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Dr. Shafer Testimony continued
Walgren Direct continued
Walgren goes over again the credentials of Dr. Shafer by showing the journal he's editor in chief and multiple research articles written by Dr. Shafer. Research articles examine the differences in regards to gender, age. Dr. Shafer also had research done on Lorazepam, Midazolam and Lidocaine. DA Walgren says that he will ask about these topics during testimony.
Walgren mentions difference between intensive care sedation and procedure related sedation (MAC). Dr. Shafer tells that intensive care sedation would be for longer time, MAC would be shorter.
Dr. shafer says that all the work he has done on this case was for free. He says he never charged money for testimony because he feels it's inappropriate and unethical to benefit from medical misadventures. Shafer says he doesn't want his integrity to be questionned as well Shafer also says he wanted to get involved in this case to restore general public's confidence in anesthesia and doctors. Dr. Shafer says that he's asked daily by his patients " Are you going to give me that drug that killed Michael Jackson?". He says that he hopes to alleviate this unneeded fear with his testimony.
mid morning break
Dr. Shafer has brought several medical items for demonstration. First he starts with explaining Saline bag and it's ports. Later Shafer tells what and IV is. Infusion(Drip) when drug drips in slowly. Shafer explains that Propofol comes in a glass vial, there's an aliminium seal and a rubber stopper on top. To get the drug out you need to go through with a slow needle or a large spike to get the drug out.
Walgren asks Shafer to demonstrate to get Propofol out of the bottle.
Shafer demonstrates to get out Propofol with a syringe / needle. Shafer tells to get Propofol out you need to replace Propofol with air so that Propofol will go into the needle.
Walgren asks Dr. Shafer to examine 100 ml Propofol bottle from the scene. Shaffer says that it has a spike hole and not a needle hole.
Dr Shafer has made a video for his case, to demonstrate what is necessary for sedation, even for 25mg propofol. Playing the video : «*an over view of safe administration of sedation*»
The doctor first prepares the room, checks the equipment. Video shows multiple equipment for airway management such a tube for the throat, a tube for the nose, an equipment for intibation, a throat mask for air. Organizes these items.
Then the doctor checks the oxygen equipment. Doctor checks if the oxygen supply work, checks nasal cannula, checks to see if nasal cannula is measuring carbon dioxide by capnometer. Doctor tests anesthesia breathing circuit. This is the equipment used if the patient stops breathing and the doctor needs to push oxygen into the lungs. Doctor then checks the back up oxygen. This is used if for some reason the breathing circuit fails.
Doctor then checks suction apparatus. This is important because if the contents of the stomach gets into the lungs or if the vomit (bile) gets into the lung, it would destroy the lungs. This is why patients are told to not to eat or drink prior to anesthesia. if the patient vomits or the contents of the stomach come to the mouth, the doctor has to be very quick to clean them with the suction equipment before it goes into the lungs and destroys the lungs.
Next step is to set up the infusion pump. It takes a few minutes to set it up. In the video they use a syringe pump. Doctor first draws Propofol into the syringe. As Dr. Shafer demonstrated this is not easy. You need to draw air into the syringe and do multiple draws to fill the syringe. Dr. Shafer tells a narrow tubing has to be used in the infusion pump as the wide tubing could be problematic. Then the doctor programs the pump, putting the patients weight, correct drug name, infusion rate. Doctor verifies the information for a second time.
Next step is to assess the patient. Anesthesiologist is repsonsible for knowing his patient. Makes a physical examination, first thing is airway, listens to the lungs, checks the heart. Always done for each procedure, for every patient. No exception.
Doctor also gets the informed consent of the patient. Doctor informs the patient of risks and explains what the procedure entails, asks the patient if he has any questions, then patient signs the informed consent form. Dr. Shafer says oral consent is not binding, and is not recognized.
Some steps are not shown on the video. These are: patient put on table, monitoring equipment such as blood pressure cuff, pulse oximeter, ECG are put on patient. Oxygen in place, intravenous catheter is put into the patient. Afther these doctor pauses to verify again. Doctor does one last check before injecting the propofol.
Propofol infusion pump is started. Anesthesiologist is close to the patient, monitors the patient. Doctor keeps records of the vitals. Chart is a necessity to track the patient and the patterns. It's a responsibility to the patient.
In this part of the video, we are shown examples of what can go wrong.
First example is when blood pressure drops. Dr. Shafer says this is very common and they see it everyday. Propofol lowers blood pressure especially if the patient is dehydrates. Doctor gives ephedrine through the IV line. Generally blood pressure comes to normal levels.
Second example is carbon dioxide. The monitor shows that carbon dioxide stopped. It means the patient is not exhaling and the airway is obstructed. Doctor immediately does chin lift and jaw thrust. Dr. Shafer this is also done very routinely. Shafer says the most common reason is because the tongue is blocking the airway and by doing a chin lift and jaw thrust you can move the tongue.
Third example is apnea. This is when the patient doesn't even try to breath. In this instance you need to take over for the patient and force air into the lungs. Doctor removes the nasal cannula, places the mask on the patient's mouth and nose and squeeze the bag to push oxygen into the lungs.
Fourth example is aspiration (not shown on video). This is when the patient vomits and/or stomach contents come to the mouth. Patient is turned sideways and before the next breath you need to suction everything.
Fifth example is cardiac arrest. Heart stops beathing and the patient stops breathing. Doctor does a 2-3 second assesment to make sure that the monitor has not failed. Then the doctor calls for help. First thing is always to call for help. One person begins CPR, one person is ventilating the patient and other person gives resuscitation drugs. Alls of this is done to keep the patient alive for enough time to fix the problem that caused the arrest. These efforts are continued until the patient is revived, or is pronouced dead.
Lunch break
Afternoon session
Dr. Shafer Testimony continued
Walgren Direct continued
Dr. Shafer says that the safeguards and requirements apply to all doctors who perform sedation, for any type of IV sedatives. Some nurses are also trained about sedation. These guidelines apply to them as well.
Walgren asks if CM's intent were to give 25mg would these standards still apply. Shafer says yes and continues to say the patient (MJ) had other IV sedatives, profound inability to sleep, he was exhausted, dehydrated; and he had been given sedatives for some time and he could have saome elements of dependency or withdrawal.
Walgren asks if it possible to go in saying I'll only give a small amount so I don't need these guidelines. Dr. Shafer says it's a trap. Even for a little sedation , it's a slippery slope, you may have to give more. You never know how the patient will react. Shafer says there's no such thing as a little sedation and the worst disasters happen when people cut corners.
Facts in this case suggest that virtually none of the safeguards for sedation were in place when propofol was administered to MJ.
Walgren asks Shafer explain how patients reacts different to the same dose of sedatives. Shafer says that some patients will need half the usual dose and some patients will need double the dose. Shafer says 25 mg is the limit when a patient migh stop breathing. Shafer says you can't assume that this will be an average patient. Shafer says you always assume your patient is at the edge of sensitivity and prepare for the worst case scenario.
Shafer did a report about this case dated April 15th, 2011. In his report he used some terms.
Minor violation : not consistent with standard of care, but would not expect to cause harm for the patient unless there are several other violations
Serious violation : expected to cause harm to the patient, in combination of other violations
Egregious violation : These should never happen in the hand of comptent doctors. An egeregious violation can alone be catastrophic for the patient. Competent doctors know that bad outcome is a high possibility
Unconscionable vioation : It goes beyond the standard of care. It's an ethical and moral violation as well as a medical violation.
Walgren goes over Dr. Shafer's report and 17 egregious violations he identified.
Lack of basic airway equipment, egregious violation. MJ died because he stopped breathing which is expected when you give IV sedatives. It must be there without question.
Walgren asks Dr. Shafer assume that CM had left only for 2 minutes and CM had the equipment if MJ could have been saved? Dr. Shafer says yes and probably MJ had an obstructed airway and even a simple chin lift might have been required to save MJ. Shafer says that CM says he didn't use the ambu bag. Shafer says mouth to mouth is less effective and gives used air.
Lack of advanced airway equipment. Those are eqipment such as laryngeal mask, or laryngoscope and endotracheal tube. Shafer had described it a a serious deviation originally but changed his mind to en egregious because of the setting. CM had no help.
Shafer says that it's his view that CM had anticipated to give 100 ml vials. CM had purchased at least 130 100 ml vials, Shafer believes that's at least one per night. Shafer says it's an extraordinary amount for one patient; between april – to 25th june, that 80 nights, 1937 mg/night. Walgren asks how he came to this determination. Shafer says Propofol is an environment for bacteria dveelopment. Once a bottle is opened with a needle, it has to be used within 6 hours. Shafer says this suggests CM planned to use 100ml, if he didn't he would purchase smaller vials.
Lack of suction apparatus, egregious violation. Shafer reminds the jury that any stomach content and/or vomit has to be suctioned so that it won't go into the lungs. Shafer says there's no evidence that MJ was asked to fast for 8 hours prior being given Propofol. Due to this MJ was at greatly higher risk. Therefore a suction equipment was needed.
Lack of infusion pump, egregious violation . There was no infusion pump. Without it the rate can not be precisely controled and the risk of overdose is very high. Shafer says in his opinion this is likely contributed to MJ's death.
Walgren asks without an infusion pump how can one person control the drip. Shafer answers by roller clamp. It's a plastic wheel that pinches the tubing to decrease the amount . Shafer says it's extremely imprecise and that was the only thing available to CM when he gave propofol.
Lack of pulse oximetry, egregious violation . The pulse oxieter that CM used was completely inappropriate. It's not intended to be used for continuous care as it had no alarm. Shafer says that on monitors in hospital they can see it on the screen and there is a tone. Doctors will hear the tone changes which alerts them that there's a problem. In MJ's case only way to monitor was to take his hand and continoiusly look to it. If there was a proper equipment, there would be a monitor showing the vital signs from distance and there would be an alarm that could have saved MJ's life.
Lack of blood pressure cuff,egregious violation. Propofol lowers everyone's blood pressure. Doctors would treat it with additional saline solution or with less propofol. MJ was dehydrated, the risk are higher for exagerated response. If blood pressure falls the body shuts down the flow to the arms and legs and concentrates on providing blood to heart and the brain. The drug becomes more potent. Dr. Shafer says the manual blood pressure cuff that CM had in his bag in the cabinet is useless.
Lack of ECG, egregious violation . ECG allows you te see he heart rate, the heart rythm. This is routine monitoring. In this case CM couldn't know what kind of therapy to use when MJ went into arrest.
Lack of capnography, an egregious violation. Dr. Shafer initially thought that it was not a violation as other specialist doesn't use it. However in MJ's environment it was a disaster. If CM had it he would have known immediately that MJ had stopped breathing.
Lack of emergency drugs, serious violation. Dr. Shafer doesn't think lack of emergency drugs contributed to MJ's death. Shafer says if MJ had a low blood pressure as he wasn't going through surgery, MJ could have been woken up and hydration and stopping propofol would have been enough.
Lack of charts, egregious violation as well as unethical. Shafer says a doctor needs charts to asses what's going on and the changes. Shafer says the patient or if the patient doesn't survive the family has a right to know what happened and what the doctor did.
Dr. Shafer gives an example and Dr. Shafer looks clearly upset. Dr. Shafer says he knows how he would feel if his father , brother or son went to a medical facility for 80 days and died and the doctors told him they don't know what happened because they have no reports. Dr.Shafer says it's unbelieveable that after 80 days of treatment there's not a single record of treatment. Dr.Shafer says that not keeping records is also illegal in California. Dr. Shafer says that doctors has to keep records even if the patient doesn't want them and confidentiality cannot be an excuse.
Shafer says that in CM's interview he mentioned MJ could have been dependent on Propofol and that would require a referral but he can't do that referral as he had no records.
Obligation to get information about the patient. Shafer says it's doctors responsability to know everything about their patient to provide care. Shafer says CM mentions IV sites but didn't follow it through and asked what's happening. Walgren asks what if the patient says it's none of your business, Shafer says that then he would say "Then I can not be your doctor".
Dr. Shafer the only physical evidence of Michael was done months ago. Shafer says CM mentioning MJ being dehydrated but yet he do a simple blood pressure check. Shafer says there's no history, not even a simple recording of the vital signs. Shafer calls this serious violation and that no doctor does that.
Failure to maintain a doctor patient relationship , egregious violation. In this relationship doctor would put the patient first. It doesn't meean to do what the patient asks, it's to do what's best for patient. If patient asks for something foolish or dangerous, doctor should have said no. Dr. Shafer describes the relation between Cm and MJ as employer employee relationship. Patient stated what he wanted, CM says yes. Shafer compares CM to a housekeeper that does what she's told. That's what an employee does. Shafer says CM was not exercising his medical judgement and he was not acting in MJ's best interest. CM completely abandonned medical judgement.Shafer says the very first time MJ asked for propofol, CM should have sent MJ to a sleep specialist.
Lack of Inormed consent , egregious and unconscinable. An informed consent would have involved that propofol is not a treatment for insomnia, It woud have explained risk of death and alternative treatments. Dr. Shafer says there's no proof that MJ knew that he was putting his life at risk. Shafer again mentions that the consent has to be written. MJ was denied his right o make an informed decision.
Need to continuously observe the mental satus, egregious and unconscinable. Dr. Shafer says that doctors need to stay with the patient and CM abadonned his patient. Shafer compares giving sedation to driving a motor home. Shafer says you cannot leave the steering wheel on a highway to relieve yourself. If you do it would be an disaster. Dr. Shafer says in 25 years he has been a physician he have never walked out of the room.
Continious monitoring / observation, egregious violation . CM left MJ alone and he was on the phone. Shafer says youcan't multi task especially if you have no monitoring equipment. Dr. Shafer a patient who is about to die, doesn't look that different from a patient that is okay. Dr. Shafer says from a distance you can't tell if a person is breathing. Shafer says he believes Murray may have been in the room and have not realised MJ stopped breathing.
Shafer says resuciation would have been easy as all needed is to stop propofol and make MJ beathe. Shafer once ahain reminds that it's common that patients would stop breathing during anesthesia and it's expected. Shafer says all CM was monitoring all he needed to do was to lift the chin and ventilate.
mid afternoon break
Lack of continuous documentions, egregius and unconscionable violation. Dr. Shafer says documentation is part of giving care. Shafer says if CM had the reports he would have seen that the oxygen saturation lowered or the heart rythm changed.
Failure to call 911 timely, egregious violation. Shafer says in that setting MJ could not have been revived without assistance. Shafer says calling 911 was the highest priority given the lack of help and equipment. Shafer says if calling 911 was not possible, Propofol should not been given at all.
Shafer says assuming CM realised there was a problem at 12:00 he doesn't understand that CM left a voice message to MAW and how it took 20 mn to call 911. Shafer calls it unconceivable and completely and utterly inexcusable.
Shafer says if CM left only for 2 minutes and called paramedics immediately MJ would be alive with some brain damage. If CM realized MJ was in trouble in 2 minutes and had the airway equipment MJ would be alive and uninjured.
Walgren asks how effective is a one handed CPR on a bed. Shafer says the patient sinks into the bed and it's ineffective. Even if CM had his hand behind Mj's back it's ineffective because you need your body weight to do effective CPR. Shafer says you need 2 hands, one hand is not enough. Shafer says CM hould have called 911 first and then moved Mj to the floor. Shafer also says based on CM's interview the issue here was not that the heart stopped; MJe stopped breathing. CM said there was pulse. If there was a pulse what he needed to do was to have oxygen into his lungs. There was no need for CPR if there was a pulse. Shafer says a lay person would use mouth to mouth as they have no other means. For a doctor it shows that the doctor doesn't have equipment needed.
Shafer says that he doesn't understand why CM raised MJ's legs. Shafer calls it a waste of time. Shafer says raising the legs is done when you thing there's not enough blood in the heart but that wasn't MJ's problem. His breathing had stopped. Shafer says that it shows CM was clueless about what to do.
Walgren asks what is flumazenil. Shafer explains it's a frug that reverses the effects of lorazepam and midazolam. Dr. Shafer says he's curious why CM gave it. Shafer says it doesn't fit with only giving 2 doses of 2 mg several hours before. Dr. Shafer says he believes that CM knew that there was a lot more lorazepam.
Dr. Shafer talks about deception of paramedics and UCLA doctors and not mentionning propofol, egregious and unconscionable violation. Dr. Shafer says a person's life was in the balance, it's inexcusable. Shafer says he also mischaracterized this event as a witnessed arrest. Shafer says a witnessed arrest is not an arrest for lack of breathing, it is usually something like a heart attack. So the therapy of the paramedics and ER doctors was not appropriate. In an arrest you have only seconds to choose a treatment, paramedics and ER doctors were not given the corect information. Shafer says witholding information is a violation of patient's trust.
Walgren asks what is polypharmacy. Shafer explains it's administering many drugs at once and it's a serious violation. Shafer says what CM gave to MJ didn't make any sense. Shafer says Midazolam and lorazepam are very similar drugs and the only difference is how long they stay in the system. Shafer says he doesn't understand why CM switched from midazolam to lorazepam and back. Shafer says that he thinks that CM did not understand the drugs he was giving.
Walgren asks if 25mg Propofol is a safe dose. Shafer says in this setting there was no safe dose. Midazolam an lorazepam were given. MJ had received benzos for 80 nights, he could have been dependant or in withdrawal from the benzos or propofol. Dr. Shafer says he never heard a person given propofol for 80 nights and doesn't know what would happen.
Walgren asks about the Taiwan study. Shafer says there are over 13000 medical articles about propofol, 2500 articles about propofol and sedation and there's only one article on Propofol and insomnia. It's this study done in 2010. Dr. Shafer says that he wouldn't published the Taiwan study because the dose of Propofol that was given is not mentioned. Dr. Shafer also says that the conditions of the study doesn't apply here. That study was done in a hospital, by anesthesiolgists, patients had fasted for 8 hours, they were monitored, an infusion pump was used, propofol was used for 2 hours for 5 days during two weeks. There was no other medication. The patients were treated within the standard of care. Shafer says the article actually highlights CMs deviations from standard of care.
Walgren asks even if MJ had taken Lorazepam and/or Propofol would these 17 deviations would still be relevant and if Shafer would consider CM responsible for MJ's death. Dr. Shafer answers yes.
Walgren asks about doctor patient relationship. Dr. Shafer says it's dated back centuries ago. Dr. Shafer says that doctors have power to give drugs and cut open a patient etc and this is because they are entrusted to do that because they are supposed put the patient first. Dr. Shafer reads hippocratic oath. Shafer says when Cm agreed to give propofol to MJ, he put CM first. When CM was showing up every night with propofol and saline bags, he was putting CM first. When Cm withheld info from paramedics and ER doctors, he put CM first.
Walgren Direct continued
Walgren goes over again the credentials of Dr. Shafer by showing the journal he's editor in chief and multiple research articles written by Dr. Shafer. Research articles examine the differences in regards to gender, age. Dr. Shafer also had research done on Lorazepam, Midazolam and Lidocaine. DA Walgren says that he will ask about these topics during testimony.
Walgren mentions difference between intensive care sedation and procedure related sedation (MAC). Dr. Shafer tells that intensive care sedation would be for longer time, MAC would be shorter.
Dr. shafer says that all the work he has done on this case was for free. He says he never charged money for testimony because he feels it's inappropriate and unethical to benefit from medical misadventures. Shafer says he doesn't want his integrity to be questionned as well Shafer also says he wanted to get involved in this case to restore general public's confidence in anesthesia and doctors. Dr. Shafer says that he's asked daily by his patients " Are you going to give me that drug that killed Michael Jackson?". He says that he hopes to alleviate this unneeded fear with his testimony.
mid morning break
Dr. Shafer has brought several medical items for demonstration. First he starts with explaining Saline bag and it's ports. Later Shafer tells what and IV is. Infusion(Drip) when drug drips in slowly. Shafer explains that Propofol comes in a glass vial, there's an aliminium seal and a rubber stopper on top. To get the drug out you need to go through with a slow needle or a large spike to get the drug out.
Walgren asks Shafer to demonstrate to get Propofol out of the bottle.
Shafer demonstrates to get out Propofol with a syringe / needle. Shafer tells to get Propofol out you need to replace Propofol with air so that Propofol will go into the needle.
Walgren asks Dr. Shafer to examine 100 ml Propofol bottle from the scene. Shaffer says that it has a spike hole and not a needle hole.
Dr Shafer has made a video for his case, to demonstrate what is necessary for sedation, even for 25mg propofol. Playing the video : «*an over view of safe administration of sedation*»
The doctor first prepares the room, checks the equipment. Video shows multiple equipment for airway management such a tube for the throat, a tube for the nose, an equipment for intibation, a throat mask for air. Organizes these items.
Then the doctor checks the oxygen equipment. Doctor checks if the oxygen supply work, checks nasal cannula, checks to see if nasal cannula is measuring carbon dioxide by capnometer. Doctor tests anesthesia breathing circuit. This is the equipment used if the patient stops breathing and the doctor needs to push oxygen into the lungs. Doctor then checks the back up oxygen. This is used if for some reason the breathing circuit fails.
Doctor then checks suction apparatus. This is important because if the contents of the stomach gets into the lungs or if the vomit (bile) gets into the lung, it would destroy the lungs. This is why patients are told to not to eat or drink prior to anesthesia. if the patient vomits or the contents of the stomach come to the mouth, the doctor has to be very quick to clean them with the suction equipment before it goes into the lungs and destroys the lungs.
Next step is to set up the infusion pump. It takes a few minutes to set it up. In the video they use a syringe pump. Doctor first draws Propofol into the syringe. As Dr. Shafer demonstrated this is not easy. You need to draw air into the syringe and do multiple draws to fill the syringe. Dr. Shafer tells a narrow tubing has to be used in the infusion pump as the wide tubing could be problematic. Then the doctor programs the pump, putting the patients weight, correct drug name, infusion rate. Doctor verifies the information for a second time.
Next step is to assess the patient. Anesthesiologist is repsonsible for knowing his patient. Makes a physical examination, first thing is airway, listens to the lungs, checks the heart. Always done for each procedure, for every patient. No exception.
Doctor also gets the informed consent of the patient. Doctor informs the patient of risks and explains what the procedure entails, asks the patient if he has any questions, then patient signs the informed consent form. Dr. Shafer says oral consent is not binding, and is not recognized.
Some steps are not shown on the video. These are: patient put on table, monitoring equipment such as blood pressure cuff, pulse oximeter, ECG are put on patient. Oxygen in place, intravenous catheter is put into the patient. Afther these doctor pauses to verify again. Doctor does one last check before injecting the propofol.
Propofol infusion pump is started. Anesthesiologist is close to the patient, monitors the patient. Doctor keeps records of the vitals. Chart is a necessity to track the patient and the patterns. It's a responsibility to the patient.
In this part of the video, we are shown examples of what can go wrong.
First example is when blood pressure drops. Dr. Shafer says this is very common and they see it everyday. Propofol lowers blood pressure especially if the patient is dehydrates. Doctor gives ephedrine through the IV line. Generally blood pressure comes to normal levels.
Second example is carbon dioxide. The monitor shows that carbon dioxide stopped. It means the patient is not exhaling and the airway is obstructed. Doctor immediately does chin lift and jaw thrust. Dr. Shafer this is also done very routinely. Shafer says the most common reason is because the tongue is blocking the airway and by doing a chin lift and jaw thrust you can move the tongue.
Third example is apnea. This is when the patient doesn't even try to breath. In this instance you need to take over for the patient and force air into the lungs. Doctor removes the nasal cannula, places the mask on the patient's mouth and nose and squeeze the bag to push oxygen into the lungs.
Fourth example is aspiration (not shown on video). This is when the patient vomits and/or stomach contents come to the mouth. Patient is turned sideways and before the next breath you need to suction everything.
Fifth example is cardiac arrest. Heart stops beathing and the patient stops breathing. Doctor does a 2-3 second assesment to make sure that the monitor has not failed. Then the doctor calls for help. First thing is always to call for help. One person begins CPR, one person is ventilating the patient and other person gives resuscitation drugs. Alls of this is done to keep the patient alive for enough time to fix the problem that caused the arrest. These efforts are continued until the patient is revived, or is pronouced dead.
Lunch break
Afternoon session
Dr. Shafer Testimony continued
Walgren Direct continued
Dr. Shafer says that the safeguards and requirements apply to all doctors who perform sedation, for any type of IV sedatives. Some nurses are also trained about sedation. These guidelines apply to them as well.
Walgren asks if CM's intent were to give 25mg would these standards still apply. Shafer says yes and continues to say the patient (MJ) had other IV sedatives, profound inability to sleep, he was exhausted, dehydrated; and he had been given sedatives for some time and he could have saome elements of dependency or withdrawal.
Walgren asks if it possible to go in saying I'll only give a small amount so I don't need these guidelines. Dr. Shafer says it's a trap. Even for a little sedation , it's a slippery slope, you may have to give more. You never know how the patient will react. Shafer says there's no such thing as a little sedation and the worst disasters happen when people cut corners.
Facts in this case suggest that virtually none of the safeguards for sedation were in place when propofol was administered to MJ.
Walgren asks Shafer explain how patients reacts different to the same dose of sedatives. Shafer says that some patients will need half the usual dose and some patients will need double the dose. Shafer says 25 mg is the limit when a patient migh stop breathing. Shafer says you can't assume that this will be an average patient. Shafer says you always assume your patient is at the edge of sensitivity and prepare for the worst case scenario.
Shafer did a report about this case dated April 15th, 2011. In his report he used some terms.
Minor violation : not consistent with standard of care, but would not expect to cause harm for the patient unless there are several other violations
Serious violation : expected to cause harm to the patient, in combination of other violations
Egregious violation : These should never happen in the hand of comptent doctors. An egeregious violation can alone be catastrophic for the patient. Competent doctors know that bad outcome is a high possibility
Unconscionable vioation : It goes beyond the standard of care. It's an ethical and moral violation as well as a medical violation.
Walgren goes over Dr. Shafer's report and 17 egregious violations he identified.
Lack of basic airway equipment, egregious violation. MJ died because he stopped breathing which is expected when you give IV sedatives. It must be there without question.
Walgren asks Dr. Shafer assume that CM had left only for 2 minutes and CM had the equipment if MJ could have been saved? Dr. Shafer says yes and probably MJ had an obstructed airway and even a simple chin lift might have been required to save MJ. Shafer says that CM says he didn't use the ambu bag. Shafer says mouth to mouth is less effective and gives used air.
Lack of advanced airway equipment. Those are eqipment such as laryngeal mask, or laryngoscope and endotracheal tube. Shafer had described it a a serious deviation originally but changed his mind to en egregious because of the setting. CM had no help.
Shafer says that it's his view that CM had anticipated to give 100 ml vials. CM had purchased at least 130 100 ml vials, Shafer believes that's at least one per night. Shafer says it's an extraordinary amount for one patient; between april – to 25th june, that 80 nights, 1937 mg/night. Walgren asks how he came to this determination. Shafer says Propofol is an environment for bacteria dveelopment. Once a bottle is opened with a needle, it has to be used within 6 hours. Shafer says this suggests CM planned to use 100ml, if he didn't he would purchase smaller vials.
Lack of suction apparatus, egregious violation. Shafer reminds the jury that any stomach content and/or vomit has to be suctioned so that it won't go into the lungs. Shafer says there's no evidence that MJ was asked to fast for 8 hours prior being given Propofol. Due to this MJ was at greatly higher risk. Therefore a suction equipment was needed.
Lack of infusion pump, egregious violation . There was no infusion pump. Without it the rate can not be precisely controled and the risk of overdose is very high. Shafer says in his opinion this is likely contributed to MJ's death.
Walgren asks without an infusion pump how can one person control the drip. Shafer answers by roller clamp. It's a plastic wheel that pinches the tubing to decrease the amount . Shafer says it's extremely imprecise and that was the only thing available to CM when he gave propofol.
Lack of pulse oximetry, egregious violation . The pulse oxieter that CM used was completely inappropriate. It's not intended to be used for continuous care as it had no alarm. Shafer says that on monitors in hospital they can see it on the screen and there is a tone. Doctors will hear the tone changes which alerts them that there's a problem. In MJ's case only way to monitor was to take his hand and continoiusly look to it. If there was a proper equipment, there would be a monitor showing the vital signs from distance and there would be an alarm that could have saved MJ's life.
Lack of blood pressure cuff,egregious violation. Propofol lowers everyone's blood pressure. Doctors would treat it with additional saline solution or with less propofol. MJ was dehydrated, the risk are higher for exagerated response. If blood pressure falls the body shuts down the flow to the arms and legs and concentrates on providing blood to heart and the brain. The drug becomes more potent. Dr. Shafer says the manual blood pressure cuff that CM had in his bag in the cabinet is useless.
Lack of ECG, egregious violation . ECG allows you te see he heart rate, the heart rythm. This is routine monitoring. In this case CM couldn't know what kind of therapy to use when MJ went into arrest.
Lack of capnography, an egregious violation. Dr. Shafer initially thought that it was not a violation as other specialist doesn't use it. However in MJ's environment it was a disaster. If CM had it he would have known immediately that MJ had stopped breathing.
Lack of emergency drugs, serious violation. Dr. Shafer doesn't think lack of emergency drugs contributed to MJ's death. Shafer says if MJ had a low blood pressure as he wasn't going through surgery, MJ could have been woken up and hydration and stopping propofol would have been enough.
Lack of charts, egregious violation as well as unethical. Shafer says a doctor needs charts to asses what's going on and the changes. Shafer says the patient or if the patient doesn't survive the family has a right to know what happened and what the doctor did.
Dr. Shafer gives an example and Dr. Shafer looks clearly upset. Dr. Shafer says he knows how he would feel if his father , brother or son went to a medical facility for 80 days and died and the doctors told him they don't know what happened because they have no reports. Dr.Shafer says it's unbelieveable that after 80 days of treatment there's not a single record of treatment. Dr.Shafer says that not keeping records is also illegal in California. Dr. Shafer says that doctors has to keep records even if the patient doesn't want them and confidentiality cannot be an excuse.
Shafer says that in CM's interview he mentioned MJ could have been dependent on Propofol and that would require a referral but he can't do that referral as he had no records.
Obligation to get information about the patient. Shafer says it's doctors responsability to know everything about their patient to provide care. Shafer says CM mentions IV sites but didn't follow it through and asked what's happening. Walgren asks what if the patient says it's none of your business, Shafer says that then he would say "Then I can not be your doctor".
Dr. Shafer the only physical evidence of Michael was done months ago. Shafer says CM mentioning MJ being dehydrated but yet he do a simple blood pressure check. Shafer says there's no history, not even a simple recording of the vital signs. Shafer calls this serious violation and that no doctor does that.
Failure to maintain a doctor patient relationship , egregious violation. In this relationship doctor would put the patient first. It doesn't meean to do what the patient asks, it's to do what's best for patient. If patient asks for something foolish or dangerous, doctor should have said no. Dr. Shafer describes the relation between Cm and MJ as employer employee relationship. Patient stated what he wanted, CM says yes. Shafer compares CM to a housekeeper that does what she's told. That's what an employee does. Shafer says CM was not exercising his medical judgement and he was not acting in MJ's best interest. CM completely abandonned medical judgement.Shafer says the very first time MJ asked for propofol, CM should have sent MJ to a sleep specialist.
Lack of Inormed consent , egregious and unconscinable. An informed consent would have involved that propofol is not a treatment for insomnia, It woud have explained risk of death and alternative treatments. Dr. Shafer says there's no proof that MJ knew that he was putting his life at risk. Shafer again mentions that the consent has to be written. MJ was denied his right o make an informed decision.
Need to continuously observe the mental satus, egregious and unconscinable. Dr. Shafer says that doctors need to stay with the patient and CM abadonned his patient. Shafer compares giving sedation to driving a motor home. Shafer says you cannot leave the steering wheel on a highway to relieve yourself. If you do it would be an disaster. Dr. Shafer says in 25 years he has been a physician he have never walked out of the room.
Continious monitoring / observation, egregious violation . CM left MJ alone and he was on the phone. Shafer says youcan't multi task especially if you have no monitoring equipment. Dr. Shafer a patient who is about to die, doesn't look that different from a patient that is okay. Dr. Shafer says from a distance you can't tell if a person is breathing. Shafer says he believes Murray may have been in the room and have not realised MJ stopped breathing.
Shafer says resuciation would have been easy as all needed is to stop propofol and make MJ beathe. Shafer once ahain reminds that it's common that patients would stop breathing during anesthesia and it's expected. Shafer says all CM was monitoring all he needed to do was to lift the chin and ventilate.
mid afternoon break
Lack of continuous documentions, egregius and unconscionable violation. Dr. Shafer says documentation is part of giving care. Shafer says if CM had the reports he would have seen that the oxygen saturation lowered or the heart rythm changed.
Failure to call 911 timely, egregious violation. Shafer says in that setting MJ could not have been revived without assistance. Shafer says calling 911 was the highest priority given the lack of help and equipment. Shafer says if calling 911 was not possible, Propofol should not been given at all.
Shafer says assuming CM realised there was a problem at 12:00 he doesn't understand that CM left a voice message to MAW and how it took 20 mn to call 911. Shafer calls it unconceivable and completely and utterly inexcusable.
Shafer says if CM left only for 2 minutes and called paramedics immediately MJ would be alive with some brain damage. If CM realized MJ was in trouble in 2 minutes and had the airway equipment MJ would be alive and uninjured.
Walgren asks how effective is a one handed CPR on a bed. Shafer says the patient sinks into the bed and it's ineffective. Even if CM had his hand behind Mj's back it's ineffective because you need your body weight to do effective CPR. Shafer says you need 2 hands, one hand is not enough. Shafer says CM hould have called 911 first and then moved Mj to the floor. Shafer also says based on CM's interview the issue here was not that the heart stopped; MJe stopped breathing. CM said there was pulse. If there was a pulse what he needed to do was to have oxygen into his lungs. There was no need for CPR if there was a pulse. Shafer says a lay person would use mouth to mouth as they have no other means. For a doctor it shows that the doctor doesn't have equipment needed.
Shafer says that he doesn't understand why CM raised MJ's legs. Shafer calls it a waste of time. Shafer says raising the legs is done when you thing there's not enough blood in the heart but that wasn't MJ's problem. His breathing had stopped. Shafer says that it shows CM was clueless about what to do.
Walgren asks what is flumazenil. Shafer explains it's a frug that reverses the effects of lorazepam and midazolam. Dr. Shafer says he's curious why CM gave it. Shafer says it doesn't fit with only giving 2 doses of 2 mg several hours before. Dr. Shafer says he believes that CM knew that there was a lot more lorazepam.
Dr. Shafer talks about deception of paramedics and UCLA doctors and not mentionning propofol, egregious and unconscionable violation. Dr. Shafer says a person's life was in the balance, it's inexcusable. Shafer says he also mischaracterized this event as a witnessed arrest. Shafer says a witnessed arrest is not an arrest for lack of breathing, it is usually something like a heart attack. So the therapy of the paramedics and ER doctors was not appropriate. In an arrest you have only seconds to choose a treatment, paramedics and ER doctors were not given the corect information. Shafer says witholding information is a violation of patient's trust.
Walgren asks what is polypharmacy. Shafer explains it's administering many drugs at once and it's a serious violation. Shafer says what CM gave to MJ didn't make any sense. Shafer says Midazolam and lorazepam are very similar drugs and the only difference is how long they stay in the system. Shafer says he doesn't understand why CM switched from midazolam to lorazepam and back. Shafer says that he thinks that CM did not understand the drugs he was giving.
Walgren asks if 25mg Propofol is a safe dose. Shafer says in this setting there was no safe dose. Midazolam an lorazepam were given. MJ had received benzos for 80 nights, he could have been dependant or in withdrawal from the benzos or propofol. Dr. Shafer says he never heard a person given propofol for 80 nights and doesn't know what would happen.
Walgren asks about the Taiwan study. Shafer says there are over 13000 medical articles about propofol, 2500 articles about propofol and sedation and there's only one article on Propofol and insomnia. It's this study done in 2010. Dr. Shafer says that he wouldn't published the Taiwan study because the dose of Propofol that was given is not mentioned. Dr. Shafer also says that the conditions of the study doesn't apply here. That study was done in a hospital, by anesthesiolgists, patients had fasted for 8 hours, they were monitored, an infusion pump was used, propofol was used for 2 hours for 5 days during two weeks. There was no other medication. The patients were treated within the standard of care. Shafer says the article actually highlights CMs deviations from standard of care.
Walgren asks even if MJ had taken Lorazepam and/or Propofol would these 17 deviations would still be relevant and if Shafer would consider CM responsible for MJ's death. Dr. Shafer answers yes.
Walgren asks about doctor patient relationship. Dr. Shafer says it's dated back centuries ago. Dr. Shafer says that doctors have power to give drugs and cut open a patient etc and this is because they are entrusted to do that because they are supposed put the patient first. Dr. Shafer reads hippocratic oath. Shafer says when Cm agreed to give propofol to MJ, he put CM first. When CM was showing up every night with propofol and saline bags, he was putting CM first. When Cm withheld info from paramedics and ER doctors, he put CM first.
