Medical Malpractice News and Views

Welcome to our blog where we discuss current issues in medicine and law. We welcome your comments.

Defective Surgical Staplers And The FDA.

November 02, 2020

The surgical stapler is an important tool.  Rather than spend substantial time sewing body parts together during abdominal, thoracic or bowel surgeries, surgeons can use a stapler to close up wounds and attach body parts.  Removable staples are also used to pull together scalp wounds or other skin wounds under tension.  On the other hand, if the stapler malfunctions, it can cause grave damage to the patient up to and including death.

ETHICON Surgical Staplers | ECHELON > A better way to staple

For many, many years the Food and Drug Administration (FDA) has maintained a public database of reports of problems with medical devices.  The database is called Manufacturer and User Facility Device Experience (MAUDE).  Manufacturers, importers and device-using facilities are required to report device malfunctions to the FDA.  Physicians and others can make voluntary reports and are encouraged to do so.  The MAUDE database is a vital tool for hospitals, physicians, manufacturers and regulators in their efforts to ensure that the devices they use are safe and to identify and fix problems.  Patients who are injured by a device can see if it is an isolated incident or part of a larger problem.

Until recently, the system was thought to work well.  Specifically with regard to surgical staplers, there were few reports of malfunctions and the devices were thought to be safe.  However, some surgeons were experiencing problems with staplers.  Sometimes they would jam and not work at all.  If a patient had an open wound that was actively bleeding, the failure of the stapler to work might cause the patient to bleed to death.  Some other surgeons experienced a different problem with staplers; they fired on their own.  Sometimes this caused significant injury to the patient, including death and brain damage.

When these surgeons reported the problems to the FDA and examined the MAUDE database for stapler complaints, they were surprised to see very few.  Some of the surgeons began asking questions of their colleagues and found that many of them were having similar stapler problems.  Stapler problems were actually quite widespread.  What was going on?  Why were significant stapler malfunctions not recorded in the MAUDE database.

After a lengthy investigation by Kaiser Health News, it was discovered that the FDA for almost 20 years had been granting secret reporting exemptions to manufacturers who requested them.  These exemptions allowed the manufacturers to have their malfunction reports go into an “alternative summary reporting” database, which was not available to the public or to the medical profession.  It made their products look far safer than they were and prevented the public and the medical profession from demanding safety changes, where they were needed.

The number of devices covered by the alternative reporting system was large.  There were thousands of  them.  The number of secret reports was therefore also large.  Since 2016, over a million reports were made to the secret database.  In 2017 alone, there were 480,000 reports of patient injuries or device malfunctions that were hidden from public view.

In 2016, for example, there were only 84 public reports of stapler malfunctions or patient injuries made to the public MAUDE database.  In the same year, there were nearly 10,000 malfunction reports made to the secret database.  This is a scandal and an outrage.  The FDA has since mostly ended the special exemption program and publicly-available device malfunction reports have soared.

According to the FDA, the exemption program began innocently enough as a way of reducing duplicative reports of malfunctions which were overwhelming staff at the FDA.  The program required manufacturers to continue to publicly report deaths but other injuries could be reported in a spreadsheet format on a quarterly basis.  The public and the medical profession were never told about this alternative reporting database.

Although the FDA has ended the program for most devices, it refuses to identify the 100 or so devices that were granted the special exemption.  Apparently, the alternative reporting program remains in place for pacemaker electrodes and implantable defibrillators.

Although some progress has been made, there is lots of room for improvement of the FDA’s management of device safety.  I have blogged on a number of occasions about problems with reusable endoscopes and the FDA’s changing guidance.  Medical devices are becoming more complicated and more important to patient care.  We need to demand more transparency on the part of the FDA and greater Congressional oversight to make sure this important task is given the priority and resources it deserves.



Posted in disclosure of medical mistakes, Doctors, health, Hospitals, Medical Devices, medical mistakes, medical research, Secrecy |

“Time Is Brain.”

October 26, 2020

“Time is brain” is what neurologists and neurosurgeons say to emphasize the importance of seeking prompt treatment in the event of a stroke.

There are two types of strokes and they can both be terrible.  The first type is the hemorrhagic stroke.

Surgery for Hemorrhagic Stroke vs. Ischemic Stroke: What Options Exist?

As its name implies, it occurs when a blood vessel in the brain begins to bleed.  Sometimes, the bleed can be small but, at other times, it can be a full-on hemorrhage.  Blood is very irritating to the tissue of the brain.  Its presence can damage the brain and prevent it from functioning properly.  It can cause other vessels in the brain to go into spasm.  It can cause the brain to swell and can increase pressures inside the skull.

What the doctors do in response to a hemorrhagic stroke depends on the size of the bleed and the degree to which pressures rise inside the skull.  If the bleed is small enough, doctors may just wait and watch to see if the bleed stops on its own.  If it does, no invasive brain surgery is necessary.  On the other hand, if the bleed is larger, it may cause dangerous rises in pressure.  Most of the management of a hemorrhagic stroke is devoted to monitoring and managing pressures inside the brain.

The second type of stroke is called an ischemic stroke.

Neurology expert witness discusses ischemic stroke and emergency room  treatment

Ischemia means not enough oxygen is reaching the tissue.  In the case of an ischemic stroke, it occurs because a blood clot has completely or partially blocked an artery in the brain.  As with the hemorrhagic stroke, the part of the brain downstream from the clot does not get enough oxygen and can die as a result.

Doctors treating a patient who is experiencing an ischemic stroke can administer drugs called “clot busters” that can break up the blood clot and restore the flow of blood to the brain.

The sooner the stoke patient arrives at the hospital, the sooner he or she can be evaluated to determine the type of stroke which is present.  The last thing the doctors want to do is administer clot busting drugs to a patient having a hemorrhagic stroke.  Clot busters work by reducing the body’s ability to form blood clots.  If anything, clot busters would make a ruptured artery bleed more freely.

The sooner the doctors can identify an ischemic stroke, the sooner they can determine if the patient is a candidate for clot busting drugs.  The longer the time before the patient arrives at the hospital following the onset of an ischemic stroke, the more likely it is that the brain tissue, which has been deprived of oxygen, will die.  At the present time, patients with ischemic strokes are recommended to receive clot busters only within three hours of onset of the stroke.  While some doctors may give clot busters even after three hours, the chances for successful restoration of brain function are greatly reduced.  At four or five hours, most doctors won’t even try clot busters.

No matter the type of stroke a patient might experience, it is critical to get to the hospital as soon as possible.  Some of the symptoms of stroke are sudden weakness, paralysis of a limb or weakness on one side of the body, inability to speak, drooping of the mouth or eye, difficulty walking, nausea and vomiting, a sudden “thunderclap” headache, confusion, and inability to look at bright light.  If you have any of these symptoms or if you see them in a friend or loved one, call 911 immediately.

“Time is brain.”  The sooner a stroke patient is evaluated and treated, the better the quality of the recovery.

Posted in Blood Clots, Doctors, health, Hospitals, Stroke |

Hospital Greed in the Era of Covid.

October 22, 2020

It is late May 2020 in the Imperial Valley of California.  The sun is high and hot.  Temperatures exceed 110 degrees.  The Novel Coronavirus is also running hot.  The only two hospitals in the entire Imperial Valley are swamped with sick Covid patients.  They have more patients than they can possibly treat.  They need to find hospitals that can take some of their patients.  When they call other Southern California hospitals, they find some are more interested in making sure they get paid than they are in helping out in a time of need.

Greed - Wikipedia                                   1909 Painting, “The Worship of Mammon.”

The Imperial Valley is located in the desert between Yuma and San Diego.  It is an area of intense agriculture.  It is also a very poor area.  Nearly a quarter of the population is below the poverty line.  Most of its residents are of Hispanic descent and work in the fields or elsewhere in agriculture.  Many of the residents are uninsured or, if they are insured, are on Medicaid or Medicare.

The magnitude of the problem facing the hospitals was significant.  The two hospitals were forced to transfer 250 patients over a two week period when things were the worst.

There were at least four hospitals that either outright refused patients from the Imperial Valley or refused them until they were guaranteed that someone would pay for the care of any patients they accepted.  Each of the four was a non-profit entity that operates on a tax free basis.  If you thought that non-profit hospitals, which get their tax free treatment in return for promising to serve the public good, really lived up to their promise, good luck with that.

The hospitals were taking advantage of some loopholes and gray areas in the federal and state laws that require hospitals to provide care to emergency patients regardless of their insurance status.  The care must be provided until the patient is stabilized.  The refusing hospitals took the position that the Imperial Valley patients had been stabilized and that they therefore had no legal obligation to accept them.

While there may be some dispute over the requirements of federal law, there is little doubt that the refusals were a breach of medical ethics.  The Imperial Valley hospitals were overrun and could not provide the care that was needed by the patients arriving at their emergency rooms.  The refusing hospitals had capacity and the ability to provide the needed care.  They should have been willing to accept some of the patients.

When they could not find hospitals willing to accept their patients, the Imperial Valley hospitals did the best they could.  In some cases, they just kept calling till they found a hospital willing to accept a patient.  In some cases, the state of California stepped in and promised to pay for the carer of uninsured patients.  In some cases, the patients were placed in hallways or anywhere the hospital could find space while the search for a hospital that would accept them went on or until room could be made for them.  In some cases, patients who were deemed least sick were sent to an alternative-care site set up at a local community college, where they received limited treatment.  According to news stories about the transfer problems, some patients suffered lung damage and other complications as a result of the delays in getting them transferred out of the overwhelmed hospitals.

Healthcare is a big business.  Hospital chains keep getting larger and acquiring more power.  If you can’t pay, you may not get the care you need.  Don’t be fooled by hospitals trumpeting their non-profit status and asking you to donate money to them or give them some kind of a legal break.  The truth is often a lot uglier than they wish to admit.

Posted in Fee for Service, health, Health Care Costs, Hospitals, Medical Costs, medical ethics, Medicare, Rationing |

Lots of Malpractice Out There.

October 19, 2020

I have spoken to or reviewed records for thousands of patients over the years I have been representing people injured by medical malpractice.  I have also read a lot of articles about the incidence of medical malpractice.  I can say with confidence that in any hospital stay of three days or more, the patient will be the victim of at least one instance of medical malpractice.  Fortunately, most of these instances will cause little harm but the fact of that much malpractice should be of concern to all of us.

Consider change to Guam's medical malpractice law

It is not hard to understand why there is so much malpractice in hospitals.  They are large, complex institutions with many employees performing complicated tasks.  There is a lot of truth to the old adage, “Too many cooks spoil the broth.”  This applies to hospitals as there are lots and lots of cooks helping to care for a patient.

By way of example, I have a friend who is quite sophisticated about malpractice issues as he works for a malpractice insurance company.  He had to be admitted to the hospital a few years ago.  He told me that each night for the first three nights, the nurses brought him the wrong medication.  They insisted it was the medication he took at home and he insisted to them that he had never taken that medication in his life.  You would think that after the first night, the nurses would have discovered their mistake.  You would be wrong.  They just kept coming back night after night with the wrong medication.

Think about a hospital stay for a routine surgical procedure.  This should turn out well.  The surgery is elective and therefore not an emergency.  The doctor, the patient and the hospital should all be well-prepared for the event.

Now think for a moment about all the people who will participate in the care of the patient and how many ways mistakes can be made.  First, the intake people meet the patient and admit her.  Always a chance at this stage for mistakes to be made about patient identity (and what medications they take at home).

Once the patient arrives on the floor, she is introduced to the nurse who will be caring for her on the current shift.  Hospitals run either two or three shifts each day.  Each time there is a shift change, the nurse caring for the patient must give a report to the successor nurse.  This report is to include tests that have been done but not yet reported, scheduled medications, status of the patient and many other things.  When the shifts have been busy, the hand off of the patient from one nurse to another may not go as smoothly as it should and information may get garbled or not given at all.

Even though the patient has been admitted by her surgeon for the procedure and the surgeon is usually the attending physician, many doctors may be involved in the patient’s care.  There may, for example, be a hospitalist, who only sees patients in the hospital for other doctors.  There will likely be other doctors involved, such as radiologists and pathologists as well as many other specialists, if things go a little sideways.  The communications between these doctors can be complicated.  It usually takes place through chart entries.  If one of the doctors does not do a good job charting, it can lead to misunderstandings among the physicians.  Misunderstandings often lead to mistakes in care.

Orders have to be given, recorded and followed.  Often orders are changed as circumstances change.  Doctor A may change the orders given by Doctor B or Doctor A may change them herself.  The old orders must be closed out and the new orders recorded in the chart.  Tests have to be performed, reported and the results evaluated.  Many is the time I have seen important test results that just fell through the cracks.  Many is the time I have seen important orders missed or just plain disregarded.

Most importantly, the nurses who are in direct contact with the patient must keep the doctors fully informed about what is going on with the patient.  Communication is always a problem for human beings.  Even under the best of circumstances, there can be misunderstandings or just plain old failures to act.  I have had a number of cases in which a patient became paralyzed during the night following surgery and, due to a failure on the part of the nurse, the doctor did not learn of the paralysis until he arrived for rounds the following morning, when it was too late to do anything about it.

I recommend to my family and friends that they have someone stay with them in the hospital to monitor things, to act as their advocate, to ask questions and to make sure, to the greatest extent possible, that things go well.  I suggest they be polite but firm in asking questions and insisting people be notified and action taken.  Nothing can guarantee you won’t be the victim of malpractice at the hospital but doing these things will reduce the risk of a major injury.

Posted in Doctors, electronic medical records, Hospital Negligence, Hospitals, Lawsuits, medical charts, medical errors, Medical Malpractice, medical malpractice cases, medical mistakes, Medical Negligence, Medication Errors, Nurses |

Telephone, Anyone?

October 12, 2020

I am sure most of you remember the children’s game of Telephone.  You get a group of people and the first tells a secret to the second.  The second repeats the secret to the third person, who tells it to the fourth and so on until everyone has been told.  Then you compare the secret the first person told with what the last person was told.  There is almost always a big difference.  The message gets garbled and mangled as it goes from person to person.  Like it or not, the game of Telephone accurately describes what happens in your medical records. : EC VISION Rotary Phones for Landline, Retro Landline ...

In the course of my practice, I read a lot of medical records.  It is the rare case in which I fail to find some significant mistake.  My client may be seeking compensation for the results of a head injury resulting from an accident in May.  Her records may say that she has been experiencing the effects of a head injury since March, two months before the accident.  The timing of the onset of problems is one of the most common errors I see.  Another common error is the patient who is having problems at the time of the office visit but they are not mentioned in the chart.  Needless to say, the defense jumps on these mistakes and uses them to weaken my client’s case.

Your medical records are like the game of Telephone because, once an error appears, it is repeated over and over.  Sometimes, it gets worse, as the mistake becomes even more egregious, but it never gets better.  So how do medical records get corrupted in the first place?

The first part of any medical encounter should be a patient history.  It should be careful, thorough and accurate.  It should address not only the chief complaint which brings the patient to the encounter but events which have occurred in the past, which may be relevant to diagnosis and treatment.

Unfortunately, due to the economic realities of running a medical office today, it is rarely the doctor who takes the history.  It is usually taken by an member of the doctor’s office staff.  That person is never going to be as well-trained as the doctor.  The staff member may be well-trained and experienced or may have just started last week.  That person is almost never going to understand the significance of every event in the patient’s history.  That person is not usually going to know what questions to ask to draw out additional relevant information from the patient.

The office person taking the history is not going to write down everything the patient says.  The staff member is usually busy with a number of duties and will usually write down only what seems important to them.  That may or may not be what is actually the most important information for this particular encounter.

Many staff members will look at the patient’s chart and just ask if there have been any changes since the patient last saw the doctor.  If the answer is no, the staff member may just cut and paste the history from the last visit, which may itself just be a copy of the history from the visit before that.  I see these word-for-word histories repeated, sometimes even over a course of years.  Once an error is made, it gets repeated over and over.

Errors which appear in your history may affect the treatment you receive from the doctor.  The doctor may not go over all the history with you on his or her own.  She or he may simply accept the history taken by the staff member.

Errors which appear in your history may affect legal claims you bring.  As I noted above, an error in your records can undermine your claim in a number of different ways.  The defense may argue, for example, that you could not have been severely injured because you didn’t tell the doctor about the problems you are now claiming.  It won’t do you much good to point out that you did tell the office staff but they must have failed to note it in the records.  Juries tend to treat medical records as the Bible.  If it is in the records, it is true.  If it is not in the records, it didn’t happen.

All this means that you should be proactive about the quality of your medical records.  You have the right to see your records and the right to insist that erroneous information be removed or otherwise corrected.  You may not find your doctor or the doctor’s office all that willing to accommodate you in making changes, but you should at least make the effort.  If they refuse to make the changes you believe are necessary, write up your version of the facts and ask them to place it in your chart.  For a whole host of reasons, it is better to do this sooner than later, so get over to the offices of your doctors and see what they have been saying about you.


Posted in Doctors, electronic medical records, health, Lawsuits, medical charts, medical ethics, plaintiff |

Caesarian Sections

October 05, 2020

The Caesarian section can be a life saver for both the mother and her baby.  There are a number of conditions which can develop during pregnancy or during the delivery process which require that the baby be delivered by C-section.  Among them are shoulder dystocia, fetal distress, failure of the labor to progress, malposition of the baby and a baby too large for the pelvis of the mother.  But Caesarian section is not risk free and the evidence is that it is being used when it is not necessary.  This is a serious problem.

304 Cesarean Section Photos - Free & Royalty-Free Stock Photos ...

So what are the risks of a Caesarian section?  In the first place, all of the usual risks of an operation are present:  bleeding, infection, clotting problems, reactions to anesthesia, and surgical accidents.  Mothers who have had C-sections are also usually in the hospital longer and face larger medical bills.  Their recovery takes longer than that of the average mother who has delivered vaginally.  Pain levels may be greater due to the surgical incision.  Finally, there is an increased risk to future deliveries.  While it is possible to deliver a later baby vaginally after having had a C-section, there is a greater risk of uterine rupture during labor.

C-sections present some risk to baby as well.  Babies delivered by C-section are more likely to develop breathing difficulties.  There is also a chance baby will be nicked by the surgical instruments during the procedure.

All of these risks are greatly outweighed, if either the mother’s health or that of the baby are in danger with the continuation of labor and a vaginal delivery.

Since doctors began to keep records of the number of C-sections being performed, the numbers have been going up.  Beginning particularly in 1996, there has been a sharp rise in the percentage of Caesarian births.  In 1996, one in five women had a C-section.  Today that number is one in three.  That is approximately a 65% increase.  If C-sections are being performed to save the mother or the baby from a risk, we would expect to see decreases in maternal and fetal injuries and death.  Unfortunately, there has been no such decrease.  C-sections are clearly being performed for reasons other than the safety of the mother or the baby.  When not done to protect the mother or the baby, a C-section presents greater risks to both of them than a routine vaginal delivery.  For this reason, the American College of Obstetricians and Gynecologists (“ACOG”) has offered guidance to obstetricians about the risks of the procedure in an effort to discourage its use when not necessary to protect either the mother or the baby.

There is no agreement on the reason so many more women get C-sections than in the past.  It does not appear that there are more risky pregnancies or that women are more frequently demanding a C-section.  One factor that some observers have remarked upon is our old friend “fee for service.”  Obstetricians are usually paid for more a Caesarian section delivery than for a vaginal one.

What does all of this mean for the woman approaching labor?  My advice is to think about these issues before arriving at the hospital.  Every0ne hopes that the delivery will go smoothly and the vast majority do.  However, babies have a way of acting unexpectedly and the mother and her partner, if he or she is there, must be prepared to be flexible and to make decisions as the situation changes.  To those mothers who really want a natural, vaginal delivery, I say, “Don’t let that desire outweigh the safety of your baby.”  Don’t delay the decision to go Caesarian wait too long.  The obstetrician should be closely monitoring the situation but don’t count on her or him to the point that you risk the health of your baby.  This is your baby. Ask questions and be proactive.  Lean on your partner.  After hours of labor, you may not be in the best place to ask questions and make decisions.  Have someone there to help you, if possible.  Most of all, good luck.  Mothers have been delivering babies for thousands and thousands of years.  You have the best medical technology available to you in the history of mankind.  Everything should be fine.


Posted in Birth Injuries, Cesarean Section, Fee for Service, Health Care Costs, Infection, Informed Consent, Sepsis |

Hip Replacements.

September 28, 2020

One consequence of our lengthening life spans is that we are wearing out our original equipment.  Our knees and hips were not intended to last 60 or 70 years.  They certainly weren’t intended to support the heavy bodies so many of us now have.  Our remote ancestors were lucky to have anything at all to eat.  You didn’t find any fatties on the savannas in prehistoric Africa.  All of this has made joint replacement, especially hips, an important and lucrative field for orthopedic surgeons.

Total Hip Arthroplasty No Better Than Partial Joint Replacement ...

The hip replacement is a wonderful surgery.  It has improved the lives of many people who suffer from degenerative joint disease.  I am one of them.  I had my hip replacement almost 10 years ago and it is still doing great.  The technology and operative techniques continue to improve so expect even better results in the future.

There are a number of risks associated with hip replacement, the greatest of which is infection.  Other risks are heart attack, pneumonia, sepsis, shock, blood clots, pulmonary embolism, surgical site bleeding and mechanical problems with the prosthesis.  For most patients, the risk of complications, other than infection, are small.  Not all hospitals are the same, however.  Some do a better job of preventing infection or other complications of hip replacement surgery.  If you are a candidate for hip replacement surgery, you can and should look at the data the federal government collects about complications for hip replacement surgery.  You can find it here, at Hospital Compare.

According to the Centers for Disease Control, on any given day a hospital patient has a 1 in 31 risk of developing a Hospital Acquired Infection (HAI).  Some of these infections will be minor, but some of them will be resistant to antibiotics and may be devastating.  Infection rates are also tracked and available for review at Hospital Compare.

Just as all hospitals are not equal when it comes to preventing infection and other complications of hip replacement surgery, not all surgeons are equally skilled in performing the procedure.  You can and should investigate the qualifications and record of the surgeon you are going to entrust with one of the most important surgical procedures you may ever have.

You want a surgeon who is well-trained and experienced.  Go to the web site of your state medical board and look up your surgeon.  Is he or she an orthopedic surgeon?  These are the surgeons who have been specifically trained in joint surgery.  Is she or he Board Certified?  While Board Certification does not guarantee a good result, it does mean that the surgeon is well-trained and experienced and has demonstrated competence to his or her peers.  Does the surgeon have a record of discipline with the Medical Board?  Discipline is uncommon, even with doctors who are not all that good.  If a surgeon has been disciplined by the Medical Board, that should be a giant warning flag.

How often does your surgeon perform hip replacements?  As the old adage goes, “Practice makes perfect.”  The more often your surgeon and his or her team perform a procedure, the more routine it becomes for them and the better they usually are at doing it.

Plan your procedure for a Tuesday or Wednesday, if possible.  You do not want to be in the hospital over the weekend, if you can avoid it.  Bad things are more likely to happen at hospitals over the weekend for a number of reasons.  Go home before the weekend.

When you get home, you have control over many aspects of your recovery.  Even if you had a successful surgery, you can degrade the ultimate result by failing to do what the surgeon and therapists tell you.  Follow the orders of your surgeon and therapists.  Do your exercises.  Avoid weightbearing.

Do these things and you will have done what you can to get the best outcome from your hip replacement surgery.

Good luck.  I hope yours turns out as well as mine.

Posted in Arizona Medical Board, Blood Clots, blood infections, Board Certification, Doctors, heart attack, Hip Replacement, Hospital Negligence, Hospitals, Infection, joint replacement, Medical Devices, Medicare, Nurses, Obesity, Orthopedics, Pulmonary Embolism, Sepsis, Surgical Errors |

The Pre-Existing Condition

September 21, 2020

For quite a few years now, we have been bombarded with references to “pre-existing conditions.”  All politicians seem to promise that they will protect the voters from losing coverage for pre-existing conditions.  A review of the record and of the facts of insurance coverage show that many of these politicians are not telling the truth.  In order to understand the issue and to determine who is telling the truth and who is not, a brief review of the elements of insurance is in order.

I Have a Pre-Existing Condition. Don't people with illnesses need ...

Insurance is a means of spreading the risk.  For example, we know that a certain number of people will have an automobile accident next year.  We don’t know exactly who but we can identify some people whose driving records suggest that they are at higher risk than others.  In return for the privilege of driving on our streets, we require all drivers to have automobile liability insurance.  Each driver pays a premium, the amount of which depends on the driver’s relative risk of having an accident and the amount of coverage the driver wishes to purchase.  If a driver does not have an accident, the insurance company gets to keep that driver’s premium.  If a driver does have an accident which is his or her fault, the insurance company takes their premium and the premiums of others and pays for the damage done.  All of the insurance company’s customers share the risk that one or more of them will have an accident.

In order for an automobile insurance company to stay in business, it must correctly figure out how much to charge its policyholders for coverage.  If it charges too little, it will not have enough money to pay for the claims against its policyholders.  If it charges too much, prospective customers will go elsewhere to buy automobile liability insurance.  All insurance companies hire actuaries to evaluate the driving records of drivers applying for insurance and to determine how many are likely to have accidents and how much those accidents will cost.  That is how they decide how much to charge by way of premium.

Everything in insurance is based upon these predictions of the future.  One thing no insurance company will do is sell you automobile liability insurance after you have had an accident.  You have to buy insurance before an accident.  These same principles apply to health insurance.

Health insurance operates the same way as car insurance.  The health insurer must determine how much money to collect in premiums in order to have enough to pay all of the covered medical bills of its policyholders.  As drivers with bad driving records can be expected to have more accidents, customers applying for insurance who have pre-existing conditions can be expected to have higher medical bills in the future to treat those conditions.

In the past, health insurance companies protected themselves from this risk by inserting language in their policies saying they would not pay medical bills related to customers’ pre-existing conditions.  Alternatively, the health insurance company would just refuse to sell insurance to people with significant pre-existing conditions.  The Affordable Care Act (also known as Obamacare) put an end to that.

The Act required health insurers to sell to anyone who applied for coverage and prohibited the health insurers from refusing to pay bills related to pre-existing conditions.  The Act also required that all health insurance policies meet certain minimum standards and that there be no limitation on the total bills over a customer’s lifetime.  These were big changes and required that some other changes be made to keep the insurance companies from going broke.

If health insurers could not refuse to sell insurance to anyone and if they had to pay the bills for whatever conditions the customer had, what was to prevent a person from waiting until after they developed cancer, for example, before buying health insurance?  No insurance system could survive if people could wait until they were sick to buy insurance.  The answer the Affordable Care Act came up with was similar to that of auto insurance:  Everyone had to buy insurance.  This was understandably unpopular with younger, healthier people but it was necessary for the system to be able to work.

When the Republicans took control of the federal government, they eliminated the requirement that everyone had to buy insurance but they did not eliminate the requirement that insurance companies cover all pre-existing conditions.  That was a popular provision with the public.  Unfortunately, this enabled people to once again wait until they were sick to buy health insurance.

To keep the system from hemorrhaging money, the Republicans tried a number of band aids.  They stripped out the requirement that all policies provide certain minimum coverages.  This allowed unscrupulous companies to sell policies with large deductibles or large co-pays or both.  The policies looked like health insurance but were actually of little value to the person who got seriously ill; they just didn’t cover much or pay much.

They allowed health insurance companies to sell across state lines.  This meant that no longer could your state require an insurance company to be financially strong in order to sell insurance in your state.  Now, if any state would let them operate, they could sell insurance in your state.  Again, unscrupulous companies could sell policies and then go bankrupt when the time came to actually pay the customer’s medical bills.

Another band aid allowed insurance companies to set up special risk pools for people with serious medical conditions.  Insurance companies forced to sell insurance to people with pre-existing conditions can put those customers in these risk pools and charge much higher premiums.  The politician can then argue that she or he protected coverage for pre-existing conditions; the only problem is that you can no longer afford that coverage.  This is just the illusion of insurance coverage.  If you can’t afford it, it isn’t real.

These are just a few examples of the ways in which some politicians say they are protecting pre-existing condition coverage while actually allowing it to be so undermined that it cannot do what the voting public wants it to do.  The public wants affordable coverage for pre-existing conditions sold to them by companies which are financially sound.  When you think about your vote in the coming election, look and see whether the candidates actually support a health insurance system which is affordable, which covers pre-existing conditions and which requires companies to be financially sound.

There is no free lunch in life and there is no free lunch when it comes to pre-existing conditions in health insurance.  If you want coverage for pre-existing conditions, you cannot let people wait until they are sick to buy insurance.  Healthy people need to participate in the system for it to work.


Posted in Health Care Costs, Health Insurers, Insurance Law, Medical Costs |

“Doctor, I Think You Forgot Something.”

September 14, 2020

There are certain events which are never supposed to happen.  They are called “never” events.  One of them is the foreign object left behind in the body of the surgical patient.  Prior to the adoption of procedures and checklists requiring multiple counts of instruments and sponges, this used to be a more significant problem.  Today, this complication occurs only once in many thousands of surgeries.

Objects Commonly Left Inside the Body After Surgery

A lot of thought has gone into preventing foreign objects from being left behind at surgery.  In the first place, all surgical instruments and sponges are counted before the surgery begins.  They are counted again after the surgery is complete and before the surgical incision is closed.  If the count is incorrect, the surgeon will go looking for the missing object.  If the count is correct, the surgeon will close the incision and send the patient on to the PACU.

Another innovation to prevent this complication is the requirement that all sponges used in surgery be able to be detected by x-ray.  If there is a problem, or sometimes as a matter of routine, post-surgical patients are x-rayed to check for the presence of any sponges or instruments which may have been left behind.  An even more recent innovation is the use of radiofrequency tags on sponges so they can be identified, located and counted by a computer.

Even with the adoption of these procedures and checklists, foreign objects, especially sponges, continue to be left behind at surgery.

According to the studies, no body cavity is safe from a foreign object being left behind but the greatest number are left behind in the abdomen or the thorax.  Over three quarters of the objects left behind are sponges.  The remainder are instruments.

The presence of the object may go undetected for years.  Only rarely are they discovered shortly after the surgery.  They can be quite damaging as well.  Sometimes the object can perforate a body part, such as the bowel.  Serious consequences, including death, can result.

How and why does this happen and what can be done to prevent it?

A number of research studies have tried to identify the risk factors associated with the retention of foreign objects.  Here are some of their findings.

Change in OR nursing team.  Sometimes it is necessary during the course of a surgery to change the nurses in the operating room.  When the nurses who end the procedure and make the final counts are different than the nurses who counted the objects and began the operation, there is a greater risk of a mistake.  Significantly, in the case of most foreign objects, the count at the end of the surgery was correct.

Emergency surgery.  This seems to make sense.  The bigger the hurry the surgical team is in, the greater the likelihood something will be left behind and no one will notice.

Change in procedure.  This one is similar to the emergency surgery.  The team plans a particular surgery but, during the procedure, makes a discovery which requires them to perform a different or additional procedure.  The change may throw things off and such changes are associated with a greater risk of a retained object.

Excessive blood loss.  This is another one which makes sense.  In a very bloody surgery, it is easier to lose track of an instrument or a sponge and not notice that it has been left behind.

Excessive body mass index.  It is easier to lose track of an instrument or sponge if the patient is morbidly obese.

Lengthy surgery.  The longer the surgery, the greater the likelihood the surgical team will become fatigued and make a mistake in counting.

Absence of a count.  In spite of the requirement at all institutions that instruments and sponges be counted at the beginning and end of all procedures, some of the cases of retained objects had no recorded count.  It is unclear whether one was done but not recorded or, perhaps more likely, was overlooked for one reason or another.

Unlike most medical malpractice cases, where there is a fight over whether the health care provider acted within the standard of care or not, cases involving retained foreign objects after surgery are very clear cut and among the easiest for the patient to win.  There is no defense to having left an object behind.  The only question is what were the damages caused by the object.

Fortunately, this is a rare occurrence.  When it does occur, it can cause little injury or the injury can be catastrophic.  If you have been the victim of a retained foreign object, call an experienced malpractice attorney to see what your rights may be.

Posted in Doctors, Hospital Negligence, Hospitals, Lawsuits, medical errors, Medical Malpractice, medical malpractice cases, medical malpractice lawyers, medical mistakes, Medical Negligence, never events, retained sponge, retained surgical instruments, Surgical Errors |

Drug Prices

September 07, 2020

We are in election season and there is much talk about the high price of prescription drugs and promises by politicians to do something about it.  Don’t hold your breath.  Drug prices are like the weather:  Everyone complains about it but no one ever does anything to change it.

Prescription Drug Prices Impact All Americans

Big Pharma, the name given to the global pharmaceutical industry, spends more money on lobbying in the United States than any other industry and it outspends the others by a wide margin.  Last year the pharmaceutical industry reported spending $166,038,670 on lobbying activities.  There are a couple of significant takeaways here.

That is a lot of money.  How can they afford to spend so much?  The simple answer to that question is that they can spend so much because they make so much.  We pay more for prescription drugs than any other nation on earth.  These large profits are driven by the refusal of the United States government to take action to reduce prices.  There are many ways the government could do that, including reducing patent protections, increasing competition from generics, legislating price reductions, and importing drugs from other countries where they are cheaper.

Big Pharma spends that much on lobbying because it believes it is cost effective to do so.  In other words, spending this much is a bargain, if it keeps the United States from acting meaningfully to reduce prices and thereby insuring the big profits continue to roll in.

Another little secret is that this money flows to both Republicans and Democrats.  By donating to and lobbying both sides, the drug companies avoid the problem of having backed the losing side and being on the wrong end of price reform legislation.  This is why it is so hard to get action on drug prices despite the changes in administrations over the years.

The drug companies are not run by fools.  They have been going to Washington for a long time and know exactly what they are doing and how to do it.  Your representatives in Washington will talk a good game about reducing the cost of drugs to the American people, but, in the end, little will actually happen.  There may be some cosmetic changes or some big announcements but, when the rubber meets the road, not much will change.  When they do pass some legislation, it often gets bogged down in the courts where the pharmaceutical companies go to stop changes that get through Congress or the White House.

Drug companies also spend huge amounts on advertising to get patients to ask their doctors for a certain medicine.  If you listen closely to the warnings spoken in a rapid monotone at the end of these ads, you wonder why anyone would ever risk taking the medication.  As with lobbying, the drug companies have the research to show that their outlays on advertising pay big returns.  When a patient pesters a doctor about a particular drug, the doctor may just give in to avoid making the patient unhappy.

The drug companies also spend large amounts lobbying doctors to prescribe their products.  They have representatives who go from office to office with free samples and gifts of appreciation.  This is yet another investment that the drug companies have found pays off well in the end.

Lastly, there are the out and out bribes paid to doctors to prescribe costly drugs.  One drug company based here in Scottsdale hired a stripper as a director of marketing on the grounds that she knew how to communicate with doctors.  I am sure she did.  These bribery schemes are often part of a larger fraud on the health care system.  Sometimes the drugs involved are useless.  Sometimes the treatments are faked but invoices are submitted to the government.  A search on line for these frauds will keep you entertained for hours.

I am probably foolish to keep hoping for a change in light of all the history of drug company success in fighting it off but I keep thinking this can’t go on forever.  We need to make a change.  Vote for someone who will make a change and keep reminding them of their promises once they get in office.


Posted in Doctors, drug companies, Fraud, Health Care Costs, Medical Costs, medical ethics, Medicare |