Opinion
No. 10-332.
Filed: September 7, 2010.
JOSEPH EDWARD RUSSELL, Counsel of Record, AUDET PARTNERS LLP, San Francisco, CA.
1. Whether the FDA's approval of the Ancure medical device provides EVT and Guidant with a complete defense to McGuan and Johnson's tort claims.
2. Whether a state tort claim for fraud on patients and physicians, based on violations of Food and Drug regulations, is federally preempted under Buckman.
3. Whether fraud on the FDA, admitted by EVT and Guidant, is admissible evidence in McGuan and Johnson's tort claims. Lohr Buckman Riegel Wyeth Buckman
TABLE OF CONTENTS OPINIONS BELOW.....................................................1 JURISDICTION.......................................................1 CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED................................................1 STATEMENT..........................................................2 A. The Regulatory Structure of the Medical Device Amendments..................................................6 B. Premarket Approval of the Ancure Device and Subsequent Events..............................................8 C. The Ancure Aortic Medical Device Litigation.....................12 D. The Court of Appeal Decision....................................14 REASONS FOR GRANTING THE PETITION..................................16 I. This Case Is Within the Ambit of , , and ...................................20 II. The Leading California Case On Implied Preemption Under Reached the Opposite Conclusion................................................21 III. The Decision Below Is Incorrect...............................24 IV. The Issues Presented Are Recurring and of Great Importance................................................28 CONCLUSION.........................................................30 21 U.S.C. § 360k 21 U.S.C. § 337 CONTENT OF APPENDIX Opinion by California Court of Appeal, 6th District, re McGuan and Johnson (Feb. 9, 2010)...........................................................App. 1 Trial Court Judgment in McGuan (June 13, 2008)..........................................................App. 26 Exhibit to McGuan Judgment, Order (May 19, 2008)..........................................................App. 28 Trial Court Judgment in Johnson (June 13, 2008)..........................................................App. 35 Exhibit to Johnson Judgment, Order (May 19, 2008)..........................................................App. 37 Trial Court Order Denying McGuan Motion to Amend Complaint (June 23, 2008)................................App. 44 Trial Court Order Denying Johnson Motion to Amend Complaint (June 23, 2008)................................App. 46 California Supreme Court Denial of McGuan Petition for Review (June 9, 2010).............................App. 48 California Supreme Court Denial of Johnson Petition for Review (June 9, 2010).............................App. 49 ...............................................App. 50 ................................................App. 51 McGuan Notice of Motion to Amend Complaint (May 12, 2008).................................................App. 53 McGuan Proposed 1st; Amended Complaint (partial; new 7th c/a).........................................App. 56 Johnson Notice of Motion to Amend Complaint (May 12, 2008)..................................................App. 61 Johnson proposed 2nd Amended Complaint (partial; 9th new 10th c/a)...................................App. 65 Bates v. Dow Agrosciences LLC 544 U.S. 431 Buckman Company v. Plaintiffs' Legal Committee 531 U.S. 341 passim Farm Raised Salmon Cases 42 Cal. 4th 1077 cert. den. sub nom. Albertson's Inc. v. Kanter 129 S. Ct. 896 McGuan and Johnson v. Endovascular Technologies Inc. 106 Cal. Rptr. 3d 277 Medtronic, Inc. v. Lohr 518 U.S. 470 passim Rice v. Santa Fe Elevator Corp. 331 U.S. 218 Riegel v. Medtronic, Inc. 552 U.S. 312 passim Wawrzynek v. Statprobe, Inc. 2007 U.S. Dist. LEXIS 80155 Woods v. Gliatech, Inc. 218 F. Supp. 2d 802 Wyeth v. Levine 129 S. Ct. 1187 passim U.S. Const. art. VI 18 U.S.C. § 1001 21 U.S.C. §§ 301 21 U.S.C. § 331 21 U.S.C. § 333 21 U.S.C. § 337 passim 21 U.S.C. § 343-1 21 U.S.C. §§ 360c 21 U.S.C. § 360c 21 U.S.C. § 360e 21 U.S.C. § 360e 21 U.S.C. § 360e 21 U.S.C. § 360i 21 U.S.C. § 360k passim TABLE OF AUTHORITIES CASES: , (2005) .......................................................22, 23, 24 , (2001)........................................ , (2008), , , (2009)................................................16, 21, 22, 23, 24 , , et al., (6th Dist. 2010)...................................................1, 24 , (1996)....... , (1947).................................................................17 , (2008)..... . No. 05-1342, (E.Dist. Penn. 2007)..................................................................28 , (W.D. Virginia 2002)...............................................26, 27 , (2009)............ CONSTITUTIONAL AND STATUTORY PROVISIONS: , cl. 2.............................................2 .....................................................11 et seq............................................3, 6 (a)...................................................11 (a)(2)................................................11 (a).......................................... .................................................21,23 et seq..............................................6 (a)(1)................................................6 (b)(1)(A).............................................7 (b)(1)(B).............................................7 (d)(6)................................................7 ......................................................7 (a)......................................... Labeling and Education Act of 1990 (NLEA) § 343-1..............................................................22 REGULATORY PROVISIONS: 21 CFR § 20.20(a)-(c).................................................8 21 CFR § 803.9(a).....................................................8 21 CFR § 803.50(a)....................................................7 21 CFR § 803.50(b)(2).................................................8 21 CFR § 814.39(c)....................................................7 21 CFR § 814.84(b)(2).................................................7PETITION FOR A WRIT OF CERTIORARI OPINIONS BELOW
The opinion of the Court of Appeal of California, Sixth Appellate District, McGuan and Johnson v. Endovascular Technologies, Inc., et al. (App., infra, 1-25) is reported at 106 Cal. Rptr. 3d 277 (6th Dist. 2010). The judgments of the Santa Clara trial court in McGuan (App., infra, 26-27) and in Johnson (App., infra, 35-36) include as attachments the trial court opinions in its orders granting summary judgment (App., infra, 28-34 and 37-43, respectively), and in its orders denying motions to amend complaint (App., infra, 44-45 and 46-47, respectively), which are unreported.
JURISDICTION
The court of appeal judgment was entered on February 9, 2010. Timely petitions for hearing were denied on June 9, 2010 by the California Supreme Court (App., infra, 48 and 49, respectively). The jurisdiction of this Court is invoked under 28 U.S.C. § 1257.
CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED
The Supremacy Clause of the Constitution provides in relevant part: "[T]he Laws of the United States * * * shall be the supreme Law of the Land * * * any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2.
The relevant provisions of the Medical Device Amendment, 21 U.S.C. § 360k and § 337, are reproduced at App., infra, 70.
STATEMENT
This case raises important, recurring questions relating to the preemptive scope of the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360k(a) and 21 U.S.C. § 337(a), the meaning of this Court's decisions in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and Wyeth v. Levine, 129 S. Ct. 1187 (2009), and the validity of efforts by litigants to circumvent Congress's intent through blanket assertions of federal preemption of genuine claims of serious bodily injuries based on violations of federal regulations.
In 1976, Congress expanded the authority of the Food and Drug Administration (FDA) to regulate medical devices, such as orthopedic bone screws and artificial arterial grafts, by enacting the MDA in order to protect the health and safety of the public. To ensure the effectiveness of the federal regulatory scheme, the MDA provides that no State may impose any requirement relating to the safety or effectiveness of a medical device that "is different from, or in addition to, any requirement applicable * * * to the device" under federal law. 21 U.S.C. § 360k(a). The MDA also provides that "All such proceedings for the enforcement, or to restrain violations, of this Act [ 21 U.S.C.S. §§ 301 et seq.] shall be by and in the name of the United States." 21 U.S.C. § 337(a). These provisions have been the focus of considerable litigation over the past 20 years, and are squarely involved in these cases.
In Lohr, this Court interpreted and examined the foundations of preemption and the MDA's express preemption provision, and that opinion has continued to inform and influence decisions by this and most courts faced with preemption issues. In Buckman, this Court interpreted the MDA enforcement provisions to support an implied preemption of claims of fraud on the FDA, and that opinion has been broadly or narrowly applied. In Riegel, this Court concluded that the preemption provision expressly preempts all state common law claims relating to Class III medical devices, unless those claims are based on violations of FDA regulations, without mentioning the enforcement provisions or Buckman. In Wyeth, this Court reviewed the assertion of implied preemption in a pharmaceutical case, revisited the Buckman enforcement issues. The Buckman opinion, especially after the Riegel opinion, has engendered widespread confusion and conflicts in the lower courts, as reflected in decisions in California and in other state and federal courts. Wyeth clarified implied preemption based on enforcement issues in pharmaceutical drug cases, and could also clarify implied preemption in medical device cases.
The first conflict concerns whether the MDA impliedly preempts claims that a manufacturer deceived patients and their physicians, by violating regulations, which the court below held are preempted under Buckman even though they are parallel claims under Riegel and as such are expressly not preempted by Congress in § 360k(a). In reaching it's holding the court concluded the Buckman "principles" concerning "fraud on the FDA" apply equally to fraud on patients and their physicians, in conflict with this court's Wyeth opinion, and in conflict even with the principles expressed by the California Supreme Court in a case involving other products regulated by the FDA.
Contrary to the plaintiff in Buckman, petitioners have not and do not attack the FDA decision to grant the initial approval or re-approval of the Ancure device as a "but for" cause of their injuries. Their proposed complaint alleges defendants' failure to comply with required regulatory obligations to investigate for serious injuries and issue Medical Device Reports (MDR) about such injuries, as well as the equipment failures which the FDA found had been fraudulently withheld. Pursuant to a strong FDA policy, all of such information in the MDRs would have been made available to the public, including to petitioners and their physicians, to be considered separate and apart from the FDA approval of the device, and formed part of the bases for petitioners' decisions whether to use or not use the device. Such information, unlike information that is intended to only be communicated to the FDA in the application process, is intended for public consumption and thus the withholding or misstating such information to the public amounts to a fraud on patients and their physicians.
The second conflict concerns whether, after the FDA has found it was defrauded by a device manufacturer, the MDA preempts a subsequent state tort claim of injury caused by the device based on the same fraud found by the FDA as well as by additional and related fraud not found by the FDA but discovered in the state action. The court below applied Buckman to defeat petitioners' claim of fraud on the FDA even though in Buckman there was no prior investigation or finding of fraud by the FDA. If permitted, such fraud on the agency evidence would allow state judges and jurors to have the benefit of the FDA's determinations in deciding whether fraud on patients and their physicians contributed to their decisions to use the products, and thereby contributed to the cause of serious injuries.
Respondents' common law fraud on petitioners and their physicians is part of the evidence that includes the regulatory violations found by the FDA and admitted by respondents in the plea agreement briefly mentioned and discussed by the court below. App., infra, 7. The plea agreement resulted in substantial fines and a civil settlement for the government, but not for injured users of the device who were not represented by the government. We know the FDA's response to the fraud it found, which makes highly likely its concurrence with petitioner's claims and appreciation for the discovery by petitioners of respondents' additional violations of regulations.
Both of these issues merit further review.
A. The Regulatory Structure of the Medical Device Amendments
In enacting the Medical Device Amendments of 1976 (MDA) ( 21 U.S.C. §§ 360c et seq.) to the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. §§ 301 et seq.), Congress sought "to provide for the safety and effectiveness of medical devices intended for human use." Lohr, 518 U.S. at 474. The MDA divides medical devices into three classifications: Class I, Class II, and Class III. 21 U.S.C. § 360c(a)(1). The FDA designates as Class III those devices that are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or which "present a potential unreasonable risk of illness or injury." Id. § 360c(a)(1)(C). A Class III device, such as the Ancure Device, receives the most federal oversight, and requires premarket approval by the FDA.
There are two statutory exceptions to the premarket approval requirement for Class III devices not relevant here. They are the "grandfathering provision," 21 U.S.C. § 360e(b)(1)(A) and the "substantially equivalent" provision, 21 U.S.C. § 360e(b)(1)(B), often referred to as the "510(k)" process, after the section number in the original act. See Lohr, 518 U.S. at 478.
Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. 21 U.S.C. § 360e(d)(6)(A)(i). If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application. § 360e(d)(6); 21 CFR § 814.39(c). After premarket approval, the devices are subject to reporting requirements. 21 U.S.C. § 360i. These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of, 21 CFR § 814.84(b)(2), to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred, on a Medical Device Report (MDR), 21 CFR § 803.50(a), and to seek and obtain for the FDA "information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters." 21 CFR § 803.50(b)(2). The policy of the FDA is to make the MDR available to the public after redacting personal identities. 21 CFR § 803.9(a) and 21 CFR § 20.20(a)-(c).
B. Premarket Approval of the Ancure Device and Subsequent Events
The following paragraphs contain the undisputed facts and evidence found by the court below. App., infra, 4-8.
This section contains the undisputed facts and evidence found by the court below, most all of which came from petitioners' civil discovery. App., infra, 4-8. Substantial additional relevant facts and evidence are contained in McGuan and Johnson's opposition to motion for summary judgment, and support for motions to amend. (Record, 941-1988) No discovery was obtained from the FDA or its employees.
In the spring of 1999, defendants filed a premarket approval application for the Ancure Device. On September 28, 1999, the FDA approved the Ancure Device for commercial distribution, subject to certain conditions and requirements. Within the first year after the premarket approval of the Ancure Device, several serious problems arose. They included: a limited recall of some units due to a "monofilament" problem; non-unique serial numbers; "Figure 8" problem involving wire controls; the Cassini Project involving several changes to the device; off-label promotion to the medical services group; jacket retraction problem; handle breaking technique to be used to retract device if it became stuck after the graft was implanted; need for medical device report (MDR) policy; aneurysm rupture; non-validated processes; and labeling mix-ups. In October 2000, several employees informed Guidant about these problems. In response, Guidant initiated both an internal investigation and one by outside auditors. App., infra, 4.
As of December 14, 2000, Guidant was informed of "significant weaknesses in the quality systems" by the outside auditor. Outside counsel also gave its opinion to Guidant that the Ancure Devices "currently being manufactured" were "at least `technically' adulterated" under federal law, presented "a potential risk to the public health," and Guidant's "continued distribution of certain devices . . . expose[d] the devices, the Company and responsible individuals to potential FDA regulatory action." Id., 5.
Guidant assembled a team of employees under the supervision of Steve Wirkus to investigate the safety of the Ancure Device. The team reviewed Ancure case experience forms (E-Forms), voice mail, and complaints. Over 7,600 patients were implanted with the Ancure Device, and approximately 4,400 E-Forms were submitted. Though the E-Forms contained check boxes for equipment malfunctions and comments, they did not contain a check box for injuries except where death was an outcome. According to Wirkus, other injuries could be listed in the comment box, but the data in the comment box was sometimes missing due to the limited size of the box. No one on the team contacted anyone with knowledge of the complaints. In summarizing the data, Wirkus initially acknowledged that the "E-Form data may be under-reported," but a later report stated that the data might be "skewed." Id., 5.
A new E-Form was issued in September 2001, but it [also] had no check boxes or questions about injuries. Id., 5.
After Guidant became aware of an FDA investigation, outside counsel to Guidant wrote a memo indicating that Guidant would stop shipment of the Ancure Device and recall the product due to "deficiencies in the GES regulatory submission and communications with FDA." On March 16, 2001, defendants recalled the Ancure Device. On March 23, 2001, Guidant provided evasive, if not false, information to the FDA. In response to the FDA's request for an audit report, Guidant also sent a report, which stated that it had "found nothing that indicated any intent or desire to hide information from FDA." The FDA subsequently reviewed several MedWatch reports and approved premarket approval supplements. On August 17, 2001, the FDA re-approved the Ancure Device. Id., 6.
Several specific instances of false answers to FDA questions were contained in plaintiffs' opposition to the Motions for Summary Judgment, and were uncontroverted, such as whether anyone had been contacted about whether serious injuries had occurred in the unreported incidents.
In the fall of 2001, the United States Department of Justice began an investigation and subpoenaed the independent auditor reports. Guidant's motion to quash was denied in July 2002. The trial court noted Guidant's use of these reports "for the purpose of influencing the FDA." The trial court also cited the declaration of an FDA representative, who stated that the existence of the reports persuaded the FDA "not to pursue additional regulatory measures beyond those proposed by the company." Id., 6.
Though Guidant played a central role in the fraudulent conduct, EVT entered into a plea agreement in June 2003. EVT pleaded guilty to nine counts of shipping misbranded medical devices ( 21 U.S.C. §§ 331(a), 333(a)(2)) arising from the shipping of nine devices between November 3, 1999, and September 24, 2000, and one count of making false statements ( 18 U.S.C. § 1001), arising from the provision of incomplete information to an FDA inspector in July 2000. The plea agreement also states: "From September 30, 1999 to March 16, 2001, defendant introduced approximately 7,632 Devices into interstate commerce. Between September 30, 1999 and March 16, 2001, defendant filed 172 MDRs [Medical Device Reports] for the delivery system of the Ancure Device. On or about March 23, 2001, defendant disclosed to [the] FDA the existence of approximately 2,628 additional MDRs concerning the delivery system of the Ancure Device that had not been previously reported to [the] FDA, as required by law. . . . On or about March 23, 2001, defendant informed [the] FDA that it had failed to seek prior approval to amend its instruction for use to include the Handle Breaking Technique as legally required." The plea agreement required EVT to forfeit $10.9 million as well as pay a criminal fine of $32.5 million and a civil settlement of $49 million. Id., 7.
As of June 23, 2003, the Ancure Device "was no longer available." Id., 8.
C. The Ancure Aortic Medical Device Litigation
In August 2004, petitioner McGuan filed a complaint in which he alleged severe injuries suffered when he was implanted with the Ancure Device on February 8, 2002. His complaint alleged eight causes of action: strict product liability (failure to warn); strict product liability (Restatement Second of Torts § 402A); negligence; breach of express warranty; breach of implied warranty; fraudulent concealment; punitive damages; and violations of the Consumer Legal Remedies Act. In June 2005, petitioner Johnson filed a first amended complaint in which she alleged severe injuries when she was implanted with the Ancure Device on May 17, 2002. Her complaint alleged the same causes of action as those alleged in McGuan's complaint. However, her complaint also added a cause of action for fraud and misrepresentation. Plaintiffs' complaints focus on defects in the design, testing, and manufacture of the Ancure Device, the failure to warn of all possible adverse side effects, and the fraudulent concealment of the dangers and defects of the product. The complaints do not refer to violations of federal law. App., infra, 8.
On September 22, 2005, respondents filed a motion for summary judgment on the ground that petitioners' claims were preempted by federal law. Petitioners were granted leave to conduct, and did conduct extensive discovery. On May 5, 2008, plaintiffs filed opposition to the summary judgment motion. On May 13, 2008, petitioners McGuan and Johnson noticed motions to amend their complaints (App., infra, 53 and 61, respectively) attaching their proposed amended complaints and supporting their motions with the facts and evidence submitted in opposition to the motions for summary judgment. McGuan added new cause of action, No. Seven (App., infra, 56), and Johnson added new cause of action, No. Ten (App., infra, 65), alleging common law fraud on the FDA as well as on petitioners and their physicians, based on the FDA findings of fraud in June 2003 and on substantial discovered evidence of respondents intentional failures to investigate and report about serious injuries. App., infra, 9.
The trial court granted defendants' motions for summary judgment on the ground that petitioners' claims in their complaints were preempted by 21 U.S.C. section 360k(a) of the MDA. The trial court also ruled that plaintiffs could not avoid preemption by arguing that defendants engaged in fraud-on-the FDA because this claim was preempted under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341. The trial court denied petitioners' motions to amend their complaints, rejecting petitioners' parallel exception argument pertaining to fraud on petitioners and their physicians. Petitioners filed timely notices of appeal following judgments of dismissal. App., infra, 9.
The court below affirmed the trial court's rulings. App., infra, 1. Petitioners McGuan and Johnson timely filed petitions for review with the California Supreme Court, which were denied. App., infra, 48 and 49, respectively.
D. The Court of Appeal Decision
The court below, after discussing at length the principles of federal preemption under 21 U.S.C. § 360k and Riegel, affirmed the dismissal of McGuan's and Johnson's original complaints, holding that the MDA preempts all of their original claims. App. infra, 14. As to appellants' attempted addition of a fraud cause of action, the court discussed "fraud on the FDA" claims under Buckman and rejected the argument that the Department of Justice investigation leading to an agreed conviction in June 2003, and removal of the Ancure device from the market a few days later, was sufficient to overcome the Buckman preemption of "fraud on the FDA" claims. App., infra, 16-19.
The court acknowledged that the new fraud cause of action also contains allegations of "fraud on patients and their physicians" based on violations of federal requirements, and such claims are therefore entitled to be exempted from express preemption under 21 U.S.C. § 360k and this court's Riegel opinion. App., infra, 19.
However, the court then held that the Buckman "principles" concerning implied preemption of "fraud on the FDA" applies "with equal force to claims involving defendants' misrepresentations to plaintiffs and their physicians after March 2001" and, without any further discussion, that "if plaintiffs were allowed to proceed with their state law fraud claims, a finding of liability would also `conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives.'" App., infra, 19.
No evidence exists that the FDA actually investigated violations that occurred after March 2001; thus, the lack of such findings in the Plea Agreement is not surprising. Moreover, the FDA did not find out about Defendants' fraud until July 2002 at the earliest. Furthermore, the FDA's finding or not finding of fraud is not essential to a claim of fraud on patients and their physicians and does not impliedly preempt private state claims for fraud on patients and their physicians, as discussed infra.
Plaintiff's fraud claims are based on violations that occurred before as well as after March 2001. (See App., infra, 14, fn 6 after the first sentence, for a more accurate description of petitioners' argument. The court's description of petitioners' "main issue" on appeal, in the first sentence, is not supported in the record).
The court below then affirmed the denial of petitioners' motions to amend by concluding that "Here, as previously discussed, plaintiffs' proposed amendments could not cure the complaints' defects. Accordingly, the trial court did not abuse its discretion in denying plaintiffs' motions to amend the complaints." App., infra, 22.
REASONS FOR GRANTING THE PETITION
The decision below creates unnecessarily one supreme court conflict between Riegel and Buckman, and extends another between Buckman, Lohr and Wyeth, as to vitally important and frequently recurring issues of federal law: (1) whether common law claims of "fraud on patients and physicians," based on federal regulation violations, are impliedly preempted under 21 U.S.C. § 337, Lohr, Buckman and Wyeth, or whether they are parallel claim exceptions under 21 U.S.C. § 360k and Riegel; and (2) whether this Court's decision in Buckman preempts common law fraud claims based, in part, on FDA findings of fraud.
Moreover, the lower court's preemption ruling is at odds with the principles discussed and laid down by the California Supreme Court in Farm Raised Salmon Cases, 42 Cal. 4th 1077 (2008), cert. den. sub nom. Albertson's, Inc. v. Kanter, 129 S. Ct. 896. The opinion in Farm Raised Salmon Cases directly confronted the question whether fraud claims brought in California courts were preempted by § 337 and Buckman, and concluded that so long as the bases for the claims were identical to federal law such claims would not be preempted.
This Court's guidance in Lohr, Buckman, Riegel and Wyeth is relevant to the preemption issues in this case. Lohr laid down two foundational principles for determining preemption issues, both confirmed by Wyeth:
First, "the purpose of Congress is the ultimate touchstone in every pre-emption case." Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 * * * Second, "[i]n all pre-emption cases, and particularly in those in which Congress has `legislated . . . in a field which the States have traditionally occupied,' . . . we `start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.'" Lohr, * * * "We rely on the presumption because respect for the States as `independent sovereigns in our federal system' leads us to assume that `Congress does not cavalierly preempt state-law causes of action.' Lohr, 518 U.S. at 485 * * * ."Buckman, which involved a single "but for" fraud on the FDA cause of action in a 501K device suit, added to the Lohr principles by denying application of the presumption against preemption when States have traditionally not occupied a field:
Policing fraud against federal agencies is hardly "a field which the States have traditionally occupied," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947), such as to warrant a presumption against finding federal preemption of a state-law cause of action. To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.
Buckman, 531 U.S. at 347.
Then, after discussing the justifications for preempting the "fraud on the agency" claim, the Buckman opinion observed that the FDCA enforcement provisions ( 21 U.S. C.A. 331 thru 334 and 372) allow "the FDA (fn 4) * * * to make a measured response to suspected fraud upon the Agency."
Fn 4 The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: "All such proceedings for the enforcement, or to restrain violations, of this chapter [sic] shall be by and in the name of the United States." 21 U.S.C. § 337(a)."
531 U.S. at 349, emphasis added.
While the text clearly limits the ruling to "fraud on the FDA" claims, footnote 4 in Buckman may have introduced an ambiguity and unintended consequences. The footnote could be interpreted to preempt common law "fraud on patients and physician" as well as all other common law claims based on a manufacturer's "noncompliance with the medical device provisions." The unfortunate effect of this consequence may be the preemption of cases otherwise qualified as an exception from express preemption under 21 U.S.C. 360k and Riegel, and the denial of just compensation for serious injuries caused by a manufacturer's wrongful conduct.
This Court in Riegel formally established the preemption of traditional common law claims brought against manufacturers of Class III medical devices, per congressional intent under § 360k, but noted that the MDA preemption provision did not preempt all possible claims.
State requirements are pre-empted under the MDA only to the extent that they are "different from, or in addition to" the requirements imposed by federal law. § 360k(a)(1). Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case "parallel," rather than add to, federal requirements. Lohr, 518 U.S., at 495.
Riegel, 552 U.S. at 330.
Review of this case would also allow the Court to resolve widespread uncertainty over the meaning of implied preemption under Buckman. In the wake of Buckman, uncertainty exists in lower courts over whether the MDA preempts only "fraud on the agency" claims that clearly state a "but for" causal link to the federal laws, over whether it preempts all claims of fraud that "sound" like fraud on the agency, and even over whether, following Riegel, it preempts all Class III medical device claims whether or not they are based on violations of federal regulations.
Finally, there is uncertainty over whether the principles laid down in Lohr and affirmed in Wyeth have any bearing on the confusion caused by Buckman, e.g., whether the presumption against preemption should apply to claims not involving fraud on the FDA that are also "parallel" to federal requirements.
Because these uncertainties are attributable to ambiguities in the Buckman decision, or the combination of the Buckman, Riegel, Lohr and Wyeth decisions, only this Court can bring clarity to this important area of federal law.
I. This Case Is Within the Ambit of Lohr, Buckman, Riegel and Wyeth
Although the below court acknowledged that petitioners' proposed new cause of action for fraud on petitioners and their physicians stated parallel claims, based on violations of federal regulations, it nevertheless concluded that that they were preempted under Buckman.
Here, though plaintiffs' fraud claims are premised on violations of FDA regulations, that does not resolve the issue. In contrast to Riegel, Buckman was not interpreting the MDA preemption provision. Instead, Buckman relied on implied preemption principles. ( Buckman, supra, 531 U.S. at pp. 348-353.)
Those same principles apply with equal force to claims involving defendants' misrepresentations to plaintiffs and their physicians. . . .
App., infra, 19.
Thus, this case touches all four of this Court's major opinions concerning medical device preemption issues. The below court has conflated implied preemption of "fraud on the FDA" claims to include "fraud on patients and their physicians" claims, based on the misapplication or misreading of this court's Buckman rational, or perhaps based on the unintended ambiguity in footnote 4 of the Buckman opinion. Because the court below merely referenced five pages of discussion in Buckman, it is impossible to understand its reasoning.
II. The Leading California Case On Implied Preemption Under Buckman Reached the Opposite Conclusion
The California Supreme Court in Farm Raised Salmon Cases, 42 Cal. 4th 1077, faced yet another express preemption provision in the FDCA, 21 U.S.C. § 343-1. The plaintiff filed an action alleging that various grocery stores violated state law by selling artificially colored farmed salmon without disclosing to their customers the use of color additives. The court of appeal affirmed the trial court's dismissal of the action after granting defendant's demurrer, based on implied preemption under § 337(a) of the FDCA. The court reviewed relevant federal and state laws, including the express preemption provision pertaining to the Nutritional Labeling and Education Act of 1990 (NLEA), § 343-1, and observed that in contrast § 337 "is a standing provision, providing that `all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.'" Id. at 1087. The Court further observed that § 337 and Buckman are concerned with the enforcement of the FDCA, not with private claims in state court:
§ 377 precludes private enforcement of the FDCA (§ 337(a); ( Buckman) and limits the circumstances under which states may seek to enforce the FDCA in federal court (§ 337(b)). Whether or not § 337 also precludes private claims predicated on state law is the crux of the present litigation and will be discussed at greater length below. ( Id.)
Defendants in Farm Raised Salmon Cases argued that the plaintiffs' claims were impliedly preempted by § 337(a) because "they stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." 42 Cal. 4th at 1089; essentially, the same argument was made by the below court. App., infra, 17.
The California Supreme Court rejected the argument, relying heavily on this court's opinions in Lohr and Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005). First, it cited the existence of a strong presumption established in Lohr and Bates against "the existence as well as the scope of preemption" concerning § 360k, the medical devices preemption provision. 42 Cal. 4th at 1088 ("we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.") Second, it recognized the right of private suits to enforce state laws even though identical to federal FDCA laws, also based on the holdings in Lohr and Bates. Id. at 1093-94.
After a thorough analysis of § 343-1, continuing to draw a parallel to § 360k, Farm Raised Salmon Cases held that the defendants failed to meet their burden of overcoming the "strong presumption against preemption" and accordingly that "section 337 does not impliedly preempt private actions based on violations of state laws explicitly authorized by section 343-1." Id. at pp. 1094-1099.
Petitioners' common law claims in their proposed amended complaints are based on violations of federal regulations and parallel without imposing conflicting standards. The FDA's safety assessment of medical devices post approval is based in large part on the manufacture's reporting of implant incidents after investigation of such incidents to determine if serious injuries occurred. The prosecution of petitioners' private claims based on failures to comply with post-approval requirements therefore helps, and does not hinder, the FDA. In sum, there is no conflict between § 337(a) and petitioners' state law claims, and their motions to amend should have been granted and their claims should not have been preempted.
The below court's McGuan and Johnson opinion is in conflict with Farm Raised Salmon Cases, as well as with Lohr and Bates, and is not justified under Buckman. It is now arguably in conflict also with Wyeth, which reaffirmed the presumption against preemption in drug cases. The presumption should also apply in device cases alleging common law "fraud on patients and physicians" claims since states historically occupied the field.
III. The Decision Below Is Incorrect
The decision is incorrect, at least in one major part. The court's justification for its holding is based on the "trumping" of the Riegel exception with a misapplication of the Buckman rationale pertaining to "fraud on the FDA."
Here, though plaintiffs' fraud claims are premised on violations of FDA regulations, that does not resolve the issue. In contrast to Riegel, Buckman was not interpreting the MDA preemption provision. Instead, Buckman relied on implied preemption principles. ( Buckman, supra, 531 U.S. at pp. 348-353.) Those same principles apply with equal force to claims involving defendants' misrepresentations to plaintiffs and their physicians after March 2001.
App., infra, 19; emphasis added.
There is no discussion or support for the emphasized conclusion, in Buckman or any other authority.
Contrary to the conclusion, petitioners' proposed new cause of action does not limit the time period of respondents' misrepresentations — respondents failed to investigate and report required information before and after March 2001; the FDA found some failures had occurred before March 2001, petitioners found other failures occurred both before and after March 2001. Second, there is no basis in Buckman for applying the principles concerning fraud on the FDA to fraud on petitioners and their physicians; there is no discussion of fraud on patients and their physicians in Buckman, and the plaintiff in Buckman made no such claim.
Preempting petitioners' entire claims grants complete immunity for false representations made to them or their physicians. Put another way, preemption here would eliminate claims that plaintiffs would have had under state law if the MDA had not been enacted. Finally, the "structure and purpose of the statute as a whole" does not support preempting claims of fraud on patients and their physicians. The MDA and its accompanying regulations contemplate giving federal marketing clearance of medical devices the highest priority; but its scheme also contemplates giving some independent guidance to physicians and patients in the form of post-approval medical device reports provided by manufacturers.
Congress' included enforcement powers in the FDCA, just as state and local laws are enforceable by duly appointed agencies. The FDCA provisions do not express a congressional intent that patients cannot seek compensation for wrongs committed, whether prosecuted or not prosecuted by the FDA. Citizens can sue for injuries caused by those who violate state traffic and health laws. Congress' intent, expressed in § 360k and interpreted by Riegel, is that patients who are injured by the device may sue for injuries so long as their claim is based on violations of federal regulations pertaining to the device.
In accord with petitioners' position is Woods v. Gliatech, Inc., 218 F. Supp. 2d 802 (W.D. Virginia 2002). In Woods, Gliatech, the manufacturer of an ADCONN-L medical device, failed to submit required MDRs concerning problems with the device. The MDRs "are publicly available documents. Thus, back surgeons and other medical professionals, potential back surgery patients, and the general public would have had access to the MDRs had Gliatech filed them." 218 F. Supp. 2d at 804. Subsequent to the plaintiff's back surgery, an investigation by the FDA and Department of Justice uncovered Gliatech's failure. Gliatech voluntarily recalled the device and plaintiff filed suit. A criminal information was then filed against Gliatech and a plea agreement was executed admitting violations. Id. The court disposed of Gliatech's preemption argument by distinguishing the case from Buckman by pointing out that "In this case, Woods' fraud claim is based on material misrepresentations to "consumers and users and patients" and not on misrepresentations to the FDA. (Pl. Comp.) It, therefore, avoids the concerns identified in Buckman." Id. at 810. "[P]laintiff can establish his claim `without second-guessing the FDA's decision making' and without endangering important MDA policies." Id.
The court rejects the notion that Congress intended § 360k(a) to preempt traditional common law causes of action in cases where a manufacturer obtained only conditional approval from the FDA to market a medical device, the FDA determined that the manufacturer committed misconduct in the approval process, and the manufacturer pled guilty to fraud on the FDA.
Id.
In the words of Justice Stevens in Lohr,
[Defendant'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." 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," and it would take language much plainer than the text of § 360k to convince us that Congress intended that result.
The court also erred in denying petitioners' claims for "fraud on the FDA." The court below ruled that because the FDA did not formally take action to remove the Ancure device from the market, petitioners' fraud on the FDA claims were preempted by Buckman. App., infra, 18. The only known opinion since Buckman faced with allegations of fraud on the FDA, based on findings of fraud by the FDA, refused to preempt such claims. See Wawrzynek v. Statprobe, Inc., No. 05-1342, 2007 U.S. Dist. LEXIS 80155 (E.Dist. Penn. 2007) ("Because the FDA found that fraud and wrongdoing occurred during the ADCON-L approval process, the door to the Buckman concurrence was opened * * * .").
IV. The Issues Presented Are Recurring and of Great Importance
While fraudulent conduct may not occur as often as unintended negligent conduct, it is perhaps more important in skewing the balance between risk and safety envisioned for the FDA's regulation of medical devices. While the FDA has the legal structure necessary to police fraud in the face of budgetary and economic cycles, as well as regulatory cycles resulting from shifts in political power, it does not always have the budget or political weal to do so. Civil suits claiming fraud on patients and surgeons, based only on violations of federal standards, can only help the FDA achieve the goals it establishes.
On the other hand, compensation for serious injuries has been deprived for many citizens because of the federal preemption of state common law claims. Those seriously injured at the hands of others suffer the consequences. The development of federal preemption in recent years has deprived those seriously injured of the traditional means of seeking compensation from those responsible, without any alternative. The McGuan and Johnson opinion presently stands as a barrier to California courts. This court is the "last resort" for such relief.
The primary issue to decide in this case, because of the below court's conclusion that no amendment to petitioners' complaint would prevent preemption, is the same issue addressed and answered by Justice Stevens in Wyeth: "The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims." Wyeth, 129 S. Ct. at 1191. His conclusion should apply as well to petitioners' petition.
CONCLUSION
The petition for a writ of certiorari should be granted.