Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Mitchell v. Collagen Corp.

October 2, 1995






Appeal from the United States District Court for the Northern District of Indiana, Hammond Division. No. 93 C 283 -- James T. Moody, Judge.

Before CUDAHY, RIPPLE and KANNE, Circuit Judges.

RIPPLE, Circuit Judge.

ARGUED MAY 19, 1995


In this case, Barbara and Gregory Mitchell appeal the district court's decision denying them leave to amend their complaint and dismissing their state law claims on the ground that they were all preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 360c-360l. For the reasons that follow, although we conclude that some state law claims are not preempted by the MDA, we affirm the judgment of the district court.


A. Facts

In 1988, Barbara Mitchell received several injections of Zyderm or Zyplast (collectively, "Zyderm"), collagen-based products produced by Collagen Corporation. These products are used to correct skin tissue anomalies such as wrinkles. Under the Medical Device Amendments, 21 U.S.C. sec. 360c-360l (MDA), to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. secs. 301-395, Zyderm is classified as a "Class III medical device." Class III devices must be approved by the FDA before they may be sold to the public. 21 U.S.C. sec. 360c(a)(1)(C).

The premarket approval ("PMA") process is used to determine "the safety and effectiveness" of a device with respect to its intended users under the conditions "prescribed, recommended, or suggested" in its labeling. 21 U.S.C. sec. 360c(a)(2). As part of the PMA process, a manufacturer must submit samples of the device, an outline of the device's components and properties, a description of the manufacturing process, safety data, a bibliography of all reports concerning the device's safety and effectiveness, copies of all proposed labeling, and any other information the FDA requests. 21 U.S.C. sec. 360e(c); see also 21 C.F.R. sec. 814.20. The application is referred to a panel of qualified experts for study and submission of a report and recommendation respecting approval. 21 U.S.C. sec. 360e(c)(2); see id. sec. 360c(b)(2) (describing composition of panels). The FDA retains the right to withdraw its approval if it finds that a device previously approved is not safe and effective. 21 U.S.C. sec. 360e(e).

Zyderm's PMA initially was approved in 1981. The FDA approved the PMA for Zyplast, a derivative of Zyderm, in 1985. During 1991-1992, the FDA conducted a re-review of Zyderm and concluded in early 1992 that its PMA approval decision was appropriate.

B. Earlier Proceedings

Following her injections, Barbara Mitchell developed serious medical complications. In 1993, she and her husband filed suit against Collagen in Indiana state court. Their complaint included counts sounding in strict liability, negligence, fraud, mislabeling, misbranding, adulteration, and breach of warranty. Collagen removed the case to federal court. The Mitchells moved to amend their complaint to add a claim under Indiana's Deceptive Consumer Sales Act; Collagen filed for summary judgment on the ground that the Mitchells' claims were preempted by federal law.

The district court denied the Mitchells' motion for leave to amend. 870 F. Supp. 885, 887-89 (N.D. Ind. 1994). The court reasoned that amendment would be futile because the Mitchells' claim would be time-barred under the applicable limitations period. The district court further held that the Mitchells' claim was not saved by their allegation that Collagen had concealed fraudulently their claims. The court reasoned that, even if the Mitchells could rely upon a claim of fraudulent concealment to toll the applicable limitations period, such tolling would occur for only a "reasonable time." The court found the Mitchells' delay in filing suit unreasonable. It noted that the Mitchells knew that Zyderm was related to Barbara Mitchell's injuries since at least 1991 and that they had delayed thirteen months between the time they acquired this information and the time they first filed suit against Collagen, and an additional twelve months before they sought to add the Deceptive Consumer Sales Act claim.

Next, the court determined that the Mitchells' remaining state law claims were preempted. 870 F. Supp. at 889-98. The court focused upon the MDA's preemption provision, which expressly proscribes states from establishing "any requirement . . . different from, or in addition to," the requirements established pursuant to the MDA. See 21 U.S.C. sec. 360k(a). *fn1 Regulations promulgated by the FDA explain that the state "requirements" preempted under section 360k(a) include those "established by statute, ordinance, regulation or court decision." 21 C.F.R. sec. 808.1(b). Relying upon the statutory preemption provision, the court reasoned that Congress intended the MDA amendments to have a broad preemptive effect -- one that encompassed common law causes of action. It further reasoned that, in the case of Class III devices, the detailed premarket approval procedures constituted applicable federal requirements that preempted all state laws that established standards "different from, or in addition to," the federal mandates. To the extent that the FDA's regulations, such as 21 C.F.R. sec. 808.1(d), *fn2 suggested that the MDA amendments preempted only those state laws directed specifically at medical devices, the district court continued, they were inconsistent with congressional intent and entitled to no deference.


There are two basic issues on appeal. First, we must determine whether the district court erred in denying the Mitchells leave to amend their complaint. We review the district court's decision for abuse of discretion. Cleveland v. Porca Co., 38 F.3d 289, 297 (7th Cir. 1994). Second, we must consider whether the district court properly granted Collagen summary judgment on the ground that the Mitchells' remaining state law claims were preempted. We review the district court's grant of summary judgment de novo. Green v. Shalala, 51 F.3d 96, 99 (7th Cir. 1995). Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Id.; see generally Doe v. R.R. Donnelley & Sons Co., 42 F.3d 439, 443-44 (7th Cir. 1994).

A. Denial of Leave to Amend

The Mitchells submit that the district court abused its discretion in denying their motion for leave to amend their complaint. Federal Rule of Civil Procedure 15(a) directs the district courts freely to allow leave to amend a complaint "when justice so requires." Fed. R. Civ. P. 15(a). However, district courts need not entertain futile amendments to the pleadings. Moore v. State of Ind., 999 F.2d 1125, 1128 (7th Cir. 1993); DeSalle v. Wright, 969 F.2d 273, 278 (7th Cir. 1992). Thus, the district court does not abuse its discretion in denying leave to amend when the proposed amendment could not withstand a motion to dismiss. See Bower v. Jones, 978 F.2d 1004, 1008 (7th Cir. 1992) ("An amendment is futile when it . . . could not withstand a motion to dismiss."); see also Moore, 999 F.2d at 1128.

In this case, the Mitchells sought leave to add a claim against Collagen under the Indiana Deceptive Consumer Sales Act. Such claims are subject to a two-year occurrence limitations period. See Ind. Code sec. 24-5-0.5-5(b) ("Any action brought under this chapter may not be brought more than two (2) years after the occurrence of the deceptive act[.]"). Collagen notes that, in this case, the two-year period began to run no later than September 1988, when Barbara Mitchell received her final injection. Therefore, Collagen contends, the limitations period expired well before the Mitchells filed suit in 1993. The Mitchells respond, however, that Collagen should be estopped from raising the limitations period as a defense because Collagen fraudulently concealed their cause of action from them. Collagen replies that the Mitchells should not receive any equitable extension of the limitations period because their delay in seeking leave to amend was unreasonable.

Under Indiana law, when grounds such as fraudulent concealment exist for estopping a defendant from raising the expiration of the statute of limitations as a defense, a limitations period may be extended in equity to allow a plaintiff a reasonable time within which to file suit. See, e.g., Babcock v. Lafayette Home Hosp., 587 N.E.2d 1320, 1324 (Ind. Ct. App. 1992). This equitable extension, however, does not resurrect the full limitations period for the plaintiff. Rather, it affords the plaintiff merely a "reasonable period" in which to file suit. Id.; Yarnell v. Hurley, 572 N.E.2d 1312, 1315 (Ind. Ct. App. 1991); see also Cacdac v. Hiland, 561 N.E.2d 758, 759 (Ind. 1990).

Applying these principles, we cannot say that the district court abused its discretion by denying the Mitchells leave to amend. The Mitchells rely on Collagen's alleged fraudulent concealment as the basis for seeking an extension of the applicable limitations period. However, the Mitchells' own complaint makes clear that they knew Collagen might be the source of their injuries by late 1991. See Complaint, R.1, Ex.A at 3, Count I, para. 10 ("Plaintiffs Barbara and Gregory Mitchell learned that there was a relationship between Defendant Collagen Corporation's products and her injuries in the fall of 1991."). The Mitchells do not explain why they waited twenty-five months after first acquiring this knowledge, or, more particularly, over twelve months after first filing suit against Collagen, to seek leave to add their claim under the Indiana Deceptive Consumer Sales Act. Consequently, the district court did not abuse its discretion in denying leave to amend. The Mitchells' unexplained delay was not reasonable, and, therefore, there would have been no basis for extending the expired limitations period to save their time-barred claim. Cf. Babcock, 587 N.E.2d at 1324-25 (finding unreasonable plaintiff's unexplained failure to file suit until over one year after learning defendant had injured her).

B. Preemption


We begin with a review of the principles that govern preemption analyses. Under the Supremacy Clause, "the 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. Pursuant to this authority, the Congress may preempt state law. Louisiana Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 368 (1986). "Whether federal law pre-empts a state law establishing a cause of action is a question of congressional intent." Hawaiian Airlines, Inc. v. Norris, 114 S. Ct. 2239, 2243 (1994); see Morales v. Trans World Airlines, Inc., 504 U.S. 374, 383 (1992); see also CSX Transp., Inc. v. Easterwood, 113 S. Ct. 1732, 1737 (1993) (stating that preemption "will not lie unless it is 'the clear and manifest purpose of Congress' ") (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).

As the Supreme Court noted in Easterwood, evidence of preemptive purpose "is sought in the text and structure of the statute at issue." 113 S. Ct. at 1737. "If the statute contains an express pre-emption clause, the task of statutory construction must in the first instance focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' pre-emptive intent." Id. Indeed, the existence of an express preemption clause supports an inference that Congress intended to limit the federal statute's preemptive scope to the express terms of the clause, although it "does not mean that the express clause entirely forecloses any possibility of implied preemption." Freightliner Corp. v. Myrick, 115 S. Ct. 1483, 1488 (1995) (discussing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S. Ct. 2608 (1992)). "Pre-emption . . . is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose." Fidelity Fed. Sav. & Loan Ass'n v. De La Cuesta, 458 U.S. 141, 152-53 (1982) (quotations and citation omitted).


We now apply these principles to the MDA. The MDA contains an express preemption provision, 21 U.S.C. sec. 360k(a), that provides:

Except as provided in subsection (b) of this section [not relevant in this case], no 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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.