In re Davol, Inc.

• Decision Date: 05 October 2021
• Docket Number: 2:18-cv-01320
• Parties: IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION This document relates to: Milanesi, et al. v. C.R. Bard, Inc., et al. No. 2:18-cv-01320
• Court: U.S. District Court — Southern District of Ohio

IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION This document relates to: Milanesi, et al.
v.

C.R. Bard, Inc., et al. No. 2:18-cv-01320

No. 2:18-cv-01320

United States District Court, S.D. Ohio, Eastern Division

October 5, 2021

Kimberly A. Jolson, Magistrate Judge

DISPOSITIVE MOTIONS ORDER NO. 3

EDMUND A. SARGUS, JR., UNITED STATES DISTRICT JUDGE

Defendants C.R. Bard, Inc. and Davol, Inc. seek summary judgment on each of Plaintiffs', Antonio Milanesi and Alicia Morz De Milanesi, eleven state-law tort claims. (ECF No. 57.) Defendants also raise objections to exhibits Plaintiffs cite in their response brief. (ECF No. 112.) For the reasons that follow, Defendants' motion (ECF No. 57) is GRANTED IN PART AND DENIED IN PART.

I. Background

Plaintiffs' case is the second bellwether trial selected from thousands of cases in this multidistrict litigation (“MDL”) against Defendants. The Judicial Panel on Multidistrict Litigation described the cases in this MDL as “shar[ing] common factual questions arising out of allegations that defects in defendants' polypropylene hernia mesh products can lead to complications when implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses, foreign body rejection, migration of the mesh, and infections.” (No. 2:18-md-02846, ECF No. 1 at PageID #1-2.)^[1] Plaintiffs raise Florida law claims against Defendants based on the implantation

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of Defendants' Ventralex Hernia Patch in Mr. Milanesi. (ECF No. 15 at PageID #88-93.)

The Ventralex is a prescription medical device used for “umbilical and small ventral” hernia repairs. (ECF No. 57-1 at PageID #419.) The circular mesh patch is made of three layers- two of polypropylene mesh and one of permanent expanded polytetrafluoroethylene (“ePTFE”). (ECF No. 57-5 at PageID #651.) The Ventralex therefore has two sides-one of the polypropylene mesh and one of the ePTFE layer. (ECF No. 57-1 at PageID #418.) The polypropylene mesh side faces the abdominal wall, encouraging tissue to grow into the mesh, thus supporting the hernia repair. (Id.; ECF No. 57-2 at PageID #437.) The ePTFE side faces the intestines and is designed to be smooth with “sub-micronal porosity, ” minimizing tissue attachment, such as adhesions, between the intestines and other viscera and the Ventralex. (ECF No. 57-1 at PageID #418; ECF No. 57-2 at PageID #437.) Sandwiched between the two layers of polypropylene mesh is a monofilament memory coil ring, which was made of polyethylene terephthalate (“PET”) when it was implanted in Mr. Milanesi.^[2] (ECF No. 57-5 at PageID #651.) The ring is designed to help the patch “pop open” and then “lay flat” against the abdominal wall when the Ventralex is folded and inserted through the incision during surgical repair of the hernia. (ECF No. 57-1 at PageID #418, 422.) This feature of the Ventralex is helpful for these hernia repairs because the “pop open” feature allows for a smaller surgical incision, shorter surgeries, and less implanted foreign matter, which are considered advantageous. (ECF No. 57-2 at PageID #437.) The Ventralex patch also has straps on the first layer of polypropylene mesh so that the implanting “surgeon can gently pull on to keep the mesh centered under the hernia.” (Id.; ECF No. 57-5 at PageID #651.) A surgeon “anchor[s]” the mesh to the repair by suturing the straps or “the patch itself” to the edges of hernia

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defect. (ECF No. 57-2 at PageID #437.)

The Ventralex comes in three sizes: small, medium, and large. (Id.) In their surgical “Technique Guide, ” Defendants recommend selecting a Ventralex size “that is approximately twice the size of the hernia defect to provide sufficient coverage.” (ECF No. 57-1 at PageID #419.)

The small and medium sizes were approved for Section 510(k) premarket notification by the Food and Drug Administration (“FDA”) on July 16, 2002.^[3] (ECF No. 57-5 at PageID #653- 56.) Defendants listed the Composix Kugel Mesh as the predicate device. (Id. at PageID #656.) The large size was subsequently brought to market via “a no 510(k) rationale based upon the 510(k) for the Composix Kugel product.” (ECF No. 57-8 at PageID #673.) A no-510(k) rationale is when a 510(k) application does not need to be submitted because the manufacturer has made changes that do not “significantly affect the safety or effectiveness of the device.” (ECF No. 57-9 at PageID #675-76 (citing 21 C.F.R. § 807.81(a)(2)).)

Mr. Milanesi underwent a surgical repair for an approximately two-centimeter umbilical hernia on July 11, 2007. (ECF No. 57-13 at PageID #857.) Dr. Karanbir Gill, Mr. Milanesi's implanting surgeon, decided to use a large Ventralex patch for the repair. (Id. at PageID #858.) A large Ventralex patch has an eight-centimeter diameter. (ECF No. 57-1 at PageID #431.) Dr. Gill considered a non-mesh, or primary, repair, but elected to use the Ventralex because there was “undue tension” and he “could not do a primary repair.” (ECF No. 57-13 at PageID #858.)

In April 2017, about ten years after his surgery, Mr. Milanesi experienced abdominal pain, swelling or bloating, and lack of appetite. (ECF No. 57-15 at PageID #881, pp. 66-67; ECF No.

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57-17 at PageID #917, p. 19.) His primary care provider Dr. Miguel Gutierrez-Diaz, M.D., diagnosed him with a periumbilical hernia and an incisional hernia. (ECF No. 57-16 at PageID #910.) Dr. Guiterrez-Diaz referred him to a surgeon, Dr. Michael J. Caluda, M.D. (Id. at PageID #912.) On May 25, 2017, Dr. Caluda diagnosed Mr. Milanesi with a recurrent entrapped or obstructed ventral incisional hernia and recommended prompt surgery. (ECF No. 57-18 at PageID #942.) During his visual exam, Dr. Caluda noted that the area was red, firm, and swollen; he could not reduce the mass, or flatten it with manual pressure. (Id.)

Dr. Caluda performed surgery on Mr. Milanesi the next day. (ECF No. 57-19 at PageID #945.) He wrote in his operative notes that he had not discovered an entrapped hernia, but “purulent material” and that “[a] loop of the small bowel was densely adherent to the overlying mesh and an erosion of the bowel was evident into an abscess cavity involving a portion of the mesh, which had turned to expose the polypropylene to the bowel at some point, causing an area of adherence.” (Id.) In his deposition, Dr. Caluda clarified that he had found a fistula, “an abnormal connection between the intestine and other structure, ” which eroded into the subcutaneous space through the abdominal wall, and an infection in an abscess cavity. (ECF No. 57-17 at PageID #919, p. 37; PageID #931, p. 117) Dr. Caluda went on, explaining that “[t]here was definitely an opening in the abdominal wall fascia which could be construed as a recurrent hernia but more accurately should be described as part of the infectious process in the small intestinal fistula which had eroded from the abdominal cavity into the subcutaneous space.” (Id. at PageID #919, pp. 36-37.) The “purulent material result[ed] from intestinal contents contacting tissues where they do not belong.” (Id. at p. 37.)

Dr. Caluda excised the infected Ventralex from Mr. Milanesi's abdominal wall and resected the bowel, removing nine centimeters of Mr. Milanesi's small intestine. (Id. at PageID

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#920, pp. 42-45.) Dr. Caluda described the explanted Ventralex as “distorted, ” “firm, ” “not pliable, ” and in a “buckling” shape. (ECF No. 87-2 at PageID #6672, pp. 46-47.)

Several days later, on June 1, 2017, Mr. Milanesi returned for emergency surgery because he had a high-grade post-operative small bowel obstruction. (ECF No. 57-20 at PageID #947.) This obstruction was caused by “adhesions in the right lower quadrant.” (Id.) Dr. Caluda successfully removed the adhesions. (Id.)

Afterwards, Mr. Milanesi developed a recurrent incisional abdominal wall hernia near his previous surgery sites. (ECF No. 87-1 at PageID #6662.) He had “at least two areas of herniation extending laterally from the umbilicus in each direction.” (Id.) The hernia defects were two and three centimeters. (Id.) Both Dr. Caluda and a surgeon from whom Mr. Milanesi sought a second opinion recommended surgical repair. (Id. at PageID #6663.) It does not appear that Mr. Milanesi has had this surgery.

The crux of Plaintiffs' claims is that Defendants knew of certain risks presented by the Ventralex device but marketed and sold the device despite these risks and without appropriate warnings, causing Plaintiffs' injuries. Plaintiffs point to three specific issues with the Ventralex. First, they argue that polypropylene resin oxidatively degrades in vivo. (ECF No. 87 at PageID #6591-92.) Defendants were aware of these risks because the Material Safety Data Sheet (“MSDS”) for polypropylene noted that the material should not be used for human implantation because it can oxidize in the body. (Id. at PageID #6592.) Second, Plaintiffs contend that the ePTFE layer contracts more than the polypropylene, which in combination with the too-weak memory coil ring causes the device to fold or buckle or “potato chip.”^[4] (Id. at PageID #6594-95.)

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The buckling leads to the Ventralex patch pulling away from the abdominal wall and curving in toward the bowel, causing the bare polypropylene side of the Ventralex to adhere to the bowel. (Id. at PageID #6598-99.) Plaintiffs explain that Defendants knew about this issue due to the Composix Kugel device recall for broken memory coil rings, the same rings in the Ventralex device, which Defendants used even though more buckle-resistant options were available. (Id. at PageID #6596-97.) Third, Plaintiffs argue that the ePTFE layer was prone to infection because of the ePTFE layer's small pore size, which is big enough for bacteria to grow in but too small for white blood cells to enter to intercept the bacteria. (Id. at PageID #6600-01.) This risk was known by Defendants' employees, as illustrated by internal documents...