos
Inclination Set was “safe, fit, effective, and proper for Mr. Elliott and other Recipients
undergoing shoulder replacement surgery.” (Id. at p. 11.) Neither the implied nor the
express warranty claim identifies any contract between Defendant and the Elliotts. As the
Idaho Supreme Court determined in Oats v. Nissan Motor Corp., 879 P.2d 1095, 1105
(Idaho 1994), Idaho does not recognize a breach of warranty claim in personal injury
products liability actions which do not involve a contractual relationship between the
manufacturer and the injured person.8 As the Oats Court explained:
[W]hen a plaintiff brings a non-privity breach of warranty action against a
manufacturer or seller to recover for personal injuries allegedly sustained as a result
of a defective product, that action is one for strict liability in tort, governed by the
provisions of [the Idaho Product Liability Reform Act “IPLRA”]. Such an action
should not be governed by the buyer and seller concepts of the UCC…. While it
follows from our holding that [plaintiff’s] ‘breach of warranty’ claim survives under
6 The Idaho Supreme Court has expressly declined to adopt the Restatement standard for negligent

misrepresentation. Idaho Bank & Trust Co. v. First Bancorp of Idaho, 772 P.2d 720, 722 (Idaho
1989).  
7 Dismissal with prejudice is appropriate where, as here, it appears clear that no amendment to the
complaint can cure a legally deficient claim.
8  Many states have eliminated the privity requirement in order to maintain a products liability
claim for breach of implied warranty. 3 MODERN TORT LAW: LIABILITY AND LITIGATION § 27:13
(2d ed. 2012). However, in Idaho, absent privity of contract, the adoption of strict liability in tort
abolished a cause of action for breach of implied warranty. Id. (citing Oats, 879 P. 2d at 1105). 
AMENDED MEMORANDUM DECISION AND ORDER - 18

the IPLRA’s statute of limitations, we fail to see how, in a personal injury product
liability action not involving a commercial relationship between the manufacturer
and the injured person, [plaintiff’s] warranty allegations add anything to his other
allegations of strict liability and negligence.
Id. (citation omitted)
Without any allegations to establish existence of a contract between the Elliotts and
Defendant, Counts V and VI fail to state a claim other than that for strict liability in tort.
Plaintiffs’ Opposition to Defendant’s Motion to Dismiss states only that their warranty
claims are “well plead,” but does not provide any analysis or argument as to how their
breach of warranty claims differ from their claim for strict liability. (Dkt. 22, p. 8.)
Counts V and VI are accordingly dismissed without prejudice.

5.

Fraud-Count VII
Count VII of the Complaint alleges Defendant falsely and fraudulently represented

to Mr. Elliott, his physician, and to other recipients of the Promos Inclination Set that the
device was safe for use in shoulder replacement surgery, that such representations were
false, that Defendant knew or should have known such representations were false, and that
Defendant made such representations with the intent to defraud and deceive Mr. Elliott, his
physician, and other recipients. (Dkt. 1-3, p. 12.) Federal Rule of Civil Procedure 9(b)
requires fraud claims to be plead with particularity. Federal rules of procedure apply in
federal court irrespective of the source of subject-matter jurisdiction and irrespective of

AMENDED MEMORANDUM DECISION AND ORDER - 19

whether the substantive law at issue is state or federal. 36 C.J.S. FEDCOURTS § 244
(2013).
Rule 9(b) ensures that allegations of fraud are specific enough to give defendants
notice of the particular misconduct which is alleged to constitute the fraud charged so that
they can defend against the charge rather than simply deny that they have done anything
wrong. Ebeid ex. Rel. U.S. v. Lungwitz, 616 F.3d 993, 999 (9th Cir. 2010). It also prevents
the filing of a complaint as a pretext for the discovery of unknown wrongs. Semegen v.
Weidner, 780 F.2d 727, 731 (9th Cir. 1985). Under Rule 9(b), a fraud claim must state the
time, place and specific content of false representations as well as the identities of the
parties to the misrepresentation. Miscellaneous Service Workers, Drivers & Helpers,
Teamsters Local No. 427 v. Philco-Ford Corp., 661 F.2d 776, 782 (9th Cir. 1981).
Here the Elliotts have done nothing more than recite the elements of fraud,
punctuated with conclusory, non-specific allegations. The absence of any times, dates,
specific representations (other than the general representation that the Promos Device “was
safe for use in shoulder replacement surgery”), places or other details of Defendant’s
allegedly fraudulent conduct is contrary to the fundamental purposes of Rule 9(b).
Because the Plaintiffs have not complied with the specificity requirement of Rule 9(b),
Count VII is dismissed without prejudice.9

9 As with Rule 12(b)(6) dismissals, “dismissals for failure to comply with Rule 9(b) should

ordinarily be without prejudice.” Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1108 (9th Cir.
2003); Balistreri v. Pacifica Police Dept., 901 F.2d 696, 701 (9th Cir.1988) (“[L]eave to amend
should be granted if it appears at all possible that the plaintiff can correct the defect.”).
AMENDED MEMORANDUM DECISION AND ORDER - 20

6.

Punitive Damages-Count IX
Defendant argues Count IX of the Complaint, regarding punitive damages, violates

Idaho Code § 6-1604(2) and should be stricken. (Dkt. 16-1, pp. 12-13.) Claims for
punitive damages are substantive and Idaho law is therefore controlling. See Strong v.
Unumprovident Corp., 393 F.Supp.2d 1012, 1025 (D. Idaho 2005).
Idaho Code § 6-1604(2) provides that “no claim for damages shall be filed
containing a prayer for relief seeking punitive damages.” Idaho Code § 6-1604(2).
Instead, punitive damages may be sought in a lawsuit only after the claimant proves “by
clear and convincing evidence, oppressive, fraudulent, malicious or outrageous conduct by
the party against whom the claim for punitive damages is asserted.” Id. After presenting
such proof at a hearing, the party seeking punitive damages may then amend the complaint
to add a claim for punitive damages.
Count IX of the Complaint does not pray for punitive damages or allege a specific
damage amount, but instead reserves the right of Plaintiffs “to seek leave of the Court to
amend their Complaint to plead for the recovery of punitive damages against Smith &
Nephew and ABC Corporations 1-5.” (Dkt. 1-3, p. 13.) However, under Idaho Code §
6-1604(2), Plaintiffs would have to seek leave to amend their Complaint to add punitive

AMENDED MEMORANDUM DECISION AND ORDER - 21

damages regardless of the inclusion of Count IX in the Complaint. Count IX is
accordingly meaningless, and is stricken from the Complaint.10
ORDER
1. Defendant’s Motion to Dismiss (Dkt. 16) is GRANTED in part and
DENIED in part. Count IV of the Complaint for Negligent
Misrepresentation is DISMISSED WITH PREJUDICE. Count V-Breach
of Implied Warranty, Count VI-Breach of Express Warranty and Count
VII-Fraud are DISMISSED WITHOUT PREJUDICE. Count
IX-Punitive Damages is STRICKEN from the Complaint. Finally,
Defendant’s Motion to Dismiss with respect to Count I-Violation of Idaho
Product Liability Reform Act, Count II-Strict Liability, Count
III-Negligence, and Count VIII-Loss of Consortium is DENIED.

10 After the requisite pretrial hearing, Plaintiffs may later seek to amend their Complaint to add a

claim for punitive damages.
AMENDED MEMORANDUM DECISION AND ORDER - 22

2. Plaintiff’s Motion for Permission to Conduct Limited Discover Under Rule
56(d) Federal Rules of Civil Procedure (Dkt. 21) is MOOT. The Court has not
considered evidence outside of the pleadings in granting in part and denying in
part Defendant’s Motion to Dismiss, and has not converted Defendant’s Motion
to Dismiss into one for summary judgment pursuant to Rule 56(d).

DATED: April 15, 2013

_________________________
Edward J. Lodge
United States District Judge

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