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Ethicon 14/8
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J&J Wants Punitives Axed In Philly Pelvic Mesh Cases
Aug 13, 2015 | Law360
By Matt Fair
A Johnson & Johnson unit asked a Pennsylvania state judge on Monday to apply a provision of a New Jersey law forbidding punitive damage awards in cases stemming from faulty medical devices to nearly 200 cases pending as part of a mass tort program over alleged pelvic mesh product injuries. -
A women’s operation has risks that are like a “ticking time bomb” says city councillor
Aug 13, 2015 | Cambs Times
By Kath Sansom
John Whitby, Peterborough city councillor and Kath’s former high boarding dive coach, said: “I have spoken to members of the health scrutiny committee of Peterborough City Council about the Sling the Mesh campaign. -
Without more monitoring, medical devices will keep harming patients
Aug 13, 2015 | Kentucky.com
By Dr. Kevin Kavanagh
High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
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J&J Wants Punitives Axed In Philly Pelvic Mesh Cases
Aug 13, 2015 | Law360
By Matt Fair
A Johnson & Johnson unit asked a Pennsylvania state judge on Monday to apply a provision of a New Jersey law forbidding punitive damage awards in cases stemming from faulty medical devices to nearly 200 cases pending as part of a mass tort program over alleged pelvic mesh product injuries.
Ethicon Inc. said its corporate citizenship in the Garden State meant New Jersey law, including its ban on punitive damages in certain pharmaceutical and medical device liability cases, should govern in the pelvic mesh mass tort program pending in Philadelphia County.
“Because there is a conflict between the laws of New Jersey and Pennsylvania, the court must determine which state has the greater governmental interest in the application of its law. In this litigation, New Jersey has the greater interest,” the brief said. “Here, both Ethicon Inc. and Johnson & Johnson are incorporated in New Jersey and maintain their principal places of business in New Jersey. More important, all acts and omissions that Plaintiffs say support their claim for punitive damages occurred in the state of New Jersey.”
The motion seeks to apply the New Jersey Product Liability Act, a 2008 law that bars punitive damages from being awarded against pharmaceutical companies and medical device manufactures for claims over products that were subject to oversight by the Food and Drug Administration.
Pennsylvania, the company said in its brief, has no such cap on the books.
With a conflict between the two states, Ethicon said the court was required to analyze whether Pennsylvania or New Jersey had a great interest in the litigation.
While plaintiffs in the mass tort program have alleged that Ethicon failed to conduct adequate safety testing of the mesh and knew that the products could shrink, disintegrate or degrade after being implanted in patients, the company argued in its brief that all of this claimed activity took place at its offices in New Jersey.
“The key corporate decisions relating to pelvic mesh, including decisions about design, manufacturing, marketing, selling, testing and labeling (which serve as the crux of plaintiffs’ allegations for punitive damages) were made from Ethicon’s headquarters in New Jersey,” the company’s brief said. “No decisions or activities related to the pelvic mesh products at issue in this litigation occurred in Pennsylvania.”
This is not the first time that J&J has sought to dodge punitive damages in a mass tort program pending in Philadelphia County court.
Judge Arnold New, the supervising judge of Philadelphia County’s Complex Litigation Center, issued a ruling in May 2014 agreeing that the NJPLA should apply to some 500 cases that were pending as part of a mass tort program over the J&J antipsychotic medication Risperdal.
J&J argued similarly in that case that alleged decision that could lead to punitive damages had occurred at a subsidiary’s facilities in New Jersey.
Judge New is also tasked with considered Ethicon’s motion to dodge punitives in the pelvic mesh program.
An attorney for the plaintiffs did not immediately return a message seeking comment on Thursday.
J&J is represented by Kenneth Murphy and Melissa Graff of Drinker Biddle & Reath LLP.
The plaintiffs are represented by Lee Balefsky and Michelle Tiger of Kline & Specter PC, and Clayton Clark of Clark Love & Hutson.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania. -
A women’s operation has risks that are like a “ticking time bomb” says city councillor
Aug 13, 2015 | Cambs Times
By Kath Sansom
John Whitby, Peterborough city councillor and Kath’s former high boarding dive coach, said: “I have spoken to members of the health scrutiny committee of Peterborough City Council about the Sling the Mesh campaign.
“I spoke to them not only on the health impact on women but also the potential very costly liability that Peterborough and Stamford NHS Trust could be putting itself under if this operation continues locally.
“It is a ticking time bomb waiting to explode,” he said.
“As the former dive coach for Kath I know she was a very active and sporty person until the operation and has suffered immensely as a result of it. I’m shocked by the whole story.”Sling The Mesh campaign logo
The campaign is raising awareness about the life changing risks of the TVT and TVTO mesh sling operation which is perofmred to cure incotnience in women suffered after natural childbirth.
It is also calling for the operation to be suspended in England and Wales as it was in Scotland in June 2014.
Campaigners say the risks of the operation are not properly explained and when it goes wrong can leave women in life long chronic pain.
In a meeting at the House of Commons NE Cambs MP Steve Barclay met with the NHS director of episodes of acute care, Professor Keith Willett, and plans to meet again once an interim report into the safety of mesh is released in September.
Cllr Whitby said: “I discovered that a top US surgeon advised the Scottish Parliament that operations should be stopped.
“It’s a growing issue and I suggested that councillors look very closely at the campaign.
“Look at how devastating the PIP implants were. The health risks with this mesh operation are more acute so therefore the liability is much higher.
“From what I can see in this situation the medical profession seem to be closing their ears and they are not listening to the terrible stories of suffering from women and try to blame it on other causes when it goes wrong.
The MHRA said: “As with all medical devices we will continue to monitor their safety and performance and we encourage women to report any adverse incidents to us via our Yellow Card scheme at yellowcard.mhra.gov.uk. Any women who are concerned should speak to their doctor or surgeon.”
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Without more monitoring, medical devices will keep harming patients
Aug 13, 2015 | Kentucky.com
By Dr. Kevin Kavanagh
A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?
I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
What are patients to do?
First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
■ What is the implant's failure rate?
■ How does the tissue react around the implant?
■ If the implant fails can it be taken out?
I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (https://www.medicare.gov/hospitalcompare/).
If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(https://projects.propublica.org/surgeons/).
Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
Almost everyone has a stake in health-care policy regarding implants.
We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
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