Court Opinion

ID: 9483796
Source: CourtListenerOpinion
Date Created: 2023-08-05 09:31:49.413858+00
Date Added: 2024-06-11T17:49:50.578143
License: Public Domain

BAILEY ALDRICH, Senior Circuit Judge,
with whom LEVIN H. CAMPBELL, Senior Circuit Judge, joins, concurring.
While we agree with our brother Torruel-la’s result, and a good deal that he says, we approach this case somewhat differently. First, a matter of housekeeping. On December 13, 1991, a year past the scheduled date for completion of the pleadings, plaintiff filed a motion to allow an amended complaint, accompanied by the complaint. On December 17 she wrote defendant that she would withdraw her motion. Defendant, accordingly, did not oppose. On December 27 defendant moved for summary judgment. In opposing defendant’s motion for judgment plaintiff made no mention of the proposed new complaint, but, in fact, she did not withdraw her motion, and the court later allowed it. However, the court’s ultimate order granting summary judgment did not mention the amendment.
At first blush we might agree with defendant’s objection that there were substantive additions in the amended complaint, particularly with relation to fraud. Apart from fraud, the rest of the amended complaint contains six claims as against, originally, two — negligence and breach of implied warranty. There was definitely a purported enlargement — a state tort of strict liability, and a claim of express warranty. While the negligence alleged is limited to designing and producing a dangerous product, and not that the sample sold plaintiff was in some way a departure and individually defective, plaintiff adds mislabeling and misrepresentation, and, finally, failure to warn.
Taking defendant’s now alleged seven sins, we group them as follows. Strict liability (negligent design), implied warranty, negligence, mislabeling, and failure to warn are really all of a piece — failure to warn. On the record it is clear that had there been a warning that the product might cause the disease that plaintiff allegedly suffered she would have no claim under any of these headings. On this basis there is thus no real enlargement by the amended complaint. Express warranty might be enlargement, but there is no basis for claiming it.3 Finally, fraud and misrepresentation are not as newly put as they look. Defendant would have it that the original allegation related only to representations made to the plaintiff. Plaintiff states that she intended her language to include misrepresentations to the agency. Two of her exhibits seeking to raise an issue on the motion for summary judgment bear this out. The amendment should stand, as mere clarification. However, we read fraud more broadly than does our brother, and shall return to it later.
All agree that there is one basic issue: federal preemption. Preemption may apply against state judicial as well as legislative action,4 Cipollone v. Liggett Group, Inc., — U.S. -, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), and may take two forms, express and implied, with a heavy burden upon the party asserting it. Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977). This is especially so when the subject is the state interest in health and safety. Hillsborough County v. Automated Medical Labs, Inc., 471 U.S. 707, 715, 718-19, 105 S.Ct. 2371, 2377-78, 85 L.Ed.2d 714 (1985). The question is Congressional intent. Wood v. General Motors Corp., 865 F.2d 395, 401 (1st Cir.1988), cert. denied, 494 U.S. 1065, 110 S.Ct. 1781, 108 L.Ed.2d 782 (1990). Here, concededly, the statute’s purpose is health protection, but the parties disagree as to its scope. Plaintiff says it is directed to the individual user by keeping harmful products off the market and assuring proper warnings. Defendant says it is also to benefit the public at large by shield*1138ing regulated manufacturers against inconsistent state regulation, including lawsuits. If their legal risks may be too great, worthwhile medical devices may be left in the laboratory, to the public’s loss.
Public health is a valid federal purpose, and Congress can reasonably weigh possible loss to the idiosyncratic few against benefits to the public generally. See, e.g., Mary Beth Neraas, The National Childhood Vaccine Injury Act of 1986: A Solution to the Vaccine Liability Crisis? 63 Wash. L.Rev. 149 (1988). The legislative history shows that this was precisely the Congressional intent. Concededly, the U.S.Code Congressional and Administrative News, 94th Congress, Second Session, Vol. 3, pp. 1070 et seq., Medical Device Amendments of 1976, shows the principal emphasis to be on the protection of the individual user. But it also shows the intent to “encourage ... research and development” and “permit new and improved devices to be marketed without delay.” Infra. Perfection is impossible and a few individuals may be denied full protection at the cost of benefit-ting the rest.
Contained within the Senate Report (94-33)5 are the following.
As medicine progresses, as research makes new breakthroughs, an increasing number of sophisticated, critically important medical devices are being developed and used in the United States. These devices hold the promise of improving the health and longevity of the American people. The Committee wants to encourage their research and development. [1071]
S. 2368 recognizes the benefits that medical research and experimentation to develop devices offers to mankind. It recognizes, too, the need for regulation to assure that the public is protected and that health professionals can have more confidence in the performance of devices. [1075]
The Committee recognizes the rapidly changing nature of the devices field and therefore feels that provisions must be made to amend standards on the basis of improved technology or new scientific evidence. Such amendments should be made in an expedited fashion so that appropriate changes can be rapidly implemented. The purpose of this authority is to permit new or improved devices to be marketed without delay so that the public may have such beneficial devices available to them as soon as possible. [1083]
Translating this into a simple concept, and taking the difference of opinion between the parties to be whether the FDA requirements are merely minimum, or are the total maximum protection afforded the individual user, we believe this a clear demonstration of Congressional choice of the latter. We further find that the comprehensive statutory language conforms thereto.
21 U.S.C. § 360e(c)(l) provides,
(1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain—
(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;
(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;
(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;
(D) an identifying reference to any performance standard under section 360d of this title which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard;
*1139(E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this sub-paragraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;
(F) specimens of the labeling proposed to be used for such device; and
(G) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under section 360c of this title, may require.
Following these detailed requirements, and we note especially, subsection (F), comes Section 360k(a).
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
Particularly in the light of the legislative history we read this as maximum protection and express preemption, leaving no need to seek implications. As all but one of plaintiffs sustainable claims are premised on a failure to warn, preemption here is unavoidable, given the subsection (F) requirement that labels be reviewed by the FDA.
It follows that most of plaintiffs arguments are beside the mark. A few, however, may deserve mention. Plaintiff claims that because of the regulation reported in 21 C.F.R. 814.39(d)(1), to the effect that a manufacturer “may,” without prior approval, make certain changes that enhance safety, defendant had a duty to make such here. It is sufficient to say that to interpret “may” as “should” would unravel the entire garment. Second, citing Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 623, 78 L.Ed.2d 443 (1984), plaintiff says that, if defendant is correct, she has no cause of action. Given an ambiguity, this objection is a factor in statutory, construction, but, of itself, it cannot create an ambiguity, or there could never be preemption. Finally, plaintiff says that the FDA’s preemption regulation, 21 CFR § 808.1(d) conflicts with our result. When a statute is clear the agency interpretation must give way. Hillsborough County, 471 U.S. at 714-15, 105 S.Ct. at 2375-76.
A more troublesome issue is the claim labeled fraud.
FRAUD
... Defendant Collagen Corporation fraudulently obtained FDA approval of the Zyderm PMA, product and labeling, which was a producing or proximate cause of damage and injury to Plaintiff. Defendant ... further acted to suppress the facts, blame injuries or other causes that its product (sic) and prevent disclosure of the true risks.[6]
Plaintiff has a case in point. In Hurley v. Lederle Laboratories Division of American Cyanamid Co., 863 F.2d 1173 (5th Cir.1988), the court, though agreeing with the district court that the FDA regulation with respect to defendant’s vaccine labeling was intended to be preemptive, remanded. At issue was the same tension between protecting idiosyncratic individuals and the public health. Balancing these, the Court concluded,
[Tjhis issue should be presented to the jury in the form of special interrogatories, questioning whether and what information the manufacturer withheld from the FDA, if any, and whether possession of this information would have materially altered the content of the FDA’s warn*1140ing. This special procedure is justified by the federal interest in encouraging manufacturers to produce vaccines, in that those manufacturers need some assurance that if they follow certain prescribed procedures, such as including an FDA-approved warning, they are complying with the law.
Id. at 1180. With respect, one may wonder how “encouraging” manufacturers would view the ruling.7 Rather, we side with the later case of Papas v. Upjohn Co., 926 F.2d 1019 (11th Cir.1991), where the court said, at 1026 n. 8,
To the extent that Hurley purports to recognize an exception to federal preemption of common law tort labeling claims when the federal statute involved explicitly prohibits state regulation of labeling and the federal agency has received incomplete information from the manufacturer, we reject its holding at least as applied to FIFRA-regulated pesticides. Given the FIFRA regulatory scheme, it would be up to the EPA — and not a jury — to determine first (1) whether the information provided was incomplete or inaccurate; (2) whether the omitted information is significant enough to mandate a change in the label; and (3) how, if at all, the label should be corrected.
To prove fraud, plaintiff must show causality. Surely, where the FDA was authorized to render the expert decision on Collagen’s use and labeling, it, and not some jury or judge, is best suited to determine the factual issues and what their effect would have been on its original conclusions. Further, if the court erred, and incorrectly posited the effect on the FDA’s use and labeling decision, this would impose a state requirement “which is different from, or in addition to, any requirement applicable ... to the device.” 21 U.S.C. § 360k(a). In addition to running afoul of the general principle against implying personal causes of action, Royal Bus. Group, Inc. v. Realist, Inc., 933 F.2d 1056 (1st Cir.1991), plaintiff would be breaching the federal dike in the absence of its keeper.
Papas has been vacated and remanded for further consideration in the light of Cipollone, — U.S. -, 112 S.Ct. 2608, but we do not believe this to be a reversal on that point. Our position is consistent with Cipollone, that did not preempt fraud found to be outside the communication targeted by the regulation.8 — U.S. at -, 112 S.Ct. at 2623-24.

. Express warranty might have created a problem for the defense of preemption, cf. Cipollone v. Liggett Group, Inc., - U.S. -, ---, 112 S.Ct. 2608, 2622-23, 120 L.Ed.2d 407 (1992).

. A matter that may have troubled the court in Wood v. General Motors, post. See, also, 21 C.F.R. 808.1(b).

. The Senate bill was passed in lieu of the House bill.

6. As in the original complaint, plaintiff sought treble damages. Though hot mentioned, presumably this demand invoked Mass.G.L. c. 231, § 85J, that awards treble damages in certain cases of “deceit or fraud.” We do not read it, however, as limiting the scope of plaintiff’s claims.

. Indeed, we are reminded of the observation that the British hanged a negligent admiral "pour encourager Ies autres.” Voltaire, Candide, Ch. 23.

. Plaintiff similarly presents a claim for misrepresentation, both to the public and to plaintiff's physician. As the record shows no statements to the public or physicians that go beyond those approved by the FDA, this claim collapses into that of fraud on the FDA.