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Hepburn v. Boston Scientific Corp.

United States District Court, D. Idaho

May 17, 2018

CLAUDIA HEPBURN, Plaintiff,
v.
BOSTON SCIENTIFIC CORPORATION, Defendant.

          MEMORANDUM DECISION AND ORDER

          David C. Nye U.S. District Court Judge.

         I. OVERVIEW

         This 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.

         II. FACTS

         Boston 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.[1] 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 has passed.

         In 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.

         On 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.

         Hepburn 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.

         Boston 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.

         In her 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.

         III. LEGAL STANDARD

         Federal 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.

         At the 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.

         IV. ANALYSIS

         Boston 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.

         A. Whether Hepburn has alleged a cognizable injury

         Boston 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).

         “To 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).

         Boston 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 award.

         In her 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.

         Hepburn 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.

         The 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 ...


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