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Ethicon Media Monitoring 7/13/2018
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Get Ready For Digital Health Product Liability Cases
Jul 12, 2018 | Law 360
By Raymond Williams and Jae Kim
Today, more and more people are integrating digital health into their daily lives, from the smartphone app that offers therapeutic techniques for mental health improvement to the wristwatch that counts steps and measures heart rate. -
The Biggest Pa. Appellate Rulings Of 2018: Midyear Report
Jul 12, 2018 | Law 360
By Matt Fair
...In a similar ruling involving jurisdiction over out-of-state plaintiffs and foreign corporations, the Superior Court ruled in June that Johnson & Johnson subsidiary Ethicon Inc. could face claims from nonresidents in Philadelphia County over allegedly defective pelvic mesh products. -
Tragic stories of mesh slings spark restrictions in UK
Jul 13, 2018 | New Zealand Doctor
By Keira Stephenson
We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. -
Lincoln solicitor records almost 30 vaginal mesh complaints
Jul 12, 2018 | The Lincolnite
By Emily Norton
A Lincoln solicitors has welcomed an NHS ban on vaginal mesh implants, revealing the firm received almost 30 calls from potential sufferers in the last year. -
Curb on Mesh Implants for Stress Urinary Incontinence
Jul 12, 2018 | Medscape
By Peter Russell
The use of vaginal mesh implants to treat complications after childbirth will be "paused" in NHS hospitals in England, the Department for Health and Social Care (DHSC) has announced. -
Midland Woman Urges Govt To Stop Vaginal Mesh Ops
Jul 12, 2018 | Midlands 103
By Hannah Murphy
A woman from the Midlands is calling on the government to suspend vaginal mesh operations. -
‘The Bleeding Edge’ Trailer: Kirby Dick and Amy Ziering Take on a Billion-Dollar Industry in Netflix Documentary
Jul 12, 2018 | IndieWire
By Kate Erbland
Combining compelling archival footage and testimony from a slew of contemporary experts, Kirby Dick and Amy Ziering’s latest documentary, “The Bleeding Edge,” takes to task one of the most powerful industries in America, with often unsettling results.
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Get Ready For Digital Health Product Liability Cases
Jul 12, 2018 | Law 360
By Raymond Williams and Jae Kim
Today, more and more people are integrating digital health into their daily lives, from the smartphone app that offers therapeutic techniques for mental health improvement to the wristwatch that counts steps and measures heart rate. In the general consumer context, the benefits tend to outweigh the potential hazards.
Users may actively monitor their health data in real time and make better lifestyle choices at minimal risk: If your app incorrectly counts the number of steps because of a software glitch, that hiccup typically does not cause serious physical harm. But when a traditional medical device or pharmaceutical drug integrates digital health components, the product liability risk profile becomes less certain for manufacturers, because the consequences of malfunctioning software can be severe.
Take, for example, the Therac 25 radiation-emitting device from the 1980s. Due to software programming errors, the device delivered massive overdoses of radiation, which killed two patients and injured four others. Therac 25 is an extreme example of medical software gone bad; the app-connected drugs and devices we see on the market today tend to have comparatively limited capabilities. In most cases, the smartphone app works with the medical product’s existing functions: The medical product transmits data to the app to enable real-time monitoring of the patient’s medical condition.
Several medical device breakthroughs in the digital health space relate to diabetes management. For example, a device such as a wearable patch measures a patient’s insulin levels, and analytics software processes the data from the device to offer the patient personalized recommendations, ranging from dietary suggestions to insulin dose amounts. A similar breakthrough in the digital pharmaceutical space is a digital ingestion tracking system, where a tiny sensor in the pill can be used to track and monitor patients’ adherence to drug treatment regimens.
Given enthusiastic support of this industry from Congress and the U.S. Food and Drug Administration, we anticipate that in the near future, increasing numbers of companies will offer digital health products with enhanced capability functions. Yet, as laws and regulations catch up with innovation, there remains an open question: How will traditional product liability law apply to cases involving app-connected devices and drugs? Each case will be highly fact-dependent, and much of the discovery will likely aim to answer some of these threshold questions:
Who designed the various components of the digital health product?
What is the nature of the product’s defect?
How did the defect occur? Are these internal defects or external defects, such as a cyberattack on the device?
At a fundamental level, we are seeing changes in the regulatory landscape relating to digital health products. In Section 3060 of the 21st Century Cures Act, Congress amended the definition of a “device” to exclude certain software functions from the statutory definition, such as software for maintaining or encouraging a healthy lifestyle and certain types of clinical decision support software. Section 3060 also provides that when a medical device has multiple functions — i.e., both device and nondevice software functions — then the FDA is not permitted to regulate the nondevice functions, although the FDA may assess how the nondevice functions impact the safety and effectiveness of the device functions under review.
Consistent with this mandate, the FDA launched the Digital Innovation Action Plan in 2017, and is in the process of updating existing guidance documents on various topics, including mobile medical applications and general wellness products. It will be prudent to stay abreast of these regulatory developments, as they will likely impact the development and marketing of future digital health products.
For product liability, the nature of digital health products is what makes it difficult to determine who is liable. When we normally think about a device or a drug in a product liability suit, we imagine a singular, distinct product that directly injures a patient. But some digital health products are actually a system of connected parts, with each component being regulated differently.
The device or drug is subject to the FDA’s oversight, which generally entails compliance with detailed regulatory requirements on testing, manufacturing and labeling. The app software, depending on whether it has device functions under the Cures Act’s amended definition of devices, may or may not be subject to the FDA’s review. And, within this system, there may also be third parties supporting the app’s functions, such as a data analytics firm that analyzes the device’s raw data and provides personalized feedback to the app.
Significantly, too, each of these components may be designed, tested and/or manufactured in different states. This may lead to a thorny jurisdictional issue: whether the medical product manufacturer may be subject to the app developer’s forum. In the aftermath of Bristol-Myers Squibb Co. v. Superior Court of California, we have seen at least one Pennsylvania state court exercise specific personal jurisdiction over an out-of-state pelvic mesh kit manufacturer, based on its collaboration with a local Pennsylvania company in designing and manufacturing the mesh component of the product.[1]
This issue could play out in different ways in the digital health space, depending on a number of factors, such as the degree of control and oversight the medical product manufacturer has over the design and manufacture of the connecting app, and how integrated the app is to the overall functioning of the medical product.
Another potential wrinkle is whether the app’s software, if considered separate and apart from the medical product, is actually a “product” or a “service,” since product liability principles do not extend to services. Under the Restatement (Third) of Torts, a “product” is defined as “tangible personal property distributed commercially for use or consumption,”[2] and courts have reached conflicting conclusions about whether software can be regarded as a tangible product. This analysis may impact whether liability can be shifted from the medical product manufacturer to the software designer, and vice versa.
Cybersecurity threats are also an unavoidable consideration for digital health products. In 2017, the FDA recalled over 450,000 pacemakers after identifying a potential vulnerability in the software that would allow hackers to alter programmed settings, which could lead to rapid battery depletion or inappropriate pacing. As part of the recall, the pacemakers had FDA-approved firmware updates installed to correct these software deficiencies.
If a hacked digital health product injures a patient, product liability may hinge on whether the medical product manufacturer or the software designer was capable of designing a system that is immune to cybersecurity attacks, and to what extent such an alleged “defect” is reasonably foreseeable, given the general public’s awareness of cybersecurity issues. And, even if routine software updates were provided, the quality of those updates could become an important factor in this analysis.
Ready or not, the digital health field is evolving, and will fundamentally change how we use and interact with medical products. We expect there will likely be a growing number of collaborations among digital health startups, app software designers, artificial intelligence firms and drug and medical device companies. Some of the products that are born out of these collaborations may no longer look and feel like a traditional medical product that is prescribed and administered by a doctor.
Indeed, over time, digital apps will enable patients to have a greater degree of access, control and interaction with their medical products, and that in itself may impact the practice of medicine. This change is coming, and many patients will welcome it and come to expect it as part of treatment. As laws and regulations develop in response to these changes, device and drug manufacturers should be cognizant that digital health products may require a more nuanced approach to product liability law.https://www.law360.com/articles/1062741/get-ready-for-digital-health-product-liability-cases
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The Biggest Pa. Appellate Rulings Of 2018: Midyear Report
Jul 12, 2018 | Law 360
By Matt Fair
The Pennsylvania appellate courts have made their mark during the first half of the year with a number of major rulings ranging from the constitutionality of the state’s congressional districts to the ability of landowners to bring trespassing claims over hydraulic fracturing.
According to judicial records, the Pennsylvania Supreme Court handed down opinions in 39 cases from the beginning of January to the end of June, a tally that included 24 civil or administrative appeals.
Among them were decisions throwing out the state’s congressional map as an unconstitutional partisan gerrymander and declaring that the University of Pittsburgh Medical Center owed a legal duty to patients at a Kansas hospital for the actions of one of its former radiology technicians.
John Hare, the chair of Philadelphia-based Marshall Dennehey Coleman Warner & Goggin PC’s appellate group, said he was impressed by the breadth of the cases the Supreme Court has decided recently.
“It just seems as if the Supreme Court has taken up a wider breadth of cases than perhaps it has in the past,” he said.
In addition to rulings from the justices, the state’s Superior Court also handed down a slew of published decisions that have turned heads in Pennsylvania’s legal community, including rulings on jurisdiction over out-of-state plaintiffs and the ability of landowners to lob trespassing claims against drillers for using hydraulic fracturing to access oil and gas deposits trapped below their properties.
Here, Law360 takes a look at some of the most significant rulings out of the state’s appellate courts so far in 2018.
League of Women Voters v. Commonwealth of Pennsylvania
In a decision that garnered national headlines, the Supreme Court ruled in January that the state’s congressional map represented a partisan gerrymander in violation of the Pennsylvania Constitution’s free and equal elections clause.
And the justices didn’t stop there.
They ordered the legislature to submit a new map, complete with the governor’s approval, to the court in less than a month, or the justices would set the district boundaries themselves.
That is precisely what the court ended up doing after legislators and Gov. Tom Wolf submitted separate proposals to the justices.
The case represented a stark contrast from gerrymandering cases that have been brought in federal courts nationwide, where judges have found that they lacked authority to address potential partisanship in the district-drawing process.
Dennis Whitaker, an appellate attorney with Harrisburg-based Hawke McKeon & Sniscak LLP, told Law360 the court was not afraid to tackle controversial issues when it believed it was presented with constitutional violations.
“It shows that the court is willing to look at issues that were thought to be settled, and obviously the justiciability issue in the League of Women Voters was a huge issue,” he said.
And the court took heat for its decision, as a number of Republican lawmakers threatened to begin impeachment proceedings against the justices — all Democrats — who formed the majority in the case.
The case is League of Women Voters of Pennsylvania et al. v. Commonwealth of Pennsylvania et al., case number 159 MM 2017, before the Pennsylvania Supreme Court.
Briggs v. Southwestern Energy Production Co.
The Superior Court broke with more than a century of settled law in April as it ruled that a Susquehanna County family could move forward with trespassing and conversion claims against a hydraulic fracturing company for allegedly illegally tapping into gas reserves trapped under their property.
The court ruled that the so-called rule of capture, which since the 1800s has shielded drillers from liability for drainage of free-flowing oil and gas from below adjacent properties, does not apply to hydraulic fracturing.
“This is a very important decision in oil and gas development,” Whitaker said.
The case stems from claims brought against a Southwestern Energy Corp. unit alleging that a well the company drilled on one property had allowed it to pull in natural gas below a neighboring property where it did not have subsurface rights.
While a trial judge threw out the case after relying on the rule of capture, the Superior Court agreed that the differences between conventional drilling and fracking — which involves injecting high-pressure drilling fluids into the ground, and potentially across property lines, to free oil and natural gas that would otherwise have remained trapped in one place — invalidated the defense.
“That’s a case that obviously bears watching,” Whitaker said. “I could see potential proof issues there. How do you know when you’re finished sucking up all the gas in your lease and you’re not actually bringing it in from an adjacent mineral estate? It’ll be interesting to see how that plays out.”
Southwestern is currently asking the Pennsylvania Supreme Court to take up the case on appeal.
The case is Adam Briggs et al. v. Southwestern Energy Production Co., case number 1351 MDA 2017, before the Pennsylvania Superior Court.
Walters v. UPMC Presbyterian Shadyside
The Supreme Court ruled in June that the University of Pittsburgh Medical Center owed a potential duty to patients at a Kansas hospital who say they contracted hepatitis from a radiology technician who was allowed to continue working in the health care industry despite having been caught stealing, using and replacing fentanyl syringes during his tenure at UPMC.
The justices ruled 3-1 that UPMC owed a duty to the Kansas patients based, in part, on what the majority said was the clear foreseeability of the risk that the technician would continue stealing and injecting himself with the syringes if not properly reported to authorities.
“It’s significant in the context of how far the court is willing to extend tort law,” Duane Morris LLP appellate chair Robert Byer said.
But while UPMC argued that a ruling in favor of the Kansas patients could open up health care providers to potentially “limitless liability” for actions of their former employees, the opinion seemed to offer only a narrow path for the plaintiffs to follow in proving a potential breach of the health care giant’s duty.
That path centered around UPMC’s allegedly unmet obligation to report the technician’s theft to the U.S. Drug Enforcement Agency as required by federal regulation.
UPMC has argued that it did report the theft to the state’s Office of Attorney General.
“I think they were very careful with it,” said D. Alicia Hickok, the head of the appellate team in Drinker Biddle & Reath LLP’s litigation group. “The court was clear that they didn’t have an obligation to stop it, the only obligation they had was to make that report.”
The cases are Thomas Walters et al. v. UPMC Presbyterian Shadyside et al., case numbers 15 WAP 2017 and 19 WAP 2017, Laura Ficken et al. v. UPMC Presbyterian Shadyside et al., case numbers 16 WAP 2017 and 20 WAP 2017, Wanda Braun et al. v. UPMC Presbyterian Shadyside et al., case numbers 17 WAP 2017 and 21 WAP 2017, and Ronnie Murphy et al. v. UPMC Presbyterian Shadyside, case numbers 18 WAP 2017 and 22 WAP 2017, all before the Pennsylvania Supreme Court.
Webb-Benjamin LLC v. International Rug Group LLC
The Superior Court turned heads at the end of June when it ruled that out-of-state companies could face claims in Pennsylvania courts simply by virtue of their having registered to do business in the state.
The ruling revived claims from Webb-Benjamin LLC as it found that the Pittsburgh-area company could sue the Connecticut-based International Rug Group LLC in Pennsylvania courts because IRG had registered to do business in the state, bringing it under the court’s general personal jurisdiction.
“Most states have construed similar registration statutes as not automatically conferring jurisdiction,” Hare said.
Both Hare and Byer said the ruling was particularly jarring given precedent from the U.S. Supreme Court — most recently in a ruling last year that Bristol-Myers Squibb Co. did not have sufficient business contacts in California to confer courts there with jurisdiction over product liability cases from out-of-state residents — limiting the ability of state courts to hear cases involving non-residents.
“They made this decision notwithstanding the U.S. Supreme Court’s recent retrenchment on personal jurisdiction, that you can’t sue a foreign corporation that doesn’t have its headquarters or principal place of business in Pennsylvania where the cause of action didn’t accrue in Pennsylvania,” Byer said.
The case is Webb-Benjamin LLC v. International Rug Group LLC, case number 1514 WDA 2017, in the Pennsylvania Superior Court.
Hammons v. Ethicon Inc.
In a similar ruling involving jurisdiction over out-of-state plaintiffs and foreign corporations, the Superior Court ruled in June that Johnson & Johnson subsidiary Ethicon Inc. could face claims from nonresidents in Philadelphia County over allegedly defective pelvic mesh products.
The court ruled that Ethicon, which is headquartered with its parent company in New Jersey, had clear and substantial business links with Pennsylvania — including its reliance on Philadelphia-area Secant Medical Inc. to manufacture the mesh — that were sufficient to give the state jurisdiction over claims from an Indiana woman over the product’s alleged defects.
“It’s very significant from the standpoint of taking an expansive view of specific jurisdiction, and I’m not sure the U.S. Supreme Court would countenance it,” Byer said.
The decision also suggests that Ethicon is unlikely to prevail in a separate bid it has pursued to dismiss of dozens of mesh cases from out-of-state plaintiffs in a mass tort program in the Philadelphia County Court of Common Pleas.
The case is Patricia Hammons v. Ethicon Inc. et al., case numbers 1522 EDA 2016 and 1526 EDA 2016, before the Pennsylvania Superior Court.
EQT Corp. v. Department of Environmental Protection
The Supreme Court ruled 5-2 at the end of March that the continued movement of pollutants through waterways did not constitute a serial violation of the state’s Clean Stream Law that could trigger ongoing penalties.
In rejecting a $1.2 million fine that the state’s Department of Environmental Protection had sought to impose on EQT Corp. for leaks at a gas drilling site in Tioga County, the justices essentially rejected what Whitaker said was a long-standing tactic by regulators in negotiating settlement agreements with industry.
“DEP had always argued that under the Clean Streams Law the entry of contaminants in the waters of the commonwealth and their continued presence there constituted a continuing violation,” he said. “The Supreme Court rejected that.”
The ruling found that, while the statute was ambiguous about the continued movement of pollution through waterways, it was “most reasonable to conclude the legislature was focused on protecting the waters of the commonwealth with reference to the places of initial entry.”
Byer said the ruling represented a much narrower reading of the law than the DEP had sought.
“The DEP was trying to read the statute expansively, but ultimately that reading was only supported by two justices in the Supreme Court when push came to shove,” he said. “While the Supreme Court might in some respect be considered progressive, it’s still tethering its decisions to the statutory text.”
The case is EQT Production Co. v. Department of Environmental Protection, case number 6 MAP 2017, before the Pennsylvania Supreme Court.https://www.law360.com/articles/1062680/the-biggest-pa-appellate-rulings-of-2018-midyear-report
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Tragic stories of mesh slings spark restrictions in UK
Jul 13, 2018 | New Zealand Doctor
By Keira Stephenson
We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
Access to full text unavailable – subscription required.
Story can be found here: https://www.nzdoctor.co.nz/article/news/tragic-stories-mesh-slings-spark-restrictions-uk
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Lincoln solicitor records almost 30 vaginal mesh complaints
Jul 12, 2018 | The Lincolnite
By Emily Norton
A Lincoln solicitors has welcomed an NHS ban on vaginal mesh implants, revealing the firm received almost 30 calls from potential sufferers in the last year.
NHS England announced this week that all vaginal mesh implant surgeries will be immediately stopped.
Meshes have been used for many years to treat organ prolapses and hernias – they patch up weakened flesh.
Tape mesh is used to treat incontinence or prolapses, often following childbirth. Some of the issues arising from the mesh implants include erosion to muscles and organs where the thin mesh is grating the skin, and infections.
The pain caused by grating mesh can be debilitating. Because the mesh is designed to be gradually incorporated into the wall of skin and muscle it is very difficult to remove once the body has grown and repaired around it.
Lincolnshire-based Bridge McFarland said since news first broke of the issue in April 2017 they have been “overwhelmed by local people asking for help” across county offices.
Stephanie Capindale is an Associate Solicitor who specialises in mesh cases says “My colleagues have all noticed the huge increase in people getting in touch regarding mesh implants and the complications that arise for them – in Lincoln alone we have had nearly 30 individuals get in touch since last year to see if there is anything we can do to help them.
“If nearly 30 people in Lincoln have been in touch with us there must be many more people out there who are suffering from the affects of mesh surgery without support.”
The firm added there have been cases of people left unable to walk, work, have sexual intercourse or care for their families following mesh implants.
Until the extend of the affects was realised, many patients were treated for unrelated issues. In the review of mesh implants, Baroness Julia Cumberlege heard how one woman mistakenly had a hysterectomy after doctors were unable to diagnose her pain, she was left suicidal.
The official NHS estimate on the number of mesh implants used to treat vaginal prolapse or incontinence in the UK are upwards of 100,000 – and according to The Independent Newspaper, academics estimate around 10% of those treated with vaginal mesh will face complications. The health watchdog NICE recommended that these procedures be banned in 2017.
The increased number of negligence claims relating to these meshes is due in part to a campaign group called ‘Sling The Mesh’, they have been instrumental in stopping the use of these meshes and supporting women to talk about their experiences.
“A medical negligence claim would really come down to consent” explains Mrs Capindale “one of the reasons so many women are successfully bringing negligence cases regarding this mesh is that there was no clear warning about the side effects prior to surgery, nor are women told just how often the implants can lead to complications.
“My advice to anyone who has been treated in this way would be to initially make an appointment to raise your concerns with a doctor, and if you are finding yourself in pain you can get in touch with us to talk through your options.
“If anyone has been left in pain because of a mesh implant our team can offer free initial legal advice, just call 01522 518 888.”
https://thelincolnite.co.uk/2018/07/lincoln-solicitor-records-almost-30-vaginal-mesh-complaints/
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Curb on Mesh Implants for Stress Urinary Incontinence
Jul 12, 2018 | Medscape
By Peter Russell
The use of vaginal mesh implants to treat complications after childbirth will be "paused" in NHS hospitals in England, the Department for Health and Social Care (DHSC) has announced.
It follows preliminary recommendations from an independent review set up by the then Secretary of State, Jeremy Hunt, which said that surgical mesh should not be used for the treatment of stress urinary incontinence until adequate safeguards were in place to reduce the risk of injuries.
The Government said it accepted the recommendation after seeking advice from the chief medical officer and senior clinicians. It agreed that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse.'Women Are Suffering Terribly'
The procedure involves inserting a net-like fabric into the vagina to support the bladder, womb or bowel. Thousands of women have reported disabling complications as a result of the procedure.
Former health minister Baroness Julia Cumberlege, who is chairing the review, said: "I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now."Independent Review
The Independent Medicines and Medical Devices Safety Review was set up to investigate how the healthcare system had responded to concerns raised by patients and families about three medical interventions. These are:
The hormone pregnancy test, Primodos
The anti-epileptic drug, sodium valproate
Surgical mesh
The review may make recommendations regarding these interventions but also about how the healthcare system could improve its response to concerns raised about other medicines and medical devices in the future.
Vaginally inserted meshes will only be used in England when there is no alternative "and after close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times", the DHSC said.
NHS England said it would now work with other health agencies to pause procedures quickly and safely.
NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment.Conditions Set for Lifting the Pause on Procedures
The conditions of lifting the pause in the use of surgical mesh, which the review said should be met by March 2019, are that:
Surgeons should only undertake operations for stress urinary incontinence if they are appropriately trained, and only if they undertake operations regularly
They report every procedure to a national database
A register of operations is maintained to ensure every procedure is notified and a record kept of each woman who has undergone the surgery
Complications reported via the Medicines and Healthcare products Regulatory Agency (MHRA) are linked to the register
There should be identification and accreditation of specialist centres for stress urinary incontinence mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh
The latest development follows guidance in December 2017 from the National Institute for Health and Care Excellence (NICE) which said there were "serious but well-recognised safety concerns" about the use of mesh and that the procedure should only be used for research.
The Scottish government suspended the use of mesh for stress urinary incontinence in 2014.
Mesh used for bowel patients (rectopexy) in England has not been included in the temporary suspension and will be considered separately by the review.
Owen Smith MP, chair of The All Party Parliamentary Group on Surgical Mesh Implants tweeted that the decision to suspend mesh procedures "is welcome and overdue but raises significant questions about our regulators, the MHRA and NICE. Why did they not listen to the worries about mesh? Why did it take a sustained campaign and an independent review to act?"
https://www.medscape.com/viewarticle/899229
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Midland Woman Urges Govt To Stop Vaginal Mesh Ops
Jul 12, 2018 | Midlands 103
By Hannah Murphy
A woman from the Midlands is calling on the government to suspend vaginal mesh operations.
It comes as the NHS has committed this week to immediately stopping the procedure in the UK.
The mesh tape is used to control bladder leaking, but has been known to cut through a womans vaginal wall and cause pain.
Veronica told Will Faulkner on the Midlands 103 why she wants it banned;
http://www.midlands103.com/news-centre/midland-woman-urges-govt-stop-vaginal-mesh-ops/
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Jul 12, 2018 | IndieWire
By Kate Erbland
Combining compelling archival footage and testimony from a slew of contemporary experts, Kirby Dick and Amy Ziering’s latest documentary, “The Bleeding Edge,” takes to task one of the most powerful industries in America, with often unsettling results. Despite one of the most technologically advanced health care systems in the world, the United States is still home to a frightening number of deaths by “medical intervention,” often due to medical devices that never received the kind of clinical trials patients likely expect of them.
Dick and Ziering’s latest looks at the $400 billion medical device industry, finding (per the film’s synopsis) “lax regulations, corporate cover-ups, and profit driven incentives that put patients at risk daily,” and that’s just the start. It’s an eye-opening look at a world with a big reach, but the filmmakers also ground it in stirring personal stories.
In his review from Tribeca, IndieWire’s Eric Kohn wrote that the film “assembles a range of talking heads and upsetting case studies to target several key villains: Essure, the permanent contraceptive implant used by millions of women, has left many of them with long-lasting pain and endless surgeries as the small, snake-like device worms its way into the uterus. The ‘vaginal mesh’ approach yields even more gruesome results. Patients operated on by the robotic surgeries of the da Vinci System often contend with extensive infections, and others with artificial hips made with chrome-cobalt devices suffer from neurological problems.”
He adds, “Dick lays out each of these conundrums with a series of case studies, while contextualizing within the broader context of the quack medical industry. … Medical students may find this parade of mortifying tales instructive; others will recoil in terror and wonder how the hell any of these procedures remain legal during such technologically-advanced times.”
Check out our exclusive trailer for “The Bleeding Edge” below. The documentary will be available on Netflix and in select theaters on July 27.
https://www.indiewire.com/2018/07/the-bleeding-edge-trailer-kirby-dick-amy-ziering-netflix-documentary-1201983536/
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