Posts Tagged Ethicon Gynecare

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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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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Transvaginal Mesh Trials Set for Bellwether Cases

On August 5, 2013, Judge Joseph Goodwin issued pretrial Order No. 59 providing trial dates for July 14, 2014 and May 27, 2014 from the following bellwether cases.

  • Carolyn Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301 TVT;
  • Judy Brown, et al. v. Ethicon, Inc., et al., 2:12-cv-07314 TVT;
  • Jo Huskey, et al. v. Ethicon, Inc., et al., 2:12-cv-05201 TVT-O;
  • Tonya Edwards, et al. v. Ethicon, Inc., et al., 2:12-cv-09972 TVT-O;

The Court Order states “The Court will try the 1st and 2nd round of cases, set to begin 1/14/2014 and 5/27/2014, respectively, from these cases and in the order shown, etc.; the Court will try a Prolift case for the 3rd round of cases set to begin on 8/19/2014.”

Over 23,000 mesh suits pending in MDLs

Thousands of women experienced complications such as: device erosion, infection, organ perforation, intense pain and inability to have intercourse.  Many of these women have had to undergo multiple revision surgeries to attempt to manage symptoms and have since filed transvaginal mesh lawsuits against the device manufacturers. These actions are brought by women against vaginal mesh companies C.R. Bard, American Medical System, Boston Scientific Inc, and Coloplast Corp.

MDL Name

Number of Cases

MDL – 2187, IN RE: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation

3,399

MDL – 2325, IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation

7,227

MDL – 2326 IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

4,622

MDL – 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

7,117

MDL – 2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation

437

MDL – 2440 IN RE: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation

25

TOTAL: 6 Multidistrict Litigations

22,827

Donna Cisson Trial Continues

Meanwhile the trial of the case of Donna Cisson vs. Bard, 2:11-cv-00195 continues in Judge Goodwin’s courtroom.  It is anticipated Plaintiffs will seek to establish that:

  • Bard knew of the risks associated with Bard Avaulta transvaginal mesh and failed to inform doctors.
  • Bard did not do clinical testing or studies to learn the risks of Bard Avaulta transvaginal mesh.
  • Bard did not study how to remove Bard Avaulta transvaginal mesh.
  • Bard marketed and sold Bard Avaulta transvaginal mesh despite knowing the material used to make it, Marlex, was not designed to implant in the human body.
  • Bard did not tell doctors that Bard Avaulta transvaginal mesh was not fit for human use.

The company knew in 2002 and 2003 that synthetic vaginal mesh could cause significant erosion of the patient’s tissues, and infection.

Two Trial Verdicts for Plaintiffs

There have been two trials so far, both resulting in Plaintiff’s verdicts.  However, the facts in these cases are different from many of the pending cases.  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.

Over 23,000 women have filed suits detailing their injuries from the mesh inserted in them.  We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings.  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 Recalls Another DePuy Orthopedic Product

Johnson & Johnson (J&J) is no stranger to controversy.  From being embroiled in massive litigation in DePuy ASR artificial hips, Pinnacle litigation, and in the transvaginal mesh litigation with its Ethicon Gynecare products to its multiple legal troubles and fines associated with the anti-psychotic drug Risperdal, some things do not change for J&J – they continually garner negative press due to multiple, defective medical devices.

Today, the FDA and DePuy Orthopedics notified healthcare professionals of a class 1 recall of the LPS Lower Extremity Dovetail Intercalary Component.  The recall was issued, because there a potential for fracture of the dovetail, when exposed to normal physiologic loads while walking.  A Class I recall is the most serious type of recall.  Class I recalls are issued in situations where there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The LPS Lower Extremity Dovetail Intercalary component was intended for replacement of the mid-shaft portion of the femur, top (proximal), bottom (distal) and/or total femur, and top (proximal) tibia, especially in cases that require extensive resection (i.e. tumors, trauma, infections).  If the part fracture occurs, it may lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery.  Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.

Click here to read the full FDA recall: DePuy Orthopaedics, Inc – LPS Lower Extremity Dovetail Intercalary Component

On July 11, 2013, DePuy issued an Urgent Medical Device Recall informing DePuy distributors, hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots.  DePuy will be writing a patient letter to assist surgeons with discussing the risks of the implant fracture and the method for detecting implant failure with their patients.  DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device.  Like the DePuy ASR, the DePuy Pinnacle, and Ethicon Gynecare transvaginal mesh, thousands of people will be forced to live with the cloud of defective products failing within them while J&J makes no effort to effectively help.

At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh.  Instead of treating all victims of defective drugs and medical devices the same we take a different, more personalized approach with a team of experienced defective drug attorneys and paralegals working for every client.  Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions.  Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.

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Risperdal Continues to Boggle Down Johnson & Johnson

Trouble is no stranger to Johnson & Johnson.  Johnson and Johnson (J&J), embroiled in massive litigation in DePuy ASR artificial hips, and in transvaginal mesh litigation from its Ethicon Gynecare products, faces more legal issues from its anti-psychotic drug, Risperdal.  Currently, Johnson & Johnson is appealing a 1.2 billion dollar fine issued in an Arkansas court in a Medicare fraud case, Ortho-McNeil-Janssen Pharmaceuticals Inc. v. Arkansas, 12-1058.  The jury found that J&J and Ortho-McNeil-Janssen had downplayed Risperdal’s risks and marketed it for off-label uses.  The jury found that these companies had defrauded the state’s Medicaid system and deceived Arkansas consumers about the safety risks of the anti-psychotic drug Risperdal.

Click here to read the full article: State AGs Ask Arkansas High Court to Back J&J’s $1.2B Risperdal Fine

J&J has contested that “an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules.”

Arkansas Attorney General Dustin McDaniel disagrees.  He has asked the Arkansas Supreme Court to uphold the decision.  McDaniel stated, “This company lied to our medical providers and put profits ahead of people.  As state Attorney General, it is my responsibility to prevent actions like those, which defrauded our Medicaid program and jeopardized the health of our elderly and our children.”

Previously, J&J initially had agreed to pay $2.2 billion in 2012 in order to settle a Justice Department investigation into allegations that the health-products company had illegally promoted drugs including the antipsychotic Risperdal, but then balked at completing the settlement.  J&J looked to avoid admitting to conduct that could affect the outcome of pending personal-injury lawsuits alleging Risperdal caused serious side effects in kids.

Risperdal was approved in 1993 for use in adults and was later used to treat schizophrenia and bipolar disorder in children and teens.  Under federal law, drug makers can promote only the approved uses of their medicines, but doctors are free to write prescriptions for other uses.  Some physicians prescribed Risperdal to children and adolescents before the U.S. Food and Drug Administration gave its OK in 2007 for use in children and adolescents suffering from bipolar disorder and in adolescents with schizophrenia.

Contact Our Experienced San Francisco Drug Recall Lawyers Today

At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh  Instead of treating all victims of defective drugs and medical devices the same we take a different, more personalized approach with a team of experienced defective drug attorneys and paralegals working for every client.  Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions.  Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.

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Ethicon Gynecare Trial Cases to be Selected on July 25, 2013

On July 25, 2013, Judge Joseph Goodwin will hear presentations submitted by counsel for consideration for selection as bellwether cases in the Johnson & Johnson Ethicon Gynecare transvaginal mesh cases.  Based on this procedure, Judge Goodwin will then select which cases will then be tried.  It is expected that he will select 5 cases from a pool of 16 cases, with each side submitting 8 cases.  Expert reports will then be exchanged according to his Federal Rules and Expert discovery is slated to be completed by the end of October, 2013 and case specific discovery completed by November 15, 2013

There are over 12,000 transvaginal mesh cases involving all of the leading manufacturers before Judge Goodwin, nearly 4,000 of which are J&J’s Ethicon division Gynecare.

There have been two trials so far, both resulting in Plaintiff’s verdicts. However, the facts in these cases are different from many of the pending cases.  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.

Discovery is continuing in the MDL leading up to projected trials in the near future.  Over 12,000 women have filed suits detailing their injuries from the mesh inserted in them.  We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings.  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.

Complications Linked to Transvaginal Mesh After Pelvic Organ Prolapse Surgery

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