Preview Newsletter
Ethicon 3/30
-
New Jersey appeals court upholds $11m pelvic mesh decision against J&J
Mar 29, 2016 | Mass Device
By Fink Densford
A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s (NYSE:JNJ) Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal mesh. -
Just In* – Linda Gross Prolift Case Survives Appeal by J&J
Mar 29, 2016 | Mesh Medical Device News Desk
...Linda Gross, a nurse from South Dakota had been implanted with the Prolift, the largest of the polypropylene pelvic meshes made by Ethicon, a division of Johnson & Johnson. Prolift has since been quietly removed from the market. -
NJ Appeals Panel Affirms $11M J&J Pelvic Mesh Judgment
Mar 29, 2016 | Law260
By Adam Sege
...The jury heard sufficient evidence showing Linda Gross’ doctor might have offered different guidance if he'd had more information about the product’s risks, which might have led Gross to pursue a different course of treatment and avoided the injuries for which she sued Johnson and Johnson and its subsidiary Ethicon Inc., a three-judge panel ruled in the bellwether case Tuesday. -
Women’s support groups are praised for highlighting the concerns of pelvic mesh
Mar 29, 2016 | Wisbech Standard
By Kath Sansom
Women’s health support groups have been praised for raising awareness of pelvic mesh risks, according to a leading gynaecology surgeon, who admitted the number of women suffering was probably higher than Government figures reflect. -
Transvaginal Mesh: Men Also Suffer
Mar 29, 2016 | Lawyers and Settlements
By Jane Mundy
Men are also victims of transvaginal mesh. Legally it’s called loss of consortium. At home it’s called pain and no sex. And sometimes the mesh ends a relationship.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
New Jersey appeals court upholds $11m pelvic mesh decision against J&J
Mar 29, 2016 | Mass Device
By Fink Densford
A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s (NYSE:JNJ) Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal mesh.
The plaintiff in the case claimed the product caused debilitating nerve pain and said that better labeling and warnings could have prevented injuries. The plaintiff added that the product resulted in multiple complications which required intensive medical treatment and numerous operations, according to court documents.
In the initial case, the jury found for the plaintiff to the tune of $3.4 million in compensatory damages and an additional $7.8 million in punitive damages.
Johnson & Johnson argued that the trial judge “erroneously failed to apply the learned intermediary doctrine to the fraudulent misrepresentation or deceit claim,” and failed to recognize causation evidence as sufficient to prove a failure to warn, and said that punitive damages should not have been considered by the jury, according to court documents.
The appeals court held up the original finding and the award initially issued.
Earlier this month, Johnson & Johnson’s Ethicon subsidiary agreed to settle a bellwether lawsuit filed over its Prolift pelvic mesh product, the company said.
Ethicon spokesman Matthew Johnson confirmed with MassDevice.com that the company agreed to settle with plaintiffs Dianne Bellew and her husband, Dan Bellew.
“The parties have agreed to resolve the matter,” Johnson wrote.
The trial had entered its 5th day March 6 when jurors were informed of the settlement at about 11: 30 a.m., according to documents filed with the U.S. District Court for Southern West Virginia.
A judge in that court, Judge Joseph Goodwin, has been assigned to oversee more than 70,000 product liability lawsuits filed against a slate of pelvic mesh manufacturers including Ethicon, Bard, BSX and Coloplast.
A week earlier, J&J logged a loss and a win in some of the cases brought against Ethicon. In the loss, a California jury hit it with a $5.7 million verdict, finding it liable for design problems and failure to warn plaintiff Coleen Perry about the Abbrevo mesh.
But the U.S. Court of Appeals for the 4th Circuit upheld Ethicon’s year-old win in the 1st pelvic mesh bellwether to go to trial. Goodwin had issued a directed verdict Feb. 18, 2014, ordering the case dismissed and stricken from the record.
Last September Ethicon vowed to appeal a $3.3 million loss involving its TVT-O transvaginal sling.
-
Just In* – Linda Gross Prolift Case Survives Appeal by J&J
Mar 29, 2016 | Mesh Medical Device News Desk
An appeal by Johnson & Johnson in the $11.1 million Linda Gross Prolift mesh case was decided in favor of Ms. Gross by a three judge appellate panel from New Jersey this morning.
Judges Fisher, Espinosa and Rothstadt of the Superior Court of New Jersey Appellate Division ( Doc. A-0011-14T2), decided to allow to stand the $3.35 million in compensatory damages and $7.76 in punitive damages decided by an Atlantic City, New Jersey in February 2013.
Linda Gross, a nurse from South Dakota had been implanted with the Prolift, the largest of the polypropylene pelvic meshes made by Ethicon, a division of Johnson & Johnson. Prolift has since been quietly removed from the market.
Upon the jury award, J&J immediately filed an appeal. “The punitive damage award is unsupported by the evidence presented at trial,” said a J&J spokesperson to Bloomberg News at the time of the verdict. “Ethicon acted appropriately in the research, development and marketing of the Prolift.”
Upon hearing the jury verdict, a lawyer for Ethicon, Christy Jones said:
Christy Jones, Feb 2013
“I understand that you have found that we could have done a better job and that we in fact fell short,” Jones said Feb. 26.
“My clients understand that. We hear you, I promise you….while I confess to you from the bottom of my heart that it hurts, and we’re disappointed in the verdict, we nonetheless appreciate what you have said and recognize and respect your verdict.”
Jurors found in favor of Linda Gross on her claim that J&J failed to provide adequate warning to the implanting surgeon, Dr. Kevin Benson, fraudulent misrepresentation to Ms. Gross, and loss of consortium, however the jury did not find the Prolift Pelvic Floor Repair System was defectively designed.
J&J filed a motion for a new trial. On July 15, 2014, that was denied.
See the appellate decision here.
THE APPEAL
J&J argued trial judge Carol Higbee made an error when she failed to apply the learned intermediary doctrine to the fraudulent misrepresentation or deceit claim. The learned intermediary is the doctor, in this case Dr. Benson, who is the only person required to receive warnings about the product from the company.
J&J also argued that the causation evidence was insufficient to prove a failure to warn. Judge Carol Higbee also erred when she made erroneous evidence rulings and allowed the jury to consider punitive damages, said J&J in its appeal.
Adam Slater, Feb. 2013
“This decision is very good primer on learned intermediary,” says trial attorney Adam Slater to Mesh News Desk.
“Only if there is adequate warning given to Linda Gross can she have true informed consent.
“If the warning was not adequate, if she didn’t have true informed consent, the learned intermediary drops out of the case.
This is critical.”
Slater says the Bottom Line – A decision to have a pelvic mesh device permanently implanted in your body is that person’s decision.
“They put the power back in the hands of women not to the doctor to decide what happens to a woman’s body.”
Slater adds the defense has been winning a lot of arguments in court against that principle, based on the learned intermediary doctrine.
WHAT’S NEXT?
Johnson & Johnson has 20 days to Petition the New Jersey Supreme Court to ask it to hear theGross v. Ethicon case. Generally that is only granted if there are conflicting lower court rulings that must be sorted out by the high court of a state.
In this case, Slater says the respected New Jersey Appellate panel took care to carefully detail the case. A decision on whether the New Jersey Supreme Court will or will not hear it could be made by summer.
If the Gross cases is rejected by the NJ Supreme Court, J&J will have to pay $11.1 million. That would make it only the second time a plaintiff has received a jury award after the defendant company ran out of appeal options. That case was the $5.5 million pelvic mesh trial of Christine Scott in her case against C.R. Bard.
-
NJ Appeals Panel Affirms $11M J&J Pelvic Mesh Judgment
Mar 29, 2016 | Law260
By Adam Sege
A state appeals court in New Jersey has upheld a $11.1 million jury award to a woman who claims a Johnson & Johnson unit's vaginal mesh product caused debilitating nerve pain, saying ample evidence presented at trial showed that better warnings of the product's risks might have prevented her injuries.
The jury heard sufficient evidence showing Linda Gross’ doctor might have offered different guidance if he'd had more information about the product’s risks, which might have led Gross to pursue a different course of treatment and avoided the injuries for which she sued Johnson and Johnson and its subsidiary Ethicon Inc., a three-judge panel ruled in the bellwether case Tuesday.
“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff's injuries,” the panel wrote.
Gross and her husband sued in 2008, saying Ethicon had failed to fully disclose risks associated with its Gynecare Prolift mesh product, which Gross used to repair a pelvic floor collapse. Gross' case was the bellwether in New Jersey’s multidistrict litigation over Ethicon's vaginal mesh products, which it agreed to stop selling in June 2012, despite saying it did not believe the products to be harmful.
During oral arguments in February, Ethicon had challenged the judge’s determination that sufficient evidence existed to support a finding that the company was responsible for Gross’ injuries after using the product, according to the panel’s opinion. The company had previously asked the judge to issue a judgment notwithstanding the verdict or order a new trial, saying the jury award was not supported by adequate evidence, but the judge declined to do either.
The panel agreed with the judge Tuesday, noting the doctor’s testimony that he would have counseled against the procedure or spent at least 45 minutes discussing its drawbacks if he had known it “should not be implanted in sexually active people.”
“The judge also relied on plaintiff's testimony that she would not have selected the Prolift option if she had known of the risks and recognized there was overwhelming evidence to show the company had information about Prolift that it chose not to provide to the physician,” the panel wrote.
The panel’s ruling follows the decision by New Jersey Superior Court Judge Carol E. Higbee not to second-guess the jury’s February 2013 award of $3.35 million in compensatory damages and $7.76 million in punitive damages for injuries caused by her use of the Gynecare Prolift mesh product to repair a pelvic floor collapse.
The trial featured testimony from an array of Ethicon employees who were questioned about the design, testing and marketing of Prolift, which Gross had implanted in 2006 to repair a pelvic organ prolapse. Gross had 18 subsequent surgeries to remove the mesh after she said the product caused severe nerve pain that ended her nursing career and prevented her from enjoying time with her family or from having a normal sex life.
In a statement, Ethicon said the company disagrees with the panel ruling and continues to believe it "acted appropriately and responsibly in the research, development and marketing" of Prolift.
"We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events," the company said. "We have always made patient safety a top priority and will continue to do so."
Asked about the ruling, an attorney for Gross and her husband said he was "gratified" for the couple. Because the case is the first pelvic mesh case to go to trial in New Jersey, where Johnson & Johnson is headquartered, attorney Adam M. Slater also said the ruling will have a meaningful impact for more than 9,000 other women who claim injuries related to pelvic mesh use.
"I'm happy for all the other women out there who are waiting for trials, because the decision gives tremendous guidance to the courts that are going to hear these cases going forward,” he said.
Gross is represented by Adam M. Slater and David A. Mazie of Mazie Slater Katz & Freeman LLC.
Johnson & Johnson and Ethicon are represented by Christy Jones and William M. Gage ofButler Snow O'Mara Stevens & Cannada PLLC, and by Kelly Crawford-Riker, Maha M. Kabbash and Mary Ellen Scalera of Riker Danzig Scherer Hyland & Perretti LLP.
The case is Gross v. Gynecare Inc., case number Atl-L-6966-10, in the Superior Court of the State of New Jersey, County of Atlantic. -
Women’s support groups are praised for highlighting the concerns of pelvic mesh
Mar 29, 2016 | Wisbech Standard
By Kath Sansom
Women’s health support groups have been praised for raising awareness of pelvic mesh risks, according to a leading gynaecology surgeon, who admitted the number of women suffering was probably higher than Government figures reflect.Sling The Mesh
Philip Toozs-Hobson, treasurer of the British Society of Urogynaecolgy and former clinical director of gynaecology at Birmingham Women’s Hospital, said: “Complications should be reported to the MHRA and both surgeons and patients have a responsibility to do this.”
Groups like TVT Mum, TVT Info, Scottish Mesh Survivors and Sling The Mesh meant that: “Surgeons are starting to think about mesh more carefully which is a good thing,” he said.
And while he still thinks there is a role for tapes for incontinence, and a far more limited one for mesh kits for pelvic organ prolapse, the changes in how people think about surgery is good.
“We all need to pay care and attention to who, when and how we operate,” he said.STM Scottish Mesh Survivors
“There is sometimes a recourse to surgery too quickly nowadays - this often happens when you make an operation simpler it changes the goalposts and the threshold to operate changes and we have seen this with gall bladder surgery.
“I would suggest surgery may be offered too easily to too many women.” he said.
“I probably do around 40 mesh tapes a year and around 10-15 other procedures.
“I have externally reviewed a number of other cases and would estimate I would have been extremely cautious in operating on 80 per cent of them.STM TVT Info
“I see surgery as a last resort and would always consider physiotherapy first as per NICE guidelines.
“You don’t know how individual people’s metabolism behave as to why some suffer erosion and others don’t, but certainly we would recognize that patients with pre-existing pain for example and that those on certain medications such as steroids, with diabetes or recognized immunological conditions are at greater risk of doing badly” he said.
“There’s no such thing as a free lunch – if somebody has cancer and they are left with a colostomy bag after a tumour removal, but are alive then that it is a good outcome, but if a woman goes for treatment for SUI and comes out with a raft of problems then that is not a good outcome.
“You have to look at lifestyle, just how much is this affecting a woman and offer everything before mesh.
“Risks need properly explaining, there is an argument that the pre-op talk now takes longer than the operation, but it is important a woman knows what she is opting for.”
He added that mesh kits have largely been withdrawn by the companies and many surgeons will be cautious about the use of these in line with the recent SCENIHR, Scotland and NHSE reports.
He added mesh sheets were virtually impossible to fully remove as they were designed to be a permanent device, whereas some tapes were more amenable to more complete excision.
When it came to problems he said surgeons needed to be aware that reversible complications can occur including what he said were rare complications like women who wake in terrible pain who may need the tape removing.
“There is certainly a 48 hour window, some surgeons say 10 days, of opportunity to remove a tape safely before it is embedded and that is something that needs to be recognised by more doctors when things are obviously not right,” he said.
“Trust in the medical profession remains high and as surgeons we must make sure the implications of surgery are very clear to our patients because the ramifications to the small percentage of a woman suffering complication are potentially huge.
“There is now a vast amount of data in the BSUG database and many surgeons will now use this to show their own data rather than relying solely on generic information leaflets.
“Additionally the British Society of Urogynaecology is working hard at trying to generate useful audit data to help inform gynaecologists on outcomes based on the nearly 20,000 cases reported on their database,” he said and added the CE marking system for medical devices was a concern as it related to manufacture rather than clinical data, because the system only checks quality assurance of the manufacturing and not quality assurance of the product.
-
Transvaginal Mesh: Men Also Suffer
Mar 29, 2016 | Lawyers and Settlements
By Jane Mundy
Men are also victims of transvaginal mesh. Legally it’s called loss of consortium. At home it’s called pain and no sex. And sometimes the mesh ends a relationship.
Arnie’s wife had urinary incontinence and, like so many women, trusted her doctor when he advised her to have a transvaginal mesh sling. “The first time we had sex after waiting a few months after her surgery she complained of pain,” says Arnie (not his real name). “I have been telling her for months that it tears my skin tissue on my penis during intercourse, it is causing shredding on my penis and causing us to not have sex, and now we are getting divorced.”
If Arnie’s wife was able to have the mesh removed sooner, their marriage might have been saved. Again, she didn’t question her doctor or research the TVT before having the implant. “She asked her doctor if the mesh could ‘nip’ my penis during sex,” Arnie adds. “He said the mesh couldn’t possibly hurt me and I must have cut my penis on something. I would know if it was something else. This doctor made our relationship worse - perhaps my wife doesn’t trust me now.”
Loss of consortium means the inability of one’s partner to have normal sexual intercourse. This loss arises as a claim for damages when the partner has been injured and cannot participate in sexual relations for a certain length of time or permanently due to physical injury or mental distress due to a defendant’s (in this case, the transvaginal mesh manufacturer) wrongdoing.
“My wife is currently on another round of antibiotics. She has had one infection after another since getting the mesh implant and normal sex is no longer pleasurable,” says Ron. “She needs to get this stuff taken out but she can’t find a doctor to remove it. I can’t believe the surgeon who implanted this mesh won’t take it out. We haven’t had sex for almost a year; it’s got to the point where I might have to pay for sex. I should get reimbursed from the mesh maker for that too!”
Bits of eroded transvaginal mesh can protrude through the vaginal wall and can cut the penis during sexual intercourse. As well as pain, a hematoma (a collection of blood under the skin) could develop on the penis. Lacerations of the penis may be serious: it can cause damage to blood vessels and nerves.Barbara and her husband Steve filed a transvaginal mesh lawsuit that includes loss of consortium. “Since I had this transvaginal mesh sling for incontinence problems, I constantly have vaginal infections with itching, a nasty discharge and inflammation. And I have full-blast incontinence! Sex is out of the question,” said Barbara. Steve said they are also “considering a lawsuit against the ob-gyn who elected to use the mesh without warning us of its potential damage and risks - surely he must have known.” But he may not have known. And he may not know how to remove it - that part wasn’t in the training manual back in 2008.
A California jury in 2012 found that Bard, the Avaulta transvaginal mesh maker, was negligent and returned a $5.5 million verdict for plaintiff Christine Scott, including $5 million for her medical expenses, pain and suffering and other damages, and $500,000 for her husband’s loss of consortium claim.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested