Below you will find a timeline of important dates and events concerning Hernia Mesh manufactured by Bard / Davol. C.R. Bard was recently purchased by Becton Dickinson (BD) and is now known as Bard Medical. Bard is incorporated in the State of New Jersey. Davol Inc. is a wholly owned subsidiary of C.R. BARD, INC. DAVOL was incorporated in the State of Delaware. Davol’s main office is in Warwick, Rhode Island. The hernia mesh lawsuit (bard mesh) timeline set forth in this article is very complicated and convoluted, to say the least. This expose was authored by a hernia mesh lawsuit lawyer. This post addresses the full array of Bard mesh from Marlex mesh, Ventralex to the Perfix Plug. Thousands of mesh victims filed Bard hernia mesh lawsuits against Bard and their corporate subsidiary, Davol, seeking compensation by way of settlements or legal judgment as a result of purported defective hernia mesh and hernia patches.
“Publicly available information, published by DAVOL and BARD, indicates that BARD considers DAVOL to be division of BARD. Indeed, DAVOL’S website directs consumers to contact customer service Via BARD email address.Furthermore, employees of these corporations consider BARD and DAVOL to be one in the same. Finally, the hernia mesh products at issue in this case are advertised and sold on the BARD website… DAVOL acts as an agent for BARD as it is merely business conduit of BARD.” IN RE: DAVOL/ CR. BARD HERNIA MESH MESH MULTI—CASE MANAGEMENT, MASTER LONG FORM COMPLAINT AND JURY DEMAND
Update on Federal Court MDL- 9/2/020- BIG preliminary decision in favor of Victims!! A significant decision in favor of the Bard/ Davol victims occurred when Judge Edmund A. Sargus , Jr. denied the Defendant’s motion for summary judgment. “C.R. Bard Inc. and Davol Inc. must face most of a Utah man’s claims in the first test trial in multidistrict proceedings over its polypropylene hernia mesh devices, the Southern District of Ohio said. And Steven Johns may seek punitive damages, the U.S. District Court for the Southern District of Ohio held Tuesday, saying he raised fact issues concerning alleged misrepresentation or concealment of certain risk information that could lead a jury to conclude the companies acted willfully or recklessly.” Bloomberg Law
Edmund A. Sargus , Jr. ruled that “Plaintiff has presented sufficient evidence to establish genuine issues of fact exist as to whether Bard’s “intentionally fraudulent conduct” or displayed “knowing and reckless indifference.” Specifically, there are genuine issues of fact as to whether Bard misrepresented or concealed information regarding the timing of the resorption of the ST and the substantial risks associated with such early resorption—such as the exposure of bare polypropylene to the visceral organs—that could lead a jury to conclude they acted willfully or recklessly. Accordingly, Bard’s motion for summary judgment on Plaintiff’s claim for punitive damages is DENIED, subject to renewal, if appropriate, after evidence is presented at trial.” Johns v. CR Bard (In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig.)
5/24/2020– There are two consolidated Bard/ Davol Polyproplene hernia mesh lawsuits pending. There is a consolidated State Court Bard lawsuit in Rhode Island State Court as well as a consolidated Multidistrict litigation In Federal Court. Individual Bard hernia mesh lawsuits can still be filed in State Courts across the United States. “According to recent court records, about 500 new cases are being filed each month throughout the federal court system, and the total number of Bard hernia mesh cases may near 10,000 by the end of the year.” About Lawsuits
Federal Court update- 5/24/20:
- The Bard cases in Federal Court are pending in Multidistrict Litigation (MDL -2846) in the United States District Court for the Southern District of Ohio before Presiding Justice Edmund A. Sargus, Jr (Chief Judge, USDC).
- The MDL is known as, “IN RE: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation”
- United States District Court Southern District of OHIO- MULTIDISTRICT LITIGATION 2846- 2:18-md-2846 — IN RE: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation Presiding Judges: Honorable Edmund A. Sargus, Jr., Chief United States District Judge and Honorable Kimberly A. Jolson, United States Magistrate Judge
- As of May 15, 2020 there are 3,602 lawsuits pending in the Federal MDL against Bard/ Davol.
- According to National Review, “Plaintiffs and Defendants have narrowed down the initial bellwether pool to six cases – three cases chosen by each side.”
- “On January 24, 2020, the Court selected Johns v. C.R. Bard et al., Case No. 2:18-cv01509 as the first Bellwether Trial Case that will be tried in this multidistrict litigation (“MDL”). Due to the impact of the coronavirus (COVID-19) outbreak, this trial has been rescheduled to Monday, July 13, 2020.” CASE MANAGEMENT ORDER NO. 23-A
- “On January 24, 2020, the Court selected Milanesi et al. v. C.R. Bard et al., Case No. 2:18- cv-01320 as the second Bellwether Trial Case that will be tried in this multidistrict litigation (“MDL”). Due to the impact of the coronavirus (COVID-19) outbreak, this trial has been rescheduled to Tuesday, September 29, 2020.” CASE MANAGEMENT ORDER NO. 29
- On 5/5/20 the Court scheduled a pretrial conference for the first bellwether trial, Johns v. C.R. Bard et al on 9/29/20. The Court ordered, “The first Bellwether Trial Case is scheduled for trial on Tuesday, September 29, 2020, at 9:00 a.m. in Courtroom 2. Trial counsel shall meet in the chambers of Judge Sargus at 8:30 a.m. on each day of the trial. The first final pretrial conference shall be held on Wednesday, September 9, 2020, at 9:00 a.m. in the chambers of Judge Sargus. All trial counsel must appear.” Read the CASE MANAGEMENT ORDER NO. 23-B Pretrial and Trial Schedule for First Bellwether Trial Case.
State Court update- 5/24/20:
- Thousands of hernia mesh cases against Bard/ Davol are now pending in Providence Superior Court in a consolidated State Court Proceeding.
- On May 5, 2017 the Providence RI Superior Court, “set up a multi-case management coordinated proceeding for all subsequent filings alleging personal injuries from Davol / C.R. Bard hernia mesh products. Administrative Order No. 2017-02.” IN RE: DAVOL/ C.R. BARD HERNIA MESH PROCEDURAL ORDER NO. 1 Many victims who have missed a statute of limitations in their state of residence decide to file in this lawsuit because RI has an extended statute of limitations for Bard/ Davol hernia mesh.
- Only victims implanted with mesh made of polyproplene manufactured by Bard / Davol may file lawsuits in the consolidated proceeding.
- The litigation is currently titled: “IN RE: DAVOL/ C.R. BARD HERNIA MESH”
- “The primary Bard Hernia Mesh state litigation, pending in Rhode Island state court under Judge Gibney, is now set to begin its first bellwether trials that will focus on claims involving the Ventralex patch product, and proceed to trials involving the Composix E/X product.” Mass Torts Blog
- Victims across the United States, Canada, UK, EU and across the world with Bard mesh who file in Rhode Island may entitled to a nearly endless deadline. (extended statute of limitations)
- “The primary Bard Hernia Mesh state litigation, pending in Rhode Island state court under Judge Gibney, is now set to begin its first bellwether trials that will focus on claims involving the Ventralex patch product, and proceed to trials involving the Composix E/X product.” National law review
Victims get extended statute of limitations, nearly endless
Victim’s may be surprised to learn that there is a long lasting, extended deadline to file a hernia mesh lawsuit against Bard / Davol, if the lawsuit is filed in Rhode Island state courts. In some circumstances, the statute of limitations deadline for justice and compensation against Bard could be over 10 to 20 years! Bard mesh victims are seeking settlements or legal judgments from Bard as a result of the alleged defective surgical mesh. Bard’s hernia mesh medical devices have been subject to numerous mesh recalls. Will there be a hernia mesh recall in 2019? Will there be a Bard Davol hernia mesh lawsuit settlement 2019? No one can accurately predict whether such a hernia mesh settlement will occur. Many victims are wondering what are the hernia mesh patch recall symptoms. Others are researching whether there has been a Marlex mesh recall. Many people are unaware of Bard’s checkered past in which Bard plead guilty in 1993 to 391 felonies and three Bard executives were sentenced to 18 months in jail. Below you will find a mesh lawsuit update pertaining to Bard/ Davol mesh.
Before we get to the detailed and extensive Bard hernia mesh lawsuit timeline, It is important to explain the current status of the Bard hernia mesh lawsuits. The vast majority of the Bard mesh lawsuits are pending in the following places:
1993- Bard pleads guilty to 391 felonies and several executives sentenced to time in the can pertaining to heart catheters
This blog post is not only a mesh lawsuit update concerning Bard/ davol hernia mesh it also provides pertinent information to consumers and victims. No one should be surprised that Bard faces thousands of lawsuits pertaining to allegedly defective hernia mesh. No one should be surprised that Bard continues to manufacture and profit from defective hernia mesh, despite the suffering and immeasurable pain of victims. Was Bard a criminal enterprise in the early 90’s, as far as heart catheters were concerned? Has Bard shown remorse? Has Bard been rehabilitated after pleading guilty to 391 felonies? Can we trust Bard to be a good corporate citizen? Will Bard reach a 2018 hernia mesh settlement of pending hernia mesh lawsuits?
Bard Medical- Felonious past
in 1993, CR Bard plead guilty to 391 felonies resulting from Bard’s manufacturing and marketing Heart Catheters. Three Bard executives were convicted of felonies and sentenced to 18 months in the big house. “The essential facts of this case are as follows. C.R. Bard, Inc. has pled guilty to 391 felonies. These are one count of conspiracy, in violation of 18 U.S.C. § 371; 17 counts of mail fraud involving submissions to the Food and Drug Administration (“FDA)”, in violation of 18 U.S.C. § 1341; eight counts of submitting false statements to the FDA, in violation of 18 U.S.C. § 1001; 363 counts of shipping adulterated medical devices, in violation of 21 U.S.C. § 333(a) (2), including 75 counts of shipping medical devices from an unapproved facility, 108 counts of shipping products that had been changed without the required FDA approval of that change, and 98 counts of shipping devices for human testing where such testing had not been approved; and two counts of failing to submit required reports to the FDA, in violation of 21 U.S.C. § 333(a) (2).” 848 F. Supp. 287 (1994) UNITED STATES of America v. C.R. BARD, INC. Cr. No. 93-10279-WF. United States District Court, D. Massachusetts. April 8, 1994.
This was such a serious matter that the then FDA commisioner weighed in by stating, “For a company to engage in a pattern of using unsuspecting patients as guinea pigs and operating rooms as laboratories for unapproved products shows a blatant disregard for the health and safety of the patients who literally entrusted their lives to the company’s products,” FDA Commissioner David Kessler. Drug Watch
“These are serious criminal violations. In essence, Bard knowingly and willfully kept adverse information from the FDA, made product changes that affected the safety or effectiveness of angioplasty catheters produced by its USCI Division without the required FDA approval, and illegally did testing on human beings without the required exemption from the FDA.” 848 F. Supp. 287 (1994) UNITED STATES of America v. C.R. BARD, INC. Cr. No. 93-10279-WF. United States District Court, D. Massachusetts. April 8, 1994.
1995- Bard submits an FDA premarket notification for Visilex hernia mesh
On 07/31/1995, Davol Inc. a subsidiary of C.R. Bard submits an FDA premarket notification for “BARD VISILEX MESH 3 X 6” Bard Asserted that the device classification name was: “Mesh, Surgical, Polymeric” The FDA approved the mesh on 09/26/1995.
1996- Surgical Sense Inc. submits FDA application for Kugel™ Hernia Patch
On August 5th, 1996 Surgical Sense Inc. from Arlington Texas submitted a 510(k) application pursuant to 21 CFR 807.9 for the Kugel™ Hernia Patch. Surgical Sense Inc. classified this medical device as surgical mesh. Surgical Sense Inc. alleged that the “Kugel Hernia Patch” was substantially equivalent to: “Atrium Polypropylene mesh.” They asserted to the FDA that the “intended use of the Kugel hernia Patch is a surgical mesh for reinforcement of a hernia defect” Federal Drug Administration (FDA), Kugel Hernia Patch 510 (k) summary
1997- Davol introduces Composix hernia patch
“In 1997, Davol released the Composix™ Hernia Patch, a forerunner to the CK Patch.The Composix patch is composed of two layers of polypropylene mesh for tissue ingrowth on the abdominal side, and a layer of ePTFE on the other side to prevent bowel adhesion to the mesh. The Composix patch does not contain a ring. Prior to placing the Composix patch on the market, Davol conducted animal testing by implanting the patch into the abdominal cavity of pigs. Davol submitted the testing results in a so-called 510(k) application to the Food and Drug Administration (“FDA”) in order to get clearance to market the Composix patch.” CHRISTOPHER THORPE and LAURE THORPE, Plaintiffs v. DAVOL, INC. and C.R. BARD, INC., Defendants. C.A. No. 008-463ML MDL Docket No. 07-1842ML In Re: Kugel Mesh Hernia Repair Patch Litigation https://www.lawyersandsettlements.com/articles/kugel-mesh/interview-kugel-mesh-lawsuit-patch-20010.htm
2000- Davol aquires the Kugel™ hernia patch from Surgical Sense Inc.
Davol Inc is a subisidary of Bard. “Davol acquired the Kugel™ hernia patch from Surgical Sense Inc., which marketed the Kugel patch for several years.” Id. “Eventually, the CK Patch was designed with two layers of polypropylene mesh, a layer of ePTFE, and a PET memory recoil ring welded between the layers of polypropylene mesh. The XL CK Patch featured larger sizes, two PET rings, and placement pockets for easier deployment of the patch.” Id. “Because Davol considered the XL CK Patch products a modification to an existing product (the one-ringed CK Patch in small and medium sizes), it made an internal determination that a 510(k) submission to the FDA was not warranted.” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf
On 03/02/2000 the FDA gave clearance to Genzyme to market SEPRAMESH pursuant to the controversial 510(k) premarket approval process. The 510k summary was required pursuant to 21 CFR 807.92. Read the 510(k) summary here. Genzyme asserted that Sepramesh was substantially similar to other hernia mesh that was on the market at that time: Bard Mesh, Bard Composix Mesh and Mersilene Mesh manufactured by Ethicon. (In 2007, Bard essentially became the owner of Sepramesh.)
August 25, 2000: Davol / Bard submitted an application to the FDA for the Composix E/X Mesh Patch. “On August 25, 2000, Davol / Bard submitted an application to the Federal Drug Administration to notify of its intent to market the Composix E/X Mesh Patch for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Thereafter, the 510k Application was approved by the FDA and the Composix E/X Mesh Patch was classified as a Class II medical device.” Id. Beasley Allen
“The Composix E/X Mesh Patch was designed, manufactured, sold and distributed by DAVOL to be used by surgeons for hernia repair surgeries and was represented by DAVOL to be an appropriate, cost-effective and suitable product for such purpose.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/
2002- Here comes the XL CK Patch and Ventralex Patch
In 2002, the XL CK Patch medical device was sold for the first time Id. In 2002, medical doctors began reporting problems with the Composix Kugel Mesh Patch. “A growing number of physicians began to report major abdominal injuries in their patients which stemmed from broken memory recoil rings in the patches.” Legal tube
On July 16th 2002, the FDA approved the premarket notification submitted by Davol for the Ventralex Patch. Bard got the Ventralex Patch approved by using the Bard Composix Kugel Mesh as the predicate device. Davol asserted that the Ventralex patch was substantially similar to the Bard Composix Kugel Mesh. Davol asserted that the “The Ventralex Patch is intended for use in all hernia repairs requiring reinforcement with a nonabsorbable support material.”
2003- problems emerge with CK Patch
In the 2003 time period, “Davol first learned of a ring break in its CK Patch product line in 2003…In October 2003, Davol decided to enhance the weld strength of the memory recoil rings in all its CK patch products.” Id.
2005- XL CK patch recalled by Davol – hernia mesh recall
“Between December 2005 and January 2007, Davol initiated and expanded a product recall of certain CK Patch models following some reports from the field that memory recoil rings had broken…The CK Patch was the predicate product for a number of other Bard polypropylene hernia mesh devices, including Ventralex and Ventrio. In March 2012, Defendants stopped selling the CK Patch, while it continued to sell a number of other hernia repair products.” Bard objection
“The CK Patch was the predicate product for a number of other Bard polypropylene hernia mesh devices, including Ventralex and Ventrio.” Id.
“By mid to late 2005, Davol became aware of an increase in reported ring breaks in the XL CK Patch. Davol initiated a Corrective and Preventive Action (“CAPA”) investigation into the complaints. Davol also communicated the complaints to the FDA, informing it that the exact cause of the ring breaks was undetermined and that a recall did not appear warranted at that time.” Id.
“On August 31, 2005, production of XL CK Patches was halted while Davol investigated ring break complaints. Distribution of the XL CK Patches was discontinued on December 8, 2005.” Id.
“In a December 21, 2005 letter from Karen Kane (“Kane”) Manager of Davol’s marketing department, the sales force was advised that XL sizes of the CK Patch were being recalled because “the strength of the memory recoil ring may not withstand aggressive manipulation that may sometimes be applied during the placement of these extra-large sizes.. Kane further stated that customers asking for XL sizes of the CK Patch should be advised that the XL CK Patches were “currently not available and that Customer Service is offering the equivalent sizes of the Composix EX as an alternative.” Id.
“In December 2005, Bard initiated a recall of extra-large models of the CK Patch following reports that memory recoil rings were breaking. In March 2006, Bard expanded the recall to other models, specifically the 202 and 204 CK Patches manufactured before January 2004, as well as model 209 CK Patches manufactured before March 2006.” BOBBY DON BOWERSOCK, and CHARLOTTE ROBINSON as CoPersonal Representatives of the Estate of Georgia J. Bowersock, deceased, and MARK BOWERSOCK Individually, Plaintiffs, vs. DAVOL, INC., C.R. BARD, INC. ORDER ON DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT
The Composix Kugel Mesh Patch was recalled in the United States by the FDA. This Patch was manufactured to be used for ventral or incisional hernias. The reason for the recall was that the memory recoil ring was frequently breaking. Victims have been reporting dozens of hernia mesh patch recall symptoms.
“December 27, 2005: C.R. Bard notifies US customers of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch by letter delivered via Federal Express. The recall is issued after reports that a component of the patch, known as the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforations and chronic intestinal fistulae. At the time, approximately 32,000 units had been sold worldwide.’ Lawyers and settlements
“On December 28, 2005, Davol issued an “Urgent Product Recall for the XL CK Patch to Distributor: (Hospital Administrator, Materials Manager, O.R. Manager, Surgeon). Pltfs.’ Ex. 676. Davol informed its customers that it was voluntarily recalling three product codes of the XL CK Patch because it had received complaint reports of the PET recoil ring breaking which could potentially lead to bowel perforation and/or chronic enteric fistulas. We have identified a rate increase of recoil ring breaks since the introduction of these product codes in 2002. We estimate the frequency of these reported events to be in the range of 0.08%.” ” http://lawyersusaonline.com/wp-files/pdfs-3/thorpe-v-davol.pdf
2006- XL CK Patch recall is expanded- hernia mesh recall
In 2006, Bard recalled Kugel Mesh. The expanded class 1 FDA recall on Febuary 22nd 2006 included “certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product” Id. The recalling firm was: “Davol, Inc., Sub. C. R. Bard, Inc.”
Here is a list of the recalled products:
- Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206
- Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206
- Z-0762-06 – Bard® Composix® Kugel Oval, 6.3” X 12.3” For Hernia Repairs Product Code: 0010209
- Z-0760-06 – Bard® Composix® Kugel Large Oval, 5.4” X 7” For Hernia Repairs Product Code: 0010202
- Z-0761-06 – Bard® Composix® Kugel Large Circle, 4.5” For Hernia Repairs Product Code: 0010204
- Z-0526-06 – Bard Composix Kugel Mesh X-Large Patch Oval With EPTFE, 7.7” X 9.7” (19.6cm X 24.6cm) Code: 0010208
(“Recalled for potential for ring to break leading to bowel perforation and/or chronic enteric fistula.”) Drug Watch
March 24, 2006: “An urgent letter is sent by Bard to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product. A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December, 2003, and notes that “there is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas….Finally, a letter is sent to surgeons the same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products. The expanded recall is issued because Davol, Inc., has learned of further ring breaks, including cases of bowel perforation, ring migration through the abdominal wall, bowel obstruction, and one instance in which a patient died after developing septic shock, consumptive coagulopathy and acute myocardial infarction from surgery to repair bowel fistulas caused by perforation from the broken ring.” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html
Expanded Composix Kugel recall- class 1 recall
April 3, 2006: “The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device ( Bard Composix Kugel Mesh Patch) to include all lots of the oval “midline” size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.”
“The recall is due to the potential for breakage of the “memory recoil ring” under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA’s safety information and adverse event reporting program. ” http://www.medscape.com/viewarticle/529032
On June 2nd, 2006 the FDA issued a decision approving BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH pursuant to the FDA 510(k) Process. The FDA determined that the BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH was substantially similar to the following predicate devices: Composix Kugel Mesh https://www.accessdata.fda.gov/cdrh_docs/pdf6/K061314.pdf
On October 23rd, 2006 the FDA issued a decision approving Bard / Davol’s premarket notification for BARD COMPOSITE L/P MESH pursuant to the FDA 510(k) Process. The FDA determined that BARD COMPOSITE L/P MESH was Substantially Equivalent (SESE) to the following predicate devices:
- Bard Large Pore SoftTmMesh Pre-Shaped, K052155 (Davol Inc,), FDA cleared on 10/20/2005;
- Bard Composix® EIX Mesh, K002684 (Davol Inc.), FDA cleared on 10/11/2000;
- Davol Delivery System (currently marketed as Precision Pass Laparoscopic Delivery Device), K041641 (Davol Inc.), FDA cleared on 07/01/2004.
“December 18, 2006: A lawsuit is filed against Davol, Inc. related to the Kugel Mesh Patch. The plaintiff in the case, filed in Rhode Island, claims failure of the Kugel Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff’s bowel. The bowel dissection surgery resulted in chronically inflamed bowels. Lawyers for the plaintiff argue that Davol, Inc., knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.” Lawyers and settlements
2007- Davol recalls Bard®Composix® Kugel® Large Sized Patch and Bard® Composix® Kugel® Large Oval and Bard® Composix® Kugel®Large Circle
2007 time period: The Rhode Island State Courts set up a multi-case management proceeding primarily for Kugel Cases. This multi case management proceeding was set up at the same time that the Federal Court MDL, In re: Kugel Mesh Hernia Patch Products Liability Litigation MDL-1842 was set up. In 2018 Bard conceded that, “As the years have passed, many of the cases in Rhode Island state court have resolved.” Bard Response in 2018
“In 2007, this Court set up a multi-case management coordinated proceeding for cases primarily involving Davol/C.R. Bard Composix Kugel Hernia Patch. While the litigation focused on the Composix Kugel Hernia Patch, some cases involved other Bard hernia products such as the Composix E/X Mesh, Ventralex Hernia Patch, Composix Hernia Patch, Kugel Hernia Patch, CK Parastomal Patch and Modified Kugel Patch. See Administrative Order No. 2007-6. Significant discovery was done as part of that coordinated proceeding with a primary focus on the Composix Kugel products.” Procedural order
Exapanded Composix Kugel Patch Recall- Large Oval and Large Circle
(This multi-case management proceeding was the precursor for the current RI State Court Consolidated Proceeding which commenced in 2017 for Polyproplene hernia mesh manufactured by Bard and their subsidiary Davol Inc.)
January 10, 2007: Davol extends the recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.” https://www.lawyersandsettlements.com/articles/drugs-medical/kugel-mesh-timeline-00568.html
January 10, 2007 the following medical devices were recalled by the FDA:
- Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7”
- Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”
(recalled as a result of ring breakage causing Bowel Perforation and “chronic enteric fistula.” https://www.drugwatch.com/hernia-mesh/)
Bard/ Davol stated, “Davol is expanding the voluntary recall of specific lots of Bard ® Composix ® Kugel ® Large Oval and Large Circle Patches. Immediately discontinue use of the specific product codes and lot numbers listed in the attachment. Additionally, please immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall.” HERNIA REPAIR IMPORTANT PATIENT MANAGEMENT INFORMATION: Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4”x7.0” Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5 https://www.davol.com/clinical-support/product-recall-information.
The Composix Kugel Multidistrict litigation in RI Federal Court
June 22, 2007: The Judicial Panel on Multi District Litigation (JPML) issued a transfer order “for combined cases which involved allegations of defects in various models of hernia patches manufactured and sold by Bard, Davol or Surgical Sense.” Risley v Davol and Bard, Davol In re Kugel Hernia Repair Patch Litigation, MDL Docket No. 07-1842-ML.
“On June 22, 2007, the JPML created In re: Kugel Mesh Hernia Patch Products Liability Litigation, MDL-1842, and ordered that all cases involving the CK Patch be transferred to the U.S. District Court for the District of Rhode Island before Judge Mary Lisi. On January 24, 2008, the MDL further defined the products to be included: “a. All nine (9) models of Bard® Composix® Kugel® Hernia Patches (Product Codes 0010201 through 0010209); b. All other Davol hernia patches with PET rings, including the Bard® Kugel® Hernia Patch; Bard® Ventralex® Hernia Patch; Bard CK Parastomal Patch; and Bard® Modified Kugel™ Patch; and c. Other Davol hernia meshes composed of layers of polypropylene and ePTFE, including Bard® Composix® E/X.” (Practice and Procedure Order No. 6, In Re: Kugel Mesh Hernia Patch Products Liability Litigation, MDL No. 1842, Doc. 248 (D.R.I. Jan. 24, 2008); Bard response
On December 17, 2007 C.R. Bard essentially purchased Sepramesh. “MURRAY HILL, N.J., Dec 17, 2007 (BUSINESS WIRE) — C. R. Bard, Inc. (NYSE: BCR) today announced that it has entered into a license agreement with Genzyme Corporation (Nasdaq: GENZ), headquartered in Cambridge, Massachusetts, to manufacture and market the Sepramesh® IP hernia repair product line and to incorporate the related Sepra® coating technology into the development of future hernia repair applications. Bard’s Davol subsidiary, located in Cranston, Rhode Island, will begin marketing the line immediately. Details of the agreement were not disclosed.” CR Bard press release
2008- Federal Judge Expands consolidated lawsuits | hernia mesh lawsuit
“On January 8, 2008, a Federal Court judge in Rhode Island expanded the scope of the consolidated proceedings involving hernia patches manufactured by Davol / Bard to cover all Davol Marlex / Teflon products, with or without “memory recoil rings.” http://www.beasleyallen.com/news/federal-court-expands-scope-of-kugel-mesh-hernia-patch/
On October 07, 2008 the FDA determined that BARD 3DMAX MESH is substantially similar to:
- Bard Mesh (Davol Inc.)
- Bard 3DMAX Mesh (Davol Inc.)
- Usher’s Marlex Tubular Mesh (Davol Inc.)
As a result of that determination, the FDA approved Bard / Davols’ 510(k) premarket notification for BARD 3DMAX MESH and the medical device was allowed to be marketed to the public.
On December 08, 2008 C.R. Bard initiated a class 3 recall of its surgical mesh:
- Bard 3D Max Mesh, Left large, Sterile Pre-formed Knitted Polypropylene Product Code: 0151531
The FDA listed the manufacturer reason for recall as “Mislabeled: Product labeled as Left large, may contain a Right Large.” The FDA described the reason for the recall of this Bard 3Dmax mesh was “Mixed-up of materials/components”
According to the FDA, Davol took the following actions: “Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000.” Recall No. Z-0935-2009
2009- BARD PERFIX LIGHT PLUG
On August 11, 2009 Justice Gibney, the chief Justice of the Rhode Island Superior Court, issued a decision which stated in pertinent part, “By order of the Presiding Justice, dated March 8, 2007, all filings in Providence County Superior Court alleging personal injuries from Kugel Mesh hernia repair patches were assigned to this Court for multi-case management. (Administrative Order No. 2007-6.) The order authorizes this Court to dispose of any and all pre-trial motions related to this litigation and to preside over trials, should any occur. Id. The order further empowers this Court to “issue special orders for the due administration of these causes of action.” Id.” https://cases.justia.com/rhode-island/superior-court/Brokaw%20v.%20Davol%20(Assessment%20Order)%20(final).pdf
On December 8, 2009 the FDA determined that BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716 is Substantially Equivalent (SESE) to the predicate devices of:
- Bard® Soft Mesh (Davol Inc.)
- Bard® Mesh Dart (Davol Inc.)
- Bard® PERFIXTM Plug (Davol Inc.)
- Mersilene Mesh (Ethicon, Irnc.)
The FDA approved Bard / Davol’s 510(k) FDA premarket notification and approved BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716 to be marketed to the general public. The device description in the 510(k) summary for BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 011716 was “The Proposed Product, Bard® PERFIXT Light Plug is a pre-formed three-dimensional (cone shape) device constructed of a fluted outer layer and multiple inner layers of mesh attached at the tip.” 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Read more here: 3DMAX HERNIA MESH LAWSUITS: SAY IT AIN’T SO FDA!
2010- Bard wins first bellwether hernia mesh trial, victim wins 2nd bellwether trial
In NORMA OLMO and NELSON OLMO v DAVOL, INC. and C.R. BARD, INC., Justice James Cohn, in Dicta, summarized the bellwether cases in the Kugel Multidistrict litigation in Rhode Island. “Throughout the multidistrict litigation, plaintiffs have presented two general defect and causation theories: (1) a “break” of a memory recoil ring in the CK Patch; and (2) a “buckle” in which the polypropylene side of the CK Patch came into contact with the bowel. The Panel selected one “break” and one “buckle” case to serve as bellwether cases. The “buckle” case, Whitfield v. Davol Inc., No. 1:07-cv-001918, 1:07-md-01842, MDL No. 1842 (D.R.I.), ended in a defense verdict in favor of Bard. The “break” case, Thorpe v. Davol Inc., No. 1:08-cv-0463, 1:07-md-01842, MDL No. 1842 (D.R.I.), ended in a verdict in favor of the plaintiffs, but the court granted Bard’s motion for judgment as to punitive damages and failure to warn.”
Bard/ Davol wins first Bellwether trial in Kugel MDL – John Whitfield v. Davol
1st Bellwether Trial: In Kugel Patch MDL Ends In Defense Verdict: Hernia mesh attorneys lose first hernia mesh trial. “PROVIDENCE, R.I. — (Mealey’s) The first bellwether trial involving the Kugel surgical mesh patch ended in a defense verdict on April 14 when a Rhode Island federal jury found that the plaintiff had not proven that his injuries were directly caused by or contributed to by negligent design of the device (In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842; John Whitfield v. Davol, Inc., et al., No. 07-1918, D. R.I.). A nine-member jury in the U.S. District Court for the District of Rhode Island, where the Kugel mesh hernia patch multidistrict litigation is centralized, found that plaintiff John Whitfield did not prove that the CK (Composix Kugel) patch was defectively designed or inadequately labeled or that defendants C.R. Bard Inc. and subsidiary Davol Inc. were negligent in labeling the device. Lexis Nexis
Plaintiff’s win 2nd Kugel MDL bellwether trial- 1.5 million
2nd Bellweather trial: Hernia mesh attorneys win 1.5 million verdict! “PROVIDENCE, R.I. – (Mealey’s) The second Kugel surgical patch bellwether trial went to the plaintiff Aug. 23 when a Rhode Island federal court jury awarded $1.5 million to a man who claims that the device caused him internal injuries (In Re: Kugel Mesh Hernia Patch Litigation, MDL Docket No. 1842, No. 07-1842, Christopher Thorpe v. C.R. Bard, Inc., et al., No. 08-463, D. R.I.).” Plaintiff Awarded $1.5 Million In Second Bellwether Trial In Kugel Hernia Patch MDLA jury in the U.S. District Court for the District of Rhode Island, where the Kugel multidistrict litigation is centralized, found that manufacturing defendants Davol Inc. and C.R. Bard Inc. inadequately designed the Kugel patch and failed to warn plaintiff Christopher Thorpe or his doctor that the device could fail. The jury awarded Thorpe $1.3 million and his wife, Laure Thorpe, $200,000 for loss of consortium. ” https://www.aboutlawsuits.com/settlements-kugel-hernia-mesh-problems-19474/ https://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2010/08/23/plaintiff-awarded-1-5-million-in-second-bellwether-trial-in-kugel-hernia-patch-mdl.aspx?Redirected=true
According to law 360, “A jury has awarded $1.5 million to a North Carolina couple injured by allegedly defective hernia patches, but won’t get the chance to impose punitive damages, according to a federal judge overseeing multidistrict litigation against C.R. Bard Inc. and a subsidiary. Christopher Thorpe won $1.3 million Monday in the second of four bellwether trials in the U.S. District Court for the District of Rhode Island, with wife Laure Thorpe taking home $200,000 for loss of consortium. The couple had claimed that Bard’s Composix Kugel surgical mesh patches were unreasonably designed and carried inadequate warning of risk. Judge Mary M. Lisi, however, ruled in a minute entry Monday that the plaintiffs fell short of their burden to show the malicious intent, disregard for safety or egregiously wrongful acts necessary to merit punitive damages.” Law360
“Mr. Thorpe’s injuries required him to undergo multiple surgeries to repair the damage caused by the defective hernia patch, injuries from which he continues to suffer due to the serious nature of the physical damage caused by the patch. The jury found that the defendants proximately caused Mr. Thorpe’s injuries by failing to provide adequate warning or instruction for the hernia repair patch and acting unreasonably in designing the patch. The jury also found that the defendants’ negligence proximately caused Laure Thorpe to lose the consortium of her husband as a result of his injuries and subsequent physical and emotional suffering.” PR web
“Dr. Ducheyne was permitted to render expert testimony in Thorpe over Defendants’ objection. However, Dr. Ducheyne’s testimony in Thorpe is distinguishable. There, Dr. Ducheyne offered the specific opinion that scar contracture may have caused the well-documented ring break in Thorpe’s CK Patch. Dr. Ducheyne explained in detail how he arrived at this conclusion and relied on: (1) his personal observation of, among other things, “a sample patch, the explanted patch, Thorpe’s medical and surgical records, and the images made of the patch”; (2) “the generally known and accepted phenomenon of contraction due to scar tissue formation”; and (3) “the known properties of polypropylene.” UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA CASE NO. 13-62260 NORMA OLMO and NELSON OLMO, Plaintiffs, v. DAVOL, INC. and C.R. BARD, INC., Defendants. OMNIBUS ORDER, Thorpe v. Davol, Inc., No., C.A. 008-463ML, 2011 WL 470613, at *17, *25 (D.R.I. Feb. 4, 2011)
On July 15, 2010 The FDA determined that VENTRALIGHT ST MESH, a Class II Surgical Mesh, is Substantially Equivalent (SESE) to the predicate device of Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739) 510k summary
The FDA approved Bard / Davol’s 510(k) premarket notification and approved VENTRALIGHT ST MESH to be marketed to the general public. The device description in the 510(k) summary for VENTRALIGHT ST MESH was “The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.” Id.
2011- Bard opens up pocket book and pays peanuts to several thousand victims who each filed a hernia mesh lawsuit
July 11, 2011: “C.R. Bard has reportedly reached an agreement to settle Kugel hernia mesh lawsuits brought by about 2,600 people who experienced severe internal injuries caused by problems with their hernia repair patches, with in an average payout of about $70,000 for each plaintiff. However, the settlement still leaves around 1,000 claims unresolved….” Id. These settlements were negotiated by top hernia mesh product liability attorneys.2011
“Law360, New York (July 1, 2011, 3:24 PM EDT) — C.R. Bard Inc. said Thursday it had tentatively agreed to pay $184 million to settle the majority of claims in a Rhode Island multidistrict litigation over allegedly defective hernia patches. In a U.S. Securities and Exchange Commission filing, the medical equipment manufacturer said it had reached agreements in principle with scores of plaintiffs who claim they suffered significant injuries because of faulty Composix Kugel surgical mesh patches manufactured by Bard subsidiary Davol Inc.”https://www.law360.com/articles/255403/bard-offers-184m-to-settle-hernia-patch-suits
After the Bard, Kugel 184 million dollar hernia mesh lawsuit settlement, the multidstrict litigation pending in Federal Court in RI was officially disbanded in 2017. Many victims did not accept the settlement and many cases were transferred to Rhode Island State Courts.
2012- The end of the CK Patch | Marlex hernia mesh study released
March 2012: “In March 2012, Defendants stopped selling the CK Patch, while it continued to sell a number of other hernia repair products.” Bard objection
July 2012: “In this published report in the Journal of the American Board of Family Medicine, Jan-Feb 2012, doctors from Dewitt Amy Hospital, Fort Belvoir, VA, determined irritable bowel syndrome (IBS) can be caused by a mesh complication. In this case a 50-year-old woman had Marlex hernia mesh implanted 13 years earlier to treat periumbilical herniorrhaphy or a protrusion of fat or intestines outside of the muscle. It shows up as a bump near the bellybutton. The woman had one bowel movement a week and symptoms diagnosed as IBS. Large amounts of Marlex were found in her stool and a colonoscopy diagnosed her with IBS. She received Zelnorm and MiraLAX but that did not relieve the trapped umbilical hernia. The Marlex mesh “had fully eroded into the lumen of the small bowel, causing a partial obstruction” and something called fecalization. Doctors resected a section of small bowel and the patient was relieved of her IBS-like symptoms. This case raises the possibility that mesh might erode into the bowel causing symptoms that might be written off as IBS unrelated to mesh.” https://www.meshmedicaldevicenewsdesk.com/when-marlex-mesh-erosion-appears-as-irritable-bowel-syndrome/
2013- The Generic discovery process concludes in the Bard Kugel Federal Court multidistrict litigation
“Generic discovery as to the CK Patch and other MDL products concluded in the MDL in 2013, by which time Defendants had produced over 7 million pages of documents. More than thirty depositions of Defendants’ current and former employees were taken in the prior MDL. Additional document productions have taken place in other cases.” Id.
2014- Here comes the Bard Perfix Plug
July 2014: The Federal Court in Rhode Island stopped accepting new cases in the Bard Multi District Litigation. “In July 2014, the District of Rhode Island stopped accepting new cases into the MDL.” Bard Response
October 08, 2014: Bard PerFix Light Plug was subject to a Class 2 Device Recall.The Manufacturer Reason for this Mesh, surgical, polymeric Recall was “The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug”
The FDA’s description of the issue was a bit more simplistic, describing the problem as “Error in labeling.” As a result of the recall, Davol took the following action: “Davol Inc. (Subsidiary of C.R. Bard, Inc) sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.” Id.
In 2017, Kugel multi-case management coordinated proceeding pending in RI State Court since 2007 officially expands to other Bard hernia mesh medical devices
Febuary 23, 2017: Federal Court judge dismisses the Bowersock hernia mesh lawsuit because experts either lacked qualifications or their testimony was unreliable. “For the reasons stated herein, the Defendants’, Davol, Inc. and C.R. Bard, Inc., Motions in Limine to exclude the testimony of Dr. Stephen Ferzoco (Dkt. 33) and Dr. William A. Hyman (Dkt. 39), as well as the Motion in Limine to limit the testimony of Dr. Roland Kohr (Dkt. 37), are GRANTED; in addition, Defendants’, Davol, Inc. and C.R. Bard, Inc., Motion for Summary Judgment (Dkt. 30), is GRANTED. The Court will enter judgment accordingly.” BOBBY DON BOWERSOCK, and CHARLOTTE ROBINSON as CoPersonal Representatives of the Estate of Georgia J. Bowersock, deceased, and MARK BOWERSOCK Individually, Plaintiffs, vs. DAVOL, INC., C.R. BARD, INC., Defendants. No. 1:08-cv-01313-LJM-TAB, ORDER ON DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT
“A District Court in Indiana recently awarded summary judgment to a medical device manufacturer upon finding the plaintiffs were unable to proffer any expert causation evidence that satisfied the requirements of Federal Rule of Evidence 702 and Dabuert. See Bowersock v. Davol, Inc., No. 108CV01313LJMTAB, 2017 WL 711849, at *1 (S.D. Ind. Feb. 23, 2017). Plaintiffs, representatives of the Estate of Georgia Bowersock, alleged that a hernia patch manufactured by C.R. Bard, Inc. (“Bard”) and implanted in Bowersock was defective and ultimately led to her death. Bard moved for summary judgment and to exclude the testimony of Plaintiffs’ experts Dr. Stephen Ferzoco and Dr. William Hyman, as well as to limit the testimony of Dr. Roland Kohr. The court agreed that these experts lacked qualifications or failed to put forth reliable testimony on medical causation, and thus, Plaintiffs could not establish a violation of the Indiana Products Liability Act.” https://product-liability.weil.com/expert-issues/hernia-patch-case-tossed-out-along-with-expert-causation-opinions/
April 7, 2017: IN SETBACK FOR BARD VICTIMS, IN THE OLMO MESH LAWSUIT, A FEDERAL COURT DISMISSES A HERNIA MESH LAWSUIT. A judge for the UNITED STATES DISTRICT COURT for the SOUTHERN DISTRICT OF FLORIDA sitting in Fort Lauderdale, Broward County Florida dismissed a hernia mesh lawsuit, CASE NO. 13-62260. The hernia mesh lawsuit was filed by mesh victim NORMA OLMO who alleged that extra-large Composix Kugel hernia patch (“CK Patch”) manufactured by C.R. Bard and Davol Inc. was defective and caused her complications, side effects and serious symptoms. The hernia mesh lawsuit was entitled: NORMA OLMO and NELSON OLMO, Plaintiffs, v. DAVOL, INC. and C.R. BARD, INC., Defendants. The Federal Court judge issued an Omnibus order which stated in pertinent part, “Defendants’ Motion to Exclude the Testimony of Plaintiffs’ Expert Dr. Paul Ducheyne, Ph.D. [DE-MDL 5188] is GRANTED. Defendants’ Motion for Summary Judgment [DE-MDL 5185] is GRANTED. Summary judgment is entered in favor of Defendants and against Plaintiffs. The Court will enter a separate Final Judgment consistent with this Order.” OMNIBUS ORDER
In the Olmo hernia mesh lawsuit, “The judge determined that the plaintiff’s expert did not perform tests to establish his theory concerning the Composix Kugel hernia patch (“CK Patch”) The expert did not provide proper scientific studies to support his conclusions regarding the Bard Composix Kugel hernia patch (“CK Patch”) OMNIBUS ORDER
May 5, 2017: The Rhode Island State Court issues Administrative Order No. 2017-02 setting up a multi-case coordinated proceeding for all hernia mesh cases against Bard/ Davol. “..this Court set up a multi-case management coordinated proceeding for all subsequent filings alleging personal injuries from Davol / C.R. Bard hernia mesh products.” Procedural order #1 IN RE: DAVOL/ C.R. BARD HERNIA MESH
- Bard mesh that is included in the Rhode Island Coordinated Proceeding: Bard Mesh, Composite Prosthesis (also known as Composix), Composix E/X Mesh, Composix Kugel Hernia Patch, Kugel Hernia Patch, Marlex Mesh, Modified Kugel Hernia Patch, PerFix Plug, SpermaTex, Ventralex Hernia Patch, Ventralex ST Hernia Patch, Ventrio Hernia Patch, Ventrio ST Hernia Patch, Visilex Mesh, 3DMaX Mesh and Sepramesh IP Composite . All other Bard mesh not included in RI consolidated lawsuits.
Kugel hernia mesh MDL pending in RI federal Court closed
June 2017: “In June 2017 shortly before retiring, Judge Lisi transferred the MDL to Chief Judge William E. Smith of the District of Rhode Island” DEFENDANTS C. R. BARD, INC. AND DAVOL INC.’S RESPONSE TO PLAINTIFFS’ MOTION FOR § 1407 COORDINATION/ CONSOLIDATION & TRANSFER OF RELATED ACTIONS TO THE SOUTHERN DISTRICT OF OHIO
September 2017: In September 2017, The Rhode Island Federal Bard multidistrict hernia mesh litigation was terminated. “In September 2017, upon Judge Smith’s recommendation, the JPML terminated the MDL.” Bard Response
“Mealey’s (September 19, 2017, 4:20 PM EDT) — WASHINGTON, D.C. — The 10-year-old Kugel mesh hernia patch multidistrict litigation was marked closed Sept. 15 by the Judicial Panel on Multidistrict Litigation (JPMDL) (In Re: Kugel Mesh Hernia Patch Products Liability Litigation, MDL Docket No. 1842, JPMDL). On Sept. 8, Chief Judge William E. Smith of the U.S. District Court for the District of Rhode Island recommended that the JPMDL terminate the MDL because two bellwether trials have been held and all non-Rhode Island cases have been settled or remanded to their original court. He said the only remaining cases are those that originated in the District Court.” Lexislegalnews The MDL’s master case list was closed Aug. 31.
State Bard hernia mesh consolidated lawsuits commence in RI State Court
November, 2017: Chief Justice Gibney issued her first procedural order in the Bard/ Davol multi-case coordinated proceedings which stated in pertinent part, “While the litigation focused on the Composix Kugel Hernia Patch, some cases involved other Bard hernia products such as the Composix E/X Mesh, Ventralex Hernia Patch, Composix Hernia Patch, Kugel Hernia Patch, CK Parastomal Patch and Modified Kugel Patch.” Procedural order #1 IN RE: DAVOL/ C.R. BARD HERNIA MESH
Hundreds of hernia mesh cases against Bard are now pending in Providence Superior Court. The consolidated litigation is currently titled: “IN RE: DAVOL/ C.R. BARD HERNIA MESH” Master Docket No. PC-2018-9999
2019: “Currently, there are two trials scheduled in the Rhode Island state court litigation in 2019 – one in June and one in September; although those dates are tentative and may be subject to change. These initial trials are called bellwether trials. A bellwether case is selected through a lengthy process in the courts to be tried as, essentially, a “test case” to help anticipate the outcome of future similar cases. It would not be feasible for the courts to address the thousands of cases filed across the country, so the cases are consolidated for pretrial purposes.” https://www.natlawreview.com/article/bard-hernia-mesh-litigation-update
Many victims have filed in Rhode Island to get the benefit of Rhode Island’s nearly endless statute of limitations for hernia mesh lawsuits.
Becton Dickinson acquires Bard for 24 Billion
December 29, 2017: In 2017: Becton, Dickinson & Co. which is a medical technology company and is more known as BD. BD acquired C.R. Bard, Inc.,commonly known as Bard, for $24 billion. The two combined corporations will have over $16 billion in revenue per year and over 65,000 employees. Bard is now a wholly owned subsidiary of BD. “Medical technology company BD (Franklin Lakes, NJ) announced on Dec. 29, 2017, that it has completed the acquisition of CR Bard Inc. for $24 billion. By acquiring CR Bard, which plays a leading role in the development and manufacture of vascular, urology, oncology and surgical specialty products, BD said in a press release that it is creating a “new healthcare industry leader with approximately $16 billion in annualized revenue.” Plastics Today
The OLMO lawsuit: Plaintiff’s lawyer suffer setback
February 7, 2018: The United States Court of appeals for the Eleventh Circuit affirms the summary judgment dismissal ruling in favor of the defendant, Bard in the Norma Olmo hernia mesh lawsuit. This was the lawsuit related to Kugel “CK Patch.” The Court ruled in a short decision, “We have had the benefit of oral argument and have carefully reviewed the briefs and the summary judgment record in this case. The learned intermediary doctrine provides that the manufacturer’s duty to warn runs to the physician, not directly to the patient. If the physician had independent knowledge of the risk that caused the plaintiff’s injuries – substantially the same knowledge as an adequate warning should have communicated – then the plaintiff cannot prevail on a failure to-warn claim. Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192 (11th Cir. 1995). We agree with the district court that the physician who implanted the instant patch had such independent knowledge. With respect to the patch that was implanted in plaintiff, there is insufficient evidence that the ring in the patch buckled. For the foregoing reasons, including reasons fully explained at oral argument, the judgment of the district court is AFFIRMED. NORMA OLMO, NELSON OLMO v NORMA OLMO, NELSON OLMO, THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT. Read decision here.
March 20, 2018: “The New Jersey Superior Court’s appellate division refused to reinstate a hernia mesh product liability lawsuit against Becton Dickinson’s C.R. Bard because expert witnesses couldn’t prove the design of the product was defective or that significant negligence occurred.” Source
“In the instant case, none of the experts specifically opined that 3DMax is defective and that this defective design caused the medical complications complained of by the plaintiff. Instead, plaintiff’s three experts gave general opinions about the various medical risks of the product that can cause complications. This is not enough to overcome the summary judgment standard,” the judges wrote. Id. “They also noted that none of the experts who testified presented an alternative, feasible design for the 3DMax, which is one of the determining factors in a defective design case.” Id.
2018- Victim’s seek a new centralized Federal Court Bard / Davol Multidistrict litigation in Ohio
April 2018: “Several plaintiffs filed a petition with the JPML in April asserting that centralization of all federally-filed Bard hernia mesh lawsuits would improve judicial efficiency, reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and serve the convenience of the witnesses, the parties and the courts. They have proposed the U.S. District Court Southern District of Ohio, or alternatively, the Western District of Missouri, as possible venues for the multidistrict litigation.” RX injury help
“A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation that seeks centralization of all federally-filed hernia mesh lawsuits involving propylene devices manufactured by C.R. Bard, Inc. and its Davol, Inc. subsidiary. (IN RE: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, MDL No. 2846) According to the April 10th filing, there are currently more than 50 hernia mesh lawsuits pending against C.R. Bard and Davol in federal courts around the country, all of which involve injuries allegedly related to the companies’ polypropylene implants, including the Ventralex and Perfix products. Plaintiffs similarly allege that the devices were defectively designed and caused them to experience debilitating complications and adverse reactions.” PRnewswire
Bard’s response to request for federal consolidated MDL
Bard files a response to the victims motion entitled, “DEFENDANTS C. R. BARD, INC. AND DAVOL INC.’S RESPONSE TO PLAINTIFFS’ MOTION FOR § 1407 COORDINATION/CONSOLIDATION & TRANSFER OF RELATED ACTIONS TO THE SOUTHERN DISTRICT OF OHIO.” In this response Bard consents to a Multidistrict litigation on the condition that all Bard mesh made of Polypropylene are included. Bard requests that the matter be consolidated to New Jersey Federal Court or the Southern District of New York.
2017-2018 time period: Bard admits in a federal Court filing the following concerning the lawsuits in Rhode Island State Courts, “However, within the last year alone, more than more than 1,500 cases have been filed there, including approximately 280 since the initial MDL Motion was filed on April 10.” DEFENDANTS C. R. BARD, INC. AND DAVOL INC.’S RESPONSE TO PLAINTIFFS’ MOTION FOR § 1407 COORDINATION/CONSOLIDATION & TRANSFER OF RELATED ACTIONS TO THE SOUTHERN DISTRICT OF OHIO
July 2018: The JPML’s next Hearing Session will be convened on July 26th at the Santiago E. Campos United States Courthouse. Oral Arguments begin at 9:30 a.m. RX injury help
Federal Court sets up consolidated MDL lawsuits for all Bard Polypropylene mesh lawsuits filed in federal Court
August 2018: On August 2nd, 2018 the UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION centralized pretrial proceedings for the Bard Davol hernia mesh lawsuits pending in Federal Courts for all mesh comprised of Polypropylene. The panel determined that, “centralization in the Southern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” Bard MDL transfer order
“A federal panel has decided to streamline pre-trial proceedings for what could be as many as 122 Bard Davol hernia mesh lawsuits currently pending in federal court. And widespread use of the medical device could mean hundreds of other people may come forward with injuries. The Judicial Panel on Multidistrict Litigation combined 53 federal lawsuits into a multidistrict litigation (MDL) on Aug. 2, 2018. MDLs allow a large number of similar cases to move more efficiently through the legal process. The panel said another 69 cases currently in federal court may also qualify.’ Drug Watch
The case is entitled: IN RE: DAVOL, INC./C.R. BARD, INC., POLYPROPYLENE HERNIA MESH PRODUCTS LIABILITY LITIGATION MDL No. 2846
“We find that the Southern District of Ohio is an appropriate transferee district. It is centrally located geographically, making it a convenient forum for this nationwide litigation. Eight actions are pending in this district, six of them before Judge Edmund A. Sargus, an experienced transferee judge who will steer these cases on a prudent course. IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside the Southern District of Ohio are transferred to Southern District of Ohio and, with the consent of that court, assigned to the Honorable Edmund A. Sargus for coordinated or consolidated pretrial proceedings.” In re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Prods. Liab. Litig., 316 F. Supp. 3d 1380 (2018).1 Bard MDL transfer order
The hernia mesh victims’ attorneys argued that the Bard CK Patch lawsuits should be excluded from the consolidated mesh MDL. Davol Inc’s hernia mesh law firm argued that all polyproplene mesh should be part of this consolidated hernia mesh lawsuit. Ultimately, the Panel weighed in by stating, “Whether to include the CK Patch cases in centralized proceedings is a question not currently before the Panel, as none of the cases on the motion involve the CK Patch. We will address this question in due course through the conditional transfer order process.” Id.
The reasoning behind the Panels decision to consolidate the C. R. Bard hernia mesh lawsuits was: “All of the actions share common factual questions arising out of allegations that defects in 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. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.” Id.
(In 2018 Bard’s hernia mesh lawyers described the Kugel mesh litigation MDL-1842 as follows, ” In addition to the products specifically named, this expanded definition would include the following products: Ventrio, Ventrio ST, Ventralex ST, Composix, and Composix L/P, most of which were introduced after the formation of the MDL. The MDL, combined with the cases pending in Rhode Island state court, would go on to include over 4,000 cases.” Bard 2018 response )
2019 Bard Polypropylene MDL
View the Federal MDL, Bard Davol master complaint here
November 2018: Chief Judge Edmond A. Sargus of The United States District Court Southern District Of Ohio Eastern Division issued Case Management Order No 10 which was a Bellwether Scheduling Order.
January 2019: In the Ohio Federal Court Bard MDL, Chief Judge Edmund A. Sargus, Jr. entered an important discovery order stating that: “Defendants are ORDERED to produce official communications between Defendants and the six regulatory authorities identified in Plaintiffs’ Motion (id. at 3-4) regarding the safety and labeling of polypropylene hernia mesh products identified in paragraph 15 of the Master Long Form Complaint.” 1. the Scientific Committees of the European Commission; 2. the Medicines and Healthcare Products Regulatory Agency (MHRA), including Scotland’s Health Facilities Scotland (HFS) and the National Health Services (NHS) (United Kingdom); 3. the Federal Institute for Drugs and Medical Devices (BfArM) (Germany); 4. Health Canada; 5. the Therapeutic Goods Administration (TGA) (Australia); and 6. the Pharmaceuticals & Medical Devices Agency (PMDA) (Japan). Id.
March 2019: “According to recent court filings, lawyers expect the number of hernia mesh lawsuits filed against C.R. Bard in the federal court system to hit 3,000 by the end of the year, as individuals who experienced complications following a hernia repair continue to investigate and file claims. There are currently only a few hundred product liability lawsuits brought in U.S. District Courts nationwide, each involving similar allegations that plaintiffs suffered painful and debilitating complications that were caused by design defects with Bard Ventralex, Bard Perfix, Bard Composix and other polypropylene products sold by the same manufacturer in recent years. Given similar questions of fact and law raised in the complaints, the federal litigation has been centralized before U.S. District Judge Edmund A. Sargus in the Southern District of Ohio, for coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation. Following a status conference last week, Judge Sargus issued a pretrial order (PDF) on March 8, which indicates that lawyers representing plaintiffs in the litigation predict that roughly 3,000 claims will be filed by the end of 2019.” https://www.aboutlawsuits.com/bard-hernia-mesh-lawsuit-filings-2019-154645/
March 2019: “Right now in the Bard hernia mesh MDL, there are twelve cases in the bellwether pool to be worked up for trial – six cases were chosen by Plaintiffs and six cases were chosen by Defendants. As discovery in those cases proceeds, they will be whittled down to six cases. The Court will further reduce the amount of cases to three, with those cases to go to bellwether trials in May, July and September of 2020.” https://www.natlawreview.com/article/bard-hernia-mesh-mdl-moving-quickly
March 2019: The Court issued Case Management Order Number 15, “Approving bellwether discovery pool.” U.S. District Chief Judge Edmund A. Sargus approved 12 bellwether hernia mesh lawsuits. Six of he hernia mesh lawsuits were selected by Bard’s hernia mesh lawyers and six were selected by Victim’s hernia mesh lawsuit attorneys. Notably. neither party objected to the other party’s selections. This order was also signed by Kimberly A. Jolson, United States Magistrate Judge This was all done in accordance with case management order number 10. Read case management order #15
April 2019: “Right now in the Bard hernia mesh MDL, there are twelve cases in the bellwether pool to be worked up for trial – six cases were chosen by Plaintiffs and six cases were chosen by Defendants. As discovery in those cases proceeds, they will be whittled down to six cases. The Court will further reduce the amount of cases to three, with those cases to go to bellwether trials in May, July and September of 2020.” National review
May 2nd 2019: “On April 17, 2019, Judge Sargus, who is overseeing the Bard Hernia Mesh MDL in the Southern District of Ohio, held a Case Management Conference. At the time of the conference, the Court noted that there were just over 1,700 cases filed in the MDL, with approximately 80-100 new cases being filed each week. The parties advised that the protocol and schedule for conducting various depositions were still being discussed, including the depositions of the treating physicians, corporate designees, and company witnesses. Paper discovery from defendants is also still being produced and reviewed by Plaintiffs’ leadership. Another conference is scheduled for early June.” National Review
What is a bellwether case? “Again, a bellwether case is selected through a lengthy process in the courts to be tried as, essentially, a “test case” to help anticipate the outcome of future similar cases. It would not be feasible for the courts to address the thousands of cases filed across the country, so the cases are consolidated for pretrial purposes. Multiple cases are then selected as bellwether cases to potentially be tried, in hopes that an eventual global settlement may be reached between the parties. If settlement is not reached, then the cases may be remanded back to the plaintiff’s home state to be worked up for trial.” https://www.natlawreview.com/article/bard-hernia-mesh-mdl-moving-quickly
Cases we are reviewing for hernia mesh victims:
- Composix EX
- 3D Max (no 3D Max Lite)
- Perfix Plug
- Ventrio hernia mesh
- Kugel (criteria – confirmed ring break and revision)
Many victims are wondering:
- Can I file a hernia mesh lawsuit?
- What do I need to know before I file a defective medical device hernia mesh lawsuit?
- How can I get a hernia mesh settlement as a result of my defective medical device?
- Will there be a hernia mesh settlement 2018 and how do I get a mesh lawsuit update?
- What are the Kugel mesh hernia patch side effects?
- How can i find out if surgical has been subject to a Bard mesh recall and the Bard mesh recall lot numbers?
- Will I have hernia mesh symptoms and complications years later?
- What are hernia mesh patch recall symptoms?
- What is the Bard mesh price?
- Has the mesh in my body been subject to a bard hernia mesh recall?
- Was there a marlex mesh recall? When was the marlex mesh recall?
- Is Bard biological mesh an option if my surgeon does not want to use Bard polypropylene mesh?
- What are the bard mesh perfix plug recall lot numbers?
- How can I find out more about bard mesh perfix plug?
- Has there ever been a marlex mesh recall?
Bard Davol is a frequent flier using and abusing the shady and controversial FDA 510(k) Premarket Notification process. Over and over again, Bard Medical utilized mesh with an extensive, known history of victim complications as a predicate device to get allegedly defective hernia mesh to the market without proper clinical trials. It is apparent that the FDA 510(k) application process is the root of the problem for defective hernia mesh. The FDA 510(k) application is a controversial process which allows medical device manufacturers to fast track medical devices while evading FDA testing protocol. see also: SAY IT AIN’T SO! : FDA ALLOWS RELEASE OF DEFECTIVE HERNIA MESH
Drug Safety News devastating assessment of Bard Davol:
According to Drug Safety News: “It isn’t the first time C.R. Bard has run afoul of the law. In 1993, the company pleaded guilty to 391 criminal charges involving defective catheters that had been illegally modified and sold without regulatory approval. Three company executives were convicted and jailed on charges of fraud and conspiracy, and Bard wound up paying $61 million in fines and penalties. More recently, the company has been called to account over pelvic meshes and IVC filters.
In Drug Safety News opinion: “The latest fiasco with Kugel Meshes clearly demonstrates that C.R. Bard is a repeat offender. Unfortunately, because Bard is a “corporate” person and not a natural human, there is no way to jail it and make sure it doesn’t harm anyone else.” https://drugsafetynews.com/2017/04/24/bard-medical-defective-hernia-patches/
Info about Bard hernia Mesh provided by a hernia mesh lawyers:
According to My drug Justice: “Mesh products that have reports of serious problems and were manufactured by Davol C.R. Bard include:
- Bard 3D Max Inguinal Hernia Mesh
- Bard Davol Supramesh Composite
- Composix Kugel Mesh Patch
- Marlex mesh
- Bard Ventralex ST Hernia Patch
- Bard Mesh PerFix Plug” Baron and Budd
Hernia surgery is one of the most common types of surgeries that are performed. It is estimated that every year as many as 750,000 people undergo hernia repair surgery. When a patient is diagnosed with a hernia surgery is the only permanent treatment possible. While some patients may be able to wait to determine the severity of the situation, in many cases surgical care is needed to resolve the problem and keep it from worsening. Mesh patches are often necessary in hernia repair.
Repair of small incisional hernias, of less than 3 centimeters, are able to be repaired with the patient’s tissue. Larger hernias require the use of prosthetic materials such as mesh to provide a repair that is tension-free. Some of these materials are synthetic and may cause a host of complications when used in hernia surgeries.
Mesh Patches Made of Marlex Polypropylene
Patches made of Marlex polypropylene are designed to be used in laparoscopic hernia surgery. The material is flexible so that it can be folded to fit into a small incision. Once inside, it is opened to expand so that it covers the desired area. Unfortunately, there have been many medical problems and complications for patients with C.R. Bard mesh patches and others.
Marlex polypropylene is a type of manmade material that is non-absorbable. This means that the body does not absorb it, so it never disintegrates into the body. Instead, it remains in its original structure, although it may break, move, or weaken during use. The result is a hernia solution that can cause medical problems for patients.
Victims have many questions about hernia mesh including:
- How much can be learned from reviewing hernia mesh pictures?
- How many hernia mesh brands are there?
- What are the major hernia mesh complications symptoms?
- What are the symptoms of hernia mesh rejection?
- What are hernia mesh failure symptoms
- How do I get a hernia mesh recall list?
- What are the hernia mesh side effects?
- Will I get hernia mesh problems years later?
History of C.R. Bard Mesh Patches
Mesh patches are utilized to strengthen the area of repair. Hernia surgery has become more common over the last 30 years since various repair materials have been more readily available. Flexible sheets of materials are manufactured to be used as support for the repair. Polypropylene is a synthetic material that is not absorbable by the body. Therefore, it can cause some complications once it has been put into place.
The most common problems that occur in patients from the use of mesh patches are migration and erosion. Migration happens when the mesh patch moves or changes position inside the body. This can occur when tissues grow around the patch and push it out of place. The patch can actually move into a position where it can damage the intestines or create a blockage. Patches may also erode over time, creating the need for additional surgery to repair the hole that is left.
Complications from Mesh Patch Use:
Although not everyone suffers complications, many people have reported injuries and complications. Mesh subject to a bard hernia mesh recall is more likely to lead to mesh complications among victims. Do not forget that C.R. Bard is now known as Bard Medical.
Many victims have filed hernia mesh lawsuits as a result of these serious symptoms and mesh complications. The most common hernia mesh complications include:
- Migration of mesh
Complications may occur at any time after surgery but are most likely to happen months or years after the original surgical hernia repair was completed. Those who suffer from subsequent pain or other symptoms should immediately seek medical treatment. A complete doctor’s examination and diagnosis will determine the cause of the problem. Subsequently, the patient must be treated for complications due to the use of a mesh hernia patch.
Treatment of Complications
When a patient presents with a medical complication from a hernia mesh implant the cause of the problem may not be immediately known. Some symptoms may not appear for months or even years after the initial surgery. A different doctor may evaluate the patient, and the type of mesh implant that was inserted may not be noted. These details can make it difficult to evaluate and treat the patient.
Immediate care typically involves the use of pain medication and prescriptions to reduce inflammation. Once a diagnosis has been made, the patient will most likely require surgery to assess the internal damage and make the necessary repairs. The surgeon may try to remove at least part of the original patch; however, this can be difficult to do because the body’s tissue grows onto it. Instead, some of the patch will be taken out, and repairs will need to be done, sometimes using additional mesh products.
Recall of Surgical Mesh | Hernia mesh lawsuit
C.R. Bard mesh patches have been reported to cause injuries to some patients. Injuries range in severity, and some are life threatening. The injuries were caused allegedly by defects in the mesh material that caused the product to shift or move inside the body or to break while implanted. The result may be a puncture to the bowel, an obstruction to the intestines, an infection, or other problems that can be severe. The U.S. Food and Drug Administration, FDA, requires companies to follow strict guidelines for testing and product safety. Any complications should be reported to the FDA by both the patient and physician. In addition, patients may seek compensation by filing a lawsuit.
Litigation History and Current Status
C.R. Bard manufactures a number of different types of mesh implants. Complications have been reported with the use of Kugel Hernia Mesh, 3D Max, PerFix Plug, Ventralex ST Hernia Mesh and Sepramesh. The company still manufactures and sells these products. Various lawsuits have been filed against the company for injuries sustained by the use of mesh hernia implants. The lawsuits are based on the fact that the company was made aware of medical problems but did not take action to prevent further injuries from occurring. Additionally, the company did not properly warn patients of the potential for injuries caused by the use of mesh hernia products. Nothing was done to correct possible product defects.
Those who were injured because of complications from the use of hernia mesh should speak with a hrnia mesh attorney as soon as possible. Victims may be entitled to compensation for medical and other expenses that were incurred because of the defective products. To qualify for a lawsuit an individual must have received a mesh implant as part of original hernia surgery and then later suffered from complications. Medical documentation is necessary to show that the complications were a result of a defective implant. Individual lawsuits are possible, or there may be class action lawsuits that victims may take part in.
The FDA speaks
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” FDA
Please contact a hernia mesh lawyer for legal representation. A hernia mesh lawyer will help you get justice and compensation by either a judgment or settlement for your hernia mesh complications/revision surgery. Many victims are wondering if there will be a surgical mesh settlement 2017 or hernia mesh settlements 2018. Other victims are wondering what the average settlement amount is for a hernia mesh lawsuit.’
Hernia mesh lawsuits have been filed across the United States. Many of these lawsuits have been consolidated in Multi District Litigation (MDL). Here are some of the most significant Multi District Litigation:
- MDL No. 1842 | In Re: Kugel Mesh Hernia
Repair Patch Litigation UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND (This was disbanded in 2017)
- MDL No. 2753 | In Re: Atrium Medical Corp. C-Qur Mesh
Products Liability Litigation, UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE
- MDL No. 2782 | In RE: Ethicon Physiomesh Flexible
Composite Hernia Mesh Products Liability Litigation, United States District Court for the Northern District of Georgia
What is a hernia?
“A hernia occurs when an organ pushes through an opening in the muscle or tissue that holds it in place. For example, the intestines may break through a weakened area in the abdominal wall. Hernias are most common in the abdomen, but they can also appear in the upper thigh, belly button, and groin areas. Most hernias aren’t immediately life-threatening, but they don’t go away on their own. Sometimes they can require surgery to prevent potentially dangerous complications.” healthline
Bard’s checkered past | Bard is a Guilty of 391 Felonies
The U.S. Food and Drug Administration (FDA) and Department of Justice (DOJ) pursued a wide scale investigation into C.R. Bard. The Department of Justice Criminally criminally indicted Bard and six executives in 1993. The criminal indictment against Bard alleged that Bard knew problems with the catheter it manufactured, but refused to disclose the red flags to the Federal Drug Administration. The criminal indictment alleged that Bard lied to the Federal Drug Administration concerning animal testing in order to rush a particular type of catheter model to be sold to the public. The indictment alleged that Bard engaged in human testing of a catheter catheter that lacked FDA approval.
“For a company to engage in a pattern of using unsuspecting patients as guinea pigs and operating rooms as laboratories for unapproved products shows a blatant disregard for the health and safety of the patients who literally entrusted their lives to the company’s products,” FDA Commissioner David Kessler. Drug Watch
“In December 1993, Bard pleaded guilty in federal court to 391 criminal charges that involved accusations of selling defective heart catheters, hiding problems with the catheters from the FDA and conducting illegal experiments on humans. In a settlement with the FDA and DOJ, Bard agreed to pay $61 million. Half would be for a criminal fine and half for a civil liability settlement. Six Bard executives were also prosecuted in separate trials. Three were acquitted and three others were each sentenced to 18 months in prison for their roles in the catheter episode.” https://www.drugwatch.com/manufacturers/bard/