Mcgookin v. Guidant Corp..

• Decision Date: 21 January 2011
• Docket Number: No. 71A04–1001–CT–101.,71A04–1001–CT–101.
• Citation: 942 N.E.2d 831
• Parties: Jodi McGOOKIN, as Mother of the Deceased, Samantha Arlene McGookin, Vicky McGookin, Jim McGookin, and Julian E. Smith, Appellants–Plaintiffs,v.GUIDANT CORPORATION, et al., Appellee–Defendant.
• Court: Indiana Appellate Court

942 N.E.2d 831

Jodi McGOOKIN, as Mother of the Deceased, Samantha Arlene McGookin, Vicky McGookin, Jim McGookin, and Julian E. Smith, Appellants–Plaintiffs,

v.GUIDANT CORPORATION, et al., Appellee–Defendant.

No. 71A04–1001–CT–101.

Court of Appeals of Indiana.

Jan. 21, 2011.

Robert J. Palmer, May Oberfell Lorber, Mishawaka, IN, Attorney for Appellants, Jodi McGookin, Vicky McGookin and Jim McGookin.Jeffrey P. Hintermeister, O'Koon Hintermeister, PLLC, Indianapolis, IN, Attorney for Appellant Julian E. Smith.Carl A. Greci, Baker & Daniels LLP, Lynn E. Kalamaros, Dane L. Tubergen, Hunt Suedhoff Kalamaros LLP, South Bend, IN, Robert T. Adams, Matthew D. Keenan, Shook, Hardy & Bacon LLP, Kansas City, MO, Attorneys for Appellee Guidant Corporation, et al.

OPINION

BAKER, Judge.

After their newborn daughter was diagnosed with a heart defect, was given a Guidant pacemaker, and tragically passed away at the age of fourteen months, the appellants filed a state law complaint against Guidant. Among other things, they argue that Guidant should have put specific warnings on the pacemaker labeling related to its implantation into pediatric patients. Because the label had been preapproved by the Food and Drug Administration, however, and Guidant was not required to include the additional warnings, the trial court held that any state law-based failure-to-warn claims were preempted by federal law. Finding that the trial court properly found the claims preempted, we affirm.

Appellants-plaintiffs Jodi McGookin, as mother of the deceased, Samantha Arlene McGookin, Vicky McGookin, Jim McGookin, and Julian E. Smith (collectively, the Appellants) appeal the trial court's order denying their motion to correct error. The Appellants contend that the trial court erred by granting, in part, the motion for summary judgment filed by appellee-defendant Guidant Corporation (Guidant). Among other things, the Appellants argue that the trial court erred by finding a number of their claims regarding a Guidant pacemaker to be preempted by federal law. Finding no error, we affirm.

FACTS

Samantha's Story

Samantha was born on April 27, 2004, with complete heart block, which is a disorder of the heart's electrical system. Complete heart block occurs in people of all ages, and both children and adults with the condition are treated with pacemakers. Pacemakers are medical devices designed to cause the human heart to beat by providing low-voltage electrical impulses delivered from the device through wires, called “leads,” connected to the heart. On April 30, 2004, a Guidant Insignia I Ultra Model 1290 (Insignia 1290) was implanted in Samantha's abdomen and attached to her heart with two unipolar and epicardial leads. Medical records throughout Samantha's life, and testing conducted by Guidant after her death, show that her device provided therapy at all times. On July 9, 2005, Samantha died.

The Insignia 1290

The United States Food and Drug Administration (FDA) must approve all Class III medical devices—such as the Insignia 1290—before they may be commercially distributed. On August 15, 2003, Guidant filed a supplemental application for several devices, including the Insignia 1290. The application contained detailed information regarding the Insignia 1290, including its design, testing, indications for use, contraindications, warnings and precautions, and its Automatic Capture ¹ feature. The application also stated that, consistent with industry practice, pediatric patients had not been included in clinical trials. On November 4, 2003, the FDA approved the Insignia 1290 as a class III medical device, and that approval remains effective today. The FDA's approval included approval of the Insignia 1290 labeling, which is the same today as it was in November 2003.

At the heart of the Appellants' case is their claim that the labeling for Samantha's pacemaker was inadequate because it failed to warn of a lack of testing of the Automatic Capture feature with small children, unipolar epicardial leads, and abdominal implantation. In other words, their complaint challenges labeling expressly approved by the FDA.

On August 25, 2006, the McGookins filed a complaint against Guidant for wrongful death, product liability, breach of express and implied warranties, actual fraud, constructive fraud, negligence, violation of the Indiana Deceptive Consumer Sales Act, and intentional and negligent infliction of emotional distress. Julian Smith, Samantha's father, filed similar claims against Guidant, adding a claim for negligence per se.

On April 1, 2009, Guidant moved for summary judgment based on federal preemption, lack of evidence of defect or causation, and certain claim-specific reasons. On July 22, 2009, the trial court issued an order granting Guidant's motion with respect to the claim for breach of implied warranty. The trial court also held as follows:

To the extent plaintiffs seek to impose liability on the defendants under substantive legal theories on the basis that the Insignia 1290 ... should have been subject to requirements and specifications in addition to or different from the device specific requirements imposed by federal law, including specifically the [FDA] regulations, plaintiffs' claims are preempted by the Medical Device Amendments of 1976 (“MDA”). To the extent plaintiffs seek to enforce or restrain violations of federal law including the MDA, their claims are preempted. To the extent plaintiffs seek to impose liability on the defendants under substantive legal theories that seek monetary damages predicated on challenges to conduct of the defendants allowed by and not in violation of any applicable federal requirements including FDA regulations plaintiffs' claims are preempted.

Appellants' App. p. 22. To the extent that the Appellants' claims were premised on a violation of FDA regulations, the trial court held that the claims were not preempted. The trial court went on to find many genuine issues of material fact as to each of the Appellants' claims except for the implied warranty claim, and it merged the claims based on negligence, negligence per se, actual and constructive fraud, intentional and negligent infliction of emotional distress, and the Indiana Deceptive Consumer Sales Act, into a single cause of action under the Indiana Products Liability Act. The trial court then entered the following order:

1. Defendants' Motion for Summary Judgment is granted as to Plaintiffs ['] claims based on breach of implied warranty....

2. Defendants['] Motion for Summary Judgment is granted as to any claims of plaintiffs that are not premised upon a violation of an applicable federal requirement except for claims based upon an assumed duty and breach of express warranty resulting from representations made by defendants to plaintiffs or plaintiffs' physicians that were not true.

3. In all other respects Defendants' Motion for Summary Judgment is denied.

Id. at 27–28. In a subsequent order, the trial court clarified that the claims folded into the single Indiana Products Liability Act cause of action had not been dismissed.

A ten-day jury trial took place between August 25 and September 4, 2009. All of the Appellants' claims aside from implied warranty and manufacturing defect ² were litigated during the trial. On September 4, 2009, the case was submitted to the jury, with instructions on six substantive claims: product liability based on failure to warn, negligence (based on failure to warn and design defect), negligent and intentional infliction of emotional distress, breach of assumed duty, and breach of express warranty.³ The jury found in favor of Guidant on all claims on September 8, 2009.

On October 8, 2009, the Appellants filed a motion to correct error, alleging, among other things, that the trial court had erred by finding their claims preempted unless they were based on a violation of federal law. Following a hearing, the trial court denied the motion to correct error on December 21, 2009. The Appellants now appeal.

DISCUSSION AND DECISION

I. Standard of Review

The Appellants are appealing the denial of their motion to correct error, which alleged that the trial court erred in granting a portion of Guidant's motion for summary judgment. We review a trial court's ruling on a motion to correct error for an abuse of discretion. Newland Resources, LLC v. Branham Corp., 918 N.E.2d 763, 772 (Ind.Ct.App.2009).

Summary judgment is appropriate only if the pleadings and evidence considered by the trial court show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Owens Corning Fiberglass Corp. v. Cobb, 754 N.E.2d 905, 909 (Ind.2001). If there is any doubt as to what conclusion a jury could reach, then summary judgment is improper. Id.

II. Preemption

The Appellants contend, based on a series of federal and Indiana cases that will be explored below, that the trial court erroneously held that the Appellants' claims were preempted unless the claims were premised on a violation of federal statutes and/or regulations. The substantive crux of their argument is as follows:

... Although Guidant's label complied with the FDA requirements of its premarket approval, other FDA regulations gave Guidant the ability to add to or strengthen those regulations without prior FDA approval. The Indiana Product Liability Act incorporates a “reasonableness” component in determining whether warnings are inadequate. Therefore, it becomes a jury question as to whether Guidant acted reasonably in failing to add to or strengthen its warnings pursuant to 21 C.F.R. § 814.39(d). The label, for example, could have informed consumers and physicians that the pacemaker had not been tested in infants or with epicardial leads, or with an abdominal implant. The label could have stated that use with epicardial leads in infants was contraindicated. The trial court therefore erred in granting Guidant's ...