In re Orthopedic Bone Screw Product Liability Litigation

OPINION OF THE COURT

REAVLEY, Circuit Judge.

This Federal Torts Claims Act (FTCA) claim against the Food and Drug Administration (FDA) for granting clearance to market certain types of pedicle screw fixation devices (referred to generally as bone screws) was dismissed by the District Court pursuant to the discretionary function exception to the FTCA.¹ Appellants contend here that this jurisdictional exception should not apply because FDA officials were guilty of misconduct in the process of granting the clearance, and because Appellants should have been given more opportunity to discover proof of that misconduct. Moreover, Appellants argue that, even if the discretionary function exception does apply to the aspect of the bone screw clearance process challenged in their suit — i.e., the clearance of bone screws based on their substantial equivalence to devices already on the market— the exception does not bar Appellants’ claims because the FDA’s substantial equivalence determination does not involve the requisite element of judgment and choice, and is not the type of policy-based decision that the exception is designed to protect. Because the record establishes the Court’s lack of jurisdiction, we will affirm.

BACKGROUND

Thousands of plaintiffs nationwide claim to have suffered injuries resulting from the surgical implantation of bone screws in their spines and have sued their doctors and the manufacturers of the screws; and, as is relevant here, some two hundred have also sued the federal government. These actions have been consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Eastern District of Pennsylvania as MDL No. 1014.²

1. Regulatory Process

It is undisputed that marketing of the bone screws is regulated by the Federal Food, Drug, and Cosmetic Act,³ as amended by the Medical Device Amendments of 1976(MDA).⁴ At the time the lawsuits were filed, the FDA had classified the bone screws as Class III devices, a categorization reserved for devices presenting “a potential unreasonable risk of illness or injury.”⁵ Before Class III devices can be marketed, they must receive “premarket approval” from the FDA⁶ or, alternatively, they must qualify for FDA clearance based on a substantial equivalence determination.⁷ It is a criminal offense to introduce a Class III medical device into commerce without approval or clearance.⁸

Because premarket approval is a lengthy, formal, and thus costly process often involving clinical trials under FDA supervision,⁹ most new Class III devices enter the market through FDA clearance.¹⁰ New Class III devices qualify for clearance when the FDA determines they are “substantially equivalent” to a legally marketed “predicate device” (usually a device that was marketed before the Medical Device Amendments went into effect on May 28, 1976).¹¹ The process by which this clearance is granted is known as the “§ 510(k) process,” in reference to the relevant MDA section. The process requires submission of the following:

1.“[pjroposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use,”

2. “[a] statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement,”

3. “[a] statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted,” and

4. “[a]ny additional information regarding the device requested by the [FDA] Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution.”¹²

The FDA grants clearance through the § 510(k) process when the new device has the same intended use as the predicate device and the FDA determines that it possesses the same technological characteristics or is as safe and effective as the predicate device.¹³

2. Appellants’Allegations

In 1984, Zimmer Inc. applied for § 510(k) clearance for the Edwards Sacral Screw Device. After two rejections and the submission of additional supporting information, Zimmer was ultimately granted clearance. Appellants allege that the reasons for the FDA’s reversal of position are unknown, and that the clearance decision was erroneous because the evidence presented to the FDA revealed no predicate device substantially equivalent to the Edwards screw on the market. Following this determination, the FDA granted § 510(k) clearance to other bone screws. Appellants allege these applications were granted due to the erroneous clearance of the Edwards screw. Appellants also claim that the FDA granted clearance to Danek Medical to market the IFS/Luque Device for non-spinal use when it knew or should have known that the screw was intended solely for spinal use. They allege that Danek first described the screw as the “Interpedicular Segmental Fixation System” but changed its name to ‘Warsaw Orthopedic Bone Plates” and “Warsaw Orthopedic Cancellous Bone Screws” after its initial § 510(k) application was denied. Along with the name change, Danek removed all references to use of the device in the spine, describing its application as only for long or flat bones. The FDA then granted clearance. Appellants make similar complaints regarding the § 510(k) process for some of the other screws. And furthermore, they allege that an FDA official proposed the idea of changing the intended use of the screws in order to obtain clearance and provided advice on circumventing FDA rules.

Appellants claim that the FDA’s conduct in granting clearance for each of the screws was negligent, intentionally erroneous,¹⁴ and in violation of its own policy. They further contend that this misconduct resulted in the marketing and subsequent use of the bone screws that ultimately injured them. The government argues that the discretionary function exception to the FTCA precludes Appellants’ claims, regardless of their merit.

DISCUSSION

a.

Appellants first seek to get around the discretionary function exception by arguing that, because they have alleged that the FDA’s conduct in clearing bone screws for the market was intentionally erroneous, and possibly even criminal, the exception is not applicable at all. In the Appellants’ submission, the discretionary function exception was never intended to shield a government agency from liability for such dishonest and criminal conduct, and thus Appellants should be permitted to pursue their claims of intentional and criminal misconduct against the FDA without having to overcome the discretionary function bar. We are constrained to disagree.

Even prior to reaching the discretionary function exception issue, Appellants bear the burden of demonstrating that their claims fall within the scope of the FTCA’s waiver of government immunity.¹⁵ Under the FTCA, the federal government only waives its immunity for injuries “caused by the negligent or wrongful act or omission of any employee of the Government ... under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.”¹⁶ As the quoted language makes clear, the FTCA does not itself create a substantive cause of action against the United States; rather, it provides a mechanism for bringing a state law tort action against the federal government in federal court. Thus, “the extent of the United States’ liability under the FTCA is generally determined by reference to state law.”¹⁷

To state a viable FTCA claim based on their allegations of intentional and possibly criminal misconduct on the part of the FDA in the § 510(k) clearance process, Appellants need to demonstrate that such conduct amounted to a “negligent or wrongful act or omission” for which a private individual would be held liable under applicable state tort law. Appellants, however, face several hurdles to making this showing. First, we have examined the face of Appellants’ complaints, and note that the complaints do not appear to allege that the FDA’s behavior amounted to intentional or possibly criminal misconduct. Rather, in their complaints, Appellants contend that the FDA acted negligently and in violation of its own policies and procedures.¹⁸

Even if we were inclined to read Appellants’ complaints liberally as stating claims based on the FDA’s intentional and potentially criminal misconduct, we do not believe that these claims fall within the scope of the FTCA’s sovereign immunity waiver. Appellants have cast their allegations regarding the FDA’s intentional misconduct and potentially criminal behavior only in generalized terms, and our treatment of these claims is, of necessity, similarly generalized. We do not believe that intentionally improper or even criminal behavior, in the abstract, constitutes the type of “negligent or wrongful act or omission” for which the FTCA grants a waiver of sovereign immunity.¹⁹ Appellants have not pointed us to (and we could find no) precedent standing for this general proposition, and, mindful of the fact that a government’s waiver of its sovereign immunity must be construed narrowly,²⁰ we believe it is improper for us to conclude that Appellants’ claims based on the FDA’s allegedly intentionally dishonest and possibly criminal behavior fall within the scope of the FTCA’s immunity waiver. Furthermore, to the extent that Appellants’ claims have the state law analog necessary under the FTCA, we believe that the pertinent state cause of action is one for some type of intentional tort of fraud or deceit. Such intentional conduct, however, is explicitly exempted from the FTCA’s waiver of sovereign immunity.²¹

b.

Appellants’ claims do allege that the FDA acted negligently, and in violation of its own policies and procedures. This set of claims would fall within the FTCA’s general waiver of sovereign immunity, and we must therefore determine whether the District Court’s application of the discretionary function exception to these claims was correct.

In Berkovitz v. United States,²² the Supreme Court held that the discretionary function exception applies when (1) the act involves “an element of judgment or choice” and (2) that discretion “is of the kind that the discretionary function exception was designed to shield.”²³ This inquiry does not focus on anyone’s subjective intent in the exercise of that discretion, however. Instead, the inquiry focuses on “the nature of the actions taken and on whether they are susceptible to policy analysis.”²⁴

Appellants assert that both prongs of the Berkovitz inquiry support their position. They argue that the discretionary function exception does not apply to the § 510(k) clearances because (1) the FDA improperly granted the clearances, violating statutory and regulatory duties that do not allow for the exercise of any discretionary judgment or choice, and (2) the § 510(k) process involves merely scientific tasks rather than the exercise of policy-based discretion such as the exception was designed to protect. We disagree.

Under Berkovitz’s first prong, “[t]he requirement of judgment or choice is not satisfied if a ‘federal statute, regulation, or policy specifically prescribes a course of action for an employee to follow,’ because ‘the employee has no rightful option but to adhere to that directive.’ ”²⁵ FDA determinations concerning substantial equivalency are governed by 21 U.S.C. § 360c(i)(l) and 21 C.F.R. § 807.100(b), which explicitly grant the FDA discretion to require additional information “if deemed necessary” and to set standards for evaluation of safety and efficacy. Specifically, § 807.100(b) requires only (1) that the new device and the predicate device have the same intended use, (2) that the devices have the same technological characteristics or that data demonstrates the new device is as safe and effective as the predicate, and (8) that neither the Commissioner nor the courts have taken specific action against the new device.

Appellants contend that the FDA granted clearance for the screws even though it knew or should have known that screws had an altogether new intended use (namely, fixation to the vertebral pedicles of the spine), even though the screws had different technological characteristics, and even though the screws were not as safe or effective as the predicate devices. Appellants further allege that, by so doing, the FDA failed to perform the mandatory duties required by law for granting § 510(k) clearance, and thus did not exercise the judgment or choice necessary under Berkovitz’s first prong to trigger the discretionary function exception.

The government argues that the statutory and regulatory provisions grant it discretion to decide what information is relevant in the § 510(k) process. Moreover, it points out that no mandatory authority dictates how it should go about determining whether devices have the same intended use, same technological characteristics, or similar performance in safety and efficacy. Accordingly, the government contends that the § 510(k) process requires the FDA to make discretionary choices utilizing its expertise. We agree.

When § 510(k) applications are brought before the FDA, regulators must decide what data and other information is relevant, what is reliable, and how much is sufficient. Certainly in weighing evidence and comparing medical devices in this manner, the FDA utilizes judgment and choice. Appellants’ suggestion that the FDA violated statutory and regulatory provisions is, in reality, a claim that the FDA’s judgment is wrong. Because substantial equivalence determinations as well as the manner in which those decisions get made are functions committed to the discretion of the FDA, we will not second guess their outcomes. The first step of the Berkovitz test is met.

Next, Appellants argue under the second Berkovitz prong that the § 510(k) process involves merely scientific tasks rather than the exercise of policy-based discretion. They rely on language in Griffin v. United States²⁶ for the proposition that scientific decisions do not fall within this exception. But their reliance is misplaced. Griffin concludes that some scientific determinations or measurements may not implicate policymaking discretion, not that science-based decisions never involve policymaking.²⁷ Because the § 510(k) process implicates such considerations as safety, efficacy, and cost, Griffin is not applicable. Furthermore, we have previously questioned the continuing authority of Griffin in light of subsequent Supreme Court decisions.²⁸

The FDA’s regulatory judgment in the § 510(k) process is susceptible to policy analysis and therefore falls within the kind of discretion the exception is designed to protect. The § 510(k) process requires judgment regarding what evidence is relevant, how well that evidence demonstrates safety and efficacy, and what weight should be given conflicting evidence and opinions. Implicit in this judgment is the balancing of values such as safety and cost. Decisions made in this context reflect policy choices and cannot be categorized as ministerial. Thus the second step of the test is also met. The FDA’s actions were protected by the discretionary function exception.

3. Stay of Discovery

The District Court stayed discovery in this ease while it considered the government’s motion to dismiss. Our standard of review of questions concerning the scope or opportunity for discovery is for abuse of discretion.²⁹ Appellants argue that the stay was improper and prevented them from uncovering evidence of wrongdoing by the FDA. But because Appellants’ proposed discovery was aimed at supporting claims that, for the reasons stated in part l.a, fall outside the FTCA, and because the District Court had no jurisdiction over these claims, it was appropriate to stay discovery. The District Court acted within its discretion.³⁰

The judgment of the District Court will be AFFIRMED.

1 . 28 U.S.C. § 2680(a).

2 . The circumstances of this litigation have received more comprehensive attention elsewhere than is required in this appeal. See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 1015-16, 148 L.Ed.2d 854 (2001); In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781, 784-87 (3d Cir.1999).

3 . Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397).

4 . Medical Device Amendments of 1976, Pub.L. No. 94-295, 90 Stat. 539 (codified as amended in scattered sections of 21 U.S.C.).

5 . 21 U.S.C. § 360c(a)(l)(C)(ii)(II).

6 . Id. § 360e(a).

7 . Id. § 360e(b)(l); see also Buckman, 121 S.Ct. at 1015-16 (describing the FDA approval process applicable to the bone screw and similar devices).

8 . See 21 U.S.C. § 331(a); In re Orthopedic Bone Screw, 193 F.3d at 786.

9 . See generally 21 C.F.R. pt. 812.

10 . See Medtronic Inc. v. Lohr, 518 U.S. 470, 479-80, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (citing D. Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987)).

11 . 21 U.S.C. § 360e(b)(1)(B).

12 . 21 C.F.R. § 807.87; see also Buckman, 121 S.Ct. at 1016.

13 . See 21 U.S.C. § 360c(i)(l); 21 C.F.R. § 807.100(b). According to § 360c(i)(l), a device is “substantially equivalent” to a predicate device if it “has the same intended use as the predicate device” and if the FDA has found it:

(i) has the same technological characteristics as the predicate device, or

(ii) (I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

14 . Plaintiffs-Appellants accuse FDA officials of dishonest and even criminal conduct.

15 . See Cato v. United States, 70 F.3d 1103, 1107 (9th Cir.1995).

16 . 28 U.S.C. § 1346(b)(1).

17 . Reo v. U.S. Postal Serv., 98 F.3d 73, 75 (3d Cir.1996) (quoting Molzof v. United States, 502 U.S. 301, 305, 112 S.Ct. 711, 116 L.Ed.2d 731 (1992)) (internal quotation marks omitted).

18 . In fact, even in their appellate briefing, Appellants continued to emphasize that the FDA’s clearance decisions were wrongful because they were made negligently and in violation of the FDA’s policies and procedures, and not because the FDA’s behavior represented intentional misconduct or potentially criminal behavior. See Appellants' Opening Brief at 10 ("Plaintiffs allege that the FDA was negligent, careless, failed to exercise reasonable care and violated its own policy, practice and procedure with respect to substantial equivalence determinations in granting the requests by various manufacturers [for] 510(k) clearance.”). Accordingly, the government’s brief did not deal with this issue. Appellants did argue that the stay of discovery imposed by the District Court should be lifted because Appellants believed that they would obtain evidence of the FDA’s intentional and possibly criminal misconduct, but it was not until oral argument on appeal that Appellants contended that their allegations regarding the FDA’s intentional or criminal misbehavior should prevent any application of the discretionary function exception to Appellants’ claims.

19 . We express no opinion on the question whether a specific set of factual allegations supporting the contention that a government agency acted in an intentionally wrongful or criminal manner could also support a contention that the government's behavior was "negligent or wrongful” within the meaning of the FTCA.

20 . See Clinton County Comm’rs v. EPA, 116 F.3d 1018, 1021 (3d Cir.1997) ("A waiver of immunity must be unequivocally expressed and is construed strictly in favor of the sovereign.”) (internal quotation marks and citations omitted).

21 . See 28 U.S.C. § 2680(h) (stating that the FTCA does not apply inter alia to "[a]ny claim arising out of ... misrepresentation, deceit”).

22 . 486 U.S. 531, 108 S.Ct. 1954, 100 L.Ed.2d 531 (1988).

23 . Id. at 536, 108 S.Ct 1954; see also Gotha v. United States, 115 F.3d 176, 179 (3d Cir.1997).

24 . United States v. Gaubert, 499 U.S. 315, 325, 111 S.Ct. 1267, 113 L.Ed.2d 335 (1991).

25 . Id. at 322, 111 S.Ct. 1267 (1991) (quoting Berkovitz, 486 U.S. at 536, 108 S.Ct. 1954).

26 . 500 F.2d 1059, 1066 (3d Cir.1974).

27 . See id. ("At issue [is] a scientific, but not policy-making, determination as to whether each of the criteria listed in the regulation was met and the extent to which each such factor accurately indicated neurovirulence.”).

28 .See, e.g., Smith v. Johns-Manville Corp., 795 F.2d 301, 309 (3rd Cir.1986).

29 . See Brumfield v. Sanders, 232 F.3d 376, 380 (3rd Cir.2000).

30 . Cf. id.