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“Right To Try” Wins in Court Again

Judge Orders Hospitals to Administer Ivermectin to Critically Ill Covid Patients

Should a critically ill patient who is not responding to treatment be allowed to try medications that fall outside the hospital’s standard protocol?  The question goes to the heart of recent NY court battles over whether families have a right to insist that hospitals administer ivermectin and other medications to their Covid-stricken loved one, when all other medical intervention has failed.

In five recent cases, state judges have supported a terminal patient’s legal right to try the drug, based on federal and state laws. The judges overruled hospital authorities who objected to any infringement on their authority and cited the FDA’s advisory against using ivermectin to treat Covid-19.

The courtroom dramas have highlighted public confusion surrounding the drug partly because the NIH, in contrast to the FDA, reversed its stance in January. It now maintains a neutral position, saying the decision of whether to use ivermectin to treat Covid is between a doctor and his patient.

In the process of testing the Right to Try Law in court, some unexpected rulings have been handed down by state judges. One media report captured the courtroom litigation as a “David and Goliath” duel in which a sick patient is pitted against a powerful hospital system, and surprisingly triumphs.

The Right to Try Act, signed into law in May 2018 by then President Donald Trump, opens a new pathway for terminally ill patients who have exhausted their medical options. Although 41 states have passed Right to Try laws, the federal legislation makes Right to Try the law of the land, creating a uniform legal framework for terminal patients seeking access to non-conventional treatments.

To be eligible for Right to Try, a patient must be diagnosed with a life-threatening disease or condition; have exhausted approved treatment options; be unable to participate in a clinical trial involving the drug; and give written informed consent regarding the risks associated with taking it.

An Alternative to a Final Good-bye

One of the first cases to win a Right to Try case for a Covid patient involved 80-year old Judith Smentkiewicz of Buffalo, who in January was placed on a ventilator and was slowly deteriorating. Doctors gave her a 20 percent chance of recovery.

NY attorney Ralph Lorigo had argued the case before State Supreme Court Judge Henry Nowak and won a court order instructing hospital authorities to administer ivermectin, Buffalo News reported.

After one dosage of the medicine, the patient dramatically improved and was soon breathing on her own. A second order had to obtained, however, after Smentkiewicz was discharged from the ICU and placed on a Covid floor. Doctors there discontinued the medication, leading to the patient’s quick decline.

Once the medicine was resumed, Smentkiewicz continued recovering until she was ready to be discharged to a rehab. She has been home and back to her former life and routine for many weeks, her attorney testified in a media interview on Trial Site News.

In another case the same month, 65-year old Glenna Dickenson of Orleans County was languishing on a ventilator in Rochester General Hospital. State Supreme Court Justice Frank Caruso ruled in the patient’s favor in that case as well, ordering the hospital to continue ivermectin treatments while she was weaned from the ventilator and recovering.

Most hospitals have little to offer patients in the critical stages of Covid inflammatory disease, except the dreaded ventilator, sedation and keeping away loved ones. Elderly patients in particular, are at risk of losing their will to live when intubated and placed in isolation, and tend to rapidly spiral downward, doctors say.

Tragically, their “good-bye” to family members when admitted to the hospital is often a final one.

At Death’s Doorstep

In a similar court case last month involving a Covid patient, 81-year-old John Swanson of Stafford, New York, had been on a ventilator for over two weeks in a Rochester hospital when his family sued authorities for refusing him potentially life-saving treatment.

According to a legal affidavit filed in court by attorneys, Swanson had not been allowed to receive visits from his wife, Sandra, during this time, and was “at death’s doorstep.” Attorneys for Sandra, who had power of attorney in the case, had petitioned hospital authorities to administer ivermectin, but they had refused.

Under orders from State Supreme Court Justice Frederick Marshall, Swanson was given one dose of the medication. “After that one dose, he started breathing on his own. He was taken off the ventilator and was making great progress,” said Ralph Lorigo, an attorney from Buffalo, NY, who represents the Swanson family.

But in what is becoming a repeated New York State story, the hospital’s doctors then refused to give follow-up doses of ivermectin, and Lorigo went back to court. Judge Marshall issued another order directing the hospital to give Swanson four more doses of ivermectin.

The subsequent turnaround was remarkable. Swanson’s condition stabilized and he was moved out of the ICU.

“I Spoke to Him…Prayed With Him…He Opened His Eyes…”

In a meeting with the judge and the attorney for the hospital, Lorigo raised two other burning issues that have become common features on Covid floors in many hospitals.

“Here was an 81-year old man who had been isolated in an unfamiliar environment for two weeks,” noted Lorigo in a media interview with Trial Site, adding that deprived of contact with loved ones, the patient had developed hospital dementia and appeared to have lost the will to live.

In addition, the hospital had refused to turn over Swanson’s medical records to his family. Both issues were resolved at the meeting. In an agreement spearheaded by the judge, Sandra Swanson was permitted to visit her husband every day, and the hospital turned over 1700 pages of medical records.

“I got a phone call from Sandra that day telling me about her visit with her husband,” Lorigo said in the interview. “She said, ‘I stroked his cheek, spoke to him, prayed with him and he opened his eyes!’”

“It was so moving… Her husband is now in rehab, slowly convalescing,” the NY attorney said.

‘Stand Out of the Way!’

Right to Try won again in a widely publicized case that unfolded two weeks ago in Elmhurst Hospital, in the Chicago area. But it took two court hearings, an agonizing 72-hour delay and a barrage of negative publicity before a judge’s ruling, backed by his sharp command to hospital authorities to “Stand out of the way, let the medication be administered!” was finally enforced.

In this unusual case, a 68-year old hospitalized Covid patient, Nurige Fype, had been on a ventilator for a month in a medically induced coma. Anticipating her mother could die at any moment, daughter Deserata asked that she be treated with ivermectin but the hospital doctors refused.

“Every day that I’ve been requesting it, I’ve been denied this drug,” Deserata told Fox News. “So I hired lawyers to fight this.” Attorneys Ralph Lorigo and Jon Minear took on the case, securing a court order from a judge in Dupage County ordering Elmhurst Hospital to administer ivermectin to Mrs. Fype.

The attorney for the hospital, Joseph Monahan, had argued that ivermectin was “not ethical to use…an outlier…not standard of care,” reported the Chicago Tribune. He cited information the FDA has on its website titled, “Why You Should Not Use Ivermectin to Treat or Prevent Covid-19.”   The statement says the drug has only been approved at very specific doses for parasitic worms and that it is dangerous in large doses.

Monahan attested that the hospital, using its own protocol, had saved 92 percent of its Covid patients. Judge Orel issued a pointed rejoinder. “There’s still 8 percent” who died, he said. “If there’s a medicine out there that can assist a patient … and nothing else is working and she’s regressing to the point of near death, then, yes, I balance the equities.” In other words, weighing the evidence, the judge sided with the Right to Try.

They Couldn’t Find a Doctor in the Hospital to Administer the Drug

The hospital dug in its heels and refused to budge, claiming through its attorney, that they could not find a hospital-affiliated doctor to administer the drug. They had asked 20 physicians and 19 other health care workers, including nurses and pharmacists, to administer the medication. They all said “no,” Monahan said.

“I’m so devastated, so frustrated,” Deserata told Fox News. Her attorneys went back to court citing a potential life and death emergency caused by the hospital’s continued failure to comply.

The judge then issued a second order telling Elmhurst Hospital to “stand out of the way” and allow any board-certified doctor to administer the drug to the patient “immediately.”

Loriga was preparing a motion for contempt of court when the hospital buckled, announcing through its attorney that they had complied with the judge’s order. An outside doctor had been granted credentials to work at the hospital so he could administer ivermectin.

The doctor, Alex Bain, who is listed on a directory of physicians willing to prescribe ivermectin for Covid-19, was willing to travel two hours each way to administer the drug.

“Now let’s hope the good Lord allows the medication to work,” Judge Orel said at the conclusion of the emergency hearing.

“Today, after her first dose, the ventilator has been reduced from 75 percent to 65 percent,” said attorney Ralph Lorigo to Daily Herald. “That’s an improvement. Now she will get a dose of ivermectin every day until recovery.”

Infectious Diseases Expert Breaks Ranks with Hospital Policy

In another Right to Try decision on Tuesday May 4, a New York State judge upheld ivermectin treatment for Deborah Bucko Mantel, a 52-year old patient at Mount Sinai Hospital in Long Island.

As in the case of Fype, Mantel’s struggle to obtain ivervectin involved fruitless pleas to hospital doctors and administrators, and, finally, two court hearings. These delays undoubtedly threaten deterioration of ICU patients tethered to ventilators.

In court papers, the hospital said ivermectin “was not consistent with the Mount Sinai Health System Guidelines,” which were based on “recommendations of professional societies, government agencies and infectious disease expert opinions…”

Scott Mantel, Deborah’s husband, had studied the research when the family became ill in February. His wife was prescribed an antibiotic and inhaler but deteriorated and was admitted to the hospital. Feeling the onset of symptoms, he was concerned that he, too, had become infected, Mantel told Trial Site News. He said he tracked down Dr. Zev Zelenko, an early treatment “pioneer.”

“He suggested ivermectin, hydroxychloroquine, azithromycin, zinc and a steroid pill,” Mantel said. Within hours, he said, “I was 100 percent better. It was almost like completely eradicated. I’d never been treated with medicine that worked that fast in my life.”

This case had an unusual feature, noted attorney Loringo in a media interview. “The hospital’s infectious diseases expert had actually prescribed invermectin for Deborah Mantel when asked to do so, but the pharmacy and hospital administration would not allow it to be dispensed. We asked this doctor for an affidavit…At first he said he’d give one but then became hesitant. So the family went to the patient portal and found the prescription there and we put it in our affidavit.”

When the judge saw the hospital’s own infectious diseases expert had ordered ivermectin, Lorigo said, he signed an order for authorities to obtain it and administer it to Deborah Mantel. “She’s doing much better since beginning the medication,” he said.

Renowned Yale Oncologist: ‘This is Not Placebo, This is Real’

One of the most prominent physicians to take up ivermectin’s cause is Yale School of Medicine Professor and cancer researcher Dr. Alessandro Santin, an article in the World Tribune noted. “The head of a large laboratory at Yale and author of over 250 science publications, Dr. Santin is renowned in his field for pioneering a treatment used worldwide for the most aggressive form of uterine cancer,” the article said.

Dr. Santin’s research into Covid-19 treatment began when 10 to 20 percent of his cancer patients began coming down with the disease, their risk of death heightened due to their cancer and chemotherapy regimens. The need for effective treatment for Covid-19 was imperative.

When the NIH reformulated its advisory about ivermectin to allow it as a Covid-19 treatment outside of clinical trials, Dr. Santin was one of the first doctors to take advantage of the new policy. The majority of his patients receiving ivermectin saw significant improvement in one to three days.

The most dramatic progress was seen in those suffering from breathing problems, severe fatigue, and chest pain,” Dr. Santin noted in the article.

“When you have people who can’t breathe well for five, six, eight, nine months and they tried multiple drugs and supplements with no success, and you give them ivermectin,” Dr. Santin said, “and they start immediately feeling better, this is not placebo. This is real.”

Santin lamented the current situation in most hospitals where, to get treatment you have to first get sicker. “You must let the virus continue to replicate until your body enters the inflammatory stage, typified by pulmonary issues.”

“For an inpatient with severe covid right now,” Dr. Santin said, “we give them a steroid, some heparin and remdesivir. That’s it. If they improve, great. If they get worse, we unfortunately have no recourse. We watch them die.”

The need for widespread recognition and use of ivermectin as a “highly effective therapeutic against Covid-19 treatment now and into the future, remains great,” he said.

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A Constitutional Right to Help Yourself

 

“An individual has the constitutional right in this country to help himself and that means getting treatment when it’s available, especially when there’s no proven downside,” said attorney Ralph Lorigo in a media interview.

“The new NIH guidelines, which abstain from taking a government position for or against ivermectin, have been a huge benefit for my clients.  The NIH now supports the right of a patient and doctor to reach a decision themselves regarding the drug. Judges recognize this. This is an important legal foundation in our efforts to obtain it for a patient. ”

The attorney said he would advise someone who is hospitalized for Covid and faced with the possibility of needing a ventilator, to give the power of attorney to a trusted family member. If down the line, it becomes necessary for the family to go to court to obtain ivermectin, the litigant needs “legal standing” which the power of attorney confers.

The patient also needs a family doctor or other practitioner who would be willing to prescribe ivermectin. A judge can order hospital authorities to fill a patient’s prescription but has no authority to order them to write one.

A groundbreaking article appearing this month in the April-May edition of the prestigious American Journal of Therapeutics, will undoubtedly raise public awareness of ivermectin’s ability to halt and reverse Covid-19 at every stage of the disease, its advocates say.

The review by the FLCCC (Frontline Covid Critical Care) encompasses peer-reviewed studies, dozens of random-controlled trials (RCTs), expert meta-analyses, and epidemiological analyses of regions where ivermectin has been mass distributed to the population.

The studies also analyze the drug’s side effects, tracking any adverse effects associated with its use in billions of dosages over four decades, and finding it to be one of the world’s safest drugs.

“We conducted the most comprehensive review of the available data on ivermectin,” said Dr. Pierre Kory, president of FLCCC, noting that ivermectin has shown remarkable benefits at all stages of the disease while posing a very low risk of minimal side effects.

“We applied the gold standard to qualify the data reviewed before concluding that ivermectin is an effective prophylaxis and treatment for Covid-19. Along with effective vaccination and safe hygiene, it can end the pandemic,” he said.