Posts Tagged Judge Joseph Goodwin

Dallas Jury Awards $73 Million TVM Verdict against Boston Scientific

In the first victory for plaintiffs against Boston Scientific Corp. and their mesh devices, a Dallas, Texas jury found for the plaintiff Martha Salazar and ordered Boston Scientific to pay a staggering $73 million.  Jurors found Boston Scientific to be at fault for the damages that Ms. Salazar suffered as well as a finding of gross negligence, awarding punitive damages to the plaintiff.  The jury awarded approximately $23 million in compensatory damages for her actual and future suffering and $50 million in punitive damages after finding the company was grossly negligent.  (Salazar v. Lopez, District Court for Dallas County, No. DC-12-14349).

Salazar, was implanted with an Obtryx sling on January 17, 2011 by Dr. Jorge Lopez to treat urinary leakage.  As a result of the alleged defective device, Salazar suffered from permanent nerve damage, constant pelvic pain, and had to endure four subsequent surgeries.

Click here to read the full Reuters article: Boston Scientific Ordered to Pay $73 million Over Mesh Device

Boston Scientific plans to appeal the verdict.

The verdict is the third case to go to trial against Boston Scientific over their devices.  The first two, tried in Massachusetts, resulted in verdicts absolving the company of liability.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.

Two Massachusetts juries recently rejected women’s claims that Boston Scientific’s incontinence sling was defective designed and injured women.

On September 5, 2014, a federal jury in West Virginia found for the plaintiff Jo Huskey and ordered Johnson & Johnson’s Ethicon to pay $3.27 million.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Trademark Notice

Boston Scientific is a registered trademark of Boston Scientific Corp. The use of this trademark is solely for product identification and informational purposes. Boston Scientific Corp. is not affiliated with this website, and Boston Scientific Corp. has no affiliation with The Brandi Law Firm. Nothing on this site has been authorized or approved by Boston Scientific Corp.

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West Virginia Federal Jury Awards $3.27 Million Verdict against Johnson and Johnson’s Ethicon

In another victory for plaintiffs against vaginal-mesh implant manufacturers, a federal jury in West Virginia found for the plaintiff Jo Huskey and ordered Johnson & Johnson to pay $3.27 million.  Jurors found that J&J defectively designed the Ethicon TVT-O sling and failed to properly warn doctors and patients the device could erode, subsequently damaging organs and causing pain.  The case was presided over by Judge Joseph Goodwin.  (Huskey v. Ethicon, 12-cv-05201, U.S. District Court, Southern District of West Virginia (Charleston)).

Huskey, a physical therapy assistant from Illinois, was implanted with her Ethicon sling in 2011.  She had surgery to remove the device later that year after suffering pain.

Click here to read the full Bloomberg article: J&J Ordered to Pay $3.27 Million Over Mesh Implant

Ethicon TVT-O

TVT-O (transvaginal tape obturator)

The TVT-O (transvaginal tape obturator) is a polypropylene mesh hammock, sling or tape, designed to support the urethra and correct stress urinary incontinence (SUI).   Like the TVT (transvaginal tape), TVT-O is implanted through the vagina, but unlike the TVT which exits through the lower abdomen, the TVT-O has an exit point through the groin, making mesh injuries and mesh removal potentially harmful and injurious.  Both types of mesh hammocks are still on the market.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.

Two Massachusetts juries recently rejected women’s claims that Boston Scientific’s incontinence sling was defective designed and injured women.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Trademark Notice

Johnson & Johnson is a registered trademark of Johnson & Johnson Inc.  The use of this trademark is solely for product identification and informational purposes.  Johnson & Johnson Inc. is not affiliated with this website, and Johnson & Johnson Inc. has no affiliation with The Brandi Law Firm.  Nothing on this site has been authorized or approved by Johnson & Johnson Inc.

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Due to Numerous Injuries, FDA Proposes Reclassifying Vaginal Mesh Devices from Class 2 to Class 3

Based on a number of risks associated with the transvaginal mesh devices including infection, vaginal bleeding, damage to connective tissues, nerves, and blood vessels, on May 1, 2014, the FDA proposed reclassification of mesh devices from Class 2 to the more rigorous Class 3 status.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse [POP] and is now proposing to address those risks for more safe and effective products,” said William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement.  “If these proposals are finalized, we will require manufacturers to provide pre-market clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”  Previously the manufacturers avoided rigorous investigation by using the 510 k procedures.  In a scathing review of these devices the FDA said, “The published literature reveals that, although transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair and, given the risks associated with mesh, the probable benefits from use of the device do not outweigh the probable risks.”

Sadly, tens of thousands of women have already learned this lesson.

In 2011, the FDA issued a safety communication warning serious complications for the mesh devices used for POP are not rare.  In 2012, the FDA ordered post-market surveillance studies to address safety and effectiveness concerns regarding the transvaginal surgical mesh devices.  Many believe if the mesh manufacturers were not able to use the 510 k process this disaster would not have happened.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.

Next Trial

On September 29, 2014 the consolidated Boston Scientific mesh trial are scheduled to commence in the Southern District of Florida.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

 

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FDA Issues Warning Letter to Mesh Manufacturer ENDO for Federal Regulation Violations

Endo International PLC, a subsidiary of American Medical Systems, Inc. was recently issued a warning letter by the FDA for violating three federal regulations relating to how the Minnesota company facility manufactures its urological devices.

Click here to read the full article: Inspection Triggers FDA Warning for Mesh Manufacturer

While the warnings does not pertain directly to mesh, the circumstances shed light on the quality or lack thereof of Endo’s manufacturing processes.  According to the FDA, Endo has not adequately validated manufacturing processes and test methods for the AMS 800 Urinary Sphincter and AMS 700 Inflatable Penile Prosthesis.  The second violation relates to Endo’s failure to perform risk analysis for the AMS 800 and AMS 700.  Finally, Endo failed to maintain procedures for taking corrective and preventive action when there is a quality issue in the manufacturing of a device.  These violations go to essential manufacturing procedures and cast significant doubt on Endo’s overall quality of operation.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.

Next Trial

On September 29, 2014 the consolidated Boston Scientific mesh trial are scheduled to commence in the Southern District of Florida.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Trademark Notice

Endo International PLC and American Medical Scientific are registered trademarks.  The use of these trademarks is solely for product identification and informational purposes.  These trademarks are not affiliated with this website, and the trademarks have no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by the trademarks.

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Five Boston Scientific Mesh Cases Remanded for Trial in Florida

On April 11, 2014, Judge Joseph Goodwin consolidated five Boston Scientific mesh cases and set them for trial on September 29, 2014 in Southern District of Florida.

The cases are:

Eghnayem v. Boston Scientific Corporation, 2:13-cv-07965

Dotres v. Boston Scientific Corporation, 2:13-cv-10077

Nunez v. Boston Scientific Corporation, 2:13-cv-24346

Dubois-Jean v. Boston Scientific Corporation, 2:14-cv-04455, and

Betancourt v. Boston Scientific Corporation, 2:14-cv-11337

No Judge has been assigned yet.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

On April 4, 2014, a Dallas jury found for the plaintiff Linda Batiste and ordered Johnson & Johnson to pay $1.2 million for its defective design of the Ethicon TVT-O pelvic mesh.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Court Sets Key Dates Leading to Trial in Boston Scientific Vaginal Mesh Cases

Judge Joseph Goodwin set the following key dates for the run up to trial in the vaginal mesh cases vs Boston Scientific currently set for October 14, 2014. Pretrial Order 87 provides as follows:

Plaintiffs shall serve expert reports by 5/11/2014 and provide proposed deposition dates to occur by 7/1/2014;

Defendants shall serve expert reports by 6/1/2014 and provide proposed deposition dates to occur by 8/1/2014;

Plaintiffs shall serve rebuttal expert reports by 7/1/2014;

Written discovery due 6/13/2014;

Expert discovery due 8/1/2014;

Case-specific discovery due 7/28/2014;

Setting forth motions practice; deposition designations due 9/23/2014, objections due 10/3/2014, counter-designations due 10/10/2014;

Exhibit and witness lists due 10/3/2014;

Proposed integrated pretrial order due three days prior to pretrial conference;

Pretrial and settlement conference set 9:00 a.m.

10/2/2014; proposed jury instructions w/proposed verdict form due 10/10/2014;

Trial set 8:30 a.m. 10/14/2014.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

Our office represents women who have suffered horribly from these mesh products. We remain committed to representing them to a successful conclusion of their cases.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Coloplast Reportedly Settles 400 Transvaginal Mesh Cases

Coloplast CorporateThere are approximately 29,000 mesh cases pending against Johnson & Johnson, C.R. Bard, Boston Scientific, Cook Medical Systems and Endo Health Solutions before Judge Joseph Goodwin in West Virginia.  Reportedly, settlement talks are ongoing in some form with some of the defendants, with only Johnson& Johnson not participating.  As the cases move to trial, transvaginal mesh manufacturer Coloplast has reportedly agreed to settle 400 cases for 16 million.  (MDL No. 2387 In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation)  The terms have not been disclosed.  Coloplast is a worldwide company employing over 8000 people

Coloplast made Novasilk Synthetic Flat Mesh, Restorelle Smartmesh, and Exair mesh for POP (pelvic organ prolapse) and five products for SUI (stress urinary incontinence): Aris Transobdurator (TOT) sling, Minitape sling, Omnisure Sling, Supris Suprabic Sling, and T-Sling with Centrasorb.

It is not known what products are subject to the reported settlement.

Click here to read the full article: Coloplast Settles Hundreds of Vaginal Mesh Lawsuits for $16M

In June 2013, Endo Health agreed to a $54 million settlement involving an unknown number of claimants.  According to regulatory filings, Endo Health Solutions is building a stockpile of cash in the amount of $520 million increasing reserves to cover expected fallout from the pelvic mesh litigation.  Endo disclosed in a regulatory filing that the amount of money could increase due to the growing lawsuits and the ultimate outcome.

Vaginal Mesh Trial History

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc.

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

Our office represents women who have suffered horribly from these mesh products.  We remain committed to representing them to a successful conclusion of their cases.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Endo Health Solutions Saving $520 Million to Fund Transvaginal Mesh Lawsuits While Settling Off Label Marketing Claims for Lidoderm

AMSIn 2011, Endo Health Solutions bought American Medical Systems, one of the manufacturers who is currently embroiled in the transvaginal mesh litigation, with over 5,000 pending lawsuits before Judge Joseph Goodwin.  In 2008, women who used these devices began filing suits against American Medical Systems.  In 2013, Endo agreed to pay some $54.5 million toward settling some of the pending suits.

According to regulatory filings, Endo Health Solutions is building a stockpile of cash in the amount of $520 million increasing reserves to cover expected fallout from the pelvic mesh litigation.  Endo disclosed in a regulatory filing that the amount of money could increase due to the growing lawsuits and the ultimate outcome.

Click here to read the full article: Endo is Stocking up at Least $520M to Cover Vaginal Mesh Lawsuit Legal Costs

On the same day, Endo also announced it is settling with the Department of Justice for $192.7 million to resolve criminal and civil liability allegations brought by whistleblowers pertaining to claims it marketed Lidoderm, a patch approved to treat shingles pain, for off label uses including pain from diabetic neuropathy and carpal tunnel syndrome.  The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million.  In a deferred prosecution agreement to resolve the charge, Endo Pharmaceuticals Inc. admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications.  The government alleged that, from March 1999 through December 2007, Endo caused false claims to be submitted to federal health care programs, including Medicaid, a jointly funded federal and state program, by promoting Lidoderm for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by the federal health care programs.  Of the $171.9 million Endo has agreed to pay to resolve these civil claims, Endo will pay $137.7 million to the federal government and $34.2 million to the states and the District of Columbia.

Click here to read the full FiercePharma article: Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses

Vaginal Mesh Trial History

On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc.

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R. Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

Our office represents women who have suffered horribly from these mesh products.  We remain committed to representing them to a successful conclusion of their cases.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Trademark Notice

Endo Health Solutions and American Medical Scientific are registered trademarks.  The use of these trademarks is solely for product identification and informational purposes.  These trademarks are not affiliated with this website, and the trademarks have no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by the trademarks.

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A Brief Review of The Trial Testimony and Directed Verdict for Ethicon in Carolyn Lewis Mesh Bellwether Case

Judge Goodwin 2On February 18, 2014, Judge Joseph Goodwin granted Ethicon’s Motion for Directed Verdict at the close of Plaintiff’s case in Lewis vs. Ethicon, Inc. (In Re:  Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL Docket No. 2327, Carolyn Lewis, et al. v. Johnson & Johnson, et al., No. 2:12-4301, S.D. W.Va.).

What is a Directed Verdict?

Federal Rule 50 provides: “If a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue, the court may:

(A) resolve the issue against the party;”

A directed verdict is granted where the Judge decides, at the conclusion of the Plaintiff’s case, that there is no evidence to support a verdict for the Plaintiff, and takes the case from the jury who never get to deliberate or make a decision.

Basis of Ethicon’s Motion for Directed Verdict

Ethicon brought its motion on two grounds; first that Plaintiff Carolyn Lewis waited too long to bring her suit and was thus barred by the Statute of limitations.  In November 2009, Lewis, of Texas, was implanted with a Gynecare TVT (tension free tape) pelvic mesh device made by Johnson & Johnson to stop urine leakage (Stress urinary Incontinence SUI).  The medical device was marketed in 1998 by Ethicon, a subsidiary of Johnson & Johnson, for permanent implantation in women to treat stress urinary incontinence (SUI).  She filed her lawsuit in July of 2012 in Texas and Ethicon contended it should have been filed under Texas law by January or February 2010.

The second ground for the motion by Ethicon is that Plaintiff failed to present sufficient evidence of defective design. This is especially important because previously Judge Goodwin threw out Ms. Lewis claim for failure to warn. (see below)

In its brief Ethicon wrote;

  1. On her claim for strict products liability for defective design, Plaintiff has failed establish through competent expert  testimony:

(a)    That the TVT was unreasonably dangerous as designed;

(b)    That a safer and equally efficacious alternative design was available and feasible in November 2009 that would have would have prevented or significantly reduced the risk of Plaintiff’s injury without substantially impairing the product’s utility; or

(c)    That her alleged injuries were caused by the purported defect in the product.

Since the Plaintiff is from Texas, the law of that jurisdiction is applicable.  Part (b) is a requirement of Texas law that is different from the requirements of many other States requiring the Plaintiff to show there was another safer product that would have prevented or reduced the risk of injury.  In its motion, Ethicon argued that Plaintiff failed to meet this requirement and failed to show that there was a feasible alternative that would have prevented or reduced the risk of injury.

According to Ethicon’s motion, none of the Plaintiff’s witnesses testified that a specific defect in Ms. Lewis mesh resulted in degradation or particle loss.  Ethicon’s motion states that the only Plaintiff witness who examined Ms. Lewis did not make any causal connection between her symptoms and alleged defect.  The Court granted the motion verbally and did not yet issue a written opinion.

Failure to Warn Excluded

A failure to warn case often depends largely on what warnings the doctor received from the company.  If the company did not adequately warn the inserting doctor then the patient could not have had adequate warnings and can go forward on the basis of inadequate warnings.  This would open the door to all of the information the company knew about adverse reactions, problems, etc., that it failed to place in its literature or warnings.  An important part of the claim is what the doctor was told, what the doctor read, and what information the doctor received from the company as to warnings.

MurielEarlier, Judge Goodwin removed the failure to warn case on the grounds that her implanting physician, Dr. Muriel Boreham of Dallas, had NOT read the instructions for product use (IFU) since 2002.  This was especially harmful to Ms. Lewis case because the Doctor would receive any warnings on her behalf, could evaluate the adequacy of the warnings and then instruct the patient.  Since the doctor had not read any warnings since 2002, the Court did not allow that portion of the case that would establish what Ethicon knew, when they knew it and how they failed to timely warn thus gutting the case and making it a very technical defective product case with debating scientists.

Trial witnesses who testified live or on videotape included the following;

Dr. Richard Isenberg, a urogynecologist from Philadelphia, who was the first Medical Director of Ethicon for the new division with Johnson & Johnson called Gynecare, which was established to develop and market medical devices for the female population,

Kloserhalfen

Kloserhalfen

Dr. Howard Jordi, a biochemist, whose lab did an analysis of the explants from Carolyn Lewis, testified that as long as the implant remained in situ, it will continue to degrade.

Dr. Bernd Kloserhalfen, surgical pathologist from Germany, has removed approximately 500 meshes from women experiencing complications from transvaginal mesh.

Klinge

Klinge

Dr. Uwe Klinge, who has studied mesh implants at Germany’s Aauchen University and testified in the Linda Gross trial

Dr. James Hart, a surgeon from New York who was hired by Johnson & Johnson and worked in medical affairs for Ethicon from 2005 to 2007

Piet Hinoul, former Ethicon Medical Director, who testified in the Linda Gross trial.

Hinoul

Hinoul

Dan Lamont, Director of Post Marketing Surveillance for Ethicon, quality engineer for Ethicon during the time the company began producing laser cut mesh.

Robinson

Robinson

David Robinson, M.D. is a worldwide medical director.  He also testified in the Linda Gross case. He is a OBGYN from Kansas who consulted for Ethicon and was an early proponent of the devices, doing approximately 100 insertions annually.

Dan Smith, Ethicon engineer for 36 years whose testimony included his involvement in the Matrix project looking for TVT mesh replacement.

Dr. Bruce Rosenzweig, urogynecologist at Rush University, who did about 20 insertions before stopping and has done approximately 200 removals, whose testimony included there were no studies ever done on TVT with the primary end point as safety; He did not examine Ms. Lewis.

Dr. Axel Arnaud, Medical director for Europe, whose deposition was read to the jury regarding changing out the TVT for an alternative.

Click here to read the full article: Judgment As Matter Of Law Granted In 1st Ethicon Pelvic Mesh Bellwether Trial

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.

On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

Our office represents women who have suffered horribly from these mesh products.  We remain committed to representing them to a successful conclusion of their cases.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Johnson & Johnson Mesh Trial Set to Begin

The first trial against Johnson & Johnson’s line of vaginal mesh products was set to commence February 10, 2014 in U.S. District in West Virginia.  Judge Joseph Goodwin will preside over the case, Carolyn Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301 TVT.  Lewis alleges complaints over Johnson & Johnson’s Ethicon-produced TVT Retropubic and Gynecare Prolift pelvic meshes.  More than 10,000 cases against Johnson & Johnson have been filed over this litigation.

Additional Bellwether Trials Scheduled

There are 9 bellwether trials that are scheduled in 2014 involving claims against Ethicon, Boston Scientific, Bard, and Johnson & Johnson.

The trial schedule for the different manufacturers is listed below:

Bard – there was a case set for February 10, 2014, but it was continued because the plaintiff key witness wife was critically ill.  That case will be re-scheduled.

Ethicon – there are six trials set and the first begins on Feb 10, 2014 and the second on 6/23/14.

Boston Scientific – there are four trials set with the first in March and the second in July, 2014.

American Medical Scientific – four trials set with the first set for 4/7/14 and the second set for 5/5/14.

Coloplast – not set yet.

Vaginal Mesh Trial History

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries.  Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.  In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.  On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages.  The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.  Judge Joseph Goodwin upheld the 2 million verdict in October 2013 as appropriate and that Cisson’s attorneys proved the company’s vaginal mesh was the cause of her injuries.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached after the jury was selected.  Finally, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems before trial commenced in New Jersey.

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

Trademark Notice

Johnson & Johnson, C.R. Bard, Boston Scientific, Inc. American Medical Scientific, and Coloplast are registered trademarks.  The use of these trademarks are solely for product identification and informational purposes.  These trademarks are not affiliated with this website, and the trademarks have no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by the trademarks.

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