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Ethicon 3/24
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Transfer Of Pelvic Mesh MDL Cases Is Premature, Judge Says
Mar 23, 2016 | Law360
By Alex Wolf
...Tens of thousands of cases involving mesh products manufactured by Boston Scientific, Johnson & Johnson and C.R. Bard Inc. have been consolidated in multidistrict litigation pending before Judge Goodwin’s court in West Virginia. -
J&J Exec Says Married Doc's Relationship Violated Policy
Mar 23, 2016 | Law360
By Jeannie O'Sullivan
...Testifying on behalf of J&J and its medical device maker Ethicon Inc., the defendants in Joel S. Lippman's lawsuit alleging the pharmaceutical giant really fired him for raising concerns about dangerous products, Richard Martemucci described to a Middlesex County Superior Court jury how his investigation into an employee dispute unearthed a relationship between Lippman and the subordinate that was "very concerning." -
Hernia Mesh Patient Advocate – Many Questions, Few Answers for Those Patients
Mar 23, 2016 | Mesh Medical Device News Desk
By Bruce Rosenberg
...For some reason, a number of people who receive a polypropylene hernia mesh are experiencing the same pain, infection and inability to move that pelvic mesh women are experiencing.
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Transfer Of Pelvic Mesh MDL Cases Is Premature, Judge Says
Mar 23, 2016 | Law360
By Alex Wolf
A West Virginia federal judge overseeing multidistrict litigation against Boston Scientific Corp. over its pelvic mesh products denied on Wednesday a request to transfer 351 cases being handled by Kline & Specter PC to Pennsylvania, saying because pretrial discovery is incomplete, a remand would be premature.
In rejecting the motion to transfer Kline & Specter’s cases, U.S. District Judge Joseph R. Goodwin said although the plaintiffs claim that transfer is proper because some pretrial proceedings are complete, the court will not do so until all pretrial proceedings conclude.
“Neither pretrial motion practice nor discovery are complete in these cases; because pretrial proceedings remain underway, none of these cases are ready for remand,” the judge said. “Remanding these cases at this time would run contrary to the purpose of multidistrict litigation.”
Tens of thousands of cases involving mesh products manufactured by Boston Scientific, Johnson & Johnson and C.R. Bard Inc. have been consolidated in multidistrict litigation pending before Judge Goodwin’s court in West Virginia.
According to court documents, Kline & Specter filed 90 cases on behalf of plaintiffs in Pennsylvania’s Eastern District that were later transferred to the MDL, and filed 261 more directly within the consolidated litigation.
In February, the firm asked the court to move all of its cases to Pennsylvania’s Eastern District, arguing it is appropriate because “generic discovery is substantially completed,” the cases are not set to go to trial in the MDL and there is a large backlog of cases causing a delay.
Kline & Specter attorneys also said that Boston Scientific has not offered to resolve the instant group of suits.
But transferring venues at this juncture would be inappropriate, Boston Scientific argued earlier this month, saying pretrial proceedings have not even begun in 350 of the cases and in the one case selected for work-up, there are several pending summary judgment and Daubert motions awaiting rulings.
“Transferring or remanding these cases to a court of proper venue is premature and a detriment to efficiency and the expeditious disposition of the litigation because pretrial proceedings are not complete and the parties have not had opportunity to confer and address the issue of venue,” the company said.
Boston Scientific also argued that only the Judicial Panel on Multidistrict Litigation, not the court, has the authority to transfer cases that originated through the panel and that the plaintiffs have not established why Pennsylvania’s Eastern District is a proper venue, pointing out that some individuals with claims against the company are based in other parts of the country.
In an email to Law360 on Wednesday, plaintiffs' attorney Shanin Specter said that the judge indicated that case-specific discovery needs to be taken, which is what he and co-counsel will seek to do.
An attorney for Boston Scientific did not immediately respond to a request for comment Wednesday.
The plaintiffs are represented by Shanin Specter, Lee B. Balefsky and Michelle L. Tiger of Kline & Specter PC.
Boston Scientific is represented by Robert T. Adams and Jon A. Strongman of Shook Hardy & Bacon LLP.
The case is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, MDL no. 2326, in the U.S. District Court for the Southern District of West Virginia. -
J&J Exec Says Married Doc's Relationship Violated Policy
Mar 23, 2016 | Law360
By Jeannie O'Sullivan
A Johnson & Johnsonhuman resources executive told a New Jersey jury Wednesday that the secret romance between a married doctor suing the company for wrongful termination and a younger female subordinate conflicted with company policy on transparency about workplace relationships.
Testifying on behalf of J&J and its medical device maker Ethicon Inc., the defendants in Joel S. Lippman's lawsuit alleging the pharmaceutical giant really fired him for raising concerns about dangerous products, Richard Martemucci described to a Middlesex County Superior Court jury how his investigation into an employee dispute unearthed a relationship between Lippman and the subordinate that was "very concerning."
The relationship — which was Ethicon's official reason for terminating Lippman, the company's onetime worldwide vice president of medical affairs and chief medical officer, in May 2006 — consisted of emails, cards, flowers, music CDs and two overnight trips but was never consummated, according to Martemucci's recollection of interviews with Lippman and the subordinate, Yasemin Dalgali.
"Bad judgment" is how Martemucci summed up the relationship, which the defense said J&J feared would have legal ramifications.
"It's a conflict of interest and violation of policy," testified Martemucci, director of J&J's employee dispute resolution program.
The investigation that revealed the relationship was prompted by Noel Rolon, Ethicon's former director of clinical operations, who alleged Lippman discriminated against him due to his Latino heritage, created a hostile work environment and gave him an unfair performance review, Martemucci testified.
Yet the investigation revealed not discrimination but a possible, and confusing, love triangle. Martemucci testified that five employees he interviewed told him there was a suspected relationship between Dalgali and Rolon, although the duo denied they shared anything more than a friendship.
News of a relationship between Dalgali and Lippman, however, came to light when Rolon told Martemucci the alleged discrimination began after he spotted the pair embracing one summer afternoon, Martemucci testified. In her interview with Martemucci, Dalgali confirmed the relationship with Lippman and indicated things got ugly when he told her one time over dinner that "I could destroy you," Martemucci said.
When interviewed by Martemucci, Lippman said he'd been a "mentor" to Dalgali and admitted there had been a relationship, but that he ended things when his wife found out, the witness said. Lippman also denied ever saying he could destroy Dalgali.
"It was a very somber discussion," Martemucci testified.
Lippman contends J&J was trying to build a case around the relationship, although Dalgali never even complained about sexual harassment, according to Lippman's legal team. Attorney Bruce McMoran repeatedly grilled Martemucci about his investigation method, saying he "never once" asked any of the interviewed employees about Rolon's claims.
"The truth is, there was no validity to the discrimination complaint at all, was there?" McMoran asked.
"No, there wasn't," said Martemucci, who often requested to view his notes from the interviews, which were conducted 10 years ago. Martemucci explained that the scope of the interview had become broader than the discrimination claims.
"There were things I needed to better understand and look into," the witness said.
Among those things were low morale reported by employees and the fact that Dalgali, who was in her 20s, seemed to be advancing rather quickly in pay raises that were approved by both Rolon and Lippman, Martemucci testified on questioning by defense attorney Jane A. Rigby.
Martemucci did admit on questioning by McMoran that he hadn't asked to see Dalgali's email exchanges with Rolon, although there was allegedly one in which Rolon professed his love.
Testimony is expected to resume Monday.
Lippman's firing came six months after a recall that cost the company $40 million, according to his testimony when the trial began on March 15. Over the course of his employment at Ethicon, which he joined in 2000, Lippman's concerns derailed profits for a coronary artery bypass graft surgery device, a gel used to prevent post-surgery abdominal adhesions, surgical mesh and other product, according to testimony.
Lippman's concerns pitted him against executives under tremendous pressure to put new products on the market and revealed a "widespread" corporate culture that put profits before safety, his lawyers said. He claims the firing cost him $9.6 million in economic losses.
Ethicon Inc. and J&J had won summary dismissal of the lawsuit at the trial court level but saw that decision overturned by the state's Appellate Division in September 2013.
The New Jersey Supreme Court agreed to take up the case and ruled in July that so-called watchdog employees are covered under the state's whistleblower law.
Lippman is represented by Bruce P. McMoran, Michael O'Connor and Justin D. Burns of McMoran O'Connor & Bramley PC.
Ethicon and J&J are represented by Francis X. Dee, Jane A. Rigby and Stephen F. Payerle of McElroy Deutsch Mulvaney & Carpenter LLP.
The case is Lippman v. Ethicon Inc. et al., case number unavailable, in the Superior Court of New Jersey in Mercer County. -
Hernia Mesh Patient Advocate – Many Questions, Few Answers for Those Patients
Mar 23, 2016 | Mesh Medical Device News Desk
By Bruce Rosenberg
They call every day. Mostly men but sometimes women who have had a hernia mesh implant and are experiencing complications.
What doctor will see me, they ask. Who is taking these lawsuits?
The answer is there are few answers for hernia mesh patients. For some reason, a number of people who receive a polypropylene hernia mesh are experiencing the same pain, infection and inability to move that pelvic mesh women are experiencing.
But unlike TVM cases – where are the lawyers?
Bruce Rosenberg, himself injured by hernia mesh, could be called an expert on the subject, but even he comes up empty. Rosenberg fields calls from Mesh News Desk and other sources. People tell him they have pain at the site of their hernia repair. He says it’s due to mesh erosion, migration, adhesion to nerves and the spermatic cord, the erosion of mesh into the bladder and into the colon.
Hernia mesh patients have just as many systemic issues as pelvic mesh women but consider that hernia mesh is generally larger than a “sling” used to support the urethra, they are facing a larger volume of inflammatory material in the body. Take a little strip of incontinence mesh and multiply it times 20-30.
Dr. M. Tom Margolis
As mesh expert Dr. M. Tom Margolis told the FDA in 2011, “The more mesh, the more mess.”
Rosenberg should know. Injured by hernia mesh years ago, today he is disabled. See his Profile here.
Prolene mesh
As a result he’s made it his business to understand polypropylene (PP) mesh and its complications. PP hernia mesh was fashioned into pelvic mesh by consultant/industry doctors in the 90’s, so its not surprising the reactions are the same women are experiencing.
The mesh is the same as polypropylene pelvic mesh- made of the polymer polypropylene, the same plastic used in carpet backing and the top of a Tick Tac box.
Rosenberg regularly attends the American Hernia Society meetings and confers with doctors around the country who are dealing with complications. He has testified before and FDA expert panel on mesh and brought a vidotape to FDA regulators of Dr. Heniford, hitting a plasticized piece of explanted hernia mesh on a table in a Johnson & Johnson promotional ad for its new larger pore mesh.
Every week he fields at least a dozen calls from the injured community.
“It used to be a search for a removal doctor. Now the first question is about litigation. They’ve been to so many doctors they are exhausted. They are not getting better and they are running out of money, patience and time,” he says.
“The typical person says their life has been ruined and they need help they are tired of being in pain. They’ve lost everything is the most common statement I have heard. They have no life, relationships have been ruined, they have nothing.”~ Bruce Rosenberg, patient advocate.
Hernia mesh survivors believe filing a legal action will get them the medical care they need. Rosenberg points to the few doctors he knows who can help – Dr. Kevin Petersen, Dr. Bruce Ramshaw, Dr. David Chen at UCLA, Dr. John Galloway in Atlanta, Dr. Todd Heniford in Charlotte, NC, Dr. Richard Miller in Tennessee and Dr Peter Billings in Washington State.
Prolene hernia mesh removed after 1.5 yr.
Rosenberg says these are hernia surgeons who remove mesh and have had good outcomes, or at least some good outcomes.
Many injured patients have tried to return to their implanting physician, but oftentimes, says Rosenberg, “Their complaints fallen on deaf ears. They are told to go to pain management.”“They are told it’s in their head, it’s going to get better, all the while their statute of limitations is running out and their injuries are increasing due to mesh migration and failure.”
Why are trial attorneys not jumping on the hernia mesh cases? There is money to be made, speculates Rosenberg. “They’ve been led astray by an FDA trying to cover its mishandling of this and additionally by the sheer marketing power of the industry.”
Dr. Uwe Klinge, hernia mesh surgeon
The volume is there. There are an estimated one million hernia implants a year, according to the American Hernia Society.
Court testimony in pelvic mesh cases have shown that hernia mesh seems to have the same reaction once implanted in the body – it contracts, shrinks, encapsulates nerves. The small pore size prevents tissue incorporation and allowing the mesh to curl, contract and degrade, according to expert testimony was given by hernia mesh surgeon Dr. Uwe Klinge in a number of pelvic mesh trials.
Dr. Klinge has collected hernia mesh explants to study what happened while in the body. He testified at the Linda Gross trial against Ethicon he knew the polypropylene mesh was defective and tried to warn Ethicon /J&J before it was sold. See the story here.
Dr. B. Todd Heniford, MD
According to Dr. Heniford, the mesh shrinks with scarification and that in turn pulls the mesh with it. Even lightweight mesh has caused injury says Rosenberg, who himself is implanted with the Ethicon UltraPro, which was supposed to be an improvement over heavy weight mesh.
“The lightweight mesh is not the answer,” he says. “Patients still get infections and meshoma injuries.”
A meshoma is a mesh contraction moving away from the pubic bone and inguinal ligament causing the mesh to wrinkle or ball up which can cause the recurrence of the hernia. In Bruce’s case, the meshoma had eroded through the peritoneum, the lining of the abdominal cavity.What is the answer?
Collagen fibers, University of Lancaster
A better product? A non-mesh repair? Sure, says Rosenberg, but that’s not for everyone. Some people do need a mesh, he believes. It’s identifying the patient who is appropriate, that’s the answer. Patients who might not do well without mesh are those who are obese, who smoke, who have a high activity level or work in jobs where there is heavy lifting. Rosenberg and others have observed those are factors that increase the chance of a failure.
Also some people naturally have a weak collagen matrix, the natural fibrous protein in connective tissue that supports skin and tissue.
Rosenberg has a nonprofit organization, The Meshoma Foundation. He says he needs to set up a website and work on doctor and patient education. “There needs to be a school that teaches tissue repair so residents could have the choice to learn that as part of treatment protocol, to learn both mesh and non-mesh repairs.”
And he plans to attend the American Hernia Societyconference in Washington, D.C. March 30 to April 2, 2016. Rosenberg is a member of the group. Specifically you will find him in seminars that address chronic pain and he will look for any new devices patients can ask their doctor about so they are not subject to what is pushed on them.
The former social workers also continues to think about others. Too many patients cant afford to go for an initial medical consultant with an expert. He would like fundraising for that purpose to be part of the bigger plan. #
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