Electronic Medical Records Medical Malpractice Outpatient Practice

The REMS Program And Abortion Laws – What Every Physician Needs To Know

If you or the doctors at your hospital prescribe any of these 11 drugs and live in states that have abortion laws, you need to take action IMMEDIATELY. The medical malpractice implications of teratogenic drugs (those that can cause embryofetal damage) are changing and physicians who prescribe these drugs need to protect their women patients from fetal damage and to protect themselves against future lawsuits.

The FDA created the REMS program (Risk Evaluation and Mitigation Strategy) in 2007 as a way to be sure that physicians take appropriate precautions when prescribing certain high-risk drugs. Typically, the REMS program will recommend physicians to have specific training and certification before being allowed to prescribe these drugs. The problem is that hospitals and pharmacies rarely verify that a physician has been certified for drugs on the REMS list and as a consequence, many physicians prescribe them without having the proper certification. Currently, the FDA lists 60 such drugs on the REMS website. I am most familiar with the REMS drug, mycophenolate mofetil. During my career, I have prescribed mycophenolate… a lot of mycophenolate… typically as an immunosuppressant for various lung diseases.

Mycophenolate, a REMS medication

Mycophenolate mofetil is often sold under the brand names CellCept or Myfortic. It is commonly used in patients who have undergone organ transplant to prevent rejection of those organs. It is also commonly used as an immunosuppressant drug to treat various autoimmune diseases. When used properly, it can be life-saving and is considerably safer than older immunosuppressant drugs, such as cyclophosphamide. In many patients, it is also safer than corticosteroids such as prednisone. The biggest problem with mycophenolate is that it is highly teratogenic. Overall, about half of women who become pregnant while taking mycophenolate will have a miscarriage and 1 out of every 4 live births have serious congenital malformations. Because of the very high risk of embryofetal damage, mycophenolate was added to the FDA’s REMS drug list in 2012.

The mycophenolate REMS requirements are:

  1. Physicians need to apply to the mycophenolate REMS website and undergo an on-line training program before prescribing mycophenolate.
  2. Once certified to prescribe mycophenolate, physicians must educate patients about the risk of miscarriage and fetal harm.
  3. Physicians must insure that women of childbearing potential use adequate contraception – preferably either vasectomy, tubal ligation, or an intrauterine device. In the absence of any of these 3 methods, women must use 2 forms of other approved contraception (for example, birth control pills + condoms).
  4. Women should have a pregnancy test at every office visit.
  5. Woman should be counseled about emergency contraception (Plan B) in the event of intercourse without adequate contraception.
  6. Women must be given the printed REMS information about mycophenolate precautions.
  7. Women should sign an agreement form acknowledging that they understand the risks of mycophenolate and agree to the requirements of the REMS program (note: this requirement was discontinued in January 2021).

All too often, I would see women of child-bearing potential in my office who had been started on mycophenolate by other physicians and who had never been informed about the REMS program. Frequently, these women were not using adequate contraception and were not undergoing regular pregnancy testing. Until last month in Ohio, if a woman became pregnant while taking mycophenolate, we could recommend pregnancy termination. Now, that is no longer an option if it is more than 6 weeks after her last menstrual period and the Ohio legislature has signaled that later this year, it intends to make pregnancy termination illegal in all pregnancies from the time of conception.

The heightened risk of malpractice lawsuits

The implication of anti-abortion laws, such as Ohio’s, is that if a woman becomes pregnant while taking mycophenolate, then there is a 25% chance that her baby will have severe congenital deformities. Children with these deformities can require life-long care and can be very expensive for families. Women taking mycophenolate because they have had an organ transplant or because they have chronic diseases such as lupus are generally not in a good position to provide care for the life of a child with serious birth defects and usually do not have the financial resources necessary for that care. This is especially true for my patients who have undergone lung transplant – the life expectancy after transplant averages about 6 years so these women will not be alive to care for a child with severe deformities.

We live in a litigious society. When faced with the birth of a child who will never grow up to be a normal adult and will incur large healthcare costs, women (or their widower spouses) will seek financial compensation to pay for these costs. Every personal injury attorney in the country knows that the person to name in a lawsuit is the person who has the most money. Hospitals and physicians are the ones with the most money. If a physician prescribed mycophenolate without having REMS certification to prescribe it or if there is no documentation that a woman was educated about pregnancy risks with mycophenolate, then that physician will be highly vulnerable in a malpractice suit.

The best defense for physicians is to get REMS certification before prescribing mycophenolate and adhere to the REMS requirements when prescribing it to any woman with child-bearing potential. The best defense for hospitals is to ensure that every physician prescribing mycophenolate has REMS certification. Electronic medical records make it easy for hospitals to determine which of their physicians are prescribing mycophenolate or other REMS drugs.

What other drugs are on the REMS list?

There are a variety of reasons that the FDA may put a drug on the REMS list. Some are on because of a high risk of anaphylaxis (Palforzia). Some are on because of a high risk of neurological toxicity (Abecma). Some are on the list because of risk of neutropenia (clozapine). Others are on the list because of a risk of over-sedation or addiction (buprenorphine). Of the 60 drugs on the REMS list, 11 are on the list because of the risk of embryofetal toxicity. The following is a list of these 11 drugs and what physician specialties are likely to be prescribing them.

A recent article in the American Journal of Obstetrics & Gynecology lists 141 drugs that are definite teratogens and 65 drugs that are considered to be potentially teratogenic. Of these 206 drugs, only 11 are included on the REMS list. However, the risk of embryofetal toxicity exists with all of these drugs and therefore the risk of medical malpractice lawsuits exists should a woman become pregnant while taking any medication known to be teratogenic and then develops fetal abnormalities.

Currently, 3% of all abortions performed in the United States are because of fetal abnormalities. This works out to about 28,000 per year. In states that ban abortion, these fetuses will go on to be infants with severe birth defects. The implication is that in the future, there will be potentially thousands of new malpractice suits filed each year against physicians who will be blamed for these birth defects because they prescribed a teratogenic drug to a woman who could not legally have her pregnancy terminated.

What physicians need to do right now

In medicine, doctors recognize that prevention is the best cure. The same goes for malpractice lawsuits. The best time to prevent a malpractice suit about a birth defect is before the woman becomes pregnant. To that end, there are measures that all physicians practicing in abortion-ban states should take now:

  • Know which drugs are teratogenic. The recent list from the American Journal of Obstetrics & Gynecology is a good starting point.
  • If you prescribe one of the 11 teratogenic drugs on the FDA’s REMS list, get your REMS certification and follow the REMS requirements.
  • If you prescribe a teratogenic drug that is not on the REMS list, develop a process for educating women of child-bearing potential about the risks of the drug.
  • Document, document, document. Include information in your office notes documenting patient discussions about drug teratogenicity, about contraception advice, and about any printed information that you gave them. 
  • Consider signed acknowledgement forms. In the past, this was a requirement of the mycophenolate REMS program. Even though it is no longer required by REMS, a signed form scanned into the electronic medical record is still a good practice since it can provide very strong malpractice defense.
  • Get comfortable recommending contraception. I have become at ease discussing contraception with my patients and their partners. If the woman is done having children, vasectomy is usually the safest and most effective option. For other women, I am a proponent of IUDs and although I do not place them myself, I know who to refer women to in order to get one. 
  • Educate women about Plan B. The “morning after pill” is available at pharmacies over the counter without a prescription and is effective up to 3 days after unprotected intercourse. Include information about Plan B in the educational materials you give patients when prescribing any teratogenic drug.
  • Understand your state’s abortion laws. In some states, it is (or will be) illegal for a physician to even discuss abortion with a woman or to advise her to travel to another state where abortion is legal. Be very careful what you write in the chart. A note in the electronic medical record stating: “She is 6 weeks pregnant while taking mycophenolate so I recommended she go to the Acme Abortion Clinic across the state line” could be your invitation for a prison sentence and revocation of your medical license. 
  • Do a malpractice insurance check-up. For physicians in Ohio who care for adults, there is a 1-year statute of limitations for filing a malpractice lawsuit. But for cases involving children, that statute of limitation extends to 1-year after the child’s eighteenth birthday. In other words, a physician who prescribed a teratogenic drug to a pregnant woman can be sued by the child 19 years later. Be sure that you either have a comprehensive claims-made policy or a tail coverage policy that will provide coverage long after you retire or leave your practice.
  • For hospital medical directors and administrators, use your electronic medical record’s prescribing database to identify physicians who prescribe REMS drugs and require that those physicians be REMS-certified.
  • For medical schools, education during pharmacology courses about teratogenicity and about the REMS programs has suddenly become considerably more urgent.

Abortion prohibitionists have long set their sights on laws to criminalize abortion. There are a myriad of unintended consequences of banning abortion and many of the the socioeconomic consequences will not be fully recognized for several years. For physicians, waiting several years to protect against medical malpractice suits for prescribing a teratogenic drug will be too late. The time for physicians and hospitals to protect their patients and themselves is right now.

July 16, 2022

Medical Malpractice

How To Be A Medical Malpractice Expert Witness

25 years ago, I got a call from an attorney representing a physician in an academic medical center in another state. The physician was being sued by the family of a patient who had died from a condition mimicking acute eosinophilic pneumonia, a disease that I had published some articles about, and the attorney asked if I would be willing to be an expert witness for the case.

At the time, my only experience in a courtroom was when I was a fellow and was called as a witness in a malpractice case – a patient had died of a myocardial infarction and his family physician was being sued. I had done a consultation on the patient a year earlier when I was a Chief Resident moonlighting doing medical clearance exams for patients entering vocational rehabilitation.  The patient had exertional chest pain at the time and I told him he could not participate in rehab until he got a cardiac evaluation and that he needed to get in to see his primary care physician the next week. I contacted the patient’s family physician who agreed to do the work-up but the patient canceled all of his future appointments with the family physician and then several months later, had a massive MI and died. I wasn’t an expert witness in this case, just an unpaid witness to the facts of the case. However, my testimony did help the defense and the jury found in favor of the family physician.

So, I agreed to be an expert witness since I knew as much as anyone else about this particular disease and in hearing about the case, it seemed to me that the doctor had done all the right things, including publishing a case report about the patient to contribute to the medical literature about it. I spent hours reviewing the medical records, meeting with the attorney, writing an opinion letter for the court, and ultimately testifying to the jury during trial. After a short deliberation, the jury found in favor of the physician.

The attorney’s firm represented this particular academic medical center and they started calling me to review their pulmonary cases and critical care cases. Then attorneys representing other academic medical centers in the Midwestern U.S. and other hospitals in Ohio started calling me. Since that first case, I’ve reviewed somewhere around 150-200 cases, written dozens of opinion letters, done dozens of depositions, and testified in court 7-8 times. No one every told me how to be an expert witness, I had to learn on my own. Here are 40 things I have learned.

  1. Do it for the right reason. There are some physicians who are practically full-time expert witnesses and for them, being an expert is a major source of their income. Don’t be one of these physicians. It is appropriate to be compensated for your time but the bigger reason to be an expert is to be an advocate for the truth.
  2. Know who you are working for. I’ve been contacted by companies that maintain panels of physicians who are available to attorneys for expert witness work. I’ve always turned these companies down because it seemed mercenary to me. Although I’ve reviewed lots of cases, probably 90% of them were for about a dozen legal firms. These are attorneys and paralegals that I know and trust and that never pushed me to say something that I did not believe. When I encounter an attorney who wants me to say something that I don’t believe, I tell them I can’t help them and I don’t work with them again.
  3. Witness for the plaintiff or witness for the defense? I have primarily been an expert for attorneys who specialize in malpractice defense (in other words, defending the doctor or hospital) – the primary reason for this is that I limited my expert witness activities to working with a small number of law firms that I knew and trusted. Most of the companies that maintain panels of experts provide them to plaintiff’s attorneys. In a deposition and in court, you will likely be asked how many cases you’ve been an expert in and whether those cases were for the defense or the plaintiff. If you do exclusively defense expert work or do exclusively plaintiff expert work, you may come across as less believable – either a professional “hired gun” for plaintiffs, or someone who thinks that doctors can do no harm for the defense. Over the years, I’ve reviewed several cases for plaintiffs – as it turned out, in each of them, I did not think that the plaintiff had a legitimate case and was able to honestly tell the attorney that I wasn’t able to support their claims.
  4. Causality or standard of care? In our state, there are two kinds of expert witnesses in malpractice cases, those that testify about causality (what actually happened in the case and why?) and those that testify about standard of care (did the physician or the hospital do what most other physicians or hospitals would have done?). There are different requirements for these two types of experts and these requirements vary from state to state – for example, in our state, a physician has to spend at least 50% of their professional time in clinical practice to testify to standard of care but can spend less than 50% of their time in clinical care to testify to causality. Be sure of which type of expert role you are serving in for any given case and avoid crossing into the other role during testimony unless you are an expert for both causality and standard of care. As an example, if you are a pathologist testifying that the cause of death was a pulmonary embolism, decline to offer an opinion about whether or not the dose of prophylactic heparin that the patient had after surgery was appropriate.
  5. Always be consistent. Once you testify, your words will be permanently recorded. A good attorney will search for court documents from any similar cases that you have testified in and will know what you previously said. If you contradict yourself, the attorney will let the court know – at best, the jury will find you unbelievable and at worst, the judge will find that you are guilty of perjury.
  6. Charge the right amount. Your time is valuable and it is appropriate for you to be compensated accordingly. However, attorneys can (and usually will) ask you in front of the jury how much you are charging. In nearly every case, none of the jurors is going to be making anything like what you are charging per hour. Furthermore, the judge may ask you to justify your charges if they seem excessively high. There is no standard fees schedule out there and you will need to set your own. Some experts charge differently for time spent reviewing a case versus time spent in depositions versus time spent in trial. Some experts will require a retainer up front (in essence, a down payment). I always kept it simple and charged approximately the amount that our medical group billed for an hour of critical care service (remember, the charges are always set to be higher than whatever your best paying commercial insurer will pay you). I charge the same amount for record review, phone calls, depositions, and testimony. However, I charge a minimum amount for testimony at trial based on how many hours I had to block out of my schedule that day – if I testify in town, I plan on a half-day and if out to town, I plan on a full-day. To protect myself from conflict of interest with my employer, I always took vacation time to testify or do depositions (unless I could do the deposition in the evening or on a weekend) and I always did my record review during the evenings and on weekends. For what it is worth, I know of other pulmonary/critical care physicians who charge as much as $800/hour and I’ve had attorneys tell me (after trial) that my fees are too low; however, I feel that my charges are an appropriate exchange for my time. As a very general rule, the more specialized you are the more you should charge (an orthopedic surgeon will charge more than a general internist) and the more experienced you are, the more you should charge. If you are just starting out doing expert witness work, you may only charge $300/hour for record review but if you are experienced and specialized, then you may charge $600/hour for record review. Set your fees at a reasonable rate and when you are asked about them in a deposition, you can feel confident that your time is legitimately worth your fees; that way you don’t have to squirm when asked what they are.
  7. Will being an expert affect your clinical practice? Being a plaintiff’s expert for a local malpractice case in your own town can be risky because you may get a reputation by the local medical community as being “evil”. Doctors talk to each other and if you are a specialist, your referrals may dry up. Even if the case is an agregious deviation from the standard of care, you are often better off being a plaintiff’s expert for cases outside of your practice’s referral network. On the other hand, I’ve been a defense expert for every hospital in our region and this generally did not harm my profession reputation. The exception is if you are a defense expert and you tell the attorney that his/her client did not meet the standard of care. This happened to me when one of my long-time referring physicians was being sued and gave my name to his attorney as a possible expert – I looked the case over and told the attorney about the weaknesses of the case and the attorney advised the physician to settle out of court. The physician has not referred any more cases to me since.
  8. Be thorough. When you are reviewing a case, go through the medical record in its entirety. Don’t just review the progress notes. Sometimes, key pieces of information are buried in the chart. Be prepared to spend several hours reviewing the chart for even a short hospitalization. As an example, I once reviewed a case that involved multiple hospitalizations with the final hospitalization lasting many weeks. There were literally thousands of pages of print outs of the electronic medical records. However there was a single microbiology result that was buried in the lab reports that was never mentioned in any of the progress notes that ended up being the key to the causality of the case and the foundation of the defense attorney’s case.
  9. Expose the warts. No attorney likes to be surprised at trial and learn that what their doctor or hospital did was wrong. They would far prefer to learn about the weakness of their case up front and that way, if their case is indefensible, they can settle it out of court. I once reviewed a case for a hospital that gave the wrong blood to a patient needing a transfusion; the blood was mismatched and the patient sustained permanent injury from the transfusion reaction. I told the attorney that the standard of care was not met. He paid me for my time and went on to settle the case out of court. In another case, I told the attorneys that their doctor had not met the standard of care in managing fluids and electrolytes – they decided to take the case to trial anyway, and the jury found in favor of the plaintiff to the tune of $5 million. I’ve had cases where I thought that the general standard of care was met but that there were some significant problems and that if asked under oath, I’d have to acknowledge them – in those situations, the attorney has often kept me on as a consultant in the case but did not put me on the witness stand to testify, knowing what I would have to truthfully say.
  10. Be careful with your notes. I normally take notes as I go through a medical record. It helps me organize a timeline and abstract key elements of progress notes, lab values, etc. However, the opposing attorney will usually ask you in a deposition if you have any notes that you have made about the case and you will have to given them to the attorney who will make them a into an exhibit for the case. Stick with writing down things that are in the chart (actual lab values, quotes from progress notes, etc.) and do not write down your opinions – anything written down in your notes can be used to contradict you or to discredit you. Also, you are better off having telephone conversations with the attorney who is retaining you rather than sending memos or emails so that you are not asked to produce any emails or documents at trial.
  11. Don’t do literature research about the case unless your attorney tells you to. The opposing attorney can ask you if you reviewed any literature pertaining to the case that you are testifying about. If you did review literature, you are required to disclose it when asked and the opposing attorney can use that literature to try to contradict your testimony.
  12. Keep track of your time. I keep track of my time rounded to the nearest 5 minutes. I also keep track of what I was doing during that time (record review, deposition review, phone calls, travel time, etc.). When I submit my bill, I break my time out by minutes and my activities.
  13. You are now a business owner. As an expert, unless the money you get paid goes to your medical practice company, then you have to report the income on your Federal Income Tax Schedule C. You will need to fill out a W-9 form to submit with your bill to the attorney and then you will received a 1099 form at the end of the tax year. You will need to have a record system to keep track of when you sent out bills and when you received your payments. Sometimes, you won’t get a 1099 form and so you’ll need to know how much non-1099 income you will need to report on your income tax forms. Your own medical malpractice insurance will not cover your expert witness work so you are on your own – if you do a lot of expert work, you may need additional liability insurance. However, there are perks to having Schedule C income – you can deduct expenses on your Schedule C (such as journal subscriptions, textbooks, etc) if those expenses are relevant or necessary for your ability to be an expert in that area. You can also set up an SEP (simplified employment pension) for the income you have on your schedule C and this can be a pre-tax retirement savings plan that will be a tax deduction for the year that you contribute to it.
  14. There is no authoritative text. The opposing attorney will often ask you whether there is a standard, authoritative reference about your speciality or the medical condition you are testifying about. The answer should be “no”. If you say that there is, that attorney will go to that textbook/website/journal article and use whatever is in that reference to try to contradict your testimony. In reality, there is never a single authoritative reference about anything in medicine and our practice is shaped by many books, lectures, journal articles, guidelines, etc.
  15. Only talk with the attorney. Do not discuss the case with your partners, colleagues, or your golf buddies. You will be asked by the opposing attorney if you discussed the case with anyone other that the attorney who retained you and your truthful answer should always be “no”. You don’t want to have your friends get a subpoena to testify about what you discussed with them.
  16. Have an accurate CV. The attorneys are going to research you. If you wrote an article about something, they are going to find it. Don’t try to hide anything in your professional life. I’ve even been asked to present copies of the PowerPoint slides that I use for medical school lectures I’ve given in the past.
  17. Be aware (or beware) of social media. If you use Facebook, Twitter, or other social media to express your opinions on medical issues, the attorneys will find them. Anything that you have stated in social media can be used to contradict your testimony.
  18. Will you be comfortable testifying in court? I’ve spent 30 years giving lectures in classrooms and 19 years appearing in front of the camera for our weekly MedNet webcasts so I’m used to public speaking. Nevertheless, I still get pretty anxious when I am testifying in court. It can be stressful to be challenged by an opposing attorney in front of a jury, judge, and spectators. Some physicians can maintain their composure despite aggressive and persistent grilling and attempts to discredit them publicly but many physicians cannot. If you meltdown in the face of verbal adversity, you will only hurt yourself or the attorney who is paying you.
  19. Know your boundaries. If you are the anesthesiologist testifying in a case involving an anesthesiologist, a surgeon, a nurse, and a cardiologist, make sure that you stick to testifying about the anesthesiology care. If you start testifying about parts of the case outside of your specialty, you can not only risk making a fool out of yourself but you can also harm the attorney’s case.
  20. Don’t testify when you are post-call. Giving a deposition or testifying at trial is like taking a board examination: a good night sleep is essential. You have to be mentally at the top of your game for some brain gymnastics. But unlike taking an exam, you also have to be at the top of your emotional game. You cannot get flustered or angry. For example, when giving a deposition, there will usually be a court reporter transcribing your words but only rarely will there be a videographer. Words cannot portray the emotions that physical appearances do – I’ve had an opposing attorney turn red in the face, shouting questions across the table, with spittle spewing everywhere to the point that I thought he might jump over the table and physically attack me. When I read over my deposition a couple of weeks later, none of that came across in print and I realized that his emotional outburst was a performance by a clever actor to try to get me off-balance and intimidate me. When you are giving a deposition and you start to feel your emotions clouding your logic, then ask to take a restroom break – every basketball coach knows the value of a well-timed timeout.
  21. Spend time prepping for the case with your attorney. A good attorney will want to spend a couple of hours rehearsing the questions that you are going to be asked or could be asked in cross-examination. Do it and if the attorney doesn’t ask you to prep with him/her, then ask for the prep time yourself.
  22. Know the chart. When you give a deposition or testify, you need to know that medical record inside and outside. You’ll need to read it, re-read it, and then re-read it again. When any of the attorneys ask you a question about the case, you need to either know the information from the medical record by memory or know exactly where the information is in the medical record so that you can locate it. Remember, the opposing attorney will have that medical record practically memorized.
  23. Read your deposition. You’ll be asked at the end of giving a deposition if you want to read it before it becomes finalized. Read it. The court recorders are good but they are not perfect. If you used one medical term in your deposition and the court recorder typed in something else, you’ll have the chance to make a correction so that when the case goes to trial, your words that are used in the case are truly the correct words. However, you are only allowed to correct typographical errors – you can’t make changes to your testimony.
  24. Read the other depositions. The attorney who you are working for will decide what depositions he/she wants you to read. If you are given a deposition transcript to read or an expert opinion letter to read, then do so. Sometimes there are golden nuggets hidden deep within the depositions of witnesses and sometimes there are statements by the other experts that can help the attorney you are working with prepare for the case better. It can take an hour or two to read a deposition transcript and it is pretty boring reading but every once in a while there is something in a deposition that only you, in your unique position as an experienced physician, will pick up on.
  25. Avoid color commentary. I was once involved in a case where one of the plaintiff’s experts made a statement in his deposition to the effect “This is the worst care I have ever encountered in medicine”. It turns out that this expert did a lot of work as a plaintiff’s expert and had given many depositions in the past. The defense attorney pulled them all and in the trial, had the expert witness read exerts from deposition transcripts from a half dozen other cases, all of which he had said “This is the worst care I have ever encountered in medicine”. The jury did not believe anything else that the expert said during the trial.
  26. The attorneys are smarter than you think. Attorneys who work in medical malpractice, whether as defense or plaintiff attorneys, are specialists. The good ones have spent years studying medical malpractice and will know a lot about medicine. They usually know what they are talking about but usually don’t like to let on how much they know. This gets back to always be honest in your testimony or in your confidential conversations with the attorneys. Successful malpractice attorneys did not become successful because they were lucky. Assume you are going to be swimming with sharks.
  27. The attorneys are not as smart as you think. You spent years training to do what you do and the attorneys didn’t. You need to be able to explain the facts of the case, often in lay terms. They may not know that there is a difference in the significance in a 2 mEq change in the chloride level versus a 2 mEq change in the potassium level. It is YOU who is the expert.
  28. Prepare to be embarrassed  You will be asked by the opposing attorney about where you did your training, whether you have been sued before, whether you passed your board examination the first time, etc. All of this then becomes public knowledge. If you don’t want to be asked about  blemishes in your professional past, then don’t be an expert.
  29. Answer the question that you were asked. Ever watch a debate between candidates for political office? If one of them gets a question from the moderator that they don’t want to answer, then they respond with the answer to some other question that they do want to answer. In a deposition or in a trial, you can’t do this – just answer the question that you are asked. For attorneys, words matter. If you are asked, “Doctor, do you have an opinion about whether the defendant met the standard of care?”, then your answer is “Yes.”. They can then ask you specifics about your opinions. Do not go off talking about tangential things.
  30. Qualify your answers when appropriate. Remember, your ultimate obligation is to be an advocate for the truth; the attorney’s obligation is to win the case for his/her client (whether that be defendant or plaintiff). Beware of being boxed into a yes-no answer about something that is not a yes-no issue. For example, if the attorney asks you “Doctor, is it not true that if the surgeon had not amputated my client’s leg that he would now have 2 feet today?”, you don’t want to simply says “Yes”. Instead, you would say, “It is true that the amputation removed one of his two feet but if the gangrenous leg resulting from necrotizing fasciitis had not be amputated, the patient would have died.”
  31. Don’t speculate. If you don’t know something or if no one could know something, don’t guess. All of your statements should be “within a reasonable degree of medical certainty”.
  32. Be a teacher. The jury in a medical malpractice trial won’t know very much about medicine. One of your main jobs as an expert is to educate them about the medical issues. Be prepared to speak in simple, lay terms – you’re not giving grand rounds to a bunch of doctors in your specialty. When explaining complex medical issues, look at the jury members directly – make eye contact with each of them at least once. Speak slowly with well-timed pauses for them to distill what you are telling them. Talk like you are trying to explain to a patient and their family about their disease.
  33. Answer the questions succinctly. If your answers to questions are long, rambling, and drag out, you will lose the jury’s attention and their trust. Above all, don’t be boring.
  34. Be confident but not cocky. You need to appear relaxed and honest. If you come across as cocky or smug, you will neither be likable nor believable. Watch your body language – don’t touch your hands together, don’t touch your face, don’t cross your arms, and don’t lean back in your chair.
  35. Look the part. If you are going to be an effective physician expert witness, you need to look like the judge’s or jury’s idea of a physician. That means dressing the part. You want to look like a doctor so don’t wear a $1,000 suit but don’t dress too casually. I usually wear a sport coat, conservative tie, and slacks. Avoid sunglasses, expensive jewelry, lapel pins that make a social, business, or political statement, or casual shoes.
  36. The juror’s time is valuable, also. Being a member of a jury is an important civic responsibility but every one of those jurors would be doing something else that they consider important if they weren’t on jury duty. They are sacrificing their time at work or time with their family to be at that trial. Make sure that when  you are testifying to that jury, that you are treating them with the respect that they deserve and don’t be condescending as if your time is more valuable than theirs.
  37. Your best business advertisement is your deposition. There are usually attorneys from several different firms in a deposition or at trial. If you do a good job testifying, then those attorneys are going to want you on their next case. Once, I testified for the defense of an academic medical center in another city in Columbus. The plaintiff’s attorney hammered me relentlessly and I walked out of the courtroom mentally exhausted and feeling like the guy hated my guts. The day that the judge found in favor of the hospital, I got a call from the plaintiff’s attorney asking me if I’d look at a case for him. Later, his father became one of my patients.
  38. These things take time. The civil litigation process can at times be very slow. You may do a review of medical records about a malpractice case and then not hear anything from an attorney for 2 years or more. Don’t dispose of those records (or your notes) until you have hear from the attorney that the case has been dismissed or settled. Only then, send those records to the shredder.
  39. Don’t expect thanks. In all of the defense cases that I’ve reviewed, written opinion letters about, done depositions for, or testified in, I was only thanked by the defendant twice. I’ve been a defense expert for some of the most famous academic physicians in the country and never heard a word from them after successful resolution to their cases. Remember, your obligation, whether as a plaintiff expert or defense expert, is to the truth and to the integrity of the medical profession and neither the truth nor the profession will send you a thank-you note after the case.
  40. Always, always, alway be honest. You will be paid by the attorney but your primary obligation is to the truth and to the integrity of the medical profession. Your job is not to win a debate, it is to accurately explain what happened in the case and whether the care provided was appropriate. If you get as far into a case that you are going to do a deposition or testify in court, it should be because in your best judgement you truly believe the arguments that you are going to state. If, as you get into record review and deposition transcript review, you come to believe that you don’t agree with the case as the attorney who retained you is going to present it, then tell the attorney but don’t go forward in a case that you don’t believe in.

January 28, 2018

Medical Economics Medical Malpractice

The Geography Of Malpractice

There are a lot of variables that go into the cost of medical malpractice premiums. One variable that is often overlooked is geography. The cost of premiums can vary tremendously from one part of the country to another and can even vary from one part of a state to another. For hospital medical directors seeking to recruit physicians, it is important to be aware of these differences since it will impact your hospital’s competitiveness for recruitment.

75% of physicians in low risk specialties and 99% of physicians in high risk specialties are named in a malpractice case by age 65. Even though most cases never go to trial and those that do go to trial are more often won by the defense, malpractice is very expensive with an estimate that the overall cost of $31/American per year and if the cost of defensive medicine is factored in, it is $174/American per year. In obstetrics alone, 1 out of every 3,711 births results in a malpractice claim resulting in the cost per delivery just to cover malpractice liability being $296.

Let’s take a look at the spectrum of annual costs for malpractice premiums across the United States:



Even within a state, there can be huge differences in premiums. In Ohio, for example, malpractice premiums are significantly higher in Northeastern Ohio (Cleveland area) than in Central Ohio (Columbus area):

malpractice 2

So why the differences? Different states have different tort laws making it easier or harder for malpractice lawsuits to be filed. There are also state-specific monetary limits on damages that can vary considerably. As a general rule, states that have passed tort reform laws have fewer malpractice claims filed and lower overall pay-outs to the plaintiffs. Primarily for this reason, malpractice claims have been dropping over the past 20 years.

The penetration of hospital employment models also affects the vulnerability of physicians to malpractice suits and the overall cost of a given malpractice case. For example, in a community where physicians are mostly in private practices, if several physicians plus the hospital are all named in a suit, then each has to have their own attorney and expert witnesses, increasing the overall cost to defend the suit. Additionally, there can be finger pointing among the different physician named which makes the plaintiff attorney’s job easier. Where most physicians are hospital-employed, the physicians and hospital can mount a common defense and there is no finger-pointing.

In some states, certain physicians can claim “immunity” and thus not be personally named in a suit. This primarily happens with government-employed physicians, including those of us employed through the Ohio State University. In this case, the hospital is named but the individual physicians may not be. Additionally, in Ohio (for example), there are two court systems that hear malpractice cases: the Court of Common Pleas (cases decided by jury) and the Court of Claims (cases decided by a judge without a jury). Malpractice cases involving teaching physicians and government-employed physicians go to the Court of Claims where large payouts based on emotionally sensitive juries are avoided. In states without these provisions, malpractice cases are more common and more expensive.

Lastly, there can be regional cultural differences in patients’ willingness to sue physicians and in the community’s (and thus the juries’) likelihood of deciding in favor of the plaintiff. This plays out in Ohio where 50% of all malpractice cases in the state arise from the Cleveland area and as a consequence, malpractice premiums are higher there.

The regional variation in malpractice does result in regional variation in medical costs to the consumer. For example, let’s look at the difference in obstetrics in Long Island, NY versus Central California. The table below is what Medicare pays for obstetric services in the two regions; most commercial insurance companies will base their reimbursement for obstetric care off of what Medicare will pay. Obstetric costs are considerably higher in Long Island than in California (in keeping with the differences in malpractice premiums as mentioned earlier).

malpractice 3

However, since the cost of malpractice premiums is nearly $200,000 more per year in Long Island, an obstetrician in Long Island would have to do 400 more deliveries per year than an obstetrician in California and that is just not humanly possible.

So if your hospital is looking to hire a physician, know what your state-specific and region-specific malpractice insurance will cost that physician because it will affect how that physician will look at a job at your hospital. To hear more about medical malpractice, check out our OSU MedNet webcast on malpractice.

August 2, 2016