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Ethicon Media Monitoring 2/22/2019
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Britain Considers Medical Implants Registry to Improve Patient Safety
Feb 21, 2019 | International Consortium of Investigative Journalists
By Simon Bowers
The British government is drawing up plans for a compulsory register of medical implants after an International Consortium of Investigative Journalists investigation exposed weaknesses in the regulation of devices placed inside millions of patients across Europe. -
Why is it Taking So Long for TVM to Be Banned in the U.S.?
Feb 21, 2019 | Periscope News Group
By Christina Morales
Transvaginal mesh (TVM) was recently described by the publication, The Independent, as, “insufficiently tested and poorly regulated plastic mesh devices… shown to erode and disintegrate, slicing through organs and vaginal walls to cause paralysis, chronic pain, sepsis, loss of sex life and even organ failure.” -
EU Regulatory Roundup: Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials
Feb 21, 2019 | Regulatory Focus
By Nick Paul Taylor
...Politicians in the UK have become increasingly critical of how medical devices are regulated following the vaginal mesh scandal and other events, with one member of Parliament calling the industry the “wild west” in a debate last year. -
ESPN, NFL Sued Over 2017 NFL Draft; Worker Says He Fell 30 Feet Building Stage On 'Rocky' Steps
Feb 21, 2019 | Forbes
By John O'Brien and Marian Johns
...Crowthers is seeking punitive damages, and a jury might comply, considering one just awarded $25 million in punitives in a $41 million pelvic mesh verdict.
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Britain Considers Medical Implants Registry to Improve Patient Safety
Feb 21, 2019 | International Consortium of Investigative Journalists
By Simon Bowers
The British government is drawing up plans for a compulsory register of medical implants after an International Consortium of Investigative Journalists investigation exposed weaknesses in the regulation of devices placed inside millions of patients across Europe.
The move follows a similar proposal from German health ministers in January. Both initiatives were prompted by ICIJ’s Implant Files investigation.
The U.K. plans were revealed during a short parliamentary debate last week when opposition politicians called on health minister Jackie Doyle-Price to respond to the Implant Files investigation by introducing a compulsory register of all implanted devices — as recommended by the Royal College of Surgeons.
“This is a matter already under consideration by the Department [of Health and Social Care], and it’s linked to our wider digitization of agenda for the NHS [National Health Service],” said Doyle-Price. “We have the technology, so we should use it in the interests of patient safety.”
Admitting that patients had been let down over many years, she added: “I think it fair to say, perhaps in the past, regulation has focused excessively on what was in the interests of businesses and [on] maintaining competition rather than [having] patient safety at its heart.”
Doyle-Price was responding to questions from members of parliament from different political parties, who raised concerns on behalf of constituents whose lives had been blighted by dangerous medical devices.
The MPs spoke during a debate on medical device regulation, called by Labour Party’s Owen Smith, a former lobbyist for drug firms Pfizer and Amgen who, since entering politics, has been a leading campaigner on behalf of women left in agony by vaginal mesh implants gone wrong.
At the peak of their popularity in 2008, mesh implants were used to treat about 14,000 women in the U.K. for urinary incontinence or organ prolapse, Smith told parliament.
The use of these implants was temporarily suspended in the U.K. in July last year at the request of a government-commissioned committee carrying out a review of the safety of mesh products. The committee is due to report its findings later this year.
Recognizing that the controversy around mesh is common to many medical devices licensed for use under European Union rules, Smith said, “The problem is best summed up, not in my words, but by those of the Royal College of Surgeons who said … in response to a very big journalistic investigation that we need to see in our country urgent and drastic regulatory reform. In particular, we need to start with the creation of a compulsory register for all new devices that go into patients in the U.K.”
Contacted by ICIJ, a spokesperson for the Department for Health confirmed that “the scope and structure of a national registry” were under consideration but added, “When and how this might be delivered is subject to significant development.”
Professor Carl Heneghan, professor of evidence-based medicine at Oxford University, said the prospect of a compulsory implant registry was a “huge step for patient safety”.
The Implant Files investigation was carried out by 58 partner news organizations in 36 countries and revealedhow many multinational manufacturers routinely used Europe as a testbed for unproven pacemakers, breast implants, heart valves, artificial hips and other devices — some of which later proved dangerous.
Responding to reporting by ICIJ and its partners, Professor Derek Alderson, president of U.K.’sRoyal College of Surgeons, said, “There have been sufficient number of incidents to underline the need for drastic regulator changes.” He said existing light regulation presented a “risk to patient safety and public confidence.”
“All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term,” he argued.
The U.K. already has registries for some types of implants, including artificial hips and knees. Efforts to set up a similar register for breast implants have had limited success.
During last week’s parliamentary debate, Owen Smith criticized EU regulations, which he said did not adequately protect patients. As well as calling for a register of implants, Smith urged ministers to consider tougher licensing requirements for new medical implants.
In response, Doyle-Price noted that the U.K. was due to leaving the EU in March, providing an opportunity to strengthen regulation without consulting other European member states.
However, she conceded many of her pro-Brexit colleagues in the Conservative Party believe that, once out of the EU, Britain should dilute or abandon many EU regulations in the stated belief it would allow businesses to innovate and grow.
Speaking to a conference of device manufacturers last year, one of the U.K.’s top regulators said he believed Brexit would, in fact, present an opportunity for the U.K. to drop some aspects of the EU’s regulations and adopt a more industry-friendly regime.
Graeme Tunbridge, group manager of device regulation at the U.K.’s Medicines and Healthcare products Regulatory Agency, said, “I think longer term we do need to think about how we develop something that looks a little bit more unique and a little bit more different and starts to espouse some of the differences and some of the positive things that the U.K. can bring to regulation … In the EU, the pendulum has swung towards strict regulation… So I think Brexit does leave us with some opportunities. And I’m very excited about the prospect of that going forward.”
https://www.icij.org/investigations/implant-files/britain-considers-medical-implants-registry-to-improve-patient-safety/
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Why is it Taking So Long for TVM to Be Banned in the U.S.?
Feb 21, 2019 | Periscope News Group
By Christina Morales
Transvaginal mesh (TVM) was recently described by the publication, The Independent, as, “insufficiently tested and poorly regulated plastic mesh devices… shown to erode and disintegrate, slicing through organs and vaginal walls to cause paralysis, chronic pain, sepsis, loss of sex life and even organ failure.” If this medical device is so dangerous, why in the world is it still on the market in the United States?
A History of Warnings Concerning TVM
After extensive research, the FDA published in July 2011 a report with the conclusion that, “The FDA has identified serious safety and effectiveness concerns over the use of surgical mesh.” So many people reported complications to the FDA, they basically had to report that it is a dangerous product!
Then, in January 2016, the FDA published the following statement: “FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury.” TVM went from a Class II to Class III device because of the high risk it posed!
Here is an important fact to consider from Dr. Tom Margolis, a prominent pelvic surgeon in the San Francisco Bay Area: Prior to 1996, synthetic material for slings was rarely used and those who used synthetics stopped due in large part to the high complication rate. In 2001, within 5 years of the synthetic polypropylene tension-free vaginal tape’s introduction (Johnson & Johnson TVT), the American Medical Association added surgical procedure code 57287 (removal or revision of sling for stress incontinence) to the (Current Procedural Terminology) CPT codebook. Then, in 2006, CPT code 57295 (removal of mesh) was added. Between 1907 and 1996, there was no need for a surgical codes to remove slings. Shortly after the TVT was introduced, a tidal wave of complications mandated that these two new Billings codes for removal of these systems be implemented. TVM is so defective that they have their own removal codes!
Why Is TVM Still Used in the US?
So with the FDA and other studies showing the risks of TVM, why is it still used in the U.S.? Consider this: Approximately 300,000 surgeries for pelvic organ prolapse (POP) are performed each year and at least one-third of all prolapse operations involve some type of mesh. Additionally, it’s estimated that 50 percent of women over the age of 40 eventually experience symptoms of urinary incontinence (SUI) or POP. With so many women struggling with these embarrassing conditions and getting surgeries to address this issue, it’s a multi-million dollar industry.
TVM was introduced to the market as the “gold standard” to quickly fix these health conditions and was a much faster and easier surgery to perform than traditional natural tissue repair. But while TVM seemed like a good option, the risks have many times outweighed the benefits. Additionally, with the FDA warnings, new medical codes needed, and tens of thousands of lawsuits involving TVM, it seems obvious that this dangerous device should be taken off of the market.
Due to the immense number of women speaking out against TVM, New Zealand and Australia have banned the use of TVM and the UK and Ireland have halted its use. It’s time for the U.S. to follow the example of these other nations and stop future TVM surgeries. It’s time to put people above profits… the health of millions of women depend on it.
https://www.periscopegroup.com/transvaginal-mesh/tvm-ban-united-states
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EU Regulatory Roundup: Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials
Feb 21, 2019 | Regulatory Focus
By Nick Paul Taylor
Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has warned that it could suspend 1,300 clinical trials in the event of a no-deal Brexit. The warning reflects the fact that the sponsors of many studies are still registered in the UK and there are stipulations in the Medicinal Products Act (AMG) about who can run trials in Germany.
The AMG prohibits the conduct of clinical trials in Germany by organizations based outside the EU or another country subject to the agreement on the European Economic Area. If the UK leaves the EU without a deal next month, sponsors based in the UK will no longer meet those criteria. Under AMG, BfArM will then be legally obligated to order the suspension of clinical trials sponsored by the UK-based organizations.
A lot of clinical trials may suffer this fate. Last month, BfArM’s review of a database of studies found around 1,300 clinical trials sponsored by organizations registered in the UK. If these organizations are still registered in the UK at the time of a no-deal Brexit, BfArM will stop their studies and prohibit the subsequent recommencement of the programs.
BfArM wants to avoid that outcome, but is concerned that time is running out for sponsors to make the necessary changes. It takes BfArM 20 to 35 days to process changes to the location of a clinical trial sponsor. At the time of writing, there are 36 days until Brexit and little evidence that the UK can resolve the political logjam that is preventing it from signing off on a deal that would save it from a hard split from the EU.
As such, BfArM wants sponsors to contact it immediately with their amendments. Sponsors that fail to do so by late February will receive messages from BfArM asking them to comment on their situations.
BfArM has asked sponsors not to submit the location change requests as part of submissions that feature other amendments to ensure the filings are processed as quickly as possible.
If a filing only covers a change in sponsor location, BfArM will allow applicants to amend multiple clinical trials in a single submission without filling in a substantial amendment notification form. German officials want applicants that take advantage of this option to include a table listing the BfArM submission number and the EudraCT number, as well as a cover letter with the reference line of "Brexit-related change in sponsor/legal representative.”
This bulk-amendment option is not available to companies that need to change the importer or manufacturer responsible for final batch release. BfArM requires companies to use individual notifications to request these changes, as they necessitate the review of the manufacturing chain.
BfArM Notice
EMA’s PRAC Calls for Suspension of Fenspiride Medicines Amid Heart Rhythm Fears
The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended suspending fenspiride medicines. PRAC called for the EU-wide suspension of the cough medicines to protect patients while it reviews evidence of their effect on heart rhythm.
Fenspiride medicines manufactured by companies including Servier are approved for use in seven EU member states under national authorization procedures. The drugs are used to treat coughs caused by lung diseases but have been dogged by reports linking them to heart rhythm problems. While the number of case studies documenting the link is limited, France, one of the countries in which the drugs are sold, was concerned enough to request an EU-level review of the evidence.
The European Medicines Agency’s (EMA) PRAC has initiated the review and taken a precautionary action to protect patients in the meantime. As the mooted side effects of fenspiride are serious and the drug is only used for symptomatic treatment, PRAC wants healthcare professionals to stop giving it to to patients while the review is ongoing.
PRAC’s caution is underpinned by limited case reports on the effect of fenspiride on cardiac rhythm and nonclinical evidence that the drug increases QT intervals. The action came days after the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) suspended the marketing authorization of a fenspiride product, Pneumorel, sold by Servier in France.
To aid its review, PRAC is asking people to provide it with information on the link between fenspiride and QT prolongation and cardiac arrhythmia. PRAC is accepting feedback until 11 March.
EMA Notice
UK Politicians Float Prospect of Strengthening Medical Device Rules After Brexit
A government health minister has said the UK could strengthen its regulation of medical devices after leaving the EU. The minister called the incoming EU regulations a “baseline” that the UK could build on if it gains the ability to set its own rules after Brexit.
Politicians in the UK have become increasingly critical of how medical devices are regulated following the vaginal mesh scandal and other events, with one member of Parliament calling the industry the “wild west” in a debate last year.
The UK’s intention to adopt incoming EU device rules despite Brexit means regulation of the market will change in the coming years. However, Jackie Doyle-Price, a government health minister, sees the EU standards as just “a strong and improved baseline,” not necessarily the complete, final set of rules for the post-Brexit UK.
“As we depart from the European Union, we have an opportunity to alter our regulatory system. I am not sure that all my Conservative colleagues, in pushing Brexit, see it as an opportunity to tighten regulation, but that opportunity remains,” Doyle-Price said in a debate in the House of Commons.
Doyle-Price’s comment about her Conservative colleagues refers to the fact that some of the people pushing for Brexit want to leave the EU to enable the UK to adopt lighter regulations. The medical device proposal runs counter to those intentions, but could win favor from other politicians who have been highly critical of how the industry is regulated.
The future of medical device regulation in the UK will be shaped by the Cumberlege review, which is due to report its findings later this year, but it is already clear any calls for tighter regulation will find a receptive audience in parts of Parliament. Doyle-Price, for example, said regulations have perhaps “focused excessively on what is in the commercial interests of businesses.” The health minister would rather regulations focused on patient safety.
Debate Transcript
France Expands Use of Clinical Trial Fast Tracks to Slash Approval Times
France’s ANSM has opened up its clinical trial fast tracks to developers of cell and gene therapies. The processes will cut the time it takes for developers of advanced therapy medicinal products (ATMPs) to get green lights to start studies.
ANSM introduced its clinical trial fast tracks in October and outlined plans to expand them to cover ATMPs shortly thereafter. Now, ANSM has followed through on its proposal.
Developers of unapproved ATMPs can use one fast track to cut approval times from 180 days to 110 days. A second fast track for further development of approved ATMPs will process applications within 60 days.
The review times are longer than for trials of other types of drugs that board the fast track, which can be approved within 25 days, but represent improvements over the historical ATMP timelines.https://www.raps.org/news-and-articles/news-articles/2019/2/eu-regulatory-roundup-germany-warns-brexit-could
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ESPN, NFL Sued Over 2017 NFL Draft; Worker Says He Fell 30 Feet Building Stage On 'Rocky' Steps
Feb 21, 2019 | Forbes
By John O'Brien and Marian Johns
ESPN and the National Football League are facing a lawsuit that alleges safety violations during the construction of a temporary stage built for the first NFL draft ever held entirely outdoors.
A New Jersey man who allegedly suffered head trauma, broken ribs and a ruptured spleen after a 30-foot fall while working on the temporary amphitheater for the 2017 NFL Draft in Philadelphia has filed a lawsuit against the NFL, ESPN and the event production company they hired.
In the lawsuit filed in the Philadelphia County Court of Common Pleas in January, Brian Crowthers, who was employed by Tri-State Staging as a stagehand, claims the fall he suffered while building the temporary amphitheater in front of the Philadelphia Museum of Art was caused by Mountain Productions Services' "improper fall protection and prevention" measures.
The amphitheater was built in front of the famed "Rocky" steps at the Philadelphia Museum of Art.
The lawsuit alleges negligence on the parts of the NFL and ESPN, saying they failed to hire a competent outfit to build the stage.
"Prior to the date of the accident, Defendant, ESPN, knew or should have known of the hazardous and unsafe work practices that existed," the lawsuit says. "Defendant, ESPN, breached the duties that it owed to Plaintiff."
Lawyers for the NFL transferred the case to federal court recently, but Crowthers has asked that it be sent back to Philadelphia state court.
Should the case be moved back to Philadelphia state court, ESPN and the NFL will be litigating in a jurisdiction known for high-dollar verdicts. Crowthers is seeking punitive damages, and a jury might comply, considering one just awarded $25 million in punitives in a $41 million pelvic mesh verdict.
The court has long been labeled a "Judicial Hellhole" by a national legal reform group that publishes an annual report of jurisdictions it says are unfair to corporate defendants. On the day the 2018 report came out, a Philadelphia jury reached a $28 million verdict in a lawsuit over the blood-thinner Xarelto.
A judge later struck down the verdict.
Crowthers, a member of the International Alliance of Theatrical Stage Employees Union, Local No. 8, alleges that fall safety precautions for the project were not implemented or largely ignored in an effort to make sure that construction of the amphitheater was complete in time for ESPN's live broadcasts of the NFL Draft.
According to the lawsuit, Crowthers fell about 30 feet onto the stage below and suffered major injuries including loss of consciousness, closed head trauma, memory and concentration problems, several fractures, a ruptured spleen and lung hemorrhage.
Following the April 22, 2017, accident, the lawsuit states the Occupational Safety and Health Administration (OSHA) cited Mountain Productions Services for several violations of scaffold safety and fall protection. Mountain Productions has been cited on previous occasions by OSHA for fall protection and injury recording and reporting violations, the lawsuit states.
According to the lawsuit, Crowthers is seeking sums in excess of $50,000 from each defendant as well as punitive damages due to alleged negligence that led to his injuries, some of which are permanent, the lawsuit states.
The NFL removed the case to federal court, citing diversity jurisdiction.
On Feb. 15, Crowthers asked that the case be sent back to Philadelphia state court. His lawyer is Kevin Durkan of Fritz & Bianculli in Philadelphia.
"Defendant, the NFL’s, Notice of Removal did not indicate that Defendant, ESPN, consented which makes the removal procedurally defective pursuant to the 'Rule of Unanimity,'" the motion to remand says.
"Moreover, the 'Forum Defendant Rule' makes removal improper because Defendants, Mountain Productions, Inc. and Mountain Production Services, Inc., are citizens of Pennsylvania, the state where the action was brought. "
https://www.forbes.com/sites/legalnewsline/2019/02/21/espn-nfl-sued-over-2017-nfl-draft-worker-says-he-fell-30-feet-building-stage-on-rocky-steps/#631b51c6f2be
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