Tyler v. Boston Scientific Corporation

CourtDistrict Court, N.D. Illinois
DecidedMay 15, 2018
Docket1:17-cv-09170
StatusUnknown

This text of Tyler v. Boston Scientific Corporation (Tyler v. Boston Scientific Corporation) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Tyler v. Boston Scientific Corporation, (N.D. Ill. 2018).

Opinion

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

WILLIE TYLER, ) ) Plaintiff, ) ) No. 17 C 9170 v. ) ) Judge Sara L. Ellis BOSTON SCIENTIFIC CORPORATION, ) ) Defendant. )

OPINION AND ORDER In 2013, doctors implanted a Greenfield filter, a medical device designed to prevent blood clots manufactured by Defendant Boston Scientific Corporation (“Boston Scientific”), into Plaintiff Willie Tyler. Several years later, he learned that the filter had caused complications, prompting him to file this suit against Boston Scientific. Tyler brings claims for negligence (Count I), defective design (Count II), a manufacturing defect (Count III), failure to warn (Count IV), breach of express warranty (Count V), breach of the implied warranty of merchantability (Count VI), breach of the implied warranty of fitness (Count VII), and negligent misrepresentation (Count VIII). Boston Scientific has moved to dismiss the complaint. The Court finds that, although Tyler’s complaint could be more detailed, it sufficiently provides Boston Scientific with notice of Tyler’s claims for negligence, design and manufacturing defects, breach of express warranty and the implied warranty of merchantability, and negligent misrepresentation. However, the Court dismisses both Tyler’s failure to warn claim because he has not explained how the Greenfield filter’s warnings did not adequately warn him of the associated risks and his breach of the implied warranty of fitness claim because Tyler admits that he used the Greenfield filter for its ordinary purpose. BACKGROUND1 The inferior vena cava (“IVC”) is a vein that returns blood to the heart from the lower extremities. Blood clots that develop in the legs can travel through the IVC to the lungs to cause a pulmonary embolism (“PE”). Clots that develop in the deep leg veins are referred to as deep vein thrombosis (“DVT”). Individuals at risk of clotting are often treated with anticoagulants,

such as Heparin, Warfarin, or Lovenox. Alternatively, doctors may recommend the implantation of an IVC filter, a medical device inserted into the IVC designed to prevent blood clots from traveling from the legs to the heart and lungs. Boston Scientific designs, manufactures, sells, distributes, and markets the Greenfield filter, an IVC filter originally developed in 1973. The Greenfield filter is a permanent filter, having no retrieval option, designed to prevent PE and DVT as well as protect from the perforation of the vena cava wall and filter migration. In 1989, the Food and Drug Administration (“FDA”) gave Boston Scientific clearance to market the Greenfield filter under Section 510(k) of the Medical Device Amendment, meaning the FDA or its experts did not have

to independently evaluate the product for safety or efficacy. Boston Scientific’s marketing and documentation for the Greenfield filter, including its directions for use, its product brochure, and its website, all list potential complications from implantation of the Greenfield filter, including: “[m]ovement or migration of the Filter,” “[f]ormation of clots on the Filter which could result in complete blockage of blood flow through the vena cava,” “[i]nfection,” “[f]ailure of the Filter to

1 The facts in the background section are taken from Tyler’s complaint and are presumed true for the purpose of resolving Boston Scientific’s motion to dismiss. See Virnich v. Vorwald, 664 F.3d 206, 212 (7th Cir. 2011); Local 15, Int’l Bhd. of Elec. Workers, AFL-CIO v. Exelon Corp., 495 F.3d 779, 782 (7th Cir. 2007). A court normally cannot consider extrinsic evidence without converting a motion to dismiss into one for summary judgment. Hecker v. Deere & Co., 556 F.3d 575, 582–83 (7th Cir. 2009). Where a document is referenced in the complaint and central to the plaintiff’s claims, however, the Court may consider it in ruling on the motion to dismiss. Id. Here, this applies to the Greenfield filter’s directions for use, product brochure, and Boston Scientific’s webpages regarding the Greenfield filter, which Tyler references in his complaint and are central to his failure to warn claim. attach itself securely and potential migration of the Filter to the heart or lungs,” “[p]erforation of the vena cava, adjacent blood vessels or organ by one or more hooks,” and “[d]eath due to movement of clots to the heart or lungs.” Doc. 13-2 at 7; Doc. 13-3 at 7; Doc. 13-6 at 3; Doc. 13-8 at 3–4. Because of certain concerns with the long-term complications of permanent IVC filters,

medical device manufacturers began developing and marketing temporary, retrievable filters around 2003. The design of these newer filters allows removal once the patient no longer faces a risk of PE or DVT. Reports of complications with both permanent and retrievable filters surfaced in medical publications, clinical studies, and FDA warnings. In 2007, an American Journal of Roentgenology article reported that malfunctioning IVC filters may cause chest pains. It also noted that, because of long-term complications associated with permanent IVC filters, retrievable filters with lower reported complication rates had become more common. But a 2008 study found that retrievable and permanent IVC filters had comparable complication rates and no

difference in protection rate. In August 2010, the FDA issued a warning against leaving inferior filters—permanent or retrievable—implanted in patients for extended periods of time, noting that doctors should remove the devices once a patient’s risk for PE subsides. The FDA highlighted the risk in not removing retrievable filters intended for short-term placement. The FDA subsequently issued two additional alerts for IVC filters in 2010 and 2014, addressing adverse event reports and urging removal of filters, particularly retrievable filters. And removal of permanent filters appears to be a viable option, with an over 90% success rate in the retrieval of permanent filters in a clinical investigation conducted between 2011 and 2015. On July 11, 2013, after having been hospitalized for DVT and PE, Tyler received a Greenfield filter. Dr. Kevin Halstuk performed the surgery at St. Francis Hospital in Evanston, Illinois. Tyler agreed to the implantation of the Greenfield filter based on advice he received to prevent further complications from his DVT and PE. No medical professionals have suggested that Tyler have the Greenfield filter removed. On October 11, 2017, Tyler had an evaluation of

his Greenfield filter. The scan revealed that the tip of the filter was located along the posterior wall of the IVC, below the renal veins, and that all the prongs of the filter extended beyond the wall of the IVC, thus causing a perforation of the IVC. LEGAL STANDARD A motion to dismiss under Rule 12(b)(6) challenges the sufficiency of the complaint, not its merits. Fed. R. Civ. P. 12(b)(6); Gibson v. City of Chicago, 910 F.2d 1510, 1520 (7th Cir. 1990). In considering a Rule 12(b)(6) motion to dismiss, the Court accepts as true all well- pleaded facts in the plaintiff’s complaint and draws all reasonable inferences from those facts in the plaintiff’s favor. AnchorBank, FSB v. Hofer, 649 F.3d 610, 614 (7th Cir. 2011). To survive

a Rule 12(b)(6) motion, the complaint must not only provide the defendant with fair notice of a claim’s basis but must also be facially plausible. Ashcroft v. Iqbal, 556 U.S. 662

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Tyler v. Boston Scientific Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/tyler-v-boston-scientific-corporation-ilnd-2018.