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Hesik v. Boston Scientific Corp.

United States District Court, District of South Carolina, Aiken Division

November 4, 2014

Jeffrey Allen Hesik, Plaintiff,
Boston Scientific Corporation, Defendant

For Jeffrey Allen Hesik, Plaintiff: John E Parker, William Franklin Barnes, III, Peters Murdaugh Parker Eltzroth and Detrick, Hampton, SC.

For Boston Scientific Corporation, Defendant: Monteith Powell Todd, LEAD ATTORNEY, Sowell Gray Stepp and Laffitte, Columbia, SC; Michael John Carroll, PRO HAC VICE, Shook Hardy and Bacon, Kansas City, MO.


J. Michelle Childs, United States District Judge.

In this products liability action, Plaintiff Jeffrey Allen Hesik (" Plaintiff") alleges that Defendant Boston Scientific Corporation (" Defendant") manufactured and sold a defective defibrillator that proximately caused him to suffer severe and permanent injuries. (See ECF No. 11.) Plaintiff asserts causes of action against Defendant for negligence, breach of express warranty, breach of implied warranties, and strict liability. ( Id. at 4-6.)

This matter is now before the court on (1) a motion by Plaintiff for summary judgment pursuant to Fed.R.Civ.P. 56 (the " Rule 56 motion") on his causes of action for breach of express warranty, breach of implied warranties, and strict liability; and (2) a Rule 56 motion by Defendant as to all of Plaintiffs' claims. (ECF Nos. 69, 70.) For the reasons set forth below, the court GRANTS IN PART AND DENIES IN PART Defendant's Rule 56 motion and DENIES Plaintiff's Rule 56 motion.


On January 6, 2009, Plaintiff was admitted to the Aiken Regional Medical Center in Aiken, South Carolina to receive a new cardiac defibrillator. (ECF No. 11 at 1 ¶ 6.) Plaintiff's existing defibrillator was replaced with Defendant's COGNIS Cardiac Resynchronization Therapy Defibrillator, Model N118, Serial No. 559315 (the " Defibrillator"). ( Id. at ¶ 7.) The Defibrillator was manufactured on May 27, 2008, and it had been approved as a Class III medical device by the United States Food and Drug Administration (" FDA") through the supplemental Pre-Market Approval (" PMA") process. (ECF No. 70-2 at 3 ¶ 6-4 ¶ 11.) The Defibrillator also was packaged and labeled in compliance with all FDA-approved specifications and processes. (ECF No. 70-3 at 4 ¶ 9.) In addition, the Defibrillator came with a warranty (the " Warranty") that covered a period of five (5) years after the date of implantation and was available " only if the pulse generator fails to function within normal tolerances due to defects in materials, workmanship, or design during the warranty period . . . ." (ECF No. 69-4.)

On October 30, 2009, the Defibrillator failed. (ECF No. 11 at 2 ¶ 8.) As a result of the Defibrillator's failure, Plaintiff suffered a complete heart block and atrial fibrillation and had to be transported to Provena St. Joseph Medical Center in Joliet, Illinois. ( Id. at ¶ 9.) On October 31, 2009, the Defibrillator was surgically explanted due to a " Product Performance Issue" [1] and replaced. ( Id. at ¶ 10; ECF No. 69-1 at 4 (referencing ECF No. 69-5).) Defendant's Post Market Quality Assurance Laboratory examined the Defibrillator and issued a CRM Complaint Summary Report (the " CRM Report") explaining the reason for its failure as follows:

Upon receipt at our Post Market Quality Assurance laboratory, external visual inspection noted that the device case was swollen. There was blood in the atrial seal plug cavity and lead barrel. The end of the antenna housing was deformed and bubbled. All seal plugs are intact and all set screws operated normally. This is a version 1 header. An x-ray was performed and found damage at the cell terminal connection area. The pulse generator case was removed and internal visual inspection noted heat damage to the cell, hybrid and framework. Any evidence of the cause of this damage was destroyed.

(ECF No. 69-6.) Thereafter, on December 1, 2009, Defendant issued a Physician Device Advisory Notice (the " PDA Notice"), which notice advised medical personnel that listed models including the Defibrillator may experience performance failure and that the root cause is a " [w]eakened bond between the header and case." (ECF No. 69-7.) After conducting the examination of the Defibrillator, Defendant gave a credit of $25, 056.00 to Provena St. Joseph Medical Center pursuant to the Warranty on the Defibrillator and sent Plaintiff a check for $2, 500.00 to help offset unreimbursed medical expenses remaining from his defibrillator replacement surgery in accordance with its Unreimbursed Medical Expense Program. (See ECF Nos. 69-3, -9, -10.)

On November 21, 2011, Plaintiff filed suit against Defendant in the Aiken County (South Carolina) Court of Common Pleas alleging claims for negligence (Count 1), strict liability pursuant to S.C. Code Ann. § 15-73-10 (1976) (Count 2), and breach of express and implied warranties (Count 3). (See ECF No. 1-1.) On January 3, 2012, Defendant removed the matter to this court on the basis of diversity jurisdiction pursuant to 28 U.S.C. § § 1332, 1441 and 1446. (ECF No. 1.) In response to the allegations in the complaint, Defendants filed a motion on January 10, 2012, seeking dismissal of the complaint under Fed.R.Civ.P. 12(b)(6) due to Plaintiff's failure to state a claim. (ECF No. 8.) Plaintiff then amended his complaint on January 31, 2012, to allege claims for negligence (Count 1), breach of express warranty (Count 2), breach of implied warranties (Count 3), and strict liability pursuant to S.C. Code Ann. § 15-73-10 (1976) (Count 4). (ECF No. 11.) Defendant filed a motion to dismiss the amended complaint for failure to state a claim on March 1, 2012, which motion was denied by the court on November 16, 2012. (ECF Nos. 13, 25.)

On October 3, 2013, the court entered an amended conference and scheduling order that bifurcated discovery in this case into two (2) phases. (ECF No. 50.) The first phase of discovery closed on April 25, 2014, and was limited to the issue of whether Plaintiff's claims are preempted by federal law. ( Id. at 1-3.) Therefore, in accordance with the court's amended scheduling order, Plaintiff and Defendant filed cross motions for summary judgment on May 22, 2014 and May 23, 2014, respectively. (ECF Nos. 69, 70.) Moreover, each party filed a response in opposition to the other's Rule 56 motion on June 23, 2014. (ECF Nos. 74, 75.)

On September 29, 2014, the court held a hearing on the pending Rule 56 motions. (ECF No. 81.)


A. Summary Judgment Generally

Summary judgment should be granted " if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). A fact is " material" if proof of its existence or non-existence would affect the disposition of the case under the applicable law. Anderson v. Liberty Lobby Inc., 477 U.S. 242, 248-49, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A genuine question of material fact exists where, after reviewing the record as a whole, the court finds that a reasonable jury could return a verdict for the non-moving party. Newport News Holdings Corp. v. Virtual City Vision, 650 F.3d 423, 434 (4th Cir. 2011).

In ruling on a motion for summary judgment, a court must view the evidence in the light most favorable to the non-moving party. Perini Corp. v. Perini Constr., Inc., 915 F.2d 121, 123-24 (4th Cir. 1990). The non-moving party may not oppose a motion for summary judgment with mere allegations or denials of the movant's pleading, but instead must " set forth specific facts" demonstrating a genuine issue for trial. Fed.R.Civ.P. 56(e); see Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Shealy v. Winston, 929 F.2d 1009, 1012 (4th Cir. 1991). All that is required is that " sufficient evidence supporting the claimed factual dispute be shown to require a jury or judge to resolve the parties' differing versions of the truth at trial." Anderson, ...

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