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Ethicon Media Monitoring 3/19/2019
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Mesh Victims Slam J&J's 'Judge-Shopping' In Pa. Recusal Bid
Mar 18, 2019 | Law 360
By Matt Fair
A Johnson & Johnson unit was accused in court filings on Monday of “judge-shopping” as the company seeks to remove a member of the Philadelphia County bench whose mother is pursuing her own claims against the company from trying cases over injuries caused by allegedly defective pelvic mesh implants. -
FDA says more needs to be done to assess materials in devices
Mar 18, 2019 | Medical Plastics News
The FDA highlighted that while the majority of patients do not suffer from adverse effects due to medical device implants, there is a “growing body of evidence” that suggests some patients have biological responses to certain types of materials in implants.
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Mesh Victims Slam J&J's 'Judge-Shopping' In Pa. Recusal Bid
Mar 18, 2019 | Law 360
By Matt Fair
A Johnson & Johnson unit was accused in court filings on Monday of “judge-shopping” as the company seeks to remove a member of the Philadelphia County bench whose mother is pursuing her own claims against the company from trying cases over injuries caused by allegedly defective pelvic mesh implants.
While Judge Kenneth Powell has denied motions seeking his recusal in three separate cases, including one that opened before a jury last week, Ethicon Inc. asked the supervising judge in Philadelphia’s mesh litigation program earlier this month to consider its arguments.
But attorneys for women who received the mesh implants told Judge Arnold New in a filing on Monday that Ethicon’s continued efforts to remove Judge Powell was nothing more than an attempt to get its cases into a courtroom it hoped would be more friendly.
“Ethicon has filed these … motions in a blatant effort at judge-shopping and attempting to receive special treatment,” the women said.
Ethicon has argued that a case Judge Powell’s mother is pursuing against another J&J subsidiary over the anticoagulant drug Xarelto has created, at the very least, the appearance of a conflict of interest that requires his recusal in any mesh cases.
The judge has presided over four mesh trials since the beginning of 2016, including one that is underway after opening arguments last week.
It was only after the first trial that Ethicon says it learned that the judge’s mother had filed suit against J&J subsidiary Janssen Pharmaceuticals Inc. over her use of Xarelto.
The company argued that Judge Powell’s failure to disclose his mother’s lawsuit constituted an “appearance of impropriety.”
According to court records, however, Judge Powell has said that he didn’t realize his mother was targeting Janssen in her lawsuit, and he has maintained that, in any event, he believed the case did not affect his ability to preside over mesh proceedings in a fair and impartial way.
After Judge Powell rejected its recusal motions in two prior cases, Ethicon filed a motion in the latest case asking an outside judge to consider its arguments.
That motion was rejected by Judge Edward Wright earlier this month.
The company also filed a petition asking the state’s Supreme Court to exercise extraordinary jurisdiction to remove Judge Powell from mesh cases, including the one underway.
But the justices denied that petition last week.
The only motion remaining is the one pending before Judge New in his role as the supervising judge for the mesh litigation in Philadelphia.
Shanin Specter, an attorney with Kline & Specter PC representing the women, told Law360 on Monday that the recusal bids had already been denied by nine other judges.
“This motion has already been substantively denied by two judges of the Court of Common Pleas and rejected by the Supreme Court of Pennsylvania,” Specter said. “In another example of judge-shopping by this defendant, Johnson & Johnson now seeks a different ruling from a 10th judge. It should be denied again.”
Ethicon defended itself in a statement on Monday afternoon.
“Ethicon is exercising its legal rights in a manner that is lawful, appropriate and justified,” spokeswoman Mindy Tinsley said.
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.
--Editing by Haylee Pearl.
https://www.law360.com/articles/1140178/mesh-victims-slam-j-j-s-judge-shopping-in-pa-recusal-bid?copied=1
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FDA says more needs to be done to assess materials in devices
Mar 18, 2019 | Medical Plastics News
The FDA highlighted that while the majority of patients do not suffer from adverse effects due to medical device implants, there is a “growing body of evidence” that suggests some patients have biological responses to certain types of materials in implants.
The news comes following recent medical device scandals in which patients have suffered from debilitating effects. In particular, devices including breast implants and mesh designed to treat stress urinary incontinence have been linked to certain cancers and autoimmune diseases respectively.
As well as outlining the steps that are taken to ensure medical devices on the market are as safe as possible, the FDA acknowledged that more needs to be done.
In a statement highlighting the next steps, FDA commissioner Scott Gottlieb and director of the Center for Devices and Radiological Health Jeff Shuren said: “Modernising the regulatory framework pertaining to the FDA’s review of medical device materials requires a multi-step approach. We’ll gather input from patients, device manufacturers, researchers and physicians to learn more about their concerns and ideas for how the FDA should proceed. Any new initiatives we implement must be rooted in putting patient safety first and based on sound science.
“More closely evaluating the potential for certain materials to cause immune or inflammatory reactions in a small number of patients may improve our understanding of materials, help uncover ways to identify patients predisposed to these reactions and improve the overall safety and performance of medical devices.”
Some of the examples highlighted in the FDA’s evaluation with government and academia suggests patients have suffered from fatigue, rash, joint and muscle pain or weakness – suggesting they could share common underlying or immune inflammatory pathways and mimic more well-established inflammatory conditions.
The statement continued: “In the small subsets of patients who have reported these symptoms, the symptoms may not develop for several years following implantation. As a result, they may not be detected even in larger and longer clinical studies. To date, these symptoms have not been reported with most materials used in medical devices, including most metals. Moreover, when reported, they have tended to be limited to small subsets of patients.
“As an example, some patients, mostly with a history of pre-existing allergies, may develop allergic skin lesions with certain device use. This risk is usually identified by patch testing for potential device material-related allergens. However, not all device-related reactions are allergic in nature. Therefore, the utility of skin patch testing is limited.
“Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer materials. Development of new tests to identify at-risk patients would help ensure they do not receive implantable devices that contain the material to which they are sensitive, therefore further enhancing patient safety and advance a precision medicine approach to the selection of device interventions.”
https://www.medicalplasticsnews.com/mpn-north-america/fda-says-more-needs-to-be-done-to-assess-materials-in-device/
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