Find The Right Kugel Lawyer To Handle Your Recalled Hernia Patch Lawsuit

Legal Action Taken Against Manufacturer of Bard Ventralex Hernia Patch

The Ventralex patch is also known as the “Kugel Hernia Patch,” as it was invented by Dr. Kugel.  Like hundreds of other lawsuits, this one alleges that the plaintiff was injured by a defective memory recoil ring.

11. Defendant Davol designed, manufactured and distributed the Kugel Patch, a hernia mesh patch that was inserted into Plaintiff's body.

12. Defendant Davol, through its agents, servants and employees, participated in the manufacture and delivery of the Kugel Patch that was inserted into Plaintiffs body.

13. The Defendants submitted their 510k Application to the Federal Drug Administration (hereinafter referred to as the “FDA”) on January 22, 2001. Following this 510k Application the Kugel Patch was authorized by the FDA as a Class II medical device.

14. Defendants participated in the marketing, distribution and sale of the Kugel Patch as safe for its intended purpose, fully and properly tested for safety and potential risks, and free from the kinds of risks and hazards that the Kugel Patch actually posed to the public, including Plaintiff.

15. The mesh of the Kugel Patch consists of two components: 1) a polypropylene (“PPM”) layer that faces the area of incision and is to adhere to the abdominal wall; and 2) an expanded Polytetrafluoroethylene (“ePFTE” or “expanded Teflon”) layer which faces away from the incision and is to minimize tissue attachment to the patch. In addition, many Kugel Patches have a “memory recoil ring” embedded near and along the circumference of the Kugel Patch which is to pop the Kugel Patch into shape in preparation for attachment.

16. The Kugel Patch hernia repair product implanted in Plaintiff was designed, manufactured, sold and distributed by Davol to be used by surgeons for hernia repair surgeries and was further represented by Davol to be an appropriate, cost-effective and suitable product for such purpose.

17. A Class I recall is issued for problems related to medical devices that are potentially life-threatening or could cause a serious risk to health.

18. On December 22, 2005, Defendants recalled many sizes and lot numbers of the Kugel Patch under an FDA Class I recall notice. This recall was subsequently widened on several occasions to include additional Kugel Patches.

19. The recall was primarily due to defects in the “memory recoil ring” that can break, creating a sharp edge or point that can cut and/or puncture organs and tissue in the abdomen, causing the kind of injury suffered by Plaintiff. Incidents of ring migration, infection, intestinal fistulae, bowel perforation and even death have been reported.

20. Additionally, the judge overseeing the Kugel Patch litigation ( In re Kugel Mesh Hernia Patch Products Litigation, MDL No. 1842) in Rhode Island has ordered that the MDL encompass the defects associated with additional Kugel Patches, including the Kugel Patch used for Plaintiff.

Residents of Georgia File Suit Against Manufacturers of Defective Kugel Hernia Patch

In January of 2009, two Georgia residents filed suit against the manufacturers of the Kugel hernia patch.  Like many other Americans, these Georgians allege that they have been injured by defective hernia patches.

8. The Kugel Mesh line of products was first manufactured by Surgical Sense, Inc. in or around 1996. Bard acquired the Kugel Mesh line of hernia repair products in January 2000. In 2001 Bard introduced the Composix Kugel Mesh Patch through its subsidiary, Davol. The 510k application was submitted to the Federal Drug Administration (“FDA”) on January 22, 2001. Following the 510k application the Kugel Mesh was authorized by the FDA as a Class II medical device.

9. Dr. Robert D. Kugel invented the Composix Kugel Mesh Patch, a polypropylene mesh prosthetic device developed to repair abdominal or ventral hernias. The design employs a “memory coil ring” or “PET“ coil ring which deploys once inserted. The ring is a hard solid material that surrounds the mesh. The device is inserted behind the muscular defect in the abdomen. The ring deploys and opens after insertion. This mechanism was to allow for a smaller incision. Davol represented the Kugel Mesh Patch to be an appropriate, cost-effective and suitable product for implantation.

10. Defects in the design and manufacturing in certain Bard Composix Kugel Mesh Patches are demonstrated by the memory recoil ring (“ring”) when deployed and open the patch after insertion may break under the stress of placement in the intra-abdominal space. Once this ring, that is a solid hard material, breaks it can cause serious injury such as intestinal perforations, migration of the broken ring through the abdominal wall in to the pelvis; intestinal fistulas (abnormal passageways between the intestine and other organs); abscess; sepsis and death.

11. When the FDA believes a medical product is dangerous or defective and predictably could cause serious health problems or death the product may be removed from the market or recalled by the FDA. The FDA issued a Class I recall, the highest level of recall available, of the Bard Composix Kugel Mesh Extra-Large Oval Patch, Large Oval Patch and Large Circle Patch.

12. On January 13, 2006, Davol and Bard announced the recall of the Kugel Mesh Extra-Large Patch. In March 2006 the Defendants also announced the recall of the Large Patch as well. Subsequent recalls by the Defendants also were announced.

Kugel Hernia Patch Lawsuit Alleges That Manufacturer Made Over $1 Billion Dollars From 2004 to 2006

This lawsuit, filed in the U.S. District Court for the Southern District of New York, alleges that the manufacturer of the Kugel hernia patch had over $1 billion dollars in sales from 2004 to 2006.  I’m not sure how much of that figure is from sales of the recalled patch, but clearly the company was doing a lot of business.

29. Upon information and belief, Defendants had sales in 2004 from their Surgical Specialties segment of business, which includes the Kugel Hernia Patch, in excess of three hundred and thirteen million dollars ($313,000,000).

30. Upon information and belief, Defendants had sales in 2005 from their Surgical Specialties segment of business, which includes the Kugel Hernia Patch, in excess of three hundred and thirty million dollars ($330,000,000).

31. Upon information and belief, Defendants had sales in 2006 from their Surgical Specialties segment of business, which includes the Kugel Hernia Patch, in excess of three hundred and fifty-seven million dollars ($357,000,000).

32. Upon information and belief, Defendants are in the market for ventral and incisional hernia repair products.

33. The Defendants submitted their 510k Application for the Kugel Hernia Patch to the Federal Drug Administration (hereinafter referred to as the “FDA”) on January 22, 2001. Following this 510k Application, the Kugel Hernia Patch was authorized by the FDA as a Class II medical device.

34. Upon information and belief, Defendants' Kugel Hernia Patch is a self-expanding patch used to repair ventral and incisional hernias.

35. The Kugel Hernia Patch is placed behind the hernia through an incision.

36. The Kugel Hernia Patch contains a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

37. The alleged purpose of the Kugel Hernia Patch, once it is inside, is to allegedly stimulate tissue growth and allegedly reduce the risk of recurrent hernias.

38. Upon information and belief, the Kugel Hernia Patch was originally approved for sale and use by the FDA on or about January 22, 2001. The FDA's decision for approval was based upon information provided to them by Defendants.

39. Upon information and belief, Defendants introduced the Kugel Hernia Patch to the market on or about February 9, 2001.

40. Soon after the Kugel Hernia Patch was placed on the market, the Defendants began receiving actual notices of Kugel Hernia Patch defects and failures.

If you think you received a defective Kugel patch, let me know and I’ll put you in touch with a Kugel lawyer who will investigate your claim.

Additional Complaint Filed In Kugel Multidistrict Litigation

Two Las Vegas, Nevada residents filed the following complaint in the lawsuit entitled, In re Kugel Mesh Hernia Patch Products Liability Litigation in Rhode Island:

7. The Kugel Patch is used to repair hernias. The Kugel Patch is made of two pieces of mesh that surround a flexible plastic ring. The surgeon places the mesh Patch in a small incision. The surgeon folds the Patch and places it at the site of the hernia. The released ring is then designed to spring back into its original shape, flattening the Patch. The mesh-like material serves as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.

8. The Kugel Patch is manufactured by BARD and their subsidiary, DAVOL, who owns the patent on the device.

9. The Defendants submitted their 510k Application to the Federal Drug Administration (hereinafter referred to as the “FDA”) on January 22, 2001. Following this 510k Application the Kugel Patch was authorized by the FDA as a Class II medical device.

10. Soon after the Kugel Patches were placed on the market, Defendants began receiving actual notices Kugel Patch defects and failures. Not only was there no device history record (DHR) review performed - as called for by protocol - but also Defendants actively and intentionally concealed these notices concerning defective and dangerous condition(s) associated with the Kugel Patches from Plaintiffs, Plaintiffs' physicians, and the general public.

11. After the defective and dangerous Kugel Patch was already placed on the market, Defendants conducted physician screenings and reviews beginning in 2002. According to protocol, these surveys and reviews were needed before placing the device on the open market. Furthermore, an Establishment Inspection Report (“EIR”) conducted by the FDA in 2006 found that the post market survey validation process of the device was incomplete and failed to include all the data from the physicians surveyed during this time. Whether intentionally or negligently, Defendants failed to properly conduct and monitor their own post market design validation physician surveys including those which demonstrated unfavorable or “dissatisfied” results. Defendants actively and intentionally these complaints and concerns of the physician surveyors from Plaintiffs, Plaintiffs' surgeons, and the public at large.

12. During the spring and summer period of 2005, there was a substantial increase in the number of complaints with the Kugel Patch. Defendants' corporate executives were notified and thus made aware of these complaints. Nevertheless, in spite of their knowledge of increasing complaints and complications, Defendants waited until August 30, 2005, to initiate a partial Kugel Patch manufacturing hold.

Davol Inc., Makers of Kugel Hernia Patch, Sued In Missouri

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).

Idaho Resident Files Lawsuit Against Makers of Defective Kugel Patch

On April 8th of 2009, an Idaho resident filed the following complaint in the U.S. District Court for Minnesota.  He alleges that the makers of the Kugel hernia patch knew the patches were defective at least three years before the patches were recalled.

11. In 2002 Defendants introduced a new, larger Patch.

12. Soon after the 2002 release, Defendants, despite beginning to receive a high number of reports of broken Patches from doctors, continued selling the Patch without informing the FDA of the increase in complaints, or misinforming the FDA about complaints that were reported.

13. These reports indicated that the plastic “memory-recoil ring” tended to break (which Defendants' own studies revealed), resulting in injury to internal organs and tissue, leading to side effects including chronic intestinal fistulas (abnormal connections that form between two parts of the intestine resulting in an accumulation of bowel contents in the cavity potentially causing abscesses or infection which, in turn, can spread to the bloodstream, causing septic shock and even death), bowel obstruction (a partial or complete blockage in the intestines that can lead to infection, gangrene, or bowel perforation), and bowel perforations (caused by breakage of the memory-recoil ring, which then migrated through the abdominal wall).

14. In mid-2005, 10 complaints about ring breaks were made to Defendants over a three-month period.

15. In August 2005, Defendants stopped making the Kugel extra-large Patches, admitting that the memory-recoil ring did not adequately withstand the stress of surgical placement.

16. On December 22, 2005, Defendants informed doctors and patients that a voluntary Class 1 recall of the Patch was being implemented for some lot numbers of the extra-large Patches.

Lawsuit Over Defective Kugel Hernia Patch Filed In New York

Two Massachusetts residents filed this lawsuit against the manufacturers of the Kugel patch.  The lawsuit, entitled Roden v. Davol, was filed April 8th in the United States District Court for the Eastern District of New York.   The lawsuit alleges that the manufacturers of the patch were aware of its defects within a year after its release on the market:

13. The Kugel Patch is used to repair ventral hernias, or hernias of the abdominal region. The Kugel Patch is made of two pieces of mesh that surround a flexible plastic ring. The surgeon places the mesh patch in a small incision. The surgeon folds the patch and places it at the site of the hernia. The released ring is then designed to spring back into its original shape, flattening the patch. The meshlike material serves as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.

14. The Kugel Patch is manufactured by BARD and their subsidiary, DAVOL (also collectively referred to as “Defendants”), who owns the patent on the device.

15. The Defendants submitted their 510k Application to the Federal Drug Administration (hereinafter referred to as the “FDA”) on January 22, 2001. Following this 510k Application the Kugel Patch was authorized by the FDA as a Class II medical device.

16. Soon after the Kugel Patch was placed on the market, DAVOL and BARD began receiving notices of Kugel Patch defects and failures. Not only was there no device history record (DHR) review performed-as called for by protocol-but also DAVOL and BARD actively and intentionally concealed these notices concerning defective and dangerous condition(s) associated with the Kugel Patch from Plaintiff, Plaintiffs physicians, the FDA and the general public.

17. After the defective and dangerous Kugel Patch was already placed on the market, Defendants DAVOL and BARD conducted physician screenings and reviews beginning in 2002. According to protocol, these surveys and reviews were needed before placing the device on the open market. Furthermore, an Establishment Inspection Report (“EIR”) conducted by the FDA in 2006 found that the post market survey validation process of the device was incomplete and failed to include all the data from the physicians surveyed during this time. Whether intentionally or negligently, BARD and DAVOL failed to properly conduct and monitor their own post market design validation physician surveys, including those which demonstrated unfavorable or “dissatisfied” results. DAVOL and BARD actively and intentionally concealed these complaints and concerns of the physician surveyors from Plaintiff, Plaintiff's surgeons, the FDA and the public at large.

If you think you might have a defective Kugel patch, then let me know and I’ll put you in touch with a Kugel lawyer who will help you.