In most states, the legal requirements a Plaintiff must meet to bring a medical malpractice claim are similar if not identical to what is required in order to bring a claim against a nursing home or assisted living facility.  One distinction between these types of cases, however, has been in the numerous claims and legal theories of recovery that Plaintiffs have historically brought against long term care providers in the same complaint.  Some states have enacted legislation in order to end the distinction between traditional “medical malpractice” claims and Adult Protection Act claims, Negligence Per Se claims, and so-called “custodial care” or ordinary negligence claims against nursing facilities.  For instance, the Tennessee Civil Justice Act of 2011 deleted the term “medical malpractice” from the Tennessee code books altogether.  It was replaced, instead, with a broader cause of action called a “health care liability action.”  Some notable provisions of the Act are as follows:         

- There is no longer any formal claim called “medical malpractice”;

- “Health care liability action” is a defined term in the statute and includes any civil action regardless of the theory of liability on which the action is based alleging that a health care provider caused an injury related to the provision of, or failure to provide “health care services.”

- “Health care provider” is a defined term and includes physicians and nurses but now also specifically includes LPNs, advance practice nurses, physician assistants, nursing technicians, pharmacy technicians, orderlies, and CNAs.

- “Health care services” is a defined term and includes care provided not only by physicians and nurses but now also specifically includes care provided by LPNs, pharmacists, orderlies, CNAs, advance practice nurses, physicians assistants, nursing technicians and also includes staffing, custodial or basic care, positioning, hydration and similar patient services.   

- Long term care facilities and their employees, such as LPNs, CNAs, and orderlies are “health care providers” whose care and services are subject to the statute’s requirements.  

- Many claims which traditionally fell under ordinary negligence (i.e. care provided in a nursing home by CNAs) are now defined as health care liability claims.  

- A Plaintiff must bring such an action in accordance with the provisions of this Act.  

Regarding the change in the law, one Tennessee opinion, Parker v. Portland Nursing & Nursing Rehab, 2012 Tenn. App. LEXIS 606, FN. 4 (Tenn. Ct. App. Aug. 30, 2012), is instructive because the case was decided after passage of the Civil Justice Act but plaintiff’s claims accrued prior to enactment.  The plaintiff initially sued the defendant nursing homes for ordinary negligence before amending her complaint to add a medical malpractice claim.  The Court allowed the amendment and applied the prior law (distinguishing between ordinary negligence (custodial care) and medical malpractice) while acknowledging the change in the law for claims that accrued after the relevant date of the Act.  The Court noted: “. . .[C]laims for ordinary negligence and medical malpractice are separate and distinct causes of action. . .”  Importantly, however, the Court added: “Both parties note that the passage of the Tennessee Civil Justice Act of 2011 ended this distinction and created a new cause of action of a "health care liability" claim.” (See 2011 Tenn. Pub. Acts ch. 510). Id. at FN 4 (emphasis added).  Clearly, the “Civil Justice Act” replaced “medical malpractice” and expanded the definition of a “health care liability claim” to include the type of claims commonly alleged against nursing homes and long term care providers.

For those interested in further discussion of this topic and learning other ways in which nursing home/ALF litigation is different from medical malpractice litigation, DRI’s Nursing Home/ALF seminar is right around the corner – September 10-11, 2015 at The Venetian/Palazzo Resort Hotel in Las Vegas, Nevada. Among the many areas discussed, there will be presentation regarding the business side of defending nursing home cases, how plaintiffs’ themes have developed and evolved, and tips and techniques for defending these types of cases from inception through trial.  This is the preeminent seminar for attorneys in private practice, in-house counsel, claims specialists, and other professionals involved in the defense of claims against long-term care facilities, assisted living facilities, and other aging services providers across the country.  Additional information on the seminar can be found here


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Frequently, nursing homes and long term care facilities find themselves the subject of claims for injuries or harm to patients stemming from insufficient staffing. Proving that the facility had enough employees on hand to properly care for its patients is essential to defending such claims.

Under California law, facilities must provide, at a minimum, 3.2 nursing hours per patient per day. (Health & Safety Code §1276.5.) However, according to the California Code of Regulations, facilities are required to have sufficient staff on hand and provide those nursing hours needed meet the individualized needs of its patients. (22 Cal.Code.Regs. §72501(e).)

An issue arises when a facility relies upon the Health and Safety Code requiring only 3.2 nursing hours per day per patient, and mistakenly believes that so long as this number is achieved, they have fulfilled their duties. However, in some cases 3.2 hours per patient may not be sufficient to care for the patient, resulting in a failure of the facility to meet the requirement of the California Code of Regulations to meet the individualized needs of its patients.

Facilities must be careful to ensure it is meeting the individual needs of its patients, rather than relying upon §1276.5 and its 3.2 hour requirement. A facility that relies only upon the 3.2 hour requirement and fails to provide care as needed may in fact demonstrate that it has disregarded the individual needs of its patients. Plaintiffs alleging wrongdoing by a nursing facility who are trying to prove the facility has failed to provide care as needed, and that as a result of insufficient staffing harm has occurred, may look to budget and cost records. A facility’s budget records can be utilized against a nursing facility to demonstrate that it budgeted only for staffing to provide 3.2 hours of nursing per day per patient. This evidence can show that the facility failed to meet the individualized needs of its patients by providing only the minimum standard of care.

Nursing facilities can help eliminate the risk of lawsuits and liability for insufficient care by ensuring the individualized needs of its patients are met. This means a careful review of the facilities’ patients and their needs is required on a consistent and frequent basis to assess the overall needs of the facility in terms of staffing.

If you are a nursing facility and have questions about the standard of care required for your patients, or have liability concerns, please contact Marc Zimet at Jampol Zimet, LLP at (213) 689-8500 or at, for a consultation to ensure your interests are protected before it is too late.

*This blog was originally posted to Jampol Zimet on December 23. Click here to read the original entry. 

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If a nurse discloses confidential patient information to a third party without authorization, and for reasons unrelated to the patient’s treatment, can the medical company that employs the nurse be held strictly liable for breach of fiduciary duty to maintain the confidentiality of personal health information?  New York’s highest court has said no.

In Doe v. Guthrie Clinic, the plaintiff was treated at the Guthrie Clinic Steuben (the “Clinic”) for a sexually transmitted disease (“STD”).  A nurse at the Clinic recognized plaintiff as the boyfriend of her sister-in-law, which apparently prompted the nurse to access plaintiff’s medical records. During plaintiff’s treatment, the nurse sent six text messages to her sister in law discussing the details of plaintiff’s medical condition, i.e., his STD.  Within five days of his treatment, plaintiff learned of these text messages and called the Clinic to complain about the nurse’s behavior. The Clinic fired the nurse.  It also sent plaintiff a letter confirming that his confidential information had been improperly accessed and disclosed, and stating that appropriate disciplinary measures had been taken.

Plaintiff filed a diversity action in New York federal court against various affiliated entities that allegedly “owned, possessed, operated, staffed and/or controlled” the Clinic.  The District Court dismissed plaintiff’s eight causes of action, most of which were based on respondeat superior, and plaintiff appealed.  The United States Court of Appeals for the Second Circuit affirmed the dismissal of most of the claims.  It held that because the nurse sent the text messages purely for personal reasons that had nothing to do with plaintiff’s treatment, the nurse’s actions “cannot be imputed to the defendants on the basis of respondeat superior.”  Doe v. Guthrie Clinic, Ltd., 710 F.2d 492, 495-96 (2nd Cir. 2013). However, plaintiff argued that “medical corporations” should be held “separately and strictly liable under New York law for breaching their fiduciary duty to keep personal health information confidential.”  Id. at 496.  With minimal case law on this important issue, the Second Circuit certified the following question to the New York Court of Appeals (New York’s highest state court):

Whether, under New York law, the common law right of action for breach of the fiduciary duty of confidentiality for the unauthorized disclosure of medical information may run directly against medical corporations, even when the employee responsible for the breach is not a physician and acts outside the scope of her employment?

The New York Court of Appeals ruled that liability does not extend to a medical corporation under these circumstances.  It held that “a medical corporation’s duty of safekeeping a patient’s confidential medical information is limited to those risks that are reasonably foreseeable and to actions within the scope of employment.”  Doe v. Guthrie Clinic, No. 224, 2014 WL 66644 (N.Y. January 9, 2014).  The Court noted, however, that where an employee discloses confidential patient information outside the scope of his or her employment, the plaintiff is not without a remedy against the medical corporation.  The plaintiff can still assert direct claims against the medical corporation for negligent hiring, training, and supervision, and for failure to establish adequate policies and procedures for safeguarding confidential patient information.  

This is an important case for medical corporations as it firmly restricts their fiduciary liability for an employee’s unauthorized disclosure of confidential patient information.  At the same time, with several direct causes of action still available to plaintiffs, there is sufficient incentive for medical corporations to diligently establish and enforce policies that protect patients’ personal health information.

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On March 11, 2013, the National Football League and the General Electric Co. announced that they are teaming up to create a Head Health Initiative that will provide $60 million dollars to assist leading neurologists in researching traumatic brain injuries and developing technology able to monitor these ailments.  $40 million will go towards developing imaging technologies, and the remaining $20 million will be available to others who seek to prevent, identify, and develop treatments for brain injuries.  Athletic apparel company Under Armour will also be providing $5 million dollars in support for the cause.

Jeff Immelt, GE Chairman and CEO, indicated that scientific support for the research would be top-notch.  “We’re trying to do this with the best minds anywhere in the world,” he noted in a news conference.  He declared that the funds would utilize GE’s expertise in sophisticated diagnostic imaging technology to increase general scientific knowledge on brain functions, noting “With this initiative, we will advance our research and apply our learning to sports-related concussions, brain injuries suffered by members of the military and neurodegenerative diseases such as Alzheimer’s and Parkinson’s.  Advancing brain science will help families everywhere.”

NFL commissioner Roger Goodell also expressed satisfaction with the initiative, stating: “The NFL has made tremendous progress in making the game safe and more exciting.  But we have more work to do.  Our collaboration with GE and Under Armour . . . puts us on an accelerated path to progress . . that will benefit athletes, the military, and all members of society.”

As orignally published at March 13, 2013.
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Harvard University and the National Football League Players Association (“NFLPA”) are negotiating a deal with the NFL seeking a $100 million grant for the purpose of studying, diagnosing, and treating injuries and ailments suffered by players as a result of their football careers.

Dr. Lee Nadler, the Harvard Medical School Dean for clinical and translational research, attested to the groundbreaking nature of the proposed project, noting “[n]o one has ever studied the players [themselves] before.  There have been postmortem studies looking at the brains of previous players but not the players today.”

One has to wonder how generous the NFL will continue to be – after all, the league just donated $30 million to the National Institutes of Health last year to study brain injuries in NFL alumni.  Still, proponents of the Harvard study made sure to stress that this would not be simply another concussion study; instead, it would consider a whole host of health ailments potentially facing former NFL players  including chronic pain, depression, heart problems, and diabetes.  The scope of the proposed research is beyond anything that has been conducted to this point – preliminary estimates called for a nation-wide group of 200 NFL alumni drawn from a 1,000 person study group, with all participants being subject a wide array of medical tests.

Dr. Herman Taylor, one of the non-Harvard medical professionals retained for the study, stated, “Typically, when we do a test or medical study, we’re taking a snapshot.  What we want to do is see the full-length movie of what happens to a player over time.”

On the issue of funding, NFLPA Executive George Atallah noted, “Given the scope of health issues that NFL players are subject to, we are committed to making sure that enough money is allocated to get answers.”  However, because the research will be funded by a portion of league revenues, the actual amount the NFL is willing to put towards the study will likely not be determined until after the Super Bowl.

As originally published at on January 31, 2013
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A recent article published on suggests that unlike other professional industries, health care providers have been slow to engage on social media.  The article posits that the key reasons for their reluctance stem from concerns about accountability and privacy.  At its root, the issue seems to be that between the protections afforded under the Health Insurance Portability and Accountability Act (HIPAA) and more generalized notions of physician-patient confidentiality, many providers are concerned that a presence in social media threatens patient confidentiality and exposes them to expanded liability.  The article makes the point that a lack of social media presence is itself risky for health care providers, and argues that the risk of not establishing a presence subjects providers to potentially negative commentary and characterization.

The risks to physicians, hospitals and similar providers posed by interaction on social media are analogous to a large extent to those faced by lawyers, a group which in my experience has fairly enthusiastically embraced social media, and opportunities for professional on-line communication and networking.  Like physicians, lawyers are bound by client confidentiality.  We are also bound by rules of professional conduct that regulate what we are permitted to communicate about our services and our experience.  This does (or should) cause us to be cautious and deliberative when engaging social media, particularly when we do so under color of our profession and/or our firm.  Notwithstanding these restrictions, lawyers have been active in social media for many years.

On the other hand, health care providers have to be concerned about additional scrutiny that we lawyers do not.  This includes state and federal oversight associated with Medicare and Medicaid, as well as board licensure review.  Health care providers also face heightened attention and expectations of accountability when there is a bad patient outcome.  Providers may be understandably leery of engaging in yet another form of exposure and communication in which there is certainly opportunity for “bad press.”  However, as the article suggests, media silence can be detrimental both from a financial point of view and in the arena of public opinion.  Even social media silence.

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It is not surprising that plaintiffs claiming to be injured in auto accidents are often evasive about their prior medical history and treaters. In an article published by the American Medical Association, “Examinee-Reported History Is Not a Credible Basis for Clinic,” Robert Barth, Ph.D., cites numerous studies confirming that claimants tend to misrepresent their pre-claim functioning as having been “superhuman,” and distort their reported history in a fashion that potentially inflates the financial compensation for their claims.

This forces defense attorneys to utilize alternative methods in their ongoing attempt to locate the pre-accident smoking gun:

Jail medical records: In a recent Michigan case, a plaintiff admitted he previously suffered a closed head injury from a prior auto accident. However, he claimed that he never had seizures before a subsequent auto/pedestrian incident, and was not taking Depakote for seizures. There was a gap in his post-MVA treatment, and it was discovered he was incarcerated. Indeed, the jail medical records confirmed a year before the accident that he suffered a seizure and was taking Depakote, an anti-seizure medication, for his condition.

MasterTrace: This service bears fruit, particularly when a plaintiff has no prior history of health insurance, and has lived in other states. MasterTrace performs an extensive canvass profile of hospitals and pharmacies within a certain designated radius and matches up with the plaintiff’s background information to come up with potential “hits.” However, this service can be expensive, depending on the nature of the search.

Prescription Drug Monitoring Programs (PDMP): A PDMP is an electronic database that collects designated data on substances dispensed to a patient in the state. Thirty-seven states currently have PDMPs. On September 1, 2011, pharmacists in Florida began submitting data to the recently implemented Florida Prescription Drug Monitoring Program. Across the country, access to this information is restricted to physicians and law enforcement personnel. While defense attorneys are not able to subpoena the information, if you are lucky, the plaintiff’s treating physician may request a PDMP if he or she suspects drug abuse or doctor shopping. Generally, the physician will not supply a copy of the PDMP in a standard subpoena unless requested, or if you happen to come across it during a review of the actual file in a doctor’s deposition. If you do land such a report, it may provide an abundance of information, including prior treaters and pharmacies, and demonstrate evidence of pre-accident drug abuse.

Veteran Administration Records: Do not skim over the fact that a plaintiff served in the military 40 years ago. He or she may still be treating and receiving prescriptions from your local VA hospital. Further, if a plaintiff is receiving a pension from the VA, he or she periodically has to undergo a disability determination, and fill out paperwork. It is always compelling to see what the plaintiff tells the VA, as compared to Social Security Disability, workers’ compensation, and plaintiff's own treaters during the identical time frame.

Health Insurance Cards: Somewhere in every treater’s medical record, hospital’s intake sheet, or hidden deep within a prior auto accident claim file is a copy of plaintiff’s health insurance card (if he or she has one). If located, these health insurance records may provide a precise history of all prior hospital, doctor and pharmacy visits.

A plaintiff is not going to hand you his or her pre-accident history on a platter, so expect to do some extra digging. With enough persistence, you may ultimately discover a wealth of information that could undermine the plaintiff’s credibility and case.

Robert Abramson is an associate in the law firm of Kopka, Pinkus, Dolin & Eads in Farmington Hills, MI. He specializes in first-party, third-party and uninsured motorist claims in Michigan. Mr. Abramson is a member of DRI's Young Lawyers and Insurance Law Committees.


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The Centers for Medicare and Medicaid Services (“CMS”) posted an alert (the “Alert”) that confirms that there has been an extension, in certain cases, of the reporting trigger date for Mandatory Insurer Reporting (“MIR”) under Section 111 of the MMSEA.  The Alert provides the new trigger dates based on gross settlement/judgment/other payment (“TPOC”)  values for claims as follows:

The implementation timeline for reporting will be based on the TPOC amount.  Below is a schedule of the new dates.

For TPOCs between $5,000 and $25,000 – the trigger date is Oct. 1, 2012 (with MIR starting the First Quarter, 2013);

For TPOCs between $25,001 and $50,000 – the trigger date is July 1, 2012 (with MIR starting the Fourth Quarter, 2012);

For TPOCs between $50,001 and $100,000 – the trigger date is April 1, 2012 (with MIR starting the Third Quarter, 2012); and

For TPOCs of $100,001 and above – the trigger date remains the same – Oct 1, 2011 (with MIR starting the First Quarter, 2012).

Below are examples of how these provisions will work: 

Example 1: If you settle a TPOC for $15,000 next week, you are not required to report that claim.  You may voluntarily report, but mandatory reporting (and the penalties associated therewith) would not apply until you settled that $15,000 claim on or after October 1, 2012.

Example 2: If you settle a $115,000 TPOC on or after October 1, 2011, mandatory reporting occurs no later than the submission window assigned during the first quarter of 2012.  The chart (in the Alert) is intended to let you know when a failure to report would trigger penalties. Penalties, therefore, could be levied if the RRE settles a TPOC of $100,000 or more, on or after October 1, 2011, and the RRE does not report under Section 111 during the reporting period in the first quarter of 2012.

The DRI Medicare Secondary Payer Task Force will continue to follow these issues and provide guidance to the DRI Community as new Alerts are posted.

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FCPA and National Security

Posted on July 6, 2010 07:39 by Jonathan Rosen

Two recent FCPA enforcement developments exemplify the government’s view that foreign corruption is a national security risk warranting increased scrutiny.

First, the newly established FCPA unit at the Securities and Exchange Commission is investigating companies in the pharmaceutical and energy industries that do business in nations designated as state sponsors of terrorism. The purpose of the investigation is to determine whether any of the companies’ operations were used to support terrorist activities in Cuba, Iran, Sudan and Syria.

Second, the Criminal Division’s Fraud Section has sent letters in recent weeks to a number of pharmaceutical companies asking about payments made to foreign officials in several nations, beyond those designated as state sponsors of terrorism. This development follows the justice department’s announcement of its own general probe into the pharmaceutical and medical device industry in November 2009.

These two investigations reflect a policy judgment that corruption is a national security issue. The government is now looking at international corporations, including those in the pharmaceutical and medical device industry, as the gatekeepers for business activity that can be used to finance terrorist activities. Moreover, the Department’s anticorruption efforts reflect an acceptance that poor governance, including corruption, has pernicious effects on development and stabilization.

These two developments are the latest manifestation of the trend in intensified FCPA enforcement targeting the pharmaceutical industry. In a speech on November 12, 2009, to the Tenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Lanny A. Breuer, Assistant Attorney General of DOJ’s Criminal Division, warned that “[o]ur focus and resolve in the FCPA will not abate, and we will be intensely focused on rooting out foreign bribery in your industry. That will mean investigation and, if warranted, prosecution of corporations to be sure, but also investigation and prosecution of senior executives.”

Breuer highlighted some of the key factors that increase FCPA liability risks for the pharmaceutical industry. First, he noted that “close to $100 billion, or roughly one-third, of total sales for [U.S. pharmaceutical companies] were generated outside the United States, where health systems are regulated, operated and financed by government entities to a significantly greater degree than in the United States” – thereby resulting in substantial interaction with foreign government officials to manufacture and market pharmaceutical products. Second, he highlighted the problem presented by interacting with foreign health care systems: “under certain circumstances and in certain countries, nearly every aspect of the approval, manufacture, import, export, pricing, sales and marketing of a drug product in a foreign country will involve a ‘foreign official’ within the meaning of the FCPA.” Third, he cited “fierce industry competition and the closed nature of many public formularies.”

Based on these factors, pharmaceutical companies must establish and implement internal controls that govern “routine” interactions with foreign officials throughout the entire product life cycle. Aggressive FCPA enforcement creates not only back-end, e.g., distribution, but also front-end, e.g., preclinical and R&D, compliance challenges for pharmaceutical management teams that may not be accustomed to focus on anything other the scientific process. The government will closely scrutinize contacts with foreign officials throughout the entire regulatory process, including: research and development, filing patents, manufacturing, registration, price fixing, licensing of professionals and establishments, selection of essential medicines, procurement, distribution, inspection of establishments, prescription, dispensing, pharmacovigilance and marketing and sales.

Some core activities implicating FCPA concerns include:

  • Engaging the services of health care professionals
  • Post-marketing studies and other clinical studies
  • Sponsoring health care professionals to attend meetings and events
  • Gifts and entertainment
  • Visits to company facilities and other travel
  • Sponsorship and grants
  • Political contributions
  • Facilitating payments
  • Actions by and payments to agents, consultants, joint-venture partners, distributors and other third party representatives
  • “hospitality” payments

FCPA enforcement is no longer only about “leveling the playing field” of corporate opportunities. Given the government’s treatment of corruption as a national security issue, business leaders must ensure that company proceeds do not finance illicit payments which can be used to sponsor terrorism or otherwise be seen as degrading the national security interests of the United States. With the dramatic increase in FCPA penalties against senior corporate executives, corporate executives must protect themselves and their companies by conducting the appropriate due diligence and implementing the necessary internal controls to identify and remediate the danger of FCPA violations.

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The courts continue to struggle with the distinction between differential diagnosis and causation assessment. In a recent case Best vs. Lowe’s Home Centers, 563 F.3d 171 (6th Cir. 2009), the Appellate Court overturning the District Court’s exclusion of a plaintiff ENT expert, Dr. Moreno, again found equivalency between the two. Other cases have found them to be separate processes as they, in fact, are.

I have written about this distinction many times, but have never before drawn a picture. Attorneys like words. Scientists like pictures. I cannot imagine describing a biochemical pathway, for example, with words alone. So, I am going to try this the medical way: with a picture. I am hoping that this diagram showing the differential diagnostic pathway, versus the causation methodology pathway clears the matter up. This may be useful to attorneys attempting to exclude medical experts who, in toxic tort matters, are claiming that “differential diagnosis” is their “causation methodology.”

The patient comes to the doctor with symptoms. Symptoms are physical complaints such as: headaches, joint pain, fatigue, insomnia, diarrhea and many, many others. The physician carries out an analytical process comprised of taking a history, performing a physical examination and ordering various tests. This approach constitutes the differential diagnostic process or Clinical Methodology (shown on the diagram) and leads to a diagnosis which is “the actual medical condition.” This is the medical condition which accounts for the symptoms. It is not the cause of that condition. Causation methodology, by contrast, asks:” What caused or contributed to the medical condition elucidated through the clinical process of differential diagnosis?” That requires a separate process (shown on the diagram as “Causation Methodology”) which must consider elements such as: 1. Proof that there is an established, known relationship between the agent at issue and the disease “ General Causation” 2. Proof that the claimant inhaled, ingested or was exposed dermally to an amount of the agent sufficiently high to produce a dose capable of causing the clinical disorder. 3. A finding that the temporal relationship between the exposure and the onset of the disease followed a recognized exposure-disease relationship. and 4. Establishing that other, more or equally-likely causes of the clinical disorder were not present.

In a medical malpractice case, if a patient is harmed, liability may depend upon differential diagnosis alone: e.g. failure to diagnose or reaching the wrong diagnosis (actual medical condition.) By contrast, in a product liability case involving chemicals or pharmaceutical agents, a separate and distinct causation analysis is essential for the determination of what was responsible for the actual medical condition.

In Best v. Lowe’s, the Appellate Court was partially correct and partially incorrect when it overturned the trial court’s exclusion of the ENT expert. It reached a proper conclusion, but its reasoning and its discussion of differential diagnosis were incorrect.

The case involved a claimant who lost his sense of smell allegedly because of exposure to a chemical released in an accident in a Lowe’s store. An ENT physician, Dr. Moreno, worked the patient up (clinical methodology = differential diagnosis) and concluded that the diagnosis was, indeed, anosmia (lost sense of smell). He thereby arrived at the Actual Medical Condition through the differential diagnostic process. He then carried out a causation analysis in which he evaluated alternate causes and discussed them, eliminated them for a variety of reasons, reasoned that the agent was capable of causing the disorder (“general causation”) and concluded that the chemical was the culprit.

The District Court did not argue with the diagnosis or the differential diagnostic process. Rather, it excluded Dr. Moreno’s testimony for lack of proper causation methodology (although, while noting the elements, it did not call it “causation methodology.”) I am not commenting here about the quality of that causation reasoning, having not reviewed all of the underlying facts of the case. From a superficial discussion by the Appellate Court, it would appear that Dr. Moreno may or may not have been wrong in his causal conclusion, but his methodological reasoning seems sound. Thus, this would, I believe, likely go to the quality of the analysis, not to the methodology: a question of fact for the jury. So, it seems that Dr. Moreno actually conducted both a differential diagnosis and a causation analysis. The appellate court, however, did not understand that. They saw his reasoning as a single methodological process which they placed under the rubric of “differential diagnosis.” To that extent they erred. Their conclusion overturning the District Court’s ruling that the testimony was inadmissible was probably correct: their explanation was not.

Another case Lee v. Marlowe, No. 3:08-CV-1739, 2009 WL 2591668, (N.D. Ohio Aug. 20, 2009) illustrates that it is easier for the Court to recognize the nature of differential diagnosis in a more commonly-understood event: an automobile accident as opposed to a chemically-induced injury.

During the evening August 31, 2007, the defendant was traveling westbound on the Ohio Turnpike when his vehicle struck a right-hand guardrail three times, and then swerved across two lanes of traffic, crossing the median separating the eastbound and westbound lanes of traffic, and struck Plaintiff's decedents' vehicle head-on, causing their deaths.

The question was why this happened.

The defendant asserted that the accident was due to a “sudden medical emergency.” Supporting that defense was the unsubstantiated testimony of the defendant’s cardiologist. He opined that the cause was syncope (or fainting). He further sated that he arrived at this conclusion based upon a “differential diagnosis.” The Court did not accept the mere proclamation that he had conducted a proper differential diagnosis. The Court ruled that he had no basis for excluding other causes such as fatigue, impairment or, simply, lack of attention. They, thus, excluded this “differential diagnostic” explanation for the accident and excluded the defense expert’s testimony.

Here the court properly ruled that the supposed “differential diagnosis” was improperly conducted. Thus, determination of the Actual Medical Condition (syncope in this case) was methodologically ill-founded. The physician had no medically reasonable way of ruling out other Conditions besides syncope.

In this case one never got to the cause of the condition, because it was not relevant. The poorly constructed differential diagnosis ended the testimony.
Assume, however, that this was a worker’s compensation case in which a worker fell from a high platform sustaining a serious injury. Assume further that the facts properly supported a diagnosis of “syncope.” Thus, the result of the differential diagnostic process—syncope—was correct. In such a matter the cause of the Condition—the syncope—could be relevant. If it were due to hot working conditions, it would compensable. If it were due to elicit drug use, it might not be (depending upon the State rules.)

To summarize:

Clinical Methodology is the Differential Diagnostic process. This leads to a determination of the Actual Medical Condition which is producing the patient’s physical complaints. Causation Methodology is an entirely separate entity which asks: “What lead to this condition?” Attorneys, defense and plaintiff, and the Courts, need to understand this critical distinction. Defense attorneys particularly need to be aware of the fact that an assertion by a treating physician stating that he/she arrived at a causal conclusion via the standard medical approach of differential diagnosis is incorrect. Differential diagnosis is only the first step in a causation analysis. This must be followed by a separate analytical process as indicated on the accompanying flow diagram.

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