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Grunig v. Johnson & Johnson, a New Jersey Corp.

United States District Court, D. Idaho

December 16, 2019

RONALD GRUNIG and SHANNON GRUNIG, husband and wife, Plaintiffs,
JOHNSON & JOHNSON, a New Jersey Corporation, and ETHICON, INC., a New Jersey corporation, Defendants.


          B. Lynn Winmill U.S. District Court Judge


         Before the Court is Defendants' Johnson & Johnson and Ethicon, Inc. Motion for Summary Judgment. (Dkt. 26.) Also before the Court is Defendants' Motion to Strike. (Dkt. 31.) Oral argument was held on the fully briefed motions on October 22, 2019. After careful consideration of the parties' memoranda, exhibits, and arguments, the Court will grant both the Motion to Strike and the Motion for Summary Judgment.


         The facts below relate to the claims in this action and are not in dispute, unless otherwise noted.

         1. Ethicon Proceed Surgical Mesh

         Defendants manufacture and distribute Ethicon Proceed Surgical Mesh, which “is a sterile, thin, flexible, laminate mesh designed for the repair of hernias and other fascial deficiencies.” (Dkt. 30-10 at 6; Dkt. 30-3 at 8.) Ethicon Surgical Mesh is at the heart of Plaintiffs' claims in this matter.

         The mesh is composed of four layers. (Dkt. 30-3 at 8.) Layer one is oxygenated regenerated cellulose-a plant-based fiber. (ORC). Id. at 8-9. Layer two is a 0.8 mm sheet of polymer film. Id. Layer three is a flexible plastic “Prolene mesh product.” Id. at 8. Finally, another layer of polymer film, this time 0.2 mm thick is placed on top of the Prolene mesh. Id. at 8-9. During production, the layers are heated and moved through a lamination roll. Id. at 8. The process results in the OCR and the Prolene mesh being securely glued to one and other by the adjacent layers of polymer film. Id.

         The OCR layer is a bioabsorbable product. (Dkt. 30-10 at 6; Dkt. 30-3 at 18.) It is designed to “physically separate” the Prolene mesh “from the underlying tissue and organ surfaces during the wound healing period to minimize tissue attachment to the mesh.” (Dkt. 30-10 at 6.) In line with its function, the ORC layer is designed to be completely absorbed by the body within four (4) weeks of implantation. Id. The polymer film also begins to break down and dissipate after surgery. Id. The polymer film is designed to be absorbed by the body within six (6) months of implantation. Id. Thus, approximately 180 days after a hernia repair surgery, only one layer of the product -the Prolene mesh- remains in the body. In a surgical setting, the Prolene side of the mesh is inserted facing the abdominal wall, thus the OCR side faces the abdominal area and organs. Id. It is expected that scar tissue will grow into the Prolene side of the mesh, securing it to abdominal wall allowing for “adequate stabilization” of the fascial defect, i.e. the hernia. Id.

         2. 2010 Hernia Repair Surgery

         In October 2010, Ronald Grunig underwent a ventral hernia repair surgery at Mercy Medical Center in Nampa, Idaho. (Dkt. 1 at 4.) “A hernia is a defect in the connective tissue called facia, and that defect allows the body to push intra-abdominal contents through the defect.” (Ballantyne Dep.; Dkt. 30-4 at 10.) The surgery was performed by Dr. Richard C. Ballantyne, D.O. Id. According to Dr. Ballantyne, he used Ethicon Proceed Surgical Mesh to repair the hernia, given the hernia's relatively large size. Id. at 10-11. There were no complications during the surgery. Id. at 11.

         Notably, Mr. Grunig had undergone one hernia repair surgery and other abdominal surgeries prior to the October 2010 surgery.[1] (Dkt. 26-2, Ex. A; Dkt. 30-4 at 9.) Dr. Ballantyne noted that the prior abdominal surgeries were significant because “with previous repairs and his surgical repair” Mr. Grunig was “going to have a lot of scar tissue, a lot of adhesions, ” which would make it more difficult to repair the hernia. (Dkt. 30-4 at 9.) Dr. Ballantyne testified that, he would have discussed these risks with Mr. Grunig, including the risk of creating more adhesions in the performance of another hernia repair. Id.

         3. 2017 Bowl Obstruction Surgery

         In July 2017, Mr. Grunig experienced several days of nausea, vomiting, pain, discomfort, and abdominal distension. (Dkt. 1 at ¶ 14.) Around July 16, 2017, Mr. Grunig was diagnosed with bowel obstruction and was admitted to the hospital. Id. On July 24, 2017, Dr. Forrest Fredline, D.O., performed an exploratory laparotomy. (Fredline Dep.; Dkt. 30-6 at 6.) During the procedure, Dr. Fredline observed that there were “dense inflammatory attachments between the loops of small intestine, ” and stated that these attachments or adhesions “were between the visera [sic], the small intestine, and the anterior abdominal wall mesh, and there was dilated bowel prior to the area of these attachments and decompressed bowel, distal or after the areas of attachments.” Id.

         Dr. Fredline testified that inflammation resultant from abdominal surgery cause bands of tissue -adhesions-to form. Id. at 6-7. According to Dr. Fredline, because there was mesh present in Mr. Grunig's abdomen, he had adhesions to the mesh. Id. Significantly, Dr. Fredline testified Mr. Grunig “would have had adhesions to the abdominal wall even if he didn't have mesh.” Id. In sum, Dr. Fredline determined that Mr. Grunig's bowel obstruction was caused by the adhesions. Id. During the laparotomy, Dr. Fredline dissected Mr. Grunig's bowel “off of the underlying mesh” and removed “a portion of the mesh” to clear the bowel obstruction. Id. The removed portion of the mesh was not retained or analyzed.[2] (Dkt. 30-9.)

         In March 2018, Mr. Grunig and his wife Shannon Grunig, filed a products liability action against Defendants. (Compl., Dkt. 1.) Therein, Plaintiffs claim Defendants are strictly liable for the defective manufacture and design of the surgical mesh removed from Mr. Grunig, and for failure to warn. Plaintiffs allege also that Defendants are guilty of negligence in design, testing, inspection, manufacture, packaging, labeling, marketing, distributing, and in preparing instructions and warnings regarding the mesh. Plaintiffs seek damages for Mr. Grunig's past, present, and future medical expenses, mental and physical pain and suffering, and for Ms. Grunig's loss of consortium and services. Plaintiffs additionally seek punitive damages.

         In June 2018, Defendants filed their answers to the Complaint. (Answer, Johnson & Johnson, Dkt. 6; Answer, Ethicon, Dkt. 7.) After the discovery period, Defendants filed a joint motion for summary judgment. (Dkt. 26.) Therein, Defendants argue the undisputed material facts show Plaintiffs cannot establish any of their claims as a matter of law, and therefore, this action should be dismissed in its entirety. By separate motion, Defendants also ask the Court to strike portions of an affidavit submitted in support of Plaintiffs' response to the motion for summary judgment. (Dkt. 31.) Defendants argue the affidavit contains inadmissible hearsay statements that do not fall within a recognized hearsay exception. The Court will set forth the relevant standards of law and analyze the merits of Defendants' motions below.


         1. Motion for Summary Judgment

         Summary judgment is appropriate when the evidence, viewed in the light most favorable to the non-moving party, demonstrates “there is no genuine issue of any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Galen v. County of Los Angeles, 477 F.3d 652, 658 (9th Cir. 2007).

         For summary judgment purposes, an issue must be both “material” and “genuine.” An issue is “material” if it affects the outcome of the litigation; an issue is “genuine” if it must be established by “sufficient evidence supporting the claimed factual dispute ... to require a jury or judge to resolve the parties' differing versions of the truth at trial.” Hahn v. Sargent, 523 F.3d 461, 464 (1st Cir. 1975) (quoting First Nat. Bank of Ariz. v. Cities Serv. Co., 391 U.S. 253, 289 (1968)); see also British Motor. Car Distrib. v. San Francisco Auto. Indus. Welfare Fund, 883 F.2d 371, 374 (9th Cir. 1989). “Only admissible evidence may be considered in ruling on a motion for summary judgment.” Stimpson v. Midland Credit Mgmt., Inc., 347 F.Supp.3d 538, 544 (D. Idaho 2018).

         “Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). Evidence includes “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits….” DeVries v. DeLaval, Inc., 2006 WL 1582179, at *5 (D. Idaho June 1, 2006).

         The moving party initially bears the burden to show no material fact is in dispute and a favorable judgment is due as a matter of law. Celotex, 477 U.S. at 323. If the moving party meets this initial burden, the non-moving party must identify facts showing a genuine issue for trial to defeat the motion for summary judgment. Cline v. Indus. Maint. Eng'g & Contracting Co., 200 F.3d 1223, 1229 (9th Cir. 2000). The Court must enter summary judgment if the nonmoving party “fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).

         In considering a motion for summary judgment, a court does not make findings of fact or determine the credibility of witnesses. See Anderson, 477 U.S. at 255. Rather, it must draw all inferences and view all evidence in the light most favorable to the nonmoving party. See Matsushita, 475 U.S. at 587-88; Whitman v. Mineta, 541 F.3d 929, 931 (9th Cir. 2008).

         2. ...

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