A Missouri resident sued Davol Inc.,on March 10th of 2009 in the U.S. District Court for the Eastern District of Missouri. The lawsuit provides the following background information regarding the Kugel Hernia Patches:
6. Plaintiff's action involves patches containing a hard “memory recoil ring” (or “PET coil ring”) that surrounds the mesh, which was first manufactured by Surgical Sense, Inc., starting in or around 1996, acquired by Defendant Davol in 2000, and then manufactured by Defendant Davol between 2001 and March 2006. These Kugel Patches were sold by Defendant Davol for implantation in patients in the course of hernia repair surgery.
7. A hernia occurs when the stomach muscles are too weak to contain the intestines, and as a result, a rupture occurs in the muscle wall which allows the intestines to protrude. The Kugel Patch was designed to treat ventral hernias caused by the thinning or stretching of scar tissue that forms after surgery.
8. The Kugel Mesh line of products was first manufactured by Surgical Sense, Inc., starting in or around 1996. In January of 2000, Bard acquired the assets and Kugel Patch product line of Surgical Sense, Inc. Shortly thereafter, in 2001, Davol introduced the Kugel Patch. The Kugel Patches manufactured by Surgical Sense, Inc., and the patches manufactured by Defendant, were approved for sale by the U.S. Food and Drug Administration, hereinafter “FDA”, under 510(k) premarket notification submissions.
9. The Kugel Patch, invented by Robert D. Kugel, M.D., is a polypropylene mesh prosthetic device developed to repair ventral hernias, or hernias of the abdominal region. The Kugel Patch is inserted behind the hernia defect in the abdomen through a small incision. In order to fit through the small incision the mesh is folded in half. Once inside the abdomen, the mesh re-deploys as a result of a hard “memory recoil ring” (or “PET coil ring”) that surrounds the mesh.
10. Due to defects in the design and manufacture of the Kugel Patch, the “memory recoil ring” (or “PET coil ring”) that opens the patch can break under the stress of placement of the product in the intra-abdominal space. Once the memory recoil ring has broken, it can come loose and cause serious injuries as it travels through the body. These injuries include intestinal perforations, ring migration through the abdominal wall; abscesses; bowel obstruction and sepsis; and chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Plaintiff, Lisa Taylor, by and through her attorneys, brings this action alleging the following, upon information and belief:
Nature of the Action
1. Plaintiff brings this action against Davol, Inc. (hereinafter “Davol”), for its sale and distribution of defective hernia patches sold under the product names Kugel(R) Hernia Patch, Bard(R) Kugel(R) Hernia Patch, and Bard(R) Composix(R) Kugel(R) Hernia Patch (hereinafter “Kugel Patch”). Defendant Davol's defective product was surgically implanted into the body of the Plaintiff. The Kugel Patch presents, and will continue to present, a substantial risk of injury or death to the Plaintiff. As a result, Plaintiff has been injured and will need continual and ongoing medical monitoring.
Parties
2. Plaintiff Lisa Taylor (hereinafter “Plaintiff”) is an individual citizen and resident of the County of St. Charles, State of Missouri. During the relevant time period, Plaintiff had hernia repair surgery which included the implantation of a Kugel Patch into her body.
3. Defendant Davol, Inc. (hereinafter “Davol”) is and was a wholly owned subsidiary of C.R. Bard, Inc. (hereinafter “Bard”) with its principal place of business at 100 Sockanosset Crossroads, P.O. Box 8500, Canston, Rhode Island 02920, County of Providence. Defendant Davol has a registered agent in Rhode Island at CT Corporation System, 10 Weybosset Street, Providence, Rhode Island 02903. At all times relevant, Davol was a corporation duly organized and existing under the laws of the state of Delaware, with its principal place of business of manufacturing hernia surgical repair products in Canston, Rhode Island. Defendant Davol designed, manufactured, tested, analyzed, distributed, recommended, merchandised, advertised, promoted, supplied and sold to distributors, physicians, hospitals and medical practitioners, certain hernia surgical repair products to be surgically implanted in patients throughout the United States.
Jurisdiction and Venue
4. This court has diversity jurisdiction over the parties pursuant to 28 U.S.C. §1332(a). Plaintiff and no defendant is a citizen of the same state as Plaintiff and the amount in controversy exceeds $75,000, exclusive of interest and costs.
5. Venue in this judicial district is proper pursuant to 28 U.S.C. §1391(c) because Defendant Davol is a corporation. A corporation is deemed to reside in any judicial district where its contacts would be sufficient to subject it to personal jurisdiction at the time the action is commenced. Defendant Davol distributed, recommended, merchandised, advertised, promoted, supplied and sold to distributors, physicians, hospitals and medical practitioners at all times relevant and including the day this action is commenced, certain hernia surgical repair products to be surgically implanted in patients in the state of Missouri, and more particularly within the jurisdiction boundaries of the United States District Court for the Eastern District of Missouri.
General Allegations
6. Plaintiff's action involves patches containing a hard “memory recoil ring” (or “PET coil ring”) that surrounds the mesh, which was first manufactured by Surgical Sense, Inc., starting in or around 1996, acquired by Defendant Davol in 2000, and then manufactured by Defendant Davol between 2001 and March 2006. These Kugel Patches were sold by Defendant Davol for implantation in patients in the course of hernia repair surgery.
7. A hernia occurs when the stomach muscles are too weak to contain the intestines, and as a result, a rupture occurs in the muscle wall which allows the intestines to protrude. The Kugel Patch was designed to treat ventral hernias caused by the thinning or stretching of scar tissue that forms after surgery.
8. The Kugel Mesh line of products was first manufactured by Surgical Sense, Inc., starting in or around 1996. In January of 2000, Bard acquired the assets and Kugel Patch product line of Surgical Sense, Inc. Shortly thereafter, in 2001, Davol introduced the Kugel Patch. The Kugel Patches manufactured by Surgical Sense, Inc., and the patches manufactured by Defendant, were approved for sale by the U.S. Food and Drug Administration, hereinafter “FDA”, under 510(k) premarket notification submissions.
9. The Kugel Patch, invented by Robert D. Kugel, M.D., is a polypropylene mesh prosthetic device developed to repair ventral hernias, or hernias of the abdominal region. The Kugel Patch is inserted behind the hernia defect in the abdomen through a small incision. In order to fit through the small incision the mesh is folded in half. Once inside the abdomen, the mesh re-deploys as a result of a hard “memory recoil ring” (or “PET coil ring”) that surrounds the mesh.
10. Due to defects in the design and manufacture of the Kugel Patch, the “memory recoil ring” (or “PET coil ring”) that opens the patch can break under the stress of placement of the product in the intra-abdominal space. Once the memory recoil ring has broken, it can come loose and cause serious injuries as it travels through the body. These injuries include intestinal perforations, ring migration through the abdominal wall; abscesses; bowel obstruction and sepsis; and chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
11. The Kugel Patches present and constitute an unreasonable risk of danger and injury in the following respects:
a. The memory recoil ring of the Kugel Patch is likely to rupture or break after being implanted;
b. The Kugel Patch was not properly manufactured;
c. The Kugel patch was defectively designed;
d. The Kugel Patch did not perform as safely as an ordinary consumer/patient would expect;
e. The Kugel Patch was inadequate or insufficient to maintain its integrity during normal use after implantation in the consumer/patient; and
f. Such further and additional defects as discovery and the evidence reveal.
12. As a result of this dangerous and defective condition, and the numerous serious injuries that resulted, the FDA issued the first Class 1 Recall of various lots of the Kugel Patches on December 22, 2005. The Class 1 Recall was expanded in subsequent recalls on March 31, 2006 and January 24, 2007. A Class 1 Recall is the highest level of recall available to the FDA. It is issued when the FDA believes a medical product is dangerous or defective and predictably could cause serious health problems or death.
13. The products that are affected by the recall were distributed to customers and implanted in patients worldwide. As of March 2006, roughly 75,000 Kugel Patches had been sold. Upon information and belief, the vast majority of the patches which have been implanted are currently still inside patients residing in the United States. From January 2000 until March 2006, Kugel Patches were sold by Defendant under Items Numbers or Product Codes: 10-101, 10-102, 10-103, 10-104, 10-105, 0010101, 0010102, 0010103, 0010104, 0010105, 0010201, 0010202, 0010203, 0010204, 0010205, 0010206, 0010207, 0010208, and 0010209. Although not all of these Kugel Patches are listed in the FDA's Class 1 Recall, they all have the defective “memory recoil ring” (or “PET coil ring”).
14. At all times herein mentioned, Defendant Davol knew, or in the exercise of reasonable care should have known, that the aforesaid products were of such a nature that they were not properly designed, manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided with proper warnings, were not suitable for the purpose they were intended and were unreasonably likely to injure the products' users.
15. Defendant Davol's Kugel Patches are defective because they possess the potential for breakage or malfunction of the “memory recoil ring” (or “PET coil ring”) and, as a result, increase the risk of resulting injury in users.
16. Defendant Davol did not timely apprise the public and physicians of the defect in its Kugel Patches, despite Defendant's knowledge that “memory recoil rings” had failed due to the described defects. Defendant Davol's concealment of a known defect from Plaintiff tolls the applicable statute of limitations. Plaintiff could not have discovered the existence of the defect in the Kugel Patch implanted in her until at least December 22, 2005, when Defendant Davol first provided notice of the recall.
17. Defendant Davol's conduct, as described in the preceding paragraphs, amounts to conduct purposely committed, which Defendant must have realized was dangerous, heedless and reckless, without regard to the consequences or the rights and safety of Plaintiff.
18. As a direct and proximate cause of Defendant Davol's conduct and the recalled Kugel Patches, Plaintiff has suffered injuries and will require continual medical monitoring and care. Accordingly, Plaintiff will incur future medical costs related to the recalled Kugel Patch that was implanted in her body.
Plaintiff's Experience
19. Plaintiff underwent a hernia repair surgical procedure on August 20, 2004 at St. John's Mercy Medical Center, and during the course thereof, her physician, Bryan R. Troop, M.D. implanted a Kugel Patch in her body.
20. The Kugel Patch implanted in Plaintiff was designed, manufactured, sold and distributed by Defendant Davol and was intended to be used by surgeons for hernia repair surgeries. Defendant Davol represented these Kugel Patches to be appropriate and suitable products for such purposes.
21. The Kugel Patch inserted in Plaintiffs body has caused her to have additional surgery in November 2007, severe pain and suffering and mental anguish, and will continue to do so in the future.
22. As a direct and proximate result of Defendant Davol's defective design, manufacture, function and/or inadequate warnings regarding the Kugel Patch, Plaintiff sustained, and will continue to sustain, injuries and damages.
COUNT I
(Strict Liability - Design Defect)
23. Plaintiff alleges and incorporates by reference each and every allegation contained in this complaint as though fully set forth herein.
24. Defendant Davol is strictly liable to Plaintiff in the following respects:
a. Defendant Davol designed, manufactured, assembled, distributed, conveyed, supplied and/or sold the Kugel Patch for hernia repair surgery in the course of its business;
b. Defendant Davol's Kugel Patch was in a defective condition unreasonably dangerous because it failed to perform safely and effectively for the purpose it was originally designed. When implanted in the Plaintiffs body, the “memory recoil ring” (“PET coil ring”) in the Kugel Patch broke, causing Plaintiff to develop serious physical injuries.
c. Defendant Davol's Kugel Patch was used in a manner reasonably anticipated because it was implanted by the surgeon in Plaintiffs body to repair a hernia; and
d. Plaintiff was damaged as a direct result of the defective condition that existed when the Kugel Patch left the possession of Defendant Davol.
WHEREFORE, Plaintiff demands judgment against Defendant Davol for:
A. A fair and just amount of actual damages in excess of seventy-five thousand dollars ($75,000);
B. A fair and just amount of punitive damages in an amount to deter Defendant Davol and others from like conduct;
C. Costs herein incurred; and
D. Such other and further relief which may in the premises be just and proper.
COUNT II
(Strict Liability-Failure to Warn)
25. Plaintiff alleges and incorporates by reference each and every allegation contained in this complaint as though fully set forth herein.
26. Defendant Davol is strictly liable for failing to warn Plaintiff in the following respects:
a. Defendant Davol, in the course of its business, sold the Kugel Patch to St. John's Mercy Medical Center for hernia repair surgeries;
b. the Kugel Patch was in a defective condition unreasonably dangerous when put to a reasonably anticipated use due to the propensity of the “memory recoil ring” (“PET coil ring”) to fail when the Kugel Patch was implanted in Plaintiff's body;
c. Defendant Davol did not give adequate warning of the danger that the “memory recoil ring” (“PET coil ring”) would fail;
d. the Kugel Patch was used in a manner reasonably anticipated because it was implanted by the surgeon in Plaintiff's body to repair a hernia; and
e. the Plaintiff was damaged as a direct result of the Kugel Patch being sold without Defendant Davol providing warning, labels or instructions regarding the Kugel Patch's dangerous propensities that were known or reasonably scientifically knowable at the time of distribution.
WHEREFORE, Plaintiff demands judgment against Defendant Davol for:
A. A fair and just amount of actual damages in excess of seventy-five thousand dollars ($75,000);
B. A fair and just amount of punitive damages in an amount to deter Defendant Davol and others from like conduct;
C. Costs herein incurred; and
D. Such other and further relief which may in the premises be just and proper.
COUNT III
(Negligent Design)
27. Plaintiff alleges and incorporates by reference each and every allegation contained in this complaint as though fully set forth herein.
28. Defendant Davol was negligent in designing the Kugel Patch that was implanted in Plaintiffs body in the following respects:
a. Defendant Davol designed and manufactured the Kugel Patch which was implanted in Plaintiffs body;
b. the Kugel Patch, as designed by Defendant Davol, had a specific latent defect because the “memory recoil ring” (or “PET coil ring”) was subject to breaking or fragmenting when implanted in the Plaintiffs body;
c. Defendant Davol failed to use ordinary care in designing the Kugel Patch to be reasonably safe when implanted in Plaintiffs body because a reasonably prudent manufacturer of hernia mesh patches knew or should have known that the “memory recoil ring” (or “PET coil ring”) in the Kugel Patch as designed would fail prematurely when implanted in the Plaintiffs body; and
d. Plaintiff sustained injuries and damages as a direct result of Defendant Davol's negligent design of the Kugel Patch.
29. Defendant Davol negligently and carelessly designed the Kugel Patch in that it was dangerous and unsafe for the use and purpose for which it was intended.
30. Defendant Davol breached its duty by failing to comply with state and federal regulations concerning the design of the Kugel Patch.
31. As a direct and proximate result of the duties breached, the Kugel Patch used in the Plaintiffs hernia repair surgery failed, resulting in Plaintiff suffering pain and harm.
32. As a direct and proximate result of Defendant Davol's negligence, Plaintiff has suffered injuries and damages.
WHEREFORE, Plaintiff demands judgment against Defendant Davol for:
A. A fair and just amount of actual damages in excess of seventy-five thousand dollars ($75,000);
B. A fair and just amount of punitive damages in an amount to deter Defendant Davol and others from like conduct;
C. Costs herein incurred; and
D. Such other and further relief which may in the premises be just and proper.
COUNT IV
(Negligent Failure to Warn)
33. Plaintiff alleges and incorporates by reference each and every allegation contained in this complaint as though fully set forth herein.
34. Defendant Davol was negligent in failing to warn the Plaintiff of hazards of the Kugel Patch in the following respects:
a. in the course of it business, Defendant Davol designed, manufactured and supplied the Kugel Patch to St. John's Mercy Medical Center for use in Plaintiff's hernia repair surgery;
b. the Kugel Patch, as designed by Defendant Davol, had a specific latent defect when put to reasonably expected use because the “memory recoil ring” (or “PET coil ring”) was subject to breaking or fragmenting when implanted;
c. Defendant Davol had no reason to believe that Plaintiff would realize the danger posed by the latent defect in the Kugel Patch and Plaintiff did not know at the time of use of the Kugel patch, nor at any time prior, of the existence of the defect in the Kugel Patch; and
d. Defendant Davol knew, or by using ordinary care, should have known of the dangerous condition of the Kugel Patch; and
e. Defendant Davol did not warn of the danger to the Plaintiff because Defendant failed to provide a warning, labels or instructions regarding the Kugel Patch's dangerous propensities that were known or reasonably scientifically knowable at the time of distribution.
35. Plaintiff suffered the aforementioned injuries and damages as a direct result of Defendant Davol's failure to warn.
36. The conduct of Davol in continuing to market, promote, sell and distribute the Kugel Patch after obtaining knowledge that the patches were failing and not performing as represented and intended, showed a complete indifference to or conscious disregard for the safety of others, justifying an award in such sum which will serve to deter Defendant Davol and others from similar conduct.
37. In addition, Defendant Davol failed to warn of the known or knowable injuries associated with malfunction of the Kugel Patch, including but not limited to intestinal perforations, ring migration through the abdominal wall; abscesses; bowel obstruction and sepsis; and chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
38. Plaintiff suffered the aforementioned injuries and damages as a direct result of Defendant Davol's negligence in failing to warn.
WHEREFORE, Plaintiff demands judgment against Defendant Davol for:
A. A fair and just amount of actual damages in excess of seventy-five thousand dollars ($75,000);
B. A fair and just amount of punitive damages in an amount to deter Defendant Davol and others from like conduct;
C. Costs herein incurred; and
D. Such other and further relief which may in the premises be just and proper.
THE LOWE LAW FIRM
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