Burgstahler v. AcroMed Corp.

Decision Date20 February 1996
Citation670 A.2d 658,448 Pa.Super. 26
Parties, Prod.Liab.Rep. (CCH) P 14,488 Lillian BURGSTAHLER, Appellee, v. ACROMED CORPORATION, Appellant.
CourtPennsylvania Superior Court

Louis A. Bove, Philadelphia & Mark Herrmann, Pro Hac Vice, Cleveland, Ohio, for appellant.

Martin Heller, Philadelphia, for appellee.

Before McEWEN, TAMILIA and KELLY, JJ.

McEWEN, Judge:

This Court granted the motion filed by appellant, AcroMed Corporation, pursuant to Pa.R.A.P. 1311, for leave to file an interlocutory appeal from an order which denied its motion for summary judgment, thus requiring that we determine whether the trial court properly found that the state law claims of the plaintiff, Lillian Burgstahler, had not been preempted by the Medical Device Amendments of 1976 ("The MDAs"), 21 U.S.C. §§ 360c et seq.

FACTUAL BACKGROUND

Appellee, Lillian Burgstahler, suffered a herniated disc as a result of a work-related accident on June 3, 1983. After a two-month course of bed rest and other non-surgical therapies, administered over a four-year period, failed to provide any relief, Burgstahler entered Thomas Jefferson University Hospital on January 18, 1987, under the care of Sanford Davne, M.D., an orthopedic surgeon and Donald L. Myers, M.D., a neurosurgeon. These doctors diagnosed Ms. Burgstahler as suffering from a bulging disc between her fourth and fifth lumbar vertebrae and recommended that Ms. Burgstahler undergo surgery to remove the disc and fuse the adjacent vertebrae.

Surgery was performed on January 19, 1987, by Dr. Davne and Dr. Myers, who performed an L-4-5 bilateral decompression laminotomy, foraminotomies, and L-4-5 diskectomy and fusion with allograft, autograft, and the implantation, as spinal fixation devices, of nested bone plates and cancellous bone screws manufactured by AcroMed Corporation and sold under the trade name "VSP Bone Plates" and "VSP Bone Screws." 1

Dr. Davne, who had attended in May of 1986, a two-day course conducted by Arthur D. Steffee, M.D., the inventor of the bone plate and screws, testified in a deposition that he was aware at all relevant times, that AcroMed's VSP bone plates and bone screws had been approved by the FDA for use only in the long bones of the extremities. 2

The surgery performed by Dr. Davne and Dr. Myers provided appellee with only a short respite from her symptoms and on August 25, 1987, x-rays revealed that the graft had not fused and that two inferior screws had broken. The bone plates and screws were removed during surgery, performed by a different physician, on June 23, 1988, and this action was subsequently instituted by appellee.

Appellee Burgstahler alleged in her complaint that AcroMed was liable for injuries resulting from the use of the VSP nested bone plate and screws as a result of its conduct in:

(a) supplying a defective VSP plate and screws;

(b) manufacturing a defective VSP plate and screws;

(c) failing properly to fabricate the aforesaid VSP plate and screws;

(d) failing properly and adequately to inspect the aforesaid VSP plate and screws;

(e) failing to warn of the defective condition; [and]

(f) failing to provide sufficient or proper information regarding the use of the aforesaid VSP plate and screws.

Appellant filed a motion for summary judgment, contending that it was entitled to judgment in its favor on all claims asserted by appellee due to the preemption afforded by section 360k(a) of the MDAs. Appellant argued in the alternative that the claims asserted by appellee based upon failure to warn or provide appropriate information on the proper use of the device were barred by application of the learned intermediary doctrine since the parties agree that the VSP nested bone plates and cancellous screws are available only upon the prescription of a physician.

The learned Judge Sandra Mazer Moss denied the motion for summary judgment, finding that the preemption provisions of the MDAs did not preempt all state tort claims since the device at issue was a Class II rather than a Class III device. The trial court did not address the argument of appellant that appellee's failure to warn claim was barred by application of the learned intermediary doctrine.

THE MDAS

The Medical Device Amendments of 1976 ("the MDAs"), 21 U.S.C. §§ 360c-360k (Supp.1995), to the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. §§ 301 et seq., were enacted:

"To assure the reasonable safety and effectiveness of medical devices intended for human use." H.Conf.Rep. No. 1090, 94th Cong.2d Sess. reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1103. The MDA gives the FDA broad powers to classify and regulate medical devices. Under the MDA, the FDA must assign a medical device to one of three statutorily delineated categories. Class I devices are those devices which pose little or no threat to public health. They are subject to only general requirements concerned with their manufacture. Tongue depressors are one example of a Class I medical device. See: 21 U.S.C. § 360c(a)(1)(A); 21 C.F.R. § 860.3(c)(1). Class II devices include items such as tampons and oxygen masks. Use of Class II devices involves some risk of injury and, as a result, the FDA establishes performance standards, postmarket surveillance programs and guidelines for their use. See: 21 U.S.C. § 360c(a)(1)(B); 21 CFR § 860.3(c)(2). Class III devices are those devices which are implanted in the body or which pose a potentially unreasonable risk of injury. See: 21 U.S.C. § 360c(a)(1)(C); 21 CFR § 860.3(c)(3). They include Zyderm, as well as pacemakers, heart valves and replacement joints. Because of their inherent dangerousness, Class III devices are subject to the most stringent FDA regulation. All Class III devices are required to obtain premarket approval prior to being released for sale and use. 21 U.S.C. § 360e; 21 CFR § 814.1(c).

Kennedy v. Collagen Corp., 67 F.3d 1453, 1455 (9th Cir.1995) (emphasis supplied). Accord: Feldt v. Mentor Corp., 61 F.3d 431, 433 (5th Cir.1995); Lohr v. Medtronic, Inc., 56 F.3d 1335, 1339-40 (11th Cir.1995); Michael v. Shiley, Inc., 46 F.3d 1316, 1319 (3rd Cir.), cert. denied, --- U.S. ----, 116 S.Ct. 67, 133 L.Ed.2d 29 (1995); Talbott v. C.R. Bard, Inc., 865 F.Supp. 37, 42-43 (D.Mass.1994), aff'd., 63 F.3d 25 (1st Cir.1995); Green v. Dolsky, 433 Pa.Super. 556, 561, 641 A.2d 600, 603, allo. granted, 539 Pa. 678, 652 A.2d 1324 (1994).

Class III devices may not be marketed or sold until the sponsoring company obtains Premarket Approval (PMA) from the FDA. Id. § 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. § 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. § 360e(c)(1)(B)-(G). After review by a panel of medical experts, the FDA may approve the PMA.

Michael v. Shiley, Inc., supra, 46 F.3d at 1320.

Although as a general rule Class II and Class III devices must obtain Premarket Approval (PMA) before they may be marketed to the public, 21 U.S.C. § 360e(c), the MDAs grandfathered into the market all devices introduced before May 28, 1976, the effective date of the Act, see: 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1), and permit the sale of a device without PMA where the device is the "substantial equivalent" of a device already on the market, including a device which was grandfathered into the market by virtue of having been first sold prior to May 28, 1976. 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. § 807.87. The manufacturer must submit a Premarket Notification (PMN), also known as a 510(k) notification, which includes specified information 90 days before marketing a device. The FDA must then clear the device for marketing. 21 U.S.C. § 360(k); 21 C.F.R. §§ 807.87, 807.90, 807.100; Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 396 (4th Cir.1995).

The Pre-Market Notification process requires applicants to submit descriptions of their devices and other information necessary for the agency to determine whether the devices are substantially equivalent. As with the Pre-Market Approval process, Pre-Market Notification applicants must also submit their proposed labeling. Id. If the FDA determines that a device is substantially equivalent to a device that was on the market prior to the enactment of the MDAs in 1976, the applicant is free to market the device.

Reeves v. AcroMed Corp., 44 F.3d 300, 303 (5th Cir.), cert. denied, --- U.S. ----, 115 S.Ct. 2251, 132 L.Ed.2d 258 (1995). See also: Lohr v. Medtronic, Inc., supra, 56 F.3d at 1340; 21 U.S.C. § 360(k), 360c(f)(1).

The VSP plate and screws at issue in the instant case have, as a result of proceeding through the PMN process, been designated as Class II medical devices, substantially equivalent to earlier marketed devices, and subject only to general controls 3 regarding labeling, reporting, and manufacturing. 21 U.S.C. § 360c(a)(1)(A)-(B).

William R. Christianson, the Vice President of Regulatory Affairs and Quality Assurance for AcroMed Corporation described in his affidavit of February 16, 1994, the PMN process in which AcroMed participated prior to marketing the VSP plates and screws:

AcroMed's nested bone plates and cancellous bone screws were submitted to the FDA pursuant to the FDA's 510(k) pre-market notification procedure. In 1985 AcroMed submitted a 510(k) application for its nested bone plates. In 1986, AcroMed submitted a similar notification for its cancellous bone screws. These notifications included the information required by the FDA to make substantial equivalence determinations, including examples of pre-1976 devices, design specifications, and proposed labeling. AcroMed's nested bone...

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