Hughes v. Boston Scientific Corp..

• Decision Date: 21 January 2011
• Docket Number: No. 09–60925.,09–60925.
• Citation: 631 F.3d 762
• Parties: Jan HUGHES, Plaintiff–Appellant,v.BOSTON SCIENTIFIC CORPORATION, Defendant–Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

631 F.3d 762

Jan HUGHES, Plaintiff–Appellant,

v.BOSTON SCIENTIFIC CORPORATION, Defendant–Appellee.

No. 09–60925.

United States Court of Appeals, Fifth Circuit.

Jan. 21, 2011.

Scott Lawrence Nelson (argued), Allison M. Zieve, Pub. Cit. Lit. Group, Washington, DC, Donald James Blackwood, Jr., Copeland, Cook, Taylor & Bush, P.A., Ridgeland, MS, for Hughes.Wade Garrett Manor, Leah N. Ledford, James P. Streetman, III, Scott, Sullivan Streetman & Fox, P.C., Ridgeland, MS, Johnathan T. Krawcheck (argued), Weinberg, Wheeler, Hudgins, Gunn & Dial, Atlanta, GA, for Defendant–Appellee.Appeal from the United States District Court for the Southern District of Mississippi.Before KING, GARWOOD and DAVIS, Circuit Judges.W. EUGENE DAVIS, Circuit Judge:

This appeal requires us to determine the extent to which Appellant Jan Hughes's state tort claims seeking recovery for injuries allegedly caused by a medical device manufactured by Appellee Boston Scientific Corporation (“Boston Scientific”) are preempted by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 301 et seq., to the Federal Food, Drug, and Cosmetics Act of 1938 (“FDCA”), 52 Stat. 1040. The district court granted Boston Scientific's motion for summary judgment, holding that all of Hughes's claims are preempted. Hughes now appeals that ruling, focusing primarily on her claim that Boston Scientific failed to provide adequate warnings of dangers or risks associated with the HTA. For the following reasons, we affirm the district court's ruling with regard to all of Hughes's claims except for her failure to warn claim to the extent that this claim is predicated on Boston Scientific's failure to comply with the applicable federal statutes and regulations. Because we conclude that this claim is not preempted, we remand that claim to the district court for further proceedings, consistent with this opinion.

I.

A.

Boston Scientific is the designer, manufacturer, marketer, and seller of the HydroThermAblator (“HTA”), a medical device designed for the treatment of menorrhagia, or excess uterine bleeding. The device works by circulating hot saline solution (194° F) through a closed cycle into and then flushing it from the uterus, causing the lining of the uterus to slough off and discharge.

The HTA was approved for entry into the market by the Food and Drug Administration (“FDA”) under its rigorous premarketing approval (“PMA”) process in 2001. Boston Scientific sold the HTA device on the market from 2002 to 2009.¹ The HTA was classified as a Class III medical device under the MDA, thus receiving the highest degree of FDA oversight.

Class III devices are those that either “presen[t] a potential unreasonable risk of illness or injury” or are “for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.” 21 U.S.C. § 360c(a)(1)(C). As part of the PMA approval process, manufacturers of Class III devices must provide the FDA with a “reasonable assurance” that the device is both safe and effective. Id. § 360e(d)(2). The applicant must submit detailed information including full reports of all relevant information that is known by the applicant, samples of both labeling and the device itself, and a full description of the methods and facilities used for manufacturing and installation of the device. Id. § 360e(c)(1). In its review, the agency must “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” Id. § 360c(a)(2)(C). Once a device has received PMA approval, the manufacturer cannot make changes to any feature of the device without obtaining FDA permission. Id. § 360e(d)(6).

After PMA approval, manufacturers of Class III devices must comply with Medical Device Reporting (“MDR”) requirements. Id. § 360i(a)(1); 21 C.F.R. § 803.50(a). The FDA may approve marketing of the Class III device subject to additional postapproval conditions, which the FDA may include in its PMA approval order. See 21 U.S.C. §§ 360c–360j; 21 C.F.R. §§ 814.80, 814.82. If a manufacturer fails to comply with the FDA regulations or postapproval conditions, the FDA has the power to withdraw PMA approval, as well as the power to impose other remedies such as additional warnings or corrective labeling. See 21 U.S.C. §§ 351, 352, 360(h), 374.

B.

Hughes filed a complaint against Boston Scientific in the Circuit Court of Jones County, Mississippi, on March 26, 2008, seeking recovery for injuries she allegedly sustained from the HTA device. Hughes alleges that on October 25, 2006, her treating physician, Dr. Weber, performed the ablation procedure on her using the HTA device. During the procedure, hot liquid leaked from the device, at which point the device's alarm sounded and shut down, as it is designed to do. The leak caused a three-inch by two-inch burn on Hughes's outer perineal body and an area of similar size inside the vaginal introitus, which Dr. Weber characterized as second-degree burns. Hughes returned for treatment of her burns every other day for two weeks, and thereafter once a week for six to eight weeks.

Hughes asserted claims in her initial complaint under the Mississippi tort law theories of products liability, breach of warranty, negligence, breach of implied warranty of merchantability, and of fitness for a particular purpose. Following Boston Scientific's removal of the action to federal district court, Hughes filed an amended complaint against Boston Scientific. In the amended complaint, Count I for “Products Liability” includes the assertions that “[t]he product failed to contain adequate warnings of dangers or risks which were known or in the light of reasonably available knowledge should have been known to Boston Scientific” and that “the product failed to contain adequate instructions to communicate sufficient information on the dangers associated with, and the safe use of the product.” Count II of the amended complaint for “Negligence” includes similar claims that “Boston Scientific failed to provide adequate warnings of dangers or risks which were known or in the light of reasonably available knowledge should have been known to Boston Scientific”; that “Boston Scientific failed to provide adequate instructions to sufficiently communicate information on the dangers associated with the product and its safe use”; and that “Boston Scientific failed to notify the users and consumers of the product of similar problems with, or malfunctions of other units when used for their intended purpose.” Count II also charges that Boston Scientific “manufactured and distributed” the product inconsistently with its FDA PMA approval by failing to report serious injuries and malfunctions of the device as defined in the MDR regulations. Hughes also included a separate Count IV for “Negligence Per Se,” charging that Boston Scientific violated the FDA regulations governing the safety, effectiveness, and reliability of the HTA.

In the district court, Hughes proceeded on the theory that Boston Scientific failed to comply with the FDA's MDR regulations requiring a manufacturer of a Class III device to report incidents in which the device may have caused or contributed to a death or “serious injury,” or malfunctioned in such a way that would likely cause or contribute to death or serious injury if the malfunction recurred. 21 U.S.C. § 360i(a)(1); 21 C.F.R. § 803.50(a).² The term “serious injury” is defined in the MDR regulations as “an injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.” 21 U.S.C. § 360i(a)(2); 21 C.F.R. § 803.3. The term “malfunction” is defined to mean “the failure of a device to meet its performance specifications or otherwise perform as intended,” with performance specification defined to “include all claims made in the labeling for the device,” and intended performance defined as “the intended use for which the device is labeled or marketed ....” 21 § C.F.R. 803.3.

Hughes supports her argument that Boston Scientific failed to abide by these reporting regulations with evidence obtained during discovery that Boston Scientific developed an “algorithm” regarding reportable events caused by the HTA according to which Boston Scientific reported some, but not all, burns, as follows:

(1) First degree burns were not reportable.

(2) Second degree burns were reportable depending on the extensiveness and intervention required to treat the injury. A second degree burn was MDR reportable if any of the following criteria were met: (a) the burn was classified as extensive by the physician; (b) the burn involved both internal anatomy such as the vagina and cervix and external anatomy such as the vulva, perineum and buttocks; (c) the burn required intervention involving a medical or surgical procedure that cannot be administered by the patient (such as: systemic antibiotics, debridement, skin grafting, etc.).

(3) Other second degree burns that can be effectively managed by application of cream or ointment were not considered to be MDR reportable.

(4) Third degree burns were reportable.

Boston Scientific included this algorithm in its annual reports for the HTA from 2002 to 2008, required by FDA regulation to be filed with the FDA's Center for Devices and Radiological Health (“CDRH”). In response to a 2003 letter from the CDRH inquiring about Boston Scientific's criteria for reportable burns, Boston Scientific included the algorithm in a 2004 letter to the CDRH.

Hughes relies on the expert report of Charles Kyper, a former FDA official. Kyper has given his opinion that Boston Scientific's failure to report certain first and second-degree burns caused by leakage from the HTA device, pursuant to the algorithm, violated...