I have Greg Monforton to blame for this title, which lends itself to a challenging task. It was not of my own choosing. However, when I considered the title further, I came to the conclusion that it was a good one for the occasion of the very first Ontario Trial Lawyers Association Mass Torts/Class Action conference. The purpose of this paper, as the title reflects, is to provide a basic introduction to the medical device action, whether within the context of a mass tort program or a class action.
Over the last decade, I have been involved in a number of medical device actions, involving TMJ implants, breast implants, pacemaker leads, pacemakers, defibrillators, internal fixation devices and heart valves. In the investigation and prosecution of these actions, there are many recurring themes. The Roman alphabet provides 26 opportunities to expand on those recurring themes, and develop a framework for considering any new medical device case which may present itself in the future.
APPROVAL BY REGULATORS
In order for a medical device manufacturer to gain entry into a marketplace, at least in Canada, the U.S.A. and Europe, it must obtain approval from the regulator in that country. The most rigorous regulatory examination is done by the U.S. Food and Drug Administration (FDA). In Canada, the regulator is Health Canada. In Europe, a private company such as TUV, called a "notified body", reviews the company's regulatory submission and makes recommendations to the EU regulator.
There are a number of other countries which have a regulatory body, but deference is given by those regulatory bodies to the decisions of the FDA, Health Canada or the EU regulatory agency.
Finally, most other countries in the rest of the world have no regulatory process for entry into their markets, so that access to their marketplaces may be gained by negotiation or simply by retraining a local business agent.
Thorough understanding of the regulatory approach of the medical device company is essential to a complete understanding of the case. For example, the pre-market scrutiny given to a medical device application by Health Canada or by the EU is less than that given by the FDA. And in the rest of the world, there is virtually no regulatory scrutiny at all. Accordingly, device manufacturers may seek to gain entry into the markets where less regulatory scrutiny prevails, in order to gain early approval and increase clinical experience for the product.
It is important to have an intimate understanding of the FDA approval processes, particularly since most device manufacturers are U.S. multi-national corporations. Since the U.S. marketplace is the most profitable (viz., because of the "for profit" health care model), a U.S. device manufacturer will wish to get FDA regulatory approval quickly.
If the device is a new one, the manufacturer must go through a complete PMA (pre-market approval) process. The FDA expends the most resources assessing such a proposal, and has a qualified staff of scientists, physicians and other specialists to review the submissions. However, if the manufacturer or any other manufacturer has already obtained a PMA approval from the FDA, then subsequent devices which can be demonstrated to be substantially equivalent to the already approved device can obtain approval through the SPMA (supplementary PMA) process. The regulatory scrutiny given to a SPMA is much less than that given to a PMA.
Finally, a manufacturer can obtain regulatory approval for a device through the 510 (K) process, if the manufacturer is applying for a minor modification of an already approved device. The regulatory scrutiny given to a 510 (K) application is less than that given to a SPMA. Recent data released by the FDA showed the average FDA review time for a 510 (K) application to be 30-49 days.
It is common for the FDA to attach conditions to the granting of regulatory approval. It is therefore important to know what these conditions are, understand why the FDA attach them as conditions, and understand what the manufacturer did to comply with those conditions, on both sides of the border. As an example, the FDA may not be satisfied that the manufacturer has established the efficacy of a device. Accordingly, it may require the manufacturer, as a condition for approval of the product, to conduct a post market study and report back to the FDA.
The Health Canada regulatory regime was started in 1976, modified by the 1981 Medical Device Regulations (MDRs), and substantially modified again by the 1998 MDRs. From 1976 to 1998, a device granted approval by Health Canada was given a Notice of Compliance or, if the device for which approval was being sought was a previously approved device with a minor modification, a Supplementary Notice of Compliance would be granted.
The MDRs were substantially overhauled in 1998. Notices of Compliance were changed to licences, which were renewed annually. For the first time, the manufacturer had an explicit duty of post market disclosure to Health Canada, at the time of the annual renewal. Surprisingly, the other major change brought about by the 1998 MDRs was the requirement of mandatory adverse event reporting by the manufacturer, something which had not existed previously.
An implantable medical device is, by definition, one that is intended to be implanted within the body for greater than 30 days. Accordingly, biocompatibility is an extremely important concept for the medical device industry. In fact, the scientific study for biomaterial science only started in the late 1970s with the advent of the regulation of medical devices by governments in Canada and the U.S.A. The essence of the notion of biocompatibility is whether the device will perform as intended when used as intended.
Location is a fundamental concept in biocompatibility. Where is the implant intended to go in the human body? If the implant is to go into a load bearing joint, is the material sufficient to withstand the movement and load? Will wear debris be generated? If so, what is the body's reaction to that wear debris? Is the device made of a substance which is toxic? May a substance be toxic in one location in the body, but not in another? Has there been previous scientific experience exploring the toxicity of this substance, in vitro or in animal studies? Is the substance carcinogenic? Has there been previous basic science dealing with the carcinogenicity of the substance? How does the host tissue react to this foreign body?
A PMA application or a licence application will contain a great deal of data about bench testing, in vitro testing, and animal studies on biocompatibility. However, SPMA, 510 (K) and supplementary licence applications tend to contain much less data on this issue.
An understanding of clinical trials, biostatistics and epidemiology is essential to this area of practice. The physicians and surgeons who decide whether a device should be purchased are influenced very strongly by the results of clinical trials. As a result, the device manufacturers are often tempted to use the conduct of clinical trials as a marketing opportunity rather than an objective scientific investigation. Seldom do doctors, scientists, hospitals, academic institutions or governments wish to expend limited financial resources to ascertain through clinical trials whether a device is safe or effective, since the medical device is a commercial product.
Accordingly, the manufacturer has little oversight over company-sponsored clinical trials which will assist in its marketing of the device.
Device manufacturers heavily market their devices using the results of clinical studies. In this age of "evidence based medicine," the randomized clinical trial ("RCT") is regarded as the most reliable of clinical studies. Lower levels of reliability come from matched cohort studies or single cohort prospective studies. Other forms of clinical studies are retrospective studies or meta-analysis, which combines the data from a number of clinical studies.
A great deal of caution should be had around the issue of how the results of a RCT are reported. Such studies have the patina of epidemiological reliability, but the results are often improperly reported by manufacturers. The key question is whether the study has sufficient statistical "power" to establish that there is a statistically significant difference between the effects of treatment by the manufacturer's device as against another device or form of treatment in the other arm of the study. It is unfortunately common for a device manufacturer to assert that the RCT demonstrates safety, efficacy, or an effect of treatment, when in fact the study has no statistical power to so demonstrate.
What drives the medical device industry at present is demographics. The "baby boomer" generation is in its 50s and 60s, is affluent, and is demanding to push the envelope of function and mortality.
By 2003, the medical devices industry was worth $25 Billion annually, largely due to the aging of baby boomers. Orthopaedics and cardiac implant revenues are growing by 10% to 20% annually. Drug costs in Canada have increased from $3 Billion in 1986 to $20.6 Billion in 2006, with a projected $30 Billion by 2010. The most common US implants are (annually):
- Lens implants – 1.8 Million
- Heart stents – 456,000
- Artificial knees – 331,000
- Artificial hips – 192,000
- Artificial pacemakers – 152,000
- Mechanical heart valves – 38,000
- Defibrillators – 34,000
- Bladder slings – 28,000
A perfect example of the demographic imperative is the growth in the demand for defibrillators.
ICD therapy had its first human implant in 1981. In 1986, the FDA approved ICDs for sale. Since that time, ICD sales worldwide have increased from 2,000 in 1986 to 90,000 in 2005. In that time, with technological advances, the ICD has been reduced in size by 583%, from 210 cc to 36 cc, with 30 joules of output and battery life between 9 and 12 years.
Finally, the ICD manufacturers have persuaded the US Medicare and Medicaide administration to fund these devices, leading to a significant increase in implantation, at a cost of $25,000- $30,000 per device.
Efficacy and safety are the twin underpinnings of medical device regulation. Efficacy is closely tied to how the product is marketed. What does the manufacturer claim that the device is effective in doing? What benefit is promised which warrants the risk of treatment with the device? Quite often there will be a disconnect between the claims of efficacy in the regulatory application and the marketing claims made subsequent to the receipt of regulatory approval. Typically, the claims of efficacy will most accurately state the claimed benefit of the device. Quite often the regulator will restrict the manufacturer's representations of the claim benefits, and restrict the indications for use in the labelling the manufacturer may use. Once the product is released into the market, the manufacturer may market the device for indications well beyond those approved by the regulator.
The U.S. Food and Drug Administration is the foremost medical device regulator in the world, with significant financial and human resources to evaluate both safety and efficacy, before a medical device application is approved. However, no regulator does its own original research.
Rather, it evaluates and critiques research designed and conducted by the manufacturer. It is dependent on the honesty and good faith of the manufacturer to disclose all material data, whether those data positively or negatively reflect on the safety and efficacy of a new device. The medical device area is well-known for significant examples of misrepresentation, nondisclosure and fraud on the FDA [c.f. pedicle screws, as an example].
The FDA regulations also include other important elements of good medical device regulation. The manufacturer is required to report all adverse events occurring not only within the U.S.A. but also worldwide. This allows for global tracking of adverse events and comparison of the device complication rates to those of other similar devices.
Perhaps most importantly, most device manufacturers are subject to an obligation to report all data acquired following regulatory approval, as a condition of the original approval. Thus, where in vitro, animal or clinical studies are concluded following approval of the device, the manufacturer is obliged to report those data. This, in theory, allows the regulator to re-evaluate a device subsequent to approval, should negative data and adverse events warrant a second look.
FOOD (AS IN GOOD LABORATORY PRACTICE, GOOD STATISTICAL PRACTICE, GOOD MANUFACTURING PRACTICE – GLP/GSP/GMP)
These are industry standards, compliance with which enhances the reliability of the study or manufacturing process. The FDA regulations require that the various tests, studies and trials conducted in support of a medical device regulatory application should be conducted in accordance with these standards, so that the regulator may be assured that the results are accurate, reliable, reproducible and can be audited.
Canada's medical device regulator has arguably done a poor job with its mandate of protecting the Canadian public from unsafe, ineffective devices. In the wake of the public health disasters created by the failed Bjork-Shiley heart valve, the Dalcon shield, and TMJ implants, the 1992 Hearn report, "Direction for Change: Report of the Medical Devices Review Committee", stated as follows:
"Canadians have an unrealistic sense of security regarding the safety of medical devices. Thus believe that most medical devices are evaluated by the federal government before they enter the marketplace. This not the case. Canadians need to develop a better understanding of risks and benefits as well as their responsibilities in the medical devices field. This they cannot do without information that empowers them to take an active decision-making role".
"Twelve years later, the Canadian Auditor of Canada reported to Parliament about Health Canada operations. In a frank and sobering assessment, the Auditor General stated: Health Canada is aware of the gaps and weaknesses in the Program, but has made limited efforts to address them. Limited financial and human resources and limited progress in advancing international regulatory cooperation prevent Health Canada from addressing these gaps and weaknesses. This, in turn, prevents it from delivering the Medical Devices Program as designed.
Our findings indicate that the current Program is not sustainable. As such, Health Canada must make a choice: It must provide adequate resources to deliver the Program as designed or redesign the Program and the Regulations to allow for health and safety risks to be managed in a way that requires fewer resources."
As a result of this divide between its mandate and its failure to meet that mandate, Health Canada has been the subject of a number of lawsuits claiming regulatory negligence.
The medical device regulations were changed as a result of these perceived inadequacies, which resulted in the 1998 MDRs. Besides bringing in a mandatory system of adverse event reporting, the regulations also created a "user pay" system, where new device and drug applications required payment of greatly increased fees, and the expectation that the approval process would become more "efficient", greatly reducing the time for approval, and greatly increasing the pressure on Health Canada evaluators to quickly review and approve the application. These changes have been subject to criticism in some quarters that the manufacturers were now considered the "client", and that the protection of the public is no longer paramount. One example of this expedited, "efficient" approval process involved the St. Jude Medical Silzone heart valve, where the time from submission (May 23, 1997) of the medical device application to the time of the granting of a licence (July 14, 1997) was about 52 days. The FDA considered the same device application for approximately 9 months, and only granted an SPMA with a number of conditions attached.
In summary, Health Canada is under-resourced, under-staffed and lacking in a political will to fulfil its mandate of safeguarding the health of Canadians. Further, it lacks the regulatory and political support to do an effective job in evaluating the safety and efficacy of device applications, monitoring port-market adverse events, and enforcing compliance with the Act and Regulations.
ISOs, or International Organization for Standardization, are risk management standards which manufacturers and regulators follow in pre-market research, design, testing, manufacturing, quality assurance and monitoring of devices. In addition to the common law standard of care, ISOs provide rigorous standards against which manufacturers' conduct can be compared and evaluated.
Medical and scientific journals are key battlegrounds where device manufacturers wage their campaigns. The marketing departments of manufacturers spend enormous amounts of money financing clinical trials to get the data needed to market the device. The medical journals publish the papers reporting the clinical trial results, and became an integral part of the manufacturers' marketing efforts.
Some journals are of high scientific repute, such as Lancet or the New England Journal of Medicine. Others inhabit a second or third tier, and knowing which tier is inhabited by the journal which has published a particular study is important. It is important to look at who is on the editorial board of the journal, whether the manufacturer is a significant advertiser in that journal, whether the journal has a "declaration of interest" policy and whether the journal has adopted as editorial policy the principles of the Cochrane Collaboration, which mandate rigorous peer review before publication, and adherence to biostatistical and epidemiological principles banning misrepresentations about the effects of treatment in a trial.
Regrettably, it is understood that journals focusing on devices and surgery often don't have strict editorial policies, and so these journals become the unwitting marketing arm of device manufacturers.
KOL is marketing short form for "Key Opinion Leaders". KOLs are the perceived leaders in their profession, and are another integral part of a device companies' marketing strategy. KOLs sit on SABs (Scientific Advisory Boards) for particular products. They are paid about $10,000- $15,000 per annum to be a "scientific advisor". In addition, KOLs are flown to various conferences to give formal or informal presentations about the merits of the manufacturers' products. KOLs are flown to seminars sponsored by the company on hot tropical islands during the cold winter months, where they speak well of the manufacturer's product at cocktail parties. KOLs are asked to do clinical trials to study the manufacturer's device. This enhances the KOL's esteemed reputation in his or her own institution as a "mover and shaker". The manufacturer provides bountiful funding to the KOL's institution to fund a research fellow who will assist in the clinical trial, or pay the salary of an employee, or fund the administration of a database. Sometimes the company has one of its employees write the paper reporting on the research outcomes for the device, so as not to overly burden the KOL, who is very busy with his or her own practice. When the device runs into trouble, and starts to have an unacceptably high number of adverse events, the manufacturer asks the regulator, which is starting to ask troublesome questions, to contact a KOL about his or her satisfactory experience with the device. In a heavenly symbiosis, the KOL's reputation is enhanced by his or her association with the company, and the company sells a lot of devices as a result of the KOL's good work. And if the KOL has a crisis of conscience because a bad device is killing people, his or her conscience is quieted by the confidentiality provisions in his or her contract with the manufacturer.
Finally, once litigation commences, KOLs are of critical importance in stick-handling the fall-out, dissuading other experts from providing assistance to the plaintiffs.
When a manufacturer submits a pre-market device application, it must also provide the labelling it proposes to use, including the indications for use and representations of safety and efficacy. When the regulator approves an application, the labelling is also approved, and the manufacturer cannot change the labelling without the permission of the regulator.
Labelling approved by one country's regulator may not necessarily be the same labelling approved by another country's regulator. Often one sees the manufacturer, in having its labelling translated into another language, making representations forbidden by the FDA. St. Jude Medical was prevented from stating in its U.S. labelling that its heart valve was effective in reducing the incidence of infection. In Canada, the Health Protection Branch had granted a licence for the Silzone valve on the basis that the valve had been shown to be safe and effective, and accordingly the manufacturer was free to represent that the valve was effective. The manufacturers' labelling, as approved by the regulator, memorializes the representations of safety and efficacy made by the manufacturer, and plaintiff's counsel should have a very clear understanding of what the labelling means, before proceeding to a consideration of marketing.
Usually, the issue of marketing is at the core of a medical device class action. While the labelling reflects a reasonably conservative tone, so as not to offend the regulator, marketing documents give an entirely different picture. The marketing documents, advertisements, emails instructions to the sales force, and what the sales force tells the market provide the evidence supporting company misconduct and punitive damage awards. The manufacturer, through its sales force and marketing efforts, will often encourage "off label use", that is, use of the device in a way other than the indicated uses approved by the regulator. Marketing documents will assert unproven benefits, in an overblown, hyperbolic way, in order to encourage sales.
As mentioned earlier, marketing always trumps good science. Manufacturers will assist KOLs in the writing of journal articles. The articles will overstate the seriousness of a medical condition in order to create demand for the product. Journal articles written by company-friendly KOLs will be used quite literally to sell the product, or attack the safety or efficacy of a competitor's product.
Marketing is where the rubber meets the road in medical device litigation. Care should be had to get full production of all internal documents from the sales force, including all emails and records of communications and complaints from customers in the field. These will provide invaluable insight into the marketing misrepresentations which will ground liability.
In the U.S.A., many medical device cases are based on deceptive or unfair trade practices legislation, which do not require proof of reliance, create a cause of action, and often allow damage multiples when breach of the legislation is proven. Organizations such as OTLA should lobby for similar legislation here, as it is impossible given the present state of our common law in Ontario to prove reliance in the medical device area, since the patients who were the ultimate recipients of the medical device did not purchase the device.
The device manufacturer owes a duty to the regulator to disclose all data, positive or negative, relating to a particular device application. Once production has been made by the manufacturer in the litigation, great care should be taken to review all pre-market research and development, and compare what the company actually did to what the company disclosed to the regulator. Where the manufacturer omitted to disclose certain data, were the data which were not disclosed material to considerations of safety and efficacy?
As an explanation for its non-disclosure, the manufacturer will state that the study from which the negative data were generated was merely a "pre-study" study, a non GLP test, the product of a flawed protocol, the product of an inexperienced company scientist, or simply immaterial to the results.
As mentioned above, the FDA often requires a manufacturer, as a condition for approval, to continue to report on the results of the manufacturer's research regarding the safety and efficacy of the device. This is particularly important in the medical device area, where competitive pressures and the demand for new medical technologies are so great that regulators are prepared to grant approval on the basis of only short term data from studies of devices intended to remain implanted for many decades. The enormous profits from a particular device provide a massive disincentive to the manufacturer to report negative data. Again, confidentiality clauses in research contracts with KOLs and in employment contracts with company scientists, and the company's willingness to enforce those confidentiality agreements through "slap suits," means that manufacturers can often get away with pre and post market non-disclosure. It often takes a very brave "whistle blower" to bring the truth to light, as was the case with a stent manufacturer, Endovascular Technologies Inc, which failed to report to the FDA 2,628 adverse events. This led to a felony conviction against the company, and a criminal fine of just under US $100 Million.
Obfuscation is the primary job of the manufacturer's VP of Government Relations/ Communications. He is the spin doctor. He puts out the public message with the right spin. Should device adverse events become so numerous that the company has no choice but to send out a "Dear Doctor" letter, this VP ensures that the wording is such that the doctors receiving the notice are reassured that the problems are
- in a small percentage of the patients
- of limited duration
- not life threatening
- should the patient die anyway, he had considerable other morbidities
- that the company is being overly prudent and ethical in sending out this letter.
When dealing with the securities analyst, following a "Dear Doctor" letter/advisory/recall, the VP gets the company's message out that
- this problem is in a very small percentage of patients
- it is not life threatening but if the patient dies he was very sick anyway
- if any adverse events have occurred, they will occur early, and not late
- the company has more than adequate insurance limits to cover any anticipated losses or claims
- the company has taken a reserve against earnings in the current financial year
- future annual earnings are not expected to be impacted
- this press conference contains forward looking statements which may be contradicted by future events beyond our present knowledge
In communicating with the government and regulators, the VP shall reinforce the message that
- only a small percentage of patients only will be affected
- no patient faces an increased mortality risk, unless they die
- the company conducted all state of the art research in order to satisfy itself that the device was safe, but in a small percentage of patients the device turned out to be unsafe
- although the company is still studying the issue, it may be that a small number of device failures are the result of patient related factors
PRODUCT PERFORMANCE REPORTS (PPRs)
The FDA requires PPRs to be filed annually. PPRs are a review of the prior year's adverse event reports, and incorporate the company's trend analysis (see infra).
Often adverse event reporting requirements provide critical information about the mechanism of failure of the device. Careful reading of the PPRs after market approval, and the comparison of the PPRs as they evolve with the regulatory submission, often provide the key evidence of the device defect.
Quality Assurance Systems are a requisite element of ISO standards, and something which the FDA expects a device manufacturer to have in place. Where the defect in a medical device involves one relating to manufacturing, the QA systems will be an important focus of the discovery process.
One illustration of the importance of QA systems discovery to the outcome of the case is the Sulzer hip implants litigation. In that case, the device manufacturer subcontracted some of the manufacturing processes to other companies. The subcontractor failed to follow the manufacturer's QA systems with respect to device cleaning and sterilization prior to packaging, with the result that a residue of oil was left on the implant. When the device was implanted, the oil residue impeded the healing process, resulting in a high rate of device failure and reoperation. The QA system failings were easily established, and the case settled at an early stage in litigation.
A more recent example of QA system failings is the Guidant defibrillator case. In that case, following the recall of various defibrillator models, the FDA performed two inspections, which resulted in two reports regarding QA systems failings. In addition, the company itself commissioned a panel of experts to review company policy and procedures which had allowed the defibrillator problem to occur, and the expert panel ultimately published a report which was a stinging indictment of the lack of QA systems at Guidant. The report criticized Guidant for the following failings:
- Guidant's failure to enforce its policy on patient safety;
- Guidant's policy of permitting performance within anticipated adverse event rates to pre-empt patient safety in the evaluation of device performance;
- Guidant's systemic lack of quality assurance systems;
- Guidant's failure to discharge its obligation to warn physicians and patients;
- Guidant's ineffective post-market surveillance process;
- Guidant's lack of an independent committee of experts to evaluate product performance and risk assessment data; and
- Guidant's lack of an independent committee of experts to advise on actions to be taken regarding device failures and malfunctions.
This expert panel's report provides a road map to proof of the liability case against Guidant.
The FDA, Health Canada and other regulators have the power to order a device manufacturer to perform a recall for a defective medical device. This power held by the regulators is in fact exercised very seldom. It is the company itself that performs the recall. However, if the company becomes insolvent and is unable to perform the recall, then the FDA has been known to do the recall itself, as was the case with respect to the Vitek Proplast TMJ implant. In that case, ironically, Health Canada refused to get involved in conducting a recall, even though the FDA was involved, Vitek Inc was bankrupt, and there was no one else to conduct the recall in Canada other than Health Canada.
The regulatory reality is that a recall is very seldom ordered. Rather, in a situation where adverse events for a device are trending into the unacceptable range, the FDA begins a dialogue with the manufacturer aimed at reaching a consensus between the manufacturer and the regulator as to what is the most appropriate course of action.
It is unusual to see something occur as happened with the Guidant defibrillator case. In the spring of 2005, the death of a Guidant defibrillator patient and persistent media interest forced Guidant to issue a device advisory or a "Dear Doctor" letter, alerting the medical profession to certain defects in the defibrillator. The FDA then reviewed this advisory, and fundamentally disagreed with the company's approach of simply reassuring physicians and patients that the defect was one which occurred very rarely. The FDA reclassified the advisory as a Class I recall, meaning that the FDA judged the situation to be serious. A Class I recall is one where the device defect, if it occurs, will likely cause death or irreversible injury. Accordingly, Guidant was compelled to recall various defibrillator models. Thereafter, as a result of the FDA scrutiny of its operations, many other Guidant models of defibrillators and pacemakers were also subject to recalls.
It is a very rare thing to see Health Canada order a recall if the FDA has not. Generally, Health Canada follows the FDA's lead. Indeed, the FDA, Health Canada and the English MHRA have regular conference calls and meetings to discuss current or evolving problems.
Other regulators in the rest of the world should not be forgotten. It sometimes happens that a device will be recalled by a regulator in another part of the world, and this becomes important evidence on the issue of the manufacturer's duty to recall. For instance, in the Silzone heart valve case, the English Medical Device Agency [as it then was] issued a device advisory for the Silzone valve in November, 1999. The Australian and New Zealand governments then ordered the Silzone heart valve recalled in November 1999, even as the FDA was negotiating with St. Jude Medical on the issue. It was only in late January, 2000, when St. Jude Medical had absolutely no choice, that the Silzone heart valve was recalled. However, the FDA had not ordered it to do so, notwithstanding the actions of other governments.
A recall in one country tends to have a domino effect on worldwide sales. It usually is the case that, once a device advisory or a recall is announced in one country, a worldwide recall of that device will become inevitable.
A device advisory or a recall is a significant event, having a massive impact on sales of the device and share price/market capitalization. In order to avoid such significant fall-out, when a manufacturer becomes aware of device defects which should prompt a device advisory, and therefore risk the prospect of a recall, manufacturers often engage in a "silent recall". This involves quietly withdrawing a particular model of the device from the market, and releasing a "new and improved" model, with a different name and model number, into the market, but without fixing the problem. Any negative perception in the collective mind of the medical profession about the device is erased, as the defects are associated with the model no longer available. In medical device litigation, great care must be had to scrutinize the company's predecessor models which are no longer available. It often turns out that the defects in the predecessor models which have been silently withdrawn from the market are the same defects as in the current model.
As discussed above, safety, along with efficacy, are the guiding concepts in medical device regulation. There is an explicit statutory requirement that in the Food and Drugs Act that medical devices implanted in humans must be safe [c.f. s.19, Food and Drugs Act, R.S.C. 1985, c. F-27]. Accordingly, the manufacturer must submit sufficient proof of safety in order to satisfy the regulator that the device is safe for the intended use.
The paradox of proof of safety for medical devices is that these devices are intended for long term implantation. However, the manufacturer is not required to have the results of long term clinical trials before receiving regulatory approval. This paradox is exemplified by the St. Jude Medical Silzone heart valve case. The manufacturer had a very successful mechanical heart valve, which had been the industry leader for over 20 years. The manufacturer decided to add silver onto the sewing cuff, and market the valve as one which would decrease the incidence of bacterial endocarditis, a potential complication with any mechanical heart valve implant. For several decades, scientific literature had characterized silver as being toxic and potentially carcinogenic. Silver had never before been used in cardiac implants. There were no clinical studies where silver had been used in cardiac implants. Notwithstanding the lack of scientific information about the short term or long term safety in humans, and only on the basis of short term animal studies, the regulators granted approval for the Silzone heart valve in Canada, U.S.A. and Europe.
Once it is granted regulatory approval, the manufacturer can and will claim that the device is safe and effective, because the regulator has licensed it. Once the device is introduced into the market place, there is an assumption amongst physicians and scientists that the device is safe. Accordingly, in order to get the product removed from the market, the burden of proof is stacked in favour of the device, and ironically more proof that the device is unsafe is required to get the device removed from the market than the safety data required to obtain regulatory approval, particularly so when the regulatory approval process was an SPMA, 510 (K) or supplementary licence.
Every device manufacturer has a department which receives adverse event reports, analyzes those adverse events reports, reports the events to regulators as may be required, and performs trend analysis.
In medical device litigation, internal trend analysis provides valuable evidence that the device is defective, the manufacturer knew about the defect, failed to recall the device, and failed to warn regulators, physicians and patients.
The duty placed on the manufacturer to report an adverse event to the regulator requires all events to be reported, where that device may have caused or contributed to the adverse event. Various studies have been performed on behalf of the FDA which indicate that less than 10% of device adverse events are in fact reported. In part, the reason for this significant underreporting is that physicians and hospitals view causation in a rigid and scientific manner, even assuming they are aware of some duty to report adverse events. Most physicians believe that they should not report an adverse event potentially involving a device unless they are convinced that the adverse event was caused by the device (in the scientific sense, with a P value < 0.5%). Where they have any doubt at all, they will not report the matter as an adverse event to the manufacturer, and accordingly the manufacturer will not report that adverse event to the FDA.
If an adverse event is reported to the manufacturer by a physician or a hospital, then the manufacturers are legally obliged to report it to the FDA and to Health Canada (where the adverse event occurs in Canada). The manufacturer's second line of defence is to turn the adverse event reporting process into an advocacy piece. The manufacturer will attempt to gather some evidence in support of an argument that the adverse event is not device-related or, that the adverse event occurred by indeterminate factors, because the device was not returned for inspection, the patient died, the treating physician would not respond to inquiries, etc.
The manufacturers usually have a well established idea of what complication rates are in comparable devices, and so trend analysis does provide a very useful monitoring function of the clinical performance of the new device.
As the now former U.S. Secretary of Defence Donald Rumsfeld has said, "there are known, unknowns and unknown unknowns". Medical device mass tort/class action litigation carries with it tremendous risks, in large measure because of the unknown, whether known or unknown. When evaluating a case initially, much information is needed in order to perform a due diligence analysis of whether the case is worthwhile, balancing risks and rewards, to become involved in. Unfortunately, much of this information is unknown or unknowable at that stage.
The manufacturer employs a number of techniques to attempt to preserve as much information in the unknown twilight zone as possible.
One technique is attorney/client privilege. This privilege is broader in the U.S.A. than it is in Canada. Accordingly, if a manufacturer believes that its device is heading into stormy waters, the in-house legal department becomes involved, and from that point forward all documents relating to the device are claimed to be privileged.
A second technique is the use of a confidentiality agreement. There will be individual mass tort cases brought against the manufacturer, where the liability, causation and damages cases are strong. The manufacturer, in order to keep these cases out of the public eye, will settle them, but only with a confidentiality agreement in place. These agreements make it a material term of the settlement that the plaintiff must keep the amount and other terms of the settlement confidential, failing which the settlement money must be returned to the defendant, and the plaintiff may be subject to damages. In a few states, there have been legislative initiatives to outlaw confidentiality agreements as being contrary to public policy. Unfortunately, there has not been sufficient public support as yet for such changes to US State laws. Even more regrettably, confidentiality agreements are slowly but surely creeping into Canadian litigation.
Another technique of keeping the unknown unknowable is court-sanctioned confidentiality orders. Again, the litigation culture in the U.S.A. is much different than in Canada. The U.S. legal environment appears to give much more deference to documents produced in a course of litigation over which business or proprietary interests are claimed. Again, the use of confidentiality orders is slowly creeping into Canada, as Canadian medical device litigation becomes more and more integrated with U.S. multi-district litigation.
Finally, confidentiality clauses in the manufacturer's agreements with doctors, scientists and other KOLs often puts a chill on open communication, and puts physicians in a conflict between their contractual confidentiality obligations to the manufacturer and their ethical obligations to their patients and to science.
VORTEX OF LITIGATION
Class actions/mass torts medical device litigation is not for the faint of heart. It requires enormous financial resources to fund experts and the lost opportunity cost involved in litigation, which may require most of a lawyer's time for the next 6-8 years, with the lost billings resulting from that concentrated long-term effort. The only sane economic model for plaintiff's medical device class action work involves multiple firms from multiple jurisdictions sharing the effort and financial resources, sharing the risk and the reward.
Medical devices are manufactured and distributed for the worldwide market. When a device fails, is recalled, or injures or kills hundreds or thousands of people worldwide, if you are one of those injured or killed, it is best to live in Canada, the U.S.A. or Australia. These jurisdictions provide satisfactory legal mechanisms for obtaining fair compensation.
Various countries within the European Union are at present considering some form of class action recovery. The debate at present, focused by industry sponsored lobbyists, has been crafted against class action reform, claiming that it would bring with it wholesale importation of an American litigious mentality and a host of other social ills apparently embodied by American social mores. Industries lobbyists also contend that European regulators do an excellent job and that there are no defective products anyway.
Combined with a lack of effective European compensation systems is an increasing reluctance of judges in the U.S.A. to sanction "long arm" jurisdiction over foreign claimants. The most recent examples are the rulings of Judge Fallon in the Vioxx MDL and Judge Higbee in New Jersey State Court, refusing to allow European resident Vioxx claimants to prosecute their actions against Merck in the U.S.A.
The sum total of all of the above is that the multinational U.S.-based device manufacturer can significantly profit from a defective device, and not have to compensate many of the patients injured by that device who happen to live outside of North America.
Towards the bottom end of the alphabet, one meets with considerable challenges, so my apologies for any liberties taken from this point forward.
Experts are the heart and soul of a medical device class action or mass tort program. The plaintiff's counsel will usually need an entire panel of experts, from different areas of specialization. These may include multiple experts from the area of speciality implanting the device, plus regulatory experts, biostatisticians, epidemiologists, marketing experts, biomaterials specialists, diagnostic testing specialists, economists, and others. A plaintiff counsel group can expect to pay over $1 Million for expert costs through to the conclusion of trial, so as stated above, this practice area is not for the faint of heart.
Experts are of critical importance to the case, in terms of getting the case certified, and proving liability and general causation at a common issues trial.
The Daubert challenge, and "Daubert-izing" your expert panel, are essential to the ultimate success of the action. The defence will at some point in the case bring a Daubert motion, and seek to strike some or all of the evidence of various key experts, either on the basis that the experts are not qualified to give the opinions they gave, or that the opinions they gave are "junk science", that is, opinions which have strayed beyond the accepted standards of their area of specialization, haven't been peer reviewed, haven't been published in scientific journals, etc.
As is often the case with implantable device litigation, the mechanism of failure of that device, and the medical problems resulting from that failure, are new to medical science, and are basically unique to that device. Accordingly, given that the device defect raises novel issues, the deck is stacked in the defence's favour for making Daubert arguments. The importance of a Daubert motion is that if the defence successfully excludes the evidence of one or more experts on the plaintiff's panel, the liability or causation case may collapse, because each of the experts on the panel relies on other experts on that panel in order to formulate his or her opinions. Destroying one or two links in the chain may collapse the entire case. It is thus very important to choose your experts wisely, and prepare them in such a way that Daubert challenges can be fought off.
This is the reward side of the risk/reward equation, and is so important to case selection. The case must affect a sufficient number of patients to make the case a financially justifiable undertaking. The damages must be reasonably clear and of sufficient magnitude per patient to make the case worthwhile. Also, an assessment must be made of whether the case is better prosecuted as a mass tort or as a class action.
The zenith is when you have prosecuted a medical device class action, for a few years or many, and have maximized value for your shareholders, the class members. Once you have done so, you may rest...until tomorrow, when your next medical device class action begins.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.