Xingxun’s Story — First, do no harm.
CMS recently reviewed the properness of giving Diamox to Dad. After reviewing the exact same complaint and the exact same supporting documents that we submitted to our state medical board, CMS determined that the care provided to Dad did not meet the professionally recognized standard, which was never recognized by the state medical board.
Here are the CMS determinations:
- “Medical records showed that the off-label use of Diamox was not appropriate, given the patient’s COPD and high risk for respiratory depression. According to the medical records and any other documentation in the file, the care provided did not meet the professionally recognized standard of care.”
- “Medical records showed that the patient has a reported history of an allergy to sulfa, which is a contraindication for Diamox use. According to the medical records and any other documentation in the file, the care provided did not meet the professionally recognized standard of care.”
- “Medical records raised a significant concern that excessive diuretics were used in an inappropriate manner when the patient was already volume depleted. According to the medical records and any other documentation in the file, the care provided did not meet the professionally recognized standard of care.”
- “Medical records showed that Diamox should have been discontinued, given the evidence of significant and worsening volume depletion and episodes of hypotension. According to the medical records and any other documentation in the file, the care provided did not meet the professionally recognized standard of care.”
Now here are the prior events that led up to the above decision by CMS:
Losing a loved one is never easy. Losing them due to someone’s negligence makes the experience even more devastating. The following story describes how Dad’s life was cut short and how our state regulatory system failed us. We are certain that no one in their right mind would want to walk in our shoes.
On April 8th, Dad was admitted to Regional Hospital for Respiratory and Complex Care to be weaned off BiPAP, a non-invasive breathing machine that is typically used to treat sleep apnea at home. Upon his arrival at the hospital, a red allergy band was fastened to his wrist to warn about his life-threatening sulfa allergy that had been well documented in all his medical records since 2004.
On admission day, the hospital records noted that he was “alert,” “smiling,” “chatting with family,” and able to finish 100% of hospital-provided meals. It was also documented that he was able to be off BiPAP for 8-9 accumulated hours.
Despite a red allergy band for sulfa drugs and all the allergy warnings in the hospital’s medication dispensing forms, on April 9, the second day after admission, the only regular doctor at the hospital and its then-medical director, Dr. Robert Clark gave Dad a sulfa-containing medication, Diamox.
Since it was the first time we had heard about this drug, we asked this doctor twice about the drug risks specific to Dad before the first dose. Dr. Clark did not tell us that Diamox contained sulfa and he did not mention that the drug would be used as a respiratory stimulant in an off-label fashion. Instead, he told us that the drug had no risks to Dad. When we learned that Diamox would lower blood pH, we expressed concerns. Instead of discussing our concerns, Dr. Clark became irritated and said these words to us that we will never forget: “I have been a pulmonologist for over 25 years and have treated many patients with Diamox. You people need to stand back and let me do my job.”
However, what Dr. Clark did not tell us was that just about three hours before, he had been warned by the hospital pharmacist of possible drug reactions and anaphylaxis if he gave Diamox to Dad. We did not learn about this warning until 6 months later after Dad’s death. We also did not know that Dr. Clark had never been certified in pulmonology.
Dr. Clark proceeded in giving Dad Diamox. While on the drug, Dad suffered 10 episodes of uncontrolled diarrhea on two consecutive days. Diarrhea is listed as one of the most common, significant side effects of Diamox and can cause one’s body to quickly lose a lot of fluid. We were concerned, but the no one at the hospital did anything to address our concerns or the sudden onset of diarrhea.
At the same time, Dad showed other signs of adverse reactions to Diamox. Because Diamox lowers the blood pH due to the drug-induced metabolic acidosis, Dad became acidotic and had to be kept on BiPAP for more time. This was the opposite of the goal to wean him off BiPAP. However, little did we know at that time that these problems were only the tip of the iceberg.
In the early morning of April 10th, about eight hours after the 4th dose, Dad complained to us of dizziness and a headache. The monitor showed his blood pressure had dropped to dangerous levels. To rescue his life-threatening low blood pressure, multiple emergency fluid resuscitations were ordered. In a short amount of time they pumped so much IV fluid into Dad’s body that it severely compromised his heart condition. His face, hands, arms, legs, and tummy became swollen up and he developed several life threatening complications.
On admission, he was recorded with no edema anywhere on his body or in his lungs. But, after the sudden hypotension and subsequent emergency fluid resuscitation, his breathing became labored even on BiPAP; his skin broke down due to the severe edema so that he suffered a large blister on his back and two large open bed sores; and his heart and kidneys started to shut down.
He had none of these conditions on admission.
On April 18th, only ten 10 days after his admission, Dad was on the verge of death as noted by a Group Health nurse. He was now suffering from acute respiratory failure, acute heart failure, and acute renal injury; the latter medical condition was neither documented, acknowledged, nor treated by the doctor.
We were devastated, helplessly watching Dad rapidly slipping away, without knowing what really was going wrong.
On April 20th, we honored Dad’s wishes and took him home. At the time of discharge, Dad could no longer get off BiPAP. He could no longer eat or talk to us. Three days later, Dad lost his fight to survive this negligent use of Diamox. He passed away only two weeks after he was admitted to Regional Hospital for a simple weaning procedure.
After Dad passed away, we discovered numerous warnings on the use of Diamox in the medical literature. Not only does the drug contain sulfa, it is contraindicative for patients like Dad who have a severe sulfa allergy and severe COPD. Furthermore, the off-label use of Diamox as a respiratory stimulant can lead to acute respiratory failure for COPD patients and, according the Cochrane Reviews, this particular off-label use of the drug has not been shown to be safe in clinical trials. As a result, this off-label use has not recommended for severe COPD patients since the 1990s.
Six months after Dad passed away, we learned that Dr. Clark had been warned by the hospital pharmacist about a risk of a cross-reaction and/or an anaphylactic reaction prior to him giving the Diamox to Dad. The hospital’s internal pharmacy document showed that Dr. Clark and the lead nurse were aware of the warning at the time when we asked him about the risks of Diamox. However, neither the doctor nor anyone else at Regional informed us about the pharmacist’s warning or the monitoring, even though we were at Dad’s bed side 24/7 in the hospital.
We were shocked. Why did Dr. Robert Clark intentionally expose such a vulnerable elderly to the risk of anaphylaxis, when there was no medical emergency and when an anaphylactic reaction can be life-threatening and harmful to even a healthy young person?
Why did Dr. Clark withhold from us the drug warning and risks, the critical information that we and Dad needed to make an informed decision?
When the risks of the Diamox treatment were significantly greater than the benefits, if any, why did Dr. Clark expose Dad to these unreasonable risks of harm? What happened to the doctor’s oath of “First Do No Harm”?
According to both state and federal patient rights laws, a doctor is required to inform a patient about treatment risks, benefits and alternatives, so that the patient can make an informed decision.
Had Dr. Clark or any one in Regional Hospital informed us about the Diamox warnings or its significant risks to Dad, we would have declined the use of this drug to avoid these risks of harm. But no one told us anything about the drug’s warnings, even after Dad showed signs of serious drug reactions. Dad and our family were the only ones who were kept totally in the dark during the whole time.
Considering Dad’s medical conditions, his age, and all the warnings in the medical literature, there is no doubt that Diamox should never have been given to Dad. The Diamox “treatment” put Dad at significant risk of worsening his respiratory condition, a life-threatening anaphylaxis, and impaired kidney functions, when there was no medical emergency at the time of Diamox prescription. .
After reviewing Dad’s records, a pulmonologist and professor at the University of Washington, who is a world leading expert on Diamox and its effects on lung functions, wrote that Dad did not need Diamox and he was at a very serious disadvantage and at extreme high risk for all the known adverse effects of the drug. Furthermore, he stated that, given his advanced age and medical condition as well as so little chance of the drug working, the administration of Diamox was below the standard of care and negligent causing irreversible harm to Dad.
To prevent Dr. Clark from harming other patients with the same dangerous practice, we filed complaints with Washington State Medical Quality Assurance Commission (MQAC) and the state hospital licensing office, hoping that they would uphold the patient rights and medical safety standard. But, we were native and proven wrong.
During the state investigations, Dr. Clark submitted extensive self-serving false information to the medical board. For example, to justify the use of Diamox, he falsely claimed there was a medical emergency which in fact did not exist until after Diamox was given; he falsely claimed Dad had no renal failure by quoting Dad’s lab results before his renal failure; he falsely claimed he had no role in discharging Dad when medical records clearly documented his instructions for discharge.
Yet, MQAC never questioned or verified any of the doctor’s false claims with the medical records or our personal observations. The medical board also never investigated the doctor’s and hospital staff’s failure to inform Dad or our family about the drug warnings and its significant risks. Despite the clear and convincing evidence that the doctor and the hospital seriously violated Dad’s patients rights, providing substandard care, and despite that we had a world-leading expert’s opinions on the misuse of the drug, MQAC and the state hospital Facilities and Services Licensing refused to take any action.
MQAC claimed there was no evidence that the doctor committed unprofessional conduct, even though the clear and convincing evidence showed that Dr. Clark engaged in the following unprofessional conducts according to RCW 18.130.80:
(1) The commission of any act involving moral turpitude, dishonesty, or corruption relating to the practice of the person’s profession, whether the act constitutes a crime or not.
(4) Incompetence, negligence, or malpractice which results in injury to a patient or which creates an unreasonable risk that a patient may be harmed.
(7) Violation of any state or federal statute or administrative rule regulating the profession in question, including any statute or rule defining or establishing standards of patient care or professional conduct or practice;
8(b) Not furnishing in writing a full and complete explanation covering the matter contained in the complaint filed with the disciplining authority;
(13) Misrepresentation or fraud in any aspect of the conduct of the business or profession;
To try to understand how MQAC could see no unprofessional conduct when the evidence was blatantly clear, we called MQAC staff. We found out that the medical board was never aware of the pharmacist’s drug warning; Dr. Clark never disclosed it to MQAC either. So we called the then-MQAC Director Maryella Jansen and asked why. Unbelievably, she told us on the phone, “The law does not require me to tell you anything, so I will not.”
In February 2009, we met two MQAC’s staff, chief investigator Jim Smith and staff attorney Karen Caille. We were told the meeting was to discuss our concerns over MQAC’s investigation. However, at this meeting these two MQAC staff showed zero interest to listen to our concerns. First they refused to discuss and accept the hospital document showing the pharmacist’s warning, claiming it was a legal issue and they could not talk to us because we were not attorneys. Then, they refused to even look at the copies of medical literature warning on Diamox that we brought to the meeting. They repeatedly told us that “it is serious to take a doctor’s license away”, “you are not medical doctors so you opinions do not count”, “MQAC never makes mistakes”, “You cannot use the information you find online”, and “If you think the doctor killed your father, go find a lawyer. The state cannot help you.”
The state Facilities and Services Licensing also refused to investigate the Patient Rights violation. The head of the office, Linda Foss told us that “the drug is generally safe” and “hospitals do not have to tell their patients the risks of every drug.”
However, under Washington State law RCW 7.70, informed consent rests on what a reasonable patient wants to know, not what a doctor wants to disclose.
Furthermore, since when is a doctor’s license more important than a patient’s life? Since when can doctors give their patients drugs without telling them about the significant risks? And since when does our state Department of Health promote a medical standard that patients do not need to be informed of significant treatment risks?
Because of the refusal by the state medical board and the state Facilities and Services Licensing, we were forced to file a complaint with the Center for Medicare and Medicaid Services (CMS) about the Patients Rights violation. After its own investigation on Dr. Clark, the nurses, the pharmacist, and after reviewing the hospital records, the federal agency had no difficulty of confirming that Dad’s patient’s rights were violated by the doctor, the nurse, and the pharmacists. CMS also cited the hospital for a violation of hospital records.
When the federal investigators asked Dr. Clark why he did not inform us about the Diamox warning and risks, he replied: “It never crossed the synapse that day.” In another words, he told federal investigators that he forgot to inform us of the risks of the treatment that day.
How could Dr. Clark forget to tell us the warning, when the pharmacist had just warned him and we had just asked about the drug risks and, yet, he told us there were no risks at all?
It turns out that Dr. Clark lied to the federal investigators. Here is his response under oath to the exact same question in court two years later:
“I don’t think the patient should be the final arbitrator of the — of medical talk in reaching a final conclusion, okay. … I can’t predict who’s going to have an allergic reaction to the drugs that we prescribe, but I need to be prepared to respond to that. I don’t need to cause unnecessary grief, unnecessary anxiety in a patient when I have a broader understanding of what’s going on with that medication. Why would I present that for the family to make the final verdict? They don’t have the training or the experience to make the final determination between is the PharmD right or is Dr. Clark right. What’s this based on is my clinical use of it, the drug warning labels and a more detailed search and a more detailed understanding because I’ve used that drug in the past, right.”
Despite his claim for a “broader understanding of what is going on with [Diamox]” and his claim that his decision was based on his clinical use, drug warning labels and “a more detailed research”, he admitted under oath that he was “not a follower of Diamox research” and not aware of any warnings about risks of Diamox on COPD patients. However, the warnings had amply existed in the medical literature for years. For example, Diamox labels in UpToDate explicitly warmed about Diamox as being contraindicated for patients with severe sulfa allergy and severe COPD. Yet, Dr. Clark stated under oath that he read UpToDate regularly.
After we received the notification of the CMS citation, we forwarded the federal agency’s letter to MQAC and the state Facilities and Services Licensing. MQAC passed the CMS letter immediately onto the office Facilities and Services Licensing, claiming it was a hospital problem so MQAC had no jurisdiction. Obviously, they believe the hospital prescribed the drug and failed to inform us of the risks; it had nothing to do with Dr. Robert Clark. Essentially, MQAC protected him from any personal responsibility.
The Office of Facilities and Services Licensing was also more than willing to drop the ball. They told us that the state has different laws from those of CMS on regulating hospitals. But, after we showed the office of Facilities and Services Licensing that both the state and CMS have almost the identical rules and laws regulating hospitals, they changed their story and then told us, “If we would have found the same violation, we would have done the same sanction. Since CMS has already sanctioned the hospital, nothing else needs to be done. We will work with CMS on monitoring the hospital in the future.”
Once again, these state agencies were not willing to do their job to protect patients by assigning responsibility and providing necessary corrections and sanctions.
On the FDA’s web site, the federal agency posts its guideline on “Off-Label” and “Investigational Use of Marketed Drugs”:
“Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”
Based on this federal guideline for the use of “off-label” drugs, one would think a physician should keep updated with the advances in medical knowledge, so they would not put patients at risks of harm. However, this was not the case for Dr. Robert Clark. During his deposition under oath, he said he learned about Diamox during his residency in the 1980s, but that he is “not a follower of Diamox research”. Furthermore, even though medical literature warns extensively about the risks of using Diamox on patients with severe COPD, Dr. Clark falsely claimed under oath that he had treated “several hundreds” of his COPD patients over the years and it was his standard practice. When asked whether he was aware of any risks of Diamox for COPD patients and any side effects had occurred, Dr. Clark replied he was not aware of any.
So, Dad and Dr. Clark’s other patients were his guinea pigs.
According to a report, “Preventing Medication Errors” by the Institute of Medicine of the National Academies, at least 1.5 million preventable adverse drug events (ADEs) occur in the United States each year. About 400,000 preventable drug-related injuries happen in hospitals alone, which adds at least 3.5 billion dollars to the cost of the hospital stays. For Medicare enrollees alone, the annual cost is estimated to be $887 million for treating medication errors. These statistics are shocking, not to mention the patients’ pain, suffering, loss of earnings, and even worse, the loss of their lives, like what happened to Dad.
To reduce medication errors effectively, the report recommends that doctors, nurses, and pharmacists must know and act on patients’ medical care rights. They should make it a standard procedure to communicate and inform their patients fully about the risks, contraindications, and possible side effects of the medications they are taking and what to do if they experience a side effect. They should also be more forthcoming when medication errors occur.
This medication error report has been out now for many years, and both federal and state Patients’ Rights laws have been enacted since the 1990s. Sadly, there has been no reduction in medication errors in our hospitals, and patient rights to be informed about treatment risks have been ignored by many including our state agencies.
Obviously, a part of the problem is our state regulatory system that is supposed to be protecting us. Their inaction to enforce patients’ right laws puts all of us at risk.
To improve our hospital safety, we fought for greater accountability and transparency in the state disciplinary process. In 2011, we worked with state legislator Rep. Jamie Petersen and passed a “transparency bill” that requires the state medical boards to provide explanations to complainants when a case is closed. The bill also provides for the first time an opportunity for medical error victims and their families to make impact statements before the boards.
On April 22nd, 2011, almost exactly three years of Dad’s passing, Governor Christine Gregoire signed this “transparency” bill into law. At the bill signing ceremony, I showed the Governor Dad’s picture and told her that Dad would be glad to know that this new law will help lots of people. The Governor replied, “He is smiling right now.”
During our litigation, Dr. Clark through his insurance company twice offered to settle the case. However, each settlement proposal came with a gag order. Their offer was that (1) Dr. Clark would not admit any wrong doing; (2) we would be barred from speaking about Dad’s case; no posting on websites, no more complaints to state and federal agencies, no more communications to newspapers and press, and we would not be allowed to talk to anyone about Dr. Clark’s involvement in Dad’s death.
We refused to settle with such a gag order because freedom of speech is our fundamental right. Our counter offer to Dr. Clark was that we would be willing to give up all monetary compensation, if he would just admit his mistake and that he would not repeat the same mistake on other patients. Dr. Clark refused.
Joining the statistic that over 90% of all medical malpractice litigations go in favor of doctors, we were not successful in court. Several factors contributed to our loss: (1) the doctor lied extensively in court and our lawyer claimed it was not to our benefit to point them out; (2) they had big insurance money backing on their side; (3) the doctor’s lawyer was successful in barring several pieces of damaging evidence in court against the doctor including the CMS findings and citation, and (4) our attorney made a fatal, legal mistake, which was pointed out in court latter by a prominent malpractice attorney in Seattle.
Even though we lost in court, we had the opportunity to tell Dad’s story on his behalf in public court and the doctor had to listen. While he lied to cover up his negligence, we doubt he will ever forget about how Dad and our family suffered as a result of his negligence and incompetence. And he knows now that we will never give up our rights to advocate for Dad and for all patients. He has also learned that we will not be silenced by insurance settlement money.
Many have a misconception that patients go to court to win a jackpot. We will tell everyone that going to court was the second toughest experience of our life; the first was watching Dad’s tragic death and the second was reliving the horror in court, especially when we had to listen to the lies and smear comments coming from this doctor and his attorney. The defense lawyer was willing to do anything to win. He called us “zealous advocates” who were on a “vendetta” mission to get the doctor. He accused us trying to change state law just to benefit ourselves. He spoon-fed the doctor in court on what to say because during his deposition the doctor clearly had a hard time keeping his story straight.
But, there was one moment that we will never forget. After the jury verdict was read, the judge came down from her bench and walked up to us. She said: “I just want to let you to know that I am very sorry about what happened to your father, and you did the right thing to continue to be his advocate.“ We were touched by her words.
Dr. Clark may have won the case in court, but he won without his integrity, morals, dignity, and his soul.
Despite our loss in court, we never lost our morals and our right to tell Dad’s story. We fought for the truth in honoring the memory of Dad. Like one of our friends said to us: “Better to lose with honor than to succeed by fraud.”
After discovering the new evidence during litigation, we filed a new complaint to MQAC. The court evidence cast considerably more light on Dr. Robert Clark’s unprofessional conduct. However, once again, MQAC refused to investigate citing nothing new and that Clark’s care met the professional standard.
In their response letter, they once again provided no explanation as to which information was not new to them and why Dr. Clark’s care met the care standard. Unfortunately, there is no mechanism for complainants to appeal a regulatory board’s decision.
The Medical board can refuse to investigate. Dr. Clark can continue to practice by hiding behind MQAC’s protection. But what happened to Dad will not be forgotten. We hope, by telling Dad’s story, we will help more people and make a difference, so that medical care will be safer to all.
Yanling Yu & Rex Johnson