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Ethicon Media Monitoring 3/27/2019
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'Imperfect' Treatment Result Not J&J Mesh's Fault, Jury Told
Mar 26, 2019 | Law 360
By Matt Stairs
The failure of a Johnson & Johnson unit’s pelvic mesh implant to cure a Philadelphia-area woman’s incontinence did not mean the device was to blame for other complications she experienced, a Pennsylvania jury heard as a trial over the product opened Tuesday. -
The FDA has years of hidden medical device incident reports and researchers want them released
Mar 26, 2019 | Kaiser Health News (In The Tampa Bay Times)
By Christina Jewett
Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices. -
A safe alternative to the pill has finally been found – thank goodness men will be the ones taking it
Mar 27, 2019 | The Independent
By Katie Bishop
More than 60 years after its release, the contraceptive pill remains the most popular form of birth control other than condoms in the UK.
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'Imperfect' Treatment Result Not J&J Mesh's Fault, Jury Told
Mar 26, 2019 | Law 360
By Matt Stairs
The failure of a Johnson & Johnson unit’s pelvic mesh implant to cure a Philadelphia-area woman’s incontinence did not mean the device was to blame for other complications she experienced, a Pennsylvania jury heard as a trial over the product opened Tuesday.
Andrea La’Verne Edney, an attorney with Butler Snow LLP representing J&J subsidiary Ethicon Inc., told jurors in Philadelphia that, even though the company’s mesh implant had failed to entirely cure Malgorzata Krolikowski of stress urinary incontinence that she complained to her doctor of 10 years ago, there were other reasons behind the pain during sex that she has experienced.
Edney instead pointed to medical complications, including uterine fibroids and the abnormal position of her uterus, as the likely causes of Krolikowski’s pain.
“An imperfect result does not equate to a defect,” Edney said. “Just because the device didn’t work and cure 100 percent doesn’t mean it was a defective device.”
Krolikowski is the ninth woman to bring claims against Ethicon over allegedly faulty mesh products before a jury in Philadelphia.
Juries in six of the previous cases have returned a total of more than $145 million in damages against Ethicon.
Unlike prior cases that have gone to trial in Philadelphia, however, Krolikowski has not experienced some of the most severe complications as some women, including when the mesh saws through tissue in the pelvis and becomes exposed in the vagina.
Edney’s opening arguments came the morning after Elia Robertson of Kline & Specter PC, representing Krolikowski, delivered her own opening in the case.
She said Krolikowski, 53, received a TVT-Secur mesh implant in November 2008 after complaining to her doctor she was leaking urine when she coughed or sneezed, a condition known as stress urinary incontinence.
But even after Krolikowski received the implant, Robertson said the incontinence persisted and has worsened over the years to the point where Krolikowski now has to wear pads that she changes multiple times per day.
In addition, Robertson said Krolikowski began experiencing pain and urine leakage during sex, which has made it all but impossible for her to pursue any romantic relationships following the death of her husband in 2001.
But Edney told jurors on Tuesday that Krolikowski’s pain during sex was likely caused by a retroflexed uterus, a condition in which the organ tilts backward toward the rectum.
Edney said Krolikowski lived with both the continued incontinence and the painful sex until she saw an advertisement from an attorney in 2013 warning about potential complications from mesh implants.
While Krolikowski subsequently consulted with four separate doctors before contacting an attorney, Edney said none of them concluded the mesh had caused any of the woman’s complications.
“We think that these treating physicians are the most important doctors you’re going to hear from, because they don’t have a dog in this hunt,” Edney told the jurors. “All of them agree that her problems were not a result of her mesh.”
Krolikowski is represented by Elia Robertson and Colin Burke of Kline & Specter PC.
Ethicon is represented by Julie Callsen and Jennifer Steinmetz of Tucker Ellis LLP, Sean Gallagher of Barlit Beck LLP, Andrea La’Verne Edney of Butler Snow LLP and Kimberly Gustafson Bueno of Scott Douglas & McConnico LLP.
The case is Malgorzata Krolikowski v. Ethicon Inc., case number 140102704, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
https://www.law360.com/articles/1142874/-imperfect-treatment-result-not-j-j-mesh-s-fault-jury-told
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The FDA has years of hidden medical device incident reports and researchers want them released
Mar 26, 2019 | Kaiser Health News (In The Tampa Bay Times)
By Christina Jewett
Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices.
A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices.
One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public.
While the FDA pledged quickly to review the safety of one such device — the surgical stapler — researchers say the agency needs to open the data on scores of other devices, which have included mechanical ventilators and pacemaker electrodes.
“The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety.
During a recent interview, FDA Commissioner Scott Gottlieb said that he had no immediate plans to release the device-safety reports, but that the matter is under review.
“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said. “I think these databases by and large should be searchable to the public.”
An agency spokeswoman said the FDA revoked most of the “alternative summary reporting” exemptions in mid-2017 and asked device makers who kept their exemptions to file a public report summarizing what information they’d send in a spreadsheet directly to the agency. That new approach doesn’t affect the hidden reports dating to 2000.
Agency data show that more than 2 million alternative summary reports have been filed since the start of 2014.
In a February guidance statement for device makers, the FDA said summary reporting can streamline reporting for the industry and simplify the agency’s review process “while maintaining or enhancing the quality, utility, and clarity of MDRs [device reports] through a more holistic view of reportable event trends.”
Makers of about 100 devices filed reports that way over the years, and the FDA has not disclosed the reports’ content beyond responding to KHN’s questions about specific devices. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA.
Asked for more detail on staplers and other devices with exemptions, the agency referred to the Freedom of Information Act process, which can take nearly two years.
That’s not soon enough for organizations like the ECRI Institute. Chief policy officer Ronni Solomon said the nonprofit does device-safety analyses for the government and evidence-based reports for hospitals and performs device-related accident investigations.
Having thorough data on device-related harm is key on all fronts, she said, noting that the organization is exploring ways to get access to more FDA data.
Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency’s public device-safety database, called MAUDE, in his research, said paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation.
He noted that an important safety tenet in hospitals is: the more eyes on the patient the better. He said there’s a clear parallel to the work researchers do with agency data to identify device-safety lapses.
“The FDA isn’t so capable that they can afford to hide data,” he said.
Hani Elias, chief executive of Lumere, said his consulting company uses the open FDA device data to advise health systems across the nation on device safety for purchasing decisions. He co-founded the company after seeing hospitals make device-buying decisions based on the effectiveness of the sales force rather than on quality and safety.
“There’s a lot of benefit in opening up this data,” Elias said.
Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.
“You don’t want to be the people known for the products known for hurting people,” said Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine.
In 2018, the FDA approved a new pathway for makers of 5,600 device types to file malfunction reports in summary format. That program relieves the device makers of seeking a special exemption. It requires one public report detailing a novel or unique type of malfunction. Information about subsequent, similar malfunctions can be sent straight to the FDA in a spreadsheet.
The agency has also quietly granted device makers other summary-reporting exemptions for injury information gleaned from litigation and from device-specific registries used for research. Device makers filing such reports also have to file a public report summarizing the data that is sent directly to the FDA and isn’t readily available to the public.
Agency records show that some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.
Prior to the KHN investigation, Zuckerman said she was aware the FDA granted reporting exemptions but the sheer number of reports “takes my breath away.”
In the interview, Gottlieb said he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.” Gottlieb has announced his resignation; his last day will be April 5.
Card also said the KHN report was a surprise, but now that it’s out, it’s time for the FDA to open the records to help doctors and patients make the safest choices. “There are a lot of people out there who are trying to make reasonable decisions on data that isn’t what it was purported to be,” he said.
https://www.tampabay.com/health/the-fda-has-years-of-hidden-medical-device-incident-reports-and-researchers-want-them-released-20190326/
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Mar 27, 2019 | The Independent
By Katie Bishop
More than 60 years after its release, the contraceptive pill remains the most popular form of birth control other than condoms in the UK. And it’s easy to see why: the ability to pop a pill that puts women in control of their reproductive destiny is an alluring option – one that has transformed our sexual freedom and given us a more equal footing in the workplace thanks to the ability to have children on our own terms.
The pill may have founded a social revolution, but in many respects little has changed since it was first prescribed. There is still no viable alternative that allows men to take equal responsibility for reproduction – and it still carries serious associated health risks.
Like many young women, I once saw the pill as the default. I was given a prescription at the age of 18 with little more than a cursory run-through of the risks and a quick blood pressure check. I hopped on and off it throughout my early twenties, as my hormones and lifestyle demanded. But, at the age of 24, a mere two weeks after starting a prescription for a new pill, I was diagnosed with a major blood clot coagulating close to my heart.
My diagnosis was horribly unlucky; research suggests that only around 12 in 10,000 women taking the contraceptive pill will experience a similar side effect. However, with around 3 million women in the UK alone being prescribed the pill, these odds still seem frighteningly high. Even more concerning is the stark evidence that the newer so-called “third generation” of the drug is by far the most dangerous. This includes the pill that I began taking briefly before developing a blood clot, still a popular prescribing option for many GPs.
So today’s news that a male contraceptive equivalent has finally been deemed safe will be received well by many women disillusioned by the lack of reproductive options. It’s a signal that healthcare is finally recognising that the battle to find the right birth control is one that women fight throughout their lives, and that they shouldn’t have to do so alone. Responsible sex is everyone’s responsibility.
It could be another decade before the male pill is on the market, but in a medical landscape that is often disproportionately perilous for women, any kind of progress is encouraging.
Of course there are notable instances where men lose out in the medical lottery, such as in the case of suicide prevention and prostate cancer funding. But women still face a disproportionate uphill battle when it comes to support for our health. We are still widely mistrusted by doctors to report our symptoms, with female conditions such as autoimmune diseases and endometriosis often taking years to be identified in patients. We are still the more likely victims of misdiagnosis of serious conditions such as heart attacks, with mistakes in diagnoses up to 50 per cent higher for women. We are still forced through the indignities of our concerns being minimised, as exposed by the vaginal mesh scandal which left thousands of women in debilitating pain and sexually incapacitated for years before their complaints were listened to.
The road to a readily available male contraceptive pill will not be without its complications. As well as testing the long-term effects of the drug, researchers will have to contend with early evidence that only half of men recently surveyed would be willing to try out the method – and many women will be reticent to trust their partner with a responsibility that disproportionately impacts their bodies and their future.
But in spite of these challenges, today’s news is a sign of something more significant: it is a sign that reproductive medicine is finally being taken seriously.
https://www.independent.co.uk/voices/sex-contraception-pill-male-pregnancy-blood-clot-sexism-a8840551.html
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