Category Archives: In the Courtroom

The Standard of Care

In order to prevail in a medical malpractice action, the plaintiff must show, by a preponderance of evidence standard, that the defendant owed a duty of care to the plaintiff, the defendant was negligent in providing that care, the plaintiff was injured, and the legal cause of the injuries was the negligent care. All four of these elements must be shown for the plaintiff to win.

The most compelling type of medical malpractice case is the failure to diagnose a life-threatening condition which results in the death of the patient. Myocardial infarction, aortic dissection, certain malignancies, and neurologic injuries represent these types of cases. If the provider can show that he considered these types of conditions and he took steps to make the diagnosis, then he will likely win even if the diagnosis is missed.

There are false positives and false negatives for all diagnostic tests and the courts recognize this. In general, expert testimony is needed to confirm or deny that the provider did what a reasonable provider would do if faced with the same or similar circumstances. Expert testimony is required because most people do not have the knowledge or experience needed to make decisions on standards of care by themselves. Under the law, an expert can be used to educate the trier-of-fact to better understand the evidence or determine a fact in issue.

In most states and in the federal courts, an expert witness must be qualified by knowledge, skill, experience, training, or education so that he can testify in the form of an opinion or otherwise. Before an expert is allowed to testify, the court must act as a gatekeeper to determine if the expert’s testimony will substantially assist the trier-of-fact. The factors that the court will use in making this determination are (1) whether the scientific evidence has been tested, (2) whether the evidence has been subjected to peer review and publication, (3) whether a potential rate of error of the evidence is known, (4) whether the evidence is generally accepted in the appropriate scientific community, and (5) whether the expert’s research in the applicable field has been conducted independent of the litigation. These factors come from the Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 U.S. 579 (1994) holdings which relate to what an expert witness is allowed to testify about in a malpractice action.

Prior to Daubert, the federal courts used the “generally accepted” standard which originated from Frye v. United States 293 F. 1013 (D.C. Cir. 1923)In Frye, the court held that novel scientific testimony is admissible in federal courts if the testimony had been “generally accepted” in the appropriate scientific community where it had originated; expert testimony must be based on scientific methods that were reasonably used and accepted. Most states then came on board with this standard and it had been used for over 70 years.

Most states and the federal Courts have adopted the holdings of Daubert but some have not. There are still 13 states which follow the standard of Frye.The Frye standard is a much easier to meet than Daubert. The courts that use the “generally accepted” standard reason that the jury should be allowed to rule on the relevance of the testimony and there should be no prior screening by a judge.

The “standard of care” is defined by statute in most states. For example, in Tennessee, it is “the recognized standard of professional practice in the profession and the specialty thereof, if any, that the defendant practices in the community in which the defendant practices or in a similar community at the time of the alleged injury or wrongful act occurred.” Most states do not have the community standard element that is in the Tennessee statute.

In medical practice, there are many conditions which now have recommendations for care and treatment. These recommendations come from committees comprised of recognized experts in the field. I was at a lecture for continuing legal education where a well-known plaintiff’s attorney stated that, as far as he was concerned, the “best practices” paradigms recommended by these committees were now the “standards of care” and any health care provider who did not follow the paradigms was committing medical malpractice. He was wrong.

Most, if not all, of the publicized treatment recommendations have a disclaimer which recognizes that it is up to the treating clinician to decided on the proper care of a particular patient. The law has not changed; the standard of care is still the care that would be provided by a reasonable physician who is faced with the same or similar circumstances. If a reasonable clinician would not have followed the committee’s recommendations, then the standard of care may still have been met.

Here is an example where the paradigm may not be the standard of care. Under the committee recommendations, a person who presents to the hospital with an acute coronary syndrome should be given morphine, oxygen, aspirin and nitrates. According to the above mentioned plaintiff’s attorney, a person not getting all elements of this treatment regimen would be the victim of malpractice. However, physicians would not give morphine to a person with a low blood pressure or to someone who is allergic to the drug. A patient who has severe chronic obstructive pulmonary disease may stop breathing if given supplemental oxygen. A person who has gastrointestinal bleeding or is allergic to aspirin should not be given that drug. We know from TV commercials that a person on Viagra or Cialis should not take nitrates as that could lead to a sudden dangerous drop in blood pressure.

Opposing attorneys will try their best to discredit the expert witness on cross-examination and they have many weapons in their arsenal to accomplish this goal. One strategy is to let the jury know how much has already been paid to review the medical records, study deposition testimony and answers to interrogatories, and how much is being charged per hour to do the reviews, give testimony at depositions, and testify at trial. The amounts can be substantial and many professionals make a significant income performing as an expert witness. If it can be shown that a particular witness has been paid a lot of money, then the jury may conclude that his opinion is being bought; the credibility of the witness will suffer accordingly.

Although there are many other ways to attack an expert on cross-examination, one of the best is to show the jury that he may not be an expert at all. This can be done by exposing weaknesses in the expert’s curriculum vitae. A national survey of 2.6 million resumes done in 2003 showed that 41 percent lied about their work experience and 23 percent lied about their credentials or licenses. A surprising 41 percent lied about their education (Thomas A. Buckhoff, Preventing Fraud by Conducting Background Checks, CPA J., Nov. 2003). Opposing attorneys now routinely check the backgrounds of medical expert witnesses and they will even look at social media sites to see if they can find some incriminating information that can be used to attack their credibility.

If it can be shown that the medical expert was willing to embellish on his qualifications, it is logical to assume he has embellished his medical opinions, also.

There are few trial lawyers that can show superior knowledge to the expert in the medical field under discussion. After all, they are lawyers and it is unlikely they have ever treated an actual patient. Book knowledge is just not enough to be a good physician and that is probably why it is called the “practice of medicine.” By practicing, you are hopefully improving your knowledge and skill as a physician all the time.

If the physician can show he used his best clinical judgment at all times while caring for the patient, he will likely win his case even if the results were not good. Physicians are forced to make judgments, some of which do not work out well for the patient. These decisions are made with the best data available; they cannot rule out every single diagnosis or provide perfect care. The courts and the juries recognize this and will generally rule in favor of the physician who has used his best judgment and done it in a timely fashion. The physician can be his own best medical expert witness in this regard.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

You Can Have Your Cake

The United States Supreme Court will soon have a decision on Masterpiece Cakeshop v. Colorado Civil Rights Commission. The decision is one of the most anticipated in the present term of the Court as it examines the rights of creative professionals to withhold their services based on religious objections. The Court must decide based on what seems to be a conflict of free speech and free exercise of religion, both provided under the First Amendment of the Constitution, and anti-discrimination law.

The facts of the case are as follows. In July 2012, Charlie Craig and David Mullins decide to get married. It was to be a same-sex marriage which, at that time, was not recognized in Colorado. They planned to be married in Massachusetts and then have a reception at a Denver restaurant. In anticipation of the Denver reception, they went to Masterpiece Cakeshop in Lakewood Colorado where they hoped to purchase a cake designed for them by the bakery’s owner.

The bakery owner, Jack Phillips, was a self-professed cake artist who was known for his elaborate cake creations for weddings and other celebrations. He was also a devout Christian who had a history of not baking any goods for any Halloween or bachelor party (sexual in nature?) themes. Since Mr. Phillips had strong religious objections to same sex marriages, he refused to design a cake that would be part of either a wedding or a marriage. Interestingly, he was willing to make them baked goods for any shower, birthday, or other occasion that was not related to the wedding. He was also willing to sell them a cake off the shelf but he just could not participate in creating a new, unique cake for the reception itself.

Craig and Mullins filed a complaint with the Colorado Civil Rights Commission against Masterpiece Cakeshop alleging they were discriminated against based on their sexual orientation. Phillips argued that his artwork was a form of speech and he could not be compelled to participate in the expression needed to make the cake. He also argued that he could not be compelled to make a cake that would impair his free exercise of religion.

The case was first heard by an administrative judge who rejected both the free speech and free exercise of religion claims. The judge reasoned that since there was no particular design or message requested by Craig and Mullins, then there could be no free speech right to deny the request.

The original decision was confirmed on appeal to the state civil rights panel. This panel then ordered Phillips to design wedding cakes for any subsequent same-sex weddings so long as he does this for opposite-sex couples. He was also ordered to provide training for his staff in regard to the state’s anti-discrimination law.

The Colorado Court of Appeals upheld this decision stating that Phillips would not be conveying a message in support of same-sex marriage just because he was following the state’s law.

Phillips followed the ruling of the courts by choosing to stop making any wedding cakes at all. This had a significant effect on his business but it allowed him to follow his religious tenets.

Phillips appealed to the Colorado Supreme Court but they declined to hear the case. However, the Supreme Court of the United States granted a review.

The issue confronting the Court is the right of artistic individuals to create works of art that are consistent with their religious convictions. One of the main hurdles for this argument is to convince the Court that custom cakes made by a self-professed “cake artist” is truly an artistic expression. One of the amicus briefs in support of Phillips includes color photos of custom cakes made for numerous occasions. Since art is in the eye of the beholder it is hard to predict how the justices will rule on this argument.

Another brief coming from then Acting Solicitor General Jeffrey Wall argues that the First Amendment protects Phillps from having to participate in any ceremony that would violate his religious beliefs. This brief is narrowly written to include only the anti-bias law relating to same-sex marriages and is clear to exclude discrimination base on race. The brief states, “[a] state’s ‘fundamental, overriding interest’ in eliminating private racial discrimination—conduct that ‘violates deeply and widely accepted views of elementary justice’—may justify even those applications of a public accomodations law that infringes on First Amendment freedoms.”

Craig and Mullins contend that any business that makes a product and is open to the public must be willing to sell to any customer. Phillips was willing to sell any cake on display in the bakery but he was not willing to use his artistic skills to make a special one relating to the same-sex marriage.

The recent Supreme Court decision of Obergefell v. Hodges 576 U.S. (2015) held that all states must recognize and license same-sex marriages. This decision rested on the Fourteenth Amendment which the majority felt protected gay couples who were trying to get married and have those marriages recognized in all of the states. In dicta, Justice Kennedy did note that “many who deem same-sex marriage to be wrong reach that conclusion based on decent and honorable religious or philosophical premises.” Will Kennedy decide that there may be a religious exception for artists who have religious convictions contrary to the written law? There is precedent for this holding in the Affordable Care Act where certain religious orders were exempted from having to provide birth control services in their mandated insurance coverage for their employees. Will the Court write in a religious exception for artists to allow them not to use their artistic skills for religious reasons?

The case is coming down as a conflict between the First and Fourteenth Amendments. Since this battle is dealing with a highly contentious social issue, I would predict that the Court will have a very narrow holding; it is likely they will rule only on a product based on artisitic expression and they may even limit it to artistic cake makers. If they are broad in their decision, then any store owner may decide to turn away customers for any reason so long as they can show that their product has some sort of artistic expression. This would likely lead to more litigation to clarify the decision.

Obergefell was a close decision with Kennedy coming down on the side of the majority. It is likely that he will be the one to cast the deciding vote in Masterpiece Cakeshop.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Apologies May Not Be Enough

Taking care of sick people can be a messy business and sometimes things don’t turn out as planned. When things go bad, the natural tendency of the physician taking care of the patient is to distance himself from the case; it is difficult to talk with the patient and the family when there is the threat of pending litigation.

Avoiding discussions of patient harm comes from the mindset that this harm is likely to result in a medical malpractice suit and it is best to not say anything that may be used for negative effect in the future, especially a statement that may be construed as admitting fault. In fact, it used to be common for malpractice insurers to encourage their physicians to “deny and defend” against any possibility of being accused of negligence in a possible lawsuit.

The thought of apologizing for a bad result was anathema; the apology may be the first indication that something has gone wrong and may be interpreted by the patient as physician negligence. Even if the apology could not be used as evidence of negligence, it may cause the patient to look for other evidence that they can use. Even without any other obvious evidence, the apology itself may be enough for the patient to file a suit and then look for other evidence during the discovery phase.

However, the lack of forthright communication may lead to anger which makes a malpractice lawsuit more likely in the long run. It is this theory that led many states to look at ways to increase physician-patient communication in hopes of decreasing the number of medical malpractice lawsuits. The goal was to resolve cases before they reached the level of litigation.

Under the theory that more physician communication may lead to a decrease in lawsuits, at least 37 states and the District of Columbia have enacted “apology laws” which encourage doctors to apologize to patients and their families whenever the patient has been harmed. Under these laws, the “apology” cannot be used as an admission of liability in any future malpractice action; these laws were meant to encourage physicians to show compassion and sympathy; when the patients saw that their physicians cared, the belief was they would be less likely to sue.

Unfortunately, the data is mixed as to whether or not the “apology laws” have led to a decrease in malpractice lawsuits. A study done by Benjamin McMichael, a postdoctoral scholar at Vanderbilt’s Owen Graduate School of Management showed, “In general, the results are not consistent with the intended effect of apology laws, as these laws do not generally reduce either the total number of claims or the number of claims that result in a lawsuit.” (Sorry Is Never Enough: The Effect of State Apology Laws on Medical Liability Risk)

There are thirty states and the District of Columbia which protect partial apologies; these are apologies that do not contain any admissions of liability for negligent actions. There are seven states that protect full apologies; these are apologies that may contain statements or expressions of fault, mistakes, and liability. The seven states which are known to protect full apologies are Washington, Colorado, Connecticut, Arizona, Georgia, South Carolina, and Vermont, and It looks like Ohio has just joined this group.

In a recent decision, the Ohio Supreme Court (Stewart v. Vivian, Slip Opinion No. 2017-Ohio-7526), held that the State’s apology law included acknowledgements that the patient’s care may have fallen below the standard of care. The Court stated, “expressing apology is a statement that expresses a feeling of regret for an unanticipated outcome of the patient’s medical care and may include an acknowledgement that the patient’s medical care fell below the standard of care.”

The case of Stewart v. Vivian, came from a lawsuit filed against Dr. Rodney Vivian after the death of Mr. Stewart’s wife. The wife had committed suicide after being admitted to a psychiatric unit at a hospital in Batavia, Ohio. Even though Mrs. Stewart was on a suicide watch, she was still able to hang herself during a period when she was not being observed. When Dr. Vivian later spoke to the family, he expressed what he claimed were statements of sorrow but the family felt the statements also expressed more than just sympathy and should be allowed into evidence as an admission of liability. Dr. Vivian denied that his statements admitted any negligence but the family was willing to testify, under oath, that he did.

The legal issue centered on whether or not Ohio’s “apology law” included an admission of fault. If the court believed that the law did not include admissions of fault, then the family would be allowed to testify on what they believed Dr. Vivian told them during his “apology.” The trial court ruled that Dr. Vivian’s apology could not be submitted in evidence even if the apology had an admission of negligence.

On the malpractice case, the trial court ruled in favor of Dr. Vivian. The family appealed claiming that the Court should have let them testify as to what they felt was conveyed in Dr. Vivian’s apology.

On appeal, the 12th District Court of Appeals held that Dr. Vivian’s statements were properly kept from the jury because the law was ambiguous and the dictionary definition of “apology” may or may not include an admission of fault. This ruling seemed to conflict with a previous ruling from the State’s Court of Appeals in the 9th District which concluded that the law did not include an “admission of fault.” (Davis v. Wooster Orthopedics & Sports Medicine, Inc.). Since there was a split at the Appellate Court level, the State Supreme Court stepped in and resolved the issue by agreeing with the Appellate Court. In Ohio, the “apology law” now includes admissions of negligence and it was proper for the trial court to keep all of Dr. Vivian’s statements of sympathy from the jury, even if negligence had been admitted.

The states that do not have any apology laws include Alaska, Nevada, New Mexico, Kansas, Minnesota, Illinois, Kentucky, Arkansas, Mississippi, Alabama, New York, and Rhode Island.

Since not all states with “apology laws” include admissions of fault, it would be wise for a physician making an apology to know which rule applies to his State. It would also be prudent for a physician expressing sympathy, condolence, or an apology, to pick his words very carefully. He should also make a note in the chart reflecting his thoughts at the time of the conversation; what the family claims they heard may be different from what the physician may claim he was trying to express; usually when there is a fact conflict like this, it is a matter for the jury to decide. Dr. Vivian was protected under his State’s law. Other physicians may not be so fortunate.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Different States; Different Suits

It is commonplace to hear advertisements both on television and radio where some legal firm is looking for clients who may have been injured by some “bad drug” such as a blood thinner which may have caused a bleeding problem, a faulty medical device such as meshes used for hernia repair, or for patients who may have developed mesothelioma from exposure to asbestos. The more clients they can get to sign up with their firm, the larger the possible settlement will be. Since these lawyers are usually working on a contingency, their share of the settlement is likely to be very large.

A recent Supreme Court decision will now make it more difficult for these plaintiff attorneys to reap a single large payday; instead, they will have to litigate in each state where a group of patients may have been harmed or they will need to bring the suit where the manufacturer is incorporated or where it is headquartered.

In BristolMeyers Squibb Co. v. Superior Court of California, San Francisco County, Et. Al., a group of plaintiffs, many of whom were California residents and some who were allegedly injured in other states, brought suit claiming that they were injured by Plavix, a blood thinner. The legal issue centered on the State’s jurisdiction for the nonresident plaintiffs. Bristol-Meyers Squibb (BMS) tried to get the nonresidents’ claims removed from the suit because of lack of personal jurisdiction in the State. The Court ruled that there was enough activity by the defendant to allow for general jurisdiction by the California Courts. In order for general jurisdiction to attach, it must be where the defendant corporation is deemed to be at home. This could only be where the defendant is headquartered or incorporated. Since BMS was incorporated in Delaware and headquartered in New York, general jurisdiction should not have attached so the Court got this legal issue wrong and BMS appealed.

The Court of Appeals agreed with BMS and found that California did lack general jurisdiction but the Court went on to hold that California did have specific jurisdiction over the claims brought by the nonresident plaintiffs. In order to have specific jurisdiction, the defendant needs to have a connection with the forum and the specific claims at issue. Was the connection enough to force BMS to defend itself in California for the injuries claimed by plaintiffs who were not injured in California? Previous jurisprudence seemed to require that there must be a connection between the forum and the specific claims at issue. How could the claims of nonresidents be connected with BMS activities in California?

The California Supreme Court felt that BMS’s contacts with the State were enough to allow for specific jurisdiction over the nonresidents’ claims because these claims were similar to the residents’ claims and because BMS had sufficient activities in the State to support jurisdiction. They relied on the fact that BMS had contracted with a California company, Mckesson, to distribute Plavix nationally.

The United States Supreme Court took the case on appeal and they held that the California courts did not have this specific jurisdiction because the suit of the nonresidents did not “arise out of or relate to the defendant’s contacts with the forum.” The Court held that the contract with Mckesson was just not enough to force BMS to defend itself against the nonresident plaintiffs.

The decision in BristolMeyers Squibb does not say what will need to be done if there is more than one defendant each headquartered or incorporated in different States, but the logical conclusion is that there will need to be separate suits for each defendant. This may make comparative fault issues very difficult to decide and is likely to lead to crossclaims and counterclaims. This will likely increase the costs of litigating these types of cases.

In a dissenting opinion, Justice Sotomayer stated that this decision will make it much more difficult for plaintiffs to hold corporations accountable for conduct that is uniform around the country. She wrote that it “does not offend ‘traditional notions of fair play and substantial justice,’” International Shoe, 326 U.S., at 316, to permit plaintiffs to aggregate claims arising out of a single nationwide course of conduct in a single suit in a single State where some, but not all, were injured.” In essence, Sotomayer believes the decision will overturn the holding of International Shoe which allowed States to go after corporations that did substantial business in their State. However, the holding still allows the States to have jurisdiction, but they can only fight for those who were injured in their State. It looks like International Shoe will still have a role in this type of litigation.

With this decision, plaintiffs will only be able to bring a legal action in the State where they were injured or in the defendant’s state of incorporation or where the defendant is headquartered. This means that actions which could have been decided in one court may now have to be divided with each interested State litigating the same type of case in their own jurisdiction. This division of cases could lead to very different results and will significantly add to the costs of the firms who are bringing suit in the first place; court costs, expert witness fees, time spent by the lawyers dealing with each court, will be multiplied by the number of States in which there are plaintiffs alleging injury.

In general, plaintiff’s attorneys do not like to bring suit in the defendant’s home State as they feel those courts are more likely to be favorable to the corporation. It is common practice for plaintiffs to bring suit in a forum which they feel will be more receptive to their cause. BristolMeyers is likely to make forum shopping by plaintiffs more difficult.

Of course, plaintiffs can try to start a “class action” on a national level, but that has a whole set of rules that can be difficult to meet. This is especially evident when different plaintiffs are looking for different remedies or when there are different attorneys looking to represent different plaintiffs.

With the decision in BristolMeyers Squibb, plaintiffs will no longer be able to consolidate a legal action in a State in which only some of them have been injured. This will hold even if the plaintiffs who were injured in different States are suing the same company for the same type of conduct that is alleged in the forum State. In the future, the only type of mass action that will be allowed will have to be brought on the defendant’s home turf. This will be to the disadvantage of the plaintiffs who would prefer the case to be heard by a more favorable State court and will make it more difficult for the plaintiff who may have to deal with a jurisdiction far from his home State.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Supreme Court Clarifies Venue Rules for Patent Infringement Suits

During the course of my career, there have been numerous advances in both medical and surgical care. In fact, some of my own research has been used to change the management of some disease entities and has been used by others to make new medical devices. When I was a resident, I was advised by several of my attendings to never “make up” a new operation unless absolutely necessary. I have followed this advice but there were some extreme occasions where I had to think outside the box to save a a patient. These new ideas led to some basic research and then, as warranted, clinical studies.

During the early parts of my career, it never dawned on me to patent any new application and/or device; I was glad that something new that I had worked on could be used to help others. However, many medical schools, recognizing there may be economic reasons to patent new ideas, began to form groups to lay claim to intellectual property emanating from their employee’s research. It turns out that patent law is now a pretty big deal in medicine.

In law school, I took a course dealing with intellectual property. The topics covered included Trademark, Copyright, and Patent law. My undergraduate training in biomedical engineering made for a good foundation for this type of law as I was able to understand the science and math that were the underpinnings for Patent Law.

As for Copyright, I was surprised to learn that you could claim an ownership interest for anything you may have written and published in a “tangible medium of expression.” However, you should still register your work in case you ever need to bring a lawsuit for infringement since a registration within five years of the publication is considered prima facie evidence that the work is yours.

We are all familiar with the recent lawsuits emanating from the various “dot coms” suing each other for patent infringement. The financial stakes in this litigation can be astronomical. Previously, the location of the suits was critical as it could sway the outcome one way or another. A recent Supreme Court decision has changed this “forum” issue in hopes of leading to more uniformity in decision-making and cut back on the strategy of “forum shopping” by the interested parties.

In TC Heartland v. Kraft Foods Group Brands, the United States Supreme Court held, that as applied to domestic corporations, the residence of the corporation will be the State of incorporation, for the purposes of the patent venue statute. In this case, the petitioner, TC Heartland was a company that was organized under Indiana law. They made flavored fruit drink mixes. The respondent, Kraft Foods, was a competitor in the same market and this company was incorporated under Delaware law even though its primary place of business was in Illinois.

The issue in Heartland v. Kraft was whether the plaintiff (Kraft) could bring a patent infringement lawsuit against another corporation in any district where the defendant corporation is subject to the court’s personal jurisdiction with respect to the civil action. There is a general venue statute, 28 U.S.C. section 1391(c), which states that , “[e]xcept as otherwise provided by law” and “[f]or all venue purposes,” a corporation “shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question.”

However, there is another law that deals specifically with patents. In 28 U.S.C. section 1400(b), “[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” In a previous Supreme Court ruling (see below), the Court held that for purposes of section 1400(b), a domestic corporation “resides” only its State of incorporation.

In this case, Kraft sued TC Heartland for patent infringement and brought the case to the District Court of Delaware even though TC Heartland was not registered to conduct business in Delaware and had no meaningful local presence in that state. However, it did ship the allegedly infringing products to that state. Kraft felt it would be better to have the suit heard in Delaware rather than the home state of TC Heartland. Of course, Heartland preferred to have the case transferred to the Southern District of Indiana where it felt it would have a more favorable court.

Heartland argued that it did not reside in Delaware under the first clause of section 1400(b), and it also argued that it did not have a regular place of business in Delaware under the second clause of section 1400(b). The District Court rejected these arguments holding that the definition of “resides” will be that found in section 1391(c). Under this definition, Delaware could excercise personal jurisdiction over TC Heartland. On appeal, the Federal Circuit agreed with the District Court.

The Supreme Court agreed to hear the case as to the venue issue and ended up reversing the holding of the Court of Appeals. In a previous decision, the Supreme Court held that the word “reside[nce] in section 1400(b) has a particular meaning as applied to domestic corporations: for patent purposes, it refers only to the State of incorporation.” (Fourco Glass Co. v. Transmirra Products Corp., 353 U.D. 222, 226) In a complex legal argument, the Court stated that subsequent laws did not change the venue statute as it applied to patent infringement cases.

Heartland wins on the venue issue and it looks like the case will now be heard in the courts of Indiana; unless a settlement is reached beforehand. This holding will probably lead to more patent infringement cases being heard in Delaware where many corporations “reside” and where the courts are more favorable to the companies incorporated there. It should lead to fewer cases being heard in courts which have a history of being more favorable to plaintiffs such as in the Eastern District of Texas.

One issue that has not yet been addressed is whether the courts will adapt the “established place of business” clause to include the internet which is being used by many companies to conduct business especially in retail sales. If the internet is deemed to be an “established place of business,” then we are likely to see a return to forum shopping by plaintiffs in patent infringement cases.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Getting Sued For Malpractice

I was a new attending in Cardiothoracic surgery at the Medical College of Pennsylvania in Philadelphia when I was sued for medical malpractice for the first time. I was shocked; then angry; then hurt. The case involved a lady in her 60’s who was undergoing a cardiac catheterization when the coronary artery closed down. Closure of a coronary during an angioplasty does not happen very often, but it is a known complication and the results can be devastating. It was early evening and I was on call.

When I first laid eyes on this patient, she was already intubated and an intra-aortic balloon pump had been placed by the cardiologists taking care of her. Obviously, there was no opportunity for me to form any kind of physician-patient relationship with her prior to going to the operating room as she was at risk for dying if we did not re-establish blood flow to that portion of her heart quickly.

Fortunately, the operation went well. We did a three-vessel coronary bypass and she came off of the heart-lung machine nicely. The intra-aortic balloon pump came out the next day and she weaned easily from the ventilator.

The hospital course was uneventful and she went home a week after the operation. So far so good.

I saw her in follow-up a week later. Her wounds were healing well and she was feeling fine. This was a good “save”. I saw her in the office one more time about a month after the operation. Since she was still doing well, we sent her back to the cardiologists for management of her rehabilitation; this is routine after heart operations.

About a year later, I was served with a malpractice suit. Apparently, she developed a Bell’s palsy about two months after the operation. A Bell’s palsy is a facial nerve paralysis which is thought to be viral in origin. The disorder varies in severity but this patient had a drooping of the eyelid and was unable to close a corner of her mouth; both bothersome but not life threatening. Even though her palsy resolved over a few months, someone convinced her that I must have done something wrong otherwise this would not have occurred. It is possible, even likely, that the operation may have affected her immune system for a period of time and this may have contributed to development of the palsy, but there was no breach of the standard of care on my part.

My malpractice carrier found me a defense lawyer who would start me on my legal education. I learned that Philadelphia was one of the most litigious areas of the country and surgeons were often sued for any adverse outcome even if the outcomes are known complications that can occur even in the absence of negligence.

I was advised to not take the suit personally but, of course, I did. This lady was on death’s door when I first saw her. She had a good and timely operation and she was doing well in routine follow-up. The Bell’s palsy was unfortunate but it was not due to any medical negligence. It did not matter. I had to suffer through the process where I had to answer interrogatories from the plaintiff many of which implied that I was a terrible surgeon. Even though the suit was eventually dropped, I had to spend hours reviewing the medical records and educating my attorney so that he could mount a competent defense. Explaining the nuances of heart surgery to a non-physician can be challenging but this had to be done so that the attorney could have the knowledge to counter the claims of the plaintiff.

This patient’s operation was done at night. Patient’s can get in trouble at any time and we physicians are trained to take care of them; sleep is lost, meals are missed, family functions go on without us. Being a physician is a calling. We know what we are getting into and we do it willingly. Most of us love what we do and we know that being sued for medical malpractice comes with the job; but it is very unpleasant.

As for cardiothoraic surgeons, four years of medical school followed by 6 to 8 more years of surgical training seems to be losing its attraction. Today, in America, we are fortunate if we can finish training 80 cardiothoracic surgeons a year. This is not nearly enough to meet the demands of the specialty for the near future. We are still uncertain of the impact of the “baby boomers” on the need for cardiothoracic services, but we know that this population is scheduled to peak in 2030; there will be an influx of 13 million people at the right age for cardiovascular disease.

With the population rising and the number of trained cardiothoracic surgeons falling, the American Association of Medical Colleges is predicting a shortage of 1500 surgeons right at the time when they will be most needed. I think that these projections are optimistic.

There are new medications to treat atherosclerosis, diabetes, and hypertension and there are new devices being developed which allow non-surgeons to stent open occluded coronary arteries and even place new heart valves. These medical advances may mean that we will not need as many surgeons in the future but we would be better served if we “plan for the worst and hope for the best.”

As long as medical malpractice premiums continue to rise and remuneration for being a physician continue to fall, it is foreseeable that there will be less surgeons in the future. This shortage is likely to become a political issue. I doubt that the government will be willing to send the patients out for care to other countries (”medical tourism”) but they may be willing to hire foreign doctors some of whom will not have the same type of training that our Boards now require.

Or we may be heading to a health care system that rations care. Patients of a certain age may not be allowed to have the operation they may need. How sad. I never thought that rationing of care would happen in my life-time, but I think that the infrastructure is already in place to do just that.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Informed Consent

The issue of informed consent is one of the theories that Plaintiff’s attorneys often use in pursuing a medical malpractice action. The legal dimensions of this theory find their origins in the Law of Battery whereby any unpermitted contact or offensive touching is considered to be a personal indignity. This personal indignity is not allowed. It relates back to a right of privacy that, although not explicitly stated in the Constitution, the Justices believe to be in there somewhere.

Under its police power, a State is allowed to make laws meant to ensure the general welfare. Laws relating to “informed consent” come from this power; the doctrine has evolved over time relating to previous court decisions and legislative enactments.

In 1992, the American Medical Association recognized the physician’s duty to provide sufficient information to the patient so that the patient could make an informed decision as to the treatment plan. They wrote this into their Code of Ethics. The Code specifies that the physician must disclose what a reasonable patient would need to know in order to give an informed consent. This requirement is now referred to as the “patient-centered” standard and is the law in Tennessee. However, most states do not use this patient-centered standard and have instead opted for what is called the “professional disclosure” standard.

Using the “professional disclosure” standare, the physician must disclose what a reasonable physician would disclose under the same or similar circumstances. Note that this standard may not provide the patient with the information he might need to make an intelligent decision. Also, this standard would require a medical expert witness to educate the jury as to what information the reasonable practitioner would need to provide under the circumstances of the case. In the “patient-centered” standard, the jury could decide what is reasonable on their own.

So what constitutes “informed consent”? In Tennessee, informed consent depends on what a reasonable patient would need to know to come to a reasonable decision as to what may be done to his body. The appropriate information that would be needed is a question for the jury and does not require expert testimony. The jury should be able to decide on their own if the patient was given the appropriate information to make a reasonable decision.

The question of what should be discussed with the patient may require expert testimony on the subject. The expert will need to opine on what a reasonable practitioner would need to discuss with the patient so that the patient would have the appropriate information to make an informed decision. Case law has clarified this issue. The practitioner must discuss the diagnosis and the nature of the condition; the reasons for the proposed treatment or procedure; risks involved and prospects for success; alternative methods of treatment along with the risks and benefits of such treatment. The practitioner must also tell the patient if the treatment or procedure is experimental. Whether the information given is sufficient will depend on the risks involved, the nature of the treatment, and the standard of care applicable to the person obtaining the consent. During the process, the patient must be allowed to ask questions and have these questions answered by the provider.

Does the hospital have an independent duty to obtain informed consent? It does not. What does the hospital know anyway? The courts recognize that only the practitioner is competent to explain the procedure or the planned course of therapy to the patient.

However, the hospital may be liable for a physician’s breach of the duty to obtain informed consent. This would occur in the situation where the provider is an employee of the hospital or the hospital controls the provider’s practice is some way. If the hospital knows that the physician is not fulfilling his duty to obtain the consent, it could have some liability. The hospital can protect itself by having a policy which would have some sort of mechanism such as disciplinary action or sanctions, to ensure that the physicians have an incentive to go through the consent process in a reasonable way.

What about the consent form itself? Most hospitals require the patient to sign a document affirming that consent has been given for the planned procedure. Is this document consent in and of itself? Obviously not. By law, consent still lies in the conclusion of the discussion between the patient (or his legal representative if the patient is unable to give consent himself) and the health care provider. However, the document is evidence that the consent process did occur.

In many hospitals, the nurses are assigned the responsibility of having the patient sign the consent form. It seems that this assignment by the hospital may be construed as the hospital assuming the duty of obtaining the consent; but this is not the case. The court cases that have addressed this issue have decided that the consent forms were not designed to replace the informed consent process required of the practitioner who will be performing the procedure. In other words, the hospital cannot gratuitously assume the provider’s duty to obtain consent.

The hospital may perform the ministerial act of documenting such consent, but the practitioner must still be the one to go through the process of obtaining the consent himself. Absent the assumption, the hospital will not be liable for lack of informed consent because the hospital cannot assume this “non-delegable” duty. In general, the courts do not want the hospitals to get involved in issues that lie at the heart of the doctor-patient relationship. This serves as a warning to the practitioner that having someone other than himself go to the patient to get the consent forms signed may come back to haunt him if he does not in some way document that he, himself, went through the process with the patient.

What if there is no consent form in the chart signed by the patient? Most plaintiffs’ attorneys will say, “If there is no consent form, then there was no informed consent.” The form will be evidence that the consent process did occur. Without the form, the practitioner may have to prove that the process did occur in another way. He can do this by writing an appropriate note in the chart. Obviously, this note should be dated prior to the time of the surgery or treatment. He can also do this with oral testimony of witnesses or his own oral testimony under oath at a deposition or in trial. He can also provide evidence with a written statement in an affidavit.

In summary, getting an informed consent in the medical setting is a process whereby the health care practitioner discusses the procedure or treatment plan with the patient. The discussion should provide the patient what he needs to know to make a reasonable decision as to what he will allow to be done to his body. Going through the process is not as easy as you may think.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

“Brain Death” At Risk

There is a case making its way through the California legal system which may result in a religious exception for the “Brain Death” statute. The case of Jahi McMath began on December 9, 2013 when she underwent a tonsillectomy and adenoidectomy at the Children’s Hospital of Oakland. She had post-operative bleeding which resulted in a cardiac arrest. Ms. McMath was successfully resuscitated but there was a period of time when her brain was not getting enough oxygen. As a result, she suffered a severe brain injury.

On December 12, 2013, McMath’s physicians declared her “brain dead,” and, without the mother’s permission, notified the California Transplant Donor network that Ms. McMath’s organs should be evaluated for possible harvesting and transplantation. As long as McMath was on a ventilator, her heart would beat and her organs would remain useful for transplant purposes.

By the physician declaring Jahi “brain dead” she would be legally dead under California law. There would be no obligation for the hospital to continue her life support and the insurance company would not have to pay for further care, regardless of any family wishes.

Ms. McMath’s mother, Nailah Winkfield, refused to acknowledge the “brain death” pronouncement and took legal steps to block the removal of her daughter’s life support. She asserted that their religious beliefs were that death only occurs with the loss of cardio-respiratory function and the loss of brain activity was irrelevant.

The case was heard by Superior Court Judge Evelio Grillo who held that Jahi met the criteria for brain death under California law; this ruling would allow the hospital to remove the ventilator. However, he stayed his ruling so that life support could be maintained while Ms. Winkfield appealed to a higher court.

During the appeals process, a U.S. Magistrate Judge oversaw negotiations between the hospital and Ms. Winkfield. The parties agreed to allow Jahi to leave the hospital, with life support, but only upon the completion of Jahi’s death certificate. The death certificate was issued but was incomplete pending an autopsy. The Coroner released the body to the family who moved the body to a location in New Jersey where a tracheostomy was done and a feeding tube placed. Obviously, an autopsy was not done.

New Jersey’s “brain death” law had an accommodation for religious beliefs. Under the accommodation, if religious beliefs preclude a brain death declaration, then the time of death could only be based on cardio-respiratory criteria. Jahi was deemed to be dead in California but alive in New Jersey.

Under New Jersey law, the physicians taking care of Jahi could not remove the ventilator and the insurance company had to pay for the ongoing medical costs. New York and New Jersey are the two states which have religious exemptions to their “brain death” laws. The exemptions were put in place due to concerns of large numbers of Orthodox Jewish residents in those states some of whom object to the concept of brain death.

According to media reports, Jahi improved and was moved to an apartment in August 2014. Her attorney claims that subsequent evaluations show blood flow and electrical activity in the brain and he further claims that Jahi will move on command. He has asked the California courts to reverse the findings of “brain death” in this case. If the brain death determination is not reversed, then moving Jahi back to California would put her at risk of not having any medical support.

Ms. Winkfield argues that they are being denied medical care even though they have a religious belief that death does not occur until the heart stops beating. The California death certificate, they claim, violates their Free Exercise rights under the First Amendment of the Constitution. California will probably argue that the law is neutral in nature and was not meant to violate any religious belief or practice.

The questions raised by this case are far-reaching. For a malpractice case originating in California, compensation is limited to $250,000 if the patient dies but there is no limit if the patient is still alive. For financial reasons, it would be in Ms. Winkfield’s best interest to have Jahi’s death declaration on neurologic grounds overturned.

In fact, in March 2015, McMath’s family filed a medical malpractice lawsuit against the surgeon who performed the operation on her tonsils and against the Children’s Hospital of Oakland. They will probably argue that Jahi is not brain dead and the California state limit of $250,000 for patients who are dead does not apply. They will have to argue that the death certificate is evidence of a violation of their Free Exercise rights under the First Amendment of the United States Constitution. This will be a difficult argument to win.

Of more concern is the effect that an overturning of the “brain death” statute would have for organ transplantation. If the McMath litigation results in an overturning of death certification by neurologic criteria, transplantation for patients with end organ dysfunction will come to a halt. Waiting for the heart to stop before declaring death will cause many otherwise suitable organs to be unusable for transplant purposes. Once again we are faced with a conflict between clinical practice, medical ethics, and religious beliefs. It would be best for a national debate, emanating from the Congress of the United States, to address these issues.

The definition of death and the interpretation of patient autonomy and best interests should not be left in the hands of individual courts who are dealing with issues that have already occurred. Since organ transplantation crosses state lines and funding for research in transplantation comes from sources across the country, the Commerce Clause would allow legislation of this complex issue to originate from Congress. Legislation is better able to look into the future and is better able to bring the debate to the public with more time and resources to come to a reasonable solution to this complex issue. This debate should start now.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

Resident Duty Hours

When I was doing my surgical training at the University of Chicago in the late 70’s and early 80’s, it was common to spend over 100 hours per week in the hospital. The term “resident” was very accurate as we were essentially living in the hospital; we stayed until the work was done. During the great snow of 1979, I lived in the hospital for a month as my car had been plowed over and the wind chill made it dangerous to walk home.

Residency training programs followed the German model. William Osler used that model for Johns Hopkins in 1899, creating the first residency training program in America. Residents learned by doing clinical work, taking on increased responsibilities as they gained experience. They lived in the hospital and, in general, they were not allowed to get married during their training. Other hospitals adopted the model and it became the norm for training physicians. Resident duty hours were to change dramatically in the mid 1980’s based on a tragic case emanating from the New York Presbyterian Hospital in 1984.

Libby Zion, an 18 year old college freshman was admitted to New York Hospital (now New York Presbyterian) with a high fever and “jerking movements.” It was the evening of March 4, 1984. She was agitated but she had periods where she was cooperative with the physicians taking care of her. Since she came in the evening, the physicians who were directly caring for her were residents—doctors in training. Ms. Zion had a history of depression and she was taking an antidepressant called phenelzine. This drug was to play an important role in her clinical course. She also used cocaine, a fact she did not tell the physicians taking care of her. This drug may also have had a role in her clinical course.

The residents made a diagnosis of viral syndrome and they ordered meperidine (Demerol), an opiate, to stop the shaking. They called Dr. Raymond Sherman, the Zion’s family doctor and the attending physician of record and, after hearing the resident’s report, he agreed with the plan. It was about 3 a.m. on March 5.

Later that night, Ms. Zion became more agitated and the first year resident, Dr. Luise Weinstein, evaluated her and ordered restraints and a shot of Haloperidol, another sedating medication. The upper level resident, a second year, had gone across the street to the call rooms to get some sleep. Dr. Weinstein was covering many other patients and did not evaluate Ms. Zion any further.

Although Ms. Zion calmed down after the shot, her vital signs were not checked until 6 a.m. when her temperature was a critical 107 degrees Fahrenheit. Cooling measures were initiated but she suffered a cardiac arrest and died. It is believed that the interaction of the phenelzine and meperidine, led to the development of “serotonin” syndrome, a condition not well known at that time. This syndrome can result in severe muscle rigidity, high fever, and seizures. It can be fatal if not treated in a timely fashion. The role of the cocaine use was not clear.

Libby’s father, a lawyer and journalist who worked for the New York Times, investigated and learned that his daughter had be restrained and was not evaluated by a physician for several hours. He also learned that the attending physician had never come in to evaluate Libby himself. Mr. Zion argued that the lack of sleep of the intern and resident and inadequate supervision by the attending physician contributed to this “medical blunder.” Mr. Zion told his daughter’s story and had several of his colleagues in other newspapers publish this story across the country. He was even able to get the Manhattan district attorney to convene a grand jury in hopes of bringing murder charges against the physicians involved in his daughter’s care.

Besides a criminal action, a malpractice claim was also made. This malpractice case finally made it to trial in 1994. After a civil trial, the jury assigned equal blame to New York Hospital and Ms. Zion for concealing her cocaine use from the physicians taking care of her. The jury found that the two residents and the primary care physician were liable for $375,000 to the Zion family for their pain and suffering. The jury also found that the primary care provider had committed perjury on the witness stand when he denied that he knew that meperidine had been given to Ms. Zion. None of the physicians was found to have committed “wanton” negligence so the malpractice claim was paid by their malpractice carrier. Wanton, or gross negligence, is generally not covered by medical malpractice insurance carriers.

The grand jury did not indict the physicians on criminal charges, but they did write a report that was highly critical of the hospital for having junior level physicians who were tired from long duty hours being the primary care givers for this type of case. The report led to the formation of a state commission, chaired by Bertrand Bell, M.D., a distinguished Professor of Medicine at Albert Einstein College of Medicine. In 1987, after 19 months of testimony, the Bell Commission issued a report which recommended that physicians in training have stricter limits on work hours and stricter rules on resident supervision. The Commission recommended that the residents work no more than 80 hours per week. Dr. Bell later acknowledged that the 80 hour cap was not based on any scientific data but was the result of a conversation he had with a medical colleague. These recommendations were only applicable in the state of New York but several other states followed this example.

It took another 16 years for the Accreditation Council for Graduate Medical Education (ACGME) to make these duty hour restrictions mandatory for all residency training programs. This restriction in duty hours has been an area of contention for students, residents, and attendings ever since. The argument that a well-rested physician is better able to make clinical decisions has never been shown to be true in clinical studies. Any training program which has duty hour violations may be subject to sanctions by the ACGME. The sanctions can be severe and can include loss of accreditation.

Despite nearly two decades of resident duty hour restrictions, the best training model for future physicians is still unknown. Patient polls indicate that the general public favors the restrictions but that should not be surprising since the public is generally naïve in regards to graduate medical education. A recent study of duty hours published in the New England Journal of Medicine, showed that residents with less restrictive hours are better able to use their time off (more “meaningful” time off) and the time off is more likely to be used for study (N Engl J Med. 2016;374:713-727). Residents in the less restrictive arm of the study could actually have some weekends free of any clinical responsibilities; weekends off rarely occur under the restrictive requirements.

The limitation of work hours has led to shift work where patient care information is relayed with “hand-offs” and these “hand-offs” have had the unintended consequence of actually increasing patient errors. This is probably predicated on the underlying belief that the most invested physician is the one originally involved with a particular patient. As the “shift mentality” became embedded, the desire of the physician to manage a critical patient until stable lessened. Shifting responsibility to another physician who does not know the patient nearly as well as the primary provider, to me, is professionally repugnant.

Although the duty hour restrictions only apply to residents in training, my fear is that this “shift mentality” persists when the resident becomes an attending. Patients get sick day and night, weekends and holidays. The best care is provided by the physician who best knows that particular patient. For a surgical patient, it is the surgeon who did the case.

There is nothing to keep the government from limiting duty hours for other health care providers, including attending surgeons and physicians. This model has already been set in the airline industry. If these restrictions become law, a patient may be dependent on a surgeon he does not know and, much worse, does not know the patient.

It is time for the ACGME to revisit its penalties for duty hour violations. If a resident chooses to stay with a sick patient, there should be no penalty levied on the training program or on the resident. This type of behavior should be encouraged. Staying with a sick patient is a hallmark of a good physician.

by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016. 

The National Practitioner Data Bank

In 1986, the Health Care Quality Improvement Act (HCQIA) went into effect. A section of this law established the National Practitioner Data Bank (NPDB) which was a repository for reporting adverse actions of health care providers. The NPDB was formed because Congress was under the impression that the quality of medical care in America was decreasing; they viewed this as a national problem. To address this issue, Congress wanted to encourage physicians to participate in meaningful peer review. What better way could there be than to have doctors discuss cases which had bad results and then learn from each other’s mistakes?

Prior to this law, any adverse action taken against a physician was not available to an outside review. As a result, it was not unusual for a physician with bad results to go to a different practice location, often in another state, and get a new license and start a new practice without having to account for his previous record.

Peer review is a good way to improve care. However, the reporting requirement of the law had a chilling effect for any meaningful review. Any settlement or judgment paid on a malpractice claim could subject the physician, or other health care provider involved in the case, to being reported to this National Practitioner Data Bank and to state licensing boards. These reports could negatively impact the practitioner’s ability to maintain his credentials and privileges at his current place of practice and his ability to seek work at another location.

The intent of Congress in setting up the NPDB was to restrict the ability of incompetent practitioners from moving from state to state without having to disclose their previous malpractice payments and other adverse actions e.g., loss or restrictions on a license, loss of privileges, or loss of professional society memberships. The NPDB was a clearinghouse to collect and release information that was believed to be related to professional conduct and competence. This data would be available to entities involved in granting, or denying, credentials and privileges to health care providers and to the appropriate licensing boards of the various states.

The NPDB would function as an alert system. The information it contained was limited but it was intended to lead to further inquiry into a listed practitioner’s licensure, malpractice history, less than professional behavior, and professional society membership actions. The burden of the further inquiry was on the hospitals, licensing boards, and other health care entities to make final hiring, credentialing, and licensure decisions.

Under this law, reports must be submitted to the NPDB if a malpractice settlement or judgment payment is made for the benefit of a licensed physician; this includes residents and interns. Payments may be made for the benefit of medical and dental students, but these will not be reported to the NPDB. Payments made for the benefit of deceased practitioners are reported because a fraudulent practitioner could assume the identity of the dead person; this reporting would help identify these individuals.

There is a dispute process available to the practitioner who has been reported but this process cannot be used to protest a payment or to appeal the underlying reasons for the reporting. It can only be used to dispute the factual accuracy of the report or claim the report was not submitted in accordance with the NPDB requirements. This written statement would be available to those entities allowed access to the NPDB reports.

Since a report to the NPDB can have significant detrimental consequences for the practitioner, it is not surprising that most are willing to defend the case through the legal process up to and including a trial. According to an article in the New England Journal of Medicine, only 2 percent of patients injured by negligent care in a hospital file malpractice claims. (New England Journal of Medicine, Vol. 324, 1991 (370-6)) The elderly and the poor are even less likely to sue. (Medical error: What do we know? What do we do? Jossey-Bass 2002) If a malpractice case makes it to trial, there is a high likelihood, about 90%, for a defense verdict.

In a study of negligence cases in 2008 by the American Medical Association, they found that 65% of claims were dropped, dismissed, or withdrawn prior to trial. Settlements occurred in 27.5% of cases and only 5% were resolved at trial. Of the cases that made it to trial, the physician defendants won 90% of the time. (Carol K. Kane, Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians)

With these kinds of statistics, it makes sense for the defendant to fight, even if he was negligent. The defendant’s goal is to keep from being reported to the NPDB.

Unfortunately, a malpractice payment may not be an accurate measure of the quality of a particular provider. It is hard to predict what a jury may do and too often they rely on the quality of the lawyers, the predilections of the judge, and the sympathetic nature of the plaintiff. If the payment is not related to a breach of the “standard of care,” then the black mark of a listing in the NPDB may not accomplish what the law was meant to do; identify the poor practitioner. Even the very best provider can have a bad result on occasion; this bad result can lead to an NPDB report even if no malpractice occurred.

It is the threat of a NPDB report which prevents the open discussion, fact-finding, and broad based analysis and problem solving which was the intent of the meaningful peer-review of the HCQIA. Perhaps it is time to do away with the reporting provisions of this law and focus on meaningful performance evaluations of our health care providers. Since the NPDB is a barrier to meaningful peer-review, it should be repealed.

New requirements for performance measures as a means of getting paid under Medicare and Medicaid may be a better way to assess the quality of our providers.





by Darryl S. Weiman, M.D., J.D.

Professor, Cardiothoracic Surgery, University of Tennessee Health Science Center and Chief of Surgery, VAMC Memphis, TN

MORE ABOUT THE AUTHOR: Darryl Weiman is a featured expert in on February 17, 2016.