Research Fellow & Lecturer in Law Kate Greenwood in a Featured Op-ed in Pharmalot on the U.S. Supreme Court and Liability for Defects in Generic Drugs
Filed under: Health Law, Pharma, Uncategorized
Research Fellow & Lecturer in Law Kate Greenwood published a Featured Op-ed in Pharmalot on the U.S. Supreme Court and the prospect of liability for personal injury from defects in generic drugs. In “Betting on Liability for Generic Defects,” Ms. Greenwood writes:
As reported on Pharmalot, the US Supreme Court has agreed to review the First Circuit Court of Appeals’ decision in Mutual Pharmaceutical Company v. Bartlett that federal law did not preempt a New Hampshire jury’s determination that the generic drug sulindac had a “design defect” and so should have been recalled (back story with briefs).
It is highly likely that the Supreme Court will reverse the First Circuit’s decision, and, in so doing, confirm that manufacturers cannot be held liable for failing to re-design or recall unsafe generic drugs, just as they cannot be held liable for failing to update the labeling of such drugs. The ball will then be in Congress’ court to fill the resulting postmarketing safety gap.
As the First Circuit explained in the Bartlett decision, New Hampshire law provides that a drug has a design defect “‘if the magnitude of the danger outweighs the utility of the product.’” At trial, plaintiff Karen Bartlett’s expert testified that sulindac met this standard and the jury agreed, finding Mutual Pharmaceutical liable for selling a product with a defective design and awarding Bartlett over $21 million for the horrific SJS/TEN-related injuries she suffered after taking sulindac.
Read more in the feature Op-ed, “Betting on Liability for Generic Defects.”
United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion
Filed under: Advertising & Lobbying, Health Law, Pharma
Earlier this week, the Second Circuit Court of Appeals at last issued its decision in United States v. Caronia and it is momentous (and predicted to be heading to the Supreme Court). A two-judge majority of the Circuit Court held that Alfred Caronia, a pharmaceutical sales representative, “was convicted for his speech – for promoting [the central nervous system depressant Xyrem] for an off-label use – in violation of his right of free speech under the First Amendment.”
The majority’s decision begins with a threshold question. Was Caronia convicted for conspiracy to misbrand Xyrem because he engaged in off-label promotion qua off-label promotion, that is, for his speech? Or, was his speech simply “evidence that the ‘off-label uses were intended ones for which Xyrem’s labeling failed to provide [the required] directions[,]” as the government argued on appeal? The former would implicate the First Amendment, but the latter would not. The Supreme Court has held that “[t]he First Amendment … does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” As the Caronia dissent (colorfully) explained, “Abby and Martha [do not have] a First Amendent right to offer arsenic-laced wine to lonely old bachelors with the intent that they drink it. … And any statements Abby or Martha made suggesting their intent—even if all of the statements were truthful and not misleading—would not be barred from evidence by the First Amendment…”
The majority found that Caronia was convicted for his speech alone, pointing to the lower court’s instructions to the jury and to a number of statements that the government made at trial including “[Caronia] conspired through some act of misbranding, and that act of misbranding … was the promotion on October 26th and November 2nd[,] marketing [a] drug for unapproved uses.” Caronia’s conviction must therefore be vacated, the majority concluded. The Food Drug and Cosmetic Act does not “criminaliz[e] the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” The majority did not disagree with the general proposition that speech may be used as evidence of intent, and it expressly declined to decide the specific question whether the FDCA violates the First Amendment by “defin[ing] misbranding in terms of whether a drug’s labeling is adequate for its intended use, and permit[ting] the government to prove intended use by reference to promotional statements made by drug manufacturers or their representatives.” Even if the Second Circuit’s decision stands, then, the government may be able to argue that Caronia is a case about an erroneous jury instruction with limited practical effect
The majority went on to hold that a ban on off-label promotion qua off-label promotion—like the Vermont law barring drug companies from using physician-specific prescribing data to craft physician-specific sales pitches at issue in the Supreme Court’s 2011 decision in Sorrell v. IMS Health (which I discussed on this blog here)—is unconstitutional regardless of whether strict or intermediate scrutiny applies. The majority gave short shrift (no shrift, really) to the argument that the ban on off-label promotion is necessary to preserve the integrity of the FDA’s drug approval process, suggesting that the government could “minimize … manufacturer evasion of the approval process” by imposing “ceilings or caps on off-label prescriptions.”
The majority did not elaborate on how ceilings or caps on off-label prescriptions would work, on the grounds that the First Amendment puts the burden on the government to demonstrate that they would not. Here, too, there may be an opening for the government, to make a stronger case to the Supreme Court than it did before the Second Circuit (in its briefs or at oral argument) that ceilings or caps would not be “administrable, feasible, or otherwise effective” and that the ban on off-label promotion therefore provides a direct, narrowly-tailored, and crucial incentive to clinical research into already-approved drugs. As the dissent suggested, “[a] ceiling on off-label prescriptions would require collecting data from countless numbers of doctors and patients and, given the medical uncertainties involved, could needlessly (and simultaneously) result in the denial of some effective treatments and the overprescription of ineffective and even dangerous ones.”
Filed under: Global Health Care, Pharma, Prescription Drugs
Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here. The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:
Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.
The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS. “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.” ”I know that I’m going to die,” she said, but “who is going to look after my children?” Her story appears in this video.
Mkhosana’s plight raises difficult interpretive issues. Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws? Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.
Sunder acknowledges the importance of patent law to incentivizing the development of new drugs. However, as she wisely notes, one can’t squeeze blood from a stone, however important the “skin in the game” ideology has become to advocates of “free-market” healthcare. According to Sunder, “creation of generic drug markets for the poor ought not significantly impact the bottom line of Big Pharma, which derives only 5 to 7 percent of its profits from this part of the world.” It may well be possible to make up for some of that figure by cutting back on promotional budgets in the developed world. It’s also a rather trivial figure compared to tax avoided or evaded on the tens of trillions now hidden away in tax havens.
On the other hand, Big Pharma has a number of justifications and excuses for aggressive assertion of their patents. Spokesmen aver that they are only concerned about what would happen to their profit margins if drugs circulated in an uncontrolled manner. They claim that, if poor countries are permitted to manufacture vast quantities of their drugs, those countries may sell them on the black or grey markets. That, in turn, would reduce the return on such drugs in the developed world, leaving less money for research in the future. Sunder responds that, “The grey-markets concern is a valid one—but . . .the World Trade Organization has begun to craft creative solutions to this problem (requiring generic drugs made for developing world markets to be distinctively labeled, for example).” As surveillance of both people and goods is better perfected by state security apparatuses and RFID technology, the grey market concern should also become more technologically manageable, enabling finer-grained and more effective price discrimination.
Access to drugs is a key area where ordinary markets simply can’t be expected to achieve humane and rational results. In 2008, the purchasing power of the average American dog was higher than that of forty percent of the world’s population. Given the extensive extant involvement of the U.S. government both in the domestic pharmaceutical industry and in the international negotiations determining its powers and duties abroad, there is a special moral obligation for U.S. citizens and politicians to assure the widespread and equitable distribution of lifesaving drugs. As Sunder states:
Economists call the millions of people who need a drug but cannot afford it “dead weight loss.” But the millions who die needlessly because of the patent system—a number that some scholars calculate as nine million in the developing world annually—are more than an inefficiency in the system. . . . We must both adopt alternative mechanisms for developing and distributing medicines to the poor (including prizes), and fully support the use of compulsory licenses by developing countries to treat their sick poor. Patent law cannot draw the line at rectifying market failure. Our law must contend with moral failure as well.
Sunder’s eloquent case for access to drugs commends respect and admiration for the Health Impact Fund, Knowledge Ecology International, Medecins sans Frontieres, and other groups for trying to close this gap.
X-Posted at Bill of Health.
Online Graduate Certificate Program in Pharmaceutical & Medical Device Law & Compliance, ‘Bringing Products to Market,’ to Start on Oct. 7, 2012
Filed under: Compliance, Health Law, Medical Device, Pharma
Through its Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School offers 3 graduate certificate programs in Pharmaceutical & Medical Device Law & Compliance. These flexible, 8-week certificate programs are designed for professionals seeking to enhance their knowledge about legal, regulatory, and ethical issues within the pharmaceutical and medical device industries. Featuring intensive, individualized feedback, the programs provide both an immersion in key substantive issues and an opportunity to develop the practical skills necessary to research and communicate effectively about the law. Online classes for the Bringing Products to Market Certificate start on October 7, 2012.
Bringing Products to Market Certificate
The Pharmaceutical & Medical Device Law & Compliance Certificate: Bringing Products to Market covers the following topics:
- The FDA approval process
- Products liability and FDA preemption
- Advertising and promotion
- Life science companies and the First Amendment
It takes 8 weeks to complete the certificate program. All coursework must be completed in the sequence in which it is offered. Students should plan to spend 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.
Seton Hall Law School’s online Graduate Certificate Programs are offered during our Spring, Summer, and Fall semesters. Start dates for upcoming offerings of the Bring Products to Market certificate and are indicated in the Certificates At-A-Glance section.
Do I need to be in a certain profession to be admitted?
No. While the program is specifically designed to meet the needs of mid- to senior-level professionals in the pharmaceutical and medical device industries, it is also open to qualified students from other backgrounds.
Applicants must submit the following:
- Online application
- Application fee of $50
- Official baccalaureate degree transcript from an accredited college or university
- Current resume
- A 500-word statement explaining why you want to study Pharmaceutical & Medical Device Law & Compliance with a focus on Bringing Products to Market
No entrance exam is required for admission. However, international applicants who are not native speakers of English must submit a TOEFL score.
Filed under: Conflicts of Interest, Drugs & Medical Devices, Pharma
When we think about health care reform, we need to remember that we have been attempting reforms through many avenues of myriad parts of our health system. The IRS revised Form 990 and schedule H in anticipation of the ACA; critics of conflicts of interest have been working on multiple fronts simultaneously. One of the challenges about all of these changes is how we measure whether they have made any positive difference.
The Accreditation Council for Continuing Medical Education (ACCME), which is the accrediting entity for Continuing Medical Education (CME), just released its annual report, which was much less interesting than I had hoped, as it is mostly a financial statement for the year’s CME activities. Nonetheless, it shows that industry grants to CME have declined from 50 to 30 percent of total CME income, which is attributed to the tremendous scrutiny CME has received over the years. Importantly, industry has not lost interest in medical conferences, as ad revenue from exhibits rose 7.2 percent to $296 million. You can read a summary of the report on Pharmalot or read the whole report.
While interesting, it’s hard to make out exactly what to conclude from this news about CME funding. First, it could be a response to the economy, but that’s belied by the increase in exhibit funding. And besides, pharma has historically been of the “you have to spend money to make money” mind. So, perhaps industry is indeed responding to the criticism about funding CME. Not mentioned is the possibility that CME sponsors have been turning away industry money, but that too is a possibility.
Some were concerned that if this happened, health professionals would be unable or unwilling to pay for their own CEUs. The total income for 2011 CME appears to be in line with prior years (especially given a methodology change adopted in 2011). While the number of physicians participating in CME was down slightly, that decline is consistent with a multi-year downward trend; the number of non-physician participants in CME is slightly up. Finally, as noted by Pharmalot, “other income, which includes registration fees paid by participants, rose 4.4 percent [in 2011] to nearly $1.2 billion.” While more than one year of experience will give a better picture, it seems fair to conclude so far that physicians are indeed willing to underwrite their own CME.
Most important to remember, however, is that the funding issue was merely a surrogate for the question of whether CME is biased either substantively or in subject matter coverage. I don’t think we really knew the answer yesterday, any more than the ACCME report enlightens us about what the answer is today. An annual report about CME in which I and others would really be interested would look at whether the subject matter of conferences has changed — are things being covered that weren’t before. Is comparative cost-effectiveness being addressed in presentations that address alternative treatments? Are real responses to racial health disparities being discussed? Is education being delivered to audiences comprised of interdisciplinary healthcare teams rather than the homogenous audiences found at many academy and similar meetings? Is CME delivery itself being studied to determine what learning methodologies are most effective? In short, if we can conclude that industry is listening to its critics by redirecting its funding, can we also infer that changes are occurring in response to other critiques of CME, such as those posed by the IOM report entitled “Redesigning Continuing Education in the Health Professions” and Seton Hall Law’s Whitepaper entitled “Drug and Device Promotion: Charting a Course for Reform?”
Presumably, it is a good thing to have less industry funding of CME — although we only see the change in the United States, not elsewhere . But it doesn’t get to the heart of the matter, which is the need for significant reform of CME generally. That’s the report I want to read.