Alexandra L. Foulkes*
When a little boy’s doctors relied on his genetic test results to guide their choice of treatment, they opted for medicines that eventually killed him. The lab that generated the genetic test results knew, at the time of the report, that these results might have meant something other than what was communicated to the doctors. Had his doctors known what the lab knew, their course of treatment would have certainly changed. Whether we see the lab as this narrative’s villain depends on our perspective. And though, of course, it is tempting to name a villain under these circumstances, doing so leaves the problem unsolved. This Article proposes that the best way to prevent outcomes like this in the future is not by punishing the lab’s conduct but by properly incentivizing it to perform for the public good. Class action theory and economics help us think of clinical genetic laboratories as DNA aggregators, free to benefit from their work. And, with this framework in mind, incentivizing labs to reorganize as benefit corporations and adopt contracts and practices that protect their business will lead to the implementation of more effective reclassification and recontacting procedures.
Beginning when he was four months old, Christian started having seizures. At first, these were mild. Then, the seizures worsened, and the treatments his doctors prescribed repeatedly failed. His doctors suggested that Christian have genetic testing done to gather more information and figure out how to better treat Christian’s now unmanageable condition. With the prospect of a better outcome, Amy did what most parents in a similar situation would do: she had Christian tested. Now, she is convinced it was the laboratory’s test-running that killed her son. And for good reason.
The lab that ran Christian’s first tests reported nothing useful. To make things simple, the lab said Christian’s genes included a variant we’ll call X. The lab not only told Christian’s doctors that he had variant X but also told them that variant X is a variant of unknown significance. So Christian’s treatment didn’t change; the doctors kept prescribing the same medications. What neither the doctors nor Amy Williams knew was that the lab—two years before they reported on Christian’s results—had some information that X was associated with Dravet Syndrome. In fact, the lab’s chief compliance director, who signed off on Christian’s test results, was an author of a publication linking X to Dravet Syndrome. And treating patients with Dravet Syndrome using the medications, such as those prescribed to Christian, kills them. Had his doctors known that Dravet Syndrome was likely as Christian’s underlying condition, their course of treatment would have certainly changed.
At this point, it’s easy to see the lab as the villain. But, as with most things, it gets more complicated. First, we have to recognize that, even though we don’t think of our DNA as something that changes, the meaning of our genetic tests constantly does. Because our understanding of the meaning of genetic test results changes as new data accumulates, the same genetic profile that once indicated to a doctor that, for example, breast cancer was certain to develop, can later be indicative of no risk at all. Sometimes, the meaning of someone’s results changes after that person has paid to have a prophylactic double mastectomy. Or, as in Christian’s case, maybe the results go from meaning nothing to meaning the difference between life and death.
Second, the labs have complicated decisions to make as they interpret and share their information. Deciding when and how variants are reclassified is no simple task. Perhaps, in Christian’s case, the lab concluded that two publications were not enough to decide that variant X now had some reportable significance. To make matters even more complicated, the reclassification process is not standardized across labs, and labs don’t always have an incentive to share information with either their competition or the doctors with whom they work. At bottom, labs function as businesses, protecting their information, investments, and property rights in a competitive market; in turn, a young boy dies, and people carry through with unnecessary surgeries.
Whether we see the labs as villains, however, depends on our perspective. The conversation in this area has focused on whether genetics labs have a duty to update the meaning of genetic results—a duty to reclassify variants. The perspective offered is usually that of the patient harmed or the uninformed doctor, and the doctor’s consequent duties should they learn of the new information. When we think of labs amidst conversations of the fiduciary duties that doctors owe to patients and the ethical considerations entwined in doctor-patient relationships, a lab that doesn’t share potentially life-changing information undoubtedly seems villainous.
But a lab doesn’t owe the same duties that a doctor might. So, perhaps, conceptualizing labs as the businesses that they are would guide the development of more effective legal and ethical policy. Once we see labs as aggregators seeking to profit from their business endeavors—not as doctors or fiduciaries—we can promote more effective incentives for them to share information and play their proper role in reclassifying genetic data. This framing, underscoring the labs’ role as an aggregator in the reclassification and recontacting saga, undercuts the prospect of casting labs as the saga’s villain. And although we may want to have a villain in stories like Christian’s, we may well be better off adjusting our frame so that we can find meaningful solutions more clearly. It will only be with these solutions that other individuals will not suffer a similar fate.
This Article proceeds as follows. Part II describes the role of laboratories in the reclassification and recontacting context, with a focus on how labs have protected and released information on the meaning of genetic variants. Part III argues that the class action framework and the extensively developed policy supporting the mechanism helps us think of labs as aggregators, free to benefit from their work. We have precedent in our legal system, after all, for how to treat an individual property right of negligible monetary value, which, once aggregated and processed by specialists, turns into an enormous pay out—for the specialists alone. Part IV explains how labs might be best incentivized in the reclassification and recontacting context. It first turns to the prospect of reorganizing labs as benefit corporations as a way to align the interests of the labs, doctors, and patients when it comes to variant reclassification. And next, it proposes a way for genetics laboratories to protect their interests and contribute positively to the process of patient recontacting.
Not long ago, scientists completed a rough draft of the human genome. And once they did, it was only the start of a scientific revolution—we did not then, do not now, and perhaps never will fully appreciate the meaning of the code they uncovered. Nonetheless, research scientists since have come to understand more about what our genetic code means. In fact, scientists make claims of having discovered a new genetic link almost every day. And these new discoveries sometimes wreak havoc on the information doctors use to diagnose their patients. Before explaining why, and what clinical genetics laboratories have to do with this, we start with a brief science lesson.
DNA is a blueprint—a set of plans—for building a body. DNA is made up of building blocks we call nucleotides, and these nucleotides string together to form sequences that code for certain messages. We call these message sequences genes. Although most humans have an identical set of genes, sometimes our genes are made up of slightly different message sequences. That is, while almost everyone has the same genes, some people have different versions of these genes, and these different versions code for different messages. We call these versions “variants.”
Doctors use genetic variants to give patients information about their health. Genetic tests can help diagnose health conditions, identify treatment options, predict health risks, understand reproductive health, and identify effective medications. Doctors usually get information about a genetic variant’s meaning from laboratories.
Depending on how much information a lab has about a certain variant, it will classify the variant under one of several categories including benign, pathogenic, or uncertain significance. If the lab finds no information that the variant is linked to a heightened risk of disease, then the lab will classify it as benign. Conversely, if a lab uncovers information linking a variant to a heightened risk of developing disease, then the lab will classify the variant as pathogenic. Easy enough—but benign and pathogenic aren’t the only options. Variants without a known risk profile are classified as variants of uncertain (or unknown) significance: a “VUS.” So, when a lab doesn’t have enough information to fully understand the medical impact of a variant, the lab doesn’t report back to the doctor any clinically actionable information. A VUS simply indicates that the patient’s version of the tested gene is different from the majority of the population’s, but the lab doesn’t know if the difference is neutral, good, or bad. It is with a VUS classification that things can get especially murky.
Most often, labs are responsible for collecting, aggregating, processing, and making sense of genetic information. This information is constantly changing because the technologies that labs are using to understand the meaning of genetic variants, and the field of genetics itself, are quite new. As new information about these variants is uncovered, their classification might change. For example, a variant that a lab categorizes as a variant of unknown significance today—because of a series of scientific discoveries that better explain what the variation means—might come to be categorized as a pathogenic variant tomorrow. The process by which a variant’s label changes is known as reclassification.
For all labs, reclassification is time-consuming, expensive, and usually unprofitable. What makes reclassification exceptionally complicated, however, is that labs classify variants on their own terms. One lab is free to classify a particular variant differently than other labs. Each lab uses its own set of internal protocols for reclassifying variants, and each lab also uses its own sets of genetic reference data to make sense of new information. Ultimately, labs are in control of the reclassification process, which is critically important for accurate medical diagnoses. There is no governing body telling labs when and how to reclassify variants. Once a lab reclassifies a variant, this reclassification must be used to reupdate the patients’ results. There is also no standard procedure for how to communicate to patients that the meaning of their genetic tests has changed.
Once a lab reclassifies a variant, it is in possession of valuable—and sometimes clinically actionable—health information. The patients that once were told by their doctors that they had variants of uncertain significance, however, will never know that their same variant now means something of importance. For example, it could indicate that they now have a heightened risk of breast cancer. Unless there is a mechanism in place for supplying the patient with this information, the patient will remain in the dark. As of now, there is no consensus on what this mechanism should be.
Whether the lab or the doctor should be responsible for recontacting the patient is unsettled. In fact, at present, there are no recognized legal duties either to reinterpret genetic variants or to recontact patients with new information. And, of course, it is patients who stand to be harmed by the variant reclassification process. VUSs can be unsettling, leading to mistrust of doctors and the healthcare system. Patients may also take unnecessary medical action. For example, a woman underwent a double mastectomy (and convinced seven of her family members to do the same) because her genetic tests revealed she was at heightened risk of breast cancer—only to find out that same genetic test later meant something different. Conversely, patients could lose the opportunity to take potentially life-saving clinical action, as in the case of young Christian.
The conversation around reclassification and recontacting, and the duties that courts might impose on labs in this context, has centered mainly on how patients might recover legally for these potential harms. As ethics and policy guidelines develop, there is a glaring omission in how we think about labs amidst conversations of the fiduciary duties doctors owe to patients and the ethical considerations entwined in doctor-patient relationships: the framing of labs as businesses.
Perhaps duties, regulations, and lawsuits have some role to play in incentivizing labs to reclassify data in the most efficient and effective way. The scope of these hypothetical duties has been explored elsewhere. But I argue here that this role is a limited one. In this context, we must consider both the carrot and the stick, and in identifying which incentives might work best, we simply must conceptualize labs as the businesses they are. Thus, I turn to the legal precedent justifying doing exactly that.
I look first to the value of DNA aggregation. Next, I address the benefits of small claimant class actions; a look to class action lawsuits serves as a helpful tool for justifying and understanding a system where the aggregator of property rights in genetic data stands to profit maximally, with no obligation to share the profits. Finally, I analogize the two mechanisms and conclude that legal and ethical policy should develop so that labs, as aggregators, can keep profitting from their business endeavors while also providing necessary information to patients.
Most of us perceive an individual’s genetic information as something of intrinsically high value. Our genome is a cipher of who we are. It’s the key to our family history and a predictor of our vulnerability to disease. But at its core, this perception is misguided because it equates the value of the interpretation of an individual’s genetic code with the value of the individual’s genetic information itself. With very few exceptions, an individual’s genetic data alone is neither useful nor valuable. Before genetic data can be analyzed and applied, aggregation on a large scale must take place. Samples from hundreds—if not thousands—of people must be collected. This data must then be processed and interpreted by specialists. And yet, the possibility that individual donors are somehow being shortchanged if they don’t benefit from the lab’s payout seems reasonable at first blush.
Keep in mind, though, that we have precedent in our legal system for how to treat an individual property right of negligible monetary value, which once aggregated and processed by specialists turns into an enormous payout only for the specialists. For example, a class action lawsuit is classically characterized by the aggregation of a large number of property rights, which individually have a trivial monetary value. Without aggregation, each claim is essentially worthless, as the cost of litigation would far surpass the underlying value of the claim. Once a lawyer has successfully aggregated, processed, and litigated the claims, the legal system allows the lawyer to profit tremendously. The individual claimants, meanwhile, get nothing more—and sometimes less—than the value of their original property right.
Proponents of small claimant class actions will most commonly point toward the class action’s use as a deterrence mechanism. Class actions provide a way to sanction bad behavior that creates a considerable total cost diffused over a large number of victims. The minimal damage to each victim guarantees that, alone, individuals will rarely bring suit. Therefore, without the class action mechanism, the bad actor is free to violate the law so long as the negative effects are widely dispersed. The value to society incurred from class action lawsuits comes not from making each plaintiff whole, but rather from the resultant regulation of private conduct in ways that would otherwise be lost. As a consequence of class actions, class members receive—at most—their claim’s market value. The lawyers responsible for processing and aggregating claims are the only ones that profit in exchange for generating a net benefit to society.
The class action mechanism also aids in avoiding regulatory capture. Capture is reflected in a regulator’s excess of passivity and reactivity and is the process by which policy begins to look more like what the regulated entity wants and less like what the public interest requires. In addition, the decisions issued by courts have external effects on non-parties. And a successful class action brought against a large corporation can set a policy agenda for generations. But because most individual members of the general public who are negatively affected by the actions of regulated entities have very little at stake, a collective action problem prevents them from pooling together to deter capture. Incentivizing lawyers to aggregate and bring class action suits solves the collective action problem by having a single interested party round up a large number of disinterested individuals.
Much like a cause of action that is well-suited to class action treatment, an individual’s genetic information is of no meaningful monetary value— although recently, some states have passed legislation creating a legally cognizable property right in a person’s DNA. All legislation passed so far requires only that informed consent be obtained from the donor of genetic material prior to collection. But in the wake of this movement, some have called for the regulation of aggregators’ profits and the imposition of some duty to share their work with competitors. When it comes to reclassifying the meaning of genetic variants, laboratory databases that collect information from various sources are especially useful. The parallels between the property rights to a cause of action (well suited for class action treatment) and genetic information help to understand and justify a system where the aggregator of property rights in genetic data stands to profit maximally. These parallels can help us think of labs as the businesses that they are and then develop policy accordingly.
In class actions, lawyers who spearhead aggregation and processing efforts for a large number of small claims provide a benefit to society. Without the lawyer looking to profit from their efforts, bad actors would be undeterred in causing dispersed but systematic widespread harm. Likewise, the potential benefit to society stemming from vastly dispersed individual genetic codes can never be realized without aggregation. To learn what genetic variation means for predicting propensity to disease, specialized parties must first collect genetic material from a large number of individuals. The aggregator must then—at their expense—process the samples and interpret the results. We can test an individual’s genetic material and deduce certain findings about predisposition to disease only because large databases against which to compare the individual’s material exist.
The benefit to society from genetic material is incurred at the expense of the aggregator, given the aggregator’s investment of effort, time, and resources into developing useful databases and identifying meaningful genetic mutations within a population. The individual holder of genetic property is unable to make use of his property alone, just like the individual who holds the right to a small value claim is unlikely to bring suit. Like the lawyer who invests their own resources into recruiting clients, processing their claims, and championing the litigation, the aggregator of genetic material should profit maximally in return for their investment, which is ultimately responsible for generating an important societal benefit.
Aggregators of genetic information also help solve another collective action problem. Under the current rules, owners of genetic information relinquish their property rights by signing informed consent. The aggregator then uses the collected samples to run a variety of tests and build a number of databases. The aggregator is typically also free (and often incentivized, although, certainly not obligated) to share the databases with other groups, who then might run different tests for investigating different conditions. All areas of research that benefit from the current aggregation process would likely receive less attention if individual property owners had to seek out the different causes independently and negotiate compensation for their individual genetic data in exchange for participation in the research. Like the aggregator in a class action scenario—steering public policy to the benefit of society through their efforts—the aggregator of genetic information also solves problems that would result from passivity and reactivity. The specialist in both cases sets in motion the mechanism by which aggregation affects third parties: the lawyer by establishing a new policy agenda through the litigation of a class action lawsuit against a large corporation, and the aggregator of genetic information by sharing the data and promoting discoveries in fields outside of the interests of the aggregator alone.
In both the class action scenario and in the context of genetic information, the aggregators solve collective action problems to the benefit of society. Make no mistake, however, in both cases, this consequence is secondary to (perhaps even dependent on) the success of the aggregator’s business. Like class action lawyers who are justified in benefitting maximally from their involvement in generating these societal benefits, so are the institutions responsible for the aggregation of genetic information.
To be sure, the labs’ role as an aggregator is only one of many aspects of their role in recontacting and reclassification. But understanding the labs’ incentives and how the law might value their role in the recontacting and reclassification scheme will be decisive in whether policy and ethical guidelines surrounding reclassification and recontacting ultimately cast the labs—seeking to profit maximally from their efforts—as genetic villains in this space. Arguably, the class action mechanism and the relevant policy that has developed in the class action context provide some guidance and justification for how legal and ethical policy should develop as it relates to labs as aggregators, seeking to profit from their business endeavors, in the reclassification and recontacting context.
Of course, I do not mean to suggest that we should let the market alone do the work of regulating labs in the space of reclassification and recontacting. But I am suggesting that, if we think of labs as DNA aggregators, the ultimate impact of legal duties on the success of variant reclassification and patient recontacting will be limited. To be sure, the duties labs might owe in the reclassification and recontacting context have been thoroughly explored elsewhere. And as of now, none has been conclusively established. Any further discussion of these is beyond the scope of this Article. Having conceptualized labs as DNA aggregators, my focus here is on proposing solutions to the benefit of the reclassification and recontacting processes that might be attractive to these businesses. I first describe below how incentivizing labs to reorganize as benefit corporations would drive labs to reclassify variants more efficiently. I then turn to recontacting and explain how labs might take minimal action to protect their business and still contribute beneficially to the process.
Many, but not all, clinical genetics labs are currently organized as corporations. The notion that labs have an ethical obligation to protect the public or the patients’ interest in the reclassification context, though often posited in the reclassification and recontacting literature, is arguably in tension with a labs’ fiduciary duties as a corporation. Recall that reclassifying genetic variants is time-consuming, expensive, and usually unprofitable for labs. It often takes as long as ten years to reclassify variants once a lab has some indication that new information might be of consequence to a gene’s classification. So long as labs are beholden to shareholders, we can expect them to continue to act as players in a competitive market. Independently of how clinical genetics laboratories are currently organized, it appears none has yet adopted a model which might align the labs’ interests with those of the patient in the reclassification context: the benefit corporation.
The benefit corporation is a fairly recent, attractive development for labs in the role of DNA aggregators that are considering a broader focus on social responsibility. The benefit corporation seeks to balance the competing and sometimes conflicting interests that arise when a business seeks to be both for-profit and mission-driven within a single entity.
As of 2021, thirty-seven U.S. states have passed legislation making it possible for companies to incorporate as public benefit corporations. A benefit corporation looks like a standard corporation in most respects. Unlike other corporations, however, a benefit corporation is required to write its mission statement directly into its official charter and is not limited to shareholder wealth maximization. Organized as benefit corporations, clinical genetic laboratories would be legally obligated to have a corporate purpose that creates a positive impact on society. Specifically, the labs’ “fiduciary duties of directors are expanded to require consideration of nonfinancial and stakeholder interests beyond the economic interests of shareholders.” And labs would have to “periodically report on their overall social and environmental performance,” which would then be assessed against a credible standard.
As part of their mission statement, then, clinical genetics laboratories could include the prospect of reclassifying genetic variants in a timely and efficient way. That way, success in the reclassification context is aligned with the organization’s success. This would incentivize labs to do what ethicists and other do-gooders have wanted them to do all along, while protecting the labs’ officers from fiduciary liability.
Incentivizing clinical genetics labs to organize (or reorganize as the case may be) as benefit corporations might serve as a more efficient alternative to enforcing complicated legal duties and pursuing expensive lawsuits, which may or may not be successful. Doctors could select the labs they use based on whether they are organized as benefit corporations. As an alternate incentive, regulatory bodies and ethics boards could condition the grant of certain benefits or permits on the labs’ mission statement and compliance with the legal requirements of benefit corporations.
If labs opt to organize in this way, they would not be the first players in the medical field to do so. Other areas of medicine have already considered shifting their mission and practices from a focus on creating public wealth to a focus on creating public good. Groups of physicians and drug developers, for example, have considered the new business structure of benefit corporations. This would be a good way for DNA aggregators to prioritize both patients and profits and make reclassification a part of their mission to the benefit of all.
Although benefit corporations are a possible solution to the reclassification of genetic variants, they do not solve problems related to reupdating patient information. As noted above, once a genetic variant has been reclassified, a patient’s information has to be reupdated. Take, for example, the following scenario: first, a particular genetic variant in the lab’s database goes from being labeled a VUS to pathogenic. Then, the information in the database has to be applied to a patient’s file to reupdate the variant’s newly uncovered meaning to their results. The patient then has to be informed of this change. Again, whether duties will be imposed on labs in the recontacting context is uncertain.
How these hypothetical duties are enforced will, in all likelihood, vary greatly depending on the size of the lab and the type of testing the labs conduct. But while the literature has focused on how labs might be punished for not doing their part in the reclassification and recontacting context, little has been said about what might incentivize labs to proactively protect their interests.
Before the courts get involved, proactive measures should serve as a primary safeguard from liability. Like most other businesses, labs can, by way of contract, reduce their liability in the reupdating and recontacting context.
Any disputes arising out of the genetic tests performed by laboratories are usually governed by the labs’ terms of service agreements. What those terms say can limit a given lab’s legal liability. For example, some labs have clauses that determine the applicable law or compel arbitration. Just like labs are free to limit their liability with respect to testing procedures, they could likewise use their terms of service to outline the contours of their obligations to patients related to reclassification and recontacting.
From the start, when a patient’s data is collected by a lab for analysis, the lab could introduce language into its terms explaining that a patient’s genetic test results are subject to change and outlining how the laboratory will communicate any updates related to those changes. In the terms of service, labs might require patients to maintain a current email address with the lab.
In the event of a reclassification, the laboratory would then email patients who have taken the relevant test to let them know of a potential change in their variant’s classification. The reupdate message might have a clear subject line, indicating to the patient that the meaning of their results has changed. The body of the email might be something as simple as the following: “Dear [patient]: Our records indicate that you have taken a genetic test related to [relevant gene]. We have recently reclassified certain variants of [relevant gene]. We encourage you to follow up with your treating physician.” Because the use of healthcare software and modern technology has become routine, this email template could be autogenerated as soon as the relevant genetic variant is reclassified in the labs’ database.
And so, automated email messages would be a relatively cost-effective tool that would both limit a lab’s liability and put the patient on notice of the reclassification. Once a patient is notified of a reclassification, the labs’ terms of service might also clearly indicate that the patient has the subsequent responsibility to take action if they want the lab to reinterpret their genetic data. In other words, the patient—not the laboratory—must initiate the reinterpretation process by talking to their doctor.
To be sure, using email and apps to provide updates regarding sensitive information is already a widespread practice in medicine and beyond. A vast majority of patients with access to the technology would prefer to have their providers contact them via email. The use of email has been linked to reduced costs and increased health outcomes. The Food and Drug Administration, along with other government agencies, have also implemented email update systems to electronically alert consumers to recalls, market withdrawals, and safety alerts. In the consumer genetics space—as opposed to the clinical genetics space—companies like AncestryDNA and 23andMe email their users regarding updates to their policies and changes to their results. In fact, AncestryDNA recently changed how it classified users based on their geographic ancestry—a reclassification of sorts—and informed its customers via email. Email updates are already a widely accepted method of mass communicating important and sometimes sensitive information.
This strategy has the benefit of communicating potentially valuable information to the patient with a minimal burden on laboratories. The labs must, of course, collect and maintain patient contact information. The terms of service, however, can charge the individual patients with ensuring that their email addresses are up-to-date. This process might be automated with the help of health information technology, reducing the burdens associated with reinterpreting and recontacting. After all, personal electronic health records now facilitate the speedy review of patient health data. Additionally, and, perhaps most importantly, the ability to simultaneously contact all patients with certain medical conditions via email is accessible.
The courts, too, will find this approach desirable. Informing patients of reclassification and making them responsible for taking action offers a clean solution for the courts. Fulfilling the legal duty associated with reclassification will be as simple as sending an email. Courts will then have a relatively straightforward inquiry: Did the laboratory email the appropriate patients regarding the reclassification within an appropriate time frame? Did the lab’s email clearly notify the patient of the change and the patient’s subsequent responsibility? The courts will not otherwise have to grapple with whether the laboratories or the providers made a reasonable effort to contact the patient and ensure they understood the updated results.
Make no mistake, patients also stand to benefit from this approach, particularly if courts are unwilling to impose more stringent duties on laboratories or providers. Of course, this is not a patient-centered solution, and certain barriers to access might make it less than ideal for some. But this approach likely provides a patient with more information than they would otherwise have had. And importantly, updates about reclassification give patients the opportunity to play a more active role in managing their health.
Generally, medical treatment—including genetic testing—requires patient consent. Simply reinterpreting genetic test results following reclassification without asking the patient whether they would like those services is arguably unethical. By contrast, informing patients of a relevant reclassification and allowing them to decide for themselves whether to seek reinterpretation preserves patient autonomy and privacy. This approach, thus, keeps with the recent trend toward cooperative medicine.
In some cases, unwanted reinterpretation could actually be harmful. Recall that receiving a VUS result may leave patients feeling frustrated and confused, even causing them to distrust their doctors. Reinterpreting a patient’s genetic data without their express consent may lead to further feelings of uncertainty and frustration. In cases where reinterpretation reveals previously unknown risk, the updated results could be devastating.
Consequently, a contractual solution—where the lab updates its terms of service and then asks the patient to take further action—protects the lab from liability and places some responsibility on the patient. We allow corporations to protect themselves in this way routinely, and there are few reasons to prevent DNA aggregators from doing the same. Further, this result, which is to the labs’ clear benefit, also has demonstrable benefits for the patient, the healthcare system, and the courts.
When we think of labs as villains, it is easy to want to punish them with sticks. But in the reclassification and recontacting context, everyone is better off if policy focuses on how to make better use of the carrot. The best way to prevent outcomes like young Christian’s in the future is not by punishing the labs’ conduct by turning to the courts and asking them to impose complicated legal duties. Nor is the answer necessarily to ask the already heavily regulated clinical genetics laboratories to comply with more regulations. Rather, we ought to properly incentivize them to perform for the benefit of all. Class action theory and economics help us think of genetics labs as DNA aggregators that are free to benefit from their work. And, with this framework in mind, we should incentivize labs to reorganize as benefit corporations and adopt contracts and practices that protect their business. By incentiizing rather than penalizing labs, they are more likely to implement more effective reclassification and recontacting procedures.