by Oliver Thorne, Michelmores law firm UK
Vaginal Mesh and English Law
There is a storm brewing over the Atlantic. With multi-million pound settlements and awards being secured in U.S. mesh claims, a picture is beginning to emerge of the global spread of these defective products, and their impact on women around the world.
C.R. Bard, a US manufacturer of mesh products in the UK, against whom I have issued proceedings, has branches in more or less every major country in the world, and use of its mesh products is widespread. Clearly the international manifestation of these large companies is helpful when bringing legal action for defective mesh in, say, England; Bard having a base of operations in this country means that we don’t have to contend with the jurisdictional headaches that a trans-Atlantic claim would attract.
I am one of the few English lawyers to have issued proceedings relating to vaginal mesh, but, given the seismic impact of the mesh legislation in the U.S., it looks to be only a matter of time before these cases start to fill our headlines. In the UK it was estimated that, as of 2012, around 1,500 women are fitted with vaginal mesh as a treatment for Pelvic Organ Prolapse annually, and a further 13,000 fitted with vaginal tape. Many of these procedures are carried out under public funding on the National Health Service.
The extensive use of mesh is great news for the manufacturer: in 2011, Bard’s annual sales peaked at $2.9 billion. What, though of the victims? With its history of faulty devices, including heart catheters and surgical patches (leading in some cases to charges of fraud and indictments of company officers), Bard is emblematic of the occasional conflict between profit-making and patient safety. Worse still, we are hearing allegations of disconcertingly close relationships between clinical professionals and manufacturers, from the US to the UK and beyond. The issue is as insidious as it is tragic.
This is a fascinating new front in personal injury and product liability litigation, particularly given the ignoble behaviour of some of the players involved. It is now well-known that Bard knew their mesh plastic should not be implanted into humans, and that they concealed the fact of its use in humans from the suppliers of the plastic. English lawyers, therefore, are now in an interesting position: there is an ocean of U.S. precedent available on vaginal mesh, and, to an extent, a clean slate on the subject in the English courts.
Mesh in the UK
The US litigation represents a huge body of what, in the English courts, is ‘persuasive’ case law. The judges here are under no obligation to follow the rulings of the American courts, but the successful US claims brought by Christine Scott, Donna Cisson and others are certainly helpful from the product liability perspective. English lawyers liaising with their US counterparts may prove to be a useful exercise as the issue develops, and should help to foster productive trans-Atlantic relationships.
An English claim would most likely be bipartite: a product liability claim against the manufacturer who produced the mesh, and a clinical negligence claim against the hospital or surgeon which fitted it. One of the most significant issues from the negligence angle is informed consent; there are risks in inherent in practically every medical procedure, but the patient’s full understanding and agreement to those risks must be absolutely unquestionable.
Sadly, some members of the English clinical profession do not seem to have upheld this principle with sufficient vigour. This is regrettable: England’s creaking, listing health service is struggling to balance its books already, and doesn’t need a slew of litigation costing it thousands, perhaps millions more. Nonetheless, fitting a patient with a device that could maim them is, in law, negligence. Securing compensation through the courts may be an unwieldy way of upholding clinical standards (we’d prefer that best practice was adhered to), but in matters such as these it appears to be the only way of gaining redress for the mesh victims.
Regulation and the Wild West of medical products
How, with our acres of statutes, and buildings full of medical regulators, were these products allowed to cause the kind of damage they have? Although it may not be the only cause, it is arguable that failures in regulation have played a large part in allowing mesh to be used so widely in spite of the dangers it poses.
American observers of the mesh litigation will be familiar with the 510(k) rule, named after the relevant section of the Federal Food, Drug and Cosmetic Act. Under this rule, medical devices that are ‘substantially equivalent’ to pre-existing products are subject to far less scrutiny than more novel products, and slip easily onto the market.
The European Economic Area (EEA), of which the UK is a part, governs medical devices with the CE mark: this symbol, similar in significance to the US FCC’s Declaration of Conformity mark on electronic goods, denotes compliance and conformity with European Union (EU) safety regulations.
In practical terms, it is a symbol of no small importance: it is a hallmark, shorthand for reliability, safety, and trust for any product traded in the EU. Not all products require a CE mark, but high-risk medical devices, such as vaginal mesh, do. The issue, however, lies in the assessment process. Unlike the centralized approval required from the FDA in the US, responsibility for CE marking lies with accredited, but privately run, ‘notified bodies’. Any EU Member State can accredit a notified body and once that body has granted a CE mark to a product, the manufacturer is then at liberty to sell it throughout the European market.
The vulnerability of this system to abuse has already been exposed. The Poly Implant Prothèse (PIP) breast implant scandal, where women were fitted with implants containing industrial-grade silicone, showed how gaining a CE mark in one country (in this case Germany) meant that the faulty, rupture-prone implants could be freely sold around Europe, until the danger they posed was realised. Monitoring was said to have been almost farcical: PIP was forewarned of an inspection of its premises, allowing the company to conceal any evidence of its liability.
The relatively loose regulatory framework of the CE mark applies to a range of high-risk devices, including pacemakers, artificial joints and, of course, vaginal mesh. However, the issues with device regulation in England and the UK do not end there. The Medicines and Healthcare Regulation Authority MHRA, which is responsible for monitoring the safety of all medicines and medical devices in the UK, cannot prevent CE-marked products from being sold, and is only able to send out ‘recommendations’ of better practice to practitioners. Enforcement, as well as regulation, can also be a fairly toothless business.
Healthcare professionals can report faulty devices to the manufacturers, or to the MHRA, but evidently to little effect. Past medical device scandals have seen the MHRA failing to broadcast proper warnings, as in the
DePuy metal-on-metal hip scandal. Here the MHRA, its advisory group featuring experts with links to the implant manufacturers, were equivocal in their warning, suggesting that a surgeon’s choice of implant would act as a sufficient safeguard. Meanwhile, the implants were suspected of having carcinogenic properties (De Puy, incidentally, is a subsidiary of Johnson & Johnson, one of the largest suppliers of vaginal mesh).
Physician, regulate thyself
Despite the damage caused to thousands of people, the current EU regulatory system boasts considerable support. Proponents applaud the speed with which new devices can be made available on the common market, while much is made of the 3-year lag that often accompanies the arrival of new high-risk medical devices in the US. The seemingly more streamlined EEA system remains a source of perhaps somewhat hubristic pride among Europhiles.
There is also political resistance to change. In September 2013, the European Parliament agreed to amendments in regulatory law that will lead to tighter controls of high-risk products. The UK lobbying group European Conservatives and Reformists, which holds seats in the European Parliament and maintains strong links with the UK’s governing Conservative party, all voted against the changes.
Self-regulation is a hot topic in the UK. The recent scandal over newspapers hacking the phones of celebrities and victims of crime has led to an as yet unresolved furore over press standards, and the question of whether the press can be relied upon to police itself is still subject to public and legal argument.
There are similarities in the vaginal mesh debate. In resisting statutory press regulation, the media cite freedom of expression and the importance of an untrammelled press; likewise, certain medical industry figures argue that tighter controls on the free market will stifle innovation, drive up prices, and, most pointedly, deprive patients of ready access to treatments.
These are arguments that will play out in the courts and the public consciousness, and it remains to be seen what kind of impact this will have on the free market in both these industries. At the sharp end, however, there are women all across the UK and Europe suffering the effects of products that have come into circulation with unacceptably low levels of scrutiny.
In the De Puy and PIP scandals, as with vaginal mesh, manufacturers concealed knowledge of the health implications of their products, clinicians failed to identify the risks posed, and regulators were either unable or unwilling to intervene. Laissez faire regulation may be good for business, but as the US litigation has shown us, it comes at quite a price.
Making a claim under English Law
One of the principal differences between U.S. and English mesh claims is the level of damages for product liability. The U.S. courts are more inclined to award punitive damages in product claims, raising the level of compensation to punish the defendant for its aberrant conduct. Successful product liability claims can therefore attract particularly large sums in the US, something which is less common in England.
In an English claim, we would tend to divide the claim into two parts: the defective product itself, and the negligent fitting of that product. This does not mean that a successful claimant will receive double the award; rather, having two avenues of claim acts as a safeguard against one claim running into difficulties. The full amount of damages can be recovered from either defendant, or shared between the two if both parties are found liable.
Under English law, the test for product liability is contained in the Consumer Protection Act 1987 (CPA). This states that, if ‘the safety of the product is not such as persons generally are entitled to expect’, every negligent producer, importer or supplier of the product will, under certain conditions, be strictly liable for the damage. The CPA also contains provisions to prevent suppliers concealing information about the producers of the product, making it easier to trace liability back to those initially responsible, who are also likely to have the deepest pockets.
The CPA came about with the shadow of the Thalidomide tragedy still looming large; this scandal was one of the defining events in the regulation of medical products, firmly asserting that patients required legislative protection which was more robust than the conventional common law approach for negligence. The Act is now an effective means of bringing manufacturers to account, and when used in conjunction with a clinical negligence claim, offers the prospect of proper compensation for victims of medical devices.
Suitability of the patient for insertion of mesh products
In terms of the negligent fitting of mesh, a proper assessment of a patient’s physical condition would have to be made, and alternatives to use of mesh would need to be discussed with the patient. Without this kind of discussion, a patient cannot give her full and informed consent to undergoing a procedure.
Those following the mesh debate in the US will be familiar with the FDA’s 2008 Public Health Notification (here), containing guidance on the kind of information that must be given to prospective recipients of mesh products. In England, the National Institute for Clinical Excellence has issued similar guidance, acknowledging the risk of complications. UK clinicians should, therefore;
‘Ensure that patients understand that there is uncertainty about the long-term results and [that] there is a risk of complications…they should provide [patients] with clear written information.’
The list of potential risks from mesh is lengthy: among other consequences, there are risks of haemorrhaging, tissue erosion, damage to the organs or blood vessels, and mesh extrusion. Previous urogynaecological issues can also lead to increased risks of complications, including infection. A declaration of consent, therefore, needs to be comprehensive and frank, and there must be convincing evidence that a patient has fully understood the risks.
What is risk? If a doctor told you that only a certain kind of treatment could restore you to normal health, it’s likely that you would agree to it. But if that treatment carried a chance of failure leading to severe injury or disablement, refusal becomes a less unlikely option. Even if the risk from the treatment is tiny, say a 1% chance, English case law suggests that the doctor needs your full, informed consent before administering it. The scenario above is an extreme one, but the principle of consent is immensely significant in medical claims, and never more so than in mesh cases.
What concerns us is that, too often, consultants are recommending mesh as a first, rather than a last, resort. This is particularly worrying with regard to women whose condition or physiology does not warrant the use of these devices, and where the clinician fails to fully explain either the risks involved or the alternatives available. As such, the medical profession may have to shoulder its share of the responsibility for the damage these products have caused.
The extent of the mesh debacle has yet to be publicly recognised in the UK as it has across the Atlantic, but thought leaders in law, medicine and manufacturing are all preparing for when the storm makes landfall. What cannot be denied is that the harm suffered by women fitted with these products is an outrage, and remedies need to be found. We hope, as English lawyers, to bring about the kind of successes seen so far in the US litigation, and secure justice for those who have suffered from these products. #