United States District Court, D. Idaho
MEMORANDUM DECISION AND ORDER
C. Nye U.S. District Court Judge.
matter comes before the Court on Defendant Boston
Scientific's Motion to Dismiss. Dkt. 4. Plaintiff Claudia
Hepburn asserts that she has an increased risk of future
injury because she has a permanent, defectively designed,
medical device-which Boston Scientific designed,
manufactured, and sold-implanted inside of her. She claims
that Boston Scientific failed to warn her about the
potentially health risks associated with the device. For the
reasons set forth below, the Court finds good cause to GRANT
the Motion to Dismiss IN PART and give Hepburn leave to amend
portions of her Complaint.
Scientific designed, manufactures, and sells a medical device
called the Greenfield Filter. The Greenfield Filter is
designed to filter blood in the inferior vena cava
(“IVC”), a vein that returns blood to the heart
from the lower extremities. In certain individuals, blood
clots or “thrombi” travel from the blood vessels
in the leg and pelvis, through the IVC and into the lungs,
where they can block one or more arteries, causing a
potentially deadly medical condition called a pulmonary
embolism (“PE”). These thrombi can also develop
and block blood flow in the deep leg veins, causing another
potentially life-threatening medical condition called deep
vein thrombosis (“DVT”). When implanted in the
IVC, the Greenfield Filter prevents blood clots from
traveling from the lower extremities to the heart and lungs.
Boston Scientific designed the Greenfield Filter in 1973 as a
permanent medical device. In the 2000s, medical device companies
began designing and selling retrievable IVC filters that a
doctor can remove once a patient's risk of blood clots
August 2010, the U.S. Food & Drug Administration
(“FDA”) issued a warning against leaving IVC
filters implanted in patients for extended periods of time.
The FDA issued an additional warning in 2014 about the health
risks associated with leaving IVC filters in place for long
periods and encouraged doctors to remove the devices
“when the risk/benefit profile favors removal and the
procedure is feasible given the patient's health
status.” Dkt. 1-2, at 5.
December 23, 2009, Doctor John Mannschreck implanted a
Greenfield Filter into Hepburn after she had been
hospitalized for recurrent DVT episodes. The Filter remains
inside of Hepburn to this day. Hepburn alleges that Boston
Scientific failed to disclose to physicians and patients the
risks associated with the Greenfield Filter while promoting
it as safe and effective. Hepburn asserts that she “is
at risk of suffering from serious health complications due to
the long-term implant of the filter.” Id. at
9. Specifically, she alleges she has an “increased risk
of DVT despite the implanted device, constant pains in the
abdominal region and includes the risk of the filter
migrating to the other parts of the vena cava, heart, lungs
or other organs, DVT, fracture or breakage of the filter,
perforation of the vena cava or other soft tissue, and other
complications.” Id. at 9-10.
filed this case in November 2017, in the Second Judicial
District, in and for the County of Nez Perce. In her
Complaint, Hepburn asserts ten claims against Boston
Scientific: I. negligence; II. strict products liability:
defective design; III. strict products liability:
manufacturing defect; IV strict products liability: failure
to warn; V. breach of express warranty; VI. breach of implied
warranty of merchantability; VII. breach of implied warranty
of fitness; VIII. fraudulent misrepresentation; IX.
fraudulent concealment; and X. negligent misrepresentation.
Hepburn seeks “compensatory damages for past, present,
and future pain and suffering, medical costs and expenses,
lost wages; prejudgment and post judgment interest as allowed
by law, costs of suit and attorneys' fees.”
Id. at 41.
Scientific removed the case to this Court on December 28,
2017, and then filed the pending Motion to Dismiss on January
12, 2018. The Court held a hearing on the Motion at the Boise
courthouse on May 3, 2018.
briefs, Hepburn does not argue that her warranty claims
(Counts V, VI, and VII), her fraudulent concealment claim
(Count IX), or her negligent misrepresentation claim (Count
X) should survive the motion to dismiss stage. The Court,
therefore, does not address those claims and will dismiss
those claims with prejudice.
Rule of Civil Procedure 12(b)(6) permits a court to dismiss a
claim if the plaintiff has “fail[ed] to state a claim
upon which relief can be granted.” “A Rule
12(b)(6) dismissal may be based on either a ‘lack of a
cognizable legal theory' or ‘the absence of
sufficient facts alleged under a cognizable legal
theory.'” Johnson v. Riverside Healthcare Sys.,
LP, 534 F.3d 1116, 1121 (9th Cir. 2008) (citation
omitted). Federal Rule of Civil Procedure 8(a)(2) requires a
complaint to contain “a short and plain statement of
the claim showing that the pleader is entitled to relief,
” in order to “give the defendant fair notice of
what the . . . claim is and the grounds upon which it
rests.” See Bell Atl. Corp. v. Twombly, 550
U.S. 544, 554 (2007). “This is not an onerous
burden.” Johnson, 534 F.3d at 1121. A
complaint “does not need detailed factual allegations,
” but it must set forth “more than labels and
conclusions, and a formulaic recitation of the
elements.” Twombly, 550 U.S. at 555. The
complaint must also contain sufficient factual matter to
“state a claim to relief that is plausible on its
face.” Id. at 570. In considering a Rule
12(b)(6) motion, the Court must view the “complaint in
the light most favorable to” the claimant and
“accept all well-pleaded factual allegations as true,
as well as any reasonable inference drawn from them.”
Johnson, 534 F.3d at 1122.
pleading stage, Rule 9(b) of the Federal Rules of Civil
Procedure requires a party alleging fraud to “state
with particularity the circumstances constituting fraud,
” although “intent . . . may be alleged
generally.” “Rule 9(b) demands that the
circumstances constituting the alleged fraud be specific
enough to give defendants notice of the particular misconduct
. . . so that they can defend against the charge and not just
deny that they have done anything wrong.” Kearns v.
Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009)
(quoting Bly-Magee v. California, 236 F.3d 1014,
1019 (9th Cir. 2001) (internal quotation marks omitted)
“Averments of fraud must be accompanied by ‘the
who, what, when, where, and how' of the misconduct
charged.” Id. (quoting Vess v. Ciba-Geigy
Corp. USA, 317 F.3d 1097, 1106 (9th Cir. 2003)).
“Rule 9(b) serves three purposes: (1) to provide
defendants with adequate notice to allow them to defend the
charge and deter plaintiffs from the filing of complaints
‘as a pretext for the discovery of unknown wrongs';
(2) to protect those whose reputation would be harmed as a
result of being subject to fraud charges; and (3) to
‘prohibit[ ] plaintiff[s] from unilaterally imposing
upon the court, the parties and society enormous social and
economic costs absent some factual basis.'”
Id. at 1125.
Scientific first argues that the Court should dismiss this
case in its entirety because Hepburn has failed to allege a
cognizable legal injury. Second, Boston Scientific argues
Hepburn has failed to state a claim upon which relief can be
granted with regard to Counts One through Four-Hepburn's
negligence and strict liability claims. Third, Boston
Scientific argues the Court should dismiss Hepburn's
fraud claim-Count Eight-because Hepburn has failed to plead
that claim with particularity as required under Rule 9(b).
The Court addresses each in turn.
Whether Hepburn has alleged a cognizable injury
Scientific first argues that the Court should dismiss all
claims because Hepburn has failed to allege a cognizable
injury under Idaho law. This reads like a standing argument,
but Boston Scientific never specifically frames it that way.
Nevertheless, it is proper for the Court to examine standing
along with Boston Scientific's arguments, as
“[f]ederal courts are required sua sponte to examine
jurisdictional issues such as standing.” Bernhardt
v. Cty. of Los Angeles, 279 F.3d 862, 868 (9th Cir.
2002) (quoting B.C. v. Plumas Unified Sch. Dist.,
192 F.3d 1260, 1264 (9th Cir. 1999).
establish Article III standing, an injury must be
‘concrete, particularized, and actual or imminent;
fairly traceable to the challenged action; and redressable by
a favorable ruling.'” Clapper v. Amnesty
Int'l USA, 568 U.S. 398, 409 (2013) (citation
omitted). “Although imminence is concededly a somewhat
elastic concept, it cannot be stretched beyond its purpose,
which is to ensure that the alleged injury is not too
speculative for Article III purposes-that the injury is
certainly impending.” Id. The Ninth
Circuit has clarified that “[i]f a plaintiff faces
‘a credible threat of harm, ' and that harm is
‘both real and immediate, not conjectural or
hypothetical, ' the plaintiff has met the injury-in-fact
requirement for standing under Article III.”
Krottner v. Starbucks Corp., 628 F.3d 1139, 1143
(9th Cir. 2010).
Scientific argues that Hepburn has failed to allege what
injury she has suffered, when she suffered those injuries, or
when and where she received treatment for those injuries. In
addition, Boston Scientific asserts that, to the extent
Hepburn seeks to recover for future injuries to which she
might be susceptible, such injuries cannot support a damages
response brief, Hepburn clarifies that she has suffered
“economic damages, emotional distress, [and]
psychological trauma [from] living with a defective product
implanted in her body.” Dkt. 7, at 7. She also asserts
that she “now requires regular medical monitoring to
ensure her health and wellbeing as a result of the long-term
implantation of the Greenfield Filter.” Id.
Thus, it appears Hepburn alleges three injuries: (1)
increased risk of future harm cause by the allegedly
defective medical device; (2) emotional distress caused by
worrying about said future harm; and (3) costs associated
with medical monitoring to prevent said future harm.
cites several cases for the proposition that she can seek
recovery for risk of future injuries under Idaho law. The
first case Hepburn cites does not in fact support
Hepburn's argument. In the first case, Conner v.
Hodges, the plaintiff alleged both past injury (after
her doctor failed to properly perform a sterilization
procedure, she had an unwanted pregnancy with complications
that required several surgeries) and potential future
injuries (she was at risk of needing additional medical care
in the future, due to the complications). 333 P.3d 130, 137
(Idaho 2014). Unlike Hepburn, the plaintiff in
Conner alleged a concrete, past injury sufficient to
establish standing. And, significantly, the question of
whether the plaintiff had standing or had alleged a
cognizable injury was not before the Conner court.
second case Hepburn cites, Neal v. Neal, is much
more relevant. The plaintiff in Neal sought
“to recover for emotional distress resulting from her
fear that she may have contracted AIDS, herpes, or other
sexually transmitted diseases.” 873 P.2d 881, 886
(Idaho Ct. App. 1993), aff'd in relevant part,
rev'd in part, 873 P.2d 871 (1994). When examining
whether the injury was compensable, the court explained that
“[m]any jurisdictions have allowed damages for
emotional distress resulting from the present fear of
developing a disease in the future where the disease has a
latency or incubation period, such as cancer, tuberculosis,
or AIDS.” Id. at 887. “In such cases,
damages are recoverable only if the mental injury alleged is
shown to be sufficiently genuine and the fear
reasonable.” Id. Typically, the plaintiff must
clearly establish that he or she was in fact exposed to a
carcinogen or disease in order to recover damages.
Id. at 887-88. Thus, a plaintiff cannot recover
damages for injuries stemming only from the fear of exposure.
Id. at 888-89 (“[A] plaintiff's fear of a
disease must be based on more ...