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Ethicon Media Monitoring 10/13/16
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UroGyn Society: Mesh on Trial: Defendant and Plaintiff Perspectives
Oct 12, 2016 | Mesh Medical Device Newsdesk
There was much anticipation about the Thursday afternoon Mesh on Trial: Defendant and Plaintiff Perspectives at the 37th annual meeting of AUGS, the American Urogynecologic Society. -
J&J Trial's Remote Witnesses Test Limits Of Subpoena Power
Oct 12, 2016 | Law 360
By Cara Salvatore
...Additionally, a federal judge approved it a year ago in a trial that came out of the MDL over Boston Scientific's pelvic mesh, saying that three Boston Scientific employees, including a manager and an executive, had to testify. -
Vaginal Mesh – Transvaginal Lawsuit Settlement & Compensation?
Oct 12, 2016 | Supplement Police
Vaginal mesh is a material that is implanted along the vagina to help women who suffer from a number of pelvic conditions, like incontinence. However, this type of procedure has recently gained the attention of the media for the numerous lawsuits against it.What is Vaginal Mesh?
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UroGyn Society: Mesh on Trial: Defendant and Plaintiff Perspectives
Oct 12, 2016 | Mesh Medical Device Newsdesk
There was much anticipation about the Thursday afternoon Mesh on Trial: Defendant and Plaintiff Perspectives at the 37th annual meeting of AUGS, the American Urogynecologic Society.
This would be the first time the 1,300 urogynecologists, urologists and gynecologists would be presented with a full explanation of the issues involved in pelvic mesh litigation. An attorney representing mesh manufacturers would explain industry’s defense of allegations of a defective product, while a plaintiffs’ attorney would reveal what industry knew before it marketed its pelvic mesh products, and when it knew it.
There had been some discussion in previous day sessions about the late night television ads soliciting pelvic mesh clients, and most doctors thought bottom-feeding trial attorneys and their legal referral services had ended up hurting patients.
Doctors believed that because of litigation, there were now fewer options on the table to correct incontinence (SUI) and pelvic organ prolapse (POP).
After pelvic mesh makers had suffered the majority of losses at trial, Prolift (made by J&J), Pinnacle (by Boston Scientific), and a host of other meshes were all taken off the market. The Food and Drug Administration now required a review of all POP mesh outcomes and a reclassification of the larger mesh kits for POP as either high risk or class III. The “business decision” to take many meshes off the market made sense to mesh makers.
None of these doctors had presumably ever sat in a trial, and from the previous day’s session, Current Status (See story here), those present did not seem to be aware of even the basics of mesh litigation, certainly not in its scope and in the fact that the 100,000 women who have filed defective product actions in this country still suffer life-altering injuries to varying degrees. Some will never be the same.
Instead, some of the doctors who sat in the Current Status session indicated women were seeking a “payday.”
So Mesh on Trial would be an eye opener. It was scheduled for the biggest space, Exhibit Hall A, that could seat nearly all of those in attendance.
The moderator was scheduled to be Pam Moalli, MD PhD, of the University of Pittsburgh; panel members included Miles Murphy, MD MSPH (and expert witness at the Linda Gross trial for defendant, J&J); Donald Ostergard, MD, who founded AUGS; Janna Nugent, a defense attorney with Greenberg Traurig (Lori Cohen’s law firm); Derek Potts, plaintiff’s attorney, and urogynecologist Dennis Miller, MD.
Just before the scheduled 4 pm start, a crowd gravitated toward the Hall A. Then I got a text message from a doctor in attendance:
“They just cancelled the mesh debate.”
“Why?” I asked.
The reason I was given was that it was “a legal issue of exposure for the society.”
An AUGS representative explained some slides for the presentation weren’t ready in time. But attorney Derek Potts said that was not true. They asked for the slides to be in at 10 am. He made sure they were in by 10 am.
“Fear got to them. They wanted to review the presentation and they didn’t like what they saw,” Potts said. His comments on suicides and divorces that followed mesh implants were too much, Potts said. See the comment here.
“It’s the truth. The sad fact is the leadership is in bed with manufacturers and they are trying to protect them. They saw the debate as a threat,” Potts explained.
Given that the exhibit hall was full of banners and booths from Medtronic, Allergan, Boston Scientific, Caldera Medical, Ethicon, Coloplast, Astellas, CooperSurgical, among others, and that more than half of the revenue supporting this conference came from industry, according to the AUGS president, Potts likely wasn’t far off.
So as it turns out, our session the previous evening on Current Status and Future Potential for the Use of Mesh was as close as the participants would come to a debate by this medical society.
Unfortunately the 20 or so in the room for Current Status were the only ones to gain some understanding of the issues.
Within an hour, the buzz was making it around the conference exhibit hall as to why this session was cancelled. Some claimed that Attorney Potts was out of control the night before and had thrown out incendiary statements like women’s husbands had divorced them and women were committing suicide.
“Okay. And what if that is true,” I asked one doctor. “There have been divorces and suicides,” I offered.
“Then you’re biased! People like you are biased,” he said in an accusatory tone.
People like you, I repeated to myself. What does that mean? Even though I had introduced myself to this doctor, he clearly didn’t know who I was or that I write about the patient perspective of mesh injuries. I had spent my own money to attend AUGS to learn what doctors in the field are experiencing first hand.
Since I was an eyewitness to yesterday’s session, I suggested that Dr. Cassidenti was the only one in the room for Current Status who raised his voice and seemed agitated, like he was ready to cross two rows of chairs to get at Mr. Potts.
No. The doctor insisted it was Potts who was out of control.
The demonizing of Derek Potts was easy to do because there were so few there to experience the session first hand.
And that would be the buzz created as an explanation for the Mesh Debate cancellation, and presumably believed.
PRECEPTORS
While Mr. Potts kept a low key response to critics at the last session, and did not engage or raise his voice, my only criticism was his suit was too nice. With a sharp blue tie, he looked like he was about to launch into an opening before a jury.
The crowd at AUGS was generally more casually clad, like a college professor, unless you were a preceptor.
Preceptors wore nice suits and looked like the leaders of the conference.
In fact, the early adopters, the technology trendsetters, were just that. They were the doctors who had gravitated toward the manufacturers early on, the “early adopters” who bought the promises of a “minimally invasive procedure” that would improve their options for their patients and their practice in the treatment of incontinence and pelvic organ prolapse.
And you could teach other doctors, hold clinics and travel to nice places to do so, all for compensation.
What is a preceptor?
In a university setting, a preceptor assists the professor and teaching assistant to design and impart certain lessons.
In the medical device world, a preceptor is one who teaches other doctors about a particular device in a weekend cadaver clinic, through industry-supported training and/or as a consultant with a device manufacturer.
AUGS was full of preceptors. In fact, some of the key opinion leaders (KOL), as industry designates them, were there. KOLs and preceptors are considered an integral part of introducing a device to market and very valuable cheerleaders for a company.
On the flip side, preceptors and the conflicts of interest they represent, have become a red flag issue for juries, who tend to side with an injured plaintiff when they learn of the millions of dollars doctors are paid to carry the water for a company.
Some preceptors have had to endure long hours of depositions at the hands of plaintiff’s attorneys. As an example, see the deposition of Dennis Miller here.
Society KOLs had created the A Time to Rethink position statement after the FDA issued its two warnings about the risk versus the benefit of pelvic mesh.
Many preceptors at AUGS are also the same names you’ve heard at pelvic mesh trials.
Dr. Vincent Lucente, MD was the $1.7 million preceptor for Ethicon (Johnson & Johnson), mentioned in the Linda Gross trial and Joan Budke case against J&J. Dr. Lucente trained Mrs. Budke’s implanting physician, who placed a Prolift mesh in Mrs. Budke, who later died of a raging infection. (See the stories here and here).
The case settled for an undisclosed amount on the eve of going to the jury after Mr. Budke, a stoic, 93-year-old widower cried, “I lost my bride.”
Dr. Lucente was front and center at AUGS, delivering Industry Expert opinion for Allergan, the maker of Botox®, which now makes a nasal spray for nocturia, or nighttime urination; for American Medical Systems; Coloplast and Medtronic.
Dr. Lucente and Dr. Andrew Cassidenti, a preceptor for AMS, see the story here, presented for Boston Scientific to promote the transition from the Elevate (AMS) to Uphold by Boston Scientific, when AMS folded its mesh-making division in March.
Kevin Benson, MD was there too.
The South Dakotan was the implanting surgeon for Linda Gross, who was awarded $11.1 million before a New Jersey jury and who has undergone in excess of 20 surgeries to remove and correct what was left behind by her Prolift implant. (See a story here).
In its Conflict of Interest Policy, AUGS requires disclosures about corporate sponsorship deemed relevant by the Program Committee, and doctors list their consulting arrangements, often without specifying their fees.
These would be some of the names juries have heard at trial, but the 1,300 physicians who attended this AUGS 37th annual conference would never hear them in that context at the Denver Convention Center. ###
http://www.meshmedicaldevicenewsdesk.com/urogyn-society-mesh-trial-defendant-plaintiff-perspectives/
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J&J Trial's Remote Witnesses Test Limits Of Subpoena Power
Oct 12, 2016 | Law 360
By Cara Salvatore
Law360, New York (October 12, 2016, 6:21 PM EDT) -- On Thursday, lawyers suing Johnson & Johnson will open a window on screen in a Texas courtroom and grill an executive a thousand miles away over the company's metal-shedding artificial hips, a controversial mode of testimony that's already piqued the Fifth Circuit's interest and that one expert calls an invitation for "court-sanctioned harassment" of executives.
The plaintiffs in the suit say that friction between the artificial hips' metal socket and the metal ball head that fits inside rubs away trillions of microscopic particles with every step and, over time, causes bone to erode and surrounding tissue to inflame. U.S. District Judge Ed Kinkeade's blanket permission for satellite testimony in the third bellwether of the 8,828-case multidistrict litigation, though, has become a major point of contention.
He approved the testimony setup just days before trial opened Oct. 3 against J&J and unitDePuy Orthopaedics Inc. The companies immediately asked the Fifth Circuit for a mandamus order to review Judge Kinkeade's decision, saying witnesses like DePuy employees, former employees and consultants live outside the court's geographical reach — generally 100 miles. And the company argued that requests for video testimony should have been considered on a case-by-case basis, not granted en masse and at will.
"It's a form of harassment. It's court-sanctioned harassment," said Diane Lifton, co-chair of the life sciences and product liability practice groups at Hughes Hubbard & Reed LLP and an expert in defending corporations against mass torts similar to this one, where, absent a settlement, there would presumably be thousands of trials.
"It means that the witness will be deposed and have to appear for trial over and over and over on the same topics. ... It's not tenable for your company employees to have to submit to testimony over and over again. Even in their own office," Lifton said.
Richard Arsenault, a lead plaintiffs attorney in the DePuy case, told Law360 that the use of remote testimony is well within established bounds, having first been used as far back as 1990, and is also better aligned with the interests of justice than a viewing of static videotape.
"It reflects the fluid dynamic of trial," said Arsenault, who was also co-lead in an MDL over the cancer risks of the diabetes drug Actos. "If the goal is truth-telling," he added, then having witnesses answer live questions and allowing the jury to see their reactions to those questions in an authentic way is the right move.
First on the plaintiffs' list is DePuy executive Pam Plouhar, scheduled to face a camera Thursday morning in a federal courtroom in South Bend, Indiana — 1,028 miles by road from Judge Kinkeade's Dallas courtroom. Also on the plaintiffs' slate for later in the trial are witnesses located in Los Angeles and Minneapolis.
In DePuy's mandamus bid the week before trial, the company cited Rule 45 of the Federal Rules of Civil Procedure, which describes the physical limits for the subpoena of witnesses, and Rule 43, which as of 1996 includes an amendment allowing satellite testimony "only on showing good cause in compelling circumstances."
The Fifth Circuit denied mandamus in a very short order, allowing Judge Kinkeade's order to stand and reinforcing the conventional wisdom that mandamus is almost never granted.
But then something curious happened. The one-sentence affirmation was replaced, apparently within hours, with a revision.
The new version included a remark from U.S. Circuit Judge E. Grady Jolly, which said in full: "Although the district court misapplied Rules 43(a) and 45(c), I concur in the denial of the petition for a writ of mandamus."
It's encouragement for a defense team that hasn't shied from engagement with the appeals process, said Pillsbury Winthrop Shaw Pittman LLP partner Eric Fishman.
"Maybe one thing the Fifth Circuit is signaling is they don't think there are compelling circumstances here ... because [the lawyers] have available to them the depositions," Fishman said. "So one thing they might be signaling is perhaps good cause in compelling circumstances isn't established here."
Such testimony has been allowed in at least a handful of federal trials before, according to Arsenault, including in 2006 in an MDL claiming the anti-inflammatory Vioxx caused heart attacks and strokes, and in 2014 in the Actos MDL.
Additionally, a federal judge approved it a year ago in a trial that came out of the MDL overBoston Scientific's pelvic mesh, saying that three Boston Scientific employees, including a manager and an executive, had to testify. But this is the first time a circuit court has taken on the issue, according to W. Mark Lanier of The Lanier Law Firm, who represents the plaintiffs in the DePuy bellwether.
Before the Boston Scientific trial, in September 2015, U.S. District Judge Barbara Crabb ruled: "Live testimony is preferable to a deposition, both because it allows for a fuller presentation of the facts and because it is more engaging for a jury." The case was scheduled for trial on Oct. 13, 2015, but settled a couple of weeks before — and a couple of weeks after Judge Crabb's testimony order. The three employees never had to testify.
On the point of which is more interesting, a video or live testimony, the defense bar may agree with the plaintiffs bar.
"Courts and litigants have been relying on deposition transcripts and video for decades, so they're not less reliable. They may be less interesting for the jury; it's more interesting for the jury to have a live witness," Lifton said.
One reason the company is pulling out every single stop and making a major issue out of this testimony is the amount of money that could be sitting on the scales. The second bellwether saw a $500 million verdict — but Texas law's punitive damages cap reduced it by about $350 million. That's not an issue in this third bellwether, which is taking place under California law.
Johnson & Johnson and DePuy sold 150,000 of the artificial hips in the 2000s, lawyers for patients told a Texas federal jury in opening arguments. J&J declined to comment for this story.
Lifton said that, all issues of law aside, the order allowing the testimony was an eyebrow-raiser among her colleagues in the product liability and MDL defense world: "We were getting calls saying, 'Have you guys ever seen that before?'"
The patients are represented by W. Mark Lanier of The Lanier Law Firm, Richard Arsenault ofNeblett Beard & Arsenault, Jayne Conroy of Simmons Hanly Conroy LLC, Wayne Fisher ofFisher Boyd Johnson & Huguenard LLP and Khaldoun Baghdadi of Walkup Melodia Kelly & Schoenberger.
DePuy and Johnson & Johnson are represented by Steve Quattlebaum of Quattlebaum Grooms Tull & Burrow PLLC, John Anderson of Stoel Rives LLP, Dawn Estes of Estes Thorne & Carr, Michael Powell and Seth Roberts of Locke Lord LLP, and Stephen J. Harburg, John H. Beisner, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.
The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.
--Additional reporting by Dani Kass. Editing by Mark Lebetkin and Catherine Sum.http://www.law360.com/articles/849787/j-j-trial-s-remote-witnesses-test-limits-of-subpoena-power
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Vaginal Mesh – Transvaginal Lawsuit Settlement & Compensation?
Oct 12, 2016 | Supplement Police
Vaginal mesh is a material that is implanted along the vagina to help women who suffer from a number of pelvic conditions, like incontinence. However, this type of procedure has recently gained the attention of the media for the numerous lawsuits against it.What is Vaginal Mesh?
Choosing to undergo a surgical procedure to help with any condition can be a frightening endeavor, especially if you have never had one before. However, there are some surgeries that seem necessary at the time. Your doctor is often the greatest resource when it comes to understanding the process of a surgery, as he or she helps you to make important medical decisions. While most surgeries are safe with limited risk, that is not the case for recent information that has been exposed regarding vaginal mesh.
Vaginal mesh was created with the original intention of helping women with urinary incontinence or pelvic organ prolapse to gain greater control over their body. With multiple types of transvaginal mesh, your doctor would normally be the one to help you determine the best solution. During the procedure, your surgeon will have the option of placing the mesh with abdominal surgery or a transvaginal procedure. Most of the time, your doctor will choose a transvaginal procedure, since the process takes less time.
Originally, the materials and products used to repair your muscles in your pelvis were used to help repair your body from a hernia almost 80 years ago. However, many surgeons that performed these implantations did not consider the changes that needed to be made to the material to customize it for this sensitive area. In fact, all that was done at the time was a little cutting and implanting. Within several years, medical device manufacturers finally started creating mesh products that were specifically designed for vaginal implantation.
When this mesh was offered to doctors, they included a whole kit. Complete with the specialized tools, some doctors speculated that these mass-produced kits were part of the beginning of complications with the procedures.Type of Vaginal Mesh
The type of vaginal mesh you end up using is a decision that is made by your doctor. This decision should be combined with the state of your body, along with any potential allergic reactions. However, as with most decisions in the medical community, the materials used will depend on your doctor’s preferences. Here are a few of the different mesh options that you may use:Animal derived mesh, which is made of processed animal tissue that has been disinfected for human useNon-absorbable mesh, which will never perish and is permanentAbsorbable mesh, which loses strength over time and is predominantly used for temporary healing
Since each material is so specific to the use and the patient, you will need to consult with your doctor to make any determinations.Companies that Produce Vaginal Mesh
With such an innovative medical device, you would think that every company with a hand in the industry would want to produce this material. However, there are five companies that seem to dominate the production of vaginal mesh in the market, which are:Johnson & JohnsonBard MedicalAmerican Medical SolutionsBoston Scientific Coloplast
Each of these brands are widely successful in other ways as well, profiting billions of dollars a year. Unfortunately, with complications and legal problems surrounding the use and implantation of the vaginal mesh lately, it is unlikely that these billions of dollars are coming from these surgeries.Recent Lawsuits Regarding Vaginal Mesh
At this time, you will be hard-pressed to find any doctor that is willing to perform this surgery, as there are many investigations and lawsuits active against transvaginal mesh procedures. According to multiple clients that have filed lawsuits, both the design and the implantation procedure for the mesh have created much bigger problems for the consumers that have it performed. Specifically, the vaginal mesh implant has contributed to significant bodily issues, like erosion and organ perforation. The improper placement and surgical procedure could also cause infection.
However, those are just a few of the potential risks you take in getting this procedure done. The lawsuits also include that the implantation of these materials can cause:Pain in the groin, genitals, and pelvic areaNerve damageFistulasScaringInfection
The lawsuits have been filed by thousands of women, specifically stating that the companies that produce the mesh gave false or misleading information to their patients. They also allege that the companies were not forthcoming with providing a complete list of the risks and potential long-term damages. Other lawsuits included accusations of:Misleading the FDAFailing to complete the proper testing of the materials to ensure safetyFailing to determine an effective way to remove the mesh when it’s no longer needed
Many women who have undergone surgery have already had to revisit the operating room for additional procedures to correct the damage caused by the mesh. There are multiple federal lawsuits that are presently being pursued.The Current State of the Lawsuits
At this time, at the U.S. District Court for the Southern District of West Virginia and many state courts, there have been about 70,000 lawsuits filed. These cases are pending for trial and assessment. However, some women have already been awarded millions of dollars for their cases.
If you have had poor reactions to your experience with vaginal mesh, but you cannot pursue your own lawsuit, you can still participate in a class-action lawsuit for a portion of the payout.Transvaginal Mesh Conclusion
With so much turmoil surrounding the use of vaginal mesh, it’s clear that the medical community needs to pursue more research before this procedure is a safe way to treat patients. If you’ve considered this procedure in the past, you may want to hold off until those changes have been made. However, if you’ve already had the procedure done, you can find multiple resources online that will allow you to pursue your own lawsuit and representation during this difficult time.
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