Source: https://m.openjurist.org/159/f3d/817
Timestamp: 2020-07-16 01:43:40
Document Index: 107943151

Matched Legal Cases: ['§ 510', '§ 360', '§ 510', '§ 510', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360']

159 F. 3d 817 - 15408 Orthopedic Bone Screw Products Liability Litigation
159 F3d 817 15408 Orthopedic Bone Screw Products Liability Litigation
159 F.3d 817
Prod.Liab.Rep. (CCH) P 15,408
In re ORTHOPEDIC BONE SCREW PRODUCTS LIABILITY LITIGATION,
Plaintiffs Legal Committee, Appellant.
In Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), the Supreme Court applied these statutory and regulatory provisions in the context of a suit against the manufacturer of a pacemaker that had been cleared as a Class III device under § 510(k). Lohr, the plaintiff there, asserted common law negligence and strict liability claims based on the design of the pacemaker as well as state law claims based on defective manufacture and mislabeling. The Court held that these claims were not preempted.
The Court gave the preemption provision of the statute a narrow reading. It stressed that preemption occurs under § 360k only when (1) there is a state "requirement" "with respect to a device;" (2) there is a federal "requirement" "applicable to the device" under the MDA; (3) the state requirement is "different from, or in addition to" the federal requirement; and (4) the state requirement relates to the safety or effectiveness of the device or some matter included in the federal requirement. See 518 U.S. at 500, 116 S.Ct. 2240.
The Court found that issuance of a § 510(k) clearance "did not 'require' Medtronic's pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the MDA process." 518 U.S. at 483-84, 116 S.Ct. 2240. The § 510(k) process thus established no federal requirement "applicable to a device" within the meaning of the MDA. "Similarly, the general state common law requirements [relied upon by Lohr] were not specifically developed 'with respect to' medical devices. Accordingly, they [were] not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements." Id. at 501, 116 S.Ct. 2240. The general obligations imposed by the state common law relied upon by Lohr were "no more a threat to federal requirements than would be a state-law duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a workforce. These state requirements therefore escape pre-emption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be 'with respect to' specific devices such as pacemakers." Id. at 501-02, 116 S.Ct. 2240.
The Court also held that "[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.... The presence of a damages remedy does not amount to the additional or different 'requirement' that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing 'requirements' under federal law." Id. at 495, 116 S.Ct. 2240.
It is, indeed, well established that Congress has not created an express or implied private cause of action for violations of the FDCA or the MDA. It is also true, as the district court pointed out, that this court, in Michael v. Shiley, Inc., 46 F.3d 1316, 1329 (3d Cir.1995), found this fact significant in the course of holding that a common law fraud claim against the manufacturer of a heart valve was preempted by the FDCA. We there concluded:
Under § 360k, states may not impose different requirements and thereby reach a different conclusion than the FDA. "[W]here the FDA was authorized to render the expert decision ..., it, and not some jury or judge, is best suited to determine the factual issues and what their effect could have been on its original conclusions." King [v. Collagen Corp., 983 F.2d 1130,] 1140 [ (1st Cir.1993) ] (Aldrich & Campbell, J.J. concurring). Under the MDA, states have no authority to police Shiley's compliance with the FDA's procedures. If Shiley knowingly misled the FDA in its PMA application, it is for the FDA to remedy that situation using the authority Congress gave it in the MDA.
Further, permitting a fraud claim based on false representations to the FDA would conflict with our precedent that plaintiffs not bring implied causes of action for violations of the Food, Drug and Cosmetic Act. Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir.), cert. denied, 513 U.S. 965, 115 S.Ct. 429, 130 L.Ed.2d 342 (1994). Plaintiffs cannot circumvent this bar by characterizing their cause as a claim for state law fraud.
It is important to note at the outset that, contrary to the district court's suggestion, our alternative rationale in Michael, like our primary one, was necessarily based on the doctrine of preemption. Absent preemption by federal law (or a ground for stay or abstention, doctrines not pertinent here), a district court having jurisdiction of the parties and the subject matter cannot decline to enforce liability imposed by the relevant state common law. See, e.g., Polselli v. Nationwide Mutual Fire Insurance Co., 126 F.3d 524, 527 n. 1 (3d Cir.1997) ("A federal court exercising diversity jurisdiction must apply the substantive law of the state whose laws govern the action."). Cf. Erie R. Co. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938) ("Except in matters governed by the Federal Constitution or by Acts of Congress, the law to be applied in any case is the law of the State."). This is important to understand because " '[t]he purpose of Congress is the ultimate touchstone' in every pre-emption case." Lohr, 518 U.S. at 485, 116 S.Ct. 2240 (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 11 L.Ed.2d 179 (1963)). Unless Congress intends preemption, there is none. Accordingly, where Congress has expressed itself on preemption in a statute, "Congress' intent, of course, primarily is discerned from the language of the pre-emption statute and the 'statutory framework' surrounding it." Id. at 486, 116 S.Ct. 2240 (quoting Gade v. National Solid Wastes Management Assn., 505 U.S. 88, 111, 112 S.Ct. 2374, 120 L.Ed.2d 73 (1992) (Kennedy, J., concurring)).
Under Medtronic's view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for persons injured by defective medical devices. Medtronic's construction of § 360k would therefore have the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order "to provide for the safety and effectiveness of medical devices intended for human use," 90 Stat. 539 (preamble to Act). It is, to say the least, "difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct," Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), and it would take language much plainer than the text of § 360k to convince us that Congress intended that result.
Lohr, 518 U.S. at 487, 116 S.Ct. 2240 (footnote omitted) (plurality).
More fundamentally, however, Lohr teaches that where Congress has expressed its intention with respect to preemption, we should look primarily to what it said. When it looked to what Congress said in § 360k, the Supreme Court in Lohr concluded that Congress did not intend to prevent a state from providing "a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Lohr, 518 U.S. at 495, 116 S.Ct. 2240.
We do not rule out the possibility that there may be some areas of preemption outside the scope of § 360k based on clear and direct conflicts between the requirements of state law and those of the FDCA. The existence of § 360k, its relatively narrow scope, and Lohr 's presumption against preemption of areas traditionally occupied by state law, however, counsel caution in finding implied preemption where no express preemption exists. Here, appellees' argument boils down to a contention that the litigation of suits of this kind is fundamentally inconsistent with the regulatory process established by the FDCA. We see no inconsistency between the FDA having the exclusive prerogative of bringing actions to enforce the FDCA and preserving the right of people in the plaintiffs' position to bring common law fraudulent misrepresentation claims. Moreover, we do not share appellees' apparent perception that litigation of such claims holds the potential for courts and juries second-guessing the FDA. Indeed, there is ample precedent, in related contexts, to support a claim premised on misrepresentations made to a federal agency. See, e.g., Learjet Corp. v. Spenlinhauer, 901 F.2d 198, 202-03 (1st Cir.1990) (allowing aircraft purchaser's claim against manufacturer based on misrepresentation to Federal Aviation Administration); Stanton by Brooks v. Astra Pharmaceutical Products, 718 F.2d 553, 568-69 (3d Cir.1983) (allowing patient's claims against drug manufacturer based on misleading the FDA); Hawkins v. Upjohn Co., 890 F.Supp. 609, 612 (E.D.Tex.1994) (same).
The district court determined that plaintiffs' fraud on the FDA claims should be dismissed because "the alleged fraud cannot be said to have been a proximate cause of plaintiffs' alleged injuries." App. at 158. In the court's view, "[l]egal causation largely fails because the object of plaintiffs' fraud-on-the-FDA claim is the FDA and not the doctors who performed surgeries on the plaintiffs or the plaintiffs themselves.... The causal connection between the alleged fraud committed on the FDA and plaintiffs' alleged injuries is so tenuous, if existent at all, that the former cannot be said to be a 'substantial factor' in causing the latter." App. at 158-59. While we are not in a position to canvass all the potentially applicable law, what we know about tort law generally makes us unwilling to say that all of the plaintiffs' claims will fail for want of the kind of a causation that will give rise to liability.
Another example is provided by our decision in Stanton by Brooks v. Astra Pharmaceutical Products, 718 F.2d 553 (3d Cir.1983). The plaintiff there, who had suffered brain damage as the result of an adverse reaction to the local anesthetic, Xylocaine, recovered a substantial judgment against the manufacturer of the drug. The plaintiff alleged that the defendant had misled the FDA by withholding information it was required to report concerning adverse effects previously suffered by others. We sustained the judgment against an attack that there was no legally sufficient causal connection between the defendant's misleading conduct and the plaintiff's injury. We concluded:
We respectfully disagree in this regard with the conclusion reached by the Court of Appeals for the Seventh Circuit in Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997). It there concluded that our holding in Michael survives Lohr. 126 F.3d at 914. While it did not explain its conclusion, one can infer from its earlier decision in the same case, 67 F.3d 1268, that it believes the first rationale for our decision in Michael retains vitality
The article explains that: "It is an accepted principle that once [the] FDA determines that a drug or device can be marketed, a physician's discretionary use of that product (the practice of medicine) is not restricted to the uses indicated on FDA-regulated labels. Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethic[ists], [the] FDA, and most court recognize." Beck & Azari, supra, at 72. The article points out that the FDA stated in a 1982 Drug Bulletin that: " 'unapproved' or more precisely 'unlabeled' uses may be appropriate and rational in certain circumstances, and may, in fact reflect approaches to drug therapy that have been extensively reported in medical literature... Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations ..." Beck & Azari, supra, at 77. With regard to bone screws in particular, the article quotes the following statement by the FDA in a 1993 publication titled Food and Drug Administration, Update on Pedicle Screws: "In practice, surgeons often use orthopedic screws which FDA has cleared for other purposes ... as pedicle screws. Such use of medical devices for non-approved purposes has traditionally been regulated by the hospitals in which the physicians practice and not by the FDA." Beck and Azari, supra, at 77
See Washington Legal Foundation v. Kessler, 880 F.Supp. 26, 28 n. 1 (D.D.C.1995), Washington Legal Foundation v. Friedman, No. 94-1306, 1998 WL 456372, at * 3 (D.D.C. July 30, 1998) and supra note 1
Recent legislation which, once effective, will supersede the FDA's restriction on distributing printed material underscores the incongruity of the majority's position. The Food and Drug Modernization Act of 1997, Pub.L. No. 105-115, 111 Stat. 2296 (to be codified at 21 U.S.C. § 360aaa, et seq.) permits manufacturers to distribute information about off-label uses of drugs and devices provided certain requirements are met. Among the requirements for a drug, for instance, is that the manufacturer must have submitted an application for approval of the new, off-label use. Thus, manufacturers are allowed to submit applications for new uses and to distribute certain information about the off-label use while an application for the off-label use is still pending. On the majority's theory, will the manufacturer have committed fraud on the FDA, notwithstanding the new statutory provisions, if the manufacturer secures approval for one use, distributes materials on off-label uses in compliance with the statute, and does so while its primary objective is to obtain approval for the off-label use pending with the FDA?