Saturday, November 17, 2012

Starr Gern Receives Tier 1 Best Law Firm Ranking for work in Medical Malpractice by national survey conducted by U.S.News and World Report


On November 1, 2012, Starr, Gern, Davison & Rubin was one of nine law firms in New Jersey recognized as a Tier 1 Best Law Firm by U.S.News and World Report in the field of Plaintiffs Medical Malpractice.
The U.S.News – Best Lawyers® “Best Law Firms” rankings is based on an annual evaluation of client critiques and peer review from leading attorneys in the field. Firms are ranked in in part based on their  expertise, responsiveness, integrity, and cost-effectiveness.

A first tier ranking includes those firms that scored within a certain percentage of the highest-scoring firm(s).

Saturday, September 22, 2012

BOOK REPORT: MMPI, MMPI-2, & MMPI-A in Court: A Practical Guide for Expert Witnesses and Attorneys (Kenneth S. Pope, James N. Butcher, Joyce Seelen)


MMPI, MMPI-2, & MMPI-A in Court: A Practical Guide for Expert Witnesses and Attorneys (hereafter "MMPI: A Practical Guide") is a book that should be in the library of any trial attorney who deals with cases involving psychiatric and psychological disorders. The MMPI tests are the most widely used personality tests in clinical practice. The exam provides several behavior and symptomatic hypotheses about the person who takes the test.  First, the answers that test takers provide in the exams aid in the diagnosis of psychiatric conditions. Second, the MMPI tests incorporate the use of scales to evaluate whether psychiatric problems are the result of specific problem areas, such as alcohol or drug abuse, or emotional control issues. Third, there are validity scales which yield information about patients’ credibility. Therefore, the MMPI tests can lead to claims about whether patients are malingering or have intentionally exaggerated their symptoms, thus lending objective support to a frequently used defense position. 

The utility of “MMPI: A Practical Guide” is that it allows attorneys to understand and interpret the results of the MMPI studies, and therefore evaluate defense experts' conclusions about the results of these tests. It is virtually impossible to challenge a psychologist or psychiatrist who utilizes an MMPI test as the basis for his opinion without a basic understanding of what the results from these tests mean. 

In a recent case involving the use of an MMPI test, I obtained the results of the MMPI test administered to my client and after reviewing “MMPI: A Practical Guide,” discovered several interesting things. First, since my client was a learning disabled 18 year old living at home and still in high school, the psychologist should have utilized the MMPI-A test on my client. Second, the psychologist administering the test cherry-picked certain validity scales to support a claim that my client was exaggerating her symptoms, despite the fact that complete use of all of the available validity scales suggested that she was not. Third, the psychologist misinterpreted other tests administered. Thus, he wrote in his expert report that my client was malingering, notwithstanding the fact that the MMPI test administered demonstrated my client was minimizing her mental problems. 

“MMPI: A Practical Guide” evens the playing field in cases involving the application of an MMPI test. Without an understanding of the results of these exams, an attorney can not challenge the claims of defense experts, who assert that they have "objective" evidence that the client is lying. Obviously, there may be occasions when defense experts have correctly interpreted the data from these tests. However, if you uncover one case in which a defense expert intentionally misinterpreted an MMPI study to inappropriately paint your client as a liar, the money ($13.63 at Amazon.com) and time invested in reviewing “MMPI: A Practical Guide” will have been well spent.

Thursday, May 24, 2012

What patients can and should expect when pursuing a medical malpractice case.




PRESUIT INVESTIGATION

In New Jersey (where I practice), and in other states that allow parties to a lawsuit to engage in full pretrial discovery, when a plaintiff-patient sues a defendant health care provider, a medical malpractice case will go through several phases and will usually take several years to get to trial.

At the outset of malpractice litigation many states require a patient to serve the doctor with an Affidavit of Merit (AOM).  The AOM must be signed by a physician with credentials similar to the defendant doctor and it must state that after reviewing the pertinent medical records the expert believes (a) that the defendant doctor practiced medicine below accepted standards of care and (b) that this harmed the patient.  For this reason, before a lawsuit is filed against a physician, a patient's lawyer must obtain all of the medical records pertinent to the claim for the expert's review. 

In addition to the medical records, my office provides a reviewing expert with the relevant medical literature and any insight obtained from our own review of the patient's records. Why? In a perfect world, paying experts hundreds of dollars an hour would guarantee a thorough review of a case. Realistically speaking, however, because (a) physician experts have extremely demanding schedules and (b) experts feel compelled to complete their review of a case as quickly as possible (because they are usually charging an exorbitant hourly rate) experts tend to speed through medical records when reviewing a file.  Highlighting the important facts in the  records and providing an expert with up to date literature allows an expert's review to be more efficient and ensures that the expert will be in a position to familiarize himself with the nuances of the medical care provided to the patient.

The pre-suit investigation is often the most critical part of a medical malpractice case. If a firm does nothing more than provide an expert with a patient's medical records, they will not be in a position to evaluate their expert's review of the case. Moreover, there are other reasons why an attorney must become conversant with the facts related to a plaintiff's medical care and educate himself with the medical literature relevant to a litigation. When the case goes into suit, a lawyer will have to have a full command of these subjects. Every defendant in a medical malpractice case is a free defense medical expert consultant to defense counsel, and they have an obvious motive to give their attorney all the help they can.  A vigilant pre-suit investigation from the patient's attorney is the best tool to neutralize this advantage.
Commencing the Lawsuit

Once the pre-suit investigation of the claim is complete and an expert has signed an AOM, a lawsuit is started when the patient files a complaint with the court that spells out the pertinent facts and the allegations. Complaints describe, in very broad strokes, the care the doctor provided to the patient, identify those aspects of the care that the patient contends were negligent, and indicate how these mistakes harmed the patient.  Once the complaint is filed, the doctor is served with a copy of the filed complaint, along with a summons. At that point, a defendant physician will notify his malpractice insurance carrier that a lawsuit has been filed, and the carrier will hire an attorney to defend the physician in the lawsuit.

Medical malpractice litigation is a very specialized field of law. As a result, there are usually a handful of defense firms representing most physicians who are sued as in a single geographic area. If your attorney regularly litigates medical malpractice cases, the firm hired on behalf of a defendant doctor will know your attorney and have a good understanding of his professional reputation. Conversely, if your attorney does not regularly litigate malpractice cases and does not have an established reputation in this field, defense counsel will know this as well.

THE DISCOVERY PHASE OF A LAWSUIT

PAPER DISCOVERY RESPONSES

Once a defense attorney enters an appearance and files an Answer, your case enters the discovery phase of litigation.  Generally speaking, during discovery, all parties have an opportunity to investigate the merits of the other side's legal and factual position.  The first phase of discovery involves the exchange of paper discovery demands and responses.  Each side propounds interrogatory questions on the other side which are written questions that require written responses. Most attorneys also serve a demand for production of documents, which requires the other side to provide copies of all documents pertinent to the case. Finally, attorneys may propound a demand for admissions, which requires the responding party to affirm or deny the truth of a set of factual allegations. 

Your attorney will draft your paper discovery responses which you will then be required to review and supplement.  After you approve your discovery responses a finalized draft will be forwarded to defense counsel, with a certification page signed by you that indicates the answers and documents are true and complete.  All pertinent medical records and other items demanded by the defendants in discovery will be attached as exhibits to your paper discovery responses.

More often than not, defendant physicians do not provide complete and comprehensive paper discovery responses.  There are a variety of reasons for this, but one is that many attorneys who represent patients simply do not insist on this.  Obtaining complete and comprehensive discovery responses takes time and effort.  First, an attorney representing a patient must send a detailed correspondence to the physician’s attorney outlining why the doctor's discovery responses are deficient, and demand more information.  Assuming the doctor does not cure the deficiencies, a motion then has to be prepared and filed with the Court to compel more specific answers.  Often, the motion will require a court appearance. Many attorneys conclude that this process is too time consuming, especially since after paper discovery is exchanged, a patient’s lawyer will have an opportunity to depose a doctor and clarify issues in the doctor's paper discovery responses.

A good lawyer knows, however, that the purpose of discovery is not only to obtain information from the other side, but to require a defendant to provide a precise factual statement about the facts of a litigation which can be used at trial as affirmative evidence, or for the purpose of impeaching or contradicting a defendant doctor’s trial testimony. Only after a doctor takes a precise position in his paper discovery responses can these be used an impeachment device in later proceedings. Additionally, insisting on comprehensive and complete paper discovery responses enables an attorney to better prepare for depositions. 

DEPOSITIONS OF THE PARTIES AND FACT WITNESSES

After paper discovery responses are exchanged the parties will schedule depositions. During a deposition a witness is placed under oath and required to provide verbal responses to questions asked by counsel. Everything said during a deposition is taken down by a court reporter, and a written transcript of the testimony is created. At trial, a party’s deposition transcript can be read  directly to the jury. Additionally, an expert’s transcript and the transcripts from non-party witnesses can be read to the jury if a witness contradicts his deposition testimony on the stand at trial. 

Most of the time plaintiffs are depose first.  Before you are deposed you will meet with your attorney to prepare for that proceeding.  Your deposition will take place in a conference room, usually at your attorney's office. The attorneys representing all parties will be present. Defendant doctors have a right to be present, but they rarely attend. The attorneys who represent the doctor will ask you questions about the following subjects:

            (a)       The care provided by the defendants;

(b)       Your medical history before and after the incident that gave rise to the malpractice claim;

(c)       The injuries and disabilities that you suffered as a result of the negligence of the defendant and how these impact your life.

After your deposition takes place your attorney will have an opportunity to depose the defendant physician and any other health care providers who may have knowledge of facts related to your claim.  It is often difficult to schedule depositions of defendant physicians because they have very demanding schedules and courts will usually provide them with latitude because of this.  Occasionally it will be necessary for your attorney to file an application with the court compelling the deposition of the defendant if the deposition is rescheduled repeatedly.

The deposition of a defendant physician is obviously focused on the care provided to the plaintiff-patient. Nevertheless, this proceeding is not the time for a patient's attorney to “discover” the medical facts relevant to the case. By the time the deposition of a defendant takes place, a patient's attorney should have a full command of the facts and a complete understanding of the medicine. The goal of the deposition of the doctor should be to lay the evidentiary foundation necessary to prove that the doctor’s medical treatment of the plaintiff was below accepted standards of care and to lock the defendant into a precise factual position.

EXPERT REPORTS

After depositions are completed, expert reports are exchanged. Generally speaking, a patient will serve his expert reports first. Depending on the nature of your case, you will have at least one medical expert. If the liability and damages issues in your case span more than one medical specialty or there are multiple defendants in the case, you will likely have more than one medical expert who will write a report on your behalf. Additionally, if the medical malpractice of the defendant made you disabled, your attorney may hire an economic expert to provide testimony about your future lost wages.

Experts base their opinion on a review of (a) the pertinent medical records, (b) the relevant literature, (c) the paper discovery responses exchanged during discovery, and (d) a review of the deposition transcripts of all of the relevant witnesses. This is a very labor-intensive process. Nevertheless, in New Jersey and many other states, the court rules enable experts and attorneys to engage in a collaborative process prior to the issuance of expert reports and these activities are protected from disclose under the work-product doctrine. As a result, knowledgeable attorneys will provide guidance to experts in the preparation of their reports for the same reasons that attorneys provide guidance with respect to an expert's initial review of a case in anticipation of securing an Affidavit of Merit.

In medical malpractice cases, experts issue reports with a common format. The report will begin by listing the evidence that an expert reviewed. Next, the expert report will provide a factual chronology that highlights the important facts based on expert’s review of the evidence. The report will finish with a discussion of the expert's conclusions about why he believes a defendant deviated (or did not deviate) from accepted standards of care, citing to the medical literature on the subject. When the experts your attorney retains complete their reports, your attorney will serve them on counsel for the defendant physicians, and you will also receive copies.

DEPOSITIONS OF THE EXPERTS

After expert reports are exchanged, the parties will be provided with an opportunity to depose the experts. Customarily, a plaintiff's expert is deposed first. Your attorney will meet with your experts to prepare them for that proceeding. In my office, we insist on meeting with an expert at least a week in advance of his deposition so that the expert has time to digest what is discussed and so that the expert can utilize the information we provide in the meeting during his own pre-deposition preparations.

After your experts are deposed, your attorney will depose the defense experts. This is a critical part of a medical malpractice litigation. It is not unusual for my firm to spend as much time preparing for expert depositions as we spend preparing for trial. In addition to all of the medical research and factual review, background checks of all experts are undertaken. All relevant medical publications of the expert are reviewed prior to the deposition. Additionally, all available deposition transcripts of an expert are reviewed, so that we are in the best position to challenge the credibility and the science behind the expert's opinions.

THE RESOLUTION PHASE OF A MALPRACTICE LAWSUIT

SETTLEMENT DISCUSSIONS

After expert depositions are complete, the case enters into the resolution phase of the litigation. In New Jersey, a defendant doctor must consent to settling a medical malpractice case. If (a) a doctor consents to settle the case and (b) the doctor's insurance carrier authorizes a defense attorney to make an offer of settlement, the parties begin settlement negotiations. This may occur in a settlement conference before the judge the parties are assigned to for trial. It may also occur during voluntary mediation, or simply through informal conversations between counsel.

As a general rule, because the stakes are so high, insurance carriers do not engage in settlement discussions in medical malpractice litigations until after they have had an opportunity to evaluate how the parties and the experts perform during discovery. 

Obviously, your attorney has more experience than you do at evaluating the merits and value of a litigation, and he will provide you with guidance about what he thinks the settlement value of your case is. Ultimately, however, the decision about whether to resolve a case for an amount offered is the client's alone. You are free to reject your attorney's advice about whether or not to resolve a case. An attorney has an ethical obligation to advise you of every offer made, and he is ethically bound to abide by your decisions in the negotiating process.

TRIAL PREPARATION

If the parties cannot find common ground through settlement discussions, a case must be prepared for trial. Your attorney will prepare motions in limine regarding legal issues that will come up during the trial. Attorneys must also prepare other pleadings in the form of voir dire questions, proposed charges, a pretrial information exchange, and a proposed verdict sheet. On top of this, your attorney will meet with you and all of the witnesses who testify on your behalf to ensure that they are ready to testify at trial.

In addition to preparing pleadings and making sure that witnesses are ready for trial, in the modern digital age attorneys must also prepare demonstrative exhibits. Slides will be prepared to assist and keep the jury's attention during opening and closing statements. Medical records will be scanned so that they can be projected onto screens or televisions when defendants and their experts testify. Deposition transcripts and paper discovery responses are also scanned so that they can be used for impeachment purposes. At my office, we have software programs that enable us to digitally reproduce any document so that it can be projected onto a screen. Evidence is bar coded so that when a witness testifies we can call up relevant documents during a trial with a bar code scanner. If a witness contradicts a medical record or sworn testimony, in less than one second we can project the pertinent impeachment evidence on a screen while we are engaging in our cross-examination. Organizing all of this information so that it can be used effectively takes a great deal of planning and is very time consuming.

THE TRIAL

Trials can last several days and complicated cases will result in trials that last several weeks. In most instances it is best if the plaintiff is in court every day during the trial. Exceptions to this rule have to be made for clients who are catastrophically injured and are physically incapable of sitting in a courtroom.

Jury selection usually takes a day to complete, but can take longer in a case that will take several weeks to try. After a jury is selected, they receive preliminary instructions from the judge. Following this, all parties present their opening statements. After opening statements, the plaintiff patient presents his witnesses; preferably the fact witnesses are called first, followed by the expert witnesses. The defense will call their witnesses after the plaintiff completes his case. The parties will then provide the jury with their summations, the judge will charge the jury and then the jury will deliberate until a verdict is reached.

POST-TRIAL MOTIONS AND APPEALS

A case is not necessarily over when a jury returns a verdict. If the trial judge made a mistake on a legal ruling of consequence either party may move to set aside the verdict and request a new trial. Additionally, legal rulings of the trial court can be appealed. Frequently, when a physician loses a malpractice trial they will file an appeal and attempt to negotiate a settlement that is less than the verdict. Your attorney will provide you with guidance throughout this process.

Wednesday, March 28, 2012

H.R. 5 - The Protecting Access to Healthcare (PATH) Act - The Health Care Industry's Latest Attempt to Avoid the Financial Consequences of Epidemic Levels of Malpractice.

On Thursday, March 22, 2012, the House of Representatives passed H.R. 5, the Protecting Access to Healthcare (PATH) Act, a bill originally introduced by Representative Phil Gingrey (R-GA), which if passed into law will cap all pain and suffering awards in medical malpractice cases at $250,000. H.R. 5 also reduces the amount of attorneys fees that can be paid to a lawyer who represents a victim of malpractice. Of course, defendant health care providers still have a right to pay lawyers they employ to defend these cases any amount they wish.  The bill also seeks to impose draconian restrictions on patients' rights of redress against drug companies and medical products manufacturers who profit off of dangerous or misleading products in the marketplace.


The rationale for the proposed medical malpractice restrictions according to the sponsors of the bill is that jury trials in medical malpractice cases are "a costly and ineffective mechanism for resolving claims of health care liability and compensating injured patients."  Additionally, the authors of the Bill contend that the threat of a lawsuit "is a deterrent to the sharing of information among healthcare professionals which impedes efforts to improve patient safety and the quality of care."  Among the stated goals of H.R. 5 is to "reduce the incidence of defensive medicine and lower the cost of health care liability insurance."


It is impossible to argue that a one-size-fits-all pain and suffering award of $250,000 is a just way to make a victim of medical malpractice whole after he suffers tragic debilitating injuries. Under the circumstances, Representative Gingrey (a retired obstetrician who has been sued for malpractice three times) has taken a page out of Orwell's 1984,  and H.R. 5 is drafted as if came straight from the Ministry of Truth.  The bill is said to be designed "to ensure that persons with meritorious health care injury claims receive fair and adequate compensation." In actuality, H.R. 5 takes away a medical malpractice victim's ability to have a jury of his peers decide what a fair measure of compensation is.  Representative Gingrey contends that H.R. 5 will benefit victims of medical malpractice "by reducing uncertainty in the amount of compensation provided to injured individuals."  The only time that the $250,000 cap on damages will result in certainty, however, is when it limits a jury award that would have otherwise been higher. Somewhat ironically, the New York Times recently reported that the $250,000 cap is half of what Representative Gingrey settled his last medical malpractice litigation for, after he was accused of providing negligent care to a pregnant woman. 


Tort reform advocates have been attempting to shift the burden of medical mistakes from the health care industry to victims of negligence for years.  The argument is cloaked in self-righteousness: Victims' rights have to be curbed, and after this occurs, physicians will no longer be afraid to disclose errors. This will cause a change in the culture of medicine and allow medical errors to be analyzed and approached in a new more comprehensive way.  Unfortunately, medical literature published by doctors (not lawyers) and the recent history of the patient safety movement provide plenty of reasons to be skeptical of this trickle-down approach to safety. 


-I-
H.R. 5 will drastically restrict innocent victims' rights of redress in medical malpractice cases, while rewarding the health care profession with immunity for its failure to police itself. This is not only incredibly irrational from a public policy standpoint, it is also immoral because for the last ten years, an epidemic medical malpractice problem in the United States has resulted in hundreds of thousands of unnecessary deaths, and despite this, advances in patient safety have stalled and error rates have held steady.


In November 1999, the Institute of Medicine,  a branch of the National Academy of Sciences, published a study declaring that a threshold improvement in the quality of health care was urgently needed because medical negligence committed in hospitals in the United States was killing more people annually than motor vehicle accidents, breast cancer and AIDS. Kohn LT, et al, To Err Is Human: Building a Safer Health System, National Academy Press pg. 26 (1999). The impact of that study, and its "jarring" analogy that the annual number of deaths from hospital negligence would be equal to the downing of a jumbo jet every single day, "galvanized the public and health professionals and led to congressional hearings, media exposes, and millions of anxious patients." Robert M. Wachter, M.D. , The End of the Beginning: Patient Safety Five Years After 'To Err Is Human," W4 Health Aff (Millwood) Web Exclusives 534 (2004).
Twelve years ago, To Err Is Human announced that the health care industry was "a decade or more behind other high-risk industries in its attention to ensuring basic safety." To Err Is Human, supra, at 5. The report was so shocking in part because "silence surrounds" the issue of medical malpractice. Id. The goal of To Err Is Human was noble: to break the cycle of inaction in the health care industry. Id. at 3. Action was urged 10 years ago because doctors (not lawyers) finally declared that the status quo was not acceptable and could no longer be tolerated. To Err is Human argued that preventable errors could be reduced by designing safety into the health care delivery system. Id. To do that, a four tiered approach was advocated. The health care industry needed to


  • undertake a national effort to create leadership, research, tools and protocols in the to enhance the knowledge base about safety;
  •  identify and learn from errors through immediate and strong mandatory reporting efforts, and voluntary reporting efforts, with the aim of making sure the system is made safer for patients;
  • raise the standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups; and
  • create safety systems inside health care organizations through the implementation of safe practices at the delivery level. Id. at 6.
In To Err Is Human, the IOM called for a 50% reduction in medical errors in five years, but ten years later it was clear that progress in the area of patient safety was still far short of that goal. Lucian Leape, et al., Transforming Healthcare, a Safety Imperative, 18 Qual. Saf. Health Care 424 (2009). Indeed, one commentator observed that "[s]hockingly modest progress has been made given the impact of the problem, how many people were made aware of it and how many efforts have been made to address it."  Howard Larkin, 10 Years, 5 Voices, I Challenge. To Err Is Human Jump-Started a Movement to Improve Patient Safety. How Far Have We Come? Where Do We Go From Here? 83 Hosp. Health Netw.  24a, 28t (2009). ''The current status of hospital safety systems is not close to meeting IOM recommendations." Daniel R. Longo, OblSb, SeD, The Long Road to Patient Safety: A Status Report on Patient Safety Systems 294 JAMA 2858, 2858 (2005).  Data from recent studies measuring safety progress suggests that "patient safety progress is slow, and cause for great concern." ld.


On Nov. 18, 2010, the New England Journal of Medicine published a study that attempted to quantify the impact of patient safety measures on in-patient hospital admissions. Christopher P. Landrigan, M.D. et al., Temporal Trends in Rates of Patient Harm Resulting from Medical Care, 363 New Eng. 1. Med. 2124 (2010). The authors specifically chose to evaluate the impact of patient safety efforts in North Carolina because that state showed a high level of engagement in efforts to improve patient safety. In spite of this, the study revealed that ''harm resulting from medical care was common, with little evidence that the rate of harm had decreased substantially over a 6-year period ending in December 2007." ld. at 2130. The review revealed that 25.1% of the patients receiving medical care in the hospitals surveyed suffered from medically induced harm. Id. at 2124-2125. Sixty-three percent of these medical mistakes were entirely preventable. ld. at 21. More recently, in April 2011, a study appearing in Health Affairs suggested that medical errors occurring in hospitals are ten times more common than previously thought.
It is difficult to imagine the lack of results in the last twelve years in the patient safety movement being permitted to occur in any other industry. If ten years ago jumbo jets were falling from the sky every day and we learned from a study (conducted by the airline industry itself) that the resulting individual tragedies were avoidable if air carriers implemented policies and procedures in a systematic way to promote safe practices, citizens would demand change and there would be bipartisan support for government intervention to stop preventable deaths. The idea that thousands of deaths already occurred because of air carriers' failure to follow safety standards would be considered utterly scandalous. You certainly would not expect people to stand idly by while the planes continued to full from the sky every day for ten more years. If the planes did keep falling, nobody would dream of suggesting that we should reduce airline accountability to the victims who were dying because of preventable errors.


-II-
Given the last twelve-year history of the patient safety movement, it is irrational to suggest that providing more immunity to the health care industry will result in "an increased sharing of information in the health care system which will reduce unintended injury and improve patient care."


Advocates of tort reform hypothesize that the one of the reasons that medical malpractice is such a pervasive problem is that the health care industry is unable to examine errors in a systematic way because doctors are afraid to admit when they make mistakes for fear of being named as a defendant in a lawsuit.  The theory is that if the financial consequences of medical mistakes are reduced, doctors will be more honest about admitting them, and this will lead to more data about errors, which will be analyzed and evaluated. Then, a "systems approach" will result in a safer health care sector.


The unsupported optimism that immunity will eventually result in a more honest approach to medical mistakes completely ignores the fact that physicians have always been required to be honest about medical mistakes, but have historically refused to act this way. Under the American Medical Association Code of Ethics, physicians have an ethical obligation to advise a patient when they commit consequential acts of medical malpractice when "a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment." Am. Med. Ass'n Code of Medical Ethics A-02 Edition, E-8.12 Patient Information, 77. Similarly, the American College of Physicians Ethics Manual mandates disclosure of errors if disclosure of this information is "material to the patient's well-being." Lois Snyder & Cathy Leffler, Ethics Manual, Fifth Edition, 142 Annals Internal Medicine 560, 563. Finally, the Joint Commissions on Accreditation of Health Care Organizations requires that patients be informed of unanticipated results that differ from the expected outcome in a significant way when a medical error occurs at a hospital. Joint Comm'n on Accreditation of Health Care Orgs., Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction 12 (2001).
Disclosure of medical errors is not only ethically mandated, literature supports that it is consistent with the fiduciary nature of the physician-patient relationship, since in most instances, disclosure of errors will benefit a patient. C.J. Wusthoff, Medical Mistakes and Disclosure: The Role of the Medical Student, 286(9) JAMA 1080, 1081 (2001). Disclosure helps gain the cooperation of a patient who has been harmed by an error. Id. Further, understanding the cause of unexpected problems can relieve anxiety about recovery or complications. Id. Finally, some commentators have suggested that since patients need information about errors to make decisions about their medical care, disclosure of malpractice is part of a physician's duty to provide a patient with informed consent. Thomas H. Gallagher, Wendy Levinson, Disclosing Medical Errors to Patients: a Status Report in 2007, 177(3) Canadian Medical Association Journal 265 (2007).


In theory, physicians agree that they have an ethical obligation to disclose medical errors. One study suggests that between 70 and 90% of the physician population believes that doctors should disclose errors to patients. Kathleen M. Mazor et al., Communicating with Patients about Medical Errors, 164 Archives of Internal Medicine 1690, 1692 (2004). In another study, 97% of the faculty and resident population surveyed indicated that they would disclose medical errors that caused minor harm, and 93% indicated that they would disclose an error causing major harm. Lauris Kaldjian , et al. Disclosing Medical Errors to Patients: Attitudes and Practices of Physicians and Trainees, 22(7) J Gen Intern Med 988-96 (2007).
Regrettably, while physicians are ethically obligated to inform their patients of consequential medical malpractice and studies suggest they intellectually support this principle, theory has not translated into practice. A study revealed that only 24% of residents surveyed reported the medical errors they committed to their patients. Albert Wu, et al. Do House Officers Learn From Their Mistakes? 12 Quality & Safety Health Care 221, 224 (2003). Another study estimated that nationwide, physicians are only disclosing errors to patients about 1/3 of the time. Robert J. Blendon et al., Views of Practicing Physicians and the Public on Medical Errors, 347 New. Eng. J. Med. 1933, 1935 (2002).


Doctors have always been ethically required to disclose medical errors, partially because it is a means to ensure good care.  That has not happened though.  Moreover, since To Err Is Human was published twelve years ago, saving 1.2 million lives was not enough incentive to cause error reporting systems to develop and preventable errors to be analyzed.  Under the circumstances, it absurd to suggest that (a) error reporting will increase and (b) a safer health care system will evolve once the impact of limiting malpractice victims' right of redress trickles down through the health care system. 


-III-
 Attempts to justify restricting the rights of medical malpractice victims as a means to decrease the cost of "defensive medicine" are misplaced because (a) the health care industry vastly exaggerates the problem of defensive medicine,  (b) other factors have increased physicians' propensity to order more diagnostic studies and make additional medical referrals, and (c) studies have repeatedly shown that capping medical malpractice damages does not impact how doctors practice medicine. 


Those who advocate tort reform often point to the problem of defensive medicine as a justification to limit the right of redress of victims of medical malpractice. The argument is that the “pervasiveness of malpractice litigation" causes health care providers to “order tests or procedures in excess of their actual need to protect themselves from the risk of lawsuits.” Tara F. Bishop, MD, Alex D. Federman, MD, MPH & Salomeh Keyhani, MD, MPH, Physicians’ Views on Defensive Medicine: A National Survey, 170 Arch Intern. Med. 1081 (2010). Accordingly, malpractice litigation is seen as creating a problem of over-deterrence, with lawsuits causing doctors to take more precautions than they otherwise should when they treat their patients.
Doctors  certainly think  the  threat  of malpractice causes  them  to be excessively cautious. Studies  surveying doctors for the  last 30 years  reveal  that  anywhere between 21%  to 98% admit  engaging in  defensive medicine. J. William Thomas  et al., Low Costs of Defensive Medicine, Small Savings from Tort Reform, 29 Health Affairs 1578-1584  (2010).  Nevertheless, it is hard  to reconcile physicians’ perception that  they  are  acting  in  an  overly  cautious manner with  reality.  Although the last few  years have  seen an  escalation in the  discussion about  the  costs  of defensive medicine, over-cautious behavior is not  evident in outcomes because medical  error rates have held  steady. Christopher P. Landrigan,  M.D.  et  aI., Temporal  Trends in Rates of Patient Harm Resulting from  Medical  Care,  363 New Eng. J.Med. 2124 (2010).


Bias is one culprit here, as some commentators have pointed out: “Because many physicians are attuned to defensive medicine as a problem, and their professional organizations agitate prominently  against it,” studies that attempt to quantify the scope of the problem of defensive medicine by  surveying physicians are prone to a “socially-desirable response bias.” David M. Studdert, LLB, SeD, MPH, et al., Defensive Medicine and Tort Reform: A Wide View, 25 J. Gen. Intern. Med. 380 (2010).
In addition to the problem of bias, surveying doctors to attempt to determine whether the threat of a medical malpractice lawsuit causes over-utilization has other inherent defects. First, there are many other causes for profligate testing in medicine, including: 1) the public culture of entitlement; 2) the expectation of immediate and perfect results; 3) the extraordinary increase in diagnostic and treatment options today; and 4) growing specialization and fragmentation of care. Marcel Frenkel, M.D., M.B.A., Consensual Medicine and the Therapeutic Partnership: Reducing the Costs of Defensive Medicine and Litigation, 25 J. Med. Prac. Mgmt. 78 (2009). Additionally, managed care contributes to over-ordering because it requires faster analysis and decisive conclusions. Id.


Studies that have attempted to quantify the costs of defensive medicine by looking at the impact that tort reform has had on health care savings have obtained inconsistent results. For example, while some studies have found lower health care costs in states with tort reform, others noted a weak relationship between tort reform and health care savings. Still other studies found no relationship at all. J. William Thomas  et al., Low Costs of Defensive Medicine, Small Savings from Tort Reform, 29 Health Affairs 1578, 1579 (2010). These varied results have been attributed to the fact that researchers invariably focus on limited sets of clinical conditions or specialties. Id. at 1579.
In 2009, a broader and more comprehensive study was undertaken to ascertain the impact of tort  reform measures on health care costs by examining Medicare spending in states that adopted tort reform. Frank A. Sloan & John H. Shadle, Is There Empirical Evidence for ‘Defensive Medicine’? A Reassessment. 28 J. Health. Econ. 481 (2009). The study concluded that its analysis, and those of previous studies, suggested that contrary to statements in the media, caps on damages and the abolition of punitive damages did not have a significant impact on the reduction of payments for the studied Medicare services. The researchers’ overall conclusion was that “tort reforms do not significantly affect medical decisions, nor do they have a systematic effect on patient outcomes.” Notably, these results meshed with the Congressional Budget Office’s estimate that if tort reform were enacted in the form of a $250,000 cap on noneconomic damages, a $500,000 cap on punitive damages and a decrease in statute of limitations, the savings from a combination of: 1) decreased use of services from less defensive medicine; and 2) lower malpractice insurance premiums would be merely .5% of the annual national expenditure of health care. Cong. Budget Office, Letter to Honorable Orrin G. Hatch, U.S. Senate, Oct. 9, 2009, available at www.cbo.gov/ftpdocs/106xx/doc10641/10-09-Tort_Refrm.pdf.


Finally, at face value, the defensive medicine argument is premised on an outdated and paternalistic view of the physician/patient relationship that is contrary to law. In most circumstances, the law  compels physicians to empower their patients to make consequential medical decisions by requiring a doctor to provide a patient with informed consent. Simply put, it is a mistake to assume that reduced exposure to liability will allow doctors to be less cautious, because doctors are no longer the only decision makers in this process.


-IV-
By capping recovery, H.R. 5 will inadequately and arbitrarily compensate victims of severe incidents of medical malpractice and simultaneously make smaller medical malpractice cases economically impossible to pursue. This later problem will have a disparate impact on the poor and elderly. 


It goes without saying that an arbitrary cap on non-economic loss damages will negatively impact victims of medical negligence injured the worst. In addition to this, damages will make cases for many victims injured less severely by medical malpractice financially unviable.  RRMedical malpractice case usually require a plaintiff's attorney to "front" expenses.  Even the most simple cases  this amounts to at least $25-$30,000. The costs are significantly more if the case goes to trial.  More importantly, these cases also almost always require a malpractice victim's attorney to invest hundreds of thousands of dollars in attorney time to prosecute, because they deal with complex issues of science, require extensive discovery and significant preparation during every stage of the litigation process and they are always vigorously defended. Assuming a contingency fee of 33%, a case usually has to have a potential financial recovery of over several hundred thousand dollars for an attorney to consider it financially viable to pursue. Therefore, if damages in these cases are capped at $250,000, unless a patient suffers a significant future loss of income as a result of a medical mistake,  the overwhelming majority of medical malpractice cases will no longer be financially viable for attorneys to prosecute.  Make no mistake about it, capping malpractice damages in the face of a permanent life-altering injury at $250,000 will hurt nearly every medical malpractice victim. Nevertheless, since a significant future wage loss will become the new polestar of whether a malpractice case is financially viable,  H.R. 5 Hwill disparately impact the elderly, who do not have a lengthily work life expectancy, and the poor, who will not show a dramatic future wage loss.
CONCLUSION


Juries sit on cases every day in the United States and determine whether accountants, attorneys, architects and engineers commit professional malpractice. Indeed, we rely on our citizens to determine whether some criminals should be sentenced to death. H.R. 5  assumes that juries are incapable of deciding the appropriate measure of compensation for people who have been injured by a health care provider's negligence.  Notably, H.R. 5 does not posit that people are ill-equipped to deal with complex medical issues, and it does not suggest that a jury cannot determine whether a medical provider made a mistake, it simply assumes people aren't smart enough to calculate what amount of damages should be awarded to patients injured in these circumstances. The fact is that juries make this identical determination in virtually every significant civil case that is decided by the courts, and no cogent explanation has ever been offered about why juries are uniquely incapable of making these kinds of calculations in medical malpractice trials.


Like every other business industry, the health care industry is influenced by a profit motive. Promoting safety is time consuming and expensive. Historically, lawsuits have actually helped advance safety measures in industries reluctant to take such initiatives on their own. In the face of a medical malpractice problem that by its own admission has reached epidemic proportions, the health care industry failed to take significant measures for the last twelve years to stop hundreds of thousands of deaths. A reasonable analysis leads to the conclusion that H.R. 5 will only exacerbate these problems.           

Tuesday, March 20, 2012

Shoulder Dystocia and the Duty of Informed Consent



This is from an article I published in Medical Malpractice  Law and Strategy Vol. 29, Number 6, March 1, 2012

Shoulder dystocia is a birth complicated by a failure to deliver the fetal shoulders through gentle downward traction on the fetal head. It poses an obstetric emergency, and is associated with brachial plexus injuries, fractures of the clavicle and humerus, and in some severe cases, hypoxic-ischemic encephalopathy and even death.

Shoulder dystocia can occur when there is impaction of either: 1) the anterior fetal shoulder behind the maternal pubis symphysis; or 2) the posterior fetal shoulder on the sacral promontory. Fetal macrosomia (a.k.a. "big baby syndrome") and maternal diabetes increase the risk of encountering shoulder dystocia during a delivery. In addition, other antepartum conditions can also forecast that a delivery is at an increased risk for shoulder dystocia, including maternal obesity, multiparity, post-term gestation, previous history of a macrosomic birth and a previous history of shoulder dystocia.

With this array of possible indicators for shoulder dystocia, when must the physician bring the possibility of this complication to the patient’s attention in order to obtain informed consent for or against induced labor or cesarean section?

ACOG Guidance Insufficient

The American Congress of Obstetricians and Gynecologists (ACOG) offers some guidance concerning the duty of the physician to obtain informed consent from a patient at risk of a delivery completed by shoulder dystocia. ACOG takes the position that "planned cesarean delivery to prevent shoulder dystocia may be considered for fetal macrosomia with estimated fetal weights exceeding 5000 grams in women without diabetes [11 lb .36 oz] and 4,500 grams [9lb 14.73 oz] in women with diabetes." Robert J. Sokol et al., ACOG Practice Bull. No. 40: Shoulder Dystocia, Compendium of Selected Publications, 682-687 (2002) (replaces Practice Pattern No. 7, Oct. 1997). Id. at 684. ACOG’s position about when it is appropriate for a physician to consider offering an expectant mother the option of a cesarean section when there is a diagnosis of fetal macrosomia seems overly rigid. First, ACOG concedes that ultrasonogaphy is not always an accurate predictor of macrosomia. Id. at 683. Second, while ACOG has suggested that a baseline level weight should be used to trigger when it is acceptable to consider a cesarean section due to a suspicion of macrosomia, the organization simultaneously recommends that when a mother has a prior history of encountering shoulder dystocia during labor and delivery, several factors need to be taken into consideration when discussing the risks and benefits of an elective cesarean section with the patient, including estimated fetal weight, gestational age, maternal glucose intolerance and the severity of the prior neonatal injury.

Issues of logical consistency aside, it would be a mistake to conclude that ACOG Practice Bulletin No. 40 sets forth the standard of care regarding when it is appropriate to discuss a planned cesarean section with an expectant mother in the face of evidence suggesting an increased risk of encountering shoulder dystocia during a delivery. A physician’s duty of informed consent is governed by state law, and different states have different legal requirements about how this obligation must be fulfilled. Moreover, common law and statutory law governing a physician’s duty of informed consent can evolve and change.

Consider State Law

State law is not uniform regarding what a physician must do to meet his or her obligation of informed consent. First, some states hold that a doctor’s duty of informed consent involves only disclosure of risks that are customarily disclosed by physicians. Laurent B. Frantz, Annotation, Modern Status of Views as to General Measure of Physician’s Duty to Inform Patient of Risks of Proposed Treatment, 88 A.L.R. 3d 1008 (1978). Arkansas is a state that follows this approach. It has a statute that requires a plaintiff alleging a breach of a duty of informed consent to prove that the information the doctor failed to provide "would customarily have been given to a patient" in the plaintiff’s circumstances "by other medical care providers with similar training and experience" and "in the locality in which the medical care provider practices or in a similar locality." A.C.A. § 16-114-206.

Other states take the position that a substantial risk must be disclosed to a patient in order for a physician to meet his duty of informed consent, unless the physician can demonstrate that there is either a local or a national standard that suggests that nondisclosure is appropriate. This second standard was used by the Colorado Court of Appeals in Stauffer v. Karabin, 492 P2d 862, 865 (Colo. App. 1971).

A third view is that a doctor’s duty of informed consent is measured by what a reasonable physician would disclose in similar circumstances. This is the approach the Supreme Court of Kansas took in Natanson v. Kline, 350 P.2d 1093, 1106 (1960).

The first three views regarding a doctor’s duty of informed consent have been characterized as the "traditional" or the "professional" standard formulation of a doctor’s duty of informed consent. D. Louisell and H. Williams, Medical Malpractice § 22.08 at 22-23 (1987). The "professional" standard "rests on the belief that a physician, and only a physician can effectively estimate both the psychological and physical consequences the risk inherent in a medical procedure might produce [in] a patient." Largey v. Rothman, 110 N.J. 204, 210 (1988).

In 1972, a new standard of disclosure for informed consent was established by the United States Court of Appeals for the District of Columbia Circuit in the case of Canterbury v. Spence, 464 F.2d 772 (D.C.Cir.), cert. den., 409 U.S. 1064 (1972). Under this fourth view of informed consent, the scope of the information a physician is required to disclose is measured by "the patient’s need for information material to his decision whether to accept or reject a course the proposed treatment." This fourth standard of informed consent is known as the "prudent patient" or "materiality of risk" standard. Under this view, for a physician to meet his duty of informed consent, he must disclose all information that is material to a patient’s decision. Canterbury, supra, at 786-787. A risk is material "when a reasonable patient, in what the physician knows or should know to be the patient’s position, would be ‘likely to attach significance to the risk or cluster of risks’ in deciding whether to forego the proposed therapy or to submit to it." Largey, supra, at 211-212 (quoting Canterbury, supra, at 787).

Conclusion

In those jurisdictions adapting the "traditional" or "professional" standard formulation of the duty of informed consent, ACOG Practice Bulletin No. 40 could certainly influence an analysis of the amount of information and options a physician is required to offer to an expectant mother when there is antepartum evidence suggesting an increased risk of shoulder dystocia. Nevertheless, jurisdictions that have adopted the more modern "prudent patient" or "materiality of risk" standard of informed consent reject the notion that a physician’s obligation to provide information is limited to what is disclosed under the customs and practices of the medical profession. Consequently, it would be prudent for obstetricians to look beyond ACOG Practice Bulletin No. 40 and examine their states’ legal requirements regarding the duty of informed consent when making office policy decisions about when to speak to patients about planned cesarean delivery in the face of antepartum evidence suggesting an increased risk of shoulder dystocia during delivery.


Saturday, March 3, 2012

Keeping Experts Honest in Medical Malpractice Cases

In every medical malpractice case that goes to trial, one set of experts conducted an unethical analysis.

In every medical malpractice case that goes to trial, there are two sets of experts who look at the same set of facts and reach entirely different conclusions. This is because experts on one side of the case have undertaken an intellectually dishonest evaluation.
Medical experts are bound by a code of ethics when they review a case on behalf of a litigant. At their core, ethical requirements related to expert testimony almost universally require that experts conduct (a) a comprehensive analysis of the facts, (b) an objective analysis of the facts and (c) a review in accord with accepted principles of science.

If an expert is taking a position that is wrong, he is usually either (a) misrepresenting the facts of the case by ignoring, minimizing or overemphasizing evidence, or (b) misrepresenting the medicine by advocating medical science that is against the consensus of opinion. Medical experts do not usually misrepresent the science in a case. There are many reasons why. First, the majority of experts are not intellectually dishonest. Second, the prevailing consensus about an issue of medical science is usually set forth in writing either in published articles, textbooks or clinical practice guidelines. From a purely strategic point of view, it is not a good idea to for a medical expert to defend a litigation by taking a position that is contradicted by published documents which are relied on by colleagues to make medical treatment decisions. Third, if expert physicians are intellectually dishonest, over time they create a paper trail that sooner or later turns them into a liability, and lawyers stop using them.

In every deposition of every expert, confirm the ethical rules that applied to his analysis.

Establishing the ethical requirements of a fair expert evaluation during the deposition of an adversary's expert provides you with powerful proofs to use at the time of trial. If the expert conducted a bias factual review, you will be able to use the expert's testimony about what is required for a fair evaluation against him.

To exploit an expert's credibility problem stemming from a faulty factual analysis at trial, you must establish in a deposition exactly what he reviewed prior to forming the opinions set forth in his report, and what facts the expert considered important to his analysis.
Make sure that you establish unequivocally at the outset of a deposition everything which was reviewed by an expert prior to the formation of the opinions set forth in his report. This is a prerequisite to exposing credibility problems at trial because until you establish this baseline information, you will not be able to demonstrate that the expert ignored, minimized or overemphasized evidence.

Establish that the expert did not intentionally leave materials off of his list because the materials were either (a) harmful to the litigation posture of the party who retained him or (b) helpful to the other side. Confirm that the expert did not do either (a) or (b), because this would be violating the rules governing how he should behave as an expert.

Expert reports always contain a factual chronology. Establish at the expert's deposition that when the expert prepares reports in other cases, he sets forth factual chronologies in those reports as well, and this process is not unique to your case. Confirm that the expert tried to be accurate when listing thefacts in the chronology in his report, and he tries to be accurate in other cases when he does this.
Confirm with the expert that the facts set forth in his chronology are facts which he believed were important. An expert will often resist committing to this position because he recognizes that you are attempting to wed him to his factual analysis, and he is aware it is not objective. You can get usually get an expert to stop resisting the idea that he listed important facts in his chronology by attempting to establish the converse conclusion. Ask the expert whether the facts listed in the chronology of his report were unimportant. Ask the expert whether the facts in the report were selected in an arbitrary fashion. Ask the expert to identify those facts in the chronology that he thinks are unimportant to his analysis. Ask the expert to identify important facts he reviewed that are not in his chronology.

Once you have confirmed the ethical rules that applied to an expert's analysis, you can then expose at the time of trial that the expert either (a) misrepresented the facts of the case by ignoring, minimizing or overemphasizing evidence, or (b) misrepresenting the medicine by advocating medical science that is against the consensus of opinion, and you can end your cross examination by getting the expert to admit that when he did this, he breached the ethical rules applicable to his analysis.

Here are links to the ethical requirements pertaining to expert testimony of the major medical societies:

Sunday, February 26, 2012

The Lack of Progress in Patient Safety

Originally published in Medical Malpractice Law & Strategy, January 2011, Vol. 28, No. 4.

In November 1999, the Institute of Medicine (IOM), a branch of the National Academy of Sciences, published a study declaring that a threshold improvement in the quality of health care was urgently needed because medical negligence committed in hospitals in the United States was killing more people annually than motor vehicle accidents, breast cancer and AIDS. Kohn LT, et al, To Err Is Human: Building a Safer Health System, National Academy Press pg. 26 (1999). (Hereafter 'To Err Is Human''). The impact of that study, and its 'Jarring" analogy that the annual number of deaths from hospital negligence would be equal to the downing of a jumbo jet every single day, "galvanized the public and health professionals and led to congressional hearings, media exposes, and millions of anxious patients." Robert M. Wachter, M.D. , The End of the Beginning: Patient Safety Five Years After 'To Err Is Human," W4 Health Aff (Millwood) Web Exclusives 534 (2004). (Hereafter 'The End of the Beginning'').

It is not an overstatement to say that as a result of the IOM study, in 1999 the United States came to the realization that medical mistakes were a problem of epidemic proportions. Id.

A Call for Change

To Err Is Human declared that the health care industry needed to take the following steps to make health care safer:
  • Create leadership roles, research patient safety issues and develop tools and protocols to enhance knowledge of safety issues that exist;
  • Create nationwide mandatory and voluntary error reporting systems so that it could identify and learn from medical errors;
  • Raise safety standards through the use of oversight organizations, professional groups and health care purchasers; and
  • Implement safety systems that enhanced safe practice at the health care delivery level.
Howard Larkin, 10 Years, 5 Voices, I Challenge. To Err Is Human Jump-Started a Movement to Improve Patient Safety. How Far Have We Come? Where Do We Go From Here? 83 Hosp. Health Netw. 24 (2009). (hereafter "10 Years, 5 Voices 1 Challenge'').

There was an initial flurry of activity following the IOM report in 1999. Five years after the study was released, the federal government, private foundations, health plans, hospitals and clinics were all investing more in patient safety then they had been in 1999. The End of the Beginning supra, at 543. Notwithstanding this fact, as early as 2004, there was recognition that efforts to advance patient safety were not moving forward comprehensively enough to be responsive to the problem ld. Studies of specific hospital systems revealed that while some areas of patient safety systems were improving, other were declining due to changing hospital priorities, budgets and philosophies. Daniel R. Longo, OblSb, ScD, The Long Road to Patient Safety: A Status Report on Patient Safety Systems 294 JAMA 2858, 2863 (2005). (hereafter ''The Long Road to Patient Safety'').

In To Err Is Human, the IOM called for a 50% reduction in medical errors in five years, but 10 years later it was clear that progress in the area of patient safety was still far short of that goal. Lucian Leape, et al., Transforming Healthcare, a Safety Imperative, 18 Qual. Saf. Health Care 424 (2009). Indeed, one commentator observed that "[s]hockingly modest progress has been made given the impact of the problem, how many people were made aware of it and how many efforts have been made to address it." 10 Years, 5 Voices 1 Challenge, supra, at 28. ''The current status of hospital safety systems is not close to meeting IOM recommendations." The Long Road to Patient Safety, supra, at 2858. Data from recent studies measuring safety progress suggests that "patient safety progress is slow, and cause for great concern." ld. 

Why the Loss of Momentum?

Various reasons have been given for loss of momentum in the patient safety movement over the last 10 years. First, there was no organization set up to implement and oversee the plans set forth in To Err Is Human. 10 Years, 5 Voices 1 Challenge, supra, at 28. Additionally, the health care industry has displayed a reluctance to engage in recommended error reporting systems. ld. Although we are beginning to see changes, for the most part, payment systems throughout the last 10 years generally did not reward patient safety or penalize unsafe practices. ld. at 27. Finally, "Some of this lack of progress may be attributable to the persistence of a medical ethos, institutionalized in the hierarchal structure of academic medicine and health care organizations, that discourages teamwork and transparency and undermines the establishment of clear systems of accountability for safe care." Transforming Healthcare, a Safety Imperative, supra, at 424.

A Scathing Review

On Nov. 18, 2010, the New England Journal of Medicine published a study that attempted to quantify the impact of patient safety measures on in-patient hospital admissions. Christopher P. Landrigan, M.D. et al., Temporal Trends in Rates of Patient Harm Resuhing from Medical Care, 363 New Eng. 1. Med. 2124 (2010). (Hereafter Trends in Rates of Patient Harm). The New York Times identified Trends in Rates of Patient Harm as "one of the most rigorous efforts to collect data about patient safety" since the publication of To Err Is Human. Denise Grady, Study Finds No Progress in Safety at Hospitals, N.Y. Times, Nov. 24, 2010 at A1

Trends in Rates of Patient Harm examined hospital admissions in a stratified random selection of hospitals in North Carolina between 2002 and 2007. Trends in Rates of Patient Harm, supra, 2124-2125. The study was restricted to adult patients. The authors specifically chose to evaluate the impact of patient safety efforts in North Carolina because that state showed a high level of engagement in efforts to improve patient safety. In spite of this, the study revealed that ''harm resulting from medical care was common, with little evidence that the rate of harm had decreased substantially over a 6-year period ending in December 2007." ld. at 2130. The review revealed that 25.1% of the patients receiving medical care in the hospitals surveyed suffered from medically induced harm. Id. at 2124-2125. Sixty-three percent of these were entirely preventable. ld. at 21 

Proposed Law Changes May Further Patient Pain

On Dec. 1,2010, The National Commission on Fiscal Responsibility (NCFR) published a report with suggestions to be pursued by Congress and the Senate to deal with the federal deficit. NCFR, The Moment of Truth, Dec. 1,2010,http://www.fiscalcommission.govsites/fiscalcommission.gov. Several recommendations of the NCFR seek to restrict the rights of redress of patients harmed by medical malpractice, in the name of reducing the federal deficit. There appears to be bipartisan support for creating "safehaven"rules for health care providers who follow best practices of care, for creating a more restrictive federal statute of limitations for all medical malpractice cases, and creating specialized "health courts" to replace the jury system Id. at 29. Some members of the NCFR recommended that the legislature consider the imposition of a federal statutory cap on damages. Id.

More of the Same?

Ten years ago, To Err Is Human announced that the health care industry was "a decade or more behind other high-risk industries in its attention to ensuring basic safety." To Err Is Human, supra, at 5. The report was so shocking in part because "silence surrounds" the issue of medical malpractice. Id. The goal of To Err Is Human was noble: to break the cycle of inaction in the health care industry. Id. at 3. Action was urged 10 years ago because doctors (not lawyers) finally declared that the status quo was not acceptable and could no longer be tolerated. 

It is difficult to imagine the last 10 years' history of the patient safety movement occurring in any other industry. If 10 years ago jumbo jets were falling from the sky every day and we learned from a study (conducted by the airline industry itself) that the resulting individual tragedies were avoidable if air carriers followed safe practices, citizens would demand change and there would be bipartisan support for government intervention to stop preventable deaths. The idea that thousands of deaths already occurred because of air carriers' failure to follow safety standards would be considered utterly scandalous. You certainly would not expect people to stand idly by while the planes continued to full from the sky every day for ten more years. If the planes did keep falling, nobody would dream of suggesting that we should reduce airline accountability to the victims who were dying because of preventable errors.

The Consequences of Truth: Compulsory Medical Error Reporting in New Jersey

Excerpted from "The Consequences of Truth: Compulsory Medical Error Reporting in New Jersey," Medical Malpractice Law and Strategy, Volume 26, Number 9, June 2009, by John Ratkowitz.

-I-

 NEW JERSEY LEGISLATIVELY MANDATES AN ETHICAL RESPONSIBILITY

A. The statutory and regulatory scheme.

In 2004, the Legislature passed the Patient Safety Act, N.J.S.A. 26:2H-12.23 (PSA). This landmark legislation changed the way medical errors are dealt with in New Jersey by creating a legal duty to immediately disclose medical errors to patients who are harmed by them. N.J.S.A. 26:2H-12.25. There are few states in the nation that require this kind of disclosure. William M. Sage et al., The Relational Regulatory Gap: A Pragmatic Information Policy For Patient Safety and Medical Malpractice, 59 Vand. L. Rev. 1263 (2006) (noting that New Jersey was one of four states that recently passed legislation requiring patients to be informed when they were the victim of medical errors). Commentators have observed that the PSA has made the communication of healthcare errors a part of ordinary medical life. Edward A. Dauer, Postscript on Health Care Dispute Resolution: Conflict Management And the Role of Culture, 21 Ga. St.U. L.Rev. 1029, 1053 (2005).

Under the PSA, a patient must be informed no later than the end of the episode of care, or, if discovery occurs after the end of the episode of care, in a timely fashion, when the patient is a victim of "a serious preventable adverse event." N.J.S.A. 26:2H-12.25(d). A "serious preventable adverse event" is any adverse event that is preventable and results in death, loss of body part, or disability or loss of bodily function either lasting more than seven days, or that is still present at the time of discharge. N.J.S.A. 26:2H-12.25(a). In addition to requiring adverse events to be reported to the victims of medical malpractice, the Patient Safety Act also requires health care providers to report medical errors to the Department of Health and Human Services (the "Department"). N.J.S.A. 26:2H-12.25(c).

On January 24, 2008, the Department enacted regulations that gave teeth to the notification and reporting requirements of the Act. As of (a) March 3, 2008, for hospitals, (b) August 30, 2008, for ambulatory care facilities, home health care agencies and hospice providers, and (c) starting March 3, 2009, for nursing homes and assisted living facilities, health care providers have five business days after discovery of a serious preventable adverse event to notify the Department that a preventable adverse event has occurred. N.J.A.C. 8:43E-10.1, N.J.A.C. 8:43E-10.6(b). The notification requires the inclusion of specific categories of information, including: (a) the date and time the event occurred, (b) a brief description of the event, (c) a statement about the impact of the event on the health of the patient, (d) the date and time the facility became aware of the event, (e) how the event was discovered, (f) the immediate corrective actions to facility took to eliminate or reduce the adverse impact of the event on the patient, and (g) what steps were taken to prevent the occurrence of future similar events. N.J.A.C. 8:43E-10.6(c). Failure to comply with these reporting requirements results in a fine of $1,000 a day. N.J.A.C. 8:43E-3.4(14).

Medical providers have 24 hours after the discovery of a serious preventable adverse event to notify a patient that it has occurred. N.J.A.C. 8:43E-10.7(b). Patients are to be notified in person if they are still at the facility or by telephone or by certified mail if they are not. N.J.A.C. 8:43E-10.7(c). Disclosure to a patient must be accompanied by documentation in the patient's medical chart which indicates: (a) that the disclosure was made, (b) the time, date and individuals present when the disclosure was made and (c) the name of the person to whom the disclosure was made. N.J.A.C. 8:43E-10.7(f). Medical providers failing to disclose a serious preventable adverse event to a patient are subject to a fine of $1,000 if the event was also not disclosed to the Department of Health and Senior Services, but $5,000 if they reported the event to department, N.J.A.C. 8:43E-3.4(15).

B. The Insufficiency of Existing Ethical Mandates to Disclose Medical Errors.

It is significant that when mandating the disclosure of medical errors under the PSA, New Jersey sought only to compel medical providers to do something already ethically required. Under the American Medical Association Code of Ethics, physicians have an ethical obligation to advise a patient when they commit consequential acts of medical malpractice when "a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment." Am. Med. Ass'n Code of Medical Ethics A-02 Edition, E-8.12 Patient Information, 77. Similarly, the American College of Physicians Ethics Manual mandates disclosure of errors if disclosure of this information is "material to the patient's well-being." Lois Snyder & Cathy Leffler, Ethics Manual, Fifth Edition, 142 Annals Internal Medicine 560, 563. Finally, the Joint Commissions on Accreditation of Health Care Organizations requires that patients be informed of unanticipated results that differ from the expected outcome in a significant way when a medical error occurs at a hospital. Joint Comm'n on Accreditation of Health Care Orgs., Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction 12 (2001).

Disclosure of medical errors is not only ethically mandated, literature supports that it is consistent with the fiduciary nature of the physician-patient relationship, since in most instances, disclosure of errors will be benefit a patient. C.J. Wusthoff, Medical Mistakes and Disclosure: The Role of the Medical Student, 286(9) Journal of the American Medical Association, 1080, 1081 (2001). Disclosure helps gain the cooperation of a patient who has been harmed by an error. Id. Further, understanding the cause of unexpected problems can relieve anxiety about recovery or complications. Id. Finally, some commentators have suggested that since patients need information about errors to make decisions about their medical care, disclosure of malpractice is part of a physician's duty to provide a patient with informed consent. Thomas H. Gallagher, Wendy Levinson, Disclosing Medical Errors to Patients: a Status Report in 2007, 177(3) Canadian Medical Association Journal 265 (2007).

In theory, physicians agree that they have an ethical obligation to disclose medical errors. One study suggests that between 70 and 90% of the physician population believes that doctors should disclose errors to patients. Kathleen M. Mazor et al., Communicating with Patients about Medical Errors, 164 Archives of Internal Medicine 1690, 1692 (2004). In another study, 97% of the faculty and resident population surveyed indicated that they would disclose medical errors that caused minor harm, and 93% indicated that they would disclose an error causing major harm. Lauris Kaldjian , et al. Disclosing Medical Errors to Patients: Attitudes and Practices of Physicians and Trainees, 22(7) J Gen Intern Med 988-96 (2007).

Regrettably, while physicians are ethically obligated to inform their patients of consequential medical malpractice and studies suggest they intellectually support this principle, theory has not translated into practice. A study revealed that only 24% of residents surveyed reported the medical errors they committed to their patients. Albert Wu, et al. Do House Officers Learn From Their Mistakes? 12 Quality & Safety Health Care 221, 224 (2003). Another study estimated that nationwide, physicians are only disclosing errors to patients about 1/3 of the time. Robert J. Blendon et al., Views of Practicing Physicians and the Public on Medical Errors, 347 New. Eng. J. Med. 1933, 1935 (2002) .

-II-

THE GENERAL IMPACT OF COMPULSORY ERROR REPORTING AND DISCLOSURE

A. Compulsory Error Reporting Will Make Significant Contributions to the Improvement of the Quality of Health Care Everywhere.

Mandatory disclosure of medical errors in New Jersey will provide invaluable information useful to medical providers everywhere. First, it will provide information about the scope of the medical malpractice problem. In November 1999, the Institute of Medicine, a branch of the National Academy of Sciences, declared that a threshold improvement in the quality of health care was needed because studies indicated that medical negligence committed in hospitals in the United States were killing more people annually than motor vehicle accidents, breast cancer and AIDS. Kohn LT, Corrigan JM, and Donaldson MS, To Err Is Human: Building a Safer Health System, National Academy Press pg. 26 (1999). (hereafter "To Err is Human"). As alarming as the statistics disclosed in the Executive Summary of this study were, it is significant that the analysis dealt only with deaths caused in hospitals. New Jersey's mandatory disclosure requirements apply not only to hospitals, but to all health care providers in the state. Not just deaths, but any preventable event that impacts a patient's health for more than seven days must be reported. Thus, mandatory disclosure of medical errors in New Jersey may provide the government and health care industry with the first accurate picture of the human and economic costs related to medical mistakes.

Beyond acquiring knowledge about the scope of the problem, analysis of the information generated from a statewide policy of compulsory error disclosure will provide the health care industry with the ability to analyze patterns in the data collected to see why system errors occur, and this will help determine what can be done to avoid or minimize certain problems. Surprisingly, such a systematic approach to dealing with medical errors is absent. In To Err is Human, the authors noted that the health care industry is at least a decade or more behind other high-risk industries in its attention to ensuring the basic safety of people it services. Id. at 5. The Institute of Medicine indicated that a multifaceted approach was needed to improve the quality of health care. Id. at 4. One of the changes it called for was mandatory reporting of serious adverse events so that these could be studied. Id. at 102. To date, the failure to disclose medical errors has undermined efforts to improve patient safety. Hebert PC, et al. Bioethics for Clinicians: 23. Disclosure of Medical Error, 164 CMAJ, 509-513 (2001); The Joint Commission on Accreditation of Healthcare Organizations, Health Care at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Patient Injury, pg. 27 (2005). New Jersey's statewide compulsory error reporting requirement is one of the most significant first steps taken to correct this problem. Clearly, industry experts all over the world will be watching what New Jersey learns on this front.

B. Compulsory Error Disclosure Will Not Necessarily Result in an Increase in Medical Malpractice Filings in New Jersey.

There are few health care systems that enforce a policy of mandatory medical error disclosure. As a result, it is difficult to estimate how the PSA's compulsory error reporting requirements will impact medical malpractice filings in New Jersey. Nevertheless, studies in smaller systems where this was done demonstrate that the impact of mandatory disclosure on filings may be negligible and perhaps even positive. The Veterans Affairs Medical Center in Lexington, Kentucky, the University of Michigan Health System and a Colorado malpractice insurance company, COPIC, developed programs to fully disclose medical errors while simultaneously attempting to compensate the victims of malpractice if warranted. Disclosing Medical Errors to Patients: a Status Report in 2007, supra, at 266. All of these organizations found that the number of malpractice claims filed either stayed the same or decreased. Id.; Christian J. Vercler, et al., Communicating Errors, 140 Cancer Treatment and Research, 195-213, 204 (2008).

Although seemingly counterintuitive, the idea that compulsory medical error disclosure may not yield more malpractice lawsuits is corroborated by studies that seek to ascertain what motivates patients to sue their doctors. Financial compensation is not the most common reason that people give for filing a medical malpractice lawsuit. In fact, it is fifth on the list, behind (1) a clear admission that a mistake was made, (2) a full explanation of the error, (3) a sincere apology, and (4) reassurances that things are being done so that the error is not repeated. Thomas Gallagher et al, Patients' and Physicians' Attitudes Regarding the Disclosure of Medical Errors, 289 JAMA 1001, 1004-1006 (2003). It may very well be that because the PSA's compulsory error reporting requirements will immediately satisfy the first four of the above desires, some potential lawsuits will not be filed.

-III-

THE PSA AND CHANGING THE CULTURE OF HEALTH CARE

An examination of the reasons why health care providers failed to meet their ethical obligation to disclose errors can shed light on how mandatory error reporting will change malpractice litigation because the same forces which discourage the reporting of medical mistakes when they occur likely discourage physicians from taking responsibility for mistakes after a lawsuit is filed.

Health care providers' failure to fulfill their ethical obligation to disclose medical errors is often blamed on the fear of potential medical malpractice lawsuits. Putting aside the question of whether avoiding being held financially responsible for a mistake is a valid basis to reject an ethical obligation to report it, scholarly articles addressing the subject of why physicians fail to disclose errors suggest motivations besides fear of lawsuits are at play. Notably, despite the fact that there are procedural safeguards in place to prevent statements made in M&M conferences from being used against a health care providers in medical malpractice cases, physicians are still reluctant to discuss medical mistakes in these forums, leading some commentators to conclude that legal liability does not inhibit the discussion of errors in these conferences as much as other factors, such as the social norms of medicine. Wei, Marlynn, Doctors, Apologies and the law: An Analysis and Critique of Apology Laws, 40(1) Journal of Health Law 107-59, 132 (2007).

Beyond M&M conferences, academics have noted that physicians do not disclose errors even when they are permitted to do so anonymously, without fear of retribution:
What is most striking is that even nonpunitive medical error reporting measures suffer from underreporting. Reporting systems at the federal and state level have attempted to build a database upon which providers can improve patient safety. Nevertheless, the detection and prevention of medical error continues to be plagued by under reporting of adverse events, even when the reports are anonymous, voluntary and confidential.
Id. at 36. (2007).

Some have suggested that the culture of medicine, instilled in physicians beginning in medical school, is responsible for the widespread abandonment of the ethical obligation to disclose errors. Gallagher TH, Waterman AD et al. US and Canadian Physicians' Attitudes and Experiences Regarding Disclosing Errors to Patients, 166(15) Archives Internal Medicine 1605-1611. (2006). Similarly, it has been hypothesized that the failure to disclose errors is due to a "medical narcissism," which develops through doctors' "idealistic, perfectionist projection of themselves" which causes the mere acknowledgment of an error to be "so psychologically damaging to the physician's sense of self that he or she will go to great lengths to rationalize and obfuscate the facts of the error." Vercler CJ et al., Communicating Errors, 140 Cancer Treatment and Research 195-213, 206 (2008). (discussing Banja J.D., Medical Error and Medical Narcissism, Jones & Bartlet: Sudbury, MA (2005). According to this theory, a kind of preexisting narcissism drives individuals to become physicians in the first place, and a narcissistic inclination is then supported and encouraged through the medical education process, where residents are encouraged to strive for perfection. Communicating Errors, supra, at 206. Emotional detachment is simultaneously developed as a survival strategy, and the loss of empathy and the goal of perfection combine to present a major barrier to disclosure of mistakes. Id.

There are other aspects of the culture of medicine that contribute to the failure of physicians to disclose errors, including the desire of physicians to remain self-regulated. Doctors, Apologies and the law: An Analysis and Critique of Apology Laws, supra, at 146. Simply put, physicians resent being told how to treat their patients, especially by non-physicians. Id. Furthermore, disclosure of errors chips away at the mask of infallibility that physicians wear. Id. at 147. Infallibility supports two fundamental aspects of the physician-patient relationship. First, it buttresses the physician's position of authority in the relationship. Id. Second, it instills a sense of certainty in the physician's treatment recommendations. Id. at 148.

Physicians also resist the disclosure of errors because doing so creates worries about costs to reputation, loss of referrals and risk of litigation. Id. Finally, there are problems of analysis that contribute to physician's failure to disclose errors because there can be doubt about the cause of a particular outcome. Communicating Errors, supra, at 204.

"The culture of an organization is the nonverbal part of the ongoing conversation among the individuals who comprise the organization." Edward Dauer, Postscript on Health Care Dispute Resolution: Conflict Management and the Role of Culture, 21 Ga.St.U.L.Rev. 1029, 1044 (2005) (discussing Debra Gerardi, The Culture of Health Care: How Professional and Organizational Cultures Impact Conflict Management, 21 Ga.St.U.L.Rev. 857 (2005)). As one commentator observed, by compelling the disclosure and reporting of medical errors, the PSA is forcing a change in the culture of health care in New Jersey. Postscript on Health Care Dispute Resolution: Conflict Management and the Role of Culture, supra, at 1053. It stands to reason that this health care culture change will impact medical malpractice litigation.

-IV-
CONCLUSION

The PSA has provisions which prevent disclosures made pursuant to its terms from being used against medical providers in a malpractice case. Any documents submitted to the Department of Health and Human Services are not subject to discovery or admissible in evidence in a civil or criminal hearing. N.J.S.A. 26:2H-12.25(f)(1). Additionally, a statement by healthcare provider advising a patient that he is the victim of a serious preventable adverse event are is not discoverable or admissible in evidence in a civil trial.

Although disclosure of a medical error under the PSA may not be brought to the attention of a jury in a medical malpractice case, it is a mistake to conclude that the compulsory immediate disclosure of a medical mistake will not impact medical malpractice litigation. Disclosure of a medical mistake under the PSA will require health care providers to immediately examine their actions and take responsibility for preventable adverse events of consequence. Not every serious preventable adverse event under the PSA will constitute a meritorious and viable medical malpractice claim. Nevertheless, every meritorious and viable medical malpractice case should meet the requirements of being a serious preventable adverse event under the PSA. Therefore, hereafter, in most medical malpractice cases, a defendant health care provider will have already examined his actions, concluded a mistake of consequence was made, and advised his patient and the state accordingly.

Failing to disclose medical error when they occur will often foreclose a physician from acknowledging the mistake in a subsequent lawsuit. Doctors, Apologies and the law: An Analysis and Critique of Apology Laws, supra, 110-111. At a minimum, if a plaintiff prevails, a defendant doctor can appear cold and unapologetic to the jury. Id. Furthermore, failing to honestly deal with a mistake at its outset can set the tone in a subsequent litigation, turning circumstances involving an honest error into a zero-sum credibility challenge, which unnecessarily escalates the stakes for everyone involved in the lawsuit.

Compulsory disclosure under the PSA should make medical malpractice cases less contentious because in many cases defendants will have already acknowledged and come to terms with the fact that they have committed a consequential mistake. Further, because the cultural and economic pressures that discourage disclosure and reporting of errors are some of the same forces that serve as obstacles to resolving a medical malpractice lawsuit, the PSA's compulsory error reporting requirements should obviate many unstated motivations medical malpractice defendants have for not taking responsibility for their actions throughout the course of a lawsuit.

In 2003, the American Arbitration Association (AAA) reported that out of the thousands of matters it handled throughout the United States, only 1 involved a claim of iatrogenic injury in a health care setting. Dauer, Edward A., Postscript on Health Care Dispute Resolution: Conflict Management and the Role of Culture, supra, at 1036. There is reason to believe that changes mandated by the PSA may make ADR a more useful tool for medical malpractice defendants.

If the changes in medical culture caused by compulsory error disclosure and reporting make medical malpractice cases in New Jersey less contentious, plaintiffs will not be the only beneficiaries. Ninety-five percent of physicians sued for malpractice report strong emotional responses related to that event, physical reactions or both. Doctors, Apologies and the law: An Analysis and Critique of Apology Laws, supra, at 139. Id. One half reported insomnia and a minority reported the manifestation of physical problems related to being sued for medical malpractice. Id. at 140.

Perhaps the PSA's error reporting and disclosure requirements will be just what the doctor ordered for patients and doctors who are unfortunate enough to have to go through a medical malpractice litigation. To be sure, many will be watching to see the impact this legislation has on the health care profession in New Jersey.