United States District Court, S.D. California
[Copyrighted Material Omitted]
For Jesus Tapia, an individual, Plaintiff: Matthew R. Lopez, LEAD ATTORNEY, Lopez McHugh, LLP, Newport Beach, CA.
For Davol, Inc., a corporation, Defendant: Eric J. Buhr, LEAD ATTORNEY, Reed Smith LLP, Los Angeles, CA.
ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT DAVOL, INC'S MOTION TO DISMISS [Dkt. No. 6.]
HON. GONZALO P. CURIEL, United States District Judge.
Before the Court is Defendant Davol,
Inc.'s motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). (Dkt. No. 6.) An opposition was filed on July 9, 2015. (Dkt. No. 10.) A reply was filed on July 17, 2015. (Dkt. No. 12.) Based on a review of the complaint, the briefs and the applicable law, the Court GRANTS in part and DENIES in part Defendant's motion to dismiss.
On January 27, 2015, Plaintiff Jesus Tapia (" Plaintiff" ) filed a complaint against Defendants Davol, Inc., Bard Devices, Inc., and C.R. Bard, Inc. (" Defendants" ) for personal injuries suffered as a proximate result of Defendants' negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, sale, and/or post-market surveillance and corrective action of the Bard Composix Kugel Hernia Repair Patch (" Kugel Patch" or " Patch" ). (Dkt. No. 1.) Defendants manufactured and sold the Kugel Patch for use in repairing hernias. (Id. ¶ 2.)
The Kugel Patch at issue was manufactured and sold by Defendants between 2001 and March 2006. (Id. ¶ 22.) The Kugel Patch is a prosthetic device used primarily to repair ventral and inguinal hernias. (Id. ¶ 23.) The Patch is composed of two sides where one side is constructed of a double layer of monofilament polypropylene (mesh), and the other side is a barrier of expanded polytetrafluoroethylene (ePTFE). (Id.) This double layer creates a positioning pocket, in which a polymer " memory recoil ring" is placed. (Id.) During the hernia repair surgery, the Kugel Patch is inserted behind the hernia defect through a small incision. (Id.) The memory recoil ring then allows the Kugel Patch to swing open and maintain its shape during placement. (Id.)
In October 2000, Defendants submitted a section 510(d) notification of intent to market the Kugel Patch with the Federal Drug Administration (" FDA" ). (Id. ¶ 24.) The FDA approved the Kugel Patch for marketing as a Class II medical device in January 2001. (Id.) Immediately after the Kugel Patch was placed on the market, Defendants became aware and obtained knowledge it was defective and causing serious injury to those persons in whom it had been implanted. (Id. ¶ 25.)
Defendants were required to conduct post market surveys as part of the device validation process. (Id. ¶ 26.) On or about January 2006, the FDA inspected a Kugel Patch manufacturing facility which resulted in the FDA issuing an Establishment Inspection Report (" 2006 EIR" ). (Id.) The 2006 EIR found that the post market survey validation process of the device was incomplete and failed to include all data from physicians surveyed during this time, including those which demonstrated unfavorable or " dissatisfied" results. (Id.) According to Plaintiff, these complaints and concerns of physician surveyors were actively concealed by Defendants from Plaintiff, the healthcare community, and other consumers. (Id.)
No later than September 2004, Defendants became aware of serious problems with the weld process involving the memory recoil ring. (Id. ¶ 27.) Despite attempts to correct the problem, the corrective measures were ineffective and the process was still not in control. (Id.) Defendants were aware that these weld issues had existed from the time the Kugel Patch was placed on the market and all current sizes and lots suffered from this
defect. (Id.) Plaintiff alleges this information was intentionally withheld from Plaintiff, the healthcare community, the FDA, and other consumers. (Id.)
According to the 2006 EIR, Davol corporate executives informed the FDA that the spring and summer period of 2005 showed a marked increase in the number of adverse event complaints regarding the Kugel Patch and the memory recoil ring. (Id. ¶ 28.) As of August 2005, Defendants received at least the following adverse event reports: seventeen (17) instances of ring breaks, at least one of which resulted in death; two (2) unexplained bowel perforations; four (4) ring breaks during implant procedures; five (5) cases of device deformity; and eight (8) instances of bowel adhesions to the Patch. (Id.)
Despite the increasing number of complaints and complications arising from the Kugel Patch, Defendants failed to cease distribution or notify Plaintiffs, physicians, hospitals, the FDA, or other consumers of the severity of complications associated with the unreasonably dangerous and defective Kugel Patch until late December 2005. (Id. ¶ 29.)
In December 2005, there was a limited recall of " Extra Large" sized Kugel Patches even though Defendant knew that there were similar serious adverse events as to the nonrecalled Kugel Patch sizes. (Id. ¶ 30.) Defendants also violated federal law by not timely notifying the FDA of the December 2005 recall. (Id.)
The FDA classified the December 2005 recall as a Class 1 recall which is the most serious type of recalls and involve situations where the FDA believes there is a reasonable probability that use of the product will cause serious injury or death. (Id. ¶ 31.)
The recall was due to the breakage of the memory recoil ring that opens the Kugel Patch, under stress or pressure, including the stress of implantation. (Id. ¶ 32.) The Kugel Patch is also known to become deformed and migrate within the body. (Id.) These defects are known to cause severe injuries including, inter alia, perforation of the bowel, ring migration through the abdominal wall, abnormal chronic enteric fistulae, infection, abscesses, bowel obstruction, intense abdominal pain, peritonitis, sepsis, and adhesions between the bowel and the Patch. (Id.) The following conditions are symptoms of these injuries: fever, unexplained or persistent abdominal tenderness, vomiting, abnormal bowel movements, tenderness at implant site, abdominal distention, or other unusual symptoms. (Id.)
On March 24, 2006, Defendants expanded the recall to include the following Kugel Patch sizes: 1) " Oval" Patches, 2) " Large Circle" Patches, and 3) " Large Oval" Patches. (Id. ¶ 34.) In January 2007, Defendants expanded the recall for the second time, to include further production lots of the " Large Oval" and " Large Circle" Kugel Patches. (Id. ¶ 35.)
The FDA inspected the Cranston, Rhode Island Kugel Patch manufacturing facility for the second time from January 23, through March 13, 2007. (Id. ¶ 36.) On April 24, 2007, the FDA issued a " Warning Letter" to Defendants that the inspection again uncovered " serious violations of the law" with regards to the quality assurance programs used in manufacturing the Kugel Patch. (Id.)
These violations were of such a degree and nature that the FDA determined the Kugel Patch to be " adulterated" under section 501(h) of the Federal Food, Drug and Cosmetic Act. (Id.) The warning letter specifically mentions, inter alia, the following violations:
a. Failure to establish and maintain adequate corrective and preventative action procedures which ensure identification of actions needed to correct and
prevent the recurrence of nonconforming product and other quality problems;
b. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained;
c. Failure to document the implementation of corrective and preventative actions;
d. Failure to validate your device's design to ensure that the device conforms to defined user needs and intended uses;
e. Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product.
Around December 15, 2005, Plaintiff Jesus Tapia underwent a hernia repair procedure during which a Bard Composix Kugel Hernia Patch (Ref. # 0010202, Lot # 43IPD472) was implanted. (Id. ¶ 37.) On or about January 27, 2013, Plaintiff Jesus Tapia was admitted to the emergency department at Menifee Valley Medical Center. (Id. ¶ 39.) He presented with redness and pain above his Kugel Patch surgical site. (Id.) He was diagnosed with abdominal wall mesh infection and abscess. (Id.) Around February 3, 2013, Plaintiff underwent emergency surgery to remove the Kugel Patch. (Id. ¶ 40.) During the removal procedure, it was noted that the plastic ring that supported the Kugel Patch broke and caused an enterotomy which led to Kugel Patch infection. (Id.)
As a result, Plaintiff will require continuous monitoring of his Kugel Patch related injuries for the remainder of his life. (Id. ¶ 42.) His physical injuries, proximately caused by his implantation with a Kugel Patch, are severe, life threatening, and permanent, and have adversely impacted the quality of his life. (Id.)
Plaintiff alleges that Defendants knew, or in the exercise of reasonable care should have known, prior to the recalls of the Kugel Patch and prior to its implantation into Plaintiff, that the Patch was not properly developed, tested, designed, manufactured, inspected, marketed, labeled, promoted, distributed and sold, were not suitable for the purpose they were intended, and were unreasonably likely to injure users of the products. (Id. ¶ 45.) Plaintiff also alleges that Defendants did not timely apprise Plaintiffs, the healthcare industry, the FDA, or other consumers of the defective and unreasonably dangerous condition of the Kugel Patch, despite Defendants' knowledge of said condition. (Id. ¶ 46.) Plaintiff further maintains that Defendants misrepresented the known risks inherent in the use of the Kugel Hernia patch. (Id. ¶ 47.)
A. Legal Standard on Federal Rule of Civil Procedure 12(b)(6)
Federal Rule of Civil Procedure (" Rule" ) 12(b)(6) permits dismissal for " failure to state a claim upon which relief can be granted." Fed.R.Civ.P. 12(b)(6). Dismissal under Rule 12(b)(6) is appropriate where the complaint lacks a cognizable legal theory or sufficient facts to support a cognizable legal theory. See Balistreri v. Pacifica Police Dep't., 901 F.2d 696, 699 (9th Cir. 1990). Under Rule 8(a)(2), the plaintiff is required only to set forth a " short and plain statement of the claim showing that the pleader is entitled to relief," and " give the defendant fair notice of what the . . . claim is and the grounds upon which it rests." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).
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