Archive for category Transvaginal Mesh

Big Pharma: Is Paying Big Fines More Profitable than Telling Doctors and Consumers the Truth in Marketing?

This week, Johnson & Johnson etched its name in the history books of another big pharma company that has been fined over billions of dollars due to a drug manufacturer practices of improper marketing and failure to warn.  Johnson & Johnson pled guilty to claims stemming from allegations that the giant pharmaceutical company knowingly marketed the anti-psychotic drug Risperdal for inappropriate uses and paid kickbacks to doctors and nursing homes in prescribing the drug.  The total amount of fines amounted to $2.2 billion.  This was not the first time that Johnson & Johnson has settled claims for their drug, Risperdal.  This is also not the first time that a major pharmaceutical company has paid fines for not properly disclosing while denying in corresponding civil litigation it failed to properly disclose.

Click here to read the full article: J&J to Pay $2.2B to Wrap Up Long-Standing Risperdal Marketing Probe

This is the second major fine that big pharma has been dealt in the last three months.  In July 2013, Pfizer, maker of the cholesterol lowering drug Lipitor, and the U.S. Justice department agreed to a $490.9 million settlement agreement with Pfizer’s Wyeth unit related to illegal marketing of a kidney-transplant prescription medication, Rapamune (sirolimus).  Previously, the Food and Drug Administration approved the immunosuppressive therapy for kidney transplant patients, but Wyeth also marketed it on an unapproved basis for other types of organ transplant patients, “which resulted in false Medicare and Medicaid claims”.

It was two years ago, that GlaxoSmithKline, the drug giant that produced the heavily litigated Avandia, agreed to pay $3 billion to settle United States government civil and criminal investigations into its sales practices for numerous drugs, including Avandia.  Company whistleblowers alleged that GSK improperly paid Doctors and manipulated medical research to promote sales of the drug.

The practices of improper marketing and failure to warn are at the heart of the current drug litigation occurring with the DePuy metal-on-metal hips, transvaginal mesh made by Bard, Johnson & Johnson and others, Pfizer’s Lipitor users being diagnosed with type two diabetes, Merck’s Fosamax users suffering atypical femur fractures, Actos users suffering bladder cancer, and a host of others.  When companies have block buster drugs, history has shown they often seek to expand market share through non-authorized uses to enhance profits during patent exclusivity.  This conduct is knowingly done at the health expense of the consumers through failure to tell the whole truth to physicians and holding back essential information and adequate warnings.

Drug manufacturers have historically been shown to engage in improper marketing practices, paying kickbacks to prescribers, concealing essential information consumers and their physicians need to know, denying all of that conduct beyond scores of corporate attorneys in litigation, then attempting to quietly settle the concealment and improper marketing claims with the federal or State authorities once the civil litigation has drawn near a close.

Despite the fines, the practice continues.  Why?

Obviously, Big Pharma believes simply telling the whole truth, so honest decisions can be made is not a good business practice.  Apparently, Big Pharma would rather pay the fines if it is caught, and ask the government for forgiveness while denying fault to the people injured by their failure to disclose the truth.

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 women contracting type two diabetes while using Lipitor, people suffering from bladder cancer while using Actos,  Fosamax users suffering atypical femur fractures, DePuy ASR hip users requiring revisions or suffering toxic poisoning, and women suffering significant pain, erosion and removal of 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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Cisson Verdict Upheld by Trial Court

According to a report in Fierce Medical Devices, the trial court has upheld the 2 million verdict in the Donna Cisson v. C.R. Bard, Inc. transvaginal trial.  Judge Joseph Goodwin reaffirmed that the initial award was appropriate and that attorneys representing Donna Cisson successfully proved the company’s vaginal mesh was the cause of her injuries.

Donna Cisson brought her case for severe injuries resulting from her use of Bard’s transvaginal mesh.  Cisson alleged that the Bard Avaulta Plus vaginal mesh implant gave her bladder spasms and caused bleeding as well as pelvic pain.

Click here to read the full Fierce Medical Devices article: Bard Vaginal Mesh Verdict Sticks as Judge Reaffirms $2M Award

On August 15, 2013, the jury found for Donna Cisson compensatory damages in the amount of $250,000 for her injuries and $1.75 million in punitive damages after considering all the evidence from the numerous experts from each side.  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.

Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced.  Bard’s implants have been targeted in more than 12,000 cases, while Boston Scientific said in an August regulatory filing that it faces more than 12,000 suits over its vaginal devices. Additionally Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, and Coloplast and Cook face about 1,000 claims combined.  J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing.

In August 2013, Judge Joseph Goodwin announced the bellwether case schedule for the Boston Scientific vaginal mesh cases occurring in West Virginia.  The first set of Boston Scientific trials is set to begin 2/11/2014 and the second set commencing on 6/17/2014.

We believe that ultimately the cause of injuries suffered by vaginal mesh users 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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Bloomberg Reports Settlement Talks in Mesh Cases

Bloomberg is reporting that C.R. Bard, Endo Health Solutions, Boston Scientific, Cook, and Coloplast are in what Judge Goodwin described a “behind the scenes” settlement talks.  Johnson and Johnson (J&J) is reportedly NOT participating.

Bard was held liable in two jury verdicts so far.  In July 2012, Bard lost an Avaulta case in a California jury trial and was ordered to pay Christine Scott and her husband over $5 million.  On August 15, 2013, the company was ordered to pay $2 million to Donna Cisson after a jury verdict.  Shortly thereafter, it settled a case in West Virginia (Queen vs. Bard and on September 13, 2013 reportedly settled Melanie Virgil’s case that was set for trial in New Jersey on September 26, 2013.

Bard’s implants have been targeted in more than 12,000 cases, while Boston Scientific said in an August regulatory filing; it faces more than 12,000 suits over its vaginal devices.  Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, and Coloplast and Cook face about 1,000 claims combined.  J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing.

C.R. Bard took a $275.1 million litigation charge earlier in 2013 year related to the lawsuits, an action that led to a sizable net loss.

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.  Based on the Bloomberg report, it is too early to know if the settlement talks will continue let alone lead to a resolution.

Click here to read the full article: Bard, Vaginal-Mesh Makers, Said to Be in Settlement Talks

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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Bard Settles Another Vaginal Mesh Suit

On September 13, 2013, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems.  The case, Virgil v. C.R. Bard Inc. (BCR), ATL-L6917-10, Superior Court of New Jersey Law Division, Atlantic County (Atlantic City), was scheduled to go to trial on September 26.  According to the complaint, Virgil, a junior high school music teacher in Colorado, sued Bard after her transvaginal mesh device began to erode.  Virgil needed three surgeries to address urinary problems created by the insert.

Click here to read the full Bloomberg article: Bard Said to Settle Vaginal-Mesh Case Set for Trial

Bard has lost two jury trials, has settled a third case after a jury selected, and now has settled a fourth before trial commenced.  Bard faces more than 8,000 claims over the Avaulta insert.

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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Boston Scientific Vaginal Mesh Bellwether Cases Trials Scheduled

On August 29, 2013, Judge Joseph Goodwin announced the bellwether case schedule for the Boston Scientific vaginal mesh cases occurring in West Virginia.  The following cases were selected for the first and second bellwether trials in this MDL:

  • Carol Lynn Fawcett, et al. v. Boston Scientific Corp. 2:12-cv-07497 Pinnacle
  • Roseanne Sanchez, et al. v. Boston Scientific Corp. 2:12-cv-05762 Pinnacle
  • Carolyn F. Smothers v. Boston Scientific Corp. 2:12-cv-08016 Obtryx
  • Katherine L. Hall v. Boston Scientific Corp. 2:12-cv-08186 Obtryx

The first set of Boston Scientific trials is set to begin 2/11/2014 and the second set commencing on 6/17/2014.

Vaginal Mesh Trial History

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.  In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached.

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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Bard Settles Queen Avaulta Solo Vaginal Mesh Suit

On August 21, 2013, after a jury of five men and four women had been selected and opening statements in the trial were ready to commence, the parties in the Wanda Queen vs. C.R. Bard Inc. Avaulta vaginal mesh case settled.  The amount was not disclosed.  Ms. Queen had the mesh inserted because of pelvic prolapse by Dr. Elizabeth Barbee at Wake Medical Center in Raleigh, North Carolina.

Bard has now lost two jury trials and settled the third before a jury could hear the evidence.  Bard now faces thousands more suits over its Avaulta product.  The next case against C.R. Bard Inc. for its Avaulta vaginal mesh is scheduled to begin October 8, 2013.  The stock closed up almost three dollars per share after last week’s $2 million Cisson vs. Bard verdict on news of the settlement, finishing over $114 per share.

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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Bard Faces Future after Cisson Verdict

In 2012, Bard lost its first vaginal mesh case and was ordered to pay $3.6 million following the California state court jury’s decision.  On August 15, 2013, a West Virginia jury ordered Bard to pay $2 million to Donna Cisson for her injuries due to her use of what the jury found to be the defective Avaulta product.  Thousands more vaginal mesh claims are building up against Bard in the MDL proceedings in Judge Goodwin’s court in West Virginia.

Timothy RingTimothy M. Ring is the Chairman and Chief Executive Officer for C. R. Bard, Inc., serving in that capacity since August 8, 2003.  He joined Bard in June 1992 as Corporate Vice President and has steadily risen through the ranks to assume corporate leadership.  Prior to Bard, he worked ten years at Abbott labs in personnel positions and before that was with General Motors.  He has a degree in Industrial relations from Cornell.

C.R. Bard Inc. stock closed at approximately $111 per share on August 16, 2013.  Shares are up about 16% for 2013 year to date.  Currently there are 5 analysts that rate C.R. Bard a buy, 1 analyst rates it a sell, and 12 rate it a hold.  It is a global company with 12,000 employees and business operations in 90 countries.  In the first quarter of 2013, the stock made a profit of $90.7 million dollars.  In the second quarter of 2013, the company reported a loss of $161.6 million because it took a $275.1 million litigation charge for product liability charges that virtually wiped out its profits.  In the remainder of 2013, Bard anticipates receiving payments from W.R. Gore & Associates, which has been ordered to pay hundreds of millions of dollars to C.R. Bard as a result of a patent infringement case related to prosthetic vascular grafts used in bypass procedures.  In June 2013, Bard reached a deal to sell its electrophysiology business for$275 million dollars to Boston Scientific.  On August 19, 2013 Bard announced that it has entered into a definitive agreement to acquire privately held Medafor, Inc., a leading developer and supplier of plant-based hemostatic agents for the purchase price of $200 million.

No doubt, Bard, like many similar companies faced with massive suits, did focus groups trying out its best arguments on mock juries, and then tailored those arguments as they applied them to the actual cases.  However Bard has now seen what two real juries have thought of its efforts to say there was nothing wrong with the Avaulta mesh product, they acted reasonably, and the pain the women are suffering is really from something else.  Bard gets another chance immediately as the next Avaulta Plus vaginal mesh lawsuit is slated to begin in West Virginia on August 19, 2013.

Soon Bard will learn the lessons of history.  Perhaps Mr. Ring will see the inevitable tide advancing and do the right thing for the injured women, their families, and the Bard shareholders.

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Cisson vs. Bard: $2 Million Victory for Donna Cisson

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.

This is the third victory for women in the three trials as Donna Cisson joins Christine Scott and Linda Gross in holding manufacturers responsible for their injuries.  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.

There are over 23,000 cases pending before Judge Goodwin in West Virginia with more trials slated.  If you would like more information, go to our website, or contact us at 1-800-481-1615 or email us.

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A Review of Testimony and Documents presented in Donna Cisson vs. C.R. Bard Avaulta Trial

During the first days of testimony, Plaintiff’s attorneys were building the case that the Bard Avaulta is defective and the warnings are inadequate.  The following is a review of some of the testimony and evidence presented from live and videotaped witnesses as reported from various outlets.  It should be noted that we are focusing on substance and not demeanor or method of presentation so it is impossible to gauge the impact on a jury so far

Avaulta

Cisson v. C.R. Bard Inc. is a bellwether case for more than 23,000 cases involving transvaginal mesh combined in the U.S. District Court for the Southern District of West Virginia.  Donna Cisson claims an Avaulta device implanted to treat pelvic organ prolapse caused her pain and permanent injury.  The Avaulta line of products is made from a resin called polypropylene, which the resin’s manufacturer warned Bard should not be permanently implanted in humans.  The company used a porcine collagen coating on the body of the Avaulta products, but not on the arms, which anchor the mesh in place.  The porcine was intended to be a barrier to reduce the body’s inflammatory response and adhesions between the polypropylene resin and tissue.

Bard voluntarily stopped selling the Avaulta line of products in July 2012 rather than meet U.S. Food and Drug Administration (FDA) requirements for further clinical testing.  Judge Goodwin has excluded this information from the trial.

Documents Indicating Notice to Bard of Problems

  • In the June 14, 2002 Patent application signed by Bard engineer and team leader Douglas Evans, Bard outlined the rationale for the new patent by describing the limitations of synthetic mesh devices made from materials like polypropylene.  The application sought a patent to create a sling-type product from a natural biological material.
  • A 2002 company e-mail produced in trial reportedly states, “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.  We’re trying to fight some battles around lack of data around kits, and on Avaulta in particular. … We’ve been chided by thought leaders. … Still waiting on data on our kit. Why are we afraid to publish any data?”
  • In a September 2008 internal market research memo, Bard executives again highlighted what they call “barriers to adoption,” or reasons many physicians refused to use Avaulta products — mostly pertaining to complications seen in patients.  “This additional analysis shows in spades the importance of reducing complications,”
  • Another internal company memo titled “The Reality of Complications” addressed complication rates from the Avaulta products, including dyspareunia (painful sexual intercourse), erosion and chronic post-operative pain.  The memo compiled market research on doctors who did not want to use the Avaulta line.  According to the document, 65 percent of physicians surveyed said they had significant concerns about dyspareunia with pelvic floor products, 58 percent had significant concerns about chronic post-operative pain, and 62 percent had significant concerns with erosion.
  • There was a discussion in Court that the arms of Avaulta were “sawing at tissue” in patients.  In an e-mail a salesperson said, “The flesh sawing issue came up again last week with a physician” and asked if Bard planned to add the porcine coating to the device’s arms.  Adam Silver, marketing manager for BUD’s women’s health division, replied by email.  “We’re not going to put (the coating) on our arms any time soon,” he wrote.  “We don’t believe it’s needed.”
  • A 2007 memo stated in part: “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.”

Dr. Brian Raybon

The first witness called in the trial was Dr. Brian Raybon, a urogynecologist from Georgia.  Dr. Raybon, who also holds an undergraduate degree in Chemistry from University of North Carolina, who spent four plus years working on behalf of  Bard teaching physicians about the products.  He also is the physician who recommended a Bard Avaulta and implanted it in Ms. Cisson.  After conceding he felt it was a good product when he implanted it, he testified he began to learn of problems and patients were showing up with complications requiring additional surgeries to remove the mesh. At that time, Dr. Raybon learned for the first time that the resin the company used to make the mesh was not to be permanently implanted in the human body.  According to media reports, he testified his reaction was that he was astounded.

On cross-examination by defense attorney Lori Cohen, he conceded he did not contact Bard to ask about the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS) for the resin, once he found out about it.

Dr. Lennox Hoyte  

It was Dr. Hoyte’s testimony in the first trial that triggered the mistrial.  Dr. Hoyte is a professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, and the chief of urogynecology and robotic surgery at Tampa General Hospital.  He is a graduate of Stanford Medical School.

The net-like device at the heart of the lawsuit includes small mesh “arms” that extend from the device to help hold it in place.  Hoyte was critical of the design and indicated it contributed to significant problems both for the women and for doctors attempting to remove the device.  Hoyte indicated the mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow through and around it, and the vaginal flesh becomes ingrown so tightly around the mesh that surgical removal can destroy so much tissue that the vagina can be difficult to reconstruct.

Anthony Brennan PhD.

Since 1991, Brennan has been a professor of Materials Science and Engineering and Biomedical Engineering at the University of Florida Brennanin Gainesville.  Brennan studies how cells interact with materials.  He is an inventor and co-inventor on six US Patents. He said his research is funded primarily by the U.S. Department of Defense and stated he did work in this case at the request of Plaintiff’s attorneys and Brennan and his team studied the Avaulta Plus product for more than two years who paid him around $200,000 for his research.

He explained that polypropylene is a polymer made with free radicals, which, once implanted, free radicals produced by the body break down the material.  “When you put an implant in, it’s seen as a foreign body,” Brennan said.  “The body will try to encapsulate it. … The problem is it continues forming an inflammatory response.  If you use free radicals to make it, you use free radicals to break it down.”  Brennan testified that polypropylene degrades in the body

The Avaulta Plus device has a design feature called “arms,” or long, narrow strands of mesh that protrude from the “body” of the device. The arms are intended to help anchor the device in place once implanted.  Brennan indicated that cutting the arms as testimony has reported some doctors did, weakens the device and exacerbates the problem polymer degradation.

He also was critical of the small pore sizes in the device, indicating the pores should be between 2 mm and 5 mm in.  As a result, it is more difficult for tissue to grow and fill in.

The mesh contains many pores by design.  Brennan said the pores need to be large enough for the body to create a scab through them, holding the arms and the entire device in place.  He said the pore size should be between 2 mm and 3.5 mm.

When Brennan measured the pore size in Avaulta Plus, he found the pores were too small.  He also said the practice of rolling the arms during the implantation surgery created an overlap in the material, ultimately deforming the pores.

“If you are deforming the pores, you’re reducing their size and making it more difficult for tissue to grow in, fill it in,” Brennan said.

Previous testimony disclosed it was common practice for surgeons to cut the arms on the Avaulta device during implantation to customize it to a patient’s body.  Brennan testified that cutting the arms affects the device’s biomedical properties.

“When you cut something, you weaken it,” Brennan said.  “If you cut a notch in a cloth, it weakens.  Anytime you take a polymer fiber and cut it, it’s going to further exasperate the problem of polymer degradation. … Those loose ends are places where degradation will start.”

Brennan said that the overall design of the Avaulta Plus was flawed from the beginning.

“The geometry of that mesh and material it’s made of is a poor design,” he said.  “Your pore sizes are so small … you’re going to get degradation of polypropylene.  We’ve known that from the literature for years. … Once degradation of a medical device begins, it’s like a cascade effect. It just continues and keeps going.”

Maureen Reitman

ReitmanDr. Reitman is an expert in polymer science and materials chemistry who testified for the defense on August 8, 2013.  She has a Doctorate in materials science and engineering from MIT (1993) and has worked for Exponent for about ten years.  According to the Exponent website biography, “Dr. Reitman’s expertise includes polymer and composite technology, mechanics of materials, adhesion science, fiber mechanics, history and technology of plastics, and material failure analysis.  She is skilled in the development and use of testing tools and methods and has applied them to plastic, rubber, textile, metal, glass, ceramic, and composite materials and systems.  She is experienced in major aspects of product development, including materials selection, formulation, scale-up, end-use testing, failure analysis, certification procedures, and issues related to intellectual property.”

Dr. Reitman testified that Bard paid about $700,000 for 400 to 500 hours of work done on the case conducting tests, researching and investigating, etc.  Based on work she did in the case, including examination of explanted Avaulta devices, she said there was biofilm on the device and there was not neither oxidation nor degradation to the material.

Also testifying for the defense was Laura Bigby, Bard’s Director of research and Development since 2007, who was questioned about cadaver studies and the absence of clinical trials in humans prior to marketing to surgeons.

Dr. John Heller

HellerDr. Heller is a orthopedist from Emory University since 1994 whose website states he is “Specializing in the research and development of instrumentation in cervical spine surgery, including cervical disc replacement and laminoplasty.  Dr. Heller is an internationally renowned lecturer and teacher.”  Called by the defense, Dr. Heller testified that the pain Donna Cisson was suffering was due to spinal issues, indicating MRIs beginning in 2007 documented degenerative spine issues.  One of the usual defenses in drug cases is to show an alternative unrelated reason for a Plaintiff’s symptoms and Dr. Heller provided that to the jury.

The trial is continuing and deliberations by the jury are expected to start shortly.  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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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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