Articles Posted in Health Care and Hospitals

The Third Circuit Rejects a Fraud Exception to the Noerr-Pennington Exemption from Antitrust Liability

December 17, 2024 | Bona Law PC

The Third Circuit Court of Appeals held that Merck is exempt from antitrust claims under the Noerr-Pennington doctrine in a lawsuit accusing it of deceiving the government about the effectiveness of its mumps vaccine to prevent competition.

Background from the Third Circuit’s Opinion

Merck was the sole licensed manufacturer of mumps vaccines in the United States for over fifty-five years, until 2022. The vaccine was FDA-approved and included an FDA-approved label that outlined its shelf life, minimum-potency requirements, and effectiveness. Merck had an ongoing duty to ensure that the drug label was accurate.

In the late 1990s, the FDA expressed concern that Merck’s mumps vaccine did not provide immunity near the end of its purported 24-month shelf life. At the FDA’s suggestion, Merck overfilled the vaccine doses to try to make the doses potent through the end of the shelf-life period.

But this did not resolve the issue, and Merck did not share that information with the FDA. Merck feared that disclosing this information would lead the FDA to require a change in the vaccine’s label. And a label change was particularly problematic for Merck because it competed with GlaxoSmithKline (“GSK”), which sold a similar vaccine in Europe. Merck thought that GSK’s vaccine would soon enter the U.S. market and a label change on Merck’s vaccine would make it easier for GSK to demonstrate that its vaccine was not inferior to Merck’s.

So, to preserve its market dominance, Merck misrepresented the vaccine’s potency and effectiveness at the end of its shelf life. To support this, Merck ran a clinical trial and claimed that it could reduce the potency of the vaccine without impairing the existing drug-label claims about immunity. But the appellees in this case said the study did not reliably capture information about the drug’s immune response in the human body. Nonetheless, the FDA continued to approve Merck’s mumps vaccine label and Merck continued to make unsupported claims about the self-life and immunity of its mumps vaccine on the drug label.

GSK eventually demonstrated that its vaccine was competitive with Merck’s. And the FDA approved GSK’s application to sell its vaccine in 2022.

The Noerr-Pennington Doctrine

The Noerr-Pennington doctrine provides limited exemption from antitrust liability for actions intended to influence governmental decision-making in all three branches of government. This doctrine protects the First Amendment right to petition the government, including the courts.

It is, however, subject to a caveat—the “sham exception.” For Noerr-Pennington to apply, the challenged action must be a legitimate government petition rather than conduct intended to interfere with a competitor. Generally, the court will look to see if the anticompetitive conduct arises from the process of the government petitioning rather than the outcome. If the anticompetitive conduct arises from the process, rather than the outcome, of petitioning the government—like baseless litigation bankrupting a competitor due to legal fees—then the sham exception is more likely to apply. But if the anticompetitive conduct is merely the outcome or result of legitimate government petitioning, then the Noerr-Pennington doctrine protects the conduct.

The Court’s Analysis

The Third Circuit engaged in this process v. outcome analysis. The crux of Appellees’ antitrust injury was that Merck’s actions delayed the launch of GSK’s competing vaccine in the United States for over a decade by maintaining deceptive statements on the vaccine label. They argued that it was the misleading statements on the label that prevented GSK from entering the market because GSK was unable to match Merck’s alleged effectiveness.

But the Court explained that the allegedly false or misleading claims on the drug label were the result of Merck’s successful petition to the FDA rather than part of the process. The Court said that Merck faced a dilemma when it was approached by the FDA: Merck could either (1) reveal that its vaccine might be mislabeled, leading to potential relabeling by the FDA; or (2) persuade the FDA that overfilling the doses fixed the problem (despite not actually doing so) and the request that the label remain unchanged. Merck did the latter, and the FDA did not order Merck to change the label or take further action against Merck after learning the truth.

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FTC Sues IQVIA To Block Healthcare Programmatic Advertising Acquisition

January 3, 2024 | Bona Law PC

Authors: Molly Donovan & Steven Cernak

Update: The FTC has won a preliminary injunction to stop IQVIA from acquiring Propel Media. The judge (Judge Ramos in the Southern District of New York) ruled the injunction is in the public’s interest and the FTC has shown a reasonable probability of a substantial impairment in competition should the deal proceed. A written opinion is not available as of this post (January 3, 2024).

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The Federal Trade Commission has sued to block IQVIA’s proposed acquisition of Propel Media—a deal the FTC says would combine two of the top three providers of programmatic advertising that target U.S. healthcare providers on a one-to-one basis. The FTC says IQVIA and Propel both operate demand-side platforms or “DSPs” (called Lasso and DeepIntent, respectively) in an already-concentrated “healthcare provider programmatic advertising market” (a “subset of the total healthcare digital advertising industry”). And the FTC argues the deal would result in further concentration in that market and would significantly decrease advertising competition, which would contribute to higher prescription drug costs for U.S. consumers.

The FTC has filed an administrative complaint and has asked the Southern District of New York to block the acquisition until the administrative trial is completed—projected for December 2023. The FTC requested that the injunction issue in the next few days on or before July 21.

According to the FTC, programmatic advertising matches buyers and sellers of advertising space in virtual auctions that occur in seconds or less. Programmatic advertising automates the more traditional negotiations between advertiser and publisher of print or digital ads. DSPs like Lasso and DeepIntent provide programmatic advertising to healthcare advertisers specifically (i.e., pharmaceutical companies and their advertising agencies).

According to the FTC, IQVIA and Propel are the leading DSPs providing programmatic advertising that targets healthcare providers on a one-to-one basis. This means IQVIA and Propel have the scope and quality of healthcare data to identify individual doctors—and their digital devices—who are relevant to a particular ad campaign. DSPs target healthcare providers because they make the “prescribing decisions” and shape consumers’ perceptions of drugs and drug brands.

Although the FTC admits that there are many “generalist” programmatic advertisers, the FTC urges that healthcare DSPs operate in a distinct relevant market specific to healthcare advertising with clients who have unique advertising demands.

The FTC calls the proposed acquisition presumptively unlawful under the Horizontal Merger Guidelines and caselaw. The FTC’s major concerns are twofold: the combination would eliminate “head-to-head” competition between 2 of only 3 competitors in the relevant market and would enhance IQVIA’s ability to reduce or eliminate potential competition by refusing to sell its healthcare data to would-be competitors or by selling it at anticompetitive prices. The FTC charges that IQVIA is the world leader in terms of the scale and quality of its healthcare data. And while IQVIA currently sells that data to DSPs and others, the FTC says IQVIA would be positioned to increase price and/or reduce access to data critical to one-to-one healthcare DSPs should the deal go through.

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Lessons from the FTC’s Settlement of the Amgen/Horizon Merger Challenge

September 5, 2023 | Bona Law PC

Authors: Steven Cernak and Luis Blanquez

In case you missed it on the eve of a holiday weekend, the FTC and several states settled their challenge of Amgen’s acquisition of Horizon last Friday. The case might have seemed like an odd one to antitrust and merger practitioners looking only at the last few decades of merger review; however, both the challenge and the settlement offer some lessons for future merging parties — and perhaps even the FTC itself.

Parties, Transaction, Challenge, Settlement

Both Amgen and Horizon are large pharmaceutical companies. According to the original complaint, each company produces drugs for which there are few if any competitors. Even according to that complaint, Amgen and Horizon do not compete with, supply to, or buy from each other.

The parties described the transaction as allowing Amgen to use its broader distributional reach to bring Horizon’s products to more consumers. The FTC, and later several states, alleged that Amgen was proficient at wringing profit out of its monopolized drugs in various ways, especially with pharmacy benefit managers (PBMs). The enforcers feared that Amgen would do the same with Horizon’s drugs, especially by bundling Amgen and Horizon drugs. The parties disputed that they had the ability or incentive to engage in such behavior but still offered to enter an order promising not to take such actions.

The FTC challenged the transaction in its internal tribunal and sought a preliminary injunction in federal court in the Northern District of Illinois to prevent the closing of the transaction. The states later joined that challenge. The parties countered with both antitrust arguments and constitutional challenges to the FTC’s structure and procedures, much as other parties like Illumina have.

Last Friday, the parties and enforcers settled all the challenges. The parties agreed to not bundle any Amgen product with Horizon’s two key products––Tepezza or Krystexxa––its medications used to treat thyroid eye disease (TED) and chronic refractory gout (CRG) or offer certain rebates to exclude or disadvantage any product that would compete with Tepezza or Krystexxa. Amgen agreed to seek FTC approval for any acquisition of pharmaceuticals competitive with Horizon’s. Finally, Amgen will submit to a compliance monitor and make annual reports for the fifteen-year duration of the order. Further details and analysis of the proposed order are here.

Analysis of the Challenge

The FTC’s challenge of the transaction might have looked different to merger review practitioners familiar only with challenges of proposed mergers of current competitors; however, the theory behind the challenge has some history. Unfortunately for the FTC, the last several decades worth of that history did not support the challenge.

When Congress passed and amended Clayton Act Section 7, it did not prohibit all mergers; instead, it prohibited only those whose effect “may be substantially to lessen competition, or to tend to create a monopoly.” This standard does not require the FTC to show that the merger will have the proscribed competitive effect with certainty, but it must establish that the competitive effect is more than a mere possibility.

Both Congress and the courts have emphasized that something more than a mere possibility is necessary for a successful Clayton Act Section 7 challenge. The Congressional report described the necessary finding as follows: “The use of these words means that [the amended Clayton Act] would not apply to the mere possibility but only to the reasonable probability of the prescribed effect.” (emphasis added).

The Supreme Court in Brown Shoe clearly drew the “certainties/probabilities/possibilities” distinction:

Congress used the words ‘may be substantially to lessen competition’ (emphasis supplied), to indicate that its concern was with probabilities, not certainties. Statutes existed for dealing with clear-cut menaces to competition; no statute was sought for dealing with ephemeral possibilities. Mergers with a probable anticompetitive effect were to be proscribed by this Act.

Courts recognize only a few ways that the FTC or any challenger can successfully show a probability of a lessening of competition or tendency to create a monopoly.

First, challengers like the FTC can allege that the parties to the proposed transaction currently compete. Such a “horizontal” merger can lessen competition or create a monopoly by allowing the merged parties to unilaterally raise prices or otherwise harm consumers or implicitly coordinate with the remaining competitors on similar actions. Here, the FTC did not allege that any of Amgen’s or Horizon’s products currently compete.

Second, challengers can allege that one of the parties is a “potential competitor” of the other party. Such “potential competition” mergers can lessen competition or create a monopoly by eliminating the current threat or actual entry into a new market by one of the parties to the transaction. Here, the FTC did not allege that Amgen or Horizon is a potential entrant into any of the markets in which the other party competes.

Third, challengers can allege that the parties have or could have a supplier-customer relationship. In certain circumstances, such “vertical” mergers can lessen competition or create a monopoly in a few ways, principally by foreclosing access to rival firms to inputs, customers, or something else they need to effectively compete with the merged parties. Here, the FTC did not allege that Amgen and Horizon are in or could be in a supplier-customer relationship.

Instead, the FTC appeared to rely on the “entrenchment” variant of the “conglomerate” competition theory, claiming that “Post-Acquisition, Amgen will possess the ability and incentive to sustain and entrench its dominant positions in the markets for [Horizon’s products].”

Under this theory, the FTC alleged that after the acquisition, Amgen would have both the ability and incentive to more effectively exploit the alleged monopoly power already possessed by Horizon. Unfortunately for the FTC, this theory has been abandoned as discredited since the 1970s. According to the latest version of the ABA Antitrust Law Developments, “[After Procter & Gamble in 1967], courts and the FTC applied the entrenchment theory very cautiously and liability has not been found in any case on this theory since the 1970s . . . and its subsequent antitrust decisions suggest it is unlikely that the Court will again apply [the theory].” Even the FTC itself just three years ago told an international body that “[c]onglomerate mergers that raise neither vertical nor horizontal concerns are unlikely to be problematic under U.S. merger law.”

And there is good reason for courts to have grown skeptical of the theory — it cannot support an allegation that the probable effect of a proposed merger “may be substantially to lessen competition, or to tend to create a monopoly.”

Certainly, the theory cannot support an allegation that the proposed merger probably will tend to create a monopoly. After all, under the theory, the seller’s products already enjoy monopoly power. The proposed merger would not have created any monopoly power. Here, the FTC alleged that Horizon already enjoys a monopoly with its two key products.

The theory also could not support an allegation that the proposed merger probably will substantially lessen competition. Because the theory required so many possible actions by both the parties to the transaction and third parties, the potential anticompetitive harm is nothing more than the “ephemeral possibility” that the Supreme Court has correctly said is not covered by the Clayton Act.

Here, as detailed by the parties in their brief, the following actions had to occur before the ephemeral possible harm alleged by the FTC would occur: The handful of products identified in the FTC’s Amended Complaint had to overcome significant clinical development and regulatory hurdles; AND at that hypothetical and uncertain time, those other products, though differentiated from Horizon’s products, must threaten them competitively; AND at that same uncertain future time, the alleged competitive position of Amgen’s products must not have changed such that Amgen will have the ability and incentive to bundle them with Horizon’s products in ways that will harm competition.

But even if the parties were wrong and the actions did happen, the FTC could have acted at that time by bringing a monopolization challenge. Now, if those ephermeral possibilities do occur, the FTC will have an easier time alleging a violation of the consent order.

Lessons for Parties and the FTC

For future merging parties in the pharmaceutical industry, this FTC action (and Chairwoman Khan’s statement accompanying the settlement) make clear that the agency will flyspeck every proposed transaction and challenge many more than in the past. These include the Pfizer/Seagen or Biogen/Reata pending transactions, for instance. As Henry Liu, Director of the FTC’s Bureau of Competition highlighted in the press release: “Today’s proposed resolution sends a clear signal that the FTC and its state partners will scrutinize pharmaceutical mergers that enable such practices, and defend patients and competition in this vital marketplace.” The FTC’s ongoing investigation of PBMs means that FTC actions in this area might not be confined to merger challenges.

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Clear Articulation and the Classic Antitrust Case of FTC v. Phoebe Putney Health System

February 23, 2021 | Bona Law PC

Authors: Luke Hasskamp and Aaron Gott

This article briefly explores the applicability of federal antitrust laws to actions taken by municipalities or other state subdivisions and, specifically, whether they have acted pursuant to a clearly articulated state policy to displace competition in the marketplace.

Federal antitrust laws are designed to prevent anticompetitive conduct in the market. Yet, the Supreme Court long ago held that antitrust laws do not apply against States themselves, even when they take actions with anticompetitive effects. Parker v. Brown, 317 U.S. 341 (1943). The Supreme Court also recognized that this state action immunity applied not only to states but also to municipalities or other state political subdivisions, and even private actors, provided they are acting pursuant to state authority.

Thus, any time a state or local government body is sued for antitrust violations, it will inevitably claim that it is exempt from liability under the state action immunity doctrine.

To obtain this immunity, the defendant will have to show, at the least, that it acted pursuant to a clearly articulated state policy to displace competition. In short, the state had to understand that the authority it was delegating to substate actors would have anticompetitive effects and that it clearly articulated such a policy in its legislative delegation.

But when is a state policy clearly articulated? That is the question the U.S. Supreme Court decided in FTC v. Phoebe Putney Health System, declaring a stricter standard than courts had been applying.

FTC v. Phoebe Putney Health System

Any antitrust lawyer who is drafting a brief on is probably going to cite Phoebe Putney. Those invoking state action immunity will probably downplay its significance and rely more heavily on earlier cases instead. Let’s talk about the case so you can understand how it dramatically raised the bar for defendants seeking immunity.

You don’t have to be an avid antitrust nerd to have noticed that the healthcare industry has undergone a lot of consolidation in recent years, with hospitals merging with or acquiring one another in already limited markets. The FTC challenges a fair number of these transactions because they reduce competition in markets that already have all sorts of competition problems. Phoebe Putney involved one of those challenges.

Phoebe Putney Health System was owned by a public hospital authority created by a city and county in Georgia. The health system owned Memorial Hospital, which was one of two hospitals in the county. The other hospital, Palmyra Hospital, was just two miles away and was owned by national nonprofit healthcare network HCA. Phoebe Putney and HCA reached an agreement for Phoebe Putney to purchase Palmyra, and the hospital authority approved.

The Federal Trade Commission scrutinized this plan and filed suit because the transaction would create a monopoly that substantially lessened competition in the local market for acute-care hospital services.

In defense, Phoebe Putney claimed that it was entitled to state action immunity because, it argued, it had acted pursuant to a clearly articulated state policy to displace competition. Specifically, Georgia state law allowed its political subdivisions to provide health care services through hospital authorities. The law authorized those hospital authorities “all powers necessary or convenient to carry out and effectuate” the law’s purpose, and more specifically granted them authority to acquire hospitals. Phoebe Putney claimed that it was foreseeable to the Georgia legislature that a hospital authority would use this power anticompetitively.

The district court agreed and dismissed the case. And since the case is FTC v. Phoebe Putney and not Phoebe Putney v. FTC, you can surmise that the Eleventh Circuit agreed with the district court. Many courts had been applying this foreseeability standard based on language from earlier Supreme Court cases like City of Columbia v. Omni Outdoor Advertising, and this case was no different. The Eleventh Circuit reasoned here, for example, that the Georgia legislature must have anticipated that granting hospital authorities the power to acquire hospitals would produce anticompetitive effects because “foreseeably, acquisitions could consolidate ownership of competing hospitals, eliminating competition between them.”

But the FTC had a good point: nothing about the rather basic corporate power to acquire a business suggests that a state clearly articulated a state policy allowing public hospital authorities to monopolize entire markets. Indeed, the statute did not even discuss competition. The Supreme Court granted certiorari, and ultimately agreed with the FTC in a rare 9-0 opinion: the Eleventh Circuit, like so many other courts, had been applying clear articulation “too loosely.” As a result, they had sanctioned all sorts of anticompetitive conduct by state and local government entities that the state legislature had not really intended. Federal antitrust policy should not be set aside so easily.

Instead, the defendant’s conduct must be not only foreseeable, but also the “inherent, logical, or ordinary result” of the state scheme. Courts had been seizing on the “foreseeability” language of the Court’s prior decisions while ignoring much of what else it had said:

State law authority to act is not sufficient; the substate governmental entity must show it was delegated the authority to act or regulate anticompetitively
There must be evidence the state affirmatively contemplated that the scheme would displace competition
Where a state’s position is one of mere neutrality to competition, the state cannot be said to have contemplated anticompetitive conduct
Simple permission to play in the market is not authority to act anticompetitively

The Court also addressed two additional arguments. First, Phoebe Putney pointed to Georgia’s certificate of need law as evidence that the Georgia legislature had contemplated the displacement of competition relating to hospitals. (Learn more about certificate of need laws here, here, and here). But the Court rejected this argument because “regulation of an industry, and even the authorization of discrete forms of anticompetitive conduct pursuant to a regulatory structure, does not establish that the State has affirmatively contemplated other forms of anticompetitive conduct that are only tangentially related.”

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Is Insurance Really Exempt from the U.S. Antitrust Laws?

February 13, 2021 | Bona Law PC

Author: Jarod Bona

In many instances, conduct involving the business of insurance is, indeed, exempt from antitrust liability.

So why does insurance sometimes get a free pass?

In 1945, Congress passed a law called The McCarran-Ferguson Act. Insurance, of course, has traditionally been regulated by the States. Territorial and jurisdictional disputes between the States and the Federal government are a grand tradition in this country. We call it Federalism. In 1945, it appears that the states won a battle over the feds.

As a result, in certain instances, business-of-insurance conduct can escape federal antitrust scrutiny.

The business of insurance isn’t the only type of exemption from the antitrust laws. There are a few. At The Antitrust Attorney Blog, we have discussed state-action immunity quite a bit (as suing state and local governments under the antitrust laws is a favorite topic of mine).

An exemption that is similar to the McCarran-Ferguson Act is the filed-rate doctrine, which we discuss here. There are, of course, several others, including–believe it or not–an antitrust exemption for baseball. The courts, however, disfavor these exemptions and interpret them narrowly.

But back to the insurance-business exemption and The McCarran-Ferguson Act. Do you notice that I keep calling it the “business of insurance” exemption and not the insurance-company exemption? That is because the courts don’t just exempt insurance companies from antitrust scrutiny. No, the exemption only applies to the business of insurance and in certain circumstances.

Below are the basic elements a defendant must satisfy to invoke the McCarran-Ferguson Act:

The conduct in question must be regulated by the state or states.
The conduct must qualify as the business of insurance—the business of insurers is not sufficient.
The conduct must not consist of a group boycott or related form of coercion.

Each of these elements, in turn, has its own requirements, case law, and doctrinal development. The most interesting of the three elements is how to define the business of insurance.

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The Seventh Circuit Explains the “Co-Conspiracy Exception” to the Illinois Brick Rule in Healthcare Antitrust Lawsuit

September 15, 2020 | Bona Law PC

Author: Jarod Bona

Antitrust law evolves in such a way that opinions from federal appellate courts are always interesting in how they affect the doctrine. But there are a select few judges who earn even closer attention when they write an antitrust opinion. Judge Diane P. Wood of the United States Court of Appeals for the Seventh Circuit is one of those judges.

Update: Justice Amy Coney Barrett is also part of the Seventh Circuit panel for this decision, along with Judge Michael Stephen Kanne.

In Marion Healthcare, LLC v. Becton Dickinson & Company, the Seventh Circuit, through Judge Wood’s opinion, effectively articulates the co-conspiracy exception to the Illinois Brick rule. The opinion is significant not because it marks a departure in the prevailing law, but because it explains it so well. This is an example of an opinion that courts and attorneys will likely cite in the future when this issue comes up.

So I thought it would be helpful to tell you about it.

Indirect Purchasers and Illinois Brick

You might need a little bit of background first. The indirect-purchaser rule—derived from a Supreme Court decision known as Illinois Brick—prohibits indirect-purchaser plaintiffs from suing for damages under federal antitrust law. This typically arises in a class action, but the doctrine isn’t limited to class cases.

We discuss the indirect-purchaser rule in more detail in a two-part article:

Indirect Purchaser Lawsuits, Illinois Brick and Apple v. Pepper (Part 1): This article describes the background and basics of the indirect-purchaser prohibition.
Apple v. Pepper, Indirect Purchaser Antitrust Class Actions, and the Future of Illinois Brick (Part 2): This article describes the Supreme Court’s recent Apple v. Pepper decision and what it means for the future of Illinois Brick and the indirect-purchaser rule.

If you haven’t already read those two articles, go read them and come back. We will wait for you.

Marion Healthcare, LLC v. Becton Dickinson & Company

Healthcare markets are complicated, distorted, and a little bit confusing. The government plays a major role, which distorts markets. In addition, there are so many layers of entities that participate in every aspect of healthcare that the markets aren’t always easy to unpack. And, of course, insurance companies pay much of the costs, but the decisions on spending are a combination of patients, insurance companies, doctors, governments and healthcare facilities, among others.

In this case, plaintiffs are healthcare companies that purchased medical devises from Becton Dickson & Company. But they don’t purchase them directly from Becton. Instead, they and other purchases rely on a GPO to negotiate prices with Becton (and other manufacturers). Once the GPO and manufacturer reach an agreement, the company that needs the supplies can accept or reject it. If they accept it, they actually purchase the product through a distributor (pursuant to the GPO-negotiated contract), who then enters contracts with both the purchaser (the healthcare provider) and the supplier (in this case, Becton).

You might anticipate at this point that figuring out whether the plaintiff is a direct purchaser could get confusing.

In this case, plaintiffs alleged that Becton (the supplier), the GPOs (that negotiated the deal), and the distributors were all part of the conspiracy, engaging in a variety of anticompetitive conduct, including exclusive dealing.

The district court dismissed the case, holding that the conspiracy rule (more on that below) didn’t apply because the case didn’t involve simple vertical price-fixing.

The Seventh Circuit held that the district court erred.

The Co-Conspirator Exception to Illinois Brick

For the Court to apply Illinois Brick, it must determine which entity is the seller and which entity is the direct purchaser. As you might recall, the Supreme Court grappled with this in Apple v. Pepper.

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Iatrogenics, the Sad Tale of Dr. Ignaz Semmelweis, and Antitrust Lawyers

July 26, 2020 | Bona Law PC

Author: Jarod Bona

I bet your first question is “What is iatrogenics?”

Have you ever gone to the doctor for something minor, only to take the prescribed medication and suffer through side effects that are worse than the initial ailment?

Iatrogenics is your net loss in welfare from the doctor. Iatros means healer in Greek. Iatrogenics is the loss caused by the healer.

The Hippocratic Oath, of course, is “first do no harm.” But it doesn’t always work out that way.

This term came up in my re-reading of Antifragile by Nassim Taleb. This is one of my favorite books of all time and I highly recommend that you read it, along with everything else that Taleb writes. And not just because we both advocate for deadlifts.

If you are a fan of Nassim Taleb, you might enjoy our article on Antitrust, Antifragility, Blockchain, and the Departement of Justice.

Dr. Ignaz Semmelweis

Taleb, in Antifragile, tells the story of Austro-Hungarian doctor Ignaz Semmelweis.

In the early to mid-1800’s, treatment by doctors wasn’t, according to Taleb, a net positive—going to the doctor actually increased your chance of death. This is iatrogenics—the healer, if you net the positive and negative, wasn’t good for your health.

Dr. Semmelweis noticed that women giving birth were substantially more likely to die of childbed fever if they were treated by doctors than if they were treated by mid-wives. Semmelweis didn’t figure out exactly why this was, but he did discover that if doctors cleaned their hands and medical instruments with a strong disinfectant, the rate of childbed fever dropped dramatically. The deaths, of course, were coming from the hospital.

You might think that the next part of the story is that people hailed Dr. Semmelweis a hero and the rate of women dying in childbirth fell dramatically from that point in time. Maybe there was a parade.

Sadly, no.

Dr. Semmelweis’s approach worked, but it wasn’t a theory developed by the “experts” and implicit, well, explicit, in his discovery of the disparity in deaths between doctor-treated patients and mid-wife-treated patients was the idea that doctors were harming their patients—killing them, in fact.

Dr. Semmelweis apparently wasn’t polite and passive in his criticism; Taleb points out that Semmelweis, for example, called the doctors “a bunch of criminals.” Semmelweis’s ideas contradicted the conventional wisdom and the people that could change the policy probably didn’t like him. Semmelweis tried to convince doctors and relevant policy makers to change, but they wouldn’t.

This led to despair and depression for Ignaz Semmelweis. And he ended up in an asylum where he died of a hospital fever, in sad irony.

Innovation in Ideas

The lessons from this story are plentiful. Obviously, doctors should wash their hands. And this, of course, is a good example of an iatrogenic situation. But, just as significantly, we must understand that our assumptions and the “experts” are sometimes wrong. And it is critical that we don’t shut out ideas that grow from the bottom up that question the experts, who force their ideas from the top down.

For example, when certain social media websites decided to hide or warn against any information relating to Coronavirus that contradicted the World Health Organization dictates, they created major systematic risks and the potential for situations like that of Dr. Semmelweis’s warnings about washing hands and killing pregnant women. Mandating information flow from the top-down creates a dogma that eliminates the possibility of bottom-up innovation and insights that can improve humanity.

Indeed, the World Health Organization, like many “experts,” and others were wrong, many times over. Wrong isn’t necessarily bad—we can learn from wrong. But forcing a specific perspective or truth on everyone, even if it is the conventional wisdom and or a widespread belief, freezes the current state of science and thinking wherever it is, instead of allowing it to prosper, grow, and progress.

The idea that science uncovers facts is true, but only for a static moment. By contrast, time is dynamic and “facts” change with it.

Think back 20 years, 40 years, 100 years, or 1000 years to what was conventional wisdom and how wrong it was. Also think back to the groups and hierarchies that tried to lock-in those ideas—which at the time were widespread and thought of as the truth or as facts. Think about Galileo.

The foundation of federal antitrust law is that “The heart of our national economy long has been faith in the value of competition.” Allowing competition creates opportunity, from the bottom up, for innovation, along with high quality and low prices, to prosper.

The same is true of ideas. If we create monopolies for ideas, even if they are considered established facts, the quality of our ideas and society will diminish. Innovation will stagnate. The experts are often wrong—let’s not follow them off the cliff, or more accurately, let’s not let them talk us off a cliff while they sit on their perch without skin in the game, preaching.

Iatrogenics Outside of Medicine

Back to Iatrogenics.

A problem that Taleb identifies is that, although mostly discussed in the context of medicine, iatrogenics is not limited to that field. Professionals and others of all walks of like sometimes create more harm than good.

In Antifragile, Taleb includes a handy table that shows interventions of various fields and the resulting iatrogenics/costs. For example—here is something that hits home in California: In Ecology, micromanaging away from forest fires can worsen total risks, by creating larger “big ones.”

Economics is an obvious example where intervention can cause harm—even intervention that appears “good” on the outside. You may agree or disagree, but Taleb cites manipulation of the business cycle, i.e. trying to make the ups and downs disappear, as a major source of fragility, which will lead to deeper crises when they happen.

Taleb cites several examples and they are interesting and persuasive, but he unfortunately leaves out your favorite profession—the antitrust attorney.

Let’s talk about the iatrogenics of antitrust attorneys.

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Certificate-of-Need Laws, Evil Trolls, and the Minneapolis Star Tribune

April 29, 2020 | Bona Law PC

Author: Jarod Bona

We do our best to describe antitrust and other legal issues as straightforwardly as possible here. We tend to speak directly and avoid the guarded language that you often see from lawyers elsewhere (a little secret: most big-firm attorneys are afraid of getting in trouble in one way or another).

So, in case there was any doubt, I’ll tell you what I really think of certificate-of-need laws. These are laws, still on the books in many states, that actually require a new healthcare provider that wants to move into a market to get permission from the state to do so (a certificate of need). And, even more bizarre, the existing competitors—who certainly don’t want any more competition—often have a say or a role in whether the new provider receives a certificate of need, which can sometimes take months or years to obtain, if at all.

We hear all the time how important health and safety is: The sanctity of human life. Take care of yourself. Eat well. Exercise. Get your yearly physical. Follow your doctor’s advice.

We also hear complaints from every politician, news agency, and anyone that’s ever paid a medical bill about the costs of health care.

And, although healthcare workers have been heroes both before and during this pandemic, I think we would all agree that there is a lot of room for improvement in healthcare in the United States. I’ve been to the Mayo Clinic in Rochester, Minnesota many times and my son was born there, so I know how good healthcare can be. We have a lot of room to improve healthcare as a country.

I think we can all agree that healthcare is vitally important to us as human beings. That is what I hear the media tell me and what politicians preach all the time. And this makes sense: If you are sick or dying, getting better shoots up the priority list of needs and wants.

Switching gears briefly, here is something that I’ve learned as an antitrust attorney and as a student of economics: Markets with monopolists and markets with less competition have higher prices, lower supply, and lower quality for products and services.

Let’s say you are an evil troll that hates people. Let’s also say that you have the single opportunity to pass legislation in a state to hurt human beings that care about health and healthcare, but you don’t want it to be something that is so obvious that they’d just repeal it after your opportunity passes. You want something that is sneaky bad.

What would you do if you were that evil troll?

You’d pass certificate-of-need laws.

These laws are sneaky bad because it takes a couple steps of reasoning to see how they harm our health and healthcare. By creating the barrier to entry of these certificate-of-need laws, the evil troll can artificially limit the supply of healthcare, decrease its quality, and raise healthcare costs—almost without detection. And by offering the existing monopolist or provider an opportunity to participate in the process, the government agency is much less likely to award the certificate to improve people’s lives. At the very least, if the existing healthcare provider is involved, they will be able to help delay any competition.

Let’s say that you end up with a pandemic and really need a lot of hospital beds or other healthcare all at once. If that happens, the evil troll has won because their certificate-of-need laws are specifically designed to reduce the supply of healthcare, including hospital beds.

Bona Law opposes certificate of need laws and we call for their repeal and challenge. You can read our earlier article about certificate of need laws on this website here.

On April 28, 2020, Aaron Gott and I published an article in the Minneapolis Star Tribune entitled “State Certificate-of-Need Laws for Hospitals Must Go: These anti-competition laws have left us unprepared for the current pandemic, with fewer hospital beds for care.”

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COVID-19 Exposes Evil of Anticompetitive State Certificate of Need Laws

March 23, 2020 | Bona Law PC

Authors: Aaron Gott and Jarod Bona

The United States is in lockdown to “flatten the curve” of COVID-19 cases because our hospital system has even less capacity to handle a surge of cases than Italy—where overload has led physicians to have to make tough decisions about which patients deserve treatment priority. New York, the U.S. epicenter of the coronavirus, is expected to reach capacity in a matter of days and some hospitals have already exceeded their intensive-care capacity.

Hundreds of thousands of people may die directly as a result of inadequate hospital capacity in the United States, which is at its lowest in decades. In fact, the U.S. had nearly 8 hospital beds per 1,000 people in 1970, a number that has steadily declined to 2.9 per 1000 people today. Our elected officials have issued orders and recommendations that have our economy screeching to a halt, while Congress is considering unprecedented economic relief measures in the trillions of dollars to soften the fallout.

What put us in this position? There are many reasons. But one major culprit that is at least partially to blame for our current predicament has been nearly 50 years in the making: state certificate of public need laws (often called CON laws) that artificially limit the supply of hospital beds and medical equipment.

In 1974, Congress passed the National Health Planning Resources Development Act, which encouraged states to enact certificate-of-need laws for medical capital investment. Nearly every state enacted them. State bureaucrats, rather than the free market, would thereafter determine whether we “need” more ICU capacity, more testing labs, and more equipment like ventilators. The idea behind CON laws, proven wrong long before COVID-19, is that allowing states to control supply would reduce runaway healthcare costs and improve access to care.

Here is how a CON law generally works: it is illegal (often with criminal consequences) to build any kind of medical facility or make a capital medical equipment purchase without first obtaining a certificate allowing you to do so from the state health agency. It can cost millions of dollars and take several years to get one, if you can get one at all. In some states, your competitors have a right to object to the issuance of the certificate. In the worst states, monopolist and oligopolist hospital systems prevent competition because they have such a stranglehold on state bureaucrats and processes that most would-be competitors don’t even bother trying to get a certificate of need.

New York, by the way, is one of those states that still has a draconian certificate of need law on its books. New York requires a certificate of need for the “establishment, construction, renovation and major medical equipment acquisitions of health care facilities.” Any project that would add new hospital and/or ICU beds would require a certificate of need, and it is likely that adding new ICU-grade ventilators would also require a certificate of need because they individually cost tens of thousands of dollars.

New York has just 3,200 ICU beds but expects it will need between 18,600 and 37,200 to handle the expected wave of hospitalizations.

As antitrust and competition lawyers, certificate of need laws long have been on our minds. They are terrible, immoral policies even in the best of times.

We’re not alone in this thinking: even Congress quickly saw the error of its ways. In 1984, recognizing that the program was a failure, Congress repealed the provisions that encouraged certificate of need laws. Some states repealed their CON laws in the years since, but 35 states still have them on the books, largely because monopolist and oligopolist healthcare systems don’t like competition, and they have lobbying strangleholds over many state legislatures.

For years, the U.S. Department of Justice Antitrust Division and the Federal Trade Commission have jointly pleaded for states to repeal their anticompetitive certificate of need laws (and criticism of CONs features prominently in their comprehensive guide on improving competition in healthcare). Yet states still have them, and courts have often refused to strike them down under the U.S. Constitution despite their disastrous effect on interstate commerce.

One example is Colon Health Centers v. Hazel, a case by our friends at the Institute of Justice challenging the constitutionality of Virginia’s parochial certificate-of-need law under the dormant Commerce Clause. The plaintiffs in that case sought to open state-of-the-art clinics with MRI machines and CT scanners that would improve and cheapen certain types of cancer screenings, but they could not do so without first risking millions of dollars in a certificate of need process that was likely to be contested by existing providers, eventually resulting in denial.

We filed an amicus brief on behalf of law and economics scholars in that case to argue that states’ claims of cost-controlling benefits of CON laws are unsupported by empirical evidence. Nevertheless, the Fourth Circuit upheld the law on summary judgment, finding that the putative benefits of the law were not speculative (even in the face of evidence showing no such benefit), and that those benefits outweighed the effect the law has on interstate commerce.

That case may have been decidedly differently if it were heard today.

Now, in the face of an unprecedented pandemic and an economy that has come screeching to a halt as a result of shelter-in-place orders and social distancing recommendations—put in place primarily to “flatten the curve” and avoid the overload our inadequately supply of healthcare facilities—these laws have proven not just ineffective, but completely unconscionable.

More importantly, CON laws could now prevent us from quickly building up temporary medical infrastructure to deal with the surge of cases. We cannot rely on government alone to rise to the occasion with military resources; CON laws must get out of the way so that private enterprise can help fill in the gaps.

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Hospitals, Antitrust, the Department of Justice, and Agreements to Not Compete on Marketing

July 7, 2015 | Bona Law PC

What is great about practicing antitrust law is that you take deep dives into the intricacies of different markets from the shelf space in drug stores for condoms—an actual case from several years ago—to insurance brokerage pricing to processed eggs and everything in between.

There are, however, certain industries that repeat themselves in the antitrust world, which isn’t a surprise because some industries are more susceptible to antitrust issues than others. For example, the airline and pharmaceutical industries consistently face antitrust scrutiny because of the nature of their markets and the regulations surrounding them.

But the industry I’d like to discuss here is the health-care or medical industry, and more specifically, hospitals. I’ve found myself with many antitrust and non-antitrust cases involving health-care of one sort or another over the last couple years, so this area has become an interest of mine.

Lately, I have also spent more time than I will publicly admit consuming materials (mostly books, blogs, and podcasts) on health, nutrition, and fitness, which (combined with my health-care cases) has my family often reminding me that I am not a doctor after some well-meaning but often unwelcome advice.

If you follow antitrust, you will notice that there are a lot of cases about hospitals. Why is that? This might seem surprising at first glance because many hospitals are non-profits or government-owned and you probably don’t picture a hospital in your mind when you think of the term “monopolizing.”

(If you can make it through the explanation below, you can read about a recent Department of Justice antitrust action against some Michigan hospitals that apparently agreed not to compete with each other in particular ways).

First, non-profit status is not a defense to the antitrust laws. Whether you have stockholders or owners that keep residual profits or not, you have to play by the antitrust rules. Non-profit entities (and their officers) still seek power, influence and prestige. And, increasingly, state and local government entities are subject to the antitrust laws. I’ve written a lot about that on The Antitrust Attorney Blog; you can access those articles in the State-Action Immunity category.

In fact, after the Supreme Court’s decision in North Carolina State Board of Dental Examiners v. FTC, it seems like many litigants want to go after state boards of various sorts. Anyway, I’ve received many calls about this and there are a few active cases, including one in Texas that I’ve written about.

Second, the health-care industry encompasses a series of narrow product, service, and geographic markets. That is because, except in limited circumstances, most people don’t travel far for medical care. They want to go somewhere near their work or home. So geographic markets are usually regional to a metro area (with some exceptions).

Within each geographic region, there are usually a limited number of hospitals or other medical facilities for particular specialties. Thus, each geographic market, that is each region, has what may be considered an oligopoly, or a handful of competitors that all know and depend upon each other. Whereas the airline industry is effectively a worldwide oligopoly, the markets for hospitals and other medical facilities are often oligopolies within metro areas. From that perspective, it isn’t a surprise that we see many hospital antitrust cases because there are so many different metro areas with oligopolies.

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