46 F.3d 1316 (3rd Cir. 1995), 94-1496, Michael v. Shiley, Inc.

Docket Nº:94-1496.
Citation:46 F.3d 1316
Party Name:Nina MICHAEL, Appellant, v. SHILEY, INC.; Hospital Products Group, Inc., (Formerly Howmedica, Inc.); Pfizer, Inc.
Case Date:February 07, 1995
Court:United States Courts of Appeals, Court of Appeals for the Third Circuit

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46 F.3d 1316 (3rd Cir. 1995)

Nina MICHAEL, Appellant,


SHILEY, INC.; Hospital Products Group, Inc., (Formerly

Howmedica, Inc.); Pfizer, Inc.

No. 94-1496.

United States Court of Appeals, Third Circuit

February 7, 1995

Argued Oct. 24, 1994.

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[Copyrighted Material Omitted]

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Gary Green (Argued), Sidkoff, Pincus & Green, Morton B. Wapner, David Kuritz, Wapner, Newman & Wigrizer, Philadelphia, PA, for appellant.

David Klingsberg (Argued), Maris Veidemanis, Kaye, Scholer, Fierman, Hays & Handler, New York City, John W. Frazier, IV, James A. Willhite, Jr., Montgomery, McCracken, Walker & Rhoads, Philadelphia, PA, for appellees.

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GARTH, Circuit Judge:

This appeal requires that we determine how the Medical Devices Amendments of 1976, which amended the Food, Drug and Cosmetic Act of 1938, 21 U.S.C. Sec. 360-360rr, allocates authority between the states and the Food and Drug Administration. To be precise, we must decide whether 21 U.S.C. Sec. 360k pre-empts Nina Michael's state law causes of action for negligent manufacture and design, strict product liability, breach of the implied warranty of merchantability, breach of an express warranty, and common law fraud against Shiley Inc., the manufacturer of the Bjork-Shiley Heart Valve.

Applying the express pre-emption analysis defined by Cipollone v. Liggett Group Inc., --- U.S. ----, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), we conclude that Sec. 360k pre-empts Michael's cause of action for negligence (both manufacturing and design), strict product liability, and breach of the implied warranty of merchantability. We also hold that Michael's complaint to the extent that it relies on fraud perpetrated by Shiley on the FDA is pre-empted. Finally, we hold that Sec. 360k does not preclude Michael from pursuing common law causes of action for express warranty and for fraud to the extent that the fraud arises from Shiley's efforts to promote its product through letters to doctors and advertisements in medical journals.

Accordingly, while we will affirm the district court's preemption rulings as to Michael's negligence, strict product liability, and implied warranty claims, we will reverse the district court's summary judgment to the extent that it entered judgment against Michael on her express warranty and fraud claims.



Nina Michael's claims arise from the discovery in the past fifteen years that the outlet strut of the Bjork-Shiley 60 Degree Convexo-Concave Disc Heart Valve ("Shiley valve"), which was designed and manufactured by Shiley Inc., fractures in approximately one percent of the patients who received a Shiley implant. App. 200. These failures result from a weak strut mechanism and from poor manufacturing standards at Shiley's facilities. A strut failure leads inevitably to death or serious injury.


The Shiley valve was one of the first medical devices to be approved under the 1976 Medical Device Amendments to the Food Drug and Cosmetics Act of 1938 (the "MDA"), a comprehensive extension of the FDA's authority beyond medical drug manufacturers to medical device manufacturers. Pub.L. No. 94-295, 90 Stat. 539 (1976). Congress passed the Amendments in response to the harm caused by the Dalkon Shield, an unregulated medical device which resulted in serious injury to a large number of women. 1 Sen.Rep. No. 33, 94th Cong., 1st Sess. 2 reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1071. Through the MDA, Congress hoped "to assure the reasonable safety and effectiveness of medical devices intended for human use." H.Conf.Rep. No. 1090, 94th Cong., 1st Sess. 51 reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1103. To do so, it granted the FDA new broad powers to regulate medical devices, which powers are based on three statutory classifications.

Class I devices, such as tongue depressors, are devices which generally pose little or no threat to public health and are subject only to general controls on manufacturing. See 21 U.S.C. Sec. 360c(a)(1)(A). Class II devices, such as oxygen masks, pose a slightly greater risk of injury to patients, and accordingly, the MDA subjects them to performance standards, post market surveillance, guidelines for use and other appropriate controls. See

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id Sec. 360c(a)(1)(B). Class III devices, such as the Shiley valve, include all devices which are to be implanted into people, which are used to sustain life, or which pose a potentially unreasonable risk of injury. See id. Sec. 360c(a)(1)(C).

Class III devices may not be marketed or sold until the sponsoring company obtains Premarket Approval (PMA) from the FDA. Id. Sec. 360e. To obtain a PMA, the sponsor must submit "all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective," id. Sec. 360e(c)(1)(A), a statement of the intended use of the product, a description of the expected manufacturing processes for the device, and any other information requested by the FDA. Id. Sec. 360e(c)(1)(B)-(G). After review by a panel of medical experts, the FDA may approve the PMA.

The FDA retains continuing oversight over approved Class III devices. It requires manufacturers to report any deaths or serious injuries which result from the use of the product. See 21 C.F.R. Sec. 803.24(c). It may require warning or instructions on the labels which accompany the product. 21 C.F.R. Sec. 814.82. Finally, the FDA regulates the manufacture of the devices through the imposition of good manufacturing processes. 21 C.F.R. Sec. 820.100-820.101. The only remedial power granted to the FDA is the power to require the sponsor of the product to notify the public of a newly discovered danger posed by the product, order the company to replace the device, or order the company to refund the purchase price to the patient. The FDA can take these actions only if it determines that the device presents an unreasonable risk of substantial harm to the public. 21 U.S.C. Sec. 360h(a). The act does not permit the FDA to require companies to compensate victims for their medical expenses or for the pain and suffering resulting from a device failure.


Shortly after the passage of the MDA, Shiley applied for Premarket Approval (PMA) to market the Shiley valve. At the time, the FDA's procedures for PMA applications had not been finalized, see 51 Fed.Reg. 26364 (July 22, 1986) (defining PMA procedures), and thus the Shiley application did not receive the same organized and comprehensive evaluation that might be expected today. Sen. Comm. on Energy & Commerce, 101st Cong., 2d Sess., The Bjork-Shiley Valve: Earn as You Learn 20-22 (Comm.Print 1990) [hereinafter Energy & Commerce Report]. For example, evidence of the first strut fracture was belatedly brought to the FDA's attention and explained as an "isolated incident" even though it was unexplained at the time of the application. Id. at 21. Further, Shiley made claims, based on unsubstantiated data, that reduced heart complications would result from Shiley valve implants. 2 Id. at 22-24. Despite these deficiencies, the FDA approved the PMA on April 27, 1979, without a recorded vote. Id. at 22.

Between 1979 and 1983, the struts which hold the mechanical valves in place in 73 Shiley valves fractured, id at 28, leading to the death of most of the implanted individuals. These fractures were the result of both the valve's design and poor manufacturing processes. In particular, the valves suffered from poor welding and poor quality control. See id. at 5-14; App. 461, 615-16, 623-25. During this period, Shiley sent a set of letters to doctors and to the FDA reassuring them that these incidents did not compromise the integrity, safety, or effectiveness of the device. Energy & Commerce Report at 14-17. Despite a redesign of the manufacturing process, continuing strut fractures forced Shiley to recall those valves which had not been implanted in 1980, 1982, and 1983. Because of continuing problems with valve failures, Shiley recalled its larger size valves and ceased production of those sizes in October

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1985. Finally, on November 24, 1986, Shiley withdrew all its remaining valves from the market and ceased production of any heart valves. On March 21, 1990, Shiley asked the FDA to withdraw its Premarket Approval. To date, approximately 501 Shiley valves have fractured, resulting in 347 deaths. App. 691.


These events first affected Nina Michael in 1981. In that year, Michael was diagnosed with a congenital defect with her mitral heart valve, which controls of the flow of blood between the left atrium and the left ventricle. Because the defect was potentially fatal, Michael underwent surgery to have her natural heart valve replaced with the Shiley valve on November 24, 1982.

The surgery was successful and the valve functioned properly. The valve implanted in Michael came with the following disclosure under the heading "Disclaimer of Warranties":

Shiley warrants that reasonable care has been used in the manufacture of this device. This warranty is exclusive and in lieu of all other warranties, whether express, implied, written or oral.

App. 680.

In the late 1980s and early 1990s, Michael became aware of the strut fracture problem through media sources and her doctor. Research disclosed that her class of valves was among the Shiley valves with the highest rate of failure. It was estimated that there was a two percent chance per year that a catastrophic valve failure would occur in the Shiley valve implanted in Michael. These disclosures caused Michael significant anxiety, which resulted in sleeplessness and...

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