Individually v. Advanced Bionics, L.L.C.

• Decision Date: 24 July 2013
• Docket Number: No. C 11–4104–MWB.,C 11–4104–MWB.
• Citation: 958 F.Supp.2d 1029
• Parties: Dennis and Melissa EGGERLING, both individually and as parents and guardians of A.E., their daughter and a minor, Plaintiffs, v. ADVANCED BIONICS, L.L.C., Defendant.
• Court: U.S. District Court — Northern District of Iowa

958 F.Supp.2d 1029

Dennis and Melissa EGGERLING, both individually and as parents and guardians of A.E., their daughter and a minor, Plaintiffs,
v.
ADVANCED BIONICS, L.L.C., Defendant.

No. C 11–4104–MWB.

United States District Court,
N.D. Iowa,
Western Division.

July 24, 2013.

[958 F.Supp.2d 1031]

Brian P. Galligan, Galligan Reid, PC, Des Moines, IA, Edwin E. Wallis, III, John Timothy Edwards, Kevin M. McCormack, Glassman, Edwards, Wyatt, Tuttle & Cox, PC, Memphis, TN, for Plaintiffs.

Stephanie Anne Reedy, Craig Ruvel May, Wheeler Trigg O'Donnell, LLP, Denver, CO, Douglas L. Phillips, Klass Law Firm, L.L.P., Sioux City, IA, for Defendant.

MEMORANDUM OPINION AND ORDER REGARDING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
MARK W. BENNETT, District Judge.

TABLE OF CONTENTS

I.	INTRODUCTION	1032
II.	LEGAL ANALYSIS	1032

A.	Summary Judgment Standards	1032
B.	Bars To Preemption	1033

1.	Issue preclusion	1033
2.	FDA approval as a prerequisite to preemption	1035
3.	“Parallel” state law claims	1036

a.	The scope of MDA preemption	1036
b.	Claims based on non-compliance with general CGMPs	1036
c.	Claims based on non-compliance with the PMA and specific CGMPs	1037

i.	Design defect claims	1037
ii.	Manufacturing defect claims	1038
iii.	Negligent and inadequate testing claims	1039

III.
CONCLUSION
1039

[958 F.Supp.2d 1032]

I. INTRODUCTION

This is another in a series of product liability cases against defendant Advanced Bionics, L.L.C., (AB) concerning an allegedly defective cochlear implant, called the HiRes 90k, with an AstroSeal feed-thru assembly, which was intended to allow some profoundly deaf people to hear. This case arises from the failure and replacement of the cochlear implant received by the minor daughter of plaintiffs Dennis and Melissa Eggerling. In this case, as in several similar cases in other jurisdictions, AB has filed a Motion For Summary Judgment (docket no. 41) on the ground that the Eggerlings' claims are expressly or impliedly preempted by the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA), pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); 21 U.S.C. § 360k(a); Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); and 21 U.S.C. § 337(a).

The Eggerlings counter that their claims are not preempted, because AB is collaterally estopped to assert its preemption defense by contrary determinations in a prior case against it over the same cochlear implant; because the specific cochlear implant that they allege caused their damage was not FDA-approved, where AB had made an unapproved substitution of a critical component, the AstroSeal feed-thru assembly, instead of a Pacific Aerospace and Electronics (PA & E) feed-thru assembly on which pre-market approval (PMA) by the FDA had been based; and because, even if AB might otherwise be able to assert preemption, their negligence and strict liability product liability claims are valid “parallel” claims that are not preempted. ¹ In order to simplify the trial, however, the Eggerlings “withdraw” their claims of breach of warranty, fraud, and intentional infliction of emotional distress.

II. LEGAL ANALYSIS A. Summary Judgment Standards

Summary judgment is only appropriate when “the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any, show that there is no genuine issue of material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c) (emphasis added); see Woods v. DaimlerChrysler Corp., 409 F.3d 984, 990 (8th Cir.2005) (“Summary judgment is appropriate if viewing the record in the light most favorable to the nonmoving party, there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law.”); see generally Celotex Corp. v. Catrett, 477 U.S. 317, 323–24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). “The nonmovant ‘must do more than simply show that there is some metaphysical doubt as to the material facts,’ and must come forward with ‘specific facts showing that there is a genuine issue for trial.’ ” Torgerson v. City of Rochester, 643 F.3d 1031, 1042–43 (8th Cir.2011) ( en banc ) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586–87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)). Summary judgment is particularly

[958 F.Supp.2d 1033]

appropriate when only questions of law are involved, rather than factual issues that may or may not be subject to genuine dispute. See, e.g., Cremona v. R.S. Bacon Veneer Co., 433 F.3d 617, 620 (8th Cir.2006). For instance, “issue preclusion,” which is central to the Eggerlings' resistance, is appropriately adjudicated by summary judgment, because whether or not the elements of issue preclusion are satisfied is a question of law. See Employers Mut. Cas. Co. v. Van Haaften, 815 N.W.2d 17, 22 (Iowa 2012).

B. Bars To Preemption

I note, from the outset, that all of the courts to consider AB's preemption arguments on summary judgment have held that at least some parts of the claims of the plaintiffs in those cases were not preempted. Similarly, I conclude that at least some of the claims presented here also survive AB's Motion For Summary Judgment based on preemption. Notwithstanding the parties' substantial briefing and the Eggerlings' lengthy statement of additional facts, only the Eggerlings' last argument, that they have asserted non-preempted “parallel” state law claims, presents any significant question on AB's Motion For Summary Judgment.

1. Issue preclusion

First, the form of “collateral estoppel” at issue here, “issue preclusion,” presents no bar to AB's assertion of preemption. As the Eighth Circuit Court of Appeals has explained,

[Courts] look to state law in determining whether to apply issue preclusion. See Royal Ins. Co. of Am. v. Kirksville Coll. of Osteopathic Med., Inc., 304 F.3d 804, 807 (8th Cir.2002). “This rule applies [even] when the original judgment is that of another federal court sitting in diversity.” Follette v. Wal–Mart Stores, Inc., 41 F.3d 1234, 1237 (8th Cir.1994) (citations omitted), cert. denied,516 U.S. 814, 116 S.Ct. 66, 133 L.Ed.2d 28 (1995).

Liberty Mut. Ins. Co. v. FAG Bearings Corp., 335 F.3d 752, 758 (8th Cir.2003). Under Iowa law, the state law applicable to the product liability and tort claims at issue in this diversity action, “[i]ssue preclusion prevents parties ‘ “from relitigating in a subsequent action issues raised and resolved in [a] previous action.” ’ ” Employers Mut. Cas. Co., 815 N.W.2d at 22 (quoting Soults Farms, Inc. v. Schafer, 797 N.W.2d 92, 103 (Iowa 2011), in turn quoting Hunter v. City of Des Moines, 300 N.W.2d 121, 123 (Iowa 1981)). More specifically,

The party invoking issue preclusion must establish four elements:

“(1) the issue in the present case must be identical, (2) the issue must have been raised and litigated in the prior action, (3) the issue must have been material and relevant to the disposition of the prior case, and (4) the determination of the issue in the prior action must have been essential to the resulting judgment.”

[Soults Farms, Inc., 797 N.W.2d at 104] (quoting Fischer v. City of Sioux City, 654 N.W.2d 544, 547 (Iowa 2002)); accord Hunter, 300 N.W.2d at 123.

Employers Mut. Cas. Co., 815 N.W.2d at 22. Issue preclusion applies “[w]hen an issue of fact or law is actually litigated” in the prior action, “can be used defensively or offensively,” ² and “applies irrespective

[958 F.Supp.2d 1034]

of the parties' mutuality or privity.” Soults Farms, Inc., 797 N.W.2d at 104. Decisions may be given preclusive effect even during the pendency of an appeal. Employers Mut. Cas. Co., 815 N.W.2d at 25.

Nevertheless “issue preclusion” is not limitless. As the Iowa Supreme Court has also explained, “Even when the requirements of the general issue preclusion rule are present, courts are required to consider if special circumstances exist that make it inequitable or inappropriate to prevent relitigation of the issue previously determined in the prior action.” Hunter v. City of Des Moines Mun. Housing Auth., 742 N.W.2d 578, 584 (Iowa 2007). Several exceptions are summarized in Restatement (Second) of Judgments § 28 (1982). Id. at 585. One such exception is that “ ‘[t]he issue is one of law and ... the two actions involve claims that are substantially unrelated.’ ” Id. (quoting Restatement (Second) of Judgments § 28(2)(a)). The Iowa Supreme Court (and the Restatement) have recognized that, when claims between the same parties are closely related, preclusion applies, because it is unfair to the winning party and an unnecessary burden on the courts to allow relitigation of a legal issue, but if the two actions are substantially unrelated, it would be unfair to preclude relitigation of a legal issue by one party, when other litigants would be free to urge that the legal rule should be rejected. Id. at 586 (citing Restatement (Second) of Judgments § 28, cmt. b ).

The Eggerlings cannot satisfy the first requirement for issue preclusion under Iowa law, because no court has yet considered whether any product liability or tort claims under Iowa law are preempted by the MDA, or even under theRestatement (Third) Of Torts, Product Liability (Restatement (Third)), as adopted by the Iowa courts. See Scott v. Dutton–Lainson Co., 774 N.W.2d 501, 504 (Iowa 2009) (explaining that the Iowa Supreme Court adopted the Restatement (Third) in Wright v. Brooke Group Ltd., 652 N.W.2d 159 (Iowa 2002)). Certainly, that was not so in Sadler v. Advanced Bionics, Inc., Civil Action No. 3:11–CV–00450–H (W.D.Ky.), on which the Eggerlings expressly rely for issue preclusion in this case. Thus, no court has considered the identical issue presented in this case. Employers Mut. Cas. Co., 815 N.W.2d at 22.³

Perhaps more importantly, even if the Eggerlings could satisfy the requirements for issue preclusion, it is inappropriate to apply issue preclusion to the preemption issue in this case....