Sadler v. Advanced Bionics, Inc., Civil Action No. 3:11–CV–00450–H.

• Decision Date: 08 March 2013
• Docket Number: Civil Action No. 3:11–CV–00450–H.
• Citation: 929 F.Supp.2d 670
• Parties: Brian and Michelle SADLER, Individually and on behalf of their Minor child, B.S., Plaintiffs v. ADVANCED BIONICS, INC., Defendant.
• Court: U.S. District Court — Western District of Kentucky

929 F.Supp.2d 670

Brian and Michelle SADLER, Individually and on behalf of their Minor child, B.S., Plaintiffs

v.ADVANCED BIONICS, INC., Defendant.

Civil Action No. 3:11–CV–00450–H.

United States District Court,

W.D. Kentucky,

at Louisville.

March 8, 2013.

Edwin E. Wallis, III, Kevin M. McCormack, Tim Edwards, Glassman, Edwards, Wyatt, Tuttle & Cox, PC, Memphis, TN, Ronald E. Johnson, Jr., Schachter & Hendy, PSC, Ft. Wright, KY, for Plaintiffs.

Kara J. Rosenthal, Michael L. O'Donnell, Sean G. Saxon, Wheeler Trigg O'Donnell LLP, Denver, CO, Kathryn T. Martin, Frost Brown Todd LLC, Lexington, KY, W. Kennedy Simpson, Thompson Miller & Simpson PLC, Louisville, KY, for Defendant.

MEMORANDUM OPINION AND ORDER

JOHN G. HEYBURN, II, District Judge.

Breanna Sadler and her parents Michelle and Brian Sadler (collectively, “Plaintiffs”) bring this action to recover for injuries Breanna incurred as a result of the malfunctioning of her cochlear implant against Advanced Bionics, the manufacturer of the device. Advanced Bionics now moves for summary judgment of most of Plaintiffs' claims on preemption grounds. Many district and circuit courts have addressed medical device preemption issues from a variety of perspectives. As yet, the Sixth Circuit has not contributed any comprehensive discussion on the precise context presented here. The Court has reviewed relevant approaches and decided upon a reasonable one. For the reasons that follow, the Court sustains the motion in part and denies the motion in part.

I.

The facts particular to this case are straightforward. Breanna Sadler suffered from permanent hearing loss until she underwent open-head surgery to receive a cochlear implant on January 16, 2006. Breanna's cochlear implant device was Advanced Bionics' HiRes 90k. With the assistance of a cochlear implant, the brain learns to decode noise, and over time, implant recipients are able to distinguish sounds such that they are able to hear again. Although the device is technologically complicated, two principal systems comprise the cochlear implant: an internal component surgically implanted in the skull and an external component that sits outside the ear. The feedthru, which must remain hermetic (waterproof) throughout the life of the device, connects these two parts.

In December 2009, a leak in the feedthru that allowed moisture into the device caused Breanna's cochlear implant to fail, and as a result, she endured an aggressive shock. As Breanna convulsed on the floor, her mother held her down. After Breanna disconnected the device, her mother reconnected it at the urging of a doctor on the telephone. The cochlear implant again shocked Breanna, and Breanna's mother allowed Breanna to once more disconnect the device. The following day, Brian Sadler took Breanna to an audiologist. While Brian held Breanna down, the doctor reconnected the external processor to Breanna's skull. For the third time, the device shocked Breanna. When Breanna underwent replacement surgery in February 2010, the Sadlers chose a competitor cochlear implant for their daughter. The lingering physical and emotional effects of the three shocks are disputed.

Breanna's cochlear implant is subject to significant federal regulation under the Federal Food, Drug, and Cosmetic Act (“FDCA”), which governs medical device manufacturing. The FDCA specifically empowers the Food and Drug Administration (“FDA”) to regulate production and labeling practices of medical product manufacturers and distributors. In amending the FDCA several times since its enactment, Congress expanded the federal role in medical product regulation while preserving the applicability of state laws to the manufacture and distribution of medical products. Wyeth v. Levine, 555 U.S. 555, 566, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).

In 1976, Congress enacted the Medical Device Amendment (“MDA”) to broaden the FDCA's regulatory scope to include medical device manufacturing. Anne–Marie Dega, The Battle Over Medical Device Regulation: Do the Federal Medical Device Amendments Preempt State Tort Law Claims, 27 Loy. U. Chi. L.J.J. 615, 625–26 (1996). Because medical devices vary in composition and risk, Congress created three classes of these devices with corresponding varied levels of federal administrative control over the covered devices. For Class III devices, such as Advanced Bionics' cochlear implant, the FDA will grant manufacturers approval to market and distribute their products after obtaining premarket approval (“PMA”).¹ PMA “requires that manufacturers conduct extensive testing to obtain clinical results that demonstrate the safety and effectiveness of a device. Both FDA staff members and outside experts must approve the PMA before the FDA will approve the device for commercial use.” Dega, supra, at 627. This involves over 1,000 hours of FDA review. Lohr, 518 U.S. at 478, 116 S.Ct. 2240. Once a device receives PMA approval, the manufacturer must

submit a PMA Supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device.... [C]hanges for which an applicant shall submit a PMA supplement include ... (6) Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device.

21 C.F.R. § 814.39(a) (emphasis added). In sum, federal regulations require Advanced Bionics to obtain PMA approval for the initial cochlear implant device and supplemental approval for any subsequent generation of the device that incorporates changes affecting device safety or effectiveness.

In 1996, Advanced Bionics obtained a PMA for its original cochlear implant, the Clarion Multi–Strategy Cochlear Implant System. Subsequently, Advanced Bionics obtained PMA Supplement # 30 for a later generation of the device, called the HiRes 90k. Advanced Bionics manufactured two versions of the HiRes 90k. First, the PMA Supplement # 30 approved the device using a Pacific Aerospace and Electronics, Inc. (“PA & E”) manufactured feedthru (“Vendor A HiRes 90k”). In July of 2003, Advanced Bionics began commercially selling the Vendor A HiRes 90k.

Shortly thereafter, Advanced Bionics began manufacturing the second version of the HiRes 90k; this cochlear implant contained a feedthru manufactured by AstroSeal, Inc. (“Vendor B HiRes 90k”). Advanced Bionics did not seek a PMA Supplement for the Vendor B HiRes 90k. When Breanna underwent cochlear implant surgery in January of 2006, she received a Vendor B HiRes 90k, manufactured in 2005.

A number of issues relating to the HiRes 90k arose prior to Breanna's implantation surgery. In 2004, Advanced Bionics thoroughly tested failed, explanted cochlear implant devices, and concluded that the devices failed due to excessive moisture concentration in the feedthrus. In September of 2004, Advanced Bionics issued a recall of its unimplanted cochlear implant devices including the HiRes 90k, claiming that moisture sealed into the device during its manufacture caused issues with the proper functioning of the device. After implementing some changes to the device manufacturing process, Advanced Bionics resumed manufacturing and distributing the HiRes 90k. Nevertheless, Advanced Bionics received a warning letter the next year from the FDA informing it of insufficiencies in its operating structure. Because some devices continued to fail, Advanced Bionics issued another recall in March of 2006, which included a recall of unimplanted Vendor B HiRes 90ks. This time, Advanced Bionics concluded that a leak in the feedthru, rather than moisture being sealed in the device during manufacture, caused the excessive moisture levels.

After the 2006 recall, the FDA conducted an on-site investigation of Advanced Bionics' operations related to the recall. In 2007, apparently as a result of the inspection, the FDA filed a civil complaint against Advanced Bionics and its president and CEO, Jeffrey Grenier, seeking administrative penalties related to Advanced Bionics' violation of the FDCA and its corresponding regulations. The parties agreed to settle the case, and Advanced Bionics and Grenier paid the maximum FDCA fine.

II.

Plaintiffs brought suit arising from the failure of Breanna's Vendor B HiRes 90k in August of 2011, alleging negligence, products liability, negligence per se, breach of implied warranty, common law fraud, and punitive damages claims. Plaintiffs have agreed to withdraw their breach of implied warranty claim. Additionally, the parties do not discern the punitive damages. Therefore, the Court's preemption analysis addresses the remaining four claims separately.

Advanced Bionics moves for summary judgment under Federal Rule of Civil Procedure 56 on these four claims. Summary judgment is appropriate where “there is no genuine dispute as to any material fact.” Fed.R.Civ.P. 56(c). Initially, the moving party bears the burden of proving that no genuine issues of material fact are extant. Matsushita Electric Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585–86, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The Court will view the facts in a light most favorable to the nonmoving party. Id. Once the moving party satisfies its burden, the nonmoving party may overcome summary judgment only by designating “specific facts showing that there is a genuine issue for trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

III.

Advanced Bionics' primary argument is that express and implied medical device preemption void the four claims. The Court will attempt to navigate the murky waters of medical device preemption, relying on controlling precedent and applying relevant and persuasive decisions to the case sub judice. As a threshold matter, though, the Supreme Court affirmatively recognizes

two cornerstones of our pre-emption jurisprudence. First, the purpose of Congress is the ultimate touchstone in every pre-emption case. Second, in all pre-emption ...