Mitchell v. Collagen Corp.

Decision Date07 November 1994
Docket NumberNo. 2:93 CV 283 JM.,2:93 CV 283 JM.
Citation870 F. Supp. 885
PartiesBarbara and Gregory MITCHELL, Plaintiffs, v. COLLAGEN CORPORATION, Defendant.
CourtU.S. District Court — Northern District of Indiana


David Cerven, Joseph Costanza, Sr., East Chicago, IN, for plaintiffs.

Jon Schmoll, Merrillville, IN, Joe Redden, Jr., Houston, TX, for defendant.


MOODY, District Judge.

This is a diversity action in which plaintiffs, the Mitchells, allege that Barbara Mitchell was injured by injections of collagen compounds, Zyderm and Zyplast, manufactured by defendant Collagen Corporation ("Collagen"). The Mitchells seek recovery under several alternative Indiana tort law theories. Before the court for decision is a motion for summary judgment filed by Collagen, and two motions filed by the Mitchells seeking to amend their complaint.

Motions to Amend Complaint

In both motions the Mitchells seek to add to their complaint a claim that Collagen has violated provisions of the Indiana Deceptive Consumer Sales Act, Ind.Code §§ 24-5-0.5-1 et seq. A brief summary of the posture of the case provides helpful context for discussion of the motions.

The Mitchells' complaint against Collagen was filed in state court on January 21, 1993. Collagen then removed the case to this court, and, on December 30, 1993, moved for summary judgment. Collagen asserts that all state law tort theories raised by the Mitchells' complaint are preempted by federal law.

On January 25, 1994, before responding to the summary judgment motion, the Mitchells moved for leave to amend their complaint to add the Deceptive Consumer Sales Act claim. The Mitchells contend that this claim is not preempted, even if all of their other claims are. Collagen immediately objected that the amendment would be futile, the amended complaint on its face showing the Deceptive Consumer Sales Act claim to be barred by the statute of limitations.

On February 17, 1994, the Mitchells filed their second motion to amend, an "amended" motion for leave to file an amended complaint. The purpose of the amended motion was to modify paragraph four of the proposed amended complaint to add the bracketed and italicized portion of the following quotation: "Plaintiffs were not reasonably able to discover or learn that there was a relationship between Defendant COLLAGEN CORPORATION'S products and her injuries until late 1991 ,and sic due to the fraud and concealment of her causes of action by Collagen Corporation." The Mitchells explained that the purpose of this amendment was to make the amended complaint read as "more clearly setting out such fraud and/or fraudulent concealment on the part of Collagen Corporation, which tolls the statute of limitations under the Deceptive Consumer Sales Act."1

Under Rule 15(a) of the FEDERAL RULES OF CIVIL PROCEDURE, the court must freely allow a complaint to be amended "when justice so requires." FED.R.CIV.P. 15(a); DeSalle v. Wright, 969 F.2d 273, 277-78 (7th Cir.1992). It would be oxymoronic to suggest that justice "requires" that an amendment be allowed when the amendment would be futile. Thus, despite the liberality required by Rule 15(a), it is not an abuse of discretion to deny leave to make a futile amendment. Id. When the proposed amendment could not withstand a motion to dismiss, denying leave saves the defendant and the court needless work. Perkins v. Silverstein, 939 F.2d 463, 472 (7th Cir.1991).

The Indiana Deceptive Consumer Sales Act contains a two-year occurrence statute of limitations: "Any action brought under this chapter may not be brought more than two years after the occurrence of the deceptive act...." Ind.Code § 24-5-0.5-5(b). Because the statute unambiguously commences the limitations period on an "occurrence" rather than "accrual" of the cause of action, the period runs from that occurrence regardless whether the resultant damage can be ascertained. See Havens v. Ritchey, 582 N.E.2d 792, 794 (Ind.1991) (construing similar statute of limitations in Indiana Medical Malpractice Act); Weinberg v. Bess, 638 N.E.2d 841, 844 (Ind.Ct.App. 1994) (for medical malpractice, "two-year period begins to run at the occurrence of the negligence rather than at the time the negligence is discovered").

Thus, the statute of limitations began to run in the present case, at the latest, on September 22, 1988, when Barbara Mitchell received her last injection—her last "purchase" of Collagen's product—not in late 1991 at the time she alleges she discovered that her injuries were related to the product. The two-year statute thus expired September 22, 1990, making her complaint filed January 21, 1993, appear untimely. It is this untimeliness that makes the Mitchells' attempt to add an allegation of fraudulent concealment important.

The statute of limitations in the Deceptive Consumer Sales Act is subject to the equitable doctrine of fraudulent concealment, which estops a defendant who has actively deceived a plaintiff from asserting the defense.2 Cwiakala v. Economy Autos, Ltd., 587 F.Supp. 1462, 1466 (N.D.Ind.1984). Thus, taking the allegations of the Mitchells' proposed amended complaint as true, Collagen's fraudulent concealment tolled the running of the two-year statute until late 1991 when the Mitchells learned of Collagen's (alleged) responsibility for her injuries.

The tolling of the limitations period until that time, however, did not allow the Mitchells a fresh two-year period in which to file their complaint. Instead, because "equity supplies what equity requires," their cause of action had to be commenced within a reasonable time. Cacdac v. Hiland, 561 N.E.2d 758, 759 (Ind.1990) (medical malpractice); O'Neal v. Throop, 596 N.E.2d 984, 988 (Ind. Ct.App.1992) ("two-year statute of limitations does not apply under the doctrine of fraudulent concealment ... Instead, a plaintiff claiming fraudulent concealment has a duty to bring the action within a reasonable time after discovering the malpractice.")

Because malpractice actions are (or at least are perceived to be) relatively common and an injury from malpractice often becomes apparent only later, the determination whether a plaintiff relying on fraudulent concealment to toll the limitations period has commenced his/her action in a reasonable time comes up there often. The following periods of delay have been held unreasonable as a matter of law: twenty-two months, Cacdac, 561 N.E.2d at 759 ("delay of twenty-two months ... was not reasonable ... trial court should have granted Dr. Cacdac summary judgment"); thirteen months, Babcock v. Lafayette Home Hospital, 587 N.E.2d 1320, 1324-25 (Ind.Ct.App.1992); twenty-one months, Yarnell v. Hurley, 572 N.E.2d 1312, 1315 (Ind.Ct.App.1991); twenty-two months, Cyrus v. Nero, 546 N.E.2d 328, 331 (Ind.Ct. App.1989); seventeen months, Basinger v. Sullivan, 540 N.E.2d 91, 95 (Ind.Ct.App. 1989); twenty-two months, Spoljaric v. Pangan, 466 N.E.2d 37, 45 (Ind.Ct.App.1984).

In the present case the Mitchells have pleaded that they became aware of the linkage between Collagen's product and Barbara Mitchell's injuries late in 1991. Even though they filed a complaint approximately thirteen months later in January, 1993, they waited twelve more months, until January, 1994, before trying to bring their Deceptive Consumer Sales Act claim, i.e., at least twenty-five months after discovering the connection to Collagen. This twenty-five month delay was unreasonable. Even if it could be argued that the January, 1994, proposed amendment should "relate back" — an argument that the court finds unappealing — to the January, 1993, filing, making the delay only thirteen months, that delay still would be unreasonable. Thus, because it is clear that the Mitchells' Deceptive Consumer Sales Act claim is barred by the statute of limitations, their attempt to add that claim to their complaint is futile, and both of their motions for leave to amend their complaint are DENIED.3

Collagen's Motion for Summary Judgment

Collagen contends that all of the state law causes of action the Mitchells assert are preempted by federal law, thereby entitling Collagen to a judgment of dismissal with prejudice. Alternatively, Collagen contends that as to any claims which are not preempted, the Mitchells have rested on their complaint and have no evidence in support of such claims, entitling Collagen to summary judgment.

Zyderm and Zyplast are classified by the Food and Drug Administration ("FDA") as "Class III medical devices" extensively regulated under the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-395, more specifically, pursuant to the Medical Device Amendments of 1976 ("MDA") thereto, 21 U.S.C. §§ 360c-360l. As explained in both Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir.), cert. denied, ___ U.S. ___, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993), and King v. Collagen Corp., 983 F.2d 1130 (1st Cir.), cert. denied, ___ U.S. ___, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993), the MDA requires that medical devices undergo a rigorous premarket approval ("PMA") process to ensure their safety and efficacy before they can be dispensed to the public.

The MDA prohibits states from subjecting a medical device to "any requirement (1) which is different from, or in addition to, any requirement applicable under the Food, Drug and Cosmetic Act to the device, and (2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under" the Act. 21 U.S.C. § 360k(a). In Stamps and King the Fifth and First Circuits have agreed with Collagen's stance that this provision preempts state tort claims like those the Mitchells have pleaded. The Mitchells respond that both decisions are "patently incorrect" and should not be followed by this court.

There is both a short and long answer to the preemption question debated by the parties. The short answer is that the court agrees with the result reached in Stamps...

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7 cases
  • Mitchell v. Collagen Corp., 94-3946
    • United States
    • United States Courts of Appeals. United States Court of Appeals (7th Circuit)
    • 22 Noviembre 1995
    ...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 limi......
  • Kennedy v. Collagen Corp., 94-15197
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • 27 Noviembre 1995
    ...District courts have addressed Sec. 808.1(d)(1) more often than appellate courts with varied conclusions. Compare Mitchell v. Collagen Corp., 870 F.Supp. 885 (N.D.Ind.1994) (rejecting plaintiffs contention, based upon Sec. 808.1(d), "that state tort laws of general applicability (i.e., not ......
  • England v. Thermo Products, Inc., 3:95-CV-756RM.
    • United States
    • United States District Courts. 7th Circuit. United States District Court of Northern District of Indiana
    • 1 Julio 1996
    ...claim is derivative in nature and wholly depends upon the validity of the spouse's underlying claim. Mitchell v. Collagen Corp., 870 F.Supp. 885, 897-898 (N.D.Ind.1994), aff'd, 67 F.3d 1268 (1995); Bailor v. Salvation Army, 854 F.Supp. 1341, 1356 (N.D.Ind.1994). Since Mr. England's claim ag......
  • Worthy v. Collagen Corp., 05-94-01574-CV
    • United States
    • Court of Appeals of Texas
    • 31 Octubre 1995
    ...The term "relates to" sweeps broadly and encompasses all state requirements that affect medical devices. Accord Mitchell v. Collagen Corp., 870 F.Supp. 885, 892 (N.D.Ind.1994), aff'd, 67 F.3d 1268 (7th Cir.1995). The United States Supreme Court has addressed the scope of the term "relates t......
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3 firm's commentaries
  • Yet Another Update on Medical Abortion Litigation: PhRMA’s Amicus Brief in Support of Petition for U.S. Supreme Court Review of the Fifth Circuit Decision
    • United States
    • LexBlog United States
    • 20 Octubre 2023
    ...727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whet......
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    • LexBlog United States
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    ...727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whet......
  • Another Update on Medical Abortion Litigation
    • United States
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    ...727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whet......

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