Clinical Pathology Laboratories Should Be Aware of New Malpractice Risks from Genetic Testing

by jeeg 9. August 2012 22:26

Genetic testing is creating a new source of medical malpractice liability and early cases have generated substantial settlements for the plaintiffs. Any clinical laboratory organization or pathologist involved in genetic testing should pay serious attention to this emerging field of malpractice law.

In particular, the media is reporting on malpractice lawsuits that involve prenatal genetic testing that was performed on behalf of parents who were attempting to determine the possibility of serious inheritable diseases in their unborn children.

In these cases, parents of a child born with a debilitating—and frequently financially-devastating—disease that could have been detected by accurate genetic testing are suing their healthcare providers, including medical laboratories. These plaintiffs claim that, through inaccurate genetic testing or lack of available testing, they were denied the choice of terminating a pregnancy that tested positive for serious inherited disease.

Judges Find Providers Negligent in Genetic Testing Cases

One malpractice case in Montana provides an example. In this case, a couple filed a lawsuit against several healthcare providers for failure to obtain diagnostic test results that would have informed them of the risk of giving birth to a child with cystic fibrosis (CF).

“This is a case about how several healthcare providers failed to deliver the most basic care and test for cystic fibrosis, resulting in the [couple’s] child being born with this incurable, painful, costly and fatal disease,” wrote plaintiffs’ attorneys E. Casey Magan and Russell S. Waddell in the complaint. The story was reported in the Bozeman Daily Chronicle.

Plaintiffs claimed that the nurse practitioner failed to properly inform them of simple blood tests to determine whether they were carriers of the CF gene. Attorneys Magan and Waddell argued that the case was analogous to a misdiagnosed cancer patient receiving damages for decreased action opportunities and increased pain and suffering. District Court Judge Mike Salvigni agreed.

In a separate genetics malpractice lawsuit filed in Tennessee, a Memphis jury awarded $13 million to a couple whose child was born with cystic fibrosis. This verdict was reported in a story published at The couple claimed that Detroit-based Genesis Genetics Institute okayed the couple’s embryos for use in in vitro fertilization, after performing tests for the presence of the genetic mutation that causes CF.

The judge found the medical laboratory and its founder, Mark Hughes, M.D., Ph.D. at fault.

In a third example of a medical malpractice lawsuit that centered upon failed genetic testing, a couple in Portland, Oregon, was awarded $2.9 million. Plaintiffs claimed that physicians misdiagnosed their child as not having Down syndrome during prenatal screening, according to a story reported by ABC News.

State Laws Prohibit “Wrongful Birth” Negligence Lawsuits

The parents in these negligence suits claim they would have terminated the pregnancies had they known of the disease-positive status. Because of these types of legal claims, these lawsuits raise complex political and moral questions relating to abortion rights, the Bozeman Daily Chronicle pointed out. Several state legislatures, responding to the issues raised in these malpractice lawsuits, have passed laws that ban “wrongful birth” lawsuits. Several other states are debating similar legislation.

Pathologists and clinical laboratory managers are likely to recognize that the terminology often used to characterize failed prenatal genetic testing lawsuits is significantly nuanced in a way that reflects the underlying contention surrounding the issue of abortion rights. The judge in the Montana case suggested that such labeling amounts to a distraction from the core issues of these cases: negligence and medical malpractice.

Judge Salvigni soundly rejected the label “wrongful birth” as “not instructive.” “[A]ny ‘wrongfulness,’” he stated, “lies not in the birth but in the negligence of the physician.” The quote appeared in a story published by the Great Falls Tribune.

Because genetic testing is highly accurate and mistakes are uncommon, cases involving failed prenatal testing are rare, observed Art Caplan, Ph.D., in a commentary on the Portland case published at Caplan, who is Head of the Division of Bioethics at New York University Langone Medical Center in New York City, suggested, however, that may not be the case in future malpractice lawsuits involving these types of claims involving errors involving genetic testing.

Over the past 40 years, one significant source of medical malpractice liability for pathologists and medical laboratories has been cytology testing and pap smear testing. A substantial amount of a medical laboratory’s malpractice premiums are associated with this area of risk.

Thus, the sizeable judgements and/or settlements associated with claims of deficiencies and/or errors associated with pre-natal genetic testing are not a positive development for the laboratory medicine profession. It is a sign that malpractice premiums may increase in coming years, at least for clinical laboratories and pathologists who perform these types of genetic tests.

Pamela Scherer McLeod, Dark Daily



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