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Eggerling v. Advanced Bionics, L.L.C.

United States District Court, N.D. Iowa

July 24, 2013

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

Page 1030

For Dennis Eggerling, both Individually and as parents and guardians for AE their daughter and a minor, Melissa Eggerling, both Individually and as parents and guardians for AE their daughter and a minor, Plaintiffs: Brian P Galligan, LEAD ATTORNEY, Galligan Reid, PC, Des Moines, IA; Edwin E Wallis , III, John Timothy Edwards, Kevin M McCormack, LEAD ATTORNEYS, PRO HAC VICE, Glassman, Edwards, Wyatt, Tuttle & Cox, PC, Memphis, TN.

For Advanced Bionics, LLC, Defendant: Stephanie Anne Reedy, LEAD ATTORNEY, Craig Ruvel May, Wheeler Trigg O'Donnell, LLP, Denver, CO; Douglas L Phillips, Klass Law Firm, L.L.P., Sioux City, IA.

OPINION

Page 1031

MARK W. BENNETT, U.S. DISTRICT COURT JUDGE.

MEMORANDUM OPINION AND ORDER REGARDING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

TABLE OF CONTENTS

I. INTRODUCTION

II. LEGAL ANALYSIS

A. Summary Judgment Standards

B. Bars To Preemption

1. Issue preclusion

2. FDA approval as a prerequisite to preemption

3. " Parallel" state law claims

a. The scope of MDA preemption

b. Claims based on non-compliance with general

CGMPs

c. Claims based on non-compliance with the

PMA and specific CGMPs

i. Design defect claims

ii. Manufacturing defect claims

iii. Negligent and inadequate testing claims

III. CONCLUSION

Page 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

Page 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 ...

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