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Ethicon Media Monitoring 4/30/2019
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Endo Not Liable In Pa. For Defective Mesh Made By Subsidiary
Apr 29, 2019 | Law 360
By Matthew Santoni
Endo Pharmaceuticals Inc. can't be held liable for a woman's defective pelvic mesh implant just because it bought out the mesh's manufacturer, a Pennsylvania federal judge ruled Monday. -
A revolution in the making for developing and testing medical devices
Apr 29, 2019 | Plastics News
By Norbert Sparrow
Computational medicine is a relatively new technique that uses computer models and advanced software to determine how diseases develop and how best to treat them. -
Why medical devices need their own law
Apr 30, 2019 | Financial Express
By Rajiv Nath
Thirty years have gone by since the 1st medical device was regulated as a drug but a comprehensive regulatory framework still remains elusive. India imports 70-90% of its medical devices of which the vast majority are unregulated for quality and safety. -
The Sunday Post’s Marion Scott wins Campaign of the Year award for mesh scandal coverage
Apr 26, 2019 | The Sunday Post
Marion was honoured for her efforts over many years in reporting the stories of women who have suffered as a result of mesh implants and campaigned against their use.
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Endo Not Liable In Pa. For Defective Mesh Made By Subsidiary
Apr 29, 2019 | Law 360
By Matthew Santoni
Endo Pharmaceuticals Inc. can't be held liable for a woman's defective pelvic mesh implant just because it bought out the mesh's manufacturer, a Pennsylvania federal judge ruled Monday.
U.S. District Judge Mark A. Kearney tossed claims brought in February by an Oregon woman against Endo and Minnesota-based American Medical Systems Inc., ruling that even though Endo purchased American Medical, Endo didn't run the company's day-to-day operations.
"We cannot hold Endo liable merely because it purchased American Medical and now holds American Medical as a wholly-owned subsidiary. The parent-subsidiary relationship is insufficient to hold Endo liable for the acts of its subsidiary," the judge wrote. "We cannot apply successor liability for a more fundamental reason as well: The original entity — American Medical — still exists."
Judge Kearney granted Endo's motion to dismiss all claims against it, along with American Medical's motion to dismiss claims of strict liability and failure to warn patients about the potential failure of its product. The other claims against American Medical, including negligence, fraud, negligent misrepresentation, breach of express warranty and infliction of emotional distress, were not addressed in the motions.
Though plaintiffs David and Darla Buck argued that Endo purchased all of American Medical's liabilities in 2011 — including its product liabilities, such as the lawsuit over an allegedly defective pelvic mesh Darla Buck received in 2014 — Judge Kearney said the deal didn't explicitly show Endo assumed those liabilities onto itself.
"Endo only purchased American Medical's liabilities in the sense it became the owner of American Medical," the opinion says. "The corporate form shields Endo from American Medical's liabilities ... Nowhere has Mr. and Mrs. Buck alleged Endo expressly assumed American Medical's liabilities."
Since American Medical still exists — and is named as the other defendant in the case — it still handled the manufacture of the mesh sling Darla Buck received, and the court could not hold Endo liable as a successor, the opinion said.
Even though the Bucks are Oregon residents, American Medical is a Minnesota company, and Darla Buck's mesh was implanted by a doctor in California, the Bucks had brought their case in Pennsylvania because Endo's principal place of business in that state, and all the parties had agreed that Pennsylvania law applied, Judge Kearney said.
Yet Pennsylvania precedent appeared to bar the Bucks' strict liability and failure to warn claims against American Medical, he said in dismissing those claims.
"While the Pennsylvania Supreme Court has not yet ruled on the issue, numerous courts in our Circuit applying Pennsylvania law hold a plaintiff cannot bring strict liability design defect or failure to warn claims for a defective medical device," the opinion says. The state's highest court had barred strict liability claims for prescription drugs that have "known but apparently reasonable risk," and the Superior Court of Pennsylvania ruled in Creazzo v. Medtronic that there was no reason why the same logic couldn't be applied to medical devices.
An attorney for the Bucks declined to comment. Attorneys for Endo and American Medical did not immediately respond to requests for comment Monday.
The Bucks are represented by Jonathan Goodall and Lee B. Balefskyof Kline & Specter PC.
Endo and American Medical are represented by Barbara R. Binis, Michael T. Scott and Rachel Beth Weil of Reed Smith LLP.
The case is Buck et al. v. Endo Pharmaceuticals et al., case number 2:19-cv-00837, in the U.S. District Court for the Eastern District of Philadelphia.
https://www.law360.com/articles/1154555/endo-not-liable-in-pa-for-defective-mesh-made-by-subsidiary
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A revolution in the making for developing and testing medical devices
Apr 29, 2019 | Plastics News
By Norbert Sparrow
Computational medicine is a relatively new technique that uses computer models and advanced software to determine how diseases develop and how best to treat them. Applying mathematics, computer science and engineering to biology brings a “whole new perspective to medical diagnosis and treatment,” explained Raimond Winslow, Director of Johns Hopkins University's Institute for Computational Medicine in an article in ScienceDaily back in November 2012. “Engineers traditionally construct models of the systems they are designing. In our case, we're building computational models of what we are trying to study, which is disease." Now, a professor at the University of Leeds has been awarded nearly £2.7 million ($3.3 million) by the UK’s Royal Academy of Engineering to use computational medicine techniques to investigate an alternative and complementary method of discovering, developing and testing new medical devices.
According to Alejandro Frangi, Diamond Jubilee Chair in Computational Medicine at the University of Leeds, the system currently used to develop and test medical devices is geared toward incremental changes to existing technology or the development of new technologies that work for most people but may be ineffective or even harmful to others. By the time side effects emerge, often late in the development lifecycle, millions of pounds may already have been spent, he said in an article posted on the university website.
Medical devices may even be on the market for many years before they are pulled following repeated patient complaints. A recent example is surgical mesh used in transvaginal repair of pelvic organ prolapse (POP). FDA imposed a ban on such surgical mesh devices marketed by Boston Scientific and Coloplast on April 16, 2019. Synthetic mesh devices had been used since the 1990s, and FDA acknowledged in 2016 that it had seen “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.” The most commonly reported problems included severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues. It took another three years before some of those devices were prohibited. The use of computational medicine may prevent products with the potential to harm patients from ever reaching the market.
Frangi and his team are developing methods and systems for what he calls “in-silico” trials, where computer analysis is used to engineer medical devices from their conception, to ensure the optimum clinical outcomes are achieved by designing for various patient groups, and with minimal harm to animals and humans compared with the current status quo.
“These in-silico trials are based on populations of virtual patients representing the natural variation, for instance, in people’s anatomical, physiological and biological make-up found in real-life or target populations,” said Frangi in the news release. The “virtual patient chimeras” are constructed based on patient and tissue databases and models of human physiology and anatomy. The upshot is that the potential failure of a device, its possible inefficacy or capacity to cause harm to some patient groups will be determined well before the device goes into clinical trials.
The grant to Frangi and his team will run for the next 10 years, according to the university, by which time “he hopes it will have revolutionized the testing of medical devices.”
https://www.plasticstoday.com/medical/revolution-making-developing-and-testing-medical-devices/113450527860718
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Why medical devices need their own law
Apr 30, 2019 | Financial Express
By Rajiv Nath
Thirty years have gone by since the 1st medical device was regulated as a drug but a comprehensive regulatory framework still remains elusive. India imports 70-90% of its medical devices of which the vast majority are unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports.
Our policymakers are surprisingly undecided and seem to be in no urgency to usher in a “Patient Safety Medical Devices Law” to protect patients, even after the recent ICIJ implant files or J&J incident, or the most recent ban on Trans-vaginal Pelvic Mesh by US FDA.
Devices do need to be regulated but, once again, the DTAB (Drugs Technical Advisory Board) has suggested forcibly notifying all medical devices that are engineering products as ‘medicines’ under the Drugs & Cosmetics Act and the road-map being defined by it does not entail migrating these to a separate ‘Medical Devices Act’ in due course.At present, only 23 out of over 5,000 medical devices are regulated by being notified as ‘drugs’. Additionally, the health ministry has recently cherrypicked and notified 12 other products as ‘drugs’. The medical devices market in India is over $10 billion (`70,000 crore) and projected to grow to $50 billion by 2025 and is the fourth-largest in Asia.
Devices, not drugs
It’s imperative to have a separate law as devices are engineering items and not medicines—an X-ray machine by no stretch of the imagination can be called a drug, and, so, continued attempts to regulate devices as drugs is illogical and incorrect unless assured that it is a temporary measure. A beginning was made to correct the anomalous situation with the introduction of the Medical Device Rules in 2018. These Rules have risk-proportionate controls correlating to the risk classification of devices. Similarly, the law and penal provisions need to be risk-proportional as you can’t have the same penalty for a manufacturing failure of a pair of spectacles as for a contact lens or for an intra-ocular lens. Patient safety is more complex with devices where the same are ‘a shared responsibility of the manufacturer, medical practitioners, product user and the regulator’. The Drugs Act itself needs reforms as it does not uniformly and equitably regulate quality from state-to-state in the absence of a national singular regulatory authority and there is no point of replicating this limitation for devices too.Can a competent builder from Mumbai, experienced enough to make a 90-storey building, risk starting the construction of a 70-storey one in Gurgaon if the building by-laws there don’t permit construction of over 36 floors only under hearsay that said by-laws are under amendment or will he wait?
Similarly, medical devices manufacturers need to know the legal requirements, penalties, rules and roles that every stakeholder in the system needs to follow, in a predictable manner. This will attract overseas and Indian investments. Presently, investors shy away from an unpredictable, incomplete and incorrect regulatory environment. In the absence of regulations, domestic manufacturing suffers as a surgeon is unsure of trying an unregulated device from a start-up on a live patient.
Road-map for a robust Medical Devices Law
Policymakers need to view devices and drugs differently in order to make them safe and consider regulating devices under the ministry of health as done for food. Food is not regulated under the Drugs Act or under DCGI, or the CDSCO, but has a FSSAI with a chairman and CEO.
The government should stick to its earlier assurance given to the industry by the MOH&FW in 2016 of four steps—starting with the Medical Devices Rules (MDR), initially experimenting with a few electronic devices under the MDR, the MDR to be amended as per experience gained after 6 months of introduction and the simultaneous drafting of a Medical Device Patient Safety Bill to be reviewed and passed by Parliament and the MDR to accordingly be tweaked in order for it to migrate to an eventual Medical Devices Law.
The National Accreditation Board of Certification Bodies is already accrediting certification bodies for voluntary quality assurance (the Indian Certification for Medical Devices (ICMED) scheme) under the QCI (Quality Council of India). Incentivizing ICMED certification by the QCI will help manufacturers in capacity building for voluntary compliance to quality standards, thereby ensuring global competitiveness and enabling the smooth transition to mandatory compliance under a Patient Safety Medical Devices Law. A strong and fair regulatory environment will help the Make in India campaign by encouraging the growth of this industry.
If we are serious about placing India as a top global medical devices manufacturing hub, then one needs to understand that piecemeal reforms will not work. Right from trade margin rationalisation to ensuring a separate set of legislations and regulatory frameworks to govern the medical device sector and everything in between needs to be looked at afresh to galvanise domestic manufacturing.
https://www.financialexpress.com/opinion/why-medical-devices-need-their-own-law/1562997/
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The Sunday Post’s Marion Scott wins Campaign of the Year award for mesh scandal coverage
Apr 26, 2019 | The Sunday Post
Marion was honoured for her efforts over many years in reporting the stories of women who have suffered as a result of mesh implants and campaigned against their use.
Marion said: “Incredibly proud to have been awarded campaigning journalist of the year for the mesh scandal.
“Giving these amazing women a voice has been an honour.
“Despite the dreadful injuries they suffered they fight on to protect other women from the same fate – that is truly inspirational.”
Marion was also named runner-up in The Nicola Barry Award, established by Women in Journalism Scotland.
Sunday Post columnist Mandy Rhodes was runner-up in the Columnist of the Year category.
https://www.sundaypost.com/fp/the-sunday-posts-marion-scott-wins-campaign-of-the-year-award-for-mesh-scandal-coverage/
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