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NextImg:The Death of Informed Consent
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Article audio sponsored by The John Birch Society

Through an open-records request, The New American has obtained documents that shed fresh light on the gravity of the decision in a landmark medical malpractice case — the only wrongful death jury trial in the country for a death officially declared to be caused by Covid. The decision in favor of the defense, handed down in June, should serve as a warning to us all.

Readers of The New American are already familiar with the story of Grace Schara, a Wisconsin teen with Down syndrome who lost her life in a Covid hospital in October, 2021. (Those new to the story can read about it here and can also access recordings of our livestream of the proceedings here.)

In short, the plaintiffs alleged that Grace died from intentional overdoses of sedative, benzodiazepine, and opioid medications, while the defense insisted that a SARS-CoV-2 infection ended her life.

Just days after the lawsuit ended, The New American interviewed Scott Schara, Grace’s dad, who said the outcome proves that informed consent, enshrined in the Nuremberg Code of 1947, is finished.

“Just by being in a hospital, you are giving implied consent,” he warned of the precedent this case sets. He said that the defense claimed, and the jury endorsed the idea, that the drugs in question were normal in an ICU, so no informed consent was necessary, nor did providers need bother to inform the family when Grace survived two drug overdoses early during her hospital stay. He also pointed out that the jury upheld defense witnesses who claimed that a “Do Not Intubate” order (DNI) is equivalent to a “Do Not Resuscitate” order (DNR), and that a doctor may unilaterally place either on a patient, also without informed consent.

However, before suing, Scott Schara filed a complaint with Wisconsin’s Department of Safety and Professional Services (DSPS), the state agency which oversees licensed professionals. It accused the physician who took care of Grace during the last two days of her life, Dr. Gavin Shokar, of “label[ing] the patient as DNR and overdos[ing] her on morphine.”

In order to obtain Shokar’s response to these charges, The New American requested the complete file pertaining to Grace’s DSPS case. We received some documents in late August, with only the patient’s name and certain private contact information redacted. However, the file merely included a reference to Scott’s complaint, a case which the agency closed on January 18, 2022 without investigation. We double-checked with DSPS, but the agency said it had nothing to add. (Interestingly, a second, unrelated complaint, filed in May 2023 against Shokar for “negligence/incompetence” and “unprofessional conduct” is listed among the documents received. DSPS reports the case as still open but offers no further details.)

Instead, the remainder of the 170 pages pertains to a complaint filed in July 2023, by Lorna Speid, Ph.D., a clinical pharmacist and president of the California-based drug development consultant, Speid & Associates.

In her initial letter to DSPS, she said she spent “many hours reviewing the medical notes and consulting with other experts in specialized fields” about Grace’s case.

Based on that collaborative analysis, she charged Shokar with “gross incompetence, gross negligence, medical malpractice, dishonesty and deliberate cause of death.” She called his actions deliberate “because the probability that one physician could make all these mistakes and errors, accidentally, is low. All reasonable physicians would know that the actions Dr. Shokar took would lead to the death of the patient.”

She also noted that “the degree and level of cruelty that Ms. [redacted] was subjected to was extraordinary, and repugnant.” According to Speid, part of that cruel treatment involved “recklessly falsif[ying] the medical records to insert a DO NOT RESCUSITATE [DNR] for a vulnerable patient, without the written and unequivocable consent of her parents/guardians,” and refusing to “administer NARCAN to reverse the Morphine overdose.” (Morphine is an opioid that Shokar ordered for Grace, and NARCAN is a brand name for the generic naloxone, an opioid reversal drug.)

Hollee McInnis was the registered nurse charged with Grace’s care on the last two days of the teen’s life, and about whom Speid filed a separate complaint with DSPS. Her report gives a play-by-play timeline of McInnis increasing a continuous infusion of Precedex (a sedative) throughout Grace’s last day on earth; Grace had survived two overdoses of this drug during the same hospital stay. The incidents are clearly documented in her medical record.

On top of that, McInnis piled three doses of the benzodiazepine lorazepam (two of which were given only three minutes apart), though this med is “contraindicated in patients in respiratory distress” (which McInnis recorded as Grace’s condition at the time). She then added two rapid intravenous (IV) pushes of morphine, which is also warned against for patients having difficulty breathing.

“There is no other explanation for a nurse with 20 years of experience, administering this cocktail of drugs.” Speid explained that it was instead McInnis’ duty to report Shokar for “inappropriate prescribing” and to “refuse to administer the drugs prescribed.”

Unfortunately, the doctor ordered, and the nurse delivered. Grace died within an hour of receiving the second morphine dose.

Besides these observations, Speid discovered glaring contradictions in her deep dive of Grace’s medical records.

For example, as noted in her complaint against Shokar, the doctor told the family that he ordered the morphine to reduce Grace’s rapid rate of breathing — a condition that began after Precedex was resumed. Rapid breathing (respiratory acidosis) is a known adverse effect of Precedex, and Grace had the same adverse effect two times in preceding days to that drug.

However, McInnis’ notes contradict Shokar’s claim by specifying that the morphine was given to alleviate pain.

This contradiction raises substantial issues. Though pain relief is usually the reason doctors prescribe morphine, McInnis mentions no other references in any notes that her patient was in pain. More significantly, respiratory depression is common adverse effect of the opioid morphine — something for which nurses must monitor closely. Morphine causes but is not typically administered to slow breathing, especially when the breathlessness is a result of a drug overdose.

However, regardless of the reason they gave it to Grace, the drug is well-documented as posing potential life-threatening risks to breathing. Therefore, the primary accrediting body for U.S. hospitals, The Joint Commission, requires healthcare providers to maintain protocols for opioid reversal agents such as naloxone. This is even true for DNR patients, because DNR does not equate to “do not treat.”

In fact, the U.S. Food and Drug Administration (FDA) requires morphine manufacturers to place several “black box” warnings on the medication’s product literature and packaging. A black box is the federal agency’s strongest measure short of pulling a drug from the market due to its risks.

A few of morphine’s black box warnings, pertinent to Grace’s situation, include cautions against administering the drug to opioid-naïve patients (which applied to Grace), and against “coadministration with other CNS depressants” (which applied to the sedative and benzodiazepine meds present in Grace’s system when morphine was introduced).

Another FDA-mandated black box warning states that the “patient should be observed for” at least 24 hours, and that medical staff should “have emergency equipment nearby,” such as opioid-reversal drugs.

Instead, as Speid noted, nurse McInnis “refused to administer NARCAN,” citing Shokar’s DNR order. In fact, as testified during the trial, she and other nurses on duty refused to even enter the room as Grace’s family begged for help. The DNR order was again their excuse.

But let’s back up for a moment to consider McInnis’ claim of Grace needing morphine for pain. At both 5:00 and 5:30 on the evening of October 13, McInnis wrote “somnolent [sleeping], min/no response” in describing Grace in her nurse’s notes. She then administered two doses of lorazepam (an anti-anxiety med) between 5:30 and 6:00. At 6:09, she noted “BP [blood pressure] undetectable.”

At this point, Grace was non-responsive. To determine if a somnolent patient is in pain, a nurse would commonly use either the Critical Care Pain Observation Tool (CPOT) or the Behavioral Pain Scale (BPS). (Both methods are described in this article from the journal Anaesthesiology Intensive Therapy.) Nurses use body language signals to determine pain levels, e.g.: grimacing, tense muscles, restlessness, rapid heart rate and high blood pressure.

Per McInnis’ notes, Grace evinced none of these, and her blood pressure was so low it was “undetectable.” Yes, her breathing was rapid, but she had reacted similarly to Precedex twice during the same hospital stay. Nevertheless, the doctor ordered and the nurse gave the first IV push of morphine at 6:30, and the second 15 minutes later. Grace died at 7:27.

Based on these observations, Speid concluded:

Dr. Shokar is not a competent or trustworthy physician and should not be treating patients. His deliberate falsification of the death certificate to state that the patient died from natural causes, and secondary to COVID19 (sic) infection, instead of as a result of the deliberate administration of Morphine at a lethal dose, and in a way that could only bring about the patient’s death, denotes a dishonesty and lack of integrity that disqualifies him from being licensed to practice medicine.

Furthermore, Dr. Gavin Shokar is not a physician who should continue to be licensed to provide medical care to patients, supervised or unsupervised. He is a danger to every patient whose care he is placed in charge of. In fact, it is appalling that he has still continued to practice after causing the death of Ms. [redacted] on 13 October 2021. It is high time that this situation is rectified, and Dr. Shokar’s license is revoked.

Speid reached similar conclusions regarding McInnis:

Ms. McInnis is not a Nurse who should continue to be licensed to provide medical care to patients, supervised or unsupervised. She is a danger to every patient whose care she is involved with. Action must be taken to remove her from the Register to practice nursing.

Shokar and McInnis responded to Speid’s allegations via letters from their attorneys. However, far from answering Speid’s claims and clearing up matters, the responses raise even more questions, especially when compared with medical records and a transcript of deposition and witness testimony. Here are a few examples:

Shokar’s letter states that he never ordered this drug. The medical records back up this claim. However, in his deposition, Shokar testified that he did order it, late in the day and verbally, but that he was not at the patient’s beside at the time. He testified that his order was for Grace’s second dose, but the medication administration record shows it to have been the third dose Grace received that day.

McInnis’ letter states that Shokar was at the patient’s bedside when she received and administered his verbal order. There is no indication that she warned him that this would be Grace’s third dose, instead of the second, for the day.

Confusing matters further, McInnis did enter a new order for lorazepam early on October 13, citing the prescribing physician as Dr. Leonard, who later testified that he was on vacation that day. Regardless, this order was unnecessary, as another physician, Dr. David Beck, had already prescribed lorazepam on an “as needed” basis for Grace on October 7.

Shokar’s letter says that on Grace’s last day, “the Precedex was being weaned … and had been discontinued prior to the administration of morphine.” The medical records show that Precedex was ramped up throughout the day and administered at the maximum dosage possible by continuous IV infusion until 6:37 p.m., after the first dose of morphine was given.

During the trial, defense witnesses convinced the jury that a DNI order is equivalent to a DNR order. (The family denies ever agreeing to either DNI or DNR; Scott says they only refused to sign pre-authorization for a ventilator.) Regardless, McInnis made a nursing note that flies in the face of defense claims. On October 12, the day before Grace died, she wrote that her patient “is currently Do Not Intubate, but a full code.” She asked for clarification; nevertheless, “full code” means the opposite of DNR.

There are many other examples of defense witness testimony that the Schara family disclaims. However, there can be no greater red flags than when defense witnesses contradict themselves and each other, and when the medical record belies them all.

Incredibly, after reviewing Speid’s complaints and the attorney responses, DSPS closed both cases without investigation. The reason given was simply “SD,” an abbreviation for “screening decision.” This means, according to DSPS, that one of the following applies in Grace’s case:

Which of these applied to Grace? As evidence by Speid’s documentation, the allegations are possible to prove and are of a very serious nature. As for “unprofessional conduct,” Speid delineated her complaints according to the “Standards Set by the Licensing Board for Physicians” (for Shokar) and the “Board of Nursing Rules of Conduct” (for McInnis).

Therefore, does DSPS consider Grace’s case to be an “isolated incident” with “compliance gained”?

Unfortunately, the judge in the Schara lawsuit allowed no DSPS evidence in the trial. The New American inquired with the agency whether Shokar or McInnis contacted it post-trial to explain the inconsistencies between their complaint responses and court depositions and testimony. The DSPS communications director confirmed they have not.

Grace’s case raises unsettling questions for the rest of us. Both the DSPS decision and the case verdict absolve the defendants of liability and set a dangerous precedent that kicks informed consent to the curb.

Regardless of evidence, courtroom contradictions, severity of the situation, or simple logic, justice is elusive in modern medicine. Accountability has slipped through the cracks, and trusting the white coat has become a game of Russian roulette.

Let the patient beware.