Haidak v. Collagen Corp., Civ.A. 98-30056-FHF.

• Citation: 67 F.Supp.2d 21
• Decision Date: 08 October 1999
• Docket Number: No. Civ.A. 98-30056-FHF.,Civ.A. 98-30056-FHF.
• Parties: Debbie P. HAIDAK, Plaintiff, v. COLLAGEN CORPORATION, Defendant.
• Court: U.S. District Court — District of Massachusetts

Page 21

67 F.Supp.2d 21

Debbie P. HAIDAK, Plaintiff, v. COLLAGEN CORPORATION, Defendant.

No. Civ.A. 98-30056-FHF.

United States District Court, D. Massachusetts.

October 8, 1999.

Steven L. Hoffman, Sugarman & Sugarman, Boston, MA, for Debbie P. Haidak, plaintiff.

Joe W. Redden, Jr., W. Curt Webb, Houston, TX, Daniel E. Rosenfeld, Kirkpatrick & Lockhart LLP, Boston, MA, Judith G. Dein, Kirkpatrick & Lockhart, Boston, MA, for Collagen Corporation, defendant.

MEMORANDUM AND ORDER

FREEDMAN, Senior District Judge.

I. INTRODUCTION

Plaintiff Debbie P. Haidak sued defendant Collagen Corporation ("Collagen") for injuries she allegedly suffered from injections of bovine collagen manufactured and sold by Collagen as Zyderm and Zyplast. Haidak's complaint claims negligence in Count I, breach of an implied warranty of fitness in Count II, breach of an implied warranty of merchantability in Count III, and violation of Mass.Gen.Laws ch. 93A in Count IV. Presently before the Court is Collagen's objection to Magistrate Judge Kenneth P. Neiman's March 31, 1999 Report and Recommendation to deny Collagen's motion for summary judgment on all four counts.

II. STANDARD

The Court reviews the magistrate's report and recommendation denying Collagen's motion for summary judgment de novo, see Unauthorized Practice of Law Comm. v. Gordon, 979 F.2d 11, 1213 (1st Cir.1992), but need only review those "portions of the report or specified proposed findings or recommendations to which objection is made," 28 U.S.C. § 636(b)(1); see United States v. Wihbey, 75 F.3d 761, 766-67 (1st Cir.1996); Scott v. Schweiker, 702 F.2d 13, 14 (1st Cir.1983). In conducting de novo review, the Court exercises independent consideration of the facts before it and includes both written findings of fact and a written statement of the reasons for its decision. See United States v. Femia, 983 F.2d 1046, 1993 WL 5893, at *4 (1st Cir. Jan 12, 1993) (Table) (de novo review of detention order). So long as the Court reviews the report and recommendation de novo, it need not enter further findings or opinions but may simply adopt the report and recommendation as its own. See 28 U.S.C. § 636(b)(1); Wihbey, 75 F.3d at 766-67; United States v. Lieberman, 608 F.2d 889, 901 (1st Cir.), cert. denied, 444 U.S. 1019, 100 S.Ct. 673, 62 L.Ed.2d 649 (1980).

III. DISCUSSION

After fully reviewing the record de novo, the Court adopts the magistrate's well reasoned report and recommendation as its own and incorporates it by reference into this Memorandum and Order. See 28 U.S.C. § 636(b)(1). The Court, nonetheless, briefly discusses why Collagen's objections to the magistrate's report and recommendation are not persuasive in this case.

A. Premarket Approval Itself as a Specific Requirement

Collagen claims that the premarket approval ("PMA") process that Zyderm endured pursuant to the Medical Devices Amendments of 1976 ("MDA"), serves as a specific federal requirement preempting Haidak's common law tort claims. In light of Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), however, this argument simply fails to hold water. See Lakie v. SmithKline Beecham, 965 F.Supp. 49, 54 (D.D.C.1997) ("The fact that the PMA process requires certain information and mandates certain procedures from manufacturers does not transform the PMA process itself into a specific federal requirement which triggers preemption and protects a manufacturer from suit."); Comeau v. Heller, 945 F.Supp. 7, 12 (D.Mass.1996) ("The Supreme Court was well aware of the distinction between a PMA-approved device and a § 510(k) — approved device, yet it failed to limit the Medtronic holding to the latter."); Sowell v. Bausch & Lomb, Inc., 230 A.D.2d 77, 84, 656 N.Y.S.2d 16 (1997) ("[W]hile a PMA review is considerably more rigorous and detailed than the premarket notification process at issue in Medtronic, it is, in fact, no more `specific' a requirement."). As a result, the Court concludes that Collagen has not established that the PMA process is itself a specific federal requirement.

B. King as Binding Precedent

Collagen next contends that King v. Collagen Corp., 983 F.2d 1130 (1st Cir.), cert. denied, 510 U.S. 824, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993), mandates summary judgment in its favor. The Court, however, is bound to follow the Supreme Court's majority holding in Lohr, instructing that the federal requirements imposed by the Food and Drug Administration ("FDA") must be specific, even in light of the rigors imposed by the PMA process. See Lohr, 518 U.S. at 506-07, 116 S.Ct. 2240 (Breyer, J., concurring). Concluding that "the MDA's pre-emption provision is highly ambiguous," Justice Breyer's concurring opinion, and the majority holding, relied specifically on 21 C.F.R. § 808.1(d) to aid in its limitation of preemption to cases of "specific [federal] requirements applicable to a particular device." Id. 505-07, 116 S.Ct. 2240.

In contrast, the First Circuit's earlier opinion in King concluded that Congress's intent that the FDA regulations serve as "the total maximum protection afforded the individual user" was so clear that it specifically declined to consider the FDA's preemption regulation, 21 C.F.R. § 808.1(d). King, 983 F.2d at 1138-39. Because the majority opinion's statement of the law in Lohr directly opposes the First Circuit's legal basis for its prior holding in King, this Court disagrees with Collagen's contention that King remains binding precedent and looks for guidance to other circuits.

C. PMA of Zyderm and Zyplast as Specific Requirements

Collagen further claims that the specificity of the FDA's examination of Zyderm and Zyplast qualify its PMA of the two products as specific requirements worthy of preempting Haidak's state common law claims. The Court finds instructive the Eleventh Circuit's comprehensive treatment of PMA preemption after Lohr in Goodlin v. Medtronic, 167 F.3d 1367 (11th Cir.1999). In Goodlin, the court followed Justice Breyer's examination of 21 C.F.R. § 808.1(d), and concluded that federal pre-emption hinged upon "(1) the imposition of a specific federal requirement that (2) applied to a particular device and (3) focused on the safety and effectiveness of the device." Id. at 1372.

Of particular interest to this case is the Eleventh Circuit's conclusion that "[d]espite the specificity and considerable rigor of [the PMA application conditions set out in 21 U.S.C. § 360e(c)(1)], neither the FDA's actual review of a device and its supporting information nor the agency's eventual approval of the device imposes any ascertainable requirement upon the device." Id. at 1375. Rather, the FDA simply issues an approval letter and a generic insert titled "Conditions of Approval," which Collagen also received in this case. See id.; Defendant Collagen Corporation's Objections to U.S. Magistrate Judge's Report and Recommendation Regarding Defendant's Motion to Dismiss or for Summary Judgment, Exhibit A. Simply stated, "because the approval itself neither reveals nor imposes any ascertainable substantive prerequisite for approval" that the Court could compare to any of Haidak's common law claims, the approval does not qualify as a specific requirement. Goodlin, 167 F.3d at 1376; see Sowell, 230 A.D.2d at 84, 656 N.Y.S.2d 16.

Collagen counters that the Texas Supreme Court's decision in Worthy v. Collagen Corp., 967 S.W.2d 360, 376 (Tex.1998), establishes that the products at issue here meet the required specificity. Because the Worthy decision does not address the lack of specificity in the approval letter and the conditions of approval insert, but rather focuses on the volumes of information Collagen submitted to the FDA and the FDA's conclusion that Zyderm "had been shown to be safe and effective," the Court finds Worthy's conclusion unpersuasive. See id.

As a result, the Court concludes that the FDA's PMA process for both Zyderm and Zyplast, while rigorous, does not meet the specificity required by Lohr and discussed in Goodlin. Consequently, Collagen fails to meet its burden of establishing that the PMA process preempts Haidak's state common law claims and that it is entitled to judgment as a matter of law.¹

IV. CONCLUSION

For the foregoing reasons, the Court DENIES defendant Collagen's Motion for Summary Judgment.

It is So Ordered.

NEIMAN, United States Magistrate Judge.

REPORT AND RECOMMENDATION REGARDING DEFENDANT'S MOTION TO DISMISS OR ALTERNATIVELY FOR SUMMARY JUDGMENT (Docket No. 2)

Debbie P. Haidak ("Plaintiff")'s complaint, originally filed in Berkshire Superior Court, alleges that she was injured by an adverse reaction to injections of Zyderm and Zyplast, products manufactured and sold by Collagen Corporation ("Defendant"). In Count I, Plaintiff claims that Defendant's negligence caused her personal injuries. In Count II, Plaintiff claims that Defendant breached an implied warranty of fitness for a particular purpose, and in Count III Plaintiff claims that Defendant breached an implied warranty of merchantability. In Count IV, Plaintiff alleges a violation of M.G.L. ch. 93A. Plaintiff's complaint was removed to this court on April 9, 1998.

Presently before the court is Defendant's motion to dismiss or, alternatively, for summary judgment. In essence, Defendant asserts that the the Medical Device Amendments of 1976 ("MDA") preempt Plaintiff's claims as a matter of law. Defendant argues that, since the subject products went through a rigorous premarket approval process with the Food and Drug Administration ("FDA") pursuant to the MDA, Plaintiff's state law claims would lead to inconsistent or different requirements than those imposed by the FDA, thus triggering preemption.

Defendant's motion has been referred to the court for a report and recommendation pursuant to Rule 3 of the Rules for United States Magistrates of the United States District Court for the District of Massachusetts. See 28 U.S.C. § 636(b)(1)(B). Without objection, the...