Filed under: Drugs & Devices, Litigation and Liability, Recommended Reading
Cross-Posted at Bill of Health
As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid. To establish but-for causation in the case, Kaiser submitted an expert report and testimony from Dr. Meredith Rosenthal, a health economist at the Harvard School of Public Health. Dr. Rosenthal conducted a regression analysis to determine the portion of physicians’ prescribing of the drug Neurontin that was caused by the defendant’s fraudulent promotion, arriving at percentages ranged from 99.4% of prescriptions for bipolar disorder to 27.9% of prescriptions for migraine.
Pfizer argued that Dr. Rosenthal’s regression analysis should not have been admitted (and at least suggested that such an analysis should never be admitted in a third-party payer case) because regression analysis could not “take into account the patient-specific, idiosyncratic decisions of individual prescribing physicians.” Dr. Rosenthal’s report, the company argued, “merely demonstrated ‘correlation’ and not ‘causation.’” The First Circuit disagreed, upholding the lower court’s determination that the challenged evidence was admissible under Federal Rule of Evidence 702, because “regression analysis is a well-recognized and scientifically valid approach to understanding statistical data” and because it “fit” the facts of the case.
Eric Alexander, a partner at Reed Smith, made a similar argument to Pfizer’s when he critiqued a decision issued in July in a third-party payer case in the Eastern District of Pennsylvania. Writing at the Drug and Device Law blog, Alexander criticized the court for failing to address “the fundamental—to us—issue of whether an economist [Dr. Rosenthal was the plaintiff’s expert in that case, too] can ever determine why prescriptions were written.” Alexander points out that “[t]o get to millions of dollars of revenue from prescriptions, many physicians have to prescribe the drug to many patients[,]” and those physicians can “pretty much do what they want[.]” Economists, Alexander argues, should not be allowed to by-pass this complexity and simply “assume” causation.
I would argue that, as idiosyncratic as physician decision-making may be, it is not uniquely so. As the First Circuit noted in Kaiser v. Pfizer, “courts have long permitted parties to use statistical data to establish causal relationships” in antitrust, employment discrimination, and other types of cases. In their article The Use and Misuse of Econometric Evidence in Employment Discrimination Cases, which is forthcoming in the Washington and Lee Law Review, Joni Hersch and Blair Druhan explain that plaintiffs have used regression analyses in employment discrimination cases for more than thirty-five years, to establish a prima facie case of disparate treatment or disparate impact. Plaintiffs in these cases use such analyses to “show that, all other qualifications equal, being a member of a protected class decreased the plaintiff’s expected wage or likelihood of receiving a promotion or being hired.” In class action cases, plaintiffs can also use regression analyses “to establish commonality between the members of the class as required by statute.”
In their article, Hersch and Druhan evaluate the three most common challenges to regression analyses—that they “suffer from omitted variables, a small sample size, and a lack of statistical significance”—and explain that there are “very few circumstances” under which these challenges are meritorious. The authors go on to describe the results of a regression analysis they performed to try to understand the consequences of courts’ considering econometric critiques in a sample of employment discrimination cases. Their analysis revealed that “if [an] opinion mentions any of the econometric critiques … then the plaintiff is 28.3 percentage points less likely to have a favorable result.” This is concerning in light of the examples Hersch and Druhan present of courts that are not “aware of the tricks that expert witnesses argue when attempting to impugn the reliability of valid statistical evidence presented by plaintiffs.” Hersch and Druhan recommend that “court[s] exercise [their] gatekeeping function by either acting under Daubert or establishing a peer-review system to guarantee that only valid challenges to regression results enter the courtroom.”
Hersch and Druhan suggest that their article could be helpful to judges evaluating statistical evidence in employment discrimination cases; I think its usefulness extends further. As plaintiffs continue to turn to regression analyses to establish causation and injury in third-party payer cases brought against pharmaceutical companies, courts will continue to be challenged to evaluate the reliability of such analyses, and to evaluate the reliability of defendants’ challenges to them. Hersch and Druhan’s article can help. Causation is causation, and doctors are no more—in fact, one would hope they would be less—idiosyncratic than employers.
Cross-Posted at HealthLawProf Blog
Nurse Kaci Hickox is a powerful reminder that states must carefully balance patient’s liberty interests when crafting appropriate, reasonable responses to potential threats to public safety.
Beginning with New York and New Jersey last Friday and now continuing with Illinois, Florida, Maine, and Virginia, states are issuing quarantine orders that exceed the CDC’s federal response. New York and New Jersey initially announced that individuals who had direct contact with a person infected with Ebola while in Liberia, Guinea, or Sierra Leone would be subject to a mandatory 21-day quarantine even if they showed no signs of infection.
Under this policy, New Jersey quarantined Maine nurse Kaci Hickox in a tent at University Hospital in Newark after she returned from caring for Ebola patients in Sierra Leone, even though reportedly she did not initially display any symptoms and subsequently tested negative for the disease. The American Civil Liberties Union demanded that Governor Chris Christie disclose how the state had determined that mandatory quarantine of healthcare workers was medically necessary and expressed its “serious constitutional concerns” regarding the policy. New Jersey quickly changed course, announcing that Ms. Hickox would be permitted to return home, subject to Maine’s home quarantine requirement.
Each state enjoys broad police powers to protect the health, safety, and welfare of those within its borders, which powers may include the authority to order quarantines to limit the spread of infectious diseases like Ebola. But individuals also have a constitutionally protected right not to have their liberty infringed without due process of law. Imposing a quarantine affects an individual’s freedom of movement. How can a state fulfill its duty to protect the health and well-being of its residents without violating individuals’ Fifth Amendment rights?
A state must carefully balance its legitimate public health concerns with the rights of individuals. Balance is the simple answer, though, and in practice, the answer is far more nuanced and difficult to identify.
In upholding a mandatory vaccination law against a substantive due process challenge in 1905, the United States Supreme Court in Jacobson v. Massachusetts recognized that courts may need to intervene to protect an individual where the state exercises its police power “in . . . an arbitrary, unreasonable manner, or . . . [goes] so far beyond what was reasonably required for the safety of the public.” A state must exercise its police powers reasonably and may not act arbitrarily.
Building on this concept of reasonableness, Professors David Fidler, Lawrence Gostin, and Howard Markel (abstract) have discerned four limits that courts have imposed on quarantine authority: The individual must be -
- Actually infectious or have been actually exposed to an infectious disease;
- Placed in safe and habitable conditions;
- Treated in a non-discriminatory manner; and
- Afforded procedural due process.
As explained by the United States Supreme Court in Mathews v. Eldridge, what procedural due process must be afforded individuals before they are quarantined is a fact-specific inquiry that generally requires the balancing of three factors: “First, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the Government’s interest, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail.”
Some lower courts have analogized quarantines to involuntary confinement of mentally ill patients and adopted similar procedural due process protections. In Greene v. Edwards, for example, a 1980 per curiam decision, the Supreme Court of Appeals of West Virginia reasoned that because “involuntary commitment for having communicable tuberculosis impinges on the right to ‘liberty, full and complete liberty’ no less than involuntary commitment for being mentally ill,” the state must provide the same procedural due process protections in both situations, namely:
(1) an adequate written notice detailing the grounds and underlying facts on which commitment is sought; (2) the right to counsel and, if indigent, the right to appointed counsel; (3) the right to be present, to cross-examine, to confront and to present witnesses; (4) the standard of proof to be by clear, cogent and convincing evidence; and (5) the right to a verbatim transcript of the proceedings for purposes of appeal.
Similarly, in City of Newark v. J.S., a New Jersey Superior Court Judge held that the standards and procedures required by the New Jersey Supreme Court in involuntary civil commitment proceedings must also be followed when the state seeks to involuntarily commit a patient to a hospital pursuant to the state’s TB control statute.
The states vary considerably in how they exercise their authority to institute quarantines. As a recent Congressional Research Service Report notes, some states like Louisiana require a court order to quarantine individuals against their will (with exceptions for some diseases), while many others permit health officers to make the call without judicial oversight. In some states, the state health department has authority to identify the diseases subject to quarantine, but in others, statutes specify eligible diseases.
One commonality among state quarantine laws that the CRS Report points out is “their ‘overall antiquity,’ with many being between 40 and 100 years old.” States should review their laws and procedures to ensure they comply with due process commands and reflect contemporary scientific knowledge about disease. The Network for Public Health Law published an issue brief in June 2012 that collected some useful model tools that states may consider, including bench books from Washington, Oregon, and Texas.
Ensuring due process does not mean that individuals will not be quarantined. Newark satisfied its due process burden in J.S., and thus the patient was quarantined. Although the Supreme Court of West Virginia in Greene granted the writ of habeas corpus, it delayed release of the patient for thirty days to permit the state to comply with the due process requirements.
Individual liberty interests may need to yield to the state’s interest in protecting public safety. But states must acknowledge and validate the fundamental value of these liberty interests by complying with due process. Remembering less restrictive alternatives, forced quarantine of an asymptomatic healthcare worker in a makeshift hospital tent with a portable toilet and no shower, hundreds of miles from her home, where she is willing to comply with home monitoring restrictions, may not be constitutional, even if the state provides wi-fi.
By Marissa A. Mastroianni
The war on tobacco took an interesting turn when CVS announced its latest move to improve public health. As of last month, CVS banned the sale of all tobacco products in 7,700 CVS locations. The decision cost CVS an estimated $2 billion annually. This choice came as a shock to many as it is not often a multi-billion dollar company voluntarily foregoes substantial profits for the public good. The plot thickened on October 20, 2014 when CVS announced the second phase of the fight against tobacco: bringing Caremark into the mix and effectively making tobacco much less profitable for its competitors. In the midst of heated public debate over the Affordable Care Act and health reform, CVS exemplifies what big business could accomplish without needing any consensus from Washington, D.C.
In February 2014, CVS vowed to stop selling tobacco products in an effort to support customer health. The decision to stop selling tobacco stunned many regarding CVS’s willingness to forego large profits in a competitive market. However, CVS deemed its new policy “simply the right thing to do ….” CVS has fostered something often more challenging to attain than pure profits—a positive public image—which is always good for business. In fact, CVS’s name (formerly CVS Caremark) recently underwent a makeover as it became the newly dubbed CVS Health.
CVS’s decision to include Caremark in the war on tobacco is strategic. Caremark, CVS’s pharmacy benefits manager (PBM), is one of the largest PBM service providers in the United States. Caremark manages drug coverage for health plans and employers with a national network of about 68,000 retail pharmacies. As a result of CVS’s big move, Caremark will soon require customers to make additional co-payments of up to $15 for prescriptions filled at pharmacies selling tobacco products. The increased co-payment will deter customers from using such pharmacies and will instead lead them straight through CVS pharmacy doors. Caremark and CVS, owned by the same parent company, can now both share the goodwill created by the fight against tobacco.
CVS completed a study showing that eliminating tobacco products at retail pharmacies in Boston and San Francisco yielded up to a 13.3% decrease in buyers of such products. In an article published in the Journal of the American Medical Association, CVS’s Chief Medical Officer Troyen Brennan explained that pharmacies have been heavily criticized by public health advocates for selling tobacco products in light of efforts taken by the pharmacy industry to become integral to the health care system.
The conditions proved to be just right in persuading CVS executives to commit to tobacco-free pharmacies. Helena Foulkes, President of CVS/pharmacy, noted the decision was consistent with the company’s purpose in helping people attain better health. Including Caremark in this plan is just plain business savvy.
CVS is currently in the process of identifying pharmacies within its network that are tobacco-free to implement the new increased co-payment plan. A list will be provided to Caremark plan members before any changes are instituted that will include CVS pharmacies and all other local or regional pharmacies that have already begun the war on tobacco. In fact, Philadelphia is the first city to join CVS by creating the Preferred Health Network. The network will identify all tobacco-free pharmacies in the city and any non-union city employee who fills prescriptions outside of the network will face a $15 surcharge.
The new plan to integrate Caremark into the fold has left some disillusioned with the original seemingly selfless decision to eliminate tobacco products in all CVS pharmacy locations. For example, the President of the Independent Pharmacy Alliance of America, Inc. recently asserted the strategy represented “unfair competitive practice.”
Irrespective of the criticism, the events reflect integration of the health care system into big corporations with the power to effectuate big changes. CVS’s willingness to give up $2 billion annually shows potential for more health reform in the coming years from what some might consider an unlikely source—big business. In a time where Congress and State legislatures cannot agree on health reform, CVS’s war on tobacco demonstrates the potential for the private sector to pick up the mantle.
We are very pleased to welcome Marissa A. Mastroianni to Health Reform Watch today. Marissa is in her third year at Seton Hall University School of Law where she is a member of the Seton Hall Law Review.
Filed under: Drugs & Devices, Monday Morning Recap
It’s Monday morning, time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think.
1. Seton Hall Law School’s Kathleen Boozang appeared on Bloomberg Radio this past week, discussing pending litigation brought by the Kentucky Attorney General against Purdue Pharma over its allegedly fraudulent marketing of Oxycontin in the state. Purdue has appealed an adverse state court procedural decision to the state’s Supreme Court; a decision is expected by early next year. If the case goes to trial, Bloomberg journalist David Armstrong writes, the company fears “a catastrophic $1 billion judgment against it, based on the state’s allegations as well as the potential for punitive damages and pre- and post-judgment interest.”
2. Also last week, at the New York Times Donald G. McNeil Jr. reported on a recently-released study “of more than 100,000 pregnant women in Argentina, Guatemala, India, Pakistan, Kenya and Zambia” that found that “[g]iving steroids to women who are about to give birth prematurely — a standard lifesaving medical practice in richer countries — may be useless or even dangerous in poor countries[.]“ Tragically, “the rate of stillbirths [in the study group given steroids] was about 10 percent higher, and so was the likelihood of [the baby dying in its] first month. And substantially more mothers who received steroids appeared to develop infections after giving birth.”
3. The week before last, Express Scripts, the largest pharmacy benefit management organization in the United States, released the second in its series of Exchange Pulse reports, and it is worth reviewing. Express Scripts found that the individuals it serves who purchased insurance on an Affordable Care Act exchange used 59% more high-cost specialty drugs than the individuals it serves who accessed insurance through an employer. This “is largely attributed to a higher prevalence of HIV and hepatitis C. … More than 56% of all specialty drug claims in health exchange plans are for HIV medications, nearly three times higher than health plans.“
4. On the subject of specialty drugs, in this article at JAMA, which came out last week in print but was published earlier this month online, Peter Bach recommends “indication-specific” pricing of cancer drugs. Per Bach, while our current system is not set up to track the indication for which a drug is used, and thus could not support indication-specific pricing, the system could be modified. Bach writes:
The primary reason to pursue this enhancement to the system is to make it possible to rationalize drug pricing. There would be some secondary benefits, consistent with important current trends in health care toward more electronic documentation and richer data on health care encounters. The cancer care system would become more transparent with regard to the utilization of cancer drugs by physicians, and the data would create an infrastructure for real-world outcomes analyses as relevant information about indication could be captured as part of the clinician’s workflow. Off-label prescribing could be identified, and outcomes data from those uses might be used to price those indications. Overall, the transparency of oncology care would be meaningfully enhanced, as the utilization of drugs and their indications would both be identified as a matter of routine care.
5. Finally, in the category of technical but important, the week before last Terry Mahn of Fish & Richardson wrote a piece at Pharmaceutical Compliance Monitor about the “legal conundrum whereby a skinny labeled generic goes to market with an FDA-approved drug label that, in fact, induces infringement of a brand patent listed in the Orange Book. And because courts are loathe to enjoin the sale of low cost generic drugs once on the market, brand drugs protected by use patents are in a potentially precarious position.“
Filed under: Health Reform, Patient Protection and Affordable Care Act
Jaime King and colleagues at UCSF/UC Hastings Consortium on Law, Science & Health Policy have been busy building a rich web resource devoted to promoting cost control and competition in health care. The Source for Competitive Healthcare seeks to create a one-stop shop for academics, journalists, state attorneys general, and potential litigants by “posting news articles, policy papers, academic articles, litigation documents, and legislative/regulatory materials, as well as legal and policy-based analysis of those materials,” focused on “market issues, such as provider leverage and reform efforts, including the promotion of price transparency in healthcare.”
The site is relatively new and actively seeking content and feedback, but it already is a valuable treasure trove of information. The Litigation/Enforcement and Legislation/Regulation tabs immediately caught my eye. Each offers an interactive map of the United States highlighting states that are active in this space with links to pleadings, proposed statutory and regulatory language, and other primary sources in addition to analyses. I am exploring ways to weave these resources into simulations in my health law skills class this spring.
There are some limits to the site design that hamper usability. The Academic Articles and Reports sections of the site seem to provide all articles and reports with only temporal and not substantive sorting capacity.
The Stakeholder Perspectives section of the site lets users sort opinion pieces, reports, and other information from different points of view, including consumers/patient, government, providers, society, payers, and employers. But it does not let you also sort these perspectives by issue area.
The Key Issues area of the site is more sophisticated, permitting users to aggregate scholarly and journalistic articles by a number of topics — healthcare markets, healthcare costs, ACA impact, quality, and price transparency. Although an improvement over the Academic Articles and Reports sections, this sorting feature may be a bit rudimentary. When I selected the ACA impact category, for example, the sort included a rather broad range of topics, including preparing for open enrollment, Medicaid costs, accountable care organizations, narrow networks, emergency room crowding, and insurance rates, leaving users to do a fair amount of digging to find articles relevant to their work. It also does not permit sorting both by perspectives and issue areas.
The Source actively is seeking feedback from its users, so there is good reason to believe improvements will come, if people share feedback. Perhaps the site will add additional tags and sorting capacity as the site grows. Until those developments are implemented, users may need to do some digging to find what they need. But undoubtedly it will be more fruitful to begin with the Source’s vetted resources than to initiate a virgin search of the behemoth internet using a generic search engine.
Although the Source is “not aligned with any advocacy-based organizations or parties to litigation,” it acknowledges that it seeks to “serve as a catalyst for change within the U.S. healthcare system . . . [and] empower individuals and groups seeking to bring rationality to healthcare markets.” It certainly is empowering users with information. It will be interesting to see what we do with these sources to advance policy reform.