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Ethicon Media Monitoring 3/26/2019
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Faulty Mesh Worsened Woman's Incontinence, Pa. Jury Hears
Mar 25, 2019 | Law 360
By Matt Fair
Alleged defects in a Johnson & Johnson unit’s pelvic mesh implant ended up worsening the incontinence it was intended to treat in a Pennsylvania woman and caused chronic pain that has left her unable to have sex, a Philadelphia jury heard during opening arguments on Monday. -
Philly Judge Won't Boot Colleague From J&J Mesh Dispute
Mar 25, 2019 | Law 360
By Kevin Penton
The judge overseeing Philadelphia’s mesh litigation program has declined a Johnson & Johnson unit’s bid to remove a judge from presiding over any further pelvic mesh trials against the company because of litigation involving that judge's mother and a different J&J product. -
Ethicon Fails in Pelvic Mesh Recusal Bid Based on Judge's Mother's Xarelto Case
Mar 25, 2019 | New Jersey Law Journal
By Max Mitchell
Johnson & Johnson subsidiary Ethicon has lost its bid to have Philadelphia Judge Kenneth Powell removed from handling any future pelvic mesh trials in Philadelphia. -
Bayer, Johnson & Johnson to Pay $775 Million to Settle Xarelto Litigation
Mar 25, 2019 | Wall Street Journal
By Sara Randazzo
Bayer AG and Johnson & Johnson have agreed to pay $775 million to resolve claims that the blood thinner Xarelto causes excessive bleeding, according to the companies. -
There are 2 types of breast implants, and both come with risks. Here’s what you need to know.
Mar 26, 2019 | Insider
By Julia Naftulin
On Monday and Tuesday, the FDA will convene to discuss breast implants and the risks associated with them.
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Faulty Mesh Worsened Woman's Incontinence, Pa. Jury Hears
Mar 25, 2019 | Law 360
By Matt Fair
Alleged defects in a Johnson & Johnson unit’s pelvic mesh implant ended up worsening the incontinence it was intended to treat in a Pennsylvania woman and caused chronic pain that has left her unable to have sex, a Philadelphia jury heard during opening arguments on Monday.
The jurors heard arguments that a TVT-Secur implant that Malgozata Krolikowski, the ninth woman to bring claims against J&J subsidiary Ethicon Inc. to trial in Philadelphia, received 10 years ago had left her in constant need of pads due to urine leakage and had irreparably interfered with her ability to pursue any romantic relationship.
“What Ms. Krolikowski wants now is a normal life,” said Elia Robertson, an attorney with Kline & Specter PC representing Krolikowski. “She wants to be able to do her job without leaking, she wants to not have to change a pad five times a day, and most of all, like all of us, what she wants is companionship. The defendants have taken that away from her.”
Juries in six previous mesh trials in Philadelphia dating back to December 2015 have returned a total of more than $145 million in damages to women who received what they say were defective implants to treat urinary stress incontinence.
According to Robertson, Krolikowski received a TVT-Secur implant to treat minor urinary stress incontinence, which she characterized as “bothersome” and “annoying,” although “not life altering.”
But just two weeks after receiving the implant in October 2008, Robertson said, Krolikowski reported that the implant had not improved her condition and that, over the years, it significantly worsened.
Robertson said that Krolikowski also began experiencing pain and urine leakage during intercourse, which has interfered with her ability to find a new romantic partner after the death of her husband in 2001.
“At just 53, Ms. Krolikowski has lost the ability to be in an intimate relationship and have a partner in life,” Robertson said. “She feels like less than a woman. She feels like damaged goods. She’s embarrassed and she’s humiliated.”
Robertson said that Ethicon’s failure to thoroughly vet the product before it was launched in September 2006 was a key factor in injuries experienced by Krolikowski and other women who have received the implant.
“They put product sales over adequate testing, they put their company’s success over safety, and they put profits over patients,” Robertson said. “This is what these defendants really cared about.”
She said that, while previous mesh slings sold by Ethicon had been the subject of study, the TVT-Secur was allowed to go on the market after only five weeks spent observing 31 women who’d received the implant pre-launch.
And the results of those five weeks of observation were not promising, Robertson said.
She said that the implant failed in 30 percent of the women who received it and that 60 percent experienced some type of complication.
The product was eventually pulled from the market in 2012.
An attorney for Ethicon is expected to give her opening statement to the jury on Tuesday morning.
Mindy Tinsley, a spokeswoman for Ethicon, told Law360 on Monday evening that the company stands by its products.
"Pelvic mesh has helped improve the quality of life for millions of women with serious, debilitating conditions," she said. "Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for many women."
Krolikowski is represented by Elia Robertson and Colin Burke of Kline & Specter PC.
Ethicon is represented by Julie Callsen and Jennifer Steinmetz of Tucker Ellis LLP, Sean Gallagher of Barlit Beck LLP, Andrea La’Verne Edney of Butler Snow LLP and Kimberly Gustafson Bueno of Scott Douglas & McConnico LLP.
The case is Malgorzata Krolikowski v. Ethicon Inc., case number 140102704, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Jack Karp.
https://www.law360.com/articles/1117135/faulty-mesh-worsened-woman-s-incontinence-pa-jury-hears
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Philly Judge Won't Boot Colleague From J&J Mesh Dispute
Mar 25, 2019 | Law 360
By Kevin Penton
The judge overseeing Philadelphia’s mesh litigation program has declined a Johnson & Johnson unit’s bid to remove a judge from presiding over any further pelvic mesh trials against the company because of litigation involving that judge's mother and a different J&J product.
Judge Arnold L. New on Friday did not expand in his sentence-long order on his rationale for denying the request by Ethicon Inc. that Judge Kenneth Powell should be removed from the cases involving allegedly defective pelvic mesh implants because his mother is part of litigation against another J&J subsidiary over the anticoagulant drug Xarelto.
Judge New’s order on Friday came before Monday’s announcement by Bayer and J&J unit Janssen Pharmaceuticals that they had struck a $775 million deal to settle about 25,000 lawsuits alleging that the companies failed to warn about internal bleeding risks caused by Xarelto, which acts as a blood thinner.
"Today we’ve learned that they’ve settled their Xarelto litigation, a fact they should have disclosed to all these courts," said Shanin Specter, an attorney representing those suing Ethicon, to Law360 on Monday. "We’ll see what new outrage they try to perpetrate next.”
Ethicon had argued that the litigation involving Judge Powell’s mother created, at the very least, the appearance of a conflict of interest that required his recusal in any mesh cases, according to court documents.
The company unsuccessfully had sought that Judge Powell recuse himself from at least three different cases involving the mesh implants. Judge Powell has said that he didn’t realize his mother was involved in the litigation targeting Janssen, maintaining that, in any event, he believed the case did not affect his ability to preside over mesh proceedings in a fair and impartial way, according to court documents.
Attorneys for women who received the mesh implants had told Judge New in a filing earlier this month that Ethicon’s continued efforts to remove Judge Powell was nothing more than judge-shopping.
“Ethicon has filed these … motions in a blatant effort at judge-shopping and attempting to receive special treatment,” the women said.
Ethicon faces allegations that it negligently designed the mesh implants and failed to provide proper warnings that the devices could erode through soft tissue in the pelvis and cause permanent scarring and other injuries.
Counsel for Ethicon could not be reached for comment on Monday.
The women are represented by Shanin Specter, Lee Balefsky and Charles “Chip” Becker of Kline & Specter PC.
Ethicon is represented by Kenneth Murphy, D. Alicia Hickok and Melissa Merk of Drinker Biddle & Reath LLP.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, before the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Matt Fair, Jeannie O’Sullivan and Emily Field. Editing by John Campbell.
https://www.law360.com/articles/1142503/philly-judge-won-t-boot-colleague-from-j-j-mesh-dispute
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Ethicon Fails in Pelvic Mesh Recusal Bid Based on Judge's Mother's Xarelto Case
Mar 25, 2019 | New Jersey Law Journal
By Max Mitchell
Johnson & Johnson subsidiary Ethicon has lost its bid to have Philadelphia Judge Kenneth Powell removed from handling any future pelvic mesh trials in Philadelphia.
The judge overseeing Philadelphia’s Complex Litigation Center on March 22 declined to grant a motion by Ethicon, which had requested that Powell be barred from handling pelvic mesh trials because his mother is pursuing a lawsuit against another J&J subsidiary over the blood thinner Xarelto. The one-sentence order, entered by supervising Judge Arnold New, did not explain the reasoning behind the decision.
A spokeswoman for Ethicon, which is the primary defendant in nearly 100 pelvic mesh cases pending in Philadelphia, said in an emailed statement, “We’re disappointed by the decision, but we appreciate Judge New’s consideration of this matter.”
Kline & Specter attorney Shanin Specter, a lead attorney representing the plaintiffs in the consolidated pelvic mesh litigation, said in an emailed statement that the ruling was in line with decisions from other members of the judiciary, including the seven-member Pennsylvania Supreme Court, which denied a similar motion that Ethicon filed earlier in the month.
“That’s now 10 judges or justices who have refused Johnson & Johnson’s efforts to run the court system through their own brand of judicial selection,” he said. “But unfortunately I expect J&J to be undeterred and to foment more mischief. Meanwhile, we’ll just keep trying these important cases one at a time to whomever is assigned.”
Ethicon’s motions to have Powell removed come as juries in Philadelphia have repeatedly awarded plaintiffs multimillion-dollar verdicts over claims that the company failed to adequately warn about the dangers of pelvic mesh implants. Of those cases, Powell oversaw Emmett v. Ethicon, which ended in a $41 million verdict in January, and Carlino v. Ethicon, which resulted in a $13.5 million award in early 2016.
In its request to have Powell removed from hearing pelvic mesh cases, Ethicon contended that, not only was Powell’s mother pursuing a case against another J&J subsidiary, he also failed to properly disclose the lawsuit, or allow for full briefing on the issue. Citing the Pennsylvania Code of Judicial Conduct, Ethicon said that judges need to avoid conduct that “creates the appearance of impropriety,” and that there had been “a history of non-disclosure, of commentary and of rulings that create the appearance of bias and warrant recusal.”
The plaintiffs had responded by saying J&J was a “bully” and “a mass tortfeasor,” and the efforts to get Powell removed from cases “was beyond the bounds of fair advocacy.”
The dispute bares at least a passing resemblance to a situation that arose several years ago involving another judge who failed to disclose a close family member’s ties to a party in a case he oversaw. That judge was Allan Tereshko, and in 2011 he dismissed an insurance dispute without first disclosing to the parties that his wife was working in Post & Schell’s professional liability department at the time that Post & Schell was representing the defendant.
That situation resulted in a warning from a Superior Court majority, as well as a scorching concurring opinion from Superior Court Anne Lazarus, who said Tereshko not only prejudiced the parties but he also “failed in his professional responsibility as set forth in the Code of Judicial Conduct.” Tereshko resigned his position as a supervising judge a few days later.
Ethics attorneys who spoke with The Legal said there appeared to be possible similarities between the situations, but the issues surrounding when a judge needs to disclose or recuse are very fact-specific.
University of Pittsburgh School of Law professor Arthur Hellman said not immediately disclosing the lawsuit of a family member could be problematic.
“It’s not one of those things where I could say it’s too speculative, or too far from the realm of an arguable conflict,” he said.
Yale Law School lecturer Lawrence Fox, who said he could not comment about the specifics of the pelvic mesh situation without knowing all the details of the case, said that in general it is the judge’s responsibility to bring any potential issues to the parties’ attention.
“The emphasis is on disclosure,” Fox said. “Even if I think I shouldn’t recuse I should tell the parties what the issue is because they might come up with another argument.”
However, regarding the actual alleged conflict, Hellman said there appeared to be sufficient distance between the pelvic mesh cases Powell has tried and his mother’s lawsuit to make the recusal argument a “stretch.” He noted that even though both companies at issue are J&J subsidiaries there are corporate distinctions between the companies. He also said it did not appear that any of Powell’s rulings could affect either the Xarelto litigation broadly, or Powell’s mother’s case specifically.
“You would have to find some overlapping issues to say her interests would be affected to trigger an obligation to recuse,” Hellman said.
https://www.law.com/njlawjournal/2019/03/25/phila-judge-declines-to-bounce-colleague-from-pelvic-mesh-trials-399-23802/
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Bayer, Johnson & Johnson to Pay $775 Million to Settle Xarelto Litigation
Mar 25, 2019 | Wall Street Journal
By Sara Randazzo
Bayer AG BAYRY -2.74% and Johnson & Johnson JNJ -0.22% have agreed to pay $775 million to resolve claims that the blood thinner Xarelto causes excessive bleeding, according to the companies.
The deal, reached with plaintiffs attorneys, will resolve 25,000 claims and is structured to limit liability going forward.
The two companies, which jointly developed the drug and will evenly split the settlement cost, have won all six Xarelto cases that have gone to trial so far.
Xarelto is Bayer’s top-selling drug and remains on the market. The companies aren’t admitting liability as part of the deal, which allows them to pull out if not enough eligible plaintiffs sign onto it.
Bayer said Monday the settlement “allows the company to avoid the distraction and significant cost of continued litigation” and that it remains committed to the more than 45 million patients world-wide who have been prescribed Xarelto.
Johnson & Johnson said “We believe this is the right thing to do for patients and their doctors” and that it stands by the safety of the drug.
Andy Birchfield, a lawyer at Beasley Allen who represents the plaintiffs, said the elderly plaintiff population and a warning-label change in 2015 that restricts future claims made now the right time to settle. “This is really difficult and challenging litigation,” he said. “I think this provides fair compensation to the claimants here.”
The settlement resolves a legal headache for Bayer and Johnson & Johnson, but several more remain for both companies.
Bayer is fighting claims that its popular weedkiller Roundup causes non-Hodgkin lymphoma and other cancers; uncertainty over the litigation and two adverse jury verdicts have depressed the company’s stock price. Other lawsuits challenge the safety of two Bayer birth-control drugs.
Johnson & Johnson faces lawsuits claiming its talcum-based baby powder causes cancer as well as claims over hip implants, pelvic mesh and diabetes medication.
Plaintiffs’ lawyers have flooded the airwaves in recent years with television advertisementswarning about the risks of Xarelto. Approved in 2011, Xarelto belongs to a new generation of blood thinners aiming to better balance keeping blood thin enough to avoid clotting but sufficiently thick to prevent bleeding episodes.
The lawsuits, which have accumulated mostly over the past five or so years, claim the drugmakers played down Xarelto’s risks, resulting in injuries including internal bleeding, stroke and death.
In light of the agreement, U.S. District Judge Eldon Fallon in New Orleans on Monday halted litigation in his courtroom that had consolidated thousands of Xarelto lawsuits filed in federal court. The judge put in place extra burdens for anyone looking to pursue claims outside the settlement process, including submitting a report from a licensed physician supporting claims that injuries were caused by Xarelto. Mr. Birchfield said he didn’t expect many new claims to be filed.
Under the settlement, payments will be substantially less for anyone who was prescribed the drug after Dec. 1, 2015, when its warning label changed, or for those whose first alleged injury came after March 1, 2016. Payments are also capped for anyone hospitalized for two or fewer consecutive days.
Xarelto has been a large revenue generator for Bayer, which is looking to develop new drugs as the patents on Xarelto and other top drugs are set to expire in coming years.
https://www.wsj.com/articles/bayer-johnson-johnson-to-pay-775-million-to-settle-xarelto-litigation-11553526678
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There are 2 types of breast implants, and both come with risks. Here’s what you need to know.
Mar 26, 2019 | Insider
By Julia Naftulin
On Monday and Tuesday, the FDA will convene to discuss breast implants and the risks associated with them.
The meeting follows a letter the FDA sent to doctors asking them to watch out for a rare form of cancer associated with the implants. Since September 2018, the FDA has received 457 individual reports on people with implants who developed anaplastic large cell lymphoma (ACLC). Nine of those cases resulted in death.
Additionally, the FDA issued warning letters to two breast implant manufacturers on Sunday after learning they were not running long-term studies to better understand the potential risks of breast implants.
During the meeting, the FDA will discuss the different types of implants available and make recommendations on how to handle their potential risks going forward.
Here's what to know about the difference between silicone-filled and saline-filled implants.
Both types of breast implants have silicone outer layers, but the inner contents of the implants is what sets them apart.
Silicone-filled implants contain silicone, which comes in a gel form that resembles human fat, according to the Mayo Clinic.
ome people who opt for silicone-filled implants do so because these implants tend to look and feel more like real breast tissue. You have to be at least 22 years old to get silicone implants for breast augmentation, but can be any age if you need them for breast reconstruction purposes, according to the Mayo Clinic.
If one of these implants ruptures while inside the body, it might go undetected because the gel would remain in the tissue around the implant. Although a ruptured silicone gel implant isn't linked to breast cancer or other health problems, it can still lead to pain and changes in the size and shape of the breast if left untreated.
To detect silent ruptures, the FDA recommends getting an MRI three years after getting either type of breast implants, and then every two years following the initial MRI. A doctor can remove a ruptured silicone implant and replace it right away if that's what the patient wants.
In an FDA report published in 2011 on breast implants linked to ACLC, 24 of the 34 cases used silicone implants, while just 7 of the cases were linked to saline-filled implants.
A 2019 National Institutes of Health (NIH) report found that silicone implants are more expensive than saline implants for reconstruction procedures, but that silicone implants proved less effective over time due to revision surgeries and complications. The 2019 report concluded that "given the relatively small cost difference, surgeon and patient preference may be important in determining type of implant used."
Saline implants are filled with a sterile salt water solution
Like silicone implants, saline implants have a silicone outer shell, but are filled with a salt water solution after the shell is placed in the body. This implant type is available for people 18 and older who want breast augmentation surgery.
If a saline implant ruptures, the salt solution is absorbed into the body. The implant shell deflates and must be removed surgically, but can be immediately replaced just like a silicone implant.
According to the FDA, saline implants are often used in revision surgeries to correct previous procedures.
Implants can also be textured or smooth, and textured implants have been linked to ACLC
In addition to their fillings, breast implants can be characterized based on the feel of their outer shells. Some implants are textured on the outside, while others have smooth outer surfaces. The textured surface of some implants acts like Velcro and helps them to better stay in place, according to Allure. These implants also come in a teardrop shape, which mimics the natural shape of a breast more than a perfectly round implant.
But the texture of the implants could also be a potential breeding ground for harmful bacteria that could lead to inflammation or infection, Adam Kolker, an associate clinical professor of surgery at the Icahn School of Medicine, told Allure.
Researchers aren't positive if the textured surface is causing ACLC cases, but they do have reason to believe it's possible, as a 2017 report linked textured implants to ACLC.
Both types of implants may complicate mammograms and breastfeedingMammograms may need to be performed differently if a person has breast implants, since the procedure requires the breast to be compressed between two discs. The Mayo Clinic website recommends telling the radiologist performing the mammogram that you have breast implants beforehand to prevent any potential complications, like rupturing your implants.
Breastfeeding may also be a challenge for someone with breast implants, according to the Mayo Clinic, but other women don't have trouble breastfeeding with implants.
Both types of implants require upkeep and usually have to be replaced every 10 years for routine maintenance, according to FDA standards. They also have similar risk factors in terms of ruptures, infections, changes in nipple sensation, and pain.
Regardless of the type of implants a person gets, both come with potential risks that should be considered before going through with the procedure.
The FDA will also discuss risks associated with women-centric procedures
In addition to talking about ACLC risks, the FDA meetings will discuss common risks associated with breast implant procedures and other women-centric health issues, like the use of surgical mesh, which has lead to past infections in women getting pelvic organ prolapse surgery.
The FDA said it also plans to discuss best practices for informing patients about potential breast implant risks and MRI screenings for detecting ruptured implants.
Susanna Heller contributed to this story.
https://www.thisisinsider.com/what-are-the-different-types-of-breast-implants-2019-3
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