The “Loss of Chance” Doctrine after Dickhoff

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.


Cyber Security Investigation and Online Tracking

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgOn April 18th, 2013, Cyber Intelligence Sharing and Protection Act (CISPA) was passed with wide spread controversies. CISPA aims to help national security agencies to investigate cyber threats by allowing private companies, such as Google and Facebook, to search users’ personal data to identify possible threats. Commentators argue that CISPA compromises the Fourth Amendment, because, under CISPA, agencies can get privacy data of suspects identified by the privacy companies without a judicial order. CISPA bridges the gap between crime investigations and the privacy data stored and analyzed by social media companies.

Google and Facebook regularly track their user’s online behaviors, such as websites they visited or products they purchased, to figure out their personal preferences to perform targeted advertisements. These personal behavior analyses raise serious privacy concerns. Omer Tene and Jules Polonetsky in their article published in Volume 13 Issue 1 of the Minnesota Journal of Law Science and Technology, To Track or “Do Not Track: Advancing Transparency and Individual Control in Online Behavioral Advertising discussed these privacy concerns.

Tene and Polonetsky described that while targeted advertisement provides many advantages, one particular criticism is that users are deprived from meaningful control of their data. This led to various administrative proposals in the US and EU. In the US, FTC proposed “Do Not Track”, a signal sent by users’ browser to internet content providers requesting them not to track cookies. In the EU, the e-Privacy Directive required an opt-in consent for cookie tracking. The authors argue that whether cookie tracking should be “opt-in” or “opt-out” depends on how tracking is valued by the society. If the society in general values tracking as a positive measure to provide valuable services, then opt-out should be applied. On the contrary, if tracking is viewed by the society as an invasion to privacy, then opt-in should be applied.


Will AIA Post-Grant Procedures Reduce Litigation?

by Nihal Parkar, UMN Law Student, MJLST StaffNihal-Parkar-Thumbnail-White-Back.jpgThe America Invents Act (AIA) was signed into law in 2011 and fully went into effect on March 16, 2013. The AIA resulted from efforts to strengthen the US patent system and bring it in conformity with global patenting standards. One of the aims of the AIA was to reduce post-grant litigation related to patent validity. It is common for alleged infringers to challenge the validity of patents that are asserted against them in court. However, such litigation can be expensive and protracted.

Pre-AIA patent law did provide for some processes for challenging patent validity, but they were limited. The AIA tries to expand on pre-existing post-grant patent challenges by providing for patent challenge procedures that mirror litigation (discovery, witness examination, and so on) at an alternative forum for resolving validity disputes: the Patent Trial and Appeal Board at the US Patent and Trademark Office.

It is interesting to contrast pre-AIA scholarly analysis of patent challenge procedures and suggested reforms with post-AIA studies. The Minnesota Journal of Law, Science & Technology provides two contrasting articles on point. An earlier, pre-AIA article by Matthew Sag and Kurt Rohde, Patent Reform and Differential Impact (8 Minn. J.L. Sci. & Tech. 1, 2006) proposed a multistage post-grant review process. They addressed the lack of discovery and other issues in pre-AIA post-grant processes, and concluded that discovery would be unnecessary as long as the scope of reviewable issues was kept narrow. A recent MJLST note by Kayla Fossen, The Post-Grant Problem: America Invents Falling Short (14 Minn. J.L. Sci. & Tech. 573, 2013), reviews the changes introduced by the AIA, and points out that post-grant processes cannot really undo the damage created by ineffective pre-grant procedures. Therefore, the AIA is unlikely to significantly impact post-grant litigation.


Shapewear Patent War: Case of the Bad Patent?

by Jennifer Nomura, UMN Law Student, MJLST Staff

Thumbnail-Jennifer-Nomura.jpgWhen most people think of patents they think of the latest computer technology or advances in medical science; but what about women’s shapewear? For those unaware of what shapewear is, it’s basically the modern version of a corset; it keeps everything pulled in, but (hopefully) more comfortable than a corset. Heather Thomson, founder of Yummie Tummie, has a patent on some of her styles of tank-top shapewear. Corset_Patent_Image.jpgWhen she found out that Spanx, a competing company, was making a very similar looking piece of shapewear, Thomson wasn’t happy. Thomson sent a cease-and-desist letter to Sara Blakely, founder of Spanx and then took to social media to complain. Websites like Forbes and the Huffington Post picked up the story. So far, the situation sounds fairly typical of other patent infringement cases, so why all the press coverage? Did I mention that Heather Thomson is a TV star of Bravo’s Real Housewives of New York? Needless to say, Thomson is not afraid of a little drama. Thomson has declared war against Blakely and Spanx. But Sara Blakely is not the underdog in this situation. Blakely founded Spanx in 2000 and is now a self-made billionaire. Blakely has now filed a declaratory judgment action in court alleging that Spanx is not infringing any of Yummie Tummie’s patents.

Spanx has been in the shapewear business 8 years longer than Yummie Tummie and has its own patents, so this might be the case of the “bad patent”. In an article entitled Patent Reform and Differential Impact, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, authors Matthew Sag and Kurt Rohde define a “bad patent” as one “that should not have been issued.” But Sag and Rohde want to go further. HeatherThomasPatent-cmp.jpg They argue that the term “bad patent” should also include “a patent that was validly issued but is now the subject of hyper-assertion.” The main concern with bad patents is that they “are capable of generating significant revenues and thus have a distorting effect on the allocation of resources in the economy.” This can happen where once a patentee sends a cease-and-desist letter, even if the patent qualifies as a “bad patent,” the alleged infringer will immediately license with the patentee. Or it could be that the parties could take their dispute to court, like Spanx and Yummie Tummie. Now there will be an expenditure of money on both sides trying to settle this issue in court. There is also a drain on public resources as the conflict has to make its way through the court system. Sag and Rohde make several proposed reforms in order to remedy the problem of bad patents. One of their proposed reforms to the litigation process is by fee-shifting. Fee-shifting would require the patentee to pay the costs of litigation if the patent was invalidated based on easily-discoverable prior art. This proposed reform could push potential patent applicants to perform a more comprehensive search through current patents before submitting their application to the PTO. Fee-shifting could prevent bad patents from being issued in the first place, or at least making patentees think twice before they try to enforce their patent against an alleged infringer.

While the public’s interest in the dispute between Yummie Tummie and Spanx has more to do with the reputations of both founders, this situation could revive a push for reform to the patent litigation system. Perhaps there will be a revival of the interest to limit or eliminate “bad patents.”


FDA Warning Letters: Knocking on the Doors of Courthouses

by Katelyn DeRuyter, UMN Law Student, MJLST Staff

Thumbnail-Katelyn-DeRuyter.jpgThe FDA is responsible for safeguarding public health by “assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The FDA inspects products and manufacturing facilities in order to ensure these important goals. If the inspection finds that a company has fallen short of the applicable standards, the FDA often will issue a Warning Letter.FDA_Letter.jpg An FDA warning letter is written correspondencee “that notifies regulated industry about violations that FDA has documented during its inspections or investigations.” The FDA views warning letters as giving the recipient an opportunity to take voluntary and prompt corrective action before the FDA initiates official enforcement action. Despite the fact that the FDA Warning Letter is considered a mechanism for inducing “voluntary” compliance, in recent student note published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, entitled “FDA Goes Loko,” Rebecca Boxhorn argues that warning letters do not induce truly voluntary compliance because recipients that do not wish to voluntarily comply have limited options. Under the current state of the law, FDA Warning Letters are not subject to judicial review. This lack of judicial review is problematic because warning letters subject recipients to real consequences. Boxhorn proposes that FDA Warning Letters should be subject to judicial review.

This positions runs contrary to current case-law but is supported by many industry participants. The crux of the Boxhorn’s argument is that given the consequence of receiving a warning letter, “judicial review of warning letters must be allowed to protect regulated parties from agency coercion and potential misapplications of the law.”

A recent Supreme Court decision in Sacketts v. EPA has sparked speculation over whether courts will begin to re-evaluate their previous view of FDA Warning Letters as not fit for judicial review. The Court in Sackett analyzed whether an EPA Compliance Order constituted final agency action that was subject to APA judicial review. The Sacketts brought suit in U.S. District of Idaho claiming the EPA’s compliance order was arbitrary and capricious and deprived them of life, liberty, or property, without due process of law, in violation of the Fifth Amendment. The district court dismissed the claims based on the lack of subject matter jurisdiction and the Ninth Circuit affirmed. The Court granted certiorari, reversed the Ninth Circuit’s decision, and held that the contested compliance order constituted “final agency action for which there [was] no adequate remedy other than APA review, and that the Clean Water Act does not preclude that review.”

The Court analyzed whether the compliance order in question constitutes final agency action and concluded that it “has all of the hallmarks of APA finality that our opinions establish.” The opinion walked through three factors that support the finding that the compliance order is final agency action: (1) the fact that “[t]hrough the order, the EPA ‘determined’ ‘rights or obligations;'” (2) the fact that “‘legal consequences . . . flow[ed]’ from issuance of the order;” and (3) that the agency action “mark[ed] the ‘consummation’ ‘of the agency’s decision making process.'” Whether applying Sackett would lead a court to conclude that an FDA warning letter is final agency action depends on the extent to which the warning letter in question is similar, or dissimilar, in language and ramifications, to the compliance order addressed in Sackett–at least in regards to the “hallmarks of finality.” A key component of the Sackett Court’s analytical approach is the fact that the Court looked beyond the EPA’s stated intent of compliance orders, and evaluated the actual effect of the compliance order on the Sacketts. If courts adopt this approach and look at the consequences of receiving a warning letter, recipients might finally gain access to judicial review.


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

by George David Kidd, UMN Law Student, MJLST Staff

Thumbnail-George-Kidd.jpgFood-Poster.jpgGlobally, 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.


Cybersecurity: Serious threat or “technopanic”?

by Bryan Dooley, UMN Law Student, MJLST Staff

Thumbnail-Bryan-Dooley.jpgWhile most would likely agree that threats to cybersecurity pose sufficient risk to warrant some level of new regulation, opinions vary widely on the scope and nature of an appropriate response. FBIwebsite-sm-border.jpgThe Cyber Intelligence Sharing and Protection Act, one of several proposed legislative measures intended to address the problem, has drawn widespread criticism. Concerns voiced by opponents have centered on privacy and the potential for misuse of shared information. Some fear the legislation creates the potential for additional harm by allowing or encouraging private parties to launch counterattacks against perceived security threats, with no guarantee they will always hit their intended targets.

In Technopanics, Threat Inflation, and the Danger of an Information Technology Precautionary Principle</strong>, published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology, Adam Thierer discusses the danger of misguided regulation in response to new and potentially misunderstood technological developments. The discussion centers on what Thierer terms “technopanics”–hasty and often irrational pushes to address a problem in the face of uncertainty and misinformation, sometimes intentionally disseminated by parties who hope to benefit financially or advance a social agenda.

In the context of cyber security, Thierer argues that advocates of an aggressive regulatory response have exaggerated the potential for harm by using language such as “digital Pearl Harbor” and “cyber 9/11.” He argues technopanics have influenced public discourse about a number of other issues, including online pornography, privacy concerns associated with targeted advertising, and the effects of violent video games on young people. While these panics often pass with little or no real lasting effect, Thierer expresses concern that an underlying suspicion toward new technological developments could mature into a precautionary principal for information technology. This would entail a rush to regulate in response to any new development with a perceived potential for harm, which Thierer argues would slow social development and prevent or delay introduction of beneficial technologies.

It’s an interesting discussion. Whether or not cyber attacks pose the potential for widespread death and destruction, there is significant potential for economic damage and disruption, as well as theft or misuse of private or sensitive information. As in any case of regulation in the face of uncertainty, there is also clear potential that an overly hasty or inadequately informed response will go too far or carry unintended consequences.


Kirtsaeng’s Parade of [Less]-Horribles

by Caroline Marsili, UMN Law Student, MJLST Staff

Thumbnail-Caroline-Marsili.jpgIn a 6-3 decision that came down March 25, the Supreme Court held that copyright’s first sale doctrine, which allows the lawful purchaser of a copyrighted product to resell the product without interference from the copyright holder, applies to copyrighted works lawfully made abroad. Kirtsaeng v. John Wiley & Sons marks the resolution of a decades-long uncertainty over the potential international reach of the first sale doctrine. This moment of clarity, however, is sure to be followed by challenges, given the newly-sanctioned threat to some domestic industries.

book_pile.jpgFrom a legal standpoint, the case was rightly decided. Briefly, plaintiff publishing company John Wiley & Sons sought relief from Cornell student-turned-professor Supap Kirtsaeng, who paid his way through university by reselling Wiley’s English-language textbooks manufactured abroad. Kirtsaeng’s family bought the books in Thailand and mailed them to Kirtsaeng, who resold them on eBay for a profit. In finding for Kirtsaeng, the majority attempted to reconcile a tension between the language of § 602(a)(1) of the Copyright Act, which gives copyright owners redress for unauthorized importation of their copyrighted work into the U.S., and the first sale doctrine (§ 109(a)), which gives owners of particular copies “lawfully made under this title” the right to sell the copy without the owner’s permission.

As author Benjamin Hamborg astutely foreshadowed in John Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First Sale Doctrine (Minnesota Journal of Law, Science & Technology, Vol. 13.2), the Court reasoned that the text of 109(a) contains no geographical limitations, and that Congressional intent and historical context further require an interpretation of first sale unbound by territory. Justice Breyer’s majority opinion further acknowledges the far-reaching policy implications a geographical limitation would have on “[a]ssociations of libraries, used-book dealers, technology companies, consumer-goods retailers, and museums.” In her dissent, Justice Ginsburg criticized the Court’s “parade of horribles” as unfounded, and observed the opinion would frustrate Congress’s intent to permit international market segmentation by copyright owners. Ultimately, in reversing the Second Circuit and criticizing a “purely geographical interpretation” of 109(a), the decision represents a victory for institutions such as libraries and for consumers.

But while the Court dodged the parade of horribles that Justice Breyer adamantly sought to avoid in oral arguments, the international reach of first sale sounds alarms for U.S. companies that will be threatened by unrestricted gray market competition. A recent NYTimes article aptly identifies some of the other horribles waiting in the wings of an international exhaustion doctrine, including the undercutting of domestic software prices, de-segmentation of international publishing markets, threats to a burgeoning secondhand digital marketplace (though first sale may not apply here), and another nail in the coffin of print publications. Further, Kirtsaeng has the potential to set an example for amateur sellers to profit from gray market goods.

So what’s to be done? In “Next Moves For IP Law After SCOTUS First-Sale Ruling,” Lisa Shuchman suggests a number of options for copyright owners to numb the sting of Kirstaeng. Options include pursuing other legal remedies like contract and more expansive trademark protection, digitizing their protected content, raising domestic prices (to off-set losses from sale of imported copies), and pursuing statutory reform. Others suggest first sale is on its way to mootness in an increasingly digital economy. Raustiala and Sprigman’s solution? “Stop selling copies. Start licensing digital files.” Still others argue statutory reform is unavoidable. Andrew Albanese suggests the Court did what was best with a convoluted statute, but that Congress will need to address the outdated Copyright Act.

Though Kirstaeng undoubtedly provides much-needed clarification on the status of first sale, the story isn’t over for domestic copyright owners seeking to prevent unwanted, but now legal, importation of their works. Grab a seat on the curb . . .


Supreme Court to the Rescue: The First Sale Doctrine Survives

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

Thumbnail-Benjamin-Hamborg.jpgAs predicted inJohn Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First-Sale Doctrine, the Supreme Court last month held, by a 6-3 margin, that the first sale doctrine does apply to works lawfully made outside of the United States. The first sale doctrine, which allows the lawful owner of a copyrighted work to dispose of that copy as he or she sees fit, was in danger of disappearing as applied to works manufactured overseas after the Second Circuit decided in August of 2011 that the doctrine only applied to works made in America.

Hailed by many as a victory for American consumers, See Gary Shapiro, Supreme Court Gives American Consumers Victory Over Copyright Owners in Kirtsaeng vs. John Wiley & Sons, FORBES (March 20, 2013, 9:16 AM), the decision also represents an important victory for American manufacturing. A decision to the contrary by the Supreme Court would have given companies in the United States, particularly publishing companies, an incentive to move manufacturing plants oversees in order to gain unlimited control over the resale of their products. In fact, any company would have been able to gain such control simply by affixing a copyrightable image or other work to an uncopyrightable product, such as a watch. Of course, as pointed out in Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, it remains to be seen whether this decision has a negative impact on the rest of the world, as publishers now have a disincentive to sell textbooks at a discounted rate in impoverished countries. See Roy Zwahlen, Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, PATENTLY BIOTECH (March 26, 2013).


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

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

Thumbnail-Ashley-Zborowsky.jpgIn 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.