An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using theclinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice. A quick snippet:
The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.
On November 19, Judge Anita Brody will hold a fairness hearing in the class action lawsuit of National Football League (NFL) Players v. NFL re: concussion injury. This is one of the final steps toward final approval (or rejection) of the settlement in the case. Before final approval Judge Brody must determine that the settlement is fair, reasonable, and adequate for the over 20,000 retired NFL players who are included in the class. A variety of concerns have been brought forth publicly regarding the proposed settlement, which received preliminary approval from Brody earlier this year. Around 140 retired NFL players filed objections to the proposed settlement and around 200 have opted out of the class. This blog post provides a brief overview of the settlement and objections to it.
Settlement terms (summarized):
Monetary Awards for those with a qualifying diagnosis. Award amount is determined based on a sliding scale that factors in diagnosis, age, and years played in the NFL.
Baseline Assessment Program. Class members who are Retired NFL Players have the option to participate in a baseline assessment and medical monitoring program.
Education Fund will be established to promote safety and injury prevention in football.
The long-form settlement document can be viewed here.
Concerns (summarized, non-exhaustive):
A variety of concerns regarding the preliminarily approved settlement have been brought forth through the media and other channels. These are the types of issues that will likely be discussed at the fairness hearing and that Judge Brody will have to weigh in her determination of whether the settlement is fair, adequate, and reasonable for the class as a whole.
Many concerns regard the categories of diagnosis that are eligible for compensation.
Compensable categories are too restrictive: Under the current settlement agreement, former players can be compensated if they have a qualifying diagnosis of Alzheimer’s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease), death with chronic traumatic encephalopathy (between January 1, 2006 and July 7, 2014), and what are called Level 2 and Level 1.5 Impairment (these categories represent a pattern of performance on a battery of neurocognitive tests that is 2 or 1.7-1.8 standard deviations below normal, respectively). Some have argued that, although the categories included are important to compensate, there are other prevalent problems such as pituitary dysfunction, depression, and mood and behavioral disorders that are associated with repetitive head trauma and should also be covered by the settlement agreement. Others are concerned that there are characteristics about the existing categories that are problematic (see next two points below). Continue reading →
I previously wrote about California Proposition 46–which proposed to raise the cap on pain and suffering awards in malpractice cases from $250,000 to $1.1 million, require doctors to check a statewide database of drug prescriptions before prescribing some narcotics, and require doctors to undergo random drug and alcohol testing–here.
On November 4, Californians will vote on Proposition 46, a ballot initiative to adjust the $250,000 state’s noneconomic damages cap in medical malpractice cases for inflation, raising it to $1.1 million virtually overnight. It’s a long overdue move – California has one of the most stringent damages caps in the country, and the cap really affects access to the legal system. Now is the perfect time to do it, because after years of turbulence, the medical liability environment has calmed.
In an analysis published October 30 in the Journal of the American Medical Association (JAMA), David Studdert, Allen Kachalia and I report that data from the National Practitioner Data Bank show that the frequency and average cost of paid malpractice claims have been declining. The rate of paid claims against physicians decreased from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, with an estimated annual average decrease of 6.3% for MDs and a 5.3% decrease for DOs. Among claims that resulted in some payment, the median amount paid increased from $133,799 in 1994 to $218,400 in 2007, an average annual increase of 5%. Since 2007 the median payment has declined, reaching $195,000 in 2013, an average annual decrease of 1.1%.
Trends in insurance premiums vary more according to which market you’re looking at, according to data from the Medical Liability Monitor’s Annual Rate Survey, but also look pretty favorable overall. None of the locations we examined showed large increases over the last 10 years, and most showed flat or declining premiums. Continue reading →
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. Continue reading →
Malpractice suits filed in connection with reproductive-choice procedures often present unique problems. The suit filed by Jami Conner against her former gynecologist, Dr. Bryan Hodges, is a case in point. The plaintiff, a mother of two children, decided that she did not want to have more children. To avoid future pregnancy, she asked the defendant to perform bilateral ligation of her tubes and the defendant granted her wish. Two and a half years later, however, the plaintiff discovered that she was pregnant again. Her suit against the defendant promptly followed that discovery. Continue reading →
The stakes were high in Sutter — under the California statute medical data breach claims trigger (or should trigger!) nominal damages at $1000 per patient. Here four million records were stolen.
Plaintiffs’ first argued the defendant breached a section prohibiting unconsented-to disclosure. The not unreasonable response from the court was that this provision required an affirmative act of disclosure by the defendant which was not satisfied by a theft.
A second statutory provision argued by the plaintiffs looked like a winner. This section provided, “Every provider of health care … who creates, maintains, preserves, stores, abandons, destroys, or disposes of medical information shall do so in a manner that preserves the confidentiality of the information contained therein.” Continue reading →
You know the King of Pop died in 2009 while rehearsing for a comeback tour in London. Here’s a twist you may not have heard about: Michael Jackson fan club members sued Conrad Murray, the doctor who administered the lethal overdose of anesthesia. And the celebrity enthusiasts won. A French court recently awarded five of the grieving fans economic damages (albeit just a euro each) to compensate for their emotional suffering.
The case highlights a neglected problem in our own law, not just medical malpractice, but constitutional and common law too. It’s this: Supreme Court rules and policies about harm, compulsion, and intentionality rely on the flawed assumption that operations of the mind are meaningfully distinct from those of the body. In our new essay on Dualism and Doctrine, Alex Stein and I (1) demonstrate just how this fiction distorts the law, (2) argue that the reasons for its persistence cannot save it, and (3) identify the ways in which courts should uproot dualism’s pernicious influence on our legal system. Continue reading →
On April 21st, the Supreme Court will hear oral argument in Pom Wonderful v. The Coca-Cola Company, a case in which Pom sued Coke under Section 43(a) of the Lanham Act arguing that Coke’s product “Pomegranate Blueberry Flavored Blend of 5 Juices” was misleadingly named.Coke countered that the suit should be dismissed because the name was specifically authorized by the Food and Drug Administration’s regulations governing flavored juice blends, and both the District Court and the Ninth Circuit Court of Appeals agreed.
In its opening brieffiled last week, Pom argues that neither the provisions of the Food, Drug and Cosmetic Act governing food and beverage labeling generally, nor the regulations that specifically address juice blends, precludes the application of the Lanham Act to Coke’s misleading juice label.This conclusion, per Pom,
“follows inexorably from this Court’s holding in Wyeth v. Levine … that FDA’s approval of a drug label does not displace state failure-to-warn suits challenging the adequacy of the warning. … Following Wyeth, there can be no serious argument that the provisions of the FDCA are in ‘irreconcilable conflict’ with the Lanham Act.FDA does not even generally review—much less approve—particular food labels; nothing even arguably prevented Coca-Cola from designing its label to avoid misleading consumers; and FDA has given no indication that its juice-naming rules set the outer bounds of labeling regulation.”
In its briefopposing Pom’s petition for certiorari, Coke distinguished Wyeth, noting that the provisions of the FDCA governing drug labeling do not expressly preempt state regulation.The provisions of the FDCA governing food and beverage labels, by contrast, “expressly supplant State laws—including those that imposed more ‘stringent’ requirements[.]”This, Coke argued, shows that the food and beverage statutory provisions and their implementing regulations “were not intended as a ‘floor’ but rather as the exclusive body of regulation to which food and beverage labels would be subject.”
Last week, I wrote the first of a two-part series on tips that may be helpful for law students and lawyers interested in or working in health/medical law. I continue with Tip #4 here.
4. If you need to learn about a disease, procedure, or drug that you know nothing about, your best starting point is probably Wikipedia. Google will lead you to some incorrect answers, and diagnose-yourself websites will give you answers that are much too broad to use practically in legal practice. Once you have familiarized yourself with the general topic on Wikipedia, you can then go back to your search engine of choice for more specific terms and weed out the wrong information. Starting on PubMed or GoogleScholar probably isn’t the best idea either because most of what you’re reading will be highly technical and the articles you find will likely be about novel uses or instances of whatever you’re searching. Another fantastic source is UpToDate, an evidence-based Wikipedia-like source for healthcare providers, but many people may not have access to all the information on this site.
As a student in the Disability Litigation Clinic, one of the many fantastic clinics here at Harvard Law school, I’ve come to appreciate the value of hands-on experience as an essential component of legal education. One issue that we as students are often faced with, however, is a lack of familiarity with the particular subject matter we are assigned to work with. Now, I know that topic-specific knowledge typically comes on the job, but I’m starting to see that many of us trying to practice law touching the medical field never really have a chance to learn the basics of the medical world and just how essential that basic knowledge really is.
As a short introduction to this post, I will say that I spent several of my college years volunteering and doing research at various hospitals and clinics, went to medical school for two years, have an M.A. in Bioethics (noting this to add to my hours spent in a hospital), have interned in the health care division in state government, have interned in a health law nonprofit firm, and, as noted above, am enrolled in the Disability Litigation Clinic right now. All that to say, please take everything I write here with a grain of salt. I am by no means an expert on this, but have found that this information has helped me throughout my healthcare-related legal experience so far and I hope that this will spark dialogue and interest on this subject.
[Blogger's Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone, in which she discusses North Carolina Board of Dental Examiners v. FTC, drawing on both her scholarly work on the intersection of health care and antitrust law and on her deep experience prosecuting medical licensing actions for the state of New Jersey.]
Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct? The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.
Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case. He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here. Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.
While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review). Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Continue reading →
For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.
The New York Times reported today that the ACLU has filed a lawsuit against the United States Conference of Catholic Bishops on behalf of Tamesha Means, a patient at Mercy Health Partners in Michigan. The suit alleges that Means suffered physical and emotional harm as a result of the Conference of Bishops’ ethical directives relating to pregnancy termination, which Mercy, as a Catholic health institution, is required to follow.
According to the ACLU press release and the Times article, when Means’ water broke 18 weeks into her pregnancy, she rushed to Mercy Health, the only hospital in her county. According to medical experts, the fetus had “virtually no chance of surviving” and posed a significant risk to Means’ health. Mercy physicians did not share this information with Means, and discharged her without informing her that terminating the pregnancy and extracting the fetus was the safest course of action from a medical perspective. Means returned to the hospital twice in the next two days, suffering from infection and extreme pain, but it wasn’t until she miscarried that the staff at Mercy attended to her medical needs. An obstetrician at the University of Wisconsin Medical School quoted in the Times described Mercy’s treatment of Means’ condition as “basic neglect.”
Rather than suing Mercy Health Partners, Means and the ACLU are suing the Conference of Bishops. They argue that by directing Catholic hospitals to avoid terminating pregnancies or providing referrals (even when a woman’s health is at risk), the Conference of Bishops is ultimately responsible for the harms suffered by Means and other women in her position. According to Louise Melling, deputy director of the ACLU, “This isn’t about religious freedom, it’s about medical care.”
There are a host of legal, ethical, and religious issues associated with the Tamesha Means case. But in this post, I’d like to focus on only one - the division of legal responsibility between health care providers and third parties when it comes to patient advocacy and quality of care.Continue reading →
The November 2013 issue of the Yale Law Journal features a very interesting comment on an important issue at the intersection of health law and policy. A First Amendment Approach to Generic Drug Manufacturing, by Connor Sullivan, argues that the First Amendment principles underlying the Supreme Court’s opinion in Sorrell v. IMS Health Inc. provide a viable legal avenue for challenging the FDA regulations that prevent generic drug manufacturers from sending letters warning physicians of the risks of their drugs.
These FDA regulations became a source of legal controversy when the Supreme Court heard PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a case concerning whether the FDA’s requirement that generic drug manufacturers use the same labels as brand name manufacturers preempts state tort laws that allow injured parties to challenge the sufficiency of a generic manufacturer’s warnings. The Court held that the FDA requirements did pre-empt state tort law on the theory that a generic drug manufacturer could not comply with both the FDA labeling requirements and state tort law at the same time because state tort law might require different, greater warnings than the brand name manufacturer of that same drug used. The Court noted the unfortunate inconsistency that had befallen the plaintiffs in the case; had they taken the brand name drug, they could challenge the labeling requirements of the brand name manufacturer, which has the flexibility under federal law to change their labeling scheme. But because the plaintiffs took the generic version of the same drug, their suit was foreclosed.
We might intuitively assume that these plaintiffs could simply sue the brand name manufacturer; after all, it is their poor labeling scheme that the plaintiffs were challenging by noting the deficiencies in the generic manufacturer’s similar label. But the law is not so wise. After many attempts and subsequent failures to convince a court of such an argument, the law has virtually foreclosed any mechanism for an injured party to recover from a brand name manufacturer for the labeling deficiencies that are passed onto a generic manufacturer. Indeed, Sullivan cites to Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013), which noted that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product.”
In sum, the combination of FDA rules and a Supreme Court pre-emption decision has created a real inconsistency in how people experience the tort laws as applied to their drug manufacturers. After the jump, I’ll explain Sullivan’s idea for solving this problem.
At the end of last month, the Secretary of Health and Human Services Kathleen Sebelius made headlines when, in a letter addressed to Representative Jim McDermott (D-WA), she announced that “[qualified health plans], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act” were not “federal health care programs under section 1128B of the Social Security Act”. One implication of the Secretary’s interpretation is that the “anti-kickback act”, which is found in Section 1128B, does not apply to qualified health plans. And that, in turn, means, among other things, that individuals insured under those plans, unlike individuals on Medicare or Medicaid, will be able to use drug company coupons to defray the cost of their prescription drugs.
Prescription drug coupons have been a source of controversy, favored by branded manufacturers and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers. Joseph Ross and Aaron Kesselheim studied a large number of coupons advertised on the website www.internetdrugcoupons.com and found that “62% (231 of 374) were for brand-name medications for which lower-cost therapeutic alternatives were available.” Ross and Kesselheim argue that the coupons are costly at the population level, but also for individual patients. This is because the coupons are nearly always time-delimited and the short-term savings do not typically outweigh the long-term cost of taking a branded drug. On the other hand, in an article in last week’s JAMA, Leah Zullig and colleagues pointed out that reducing co-payments has been proven to improve medication adherence, a problem which there “is an increasing business case for addressing[.]“
The coupon controversy has carried over into the courts. On March 7, 2012, seven lawsuits were filed in district courts by third party payers against a number of drugmakers, alleging that prescription drug coupons violate antitrust, commercial bribery, and racketeering laws. (This post at FDA Law Blog includes links to the seven complaints, and this one provides an update on the status of the litigation as of late June 2013.)
A little over two weeks ago, the Supreme Court heard oral argument in a rather obscure ERISA case—Heimsehoff v. Hartford Life & Accident Ins. Co. The case asks a rather basic question without a readily apparent answer: when a beneficiary of an ERISA-regulated insurance plan seeks to claim benefits, may the statute of limitations period for judicial review of the benefit decision begin before the completion of the plan’s mandatory internal resolution process? In other words, can a statute of limitations for judicial review begin to run before a beneficiary is permitted to file suit?
The problem this lawsuit seeks to address can be clarified through a hypothetical: Imagine beneficiary B has an ERISA-regulated disability insurance plan with (i.e. provided by her employer but issued and administered by) insurer I. B’s contract with I states that a three-year statute of limitations for judicial review of benefit decisions begins running at the date that B sends I proof of loss. Then the following takes place:
B sends I her proof of loss on January 1, 2010.
I’s internal resolution process is completed on January 2, 2013, and B is denied her claim.
B believes the decision was erroneous and seeks to challenge it in court.
The court informs B that she has no claim because the statute of limitations—three years from January 1, 2010, the date that B sent I her proof of loss—has run.
B’s case certainly seems rather compelling. After all, I has functionally denied B any opportunity to receive independent review of I’s benefit decision. But at oral argument, the Justices raised several interesting arguments that make the outcome of this case far from clear.
On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion. The decisions were noteworthy because in them the First Circuit lent its imprimatur to 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. In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the appellate court upheld a jury verdict that, after trebling, came to $142 million.
Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.” Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.” In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”
Civil RICO claims cannot be predicated on “off-label promotion”, however. To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud. In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo. On appeal, Pfizer did not contest the jury’s finding that it committed fraud. This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.
There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Continue reading →