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Ethicon Media Monitoring 02/12/2015
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UPDATE 1-J&J drops bid to probe plaintiff solicitation in mesh cases
Feb 11, 2015 | Reuters
By Jessica Dye
Johnson & Johnson dropped its request to investigate the source of what it said were illegal phone calls that may have resulted in baseless lawsuits over transvaginal mesh devices against its Ethicon Inc subsidiary. -
J&J Abandons Claim Women Were Urged to File Bogus Mesh Cases
Feb 11, 2015 | The Daily Record (Bloomberg)
Johnson & Johnson, facing almost 24,000 lawsuits over its vaginal-mesh implants, withdrew a claim that women got calls from strangers who knew their personal medical information and asked them to file fraudulent cases. -
Pelvic Mesh Maker Wants Phila. Cases Sent to MDL
Feb 12, 2015 | The Legal Intelligencer
By P.J. D'Annunzio
Boston Scientific Corp., a defendant in the Philadelphia pelvic-mesh mass tort, is seeking to remove cases from the city's Complex Litigation Center to federal court in West Virginia. -
Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries
Feb 12, 2015 | Mesh Medical Device News Desk
By Jane Akre
A patient advocate has filed a Pro Se complaint against Johnson & Johnson accusing it of organized corruption.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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UPDATE 1-J&J drops bid to probe plaintiff solicitation in mesh cases
Feb 11, 2015 | Reuters
By Jessica Dye
Johnson & Johnson dropped its request to investigate the source of what it said were illegal phone calls that may have resulted in baseless lawsuits over transvaginal mesh devices against its Ethicon Inc subsidiary.
In a court filing late Tuesday, Johnson & Johnson's lawyers moved to withdraw a Jan. 14 motion that had asked U.S. District Judge Joseph Goodwin in the Southern District of West Virginia - who oversees federal mesh litigation - to allow for an investigation into the source of the calls.
During a hearing last week in West Virginia, Goodwin told lawyers in the mesh cases that some recent motions have "not been helpful" in establishing the "mutual trust" needed to find a resolution to the litigation.
The filing did not elaborate on the reason for withdrawing the motion and the company didn't return a request for comment.
Bryan Aylstock, the lead plaintiffs' lawyer, said he was pleased with Ethicon's decision and that both sides have "pledged to work together to attempt to put an end to any wrongful solicitations of clients."
Johnson & Johnson is one of seven manufacturers that together face 70,000 lawsuits before Goodwin over injuries alleged to have been caused by mesh devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.
Plaintiffs say the devices are defective and can cause painful side effects like bleeding, infection and nerve damage.
Ethicon's Jan. 14 court motion said it had received numerous reports from women about unsolicited phone calls from strangers who either knew their private medical details or were fishing for similar information.
The callers, some of whom purported to be from Johnson & Johnson or the U.S. Food and Drug Administration, told women they could receive up to $40,000 if they filed a lawsuit, according to the court filing.
The company suggested the calls and other dodgy solicitation tactics could be a significant factor in the flood of lawsuits it has faced over mesh, which it called the "gold standard" for treating stress urinary incontinence. More than 35,000 claims have been filed in state and federal court over Ethicon mesh.
Plaintiffs' lawyers had opposed the request in a reply filed Jan. 22. While they disavowed any illegal plaintiff solicitation measures, they said that there was no evidence that fraud was tainting the mesh cases and called the motion a delay tactic.
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J&J Abandons Claim Women Were Urged to File Bogus Mesh Cases
Feb 11, 2015 | The Daily Record (Bloomberg)
Johnson & Johnson, facing almost 24,000 lawsuits over its vaginal-mesh implants, withdrew a claim that women got calls from strangers who knew their personal medical information and asked them to file fraudulent cases.
The world’s largest maker of health-care products gave no explanation in a one-sentence motion abandoning its Jan. 14 filing in the federal court handling the multi-district litigation in Charleston, West Virginia.
Callers used personal data protected by the federal Health Insurance Portability and Accountability Act and encouraged women to sue J&J regardless of whether they suffered injuries caused by the mesh, the company said.
J&J and its Ethicon unit face lawsuits by women who had the devices implanted to shore up weakened pelvic muscles or control urinary incontinence with so-called bladder slings. Women said in lawsuits that the mesh later caused organ perforation, pain, scarring and nerve damage.
“Unscrupulous groups and individuals” are stoking a spike in unwarranted lawsuits against the company over the inserts, J&J said in the Jan. 14 filing. “We have significant evidence of overt fraud.”
A J&J spokesman, Ernie Knewitz, didn’t immediately return phone calls and an email on the company’s withdrawal of the filing.
U.S. District Judge Joseph Goodwin in Charleston is overseeing all federal mesh litigation against J&J, C.R. Bard Inc. and other insert makers. Cases have been consolidated before him for pretrial information exchanges.
Settlements urged
Goodwin has been pushing manufacturers to consider settling the cases before they face billions of dollars in damages.
One of the lead plaintiffs’ lawyers, Bryan Aylstock, said an “independent, detailed and thorough sampling process failed to reveal even a single fraudulent filing” in the litigation.
Lawyers for injured women “have pledged to work together to investigate and attempt to put an end to any wrongful solicitation of clients,” Aylstock said in an email.
More than a half-dozen women contacted J&J to say phone solicitors urged them to file claims, according to the Jan. 14 filing. They were erroneously told by the callers that J&J disclosed their private medical information, the company said.
“Women across the nation are receiving unsolicited phone calls from strangers who are seeking — or, more disturbingly, already know — their very personal medical information,” J&J said. “These individuals, who on some occasions may call as often as 50 times a month, try to entice each woman into filing a lawsuit, oftentimes disregarding whether she has an injury or even had a mesh implant at all.”
The company said an Indiana woman recorded a phone solicitor urging her to file a suit even though she never had a device implanted. After she told the caller it would be a lie to say she had undergone mesh surgery, the caller was undeterred, according to a transcript filed in court.
“I do understand, but you have to tell a lie if you want to get the $30,000 up to $40,000,” the solicitor said, according to the transcript.
Juries in Texas, Florida and West Virginia have found that J&J’s, Bard’s and Boston Scientific’s inserts were defectively designed and the companies failed to warn women properly that they might damage organs and make sex painful. The panels awarded more than $135 million in damages in those cases.
In the Jan. 14 filing, J&J urged Goodwin to take steps to weed out the fraudulent cases such as forcing plaintiffs to produce medical records showing injuries and asking their lawyers about the solicitations.
The case is In Re Ethicon Inc. Pelvic Repair System Products Liability Litigation, MDL 02327, U.S. District Court, Southern District of West Virginia (Charleston).
Read more: http://thedailyrecord.com/2015/02/11/jj-abandons-claim-women-were-urged-to-file-bogus-mesh-cases/#ixzz3RVj7QH5Y -
Pelvic Mesh Maker Wants Phila. Cases Sent to MDL
Feb 12, 2015 | The Legal Intelligencer
By P.J. D'Annunzio
Boston Scientific Corp., a defendant in the Philadelphia pelvic-mesh mass tort, is seeking to remove cases from the city's Complex Litigation Center to federal court in West Virginia.
According to a notice of removal filed by defendant Boston Scientific in the U.S. District Court for the Eastern District of Pennsylvania, the allegations against Boston Scientific in Philadelphia court are similar to thousands of cases against it across the country, warranting an MDL.
"There are currently more than 15,000 cases pending against BSC" in federal court, according to the notice.
In Philadelphia, there are approximately 700 pelvic mesh cases in the mass tort program. As of press time, Complex Litigation Center Director Stanley Thompson said there had been no indication as to whether the cases would be transferred.
However, if the litigation does move to federal court, Thompson said the mass tort in Philadelphia would remain open in the event that the cases are sent back.
Explaining how these cases met the $75,000 damages minimum to qualify for federal court, Boston Scientific pointed to pelvic mesh cases against Johnson & Johnson subsidiary Ethicon Inc. in which plaintiffs recovered in excess of the minimum, as well as cases against Boston Scientific in its proposed jurisdiction of West Virginia.
"There are thousands of similar cases pending in the MDL in the Southern District of West Virginia in which plaintiffs have met the minimum amount-in-controversy such that a federal court can exercise diversity jurisdiction over those cases," the notice said.
Boston Scientific's attorneys, Joseph Blum and Joanna Vassallo of Shook, Hardy & Bacon, did not return calls seeking comment.
Lee Balefsky of Kline & Specter, liaison counsel to the plaintiffs in the litigation, said in an email to The Legal, "Given the multimillion-dollar verdicts that juries have reached against Boston Scientific in mesh cases, we agree that these cases are worth far in excess of $75,000."
Boston Scientific's attempt to transfer the cases comes six months after Secant Medical, the sole Pennsylvania-based defendant in the pelvic-mesh mass tort, was dismissed from the litigation.
In August, Philadelphia Court of Common Pleas Judge Arnold L. New found that Secant was immune from liability as a biomaterials supplier under the Biomaterials Access Assurance Act of 1998.
While the act protects suppliers of biomaterials from civil liability, it does not protect manufacturers of biomaterial-based devices. The plaintiffs in the litigation argued that Secant fit the definition of a manufacturer of mesh products.
New's ruling left Ethicon and Boston Scientific as the remaining primary defendants in the mesh cases.
Prior to the dismissal of Secant, pelvic mesh filings were on the rise. In August, there were 859 total filings, according to court records. The mass tort saw the largest influx of cases in June, with 375 filings. In July, 192 cases were filed.
Now, the mesh litigation is the third largest mass tort behind Reglan, with 2,293 case filings, and Risperdal—with its first trial in Philadelphia under way—consisting of 1,278 filings.
The plaintiffs in the Reglan litigation claim that the drug, prescribed to treat gastroesophageal reflux disease, caused them to develop an incurable neurological disorder called tardive dyskinesia.
Risperdal is an antipsychotic drug that several plaintiffs have claimed causes gynecomastia, a condition in which males grow breasts. The drug is also alleged to increase the risk of pituitary tumors.
Pelvic or transvaginal mesh is intended to treat urinary incontinence in women by supporting prolapsed organs. The plaintiffs allege that the mesh erodes prematurely, causing injuries including severe pain, sexual dysfunction and gynecological problems.
"This stacks up as a very significant litigation. There have been a number of verdicts for plaintiffs in bellwether trials, and each of the verdicts has been a seven-figure jury verdict," Kline & Specter co-founder Thomas Kline said at the outset of the litigation. "These cases are very significant cases involving injuries which are readily understandable, by women in particular, who can certainly appreciate the horrors that the mesh has caused to thousands."
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Patient Advocate Files Racketeering Charges Against FDA, Mesh Maker and Doctor Over Injuries
Feb 12, 2015 | Mesh Medical Device News Desk
By Jane Akre
A patient advocate has filed a Pro Se complaint against Johnson & Johnson accusing it of organized corruption.
In the complaint, filed in the U.S. District Court for the Southern District of Florida, the petitioner says defendants have engaged in “a fraudulent scheme in violation of the Federal Racketeer Influenced and Corrupt Organizations Act (RICO)”.
Violations include mail fraud, perjury and a worldwide effort to influence doctors to use their products accomplished through professional medical societies such as AUGS (American Urogynecologic Society) and ICS (International Continence Society).
Also named are Ethicon, a wholly owned subsidiary of J&J, Gynecare Worldwide, Dr. Willy Davila of the Cleveland Clinic, the president of the Cleveland Clinic, and the U.S. Food and Drug Administration.
Dr. Davila performed numerous surgeries on the petitioner from 2002 through 2009 to remove a bladder sling, according to the complaint. At the time he was under contract with J&J, a fact unknown to her at the time, she says. He even attended her first Truth in Medicine conference in September 2009 as a speaker. Truth in Medicine is a nonprofit organization the petitioner founded after she became aware of injuries associated with pelvic mesh after her TVT implant (Ethicon) in December of 2001.
The complaint says since the mid 1990’s, Ethicon (J&J) has hid the risks of polypropylene mesh (Prolene is the Ethicon trade name) while heralding its benefits.
The complaint states:
“Further, David Krause, Branch Chief, General Plastic Surgery Devices at the FDA’s Center for Devices and Radiological Health (CDRH), interacted with Peter Cecchini, Fellow, Regulatory Affairs, Ethicon, Inc. disclosing Keeton’s activities at the FDA in 2010. Krause alerted Cecchini to the existence of damning information in a video, “The Benefits of Light Weight Mesh” funded by Ethicon, Inc. in collaboration with one of Ethicon’s experts, Dr. B. Todd Heniford at the Carolinas Medical Center in 2007. Krause was concerned that it was being shown to Dr. Jeffrey Shuren, Director of the CDRH in a meeting in November 2010.”
The complaint, filed February 4, asks for compensatory damages in the amount of $7 million and punitive damages of $21 million.
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