Category: Blog

Henrietta Lacks Lives On

Before viewing HBO’s recent release of The Immortal Life of Henrietta Lacks, it is appropriate to gain an understanding of the true story that give rise to the film. The story begins with Henrietta Lacks, a poor black tobacco farmer from Virginia who reported to Johns Hopkins Hospital in 1951 with complaints of a “knot in her womb” and abnormal bleeding following the birth of her fifth child. After shuffling her to the segregated colored ward for treatment, Lacks’ physician gave her a devastating diagnosis: advanced cervical cancer. Less than a year later, just months after her 31st birthday, the malignant cells coursing throughout Lacks’ body caused her early death.

Yet unbeknownst to Henrietta or her family, she would continue to live on for decades following her death. During the course of her treatment, Henrietta’s physician, Dr. George Gey, received a sample of her cells. Dr. Gey incorporated the cells into his research, which involved an ongoing search for “immortal” cells, or cells that would continuously divide and grow after removal from a patient. Dubbed HeLa cells, Henrietta’s cells turned out to be the miraculous cells Dr. Gey sought; they would go on to revolutionize modern medical research. The cells played an integral role in the development of the polio vaccine, and their use was included in cancer, AIDS, radiation, and gene mapping research over the decades following Henrietta’s death. HeLa cells were also the first human cells to survive the cloning process in 1955.

Despite the widespread use of Henrietta’s cells, her family possessed no knowledge of their circulation until more than 20 years after her death. The Lacks’ family first learned about HeLa cells in the 1970s, when a scientist contacted the family to request their blood samples and other genetic materials. The family followed up on these requests with multiple inquiries about the status of HeLa cells and further information about their uses and distribution, but their questions remained unanswered until the late 1990s and early 2000s. During that period, the release of an award-winning documentary by the BBC and a bestselling book by Rebecca Skloot started to peel back the layers of the HeLa cell story.

Throughout their long and controversial history, HeLa cells raised a number of legal questions relating to the notions of informed consent and property rights. First, researchers all over the world used Lacks’ cells for medical research without her knowledge or consent (or her family’s). A landmark decision in the Supreme Court of California addressed a similar issue in the 1990 case Moore v. Regents of the University of California. In that case, John Moore argued that personal ownership of his cells continued after their removal from his body during a course of leukemia treatment. But the court disagreed, and denied Moore’s claim for conversion. The court’s weariness of Moore’s argument stemmed from fears that including bodily tissues under the umbrella of property rights would have a chilling effect on medical research. Based on this case, it appears there is little chance that a tort liability suit over the use of Lacks’ cells would have much success.

Yet other violations of Lacks’ personal information occurred as well. In 1976, Science Magazine published the article Genetic Characteristics of the HeLa Cell. Without seeking consent from the Lacks family, the article contained private information about the genetic markers contained in the DNA of Henrietta and her family members. Because DNA reveals the most fundamental makeup of a person’s body, and reveals private information about abnormalities and/or predispositions to disease, this publication constituted another circumstance where the Lacks’ family’s private information was put on public display without their consent. In a similar vein, Johns Hopkins released Henrietta’s private medical records to journalist Michael Gold in 1985 for use in his book A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused.

Some might call Henrietta’s story and its legacy a perfect storm of privacy violations. It is important to remember that the concept of informed consent barely existed in the 1950s, and statutory privacy protections such as HIPAA were still decades away from existence when her cells were first taken and used for research. Though it is now an extensive field providing comprehensive protections, the topic of medical privacy still faces some significant obstacles. One of the most difficult issues for researchers in the medical field to overcome is their inability to prospectively determine biospecimen uses and research. As HeLa cells displayed, sometimes the range of possibility connected to a specific cell or tissue sample is not determined until after scientists conduct further research on the sample. Patients are understandably weary of signing over samples for any and all uses, creating strict limitations on researchers and the ways they may use human samples. Other significant obstacles to informed consent include lack of understanding on behalf of the patient, questions surrounding the life of the consent, and ethical considerations regarding the proper time and scenario to ask patients for consent.

As the fabric of American healthcare continues to grow and change on a regular basis, these obstacles pose concrete challenges to healthcare professionals and legal practitioners in the healthcare field. Henrietta Lacks’ contentious cells may continue to teach us new lessons about privacy and informed consent for decades to come.

The Debate Over Wrongful Birth Suits in Texas

The Texas Senate may soon decide on a bill that would prohibit parents from filing “wrongful birth” suits.  Wrongful birth suits allow parents of a child born with a genetic disability to sue their doctor if they say they were not properly warned about the potential for the disability or counseled on their options, including the parents’ choice to have an abortion based on the severity of the condition.  Nine states have enacted bans on wrongful birth lawsuits, including Arizona, South Dakota, and Indiana.

Wrongful birth lawsuits are different than wrongful pregnancy cases, in which women can sue physicians if they become pregnant after receiving an operation to prevent them from having children.  They are also different from wrongful life suits, which are brought on behalf of disabled children and are not recognized in Texas.

The wrongful birth legal issue in Texas dates back to a 1975 Texas Supreme Court caseJacobs v. Theimer, 519 S.W.2d 846 (1975).  Dortha Jean Jacobs, the plaintiff in that case, contracted rubella during her first trimester, giving birth to a child with defective organs.  Consequently, the Jacobs’ medical bills totaled more than $21,000 by 1973.  Jacobs and her husband sued Dr. Louis M. Theimer on grounds that she failed to diagnose the rubella and inform them of potential long-term risks to the fetus.  The Texas Supreme Court sided with Jacobs, awarding her family the funds needed to care for the child’s disability.  Since the Jacobs case, wrongful birth lawsuits in Texas have been very rare.  In fact, medical malpractice attorneys in Texas say they rarely, if ever, see wrongful birth lawsuits.

Lawmakers brought the bill before the Texas Senate Committee on State Affairs last week in a hearing with dramatic and emotional public debate.  Senator Brandon Creighton, who authored the bill, said allowing the lawsuits could encourage doctors to seek out every possible disability and even promote abortions to avoid litigation.  Creighton said the bill would send a message that Texas “does not believe that a life in and of itself is an injury in which parents need a damage payment.”  “The presence of a disability in a child should not be grounds for a lawsuit,” Creighton said at a Senate State Affairs Committee hearing on February 27.

Proponents of the bill say that it is needed to protect doctors from wrongful birth lawsuits and to protect the rights of the disabled.  Proponents also argue that parents will still be able to sue doctors for negligence if needed.

Opponents called it another attempt by the state to infringe upon a woman’s right to choose to have an abortion and that it essentially allows doctors to withhold information from patients, and impose their religious beliefs upon them.  “It seems to be axiomatic that we should have to stand up and say that it shouldn’t be policy for the state of Texas to excuse doctors from lying to their patients, and that’s what this bill does,” said Blake Rocap, legislative counsel for National Abortion Rights Action League / Pro-Choice Texas.  He said doctors should not be held liable for disabilities “they did not cause,” and that doctors “may overcautiously seek out all potential disabilities and promote abortions in order to avoid liability.”  Despite the objections, the committee voted unanimously to send the bill to the full Senate.

Steak With A Side Of…Salt Warnings?

In September, 2015, the New York City Board of Health approved a new sodium warning measure. The law requires chain New York City restaurants with 15 or more locations nationwide to display a salt shaker symbol next to menu offerings that contain more than 2,300 mg of sodium. Shortly following the regulation’s announcement, the National Restaurant Association sued NYC, arguing that the law was arbitrary and capricious because the science regarding sodium’s health effects remains unsettled. On February 10, a New York appeals court allowed the rule to remain in force by affirming the trial court’s rejection of the National Restaurant Association’s arguments.

A stay was initially placed on the regulation shortly following its creation, preventing its enforcement until May, 2016. At that time, the Appellate Division of the New York State Supreme Court lifted the stay, and allowed enforcement of the rule throughout New York City. Health Commissioner Dr. Mary T. Bassett publicly applauded the decision, stating that the ruling “allows New Yorkers to make informed and better decisions about their diets and their health.” The Manhattan Appellate Division of the State Supreme Court then affirmed the 2016 decision in last month’s holding.

In the court’s opinion, Justice Ellen Gesmer pointed out the health risks of high-sodium foods and dishes: “Excess consumption of sodium, the primary ingredient of salt, can cause high blood pressure, which is in turn correlated with a higher risk of cardiovascular disease, congestive heart failure and kidney disease, according to the overwhelming consensus among scientists and the federal agencies charged with protecting the nation’s health.” Justice Gesmer continued by clarifying the reasoning behind the court’s decision, and pointing out that this mandate differed from other NYC dietary restrictions that came before it because it did not interfere with citizens’ personal autonomy when making individual food choices. Bloomberg’s big-soda ban, for example, entirely prohibited consumers from purchasing large sodas. The salt warnings, on the other hand, merely inform the consumer about the levels of salt rather then restricting them from purchasing such dishes altogether.

The mandate was opposed by the New York State Restaurant Association, an ardent advocate against governmental regulation of dietary information and regulation. The association fought a similar law in 2009. In that case, New York State Restaurant Association v. New York City Board of Health, the association asserted that a city law requiring chain restaurants with 15 or more locations nationwide to post calorie content information on menus and menu boards was both preempted by federal law and unconstitutional. Meeting a similar demise to the argument in the recent salt warning case, the NYC calorie warning regulation was upheld in the Second Circuit Court of Appeals on the grounds that the city law was reasonably related to its goal of reducing obesity.

The regulation (and the NY Court’s decision to uphold it) is increasingly relevant as local, state, and federal legislatures consider similar dietary warnings and regulations, and courts at all levels grapple with what constitutes an appropriate amount of government involvement (if any) in private citizens’ dietary decisions. What remains to be seen is how these and other regulations actually influence consumer decisions. American University Washington College of Law Professor Lindsay Wiley wrestles with these important questions in her 2014 research about the impact of product configuration bans. Wiley suggests that, despite the fact that such regulations are subject to a great deal of public discourse, their high visibility might lead to long-term decreases in portion size and increases in the availability of balanced meals. Despite such research, this field continues to be largely unchartered territory as the United States attempts to mitigate the nation’s growing obesity and health care epidemic.

How Climate Change Might Affect Your Health

On March 16, 2017, President Trump released a preliminary 2018 budget proposal, which outlines some of the changes that the President would like to see. Among those changes, President Trump has proposed a 29% cut to the State Department, which includes the elimination of climate-change prevention programs, including pledged payments to U.N. climate-change programs. The budget also suggested a 31% cut to the Environmental Protection Agency (EPA), which would include the elimination of more than 50 programs and 3,200 jobs and would discontinue funding for international climate-change programs.

Just one day before the budget proposal was released, a group of family physicians, pediatricians, obstetricians, allergists, internists and other medical experts launched the Medical Society Consortium on Climate and Health. More than half of all U.S. doctors are members of one of the participating groups, which include the American College of Physicians (ACP); American Academy of Allergy, Asthma, Immunology (AAAAI); the American Academy of Family Physicians (AAFP); the American Academy of Pediatrics (AAP); and the American Congress of Obstetricians and Gynecologists (ACOG), among others. The mission of the Consortium is to “inform the public and policymakers about the harmful health effects of climate change on Americans, as well as about the immediate and long-term health benefits associated with decreasing greenhouse gas emissions (i.e., heat-trapping pollution) and other preventive and protective measures.”

They presented a new report, “Medical Alert! Climate Change is Harming Our Health,” which includes scientific evidence and accounts from doctors who believe that climate change is creating or worsening a wide range of health issues, including: heart and lung diseases; heat-related health dangers; the spread of infectious disease; and physical and mental health problems. The Consortium is working to raise awareness of the health risks that climate change poses to Americans, especially vulnerable communities who experience a disproportionate impact from climate change. In addition to raising awareness of the impact of climate change on human health, these medical societies are educating and working with policymakers and industry to reduce emissions, promote effective interventions, and strengthen public health infrastructure.

Given the proposed budget changes, EPA Administrator Scott Pruitt’s history of rejection of established science of climate change, and President Trump’s view on climate change, it is unclear what the U.S’ involvement in fighting global warming will look like. In 2016, the U.S signed the Paris Agreement, building upon the United Nations Framework Convention on Climate Change, to fight climate change and to support developing countries in this endeavor.  However, it has yet to be seen whether we will honor our commitment, but if we do not, we possibly risk devastating changes to our environment and also to human health.

Change or No Change in Healthcare Fraud and Abuse Enforcement?

Practitioners are wondering whether the robust role of the federal government in healthcare fraud and abuse cases will remain the same. In Fiscal Year (FY) 2016, the federal government recovered over $3.3 billion as a result of health care fraud judgments, settlements and additional imposition in health care fraud cases and proceedings. Additionally, in June 2016, the Medicare Fraud Strike Force engaged in a nationwide healthcare fraud takedown that resulted in charges against about 300 individuals that include doctors, nurses and other licensed medical professionals. Rooting out fraud and abuse in healthcare has been a goal of every administration since President Ronald Reagan.

On October 27, 1986, President Reagan signed the False Claims Amendments Act of 1986, which soon became a successful anti-fraud law to deter and fight waste, fraud and abuse in the healthcare field. What makes the False Claims Act (FCA) an important tool to fight any malfeasance in the healthcare system is the qui tam provision that allows whistleblowers to expose fraud against federal government. In 2010, the Patient Protection and Affordable Care Act (ACA) amended portion of the FCA and some of those changes are considered by practitioners to have increased the number of healthcare-related FCA cases. It is undisputed that the FCA allows government to recover billions of dollars, however, the FCA defense bar is awaiting to see if there would be any change to the FCA related provision in ACA. During the confirmation hearing of Attorney General Jeff Sessions, when Senator Charles Grassley asked him to elaborate his intent regarding the FCA, Attorney General Sessions stated, “in the qui tam provisions and the part of that, I’m aware of those. I think they are valid and an effective method of rooting out fraud and abuse. I even filed one myself one time as a private lawyer….” At this point this testimony only serves as a mere reverence for FCA, which is not necessarily a clear indication what will be the effect of qui tam healthcare lawsuits or overall healthcare fraud and abuse enforcement during the Trump Administration.

There are two early signs that are leaning towards the continuity of a vigorous fraud and abuse enforcement. First, the budget that has been released by the Trump White House requested additional $70 million to fund for the Healthcare Fraud and Abuse Control program.  Trump’s proposed budget plan envisioned a whopping budget cut for the Department of Health and Human Service, but the additional request of fund for fraud prevention is likely an early sign of continuity of the robust fraud and abuse enforcement. Second, recently the Department of Justice has joined a whistleblower lawsuit, United States of America ex rel Benjamin Poehling v. Unitedhealth Group Inc., No. 16-08697 (Cent. Dist. Cal. Sep. 17, 2010), ECF No. 79, against UnitedHealth Group (United) and its subsidiary, UnitedHealthcare Medicare & Retirement—the nation’s largest provider of Medicare Advantage (MA) plans. This suit was originally filed in 2011 by a former United Healthcare finance director under FCA, and in accordance to FCA this case was sealed for five years while DOJ investigated the claims. The complaint alleged that United Health engaged in an upcoding scheme by falsifying about the severity of patients’ illness. This case is gaining some attention partly due to practitioners’ curiosity to gauge Attorney General Session’s approach to FCA cases. The New York Times has reported that DOJ’s court notice in this case was filed by a lawyer who joined the Civil Division as a part of Trump administration.

Perhaps it is too early to decipher the Trump Administration’s position on this particular matter.  Yet some early signs suggest the effect of FCA is not waning. In sum, ferreting out fraud and abuse has always enjoyed bipartisan support.  Moreover, the ACA made significant strides towards that bipartisan goal and allowed to recover a record amount of money to the government coffers, and those strengthened provisions of FCA as enacted in ACA will likely remain a tool for the government to maintain the integrity of the healthcare system.

Preventing Abuse in Long-Term Care Facilities

Up to one in six nursing home residents may be the victim of abuse or neglect every year. In late 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule revising the requirements that Long-Term Care Facilities must meet to participate in the Medicare and Medicaid programs. According to CMS’ chief medical officer Dr. Kate Goodrich, “these are the first comprehensive updates to long-term care requirements since 1991.” One section in particular discusses changes to prevent the abuse of residents of Long-Term Care Facilities.

Provisions related to abuse, neglect, and exploitation are now included in a separate section, which brings more attention and focus to these issues. To more accurately reflect the content, § 483.13 regarding abuse in Long-Term Care Facilities has been re-designated and revised to § 483.12. The title has been changed from “Resident Behavior and Facility Practices” to “Freedom from Abuse, Neglect, and Exploitation.” The focus of this regulation is to ensure that residents are not subjected to abuse, neglect, misappropriation of property, and exploitation, and to establish requirements for the facility’s response to any allegations that has occurred. To prevent abuse of residents in Long-Term Care Facilities, we must recognize that abuse continues to occur. Last month, CNN issued a report from an exclusive analysis of state and federal data and interviews with experts, regulators and the families of victims, and found that abuse in nursing homes is far more prevalent than most people know.  The report focused on caregiver-on-resident abuse. Caregivers in nursing homes are in a position of authority and trust, and too often when they violate that position they are not properly reprimanded due to nursing homes being slow to investigate or report allegations, police dismissal, and state regulators failing to flag patterns of repeated allegations against a single caregiver.

A key difference in the new rule expands the list of individuals whom a facility may not employ or otherwise engage. It prohibits facilities from employing individuals who “have been found guilty of abuse, neglect, exploitation, misappropriation of property, or mistreatment by a court of law; have had a finding entered into the State nurse aide registry concerning abuse, neglect, exploitation, mistreatment of residents or misappropriation of their property; or have a disciplinary action in effect against his or her professional license by a state licensure body as a result of a finding of abuse, neglect, exploitation, mistreatment of residents or misappropriation of resident property.” The new rule now also requires that facilities develop and implement written policies and procedures that prohibit and prevent abuse, neglect, exploitation of residents and misappropriation of resident property, and also requires that facilities establish policies and procedures to investigate any allegations of abuse, neglect, exploitation, or misappropriation of property. Furthermore, facilities must establish policies and procedures to ensure reporting crimes, and investigation into any allegations.

With much of the new rule now in effect, residents and families will hopefully see a significant decline in the rate of nursing home abuse, but much will depend on implementation and enforcement. Medicare will issue guidance this summer on exactly how nursing homes must comply.