Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading

Global Genes, Local Concerns: A Symposium on Legal, Ethical and Scientific Challenges in International Biobanking

I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference  we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.

A detailed program and further information is available here and here.

This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.

These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.

Speakers:

  • Bartha Knoppers, Mc Gill University (Canada)
  • Glenn Cohen, Harvard University (US)
  • Timo Minssen, University of Copenhagen (DK)
  • Tim Caulfield, University of Alberta (Can)
  • Michael Madison, University of Pittsburgh (US)
  • Jeff Skopek, University of Cambridge (UK)
  • Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
  • Jane Kaye, University of Oxford (UK)
  • Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
  • Klaus Høyer, University of Copenhagen (DK)
  • Aaro M. Tupasela, University of Copenhagen (DK)
  • M. B. Rasmussen, University of Copenhagen (DK)
  • Åsa Hellstadius, Stockholm University (Sweden)
  • Peter Yu, A&M Texas University (US)
  • Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
  • Nicholson Price, University of Michigan Law School (US)
  • Karine Sargsyan,  BBMRI/Head of Biobanking-Graz (Austria)
  • Eva Ortega-Paino,  BBMRI, Lund University (Sweden)
  • Nana Kongsholm, University of Copenhagen (DK)
  • Klemens Kappel, University of Copenhagen (DK)
  • Helen Yu, University of Copenhagen (DK).

For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.

We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.

Best wishes/

Timo Minssen

National Survey Suggests that Off-Label Status is Material to Informed Consent

As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses.  (Companies are not allowed to promote off-label uses however.)

A recent national survey by Consumer Reports includes two interesting findings:

  1. About two-thirds (63%) of Americans “would not take a doctor prescribed medication that has been approved by the FDA, but not for their specific condition.”
  2. Almost all Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition.”

Patients are right to be skeptical of off-label uses, though they may not appreciate just how common they are.  In fact, most off-label use is unsupported by scientific evidence as to safety and efficacy.  A new report by the FDA illustrates several off-label uses that were subjected to rigorous clinical trials and turned out to be ineffective or dangerous.   For example, Aliskiren is approved for treatment of hypertension and was used off-label for prevention of congestive heart failure (CHF) complications.  A large trial showed that, although it did not significantly improve CHF mortality, it did significantly increase rates of kidney failure for CHF patients.  We do not know how many other off-label uses would fail if similarly tested.   Continue reading

New dimensions in patient consent to treatment

By John Tingle

In the patient care equation doctors  and nurses will always be in a more dominant and powerful position. They have the professional  knowledge the patient needs, they are in their usual environment. The patient is ill, not in their usual environment and is often thinking the worst about their condition. The law recognises the need to correct this power imbalance and cases have gone to court over matters such as patient informed consent to treatment. Modern cases emphasise the importance of patient autonomy against that of medical paternalism. In the House of Lords case of Chester v Afshar [2004] UKHL 41 involving consent to treatment failures, Lord Steyn stated:

“In modern law medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well established, risk of serious injury as a result of surgery.” (Para 16).

The focus of the modern day law and that of many professional health organisations policy development is on patient rights, trying to balance the unequal care equation. Continue reading

Regulating genetically modified mosquitoes

By Dalia Deak

Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in the United States, pending a public comment process on a draft environmental assessment submitted by Oxitec. It should be noted that a final approval for the trial will not be made until the FDA completes the public comment process.

The genetically modified insects, which are male Aedes aegypti mosquitoes, are designed to breed with the female Aedes aegypti mosquito (primarily responsible for transmitting zika, dengue fever, and other diseases) and contain a gene lethal to their offspring. The female mosquitoes lay eggs but the larvae die well before adulthood. Oxitec claims that recent tests have shown up to a 90% decrease in the population of the Aedes aegypti mosquito, with a recent test in Piracicaba (~100 miles from Sao Paulo in Brazil) showing an 82% decline. Tests have also been conducted in the Cayman Islands and Malaysia.

In the United States, Oxitec is in the process of waiting for FDA approval to conduct trials in the Florida Keys. However, this is relatively unclear and uncharted territory for the federal government in terms of what group should be responsible for the review, and the decision for the CVM jurisdiction in this case remains hotly debated. Jurisdictional debate exists between the U.S. Department of Agriculture and the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).

Continue reading

Hormonal Treatment to Trans Children – But what if?

A few weeks ago I ran across this BuzzFeed post, telling the story of Corey Mason, a 14 year old male to female Trans teenager who was filmed getting her first pack of estrogen hormones. Her mom Erica, who uploaded the video to Facebook and YouTube, spurred a social-media discussion on the topic of hormonal treatment for Trans children and youth.

Erica said the vast majority of reactions were very supportive. On the other hand, different views and opinions were put on the table as well, even from people who ally completely with Trans identity politics.  One of them, a Trans woman, said she fears from rushing (perhaps gay) teenagers into irreversible treatments, as most Trans kids “GROW OUT OF IT”. Aoife commentThis position was also taken by Alice Dreger, a Bioethicist and a historian writing on Intersex issues, in describing the uneasy choice between the two models available at the moment: On the one hand you have the ‘therapeutic model’ offering mental health support to the Trans person and/or family, to help ease up the tensions caused by gender identity dysphoria (GID). This model aims to relax the dysphoria and so avoids any medical irreversible interventions. On the other hand, you have the ‘accommodation model’ asserting there’s nothing wrong with the trans person and/or his/her family, and so offers medical interventions to accommodate it.[1]

Continue reading

Uninsured Practice of Medicine as Actionable Tort

By Alex Stein

A week ago, the Supreme Court of New Jersey has delivered an important decision on whether uninsured practice of medicine is actionable in torts. Jarrell v. Kaul, — A.3d —- 2015 WL 5683722 (N.J. 2015). This decision involved an uninsured anesthesiologist who allegedly provided negligent pain management treatment to a patient. Under New Jersey statute, N.J.S.A. 45:9–19.17; N.J.A.C. 13:35–6.18(b), a physician’s license to practice medicine is only valid when she holds medical-malpractice liability insurance in the requisite amounts. Continue reading

Proving Decision-Causation

By Alex Stein

Proving decision-causation in a suit for informed-consent violation is never easy. Things get even worse when a trial judge misinterprets the criteria for determining – counterfactually – whether the patient would have agreed to the chosen treatment if she were to receive full information about its benefits, risks, and alternatives. The recent Tennessee Supreme Court decision, White v. Beeks, — S.W.3d —- 2015 WL 2375458 (Tenn. 2015), is a case in point. Continue reading

The South Dakota Effect: A Potential Blow to Abortion Rights

By Alex Stein

Many of us are familiar with the “California Effect.” California’s hydrocarbon and nitrogen oxide emission standards for cars are more stringent than the federal EPA standards and more costly to comply with. Yet, California’s emission standards have become the national standard since automobile manufacturers have found it too expensive to produce cars with different emission systems – one for California and another for other states – and, obviously, did not want to pass up on California, the biggest car market in the nation.

Such regulatory spillover may also occur in the abortion regulation area as a consequence of the legislative reforms implemented by South Dakota and thirteen other states. These reforms include statutory enactments that require doctors to tell patients that abortion might lead to depression, suicidal thoughts and even to suicide. Failure to give this warning to a patient violates the patient’s right to informed consent and makes the doctor liable in torts. Continue reading

Cassandra C. Goes Home – Connecticut Misses an Opportunity

By Jonathan F. Will

On Monday Cassandra C. was sent home from the hospital.  Her cancer is in remission after responding well to treatments.  Many will recall that those treatments were forced on Cassandra against her wishes and those of her mother.   Back in January, the Connecticut Supreme Court issued a two-page order agreeing with state officials that Cassandra, at seventeen years three months, should be compelled to undergo chemotherapy to treat her Hodgkin’s Lymphoma.

The success of this medical treatment may be viewed by some to vindicate the comments of those like bioethicist Art Caplan and Fox News legal analyst Peter Johnson, Jr., who agreed with the decision.  Indeed, Mr. Johnson, after giving a personal anecdote of his own history with Hodgkin’s Disease, declared this decision to be right on the law, right on the ethics, and right on humanity.

Mr. Johnson gave the impression that a minor should never be permitted to make such a medical decision, while Dr. Caplan at least implied that his conclusion might be different if the refusal was based on religious beliefs.  Then you have a commentator in The Economist who came to the exact opposite conclusion.  He expressed concerns about Cassandra’s liberty and the rights of her mother to make decisions on her behalf.

I’m not so easily convinced by their arguments.

Continue reading

Arizona Enacts “Abortion Reversal” Law

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On Wednesday, March 25, Arizona legislators passed a bill prohibiting women from buying insurance plans that cover abortions on the federal health exchange.  Senate Bill 1318 also includes a provision on medical abortions, which are typically used during the first nine weeks of gestation. Medical abortions involve taking two pills within a few days of each other.  The law requires doctors performing such abortions to tell their patients that if they reconsider their abortion after taking their first pill, they should return to the doctor for a procedure that can allegedly “reverse” the abortion.  The law amends Arizona Statute § 36-2153 to add that at least twenty-four hours before an abortion is performed, the physician must orally and in person inform the woman that “it may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” The law also requires the Department of Health Services to update its website to include information about the potential ability to reverse a medical abortion.  Republican Governor Doug Ducey, who opposes abortion rights, signed the law on March 30, 2015.

Like any law addressing abortion, the law is controversial. Abortion opponents lauded the bill, stating that Wednesday, March 25th was a “great day for women in Arizona who are considering getting an abortion to get all the facts they need.” On the other hand, women’s rights and health care providers’ groups oppose the coverage exclusion and vehemently oppose the abortion “reversal” provisions.  Senate Minority Leader Katie Hobbs called it “junk science” and “quack medicine.”  Arizona-based gynecologist Ilana Addis stated that there is no evidence to support this provision and women would essentially be “unknowing and unwilling guinea pigs.” Continue reading

“Error in Judgment” and Informed Consent

By Alex Stein

When conventional standards of practice allow a physician to choose between two or more ways to treat or diagnose a patient, she is free to select any of those ways. The fact that her chosen procedure subsequently proves inferior to the alternatives and works badly for the patient is of no consequence: the physician would not be liable for malpractice because malpractice accusations only attach to actions and not to consequences. Whether a physician did or did not deliver substandard treatment to the patient must be determined prospectively (ex ante) rather than by hindsight (ex post). Because a medically approved procedure that proves inferior to another recommended procedure appears negligent, jurors must receive an effective warning against this misleading appearance. How to best administer this warning is a matter of split among state courts. Continue reading

Federal Newborn Screening Law Emphasizes Informed Consent

Allison M. Whelan, J.D.
Senior Fellow, Center for Bioethics and Global Health Policy, University of California, Irvine
Guest Blogger

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

Continue reading

A Right to Die? The M.D. Case Before the Argentine Supreme Court

by Martín Hevia

In 2015, the Argentine Supreme Court is to hear a case involving the right to die, death with dignity, and informed consent. Because of a car accident in the Province of Neuquén, M.D., the patient, has been in a permanent, irreversible, vegetative state for 18 years. His sisters and curators have requested the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way.

This will not be the first time that the Supreme Court hears a case of death with dignity. In 2012, the Court heard the case of Albarracini Nieves, who was unconscious when admitted to a hospital in Buenos Aires. The physicians established that a blood transfusion was necessary. But, as Albarracini belonged to the cult “Jehovah’s Witnesses”, he had had made a statement before a public notary in 2008 where he expressed he would not accept any blood transfusions even if his life were in danger. His father requested a cautionary measure that would order the transfusion to be practiced. The first instance court admitted the solicited measure, considering that although Albarracini had expressed that he refused an eventual transfusion, he was not “in a condition to make decisions with full discernment.”The case then reached the Supreme Court, which argued that there were no reasons to doubt over the current validity of Albarracini’s expression of will and that there was no evidence that he would not have considered the significance of his decision.The Court argued that “…this Court has clearly established that Article 19 of the National Constitution grants the sphere of freedom, within which he can freely adopt fundamental decisions about himself without any State or third parties interference, as long as those decisions do not violate third parties’ rights.”The Court stated that“The possibility of accepting or refusing a specific treatment, or selecting an alternative form of treatment, is part of self-determination and personal autonomy; that patients have the right to choose options according to their own values or points of view, even when they may seem irrational or imprudent, and that free choice must be respected.”

The M.D. case is different in that it is difficult to prove the patient’s will – unlike in the Albarracini Nieves case – because there is not a patient’s written statement on whether it is appropriate for him to continue or not certain medical treatment to keep him alive. The Superior Court of Justice of the Province of Neuquén has decided on the case invoking the 2009 Patients´ Rights Act: according to this law, the sisters have standing to grant informed consent in the name of their brother.

The Supreme Court and Argentine lower courts have interpreted the National Constitution and concluded that it grants patients a wide range of autonomous choice as regards their autonomy, reflected in their right to refuse medical treatment.  On that basis, the Supreme Court will probably confirm the decision of the lower court.

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Continue reading

Parental Consent for Youth Contact Sports Participation

As we enter into the fall sports season, it’s unlikely that a week will go by where we don’t hear the current buzzword in sports community: concussion. Whether in reference to an acute player injury, an untimely death, new or ongoing litigation, or rule changes in sport, the athletic community and the public are increasingly aware of the impacts of these brain injuries. Although much of the media attention is directed toward college and professional athletes, youth and high school athletes significantly outnumber their older counterparts and it is thought that they take longer to recover from these injuries.

A recent publication by Mannings and colleagues surveyed 369 parents of 5-15 year old full-contact football players in order to assess the parents’ understanding of concussion (1). Although the study does have limitations, its finding could have important implications. The parents surveyed were often missing critical information about concussions. For example, less than half of parents correctly identified that concussion is a mild traumatic brain injury. Additionally, none of the parents surveyed correctly identified all of the symptoms of concussion queried in the study. Although it is mandated by statute in the majority of states (2) that parents and/or athletes are provided with information about concussions prior to sports participation, the extent to which the information provided (normally in the form of an information sheet) is read, understood, or retained is not well understood.

Sports participation is associated with a myriad of positive physical, psychological, and social outcomes. However, it also comes with the risk of injury, including concussion. For youth and adolescents, parents play a critical role. Most often, children and adolescents rely on parental consent to participate in sports. Given parents’ role as decision-makers, and the finding of Mannings and colleagues, an important ethical issue that needs to be addressed is what level of knowledge should be required for parents to provide informed consent for their child to participate in inherently risky activities such as contact sports?

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Art Caplan: WHO Ethics Committee on Ebola Just a Start

Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola.

He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care Blog. As he writes in his piece in NBC News Health:

It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.

In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:

It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?

The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.

You can read more at the links above.

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Anti-Abortion Practices at Catholic Hospitals as Medical Malpractice

By Alex Stein

The New York Times has recently reported about a suit filed by ACLU against the United States Conference of Catholic Bishops for requiring Catholic hospitals to avoid abortion “even when doing so places a woman’s health or life at risk.” The suit unfolds a disturbing story about an 18-week pregnant woman who rushed to the Mercy Health Partners in Muskegon, Michigan – the only one in her county – after breaking water. According to the suit, the plaintiff’s pregnancy was not viable but posed significant risks to her health. Instead of inducing labor or surgically removing the fetus to reduce the plaintiff’s chances of infection, the doctors at Mercy Health sent her home. The doctors also did not tell the plaintiff that her pregnancy is not viable and that it poses risk to her health. The plaintiff returned to the hospital next morning and was sent home again (!!) despite her bleeding and pain. On her third visit to the hospital – with severe pain and fever – the plaintiff miscarried and her fetus died shortly thereafter.

Described by the NYT as opening “a new front in the clash over religious rights and medical care,” the suit was filed in federal court in Michigan. Continue reading

Oregon’s Unfulfilled Tort Reform

By Alex Stein

Oregon has a statute capping noneconomic damages recoverable in medical malpractice suits at $500,000.

The Oregon Supreme Court decided that this cap is unconstitutional insofar as it clashes with a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857 when Oregon adopted its constitution. Specifically, it ruled that Article I, sections 10 and 17, of the Oregon Constitution entrench this right and deny the legislature the power to curtail it: see Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008). This ruling separated the constitutionally protected pre-1857 causes of action, which the statutory cap cannot curtail, from the constitutionally unprotected causes of action that came into existence after 1857 and that can consequently be capped.

Consequently, in order to reduce a jury’s award of noneconomic damages to $500,000, the defendant must show that the plaintiff’s complaint was not actionable before 1857. To adjudicate such claims, courts must carry out an historical investigation into Oregon’s medical malpractice law.

The Court’s most recent decision on that issue, Klutschkowski v. Oregon Medical Group, — P.3d —-, 2013 WL 5377913 (Or. 2013), made this task easy to perform. Continue reading