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Tyler v. Boston Scientific Corp.

United States District Court, N.D. Illinois, Eastern Division

May 15, 2018

WILLIE TYLER, Plaintiff,
v.
BOSTON SCIENTIFIC CORPORATION, Defendant.

          OPINION AND ORDER

          SARA L.ELLIS United States District Judge.

         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.

         BACKGROUND[1]

         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 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, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009); see also Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678.

         ANALYSIS

         I. Strict Liability: Design and Manufacturing Defect (Counts II and III)

         Tyler claims both that the Greenfield filter had a design defect and that his specific Greenfield filter had a manufacturing defect as well. Both these claims are based on different theories of a strict products liability claim. To state a strict products liability claim based on a defectively designed or manufactured product, Tyler must allege “(1) a condition of the product as a result of manufacturing or design, (2) that made the product unreasonably dangerous, (3) and that existed at the time the product left the defendant's control, and (4) an injury to the plaintiff, (5) that was proximately caused by the condition.” Mikolajczyk v. Ford Motor Co., 901 N.E.2d 329, 345, 231 Ill.2d 516, 327 Ill.Dec. 1 (2008). “A manufacturing defect occurs when one unit in a product line is defective, whereas a design defect occurs when the specific unit conforms to the intended design but the intended design itself renders the product unreasonably dangerous.” Salerno v. Innovative Surveillance Tech., Inc., 932 N.E.2d 101, 108, 342 Ill.Dec. 210, 402 Ill.App.3d 490 (2010).

         Boston Scientific argues that Tyler's allegations are too conclusory to sufficiently allege a design or manufacturing defect. It extensively relies on a recent decision from this district, Griffin v. Medtronic, Inc., in which the court found that, by merely alleging that the medical device at issue was “unreasonably dangerous, inadequate, and defective, ” the plaintiff failed to give the defendant notice of his design and manufacturing defect claims. No. 17 CV 927, 2017 WL 4417821, at *3 (N.D. Ill. Oct. 5, 2017). But the Court does not find Griffin applicable here, where the plaintiff in Griffin failed to respond to the defendant's motion to dismiss, forfeiting any arguments as to why his ...


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