Orthopedic Bone Screw Liability Litigation, In re
| Citation | 159 F.3d 817 |
| Decision Date | 17 November 1998 |
| Docket Number | No. 97-1783,97-1783 |
| Parties | Prod.Liab.Rep. (CCH) P 15,408 In re ORTHOPEDIC BONE SCREW PRODUCTS LIABILITY LITIGATION, Plaintiffs Legal Committee, Appellant. |
| Court | U.S. Court of Appeals — Third Circuit |
Michael D. Fishbein (Argued), Arnold Levin, Levin, Fishbein, Sedran & Berman, Philadelphia, PA, for Appellant.
John S. Buresh (Argued), Fred M. Feller, Buresh, Kaplan, Jang, Feller & Austin, Berkeley, CA, George P. Noel, Noel & Hackett, Media, PA, for Appellee Buckman Co.
Anthony C.H. Vale (Argued), Pepper, Hamilton & Scheetz, Philadelphia, PA, for Amicus-Appellees Danek Med. Inc., Sofamor SNC, Sofamor Danek Grp, Warsaw Orthopedic Sofamor, Inc.
Robert E. Welsh, Jr., Welsh & Recker, Philadelphia, PA, for Appellee Louis C. Bechtle.
Janet L. MacDonell, Deutsch, Kerrigan & Stiles, New Orleans, LA, for Appellee Scoliosis Research Society.
Norman J. Jeddeloh, Burditt & Radzius, Chicago, IL, for Appellee American Academy of Orthopaedic Surgeons.
Before: STAPLETON, COWEN and RENDELL, Circuit Judges.
This case involves thousands of individual plaintiffs-appellants who claim that they suffered injuries resulting from the implantation of orthopedic bone screws into the pedicles of their spines. Over 2,000 individual actions were consolidated for pre-trial proceedings pursuant to the multi-district litigation statute, 28 U.S.C. § 1407. This appeal involves plaintiffs' allegations that one defendant, Buckman Company, Inc. ("Buckman"), made misrepresentations to the Food and Drug Administration ("FDA") serious enough to play a substantial role in the events which resulted in their injuries. The district court granted Buckman's motion to dismiss this state-law "fraud on the FDA" claim, determining that: (1) the claim was "precluded by virtue of the fact that the MDA[i.e., the Medical Device Amendments of 1976, 21 U.S.C. §§ 360c-360k, to the Federal Food, Drug, and Cosmetic Act of 1938 ("FDCA"), 21 U.S.C. § 301 et seq.] does not provide for a private right of action," App. at 157; and (2) plaintiffs could not, as a matter of law, demonstrate proximate causation between the misrepresentations to the FDA and any injuries suffered. App. at 158-59. We will reverse.
The orthopedic bone screw devices that are the subject of this suit are regulated by the FDA pursuant to the MDA. Congress enacted the MDA to address concerns regarding the safety and effectiveness of the wide variety of medical devices introduced into the market. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The MDA requires classification of medical devices into three categories based upon the risk that they pose to the public. Class I devices present no unreasonable risk of illness or injury and are subject only to general manufacturing controls. See 21 U.S.C. § 360c(a)(1)(A). Class II devices are potentially more harmful and are subject to federal performance regulations. See id. § 360c(a)(1)(B). Finally, Class III devices "present[ ] a potential unreasonable risk of illness or injury" and are subject to the strictest regulation. Id. § 360c(a)(1)(C).
Class III devices may not be introduced into the market until the manufacturer provides the FDA with "reasonable assurance" that the device is both safe and effective. See id. § 360e(d)(2). This "premarket approval" process requires a manufacturer to submit, and the FDA to review, "all information, published or known ... or which should reasonably be known ... concerning investigations which have been made to show whether or not such device is safe and effective." Id. § 360e(c)(1)(A). In addition, the manufacturer must provide the FDA with a full statement of design and manufacturing plans, as well as any additional information requested by the agency. See id. § 360e(c)(1). Securing premarket approval is an arduous and time-consuming process; each submission requires an average of 1,200 hours of FDA review. See Lohr, 518 U.S. at 477, 116 S.Ct. 2240.
There are three important exceptions to the requirement that Class III medical devices receive premarket approval before being placed on the market. First, a manufacturer can obtain an Investigational Device Exemption ("IDE"), which allows limited use of an experimental medical device to gather the type of data necessary to support a premarket approval application. See 21 U.S.C. § 360j(g). Though an IDE allows use of a Class III device in clinical trials, it does not permit introduction to the general public.
Second, the MDA allows Class III devices that were in commerce prior to its enactment to remain on the market until the FDA initiates and completes a premarket approval analysis for those "predicate" devices. See id. § 360e(b)(1)(A). This "grandfathering" provision reflects Congress' recognition "that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices." Lohr, 518 U.S. at 477-78, 116 S.Ct. 2240.
Third, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices wait for FDA approval, and to ensure that improvements to existing devices are introduced quickly, the MDA allows devices that are "substantially equivalent" to an existing predicate device to avoid the premarket approval process. See Lohr, 518 U.S. at 478, 116 S.Ct. 2240; 21 U.S.C. § 360e(b)(1)(B). The procedure a manufacturer follows to take advantage of this exception is known colloquially as the " § 510(k) process," after the number of the relevant section in the original Act. A § 510(k) application must contain information supporting the device's substantial equivalence to a predicate device, proposed labeling for the device, and any additional information requested by the FDA. See 21 C.F.R. § 807.87. For a device to be approved under the § 510(k) process, the FDA must determine that the new device has the same intended use as the predicate device and that it possesses the same technological characteristics or is as safe and effective as the predicate device. See 21 U.S.C. § 360c(i)(1)(A). 1 The advantage of the § 510(k) process is significant to manufacturers: review of a § 510(k) application by the FDA requires an average of only twenty hours of agency time, compared to the 1,200 hours required for full premarket approval. See Lohr, 518 U.S. at 478-79, 116 S.Ct. 2240.
Buckman is a regulatory consultant to medical device manufacturers, and was retained by the AcroMed Corporation to act as its liaison to the FDA in its attempt to secure marketing clearance for its product. AcroMed initiated the § 510(k) process to secure marketing clearance for its orthopedic bone screw device, known as the Variable Screw Placement ("VSP") Spinal Plate Fixation System, in September 1984. 2 In this application, AcroMed indicated that it intended to market the device for use in spinal surgery. The FDA rejected the request, determining that the VSP device was a Class III device and was not substantially equivalent to any predicate device.
In September 1985, AcroMed, through Buckman, filed a second application for marketing clearance through the § 510(k) process. The application provided additional information about the VSP device and again indicated its intended use in spinal surgery. The FDA again rejected the application, determining that the device was not substantially equivalent to a predicate device and that it posed potential risks not exhibited by other spinal-fixation systems.
In December 1985, AcroMed and Buckman filed two final § 510(k) applications seeking market approval for its product. AcroMed and Buckman split the VSP device into its component parts, renamed them "nested bone plates" and "cancerous bone screws" and filed a separate § 510(k) application for each component. In both applications, a new intended use was specified: rather than seeking clearance for spinal applications, they sought clearance to market the plates and screws for use in the long bones of the arms and legs. AcroMed and Buckman claimed that the two components were substantially equivalent to predicate devices used in long bone surgery. The FDA approved the devices for this purpose in February 1986.
The subject of this appeal is plaintiffs' fraud on the FDA claim against Buckman. Plaintiffs allege that AcroMed, through Buckman, made material misrepresentations in its successful § 510(k) submission to the FDA. Specifically, plaintiffs allege that AcroMed, through Buckman, "sought approval of its VSP plates and screws for use in long bones simply as a pretext in order to market the device for its true intended use in the spine." App. at 58. According to the plaintiffs, Buckman, AcroMed and other defendants contrived a strategy in which they would (1) misrepresent the intended use of the screw system to the FDA, (2) obtain the FDA's approval to market the system for that misrepresented use, and (3) subsequently market the system for a use, spinal surgery, for which they could not obtain the FDA's approval. Plaintiffs contend that, as a result of the misrepresentations to the FDA, a § 510(k) clearance was issued, allowing the devices access to the market they would not otherwise have had.
In 1994, the Judicial Panel on Multidistrict Litigation designated the district court as the transferee court for In re: Orthopedic Bone Screw Liability Litigation, MDL No. 1014. Since that time, some 2,300 civil actions have been transferred to the district court. In March 1995 the district court granted a motion brought by AcroMed and other defendants to dismiss plaintiffs' fraud on the FDA claims, determining that those claims (1) were preempted by the MDA, and (2) impermissibly implied a private right of action for violation of the FDCA. See App. at 28 (Pretrial Order No. 12). Relying on our decision in Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir.1995), the district...
To continue reading
Request your trial
-
Sita v. Danek Medical, Inc.
...1997 WL 305257 (E.D.Pa. March 1997), should be reinstated in light of the Third Circuit's decision in In re Orthopedic Bone Screw Prod. Liab. Litig., 159 F.3d 817 (3rd Cir.1998) (holding that it was error for MDL court to determine that all MDL 1014 plaintiffs had failed to allege a causal ......
-
Steele v. Depuy Orthopaedics, Inc., CIV. 02-3783(RBK).
...In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781 (3d Cir.1999) (Bone Screw II); and In re Orthopedic Bone Screw Prods. Liab. Litig., 159 F.3d 817 (3d Cir.1998) (Bone Screw I), rev'd, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), a......
-
Zimmerman v. Novartis Pharms. Corp.
...a fraudulent misrepresentation action such as injury and proximate cause. See [889 F.Supp.2d 777]In re Orthopedic Bone Screw Liab. Litig., 159 F.3d 817, 822 (3d Cir.1998) (stating that plaintiffs' claim of fraud on the FDA “track[s] the elements of a common law cause of action for fraudulen......
-
Horn v. Thoratec Corp., 02-4597.
......Litigation Group, Washington, John M. Humphrey, Rieders, Travis, ... & Porter, Washington, for Amicus Curiae Product Liability Advisory Council, Inc. . Daniel G. Jarcho, ...A screw ring is secured over the elbow to ensure that it remains .... 10. In re Orthopedic Bone Screw Prods. Liab. Litig., 159 F.3d 817, 825 (3d ......
-
Fraud on FDA claim survives preemption.
...grounded on so-called fraud on the FDA claims, the Third Circuit held in In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3d Cir. 1998), with one of the panel's judges The litigation involves more than 2,000 individual actions that were consolidated for pretrial proc......