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Round 3: Open letter to the leadership at FDA – Please know that these are the people you were bound to protect

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In 30 years of practice, I have on numerous occasions offered to FDA leadership the opportunity to meet directly with the people who consumed food that was tainted under the FDA’s watch.  I have always thought that if they only had the chance to meet the victims and their families, they would understand just how important their jobs really are. Regardless of administration, I have yet to have a taker.

Lucas Parker, 2-year-old Canadian boy with possible pre-existing autism spectrum disorder exposed to Romaine lettuce contaminated with E. coli O157:H7 on a family road trip to Disneyland from British Columbia.

Onset of pain and bloody diarrhea on 10/18/18 causing family to head home. Made it as far as Olympia, WA ER where Lucas presented with bloody diarrhea, vomiting, nausea, and pain, diagnosed as a gastrointestinal infection and dehydration. Continued their way home but condition deteriorated the following day with Lucas becoming only minimally responsive with high fever, high blood pressure, increasing diarrhea, and dehydration. Admitted to B.C. hospital. When his kidneys began to fail and his lab work showed red blood cell destruction, he was diagnosed with HUS. Transferred to tertiary care children’s hospital on 10/21/18.

Developed seizure activity with severe decline in his neurological functioning and started on anti-convulsant medication. Intubated for head imaging and surgery. Catheter surgically inserted in abdomen for peritoneal dialysis. On 10/25 Shiga toxin 2 confirmed in the lab. More seizures on 10/28 despite medication. Labile blood pressures increased white cell count, and recurrent high blood sugars concerning for sepsis. Remained on mechanical ventilation. More seizure activity on 10/28 worrisome for brain injury with ongoing kidney failure and hemolysis (red blood cell destruction).

Kidney function began to return after 13 days but prognosis was poor given evidence of worsening brain damage. Extubated on 16th hospital day but still on dialysis for fluid removal. At high risk for aspiration due to lack of consistent gag/cough reflex. Surgery on 11/16 to remove peritoneal dialysis catheter and implant a feeding tube. Transferred to rehab facility on 11/18 bedbound in fixed, supine position, with limited visual and neurological function.

Went into respiratory distress after inadvertent drug overdose and readmitted to hospital were treated for complications of HUS including stroke, severe neurological deficit, dystonia and autonomic dysregulation (slow heart rate, high blood pressure, irregular breathing). Head imaging confirmed further brain damage. Experienced intermittent drops in his oxygen saturation levels with possible additional seizure activity and apnea (episodes of cessation of breathing). By 12/03 he was intermittently hypotensive and experiencing recurrent vomiting.

Condition stabilized and returned to rehab on 12/11/18 for multidisciplinary therapy to try to maximize function. He was assessed at a “near coma” level of consciousness with severe cognitive impairment and severe cortical visual impairment. Unable to sit, stand or maintain his head/neck/trunk position independently, with spasticity in his arms and legs, consistent with quadriplegia. He had no meaningful vocalizations and was receiving nutrition through a feeding tube.

Prognosis includes ESRD (end stage renal disease), diabetes, lifelong monitoring of his renal status, multiple kidney transplants, and prolonged periods of dialysis. Neurological deficits unlike to improve over lifetime and is at risk for hip dislocation and scoliosis due to spasticity.

Medical Bills……………………………………………$593,230.38

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.


Source: https://www.marlerblog.com/legal-cases/round-3-open-letter-to-the-leadership-at-fda-please-know-that-these-are-the-people-you-were-bound-to-protect/



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