By Kate Greenwood
Cross-Posted at Health Reform Watch
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 brief filed 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 brief opposing 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.”
In her latest article, The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, Diana Winters decries the time and money courts deciding food and beverage labeling cases must spend “negotiating the interaction between federal and state law, with inconsistent outcomes”. Continue reading
By Deborah Cho
[See Part I here]
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.
By Deborah Cho
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.]
By Tara Adams Ragone
Cross-Posted at Health Reform Watch
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.
By Nadia N. Sawicki
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.
By Kate Greenwood
Cross-Posted at Health Reform Watch
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.
By Kate Greenwood
Cross-Posted at Health Reform Watch
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
Bill of Health Contributor Art Caplan has a new opinion piece online at MedScape: “YOUR Fault if Your Unvaccinated Child Makes Someone Sick.” (Note: Registration to access MedScape is free.)
Are you doing enough to make sure that your patients and their kids are getting vaccinated? Sometimes we leave this for the pediatrician to worry about, but I think that every doctor who sees patients should make it a part of taking the history to ask if they are up to date on vaccinations. Have they gotten their boosters? What are they doing with their kids?
All over the United States, we are tragically seeing the recurrence of diseases that weren’t here 20 years ago. Whooping cough, mumps, and measles are all on the rebound because people don’t vaccinate their kids or they don’t get the booster shots that they need to grant immunity to themselves.
And Dorit Reiss has a new article up on SSRN: “Compensating the Victims of Failure to Vaccinate: What are the Options?“
By Alex Stein
When Sir Henry Maine wrote (here, on page 389) that early substantive law was “secreted in the interstices of procedure,” he did not know that he was coining a long-lasting adage. Even less did he anticipate that this adage will aptly describe our today’s system of medical malpractice.
This system normally requires plaintiffs to accompany their suits with an affidavit or certificate of merit from an eligible medical expert. The expert must show that s/he practices medicine in the same field or specialty as the defendant doctor and is familiar with the standards, protocols and procedures followed by physicians working in that field or specialty (in some jurisdictions, the expert only needs to satisfy the familiarity condition). The expert also must identify the malpractice: the defendant’ deviation from one of those standards, protocols or procedures. Finally, the expert must certify that there is a reasonable medical possibility that the defendant’s malpractice has injured the plaintiff or aggravated her condition. When a plaintiff fails to submit an affidavit that satisfies this checklist requirement, the court must dismiss her suit. The checklist requirement thus creates a “safe harbor” for doctors who go by the rules and blocks away unmeritorious suits. For details, see here.
The Supreme Court of Idaho has recently taken the checklist requirement to its extreme. This unfortunate development took place in Hall v. Rocky Mountain Emergency Physicians,— P.3d —-, 2013 WL 4768310 (Idaho 2013). Continue reading
By Matt Baum
The WHO Surgical Safety Checklist is unusual as a patient-safety intervention in that it has been widely promoted as universally effective, i.e. effective both in high-income and resource-limited settings; checklists are now used in approximately 1800 hospitals worldwide. In a paper recently published in the journal, BMJ Open, Aveling and colleagues report the results of a qualitative study on the implementation of the WHO checklist in two UK hospitals and two hospitals in resource-constrained settings in Africa. Their results suggest that the checklist is “no magic bullet” – that if adopted without proper investment and adaptation to the context of the target hospital, the checklist not only may fail to replicate benefits, but can actually levy its own unintended costs – especially in resource-limited settings. Though the study raises a number of interesting questions, given the nature of this blog, I am hoping that we might start a discussion about those in the domain of ethics and law.
For example, consider the following real case, which was reported in the BMJ paper:
“A patient admitted for cholecystectomy [surgical removal of the gallbladder] suffered hypoxic [oxygen depriviation-related] brain injury and died following surgery. Subsequently, two staff members (not the surgeon) were threatened with guns by the patient’s family, who said that the surgical team had killed the patient. The two staff members were later arrested and criminal charges brought against one of them. One of the questions asked during the police investigation was whether a pulse oximeter [i.e. a tool for measuring blood-oxygen levels] had been used. It had not: according to staff, no pulse oximeter was available for use, even though the checklist requiring use of this equipment was, officially, in use at the hospital.”
The staff members also did not get any legal representation for weeks because there were no clear policies established surrounding who was responsible for providing that counsel.
By Alex Stein
Damage caps are widespread. A typical cap provision precludes medical malpractice victims from recovering more than a specified sum for pain, suffering and other noneconomic harms. These caps vary between $250,000 (as in California that might soon increase its cap by a referendum) and a $1,500,000-$500,000 scale (as in Florida). Some state supreme courts (e.g., Georgia, Illinois, and Wisconsin) voided the caps as unconstitutional, but many others (e.g., Alaska, California, Louisiana, Mississippi, Nebraska, Ohio and West Virginia) have upheld their constitutionality. In a few states (e.g., Florida and Texas), statutory caps had to be corrected to secure their alignment with state constitutions.
Damage caps are controversial. Some people believe that they help contain the costs and secure the affordability of medical care. Others believe that caps shortchange malpractice victims and weaken the deterrence of malpractitioners. People falling into the first group generally support tort reforms. People falling into the second group ardently oppose those reforms. For my middle-way position—that supports procedural tort reforms that block away unsubstantiated malpractice suits, while opposing damage caps and other substantive tort reforms—see here.
The plaintiffs bar expectedly tries to bypass the caps: see Catherine Sharkey’s important article that identifies the “crossover” dynamic: Facing caps on their clients’ noneconomic recovery, patients’ attorneys boost and vigorously pursue their clients’ claims for economic damages with the jurors’ blessing and approval.
Another, relatively recent, way of bypassing the cap is splitting the “occurrence” or “event” of medical malpractice into several events or occurrences. When successful, this strategy doubles, or more than doubles, the recoverable compensation amount. Continue reading
By Alex Stein
Connecticut’s Appellate Court ruled in yesterday’s decision that hospitals and doctors can successfully sue their patients’ attorneys for filing a vexatious malpractice suit. The Court also ruled that the trial judge’s decision that the patient’s suit was vexatious will often create an estoppel against the attorney. The attorney will consequently be precluded from contesting that decision. The only issue will then be the amount of damages—double or treble—that the attorney and her firm will be obligated to pay the hospital or the doctor. See Charlotte Hungerford Hospital v. Creed — A.3d —-, 2013 WL 3378824 (Conn. App. 2013).
Whether this is going to be a trend in our medical malpractice law remains to be seen. In the meantime, I provide the details of that important decision. Continue reading
By Alex Stein
According to the recent New York Court of Appeals’ decision—Applewhite v. Accuhealth, Inc., 2013 WL 3185185 (N.Y. 2013)—governmental immunity is a starting point for any inquiry into EMTs’ liability for malpractice.
The Court based this immunity on the famous “duty to all is duty to none” principle: in providing a vital emergency service to public in general, EMTs function in a governmental capacity and owe no duty to any specific individual. The Court explained that EMTs differ from the regular providers of medical care—doctors and nurses, who are subject to stringent licensing requirements and must have extensive educational and training credentials—in that they provide only emergency medical stabilization in Basic (as opposed to Advanced) Life Support ambulances. EMTs are also funded and remunerated differently from doctors and nurses: they operate on a limited municipal budget that depends on the taxpayers’ money and cannot afford malpractice payouts. Dilution of the EMTs’ budget might limit the municipal emergency response systems to mere transport service—a consequence that society can ill-afford. Continue reading
By Alex Stein
On May 31, 2013, the Supreme Court of Minnesota has delivered an immensely important decision: it recognized as actionable a patient’s increased risk of dying resulting from her doctor’s negligent failure to secure timely diagnosis and treatment of cancer. Dickhoff v. Green, — N.W.2d —, 2013 WL 2363550 (Minn. 2013)
This case involved a family physician (the defendant) and her baby patient (the plaintiff). The baby had a lump on her buttock, which the defendant allegedly considered a non-issue for nearly a year. At the 1–year well-baby check, the defendant referred the baby to a specialist, who diagnosed her with alveolar rhabdomyosarcoma (ARS)—a rare and aggressive childhood cancer. The baby subsequently underwent a tumor-removal surgery, chemotherapy and radiotherapy, but remained dangerously ill. Continue reading
As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.
By Dorit Rubinstein Reiss, LLB, Ph.D.
Dorit Rubinstein Reiss (LLB, Ph.D.) is Professor of Law at UC Hastings College of the Law. She has published articles on regulation and administrative law and teaches tort law. She is also a member of the Parents Advisory Board of Voices for Vaccines and writes the blog Before Vaccines.
In a guest post on this blog, Mary Holland, JD, suggests that there are no grounds for imposing tort liability on parents for failure to vaccinate alone, even if it led to another person being infected. Holland’s post is courteous and matter-of-fact, and there are certainly arguments for that position, especially the argument that common law rarely imposes a duty to act. But Ms. Holland did not make that case.