Health Law

The “Loss of Chance” Doctrine after Dickhoff

September 19, 2013
Healthcare, Litigation

by Alison Key, UMN Law Student, MJLST Staff

In May 2013, the Minnesota Supreme Court recognized a new cause of action against healthcare providers for medical malpractice. In Dickhoff ex rel. Dickhoff v. Green, A11-0402, 2013 WL 2363550 (Minn. May 31, 2013), Minnesota joined a growing group of states that permit medical malpractice claims for “loss of chance.”

Under traditional principles of tort law, the elements of a tort include existence of a duty, breach of the duty, causation, and injury, all of which a plaintiff must prove to the standard of “more likely than not.” This standard of proof has posed problems for plaintiffs in medical malpractice suits where the patient had less than a 50% chance of survival before the alleged negligence occurred. If the patient is already “more likely than not” going to suffer the injury of death from a condition before the negligence of a physician, it is impossible to argue that any physician conduct, even if negligent, was the but-for cause of the patient’s ultimate death.

Courts across the country have long grappled with this issue, but have struggled to find a solution. From a patients’ rights perspective, states are uncomfortable with the notion that there is virtual immunity from malpractice liability for physicians who begin treating patients after they are already terminally ill. At the same time, courts have been unwilling to hastily depart from traditional principles of tort causation and standards of proof that require a physician to be the but-for cause of the patient’s injury.

States have confronted this issue in a few ways. One is to adhere to traditional principles of tort causation and not recognize a cause of action for a patient who brings a claim of medical malpractice (generally failure to timely diagnose) after an illness was already “more likely than not” the cause of death. This would not necessarily preclude a patient from bringing an action if she had a greater than 50% chance of survival (whose condition will not “more likely than not” cause death) but due to a physician’s negligence, her chance of survival was reduced to below 50%. In such a case, the physician can be said to have caused by his negligence the injury that is “more likely than not” going to cause the patient’s death. This is the approach Minnesota took before Dickhoff.

Another “solution” is the relaxed causation/substantial factor approach. Similar to the way that tort law deals with concurrent causation, some jurisdictions have held that if the physician’s negligence and the patient’s condition are concurrent causes of death, a jury will determine whether the physician was a “substantial factor” in the injury, and award damages accordingly. This acknowledges, but “relaxes,” the causation requirements in malpractice claims with terminally ill patients, permitting recovery for the whole injury.

A final approach is the doctrine of “loss of chance.” Rather than address the causation problems when a patient is already “more likely than not” going to suffer death, the loss of chance doctrine changes the nature of the compensable injury. Instead of regarding the injury as death, the court acknowledges that any loss of chance of survival is a compensable injury itself for which the physician must be held accountable. Under this doctrine, a patient who sees a physician when her illness is already terminal, let’s say 40% chance of survival, would be permitted to recover if the physician’s negligent failure to timely diagnose her injury reduced her likelihood to 30% before treatment was administered. Under the traditional approach, there would be no way to prove that the physician “more likely than not” caused death, because the illness was always 60% likely to cause death. But under the “loss of chance” doctrine, her 10% loss of opportunity to recover is itself the injury for which the patient can recover. This is the position that the Minnesota Supreme Court took in Dickhoff, permitting patients to recover for a “loss of chance” at life.

While this doctrine has intuitive appeal, it is not without its criticisms. While the Anderson opinion rightly champions patients’ rights, physicians in “loss of chance” jurisdictions raise legitimate concerns. Subjecting physicians to liability under this standard is an imposition that no other professional organization subject to malpractice faces, payment for a loss in the likelihood of success. Such a departure from professional malpractice norms should be seriously considered before imposed. Particularly as physicians are faced with limitless options for testing and treatment, all of which may be reasonable, and for all of which another physician is willing to testify that he would have taken a different course of action. Further, many raise concerns about how loss of chance can be measured, and whether juries will be able to evaluate “likelihood” claims from experts to arrive at reasonable conclusions. There is also the effect of rising healthcare costs that often comes with an increase in liability expenses for healthcare providers.

But the Minnesota Supreme Court assures that these concerns are outweighed by adopting the loss of chance doctrine, which “will advance, not undermine, the fundamental purposes of tort law: deterrence and compensation.” There is an argument that these two justifications will not outweigh the concerns of the medical community. Aside from being offended at the notion that a physician needs a lawsuit as deterrence to responsibly treat a terminally ill patient, the issue with a deterrence justification is that most medical malpractice cases claim negligence in diagnosis. In such cases, the physician is unaware the patient is terminally ill and he has “immunity” to liability. Therefore, physicians argue that the deterrence mechanism is insufficient to warrant such an imposition and uncertainty on health law and the practice of medicine as a whole. Further, the “compensation” rationale does not sit well with many physicians who claim that compensating patients for injury and treatment that was likely to occur anyway will be a windfall for the patient at the expense of the healthcare system (the treatment and outcome for 40% likelihood of success is often the same as the treatment and outcome for 30% likelihood of success). The Dickhoff case was remanded back to the district court for further proceedings after determining that “loss of chance” was a legitimate cause of action. Further cases will show how the patients’ rights issues and the physicians concerns with this system will play out.

For further discussion of the “loss of chance” doctrine, see Tory A. Weigand, Loss of Chance in Medical Malpractice: The Need for Caution, 87 Mass. L. Rev. 3 (2002), reprinted here.

Is Food the New Tobacco: Science, Advertising, and the War Against Obesity?

April 18, 2013
Administrative Law, Agriculture, Food and Drug Law, Public Health

by George David Kidd, UMN Law Student, MJLST Staff

Globally, obesity and its underlying ailments have overtaken tobacco as the top preventable cause of death. But, while eating right and exercising might go a long way towards solving the problem, the solution might not be that simple. What drives consumer buying behavior, through more modern forms of how we interact with the world, might substantiate food science and advertising as powerful mechanisms to attack the obesity epidemic.

In Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions, published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, life and health sciences author Roseann Termini and others add advertising to the already-large list of “other” factors affecting childhood obesity rates. Indeed, children are not as informed as adults about health and may be more likely influenced by certain channels of advertising, such as television. To address this concern, one of her proposed solutions is to ban, regulate, or even shift tax structure in order to control advertising that specifically targets children. While this might be an effective mechanism to reduce demand, it may only be a partial solution. For one, because children are not, generally, the direct purchaser of food, but rather depend upon parents, to what extent does advertising actually affect the buying decisions of parents?

An article recently mentioned in The New York Times, The Extraordinary Science of Addictive Junk Food, might help answer this question. Mr. Moss similarly explores the “obesity epidemic,” but from a corporate standpoint, positing that consumers are primarily driven to buy what “tastes good.” While Mr. Moss’s article also agrees that advertising is part of the problem, he paints a more complete picture of what might be the underlying cause of parental acquiescence in a child’s poor dietary choices. The perfect combination of salt, fat, and sugar might be, in part, to blame as addicting foods that influence buying behavior. In this way, food is likened to tobacco, except, unfortunately, while people can choose whether to begin smoking, all people must eat.
While the analogy between food and tobacco may be imperfect, the point is there. If the majority of the food available to the everyday consumer is manufactured as addicting, to what degree is there a choice to eat healthy? If, in order to survive in the marketplace, a corporation has to manufacture “addicting” foods to compete, how can we make these addicting foods into disease-preventing rather than disease-aiding choices? Food science and advertising may contain the answer.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
Administrative Law, Food and Drug Law, Health Law

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
Administrative Law, Food and Drug Law, Health Law

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Agriculture, Food and Drug Law, Health Law, Healthcare, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

New Medicine Into Old Bottles, Quality and the US Medical System

March 12, 2013
Healthcare, Public Health

by Eric Nielson, UMN Law Student, MJLST Staff

This entry discusses some of the challenges identified in Grout et al.’s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don’t have any health problems, have family with health problems, or pay taxes then the problem probably doesn’t impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don’t care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.

Improving Healthcare Quality: Electronic Prescribing

February 26, 2013
Food and Drug Law, Health Law, Healthcare

by Johanna Smith, UMN Law Student, MJLSTStaff

A new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors–and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.

An article in the January 23, 2013 Journal of the American Medical Association reported that once Medicare and Medicaid stopped reimbursing costs due to certain medical errors, the number of times a foreign item was left in a surgical patient dropped by half. The authors note that this number may not be truly accurate, since the hospitals would have financial incentives to hide the errors. Currently, reporting relies mainly on self-reporting by the hospitals, which is not always accurate. A new article in the Minnesota Journal of Law, Science, and Technology (MJLST) by John R. Grout, John W. Hill, and Arlen W. Langvart entitled “Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications,” discusses how to mistake-proof medicine and looks at healthcare quality on a broader level, including electronic prescribing. The MJLST article highlights that many hospital administrators are concerned more with the finances of the hospital than with patient safety. Connecting these two items increases the probability that patient safety will become a priority for hospitals. Although electronic prescribing is not a complete fix for incorrect prescriptions, it is an important part of improving the process. Compared to the cost of medical errors–including incorrect prescriptions–mistake-proofing is generally less expensive.

States Move to Implement Health Insurance Exchanges

February 13, 2013
Healthcare, Public Health

by Brianna Rohne, UMN Law Student, MJLST Articles Editor

Proponents of the Affordable Care Act breathed a collective sigh of relief in June 2012 when the U.S. Supreme Court upheld most of the law in its decision in National Federation of Independent Business v. Sebelius. As Minnesota Lawyer reports, the health care law will have a major impact in 2013 as state and federal agencies rush to implement the ACA’s key features.

Chief among those features are the Health Insurance Exchanges, which are insurance marketplaces designed to help carry out the ACA’s key feature–the individual mandate–by simplifying the process for purchasing health insurance for consumers and small businesses in every state. As Kathleen Sebelius comments, the Exchanges will provide “one stop shopping for health insurance with better information about plan benefits, quality and cost.” The Exchanges, which will be administered at the state level, must be ready for open enrollment in October 2013 and full operation on January 1, 2014.

Department of Health and Human Services rulemaking has stressed flexibility in the creation and operation of the Exchanges, encouraging each state to take the lead in shaping their Exchange in a way that best accommodates local needs and market conditions. For example, states may choose the type of entity to operate the Exchange, limit the insurance plans eligible to participate, and partner with other states to establish regional Exchanges. HHS also offers support in the way of formal partnership, grant funding, technical assistance, and guidance on key topics.

HHS also allows states to opt out of Exchange planning altogether, leaving it up to the federal government to implement Exchanges in those states. As of early January, the New York Times reported that 23 mostly Republican-run states had indicated that they will not set up their own Exchanges. Another 17 states and the District of Columbia are moving to set up their own Exchanges and seven states have asked to collaborate with the federal government.

Ensuring health coverage and subsequently affordable health care for millions of uninsured and under-insured Americans is an ambitious undertaking, fraught with challenges that states and the federal government are just beginning to work through. In a recently published article from the current issue of the Minnesota Journal of Law, Science and Technology titled Developing a Durable Right to Health Care, Erin C. Fuse Brown discusses the momentous shift in policy accomplished by the ACA’s statutory right to health care. She goes on to warn that the ACA’s right to health care is fragile–especially early in its lifespan–and faces significant political and market challenges. Ultimately, the success or failure of the ACA’s most ambitious goals may become apparent as the federal government and states begin its roll-out over the next few years.

Brains on Drugs: The Need for a Drug Policy That Embraces Scientific Understanding of Addiction

November 7, 2012
Public Health

by Mike Borchardt, UMN Law Student, MJLST Managing Editor

The strong showing in polls for marijuana legalization efforts in Colorado and Washington illustrate that America’s attitudes toward illegal drugs is starting to shift. Though the attitudes of some voters are starting to shift on pot, there is still a strong disconnect, especially when it comes to harder drugs, between what we know about addiction and the policies we use to curb drug use. In their article in MJLST 11.1, “Why Neuroscience Matters for Rational Drug Policy,” David M. Eagleman, Mark A. Correro, and Jyotpal Singh outline this disconnect between science and policy. As they explain, “Although addiction may involve volitional choices early on, it is best understood as a brain disease.” Despite this being the general consensus of the scientific community, our drug policies do too little to address addiction as a disease.

A good example of this is the use of Suboxone (buprenorphine), a drug used to treat opiate addiction . The US government spent millions of dollars funding Reckitt Benckiser’s development of Suboxone. It is an opiate which is much more difficult to overdose on than other drugs like heroin, and it is used to help manage withdrawal and cravings. Due to fears that it will be abused, Suboxone is difficult for many addicts to get. Doctors must undergo special training to prescribe it, and they are only allowed to write prescriptions for 30-100 patients a year. Additionally, many doctors are wary of prescribing it, as they don’t want to draw addicts to their offices. This makes it more difficult than necessary for addicts to gain access to Suboxone–they turn to drug dealers on the street for a supply of it, and when the dealers don’t have it, they use heroin or other opiates to satisfy their addiction.

Making Suboxone unnecessarily difficult for addicts to get is only one example of the disregard our drug policy shows towards our scientific understanding of addiction. As Eagleman, Correro, and Singh explain (at page 20) , “The United States has a history of combating the drug problem with increased law enforcement rather than customized intervention and rehabilitation.” Despite the fact that treatment has been shown to be far more effective (both cost-effective and effective in reducing drug use) than incarceration, drug treatment programs are underfunded and stigmatized. As the economic recession in the US has led to tighter budgets, drug-treatment programs are often one of the first things on the chopping block. Though US drug policy has generally been, and still is, heavily focused on law enforcement as a solution to the drug problem, there have been some hopeful developments. The Affordable Care Act includes addiction treatment as one of the “Essential Health Benefits” insurers are required to provide. If the law is successful in getting more Americans, especially low-income Americans, health insurance, it could help provide avenues of treatment that were formally unavailable to drug-addicts due to their cost.

510(k) Process Comes Under Renewed Scrutiny by Legislators, Awaiting FDA Response as Proposed Legislation Remains Stagnant

October 31, 2012
Medical Devices

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

Several months ago, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) wrote a letter to Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration, calling for an overhaul of the 510(k) pre-market notification database. The legislators cite reports of defective medical devices cleared via the 510(k) process in recent years, such as the DePuy® artificial hip, that have caused “grievous[] and irrevocabl[e]” harm to patients.

The issue? Most devices subject to premarket review are cleared through FDA’s 510(k) process which provides expedited approval for products that are deemed “substantially equivalent” to an existing predicate device. While the 510(k) process allows patients earlier access to devices, the system is inherently flawed. Referred to as “predicate creep,” the 510(k) process clears generations of devices–none of which have been subject to the exacting scrutiny of pre-market approval (the PMA process). As Markey and Merkley cite in their letter to Shuren, many predicate devices upon which new products rely for 510(k) clearance themselves have been recalled by manufacturers due to “fundamental design flaw[s].”

The legislators asked Shuren and the FDA to retrospectively update the 510(k) database to clearly indicate devices recalled for serious design flaws that could adversely affect safety or effectiveness. The letter also asked FDA, among other things, to develop a mechanism for identifying certain 510(k) entries to “reflect instances where a device’s clearance traces back to a predicate recalled for a serious design flaw adversely impacting its safety, even if the original problematic device is not the immediate predicate.” For additional in-depth discussion of issues surrounding the existing 510(k) process and substantial equivalence, including product liability considerations see “Rethinking Lohr: Does ‘SE’ Mean Safe and Effective, Substantially Equivalent, or Both?”

After the Institute of Medicine released its highly controversial report on the current 510(k) process last year (stating that the process is flawed and recommending a new pre- and post-market regulatory framework to provide a reasonable assurance of safety and efficacy), the issue of device safety has been omnipresent in policy debates surrounding related concerns of access and innovation. For a critique of the IOM report and a summary of its findings, see “A Failure to Comply: An Initial Assessment of Gaps in IM’s Medical Device Study Committee” and “Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.” In January, Representative Markey and others introduced H.R. 3847, coined The SOUND Devices (Safety of Untested and New Devices) Act of 2012. The bill proposes to amend the Federal Food, Drug and Cosmetic Act to allow the FDA to reject a claim of substantial equivalence for a device whose predicate has been “recalled, corrected or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety . . . .” in light of these concerns.

In testimony given to the House Committee on Energy and Commerce on device user fees back in February, Shuren discussed strategic priorities for the 510(k) process, including developing methods and procedures for the systematic analysis and use of medical device recall information by September 30, 2012. However, now that the Medical Device User Fee Amendments (MDUFA III) have been enacted, reauthorizing device user fees through fiscal year 2017, perhaps the FDA and CRDH will finally be able to make progress in revamping the 510(k) system. As Shuren noted in his testimony, “[w]hile it is true that providing more user fee resources alone won’t solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to, several of these problems. Adequate and stable funding is one key component to our and industry’s success in bringing safe and effective devices to market quickly and efficiently.”

Currently, the 510(k) process remains unchanged. Though legislators requested an official response no later than September 19, 2012, the FDA and Shuren have yet to release a statement (at least publicly) regarding these concerns. Additionally, it is unclear whether CDRH has made any headway in meeting its target goals. As we approach the end of 2012, 510(k) still leaves much to be desired–the highly anticipated changes to the pre-market clearance process are provisional at best. It seems as though Markey isn’t having much luck in Congress either. H.R. 3847 is awaiting approval from the House Committee on Energy and Commerce (and has been since shortly after its introduction). According to GovTrack.us, an online bill tracking website, the bill has only an estimated three percent change of being enacted.

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