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‘The Bleeding Edge’ and the Cumberlege Review

‘The Bleeding Edge’, a US documentary from directors Kirby Dick and Amy Ziering, will be released on Netflix on 27 July 2018. Through a series of hard-hitting case studies, the documentary explores the human cost of the longstanding tension, at the heart of the medical device industry, between maximizing profits whilst, in theory at least, also maximizing patient well-being.

Medical Device Mesh
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Sarah Moore specialises in product liability and claims for groups of people who have suffered an injury because of unsafe products. She has written a number of articles on topics such as drug regulation, cigarette packaging and food safety.
The message behind this documentary is captured by one of the clinicians interviewed who tells us, ‘we cannot rely on the medical device industry to do what is in the best interests of the patient’.
 
‘The Bleeding Edge’ tells the story of a group of patients who have paid the price of that shocking reality. We hear from patients implanted with a range of products including Essure, an implantable female sterilization device, and vaginal mesh; both products that the documentary alleges were rushed to market with what an authoritative list of regulators, clinicians, lawmakers and patients interviewed allege was inadequate testing to ensure patient safety. The consequence, according to the documentary makers, is that too often ‘new equates to unproven’ with medical device companies including Johnson and Johnson, Bayer and others innovating for the primary purpose of generating corporate profit which has necessarily led companies to play-down the importance of testing protocols originally designed to ensure that patient-safety was prioritized. This tension is evidenced more prosaically on the balance sheets of many medical device companies with the ‘spend’ on marketing exceeding many times the company’s investment in ‘research and development’.
 
The documentary takes viewers inside the AGMs of some of the world’s biggest medical device companies, in which corporate speakers take pride in the fact that ‘we have more power in this room than most governments around the world’. The footage looks at how that power has been used through interviews with patients and clinicians whose lives and clinical practice have been radically altered by the use of implantable medical devices that have caused injuries as a result of side-effects and problems that were not properly screened by the medical device companies prior to first marketing.
 
What the documentary perhaps does less to highlight is ‘how’ this has been allowed to happen and the fact that the story told is, tragically, not just an American one.  The fact of injuries caused by defective medical devices is just as much a feature of NHS patients’ experiences in the UK, as it is in the US. The role of inadequate scrutiny by governmental regulators the FDA (in the US) and the MHRA (in the UK) is also a common feature across the 2 jurisdictions, with campaigners on both sides of the Atlantic arguing that the clearance processes for medical devices require relatively little scrutiny of the ‘in vivo’ test data produced by the companies, that is the only data that can truly show that the product has been tested in, and is safe for use in, humans.
 
However, one key factor that does perhaps distinguish the fate of US patients injured by defective medical devices, from their UK counterparts, is the fact that in contrast with US patients, UK patients injured by devices are far less likely to have access to adequate justice in seeking to hold the manufacturer of the device to account. The reasons for this are numerous, but it is notable that in the UK there has not been a single successful group action brought on behalf of claimants against a manufacturer for more than 20 years; contrast the stream of claimant victories in the US most recently, for example, concerning carcinogenic talcum powder: Indeed earlier this year in the UK the Judge in the Pinnacle Hip Litigation, involving more than 350 Claimants against Depuy International Limited (a J&J subsidiary) returned a judgment in favour of the Defendant – and yet that same product (a metal-on-metal hip) has now been found defective and causative of injuries by the US courts on multiple occasions. For that reason whilst ‘The Bleeding Edge’ tells a far too universal story in respect of the global reach and power of medical device companies and the impact that a race to maximize profit lines has on safeguarding patient care, it does so within a jurisdiction that does at least enable those injured to seek legal redress and compensation. As it stands in the UK, as a result of the non-applicability of legal aid to product liability cases, the fact that medical device companies have infinite resources and access to experts and the fact that to date very few Davids have taken on the medical device Goliaths within the UK court system and won, NHS patients injured by medical devices are arguably in an even worse position than their US counterparts.
 
It is hoped that a government ordered Review process (the Independent Medicines and Medical Devices Safety Review) which is currently underway, chaired by Baroness Cumberlege, will do something not only to throw light on the inadequacies in the regulation of medical devices and medicines, but also on the fact that for those injured by medical products within the UK they are too often left without adequate access to justice. Baroness Cumberlege’s Review may lack the profile of ‘The Bleeding Edge’ but all of those who are committed to improving patient safety in the UK very much hope that the Baroness will seize the opportunity to produce recommendations with long-lasting positive impact– perhaps making the Review a ‘bleeding edge’ for positive patient change in the UK.
                                                                                            
‘The Bleeding Edge’, directed by Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground) premiered to positive reviews at the Tribeca Film Festival earlier this year with a running time of 1h40mins. It will be released on Netflix on 27 July 2018.
 
 

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