Guest Post: Crack Down on Those Who Don’t Vaccinate?: A Response to Art Caplan

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 Mary Holland, J.D.

Mary Holland is Research Scholar and Director of the Graduate Legal Skills Program at NYU Law School. She has published articles on vaccine law and policy, and is the co-editor of Vaccine Epidemic: How Corporate Greed, Biased Science and Coercive Government Threaten Our Human Rights, Our Health and Our Children (Skyhorse Publishing, 2012). 

Dr. Art Caplan recently posted an editorial, “Liability for Failure to Vaccinate,” on this blog. He argues that those who contract infectious disease should be able to recover damages from unvaccinated people who spread it. If you miss work, or your baby has to go to the hospital because of infectious disease, the unvaccinated person who allegedly caused the harm should pay. Dr. Caplan suggests that such liability is apt because vaccines are safe and effective. He sees no difference between this situation and slip-and-fall or car accidents due to negligence. Arguing that “a tiny minority continue to put the rest of us at risk,” he suggests that public health officials can catch the perpetrators and hold them to account through precise disease tracing.

Dr. Caplan’s assertions to the contrary, vaccines are neither completely safe nor completely effective. In fact, from a legal standpoint, vaccines, like all prescription drugs, are “unavoidably unsafe.”  [See, e.g., Bruesewitz v. Wyeth, 562 U.S. __ (2011).‎] Industry considered its liability for vaccine injury so significant that it lobbied Congress for the 1986 National Childhood Vaccine Injury Act, providing doctors and vaccine manufacturers almost blanket liability protection for injuries caused by federally recommended vaccines. [See Authorizing Legislation.] The liability risk was so serious that the federal government created a special tribunal under the 1986 Act, the Vaccine Injury Compensation Program, to pay the injured. Moreover, the Supreme Court in 2011 decided Bruesewitz v. Wyeth, prohibiting any individual from filing a civil suit for a defectively designed vaccine in any court in the country. Industry’s extraordinary protection against liability for vaccine injury does not correspond with glib statements, like those of Dr. Caplan, that vaccines are safe and effective. On the contrary, the law acknowledges that vaccines cause injury and death to some, with no screening in place to mitigate harm.  Read More

Liability for Failure to Vaccinate

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 Art Caplan

Measles are breaking out all over Britain.  Getting fewer headlines is the fact that measles are back in the USA too.  In fact they are in our region.  A mini-epidemic is raging in Brooklyn.  Measles for cripes sake!  The disease that many of us over 60 had as kids that should never occur is back with a vengeance.  The reason for the diseases reappearance is simple—failure to vaccinate.  Maybe it is time to get tough on those whose choices put others at risk.

For decades, there has been a safe, effective vaccine that works exceedingly well against the measles–95% full protection for a kid who has been vaccinated– and nearly equally well at preventing transmission to others.  The more people have been vaccinated the tougher it is for measles to gain a foothold.

NY City health officials have reported 30 cases so far–26 in Borough Park and four more in Williamsburg.  The NY Daily News reports that the consequences of this outbreak have been dire:

“There have been two hospitalizations, a miscarriage and a case of pneumonia as a result of this outbreak,” a Health Department spokeswoman said. “All cases involved adults or children who were not vaccinated due to refusal or delays in vaccination.”

So far the outbreak has been among religious Jews some of whom shun getting the vaccine for their kids out of fear it causes autism Dr. Yu Shia Lin of Maimonides Medical Center in Borough Park told The News.

Read More

Human Subjects Case Unfolds

Institutional Review Boards are in the top news at outlets such as the New York Times, as a research debacle unfolds. I looked through the documents that are publicly available to figure out what happened and what to expect.

Researchers at 22 universities or hospitals in the US enrolled premature babies in a randomized controlled trial between 2004 and 2009. This was the second part of a broader study, but the first part of the study “raised no concerns” according to the US Office of Human Research Protections on page 2 of its determination letter to the lead institution, University of Alabama-Birmingham. OHRP is the federal agency in charge of enforcing human-subjects regulation.

For the second part of the study, though, OHRP found that all 23 IRBs that approved the study (at 22 research sites) violated federal regulations: IRBs should have made researchers tell the parents that they knew their babies would be at higher risk of death, neurological damage, or blindness if they enrolled in the study (pages 2 and 10 of UAB letter). OHRP has only posted a determination letter for UAB at this point, but it explains that at all of the sites, the agency found violations with consent documents “similar to those described” to UAB. The UAB IRB is in especially hot water because it seems first to have first approved the 2.5-page template consent form, which the other institutions used (page 5). If you read the last page of UAB’s letter, you can make a good guess at who may officially be getting bad news from OHRP soon.

Read More

Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

By Michelle Meyer

As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience blogger Neurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order. Read More

Bad to the Bone

By Christopher Robertson

I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).  The article also suggests themes about medical malpractice, products liability, and physicians’ conflicts of interest too.

A Different Take on the New Murtagh Study on MedMal Disclosures, and A Few Thoughts on Friendly Attorneys

By Christopher Robertson

On these pages, Michelle Mello recently posted a discussion of her new article with Lindsey Murtagh, Thomas Gallagher, and Penny Andrew, called “Disclosure-And-Resolution Programs That Include Generous Compensation Offers May Prompt A Complex Patient Response.”

In this vignette-based online study, the authors put respondents in clinical scenarios with medical errors, and then added experimental conditions where the error was simply confessed, or confessed with an offer of waiver of the medical bills, with an offer to reimburse a limited amount of out-of-pocket expenses related (specifying $25,000 out of pocket plus $5,000 lost time), or with an offer of “full compensation.”  As the headline suggests, the authors conclude that offers of full compensation may be sometimes be bad ideas for self-interested hospitals.  I’m a big fan of this sort of vignette-based research, because it allows randomized manipulation that is impossible in observational field research.  Still, allow me to offer some of my own questions and interpretations below the fold.

Read More

Does Your Hospital Make You Sicker?

By Christopher Robertson

New hospital safety scores were released this week, and around the country, those that scored well are crowing (see e.g., here and here).  The data is provided by a nonprofit called Leapfrog Group, which compiles survey-responses  and CMS data on a website called hospitalsafetyscore.org.  Check out your own hospitals.  The Leapfrog Group includes several leaders in the hospital safety movement, including Peter Pronovost (of checklist fame) and Lucian Leape (author of the seminal 1994 JAMA article on the topic).  Is anyone aware of an empirical study that looks at the relationship between these scores and medical malpractice liability claims or payouts?  Any attorneys that use this sort of data in the litigation of individual cases?

Taking Allegations of Child Abuse Seriously: Former Penn State President Spanier Charged

By Michele Goodwin

Penn State’s former president, Graham Spanier, is the latest person to be charged in the fallout involving Jerry Sandusky’s sexual abuse of boys on the Penn State campus.  A year ago, I blogged about Spanier’s curiously timed defense of his former staff members following the horrific allegations involving the former, popular football coach.

Jerry Sandusky’s crimes are deplorable. He was convicted of molesting boys from a charity he helped to found (Second Mile) and will serve 30-60 years in prison; he will likely die there.  Yet no less problematic were Spanier’s statements immediately following the release of the grand jury’s presentment.  Last year, the statement released by Spanier could only be described as cavalier and irresponsible.  Spanier claimed that the perjury charges against his former athletic director, Timothy Curley, and Gary Schultz, his senior vice president for finance and business, were “groundless,” and that he has “complete confidence in how they… handled the allegations” against Sandusky.  Stunning.

Remember the grand jury report?  Schultz said that the allegations were “not that serious” and that he and his colleague “had no indication that a crime had occurred.”  What we know now from the Freeh Report is that there were emails between Spanier, Curley, and Schultz about allegations of Sandusky’s showers with boys in the Penn State football locker room. Spanier claims that there may have been emails that he received, but he can’t remember them.  He told Jeffrey Toobin in a New Yorker article: “I was apparently copied on two emails…I didn’t reply to them.”  A few years later, Michael McQuery (a former graduate student) reported witnessing Sandusky sexually abusing a child in the shower; he also testified before the grand jury.

Read More

Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1

It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week.  Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics?  I think this may be the case.

Perhaps most importantly, frozen oocytes will not implicate personhood laws.  Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses.  However,  IVF clinics and clinicians should also be concerned.  It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos.  There have been no such criminal proceedings brought against an IVF clinic — yet.  Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist.  Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.

Read More

Art Caplan on Liability for Non-Vaccinators

Art Caplan has a new article out in the Journal of Law, Medicine, and EthicsFree to choose but liable for the consequences: should non-vaccinators be penalized for the harm they do?” (subscription required)

Here’s the abstract: Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.