Tuesday, September 1, 2015

Wrongful life

An appeals court in Washington state has upheld a $50 million jury award in a wrongful birth/wrongful life suit filed by a couple who alleged LabCorp and Valley Medical Center were negligent when they reported the chorionic villus sampling (CVS) of their son, who was born with a severe genetic abnormality, was chromosomally normal.

Rhea and Brock Wuth were married in 2000 and had a healthy boy in 2002. In 2003, Brock’s cousin, who had “terrible seizures, anti-social behavior, and obesity that confined her to a wheelchair”, underwent genetic testing that determined she had an unbalanced translocation of chromosomes 2 and 9. After he learned of his cousin’s results, Brock had himself tested and learned he, although asymptomatic, had balanced chromosomal translocations.

Rhea and Brock decided they wanted more children but did not want to bring a child with severe genetic disabilities into the world, and sought the help of a genetic counselor after they learned of Brock’s test results. Over the course of the next 5 years, Rhea miscarried six times. She became pregnant again around November 2007, and informed Rhea’s obstetrician about Brock and his cousin’s genetic abnormalities. They also informed the obstetrician of their decision to not carry a child with an unbalanced translocation to term.

After this discussion, the obstetrician ordered genetic counseling in conjunction with CVS, but Valley scheduled Rhea’s CVS for a day on which no genetic counselor was scheduled to work...

So the couple kept the appointment at Valley and met with perinatologist and obstetrician Dr. James Harding. Dr. Harding determined the couple was well-informed about Brock’s genetic abnormalities and the potential risks associated with CVS, and agreed to proceed with the procedure.
Ordinarily, it is the genetic counselor’s responsibility to fill out the order forms for the genetic testing, but since no counselor was available, that responsibility fell to Cathy Shelton, a Valley medical assistant.

Dr. Harding later testified he knew LabCorp would “absolutely” need Brock’s genetic test results in order to assess the CVS, so he personally photocopied Brock’s results, and handed them to Ms. Shelton to send to LabCorp. He told her to only order fetal karyotype testing, but not FISH, which is more sensitive. Dr. Harding said he did not order FISH testing because LabCorp would be able to determine for itself whether additional tests were necessary based on Brock’s test results. Although Ms. Shelton could not recall Rhea’s appointment specifically during testimony, it was “undisputed” Brock’s results were not actually sent to LabCorp.

When the CVS was received at LabCorp, it was assigned to a cytogenetic technician in training, who, according to LabCorp’s own expert witness, had “little experience testing fetal tissue samples” and was the “sole person to review the karyotype of Rhea’s sample”. LabCorp’s expert also testified LabCorp’s policies required a second person to supervise the technician in training.

This technician in training never looked at the indication for the testing on the requisition (family history unbalanced translocation) and therefore could not have known he was looking for a translocation. No additional genetic testing was performed, and no one contacted Valley or the Wuths for more information.

The final report sent to Valley said the Wuth’s unborn child had a normal male karyotype, and was received by a part-time genetic counselor. The counselor called Rhea and told her the results were normal, and sent letters, but not the actual final report, to both the Wuths and their obstetrician. In addition, the Wuths were not told Dr. Harding had not requested FISH testing, which they wanted, or that FISH testing had not been performed at all.

The Wuths were “overjoyed” at the results, but months later when their son Oliver was born, it was immediately obvious something was wrong:
He was not physically proportional—his feet and toes were tiny; his fingers were long, but his hands were very small. He had inverted nipples and a buried penis. His head was bent and turned. The muscles and tendons in his legs were so tight that his legs would not straighten. When the Wuths brought Oliver home from the hospital, he did not feed normally and rapidly lost weight.
Subsequent genetic testing confirmed Oliver had an unbalanced translocation between chromosomes 2 and 9, just like Brock’s cousin.

At the time of the trial in October 2013:
…physical therapy and other interventions had alleviated some of Oliver’s defects. His head and neck had been reformed and his leg muscles loosened and straightened. But he could not walk up stairs or run. His vision, judgment, and fine motor skills remained in the impaired or severely impaired range. His brain was underdeveloped and small. And, although he was working with a speech therapist and special education teachers to learn to use a computerized “talker,” his own speech was limited to a few dozen words understandable only to his immediate family...
After a six week trial, the jury found Valley and LabCorp were negligent, but not Dr. Harding, and awarded $25 million in special damages to Oliver and $25 million in general damages to his parents.

Courtesy of  http://www.medpagetoday.com/PracticeManagement/Medicolegal/53341?isalert=1&uun=g906366d4491R5793688u&xid=NL_breakingnews_2015-09-01

1 comment:

  1. On May 18, 1992, Kimberly Molloy consulted with Dr. Diane Meier to determine the source of S.F.'s developmental abnormalities.   Molloy told Dr. Meier that Molloy had a brother with mental retardation, and she expressed a desire to determine whether S.F.'s problems might be genetic.   In the notes for that exam, Dr. Meier wrote “? Chromosomes plus Fragile X” and ordered chromosomal testing of S.F. Dr. Meier advised Molloy that if S.F.'s tests were abnormal, Molloy would need to return for testing.   Molloy assumed that if testing were required, Dr. Meier would order it.   Dr. Meier also referred S.F. to Dr. Reno Backus at the Minneapolis Clinic of Neurology.

    On June 23, 1992, Molloy, along with Robert Flomer and his new spouse, Randine Flomer, brought S.F. to Dr. Backus and told him about Molloy's brother.   Dr. Backus diagnosed S.F. as developmentally delayed with autistic tendencies of unknown etiology. Molloy told Dr. Backus that she had remarried and asked him about the risk that she might give birth to another child with problems like those suffered by S.F. Dr. Backus told Molloy that the chances she would have another child like S.F. were extremely remote, especially with a father other than Robert Flomer.   Dr. Backus told Molloy that S.F.'s problems were not genetic but were “just one of those things that happen.” 2  S.F. had only this one appointment with Dr. Backus and neither the Flomers nor Molloy saw Dr. Backus again.   Dr. Backus testified that he was not involved with S.F.'s care but that his role was to evaluate her from a neurological point of view and that he was merely acting as an adviser to Dr. Meier, the referring physician.

    Approximately one month later, Randine Flomer brought S.F. to North Memorial Medical Center for the chromosomal testing that Dr. Meier ordered.   Although Dr. Meier admitted that it was her intention to order fragile X testing, for unknown reasons, this test was not performed.   The tests that were done did not reveal any chromosomal abnormalities, and Dr. Meier related those test results to the Flomers over the phone.   The results were also relayed to Molloy, who believed that the normal test results included fragile X testing.

    On December 14, 1992, Dr. Meier saw the Flomers for a consultation with S.F. In her notes about this visit, Dr. Meier wrote, “check fragile X (if done 6/92).”   Dr. Meier did not determine at this time whether S.F. had been tested for fragile X. S.F. treated at Oakdale Pediatrics with Dr. Meier until December 19, 1995, when her father switched her to a different primary-care physician, Dr. Marilyn Campbell, at Columbia Park Medical Clinic.

    Dr. Campbell referred S.F. to Dr. Kathryn Green, a pediatric neurologist at the Minneapolis Clinic of Neurology.   Dr. Green met with the Flomers, examined S.F., and reviewed S.F.'s diagnostic history, including the chromosomal testing ordered by Dr. Meier.   Dr. Green also reviewed S.F.'s family history and noted a maternal half-uncle with mental retardation.   Dr. Green never met with or spoke to Kimberly Molloy.   Dr. Green did not order or recommend fragile X testing.   Dr. Green testified that she was not asked by Dr. Campbell to make a diagnosis of S.F., but rather to give an opinion of how to manage S.F.'s hyperactivity, and therefore prescribed Clonidine to replace the Ritalin that S.F. had been taking.   The Flomers never returned to visit Dr. Green.

    Kimberly Molloy became pregnant in September 1997, and, on June 30, 1998, she gave birth to M.M. After M.M. began showing signs of developmental delay, but before M.M. or S.F. were diagnosed with fragile X, Molloy underwent surgical sterilization because of concerns that she was a carrier of genetic defects.   In June 2000, M.M. was diagnosed as suffering from fragile X syndrome;  subsequent testing established that S.F. also has fragile X syndrome.   Kimberly Molloy was tested, and it was determined that she is a carrier of fragile X.