Every quarter we provide our readers with an update on select health care and medical malpractice developments. These updates are generally helpful as a quick reference for recent developments or practice pointers for those involved with and/or employed by the health care industry. In these updates, we will note statutory or regulatory changes, and report on health care and medical malpractice litigation and judicial decisions that influence related cases in these areas. Guy C. Curry, Managing Partner
Health Care Updates ADVERSE EVENTS IN SKILLED NURSING FACILITIES Susan E. Henning Partner In February of 2014, the Office of the Inspector General (OIG) released the results of a study designed to evaluate post-acute care provided in skilled nursing facilities (SNFs). This study built upon a series of studies about hospital adverse events (harm resulting from medical care) that had been conducted by the OIG from 2008 to 2012. The SNF study involved a twostage medical record review of a sample of 653 Medicare beneficiaries who had been discharged from hospitals to SNFs for post-acute care for a period of thirty-five days or less. The study found that twenty-two percent of Medicare beneficiaries experienced adverse events during their SNF stays. For this study, an “adverse event” was considered an event that resulted in harm that (a) resulted in a prolonged SNF stay, transfer to another facility, or hospitalization, (b) contributed to or resulted in permanent resident harm, (c) required an intervention to sustain the resident’s life, or (d) contributed to or resulted in resident death. Thirty-seven percent of the adverse events were found to be medication related ( e.g. medication- induced mental status changes, excessive bleeding, fall or trauma due to medication effects, constipation or ileus, related to medications). Thirty-seven percent of the adverse events (continued on page 2)
Health Care Updates Adverse Events in Skilled Nursing Facilities ............ Page 1
Focus on the Firm ............................ Pages 2, 5, 10, 13 The “Legal Health Record” in the Age of Digitization Part I: Are System-Generated Alerts and “Flags” Part of the Legal Health Record? .................... Page 3
medical malpractice LAW Updates Jurisprudential Updates ............................................. Page 6
TAR: It’s Sticking Around - A Report from the Sedona Conference’s 8th Annual Institute on eDiscovery ....... Page 11
Labor and Employment Law Corner President Obama wants to Affect the Workplace ...... Page 14
This update is intended for general informational purposes only. The contents contained herein should not be construed as formal legal advice nor the formation of a lawyer/client relationship. The reader is urged to consult his or her personal attorney concerning specific legal questions and/or situations. This is an advertisement.
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were related to resident care or inadequate monitoring (e.g. falls, exacerbation of pre-existing conditions due to care omissions, acute renal injury due to inadequate fluid management, DVT or PE related to inadequate monitoring). Twenty-six percent of the events were related to infections (e.g. due to aspiration, UTIs associated with catheterization, clostridium difficile infection, surgical site infection due to inadequate wound care). An estimated 1.5% of SNF residents experienced events that caused or contributed to their deaths. Although no single type of event was prominent within the sample as contributing to death, residents who died as a result of events tended to have multiple, complex co-morbidities that made their care more challenging, weakened their conditions, or both. Although deaths were expected in many cases, most commonly, death during the SNF stay was not an expected outcome.
those that could have been prevented through improved assessment or alternative actions. Thirty-seven percent of the adverse events were considered not preventable (given the complexity of the resident’s condition or care required). In 4.2% of the cases, preventability could not be determined because of incomplete documentation or extreme complexities in resident condition or care. The physicians determined that 66% of medication events were preventable, 57% of resident care events were preventable, and 52% of infection events were preventable.
An additional 11% of residents experienced events that resulted in only temporary harm that required medical intervention, but did not cause lasting harm (no prolonged stay or transfer to a hospital). Forty-three percent of those experienced minor events associated with medications, 40% were related to resident care, and 17% were related to infections.
The study also considered the cost of adverse events in SNFs. Based on the study, the OIG estimated that $136 million was spent on hospitalizations associated with preventable events in this population.
Physician reviewers estimated that 59% of adverse events and temporary harm events were either clearly or likely preventable. “Preventable” events were defined as
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CURRY & FRIEND SPONSORS Daughters of Charity Gala
Since its founding in 1978, Curry & Friend, PLC has been a proud supporter of numerous civic and charitable organizations. The firm’s time, resources and talents are regularly contributed to charities and non-profit organizations that do so much to strengthen our communities and enrich the lives of those less fortunate. On Friday, March 28, 2014. Curry & Friend was proud to be a Creativity Sponsor of the 3rd annual Daughters of Charity Foundation “Keeping Our Promises” gala at the Hyatt-Regency Hotel Downtown in New Orleans. This is Curry & Friend’s third time sponsoring the event, which raises funds to help the Daughters of Charity achieve their mission of improving the health status of the Greater New Orleans community and providing high quality, compassionate care for all — the insured, underinsured and uninsured. The event also celebrated the Daughters of Charity’s 180th anniversary of providing health services to the New Orleans community.
Managing Partner & DCSNO Board Secretary Guy Curry with Michael Griffin, DCSNO President and CEO; Patty Lorio; Senator David Heitmeier, O.D.; Maureen Larkins, DCSNO VP of Strategic (continued on page 11) and Community Affairs; & Shawn Barney, DCSNO Board Member
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The OIG determined that the study confirmed the need and opportunity, through a coordinated effort by providers and overseers, to significantly reduce the incidents of adverse events in SNFs. The OIG recommended that the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS) raise awareness of adverse events to reduce harm to nursing home residents through methods that had been used to successfully promote hospital safety. In particular, the OIG recommended that AHRQ and CMS should collaborate to create and promote a list of potential nursing home events in order to educate SNF staff about the full range of potential resident harm. Additionally, CMS should include potential adverse events and information about resident harm in its Quality Guidance to Nursing Homes in offerings provided to nursing homes to improve practices in connection with goal setting. The OIG recommended that AHRQ and CMS should encourage nursing homes to report adverse events to external Patient Safety Organizations in order to provide an analysis of events across facilities and to assist providers in directing resources to the areas of greatest need in assessing progress and reducing incidents. Finally, the OIG recommended that CMS should instruct nursing home surveyors to review facility practices for identifying and reducing adverse events. This would include an assessment of adverse event identification and reduction in connection with State agency surveyors’ evaluations of quality assessment and quality improvement initiatives and compliance. The thinking was that review of such practices by the surveyors would provide an incentive to nursing homes to develop strategies to reduce adverse events. The AHRQ and CMS were provided with these recommendations and responded by concurring with the recommendations and committing to implementing the recommended strategies. SNFs can therefore expect greater focus by State survey agencies in assessing how SNFs are addressing the kinds of preventable adverse events that were identified in this study. The complete 65 page study (OEI-06-11-00370) is available on the Office of the Inspector General’s website ( http://oig. hhs.gov/ ). Data from the study could offer SNFs valuable information upon which to base more focused quality improvement undertakings. n
THE “LEGAL HEALTH RECORD” IN THE AGE OF DIGITIZATION PART I: ARE SYSTEM-GENERATED ALERTS AND “FLAGS” PART OF THE LEGAL HEALTH RECORD? Meredith M. Miceli Partner A physician receives a system-generated automated “popup” notification on his desktop computer, stating that the elderly patient who visited him the previous day for a six-month check-up has significantly increased cardiac enzymes, according to the lab who has examined his blood work. Yet, nothing is done to notify the patient, who soon suffers a heart attack and dies. When the attorney of the patient’s family subpoenas his “medical record,” must this alert be produced as part of the legal medical record? Is it even memorialized and stored in any meaningful manner by the medical facility? And what of the physician’s response? Can they be found in the audit trail or metadata of the facility’s computer system? Health information management (“HIM”) in this burgeoning era of electronically created and stored medical records is a field yet without clear boundaries, definitions, or customs. An enormous body of literature, in professional journals and on websites, by professional HIM societies and all manner of health care administrators, providers, and aficionados, has developed as to how electronic medical records should be created, utilized, saved, and stored, as well as how they should be disclosed in litigation. But no definitive brightline rules yet exist about what exactly an electronic record is comprised of, which part of it is to be considered the “legal health record,” and how such a record should be produced upon request. Much of the impetus behind the transition from paper to (continued on page 4)
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electronic health records lies in $19 billion in incentives built into the 2009 federal stimulus package, the American Recovery and Reinvestment Act, to encourage health care providers and hospitals to computerize medical records and optimize the use of technology. Undoubtedly, the mission is a noble one in light of data on the favorable association between the use of such technology and improved patient safety, health care quality and efficiency, and coordinated continuity of care. However, this dash to digitization has left a crater in the litigation landscape the size of Silicon Valley. What must a provider produce when served with a subpoena for a patient’s “medical record”? Must the stored paper record replicate the provider’s decision pathway during a patient encounter and treatment, i.e., must every screen viewed by the physician be captured for the patient’s record? Are data and communications reviewed or created by the provider on his or her mobile device (an increasingly common practice) part of the legal health record? What about patient e-mails and electronically stored voicemails? And, if so, how is all of this stuff supposed to be produced anyway? This two-part series will focus on two significant issues in health care litigation: (1) Increasingly utilized automated, system-generated “pop-up” notifications for, to cite but two examples, abnormal test results and medication contraindications, and whether they are part of the legal health record; and (2) “Legal holds” of electronic medical records, the latter-day “Sequestered for Litigation—Do Not Destroy” file for digitized records. A legal health record, or “LHR,” is a provider’s official business record generated for one patient’s health care and kept in the ordinary course of business for evidentiary purposes, and is released upon request for the patient’s medical record. It has been defined by the Health Information and Management Society (HIMSS) as the “officially declared record of health care services provided to an individual by a provider.” See HIMSS, The Legal Health Record in the Age of e-Discovery: A White Paper of the Electronic Health Record Adoption Task Force, Healthcare Information and Management Systems Society (Nov. 2008). As HIMSS’ White Paper of 2008 noted, an existential shift in the nature of a medical, or health, record has upended not only the processes of their creation, use, and storage, but also of their disclosure and production: [I]n the era of electronic records, “documents” are virtual entities that are created from underlying data and presented to users as necessary. This requires a different approach, one that is focused on data
management more so than physical documents. Since data that makes up a single virtual document may reside in multiple systems, which are themselves geographically separate, a data-centric approach to managing organizational information and defining the LHR is required in addition to the traditional documentcentric approach. The data-centric view of the electronic LHR regards the electronic health record as a collection of data that exists in multiple systems and in multiple formats. The data-centric view recognizes the realities of e-discovery in that disclosures may require organizations to provide information that may include anything from discharge summaries and medication lists to instant messages and e-mail header files. HIMSS White Paper, supra. As such, each provider/facility must explicitly define the content, sources, medium, and location of the individually identifiable data of its LHR, based on any applicable state and federal law and regulations, standards of accrediting agencies, community standards, the requirements of third-party payers, as well as ease of access to different components of patient care information. Id. See also American Health Information Management Association (AHIMA), “Fundamentals of the Legal Health Record and Designated Record Set,” J. AHIMA 2011 Feb.; 82(2); Addison K et al., J AHIMA 2005 Sep; 76(8): 64A-64G. (Of course, it cannot be overstated that the provider’s internal definition of its LHR does not affect the discoverability of other information found in the patient’s “record” as a whole. All electronic data are subject to being disclosed if deemed pertinent, not what a provider deems its LHR. If the legal request is for information other than just the patient’s “medical record” on the patient, the terms of that request itself dictate what information must be disclosed, if discoverable.) Notably, Louisiana law does not define exactly what constitutes an LHR in this age of electronic records. Certainly, no state or federal law or regulation could be found addressing the issue at hand: are system-generated alerts or “pop-ups,” which appear on a provider’s computer or personal device screen and which may very well be pivotal to litigation, part of the LHR? These alerts, known in the HIS world as one of many “clinical decision support,” or “CDS, within an electronic information system, are electronic prompts, which, for instance, alert a provider of an abnormal test result or a drug contraindication and can also remind a provider as to needed follow-up, etc. They have been promoted as a means to ensure quality care. (continued on page 5)
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While no legal regulations or courts have, to our knowledge, as yet commented on whether automated notifications are part of the LHR, health information societies, predictably, have found the question significant and have published their own opinions. In sum, system-generated notifications are usually not considered part of the medical record, though associated documentation by a provider is considered to be.1 For example, an OB-GYN is alerted to perform a breast exam on a patient with a history of cysts. The initial alert that prompts the provider is not part of the legal health record, but the subsequent action taken by the provider, including the condition acted upon and the associated note detailing the exam, is considered part of the record. Additionally, any annotations, notes, and results created by
the provider as a result of an alert, reminder, or pop-up are also considered part of the legal health record. Nevertheless, please note that some equivocation on this issue still exists and serves to remind us that each provider or entity must decide for itself and craft a policy that such CDS are or are not included in its LHR. Specifically, providers that consider alerts as part of their LHR need to define if all triggers are part of the record, i.e., appointment reminders may not be considered part of the LHR, but alerts for drug allergies may be. Moreover, providers must determine if the notification and action are captured in a metadata audit trail and track all revisions to the notification system for archival purposes. n
1 See AHIMA, “Fundamentals of the Legal Health Record and Designated Record Set,” J. AHIMA 2011 Feb.; 82(2); Warner D, “Evaluating Alerts and Triggers: Determining Whether Alerts and Triggers Are Part of the Legal Health Record,” Warner D, J AHIMA 2010 Mar; 81(3): 40-41; AHIMA e-HIM Work Group on Maintaining the Legal EHR. “Update: Maintaining a Legally Sound Health Record—Paper and Electronic.” J AHIMA 2005 Nov-Dec.; 76(10): 64A-L; Addison K et al., “Update: Guidelines for Defining the Legal Health Record for Disclosure Purposes,” J AHIMA 2005 Sep; 76(8): 64A-64G.
PRO BONO EFFORTS: CURRY & FRIEND HELPS REUNITE SOPA THE TORTOISE WITH HIS FAMILY
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On Monday, April 7th, the legal team at Curry & Friend obtained a joyful reunion of a rare African Sulcata tortoise with his family. The tortoise, named SOPA, wandered away from his home in Algiers last August. He caused quite a stir in the neighborhood, which wasn’t accustomed to seeing a tortoise wandering the streets. Neighbors called Louisiana Wildlife & Fisheries to rescue the animal, and sent a photo to WDSU, who publicized it widely in an effort to located the tortoise’s owners. Wildlife & Fisheries agents then brought SOPA to Audubon Zoo for a medical exam and safekeeping until his owner was found. A stranger, who had seen the WDSU report, came to the zoo to claim the animal, mistakenly believing that SOPA was the tortoise that had been stolen from him over a year earlier. When SOPA’s real family discovered he had been found, they rushed to the zoo to claim their family pet; however, the other alleged owner refused to bring him back for inspection, claiming that the tortoise belonged to him. The family contacted the LSBA for legal help, and the Animal Law Section asked Curry & Friend attorney Sue Laporte to help the family get their tortoise back. With the firm’s support for this probono effort, Sue investigated, and filed a Petition for Revendication and Damages seeking to have the tortoise returned to its rightful owners. After the defendant was served and obtained counsel, he agreed to participate in an expert examination of the tortoise, to determine whether it was his or belonged to the firm’s clients. Curry & Friend’s legal team found a tortoise expert, who examined the tortoise and found distinctive features on his shell, including a “Harry Potter”-like mark, that matched features shown in a collection of photos of SOPA going back to 1998. After several months of missing their beloved family member, Dave, April and Avery were finally reunited with SOPA and took him home.
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Medical Malpractice Updates The following are synopses of notable holdings, some published and some not, rendered since the beginning of 2014 by Louisiana appellate courts.
Jurisprudential Updates Meredith M. Miceli Partner The following is an update on a recent finding from the Florida Supreme Court.
Estate of McCall v. United States Florida Supreme Court Tosses Caps On Wrongful Death Medical Malpractice Awards The Florida Supreme Court recently held its statutory cap on wrongful death noneconomic damages in medical negligence cases to be unconstitutional. Estate of McCall v. United States, No. SC11-1148 (March 13, 2014). The case was before the court on certification from the U.S. Eleventh Circuit Court of Appeals. The court held that the cap violated the Equal Protection Clause of the Florida Constitution, as it “irrationally impacts” multiple claimants/ survivors “differently and far less favorably” than a single claimant/survivor. The most significant aspect of McCall, however, is the court’s dismissal of the evidence relied upon by the Florida Legislature in 2003 in confirming the perceived medical malpractice insurance crisis and its effect on health care availability, which purportedly justified the cap. The lone dissenting judge in McCall contests the plurality opinion’s own countervailing data that no such crisis exists. This issue may very well be the battleground upon which a new spate of cap challenges across the country will be fought. Louisiana will be no exception, despite the Louisiana Supreme Court’s en banc upholding of La. R.S. 40:1299.42(B)’s cap in 2012, also on equal protection grounds. Read more.
La. Supreme Court Weighs in on PCF’s Unilateral Ability to Deny Subsequent Future Meds Claims Watkins v. Lake Charles Mem. Hosp., 13-1137 (La. 3/25/14), 2014 WL 1190744. As the Louisiana Supreme Court framed the question before it: “At issue in this medical malpractice action is the extent to which the Louisiana Patient’s Compensation Fund (“PCF”) continues to be obligated to make advance payments for custodial/ attendant [“future medical”] care for a medical malpractice victim, after receiving information indicating that such care may no longer be needed, and whether the PCF had the right to unilaterally terminate such payments, without prior court approval, when a judgment was previously rendered ordering it to make said payments.” Under La. R.S. 40:1299.43(A), once a judgment is entered in favor of a patient who is found to be in need of future medical care and related benefits, as long as medical or surgical attention is reasonably necessary, the patient may make a claim to the PCF for all future medical care and related benefits directly or indirectly made necessary by the health care provider’s malpractice, which are to be paid as incurred. Nevertheless, the district court from which the final judgment has issued retains continuing jurisdiction in cases where medical care and related benefits are determined to be needed by the patient. La. R.S. 40:1299.43(E)(1). Justice Hughes, writing for the majority, set forth the “decision-making structure established by LSA–R.S. 40:1299.43 for determining whether to pay claims for future medical care and related benefits”: (1) the district court issues a judgment decreeing the plaintiff/patient is in need of future medical care and/or related benefits; (2) the plaintiff/patient submits an initial claim for payment of future medical care or related benefits to the PCF; and (3) if the PCF decides to deny the initial claim, as authorized, the district court may be asked to exercise its continuing jurisdiction and determine whether the denial was reasonable under its continuing jurisdiction. But, thereafter, once a district court exercises its continuing jurisdiction, the PCF is then obliged to comply with the district court’s rulings, orders, or judgments until such time as the district court modifies or recalls same. Knowledge of Potential Status as Victim of a Tort Upon Continued Post-Op Complaints? Morgan v. Patwardhan, 48,626 (La. App. 2 Cir. 3/12/14), 2014 WL 948996. Plaintiff whose subsequent neurosurgeon (continued on page 7)
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told him of test results showing that hardware implanted by defendant neurosurgeon did not sit correctly and was impinging a nerve knew or should have known at that time, at the very latest, that he was possibly the victim of a tort. Indeed, plaintiff arguably should have known almost immediately after the surgery, when his pain was actually significantly worse. In any event, his claim was untimely under either measure. No Defense Credit for PCF’s Pre-Trial Settlement Fruge v. Foret, 13-1071 (La. App. 3 Cir. 3/5/14), 2014 WL 852599. The Louisiana Third Circuit examined the question of “whether a pre-trial settlement with the PCF should be applied as a credit to the damages awarded at trial against a non-settling healthcare provider.” Prior to trial, plaintiff settled with the PCF for $600,000. A bench trial against the defendant physician proceeded and resulted in a $700,000 award against him. The trial court reduced the amount to $500,000, pursuant to La. R.S. 40:1299.42(B)(1), and ordered that the physician’s liability was limited to $100,000.00 plus legal interest, pursuant to the provision’s Subsection (B) (2). The physician defendant argued on appeal that the trial court erred in not first reducing the amount awarded to the statutory cap and then further reducing the amount awarded by the $600,000.00 pre-trial settlement with the PCF. As such, he owed nothing on the judgment. He based this position on La. R.S. 40:1299.42(D), which provides in pertinent part: D. (1) Evidence of an advance payment is not admissible until there is a final judgment in favor of the plaintiff, in which event the court shall reduce the judgment to the plaintiff to the extent of the advance payment. (2) The advance payment shall inure to the exclusive benefit of the defendant or his insurer making the payment. (3) In the event the advance payment exceeds the liability of the defendant or the insurer making it, the court shall order any adjustment necessary to equalize the amount which each defendant is obligated to pay, exclusive of costs. The Third Circuit agreed with the lower court that “credit for any advanced payments is only given if the payment was made by a defendant healthcare provider or his insurer. In this instance[,] the [Fund] settled with the [p]laintiff before trial, making an advanced payment. However[,] the [Fund] is neither a defendant healthcare provider[ ] nor his insurer . . . . Dr. Foret has not paid anything; therefore[,] he cannot receive any credit.”
Patient Noncompliance and Comparative Fault Justifies, In Large Part, Defense Verdict Doyle v. Ramos, 13-1143 (La. App. 3 Cir. 3/5/14), 2014 WL 852238. In this case involving claims of lost chance of survival due to a delayed breast cancer diagnosis, the appellate court affirmed a defense verdict based, in large part, on evidence of plaintiff’s comparative fault and failure to comply. The court found that evidence supported the finding of no breach by the defendant internist in failing to teach the patient how to examine her own breasts, where defendant testified that she customarily taught patients how to perform breast exams while performing such an exam herself, and that plaintiff had refused to allow her to perform the exam. Further, there was no evidence requiring a finding that failure to instruct as to self-breast exams contributed to the delay in diagnosis. Additionally, the finding of no breach on the claim of failing to follow up on an abnormal mammogram was supported by the evidence, including plaintiff’s history of ignoring defendant’s recommendations for and her rescheduling of mammograms. Broad Interpretation of MMA in Granting of Prematurity Exceptions Miller v. Acadian Ambulance Serv., Inc., 13-1269 (La. App. 3 Cir. 3/5/14), 2014 WL 853049. The family of a motorcycle crash victim filed a civil action against defendant ambulance service, Interim LSU Public Hospital (“LSU”), and the Louisiana Emergency Response Network (“LERN”), a “clearing house” whose dispatch center is staffed with a trained paramedic who receives incoming calls from medical facilities where an emergency patient is first taken, and, based on the information provided from the transferring provider, makes a determination as to the most appropriate trauma facility to treat the injured patient. Plaintiffs claimed, inter alia, that LERN was negligent in selecting an appropriate transferee facility, failed to timely arrange transport, and then failed to monitor or alter the mode of transportation to the trauma center despite delays thereto. The Third Circuit affirmed the trial court’s ruling that the suit against all defendants was premature. As to LERN, the court found that the LERN dispatcher’s subject decision-making involved the exercise of medical judgment. Plaintiff’s claims against LSU for delaying transport by requiring diagnostic testing to be completed at the local transferring E/R were also premature because its decisions, too, were medically related, in that testing was designed to assist trauma personnel in determining whether patient was stable enough to attempt transport and what types of surgeons and facilities would be required. As to the allegations that Acadian Ambulance (continued on page 8)
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failed to coordinate use of its helicopter for transport, those claims were premature because Acadian’s determination to wait for helicopter rather than risk transporting critically-ill patient by ambulance, given road conditions and potential for delay, was also an exercise of medical judgment. No Suspension of Rx By Either Premature Lawsuit or PCF Complaint Unaccompanied By Filing Fees Lewis v. Serenity Springs Hosp., 48,820 (La. App. 2 Cir. 2/26/14), 2014 WL 740059). The Louisiana Second Circuit reiterated the established interpretation of La. R.S. 40:1299.47 in holding that neither plaintiff’s timely filed PCF complaint which failed to include statutorily-required filing fees nor her timely filed but premature civil action served to suspend or interrupt prescription. Plaintiff’s MSJ on Damages Against PCF Denied— Settlement with Provider Established Only Negligence and Causation of Some Injury Up to $100K Pitre v. Marino, 13-0711 (La. App. 5 Cir. 2/26/14), 2014 WL 766421. After they settled with defendant physician and then sought excess damages against the PCF, plaintiffs filed a Motion for Summary Judgment on the basis that the doctor’s settlement for the statutory limit of $100,000 was an admission that his treatment fell below the standard of care and, because the patient died, the admitted negligence was necessarily the cause of her death. The trial court agreed and ruled, without any other evidence, that plaintiffs were entitled to $400,000 from the PCF. The Louisiana Fifth Circuit reversed the ruling, holding as follows: “While Dr. Marino’s settlement with Mr. Pitre establishes that he was negligent, and that his negligence caused some injury to Mrs. Pitre up to the value of $100,000, the settlement, standing alone, does not establish that the particular injury that he caused was her death.” Plaintiffs had to show by competent evidence “that there was no genuine question that the malpractice admitted to by Dr. Marino caused an injury to Mrs. Pitre, whether it be her death or some other injury, that is valued in excess of $100,000.” Plaintiffs failed to do so. Evidence of Medical Expert’s Failure of Initial Board Exams Admissible and Not Overly Prejudicial Sanders v. Ballard, 48,714 (La. App. 2 Cir. 2/14/14), 2014 WL 585952. Following trial resulting in a verdict in favor of the orthopaedist defendant, plaintiff appealed various rulings of the trial court, including its denial of plaintiff’s motion in limine to prevent testimony that his expert had initially failed to pass his written and oral examinations to become a board-certified orthopaedic surgeon. Plaintiff argued that any probative value of that information was outweighed by
its unfair prejudice and, additionally, the qualifications for expert witnesses set forth in La. R.S. 9:2794 do not include board certification. The appellate court found no abuse of discretion, explaining that plaintiff’s attorney raised the issue of board certification in tendering his expert and also that the jury heard of many other impressive qualifications of the expert. Only Physician Panelists in Panel Proceeding Against Two Nurses and Employer Hospital In re Medical Review Panel of Vankregten, 48,622 (La. App. 2 Cir. 2/5/14), 2014 WL 462304. Does the MMA allow for a registered nurse to be a medical review panelist in a case against a hospital and its two nurses? Plaintiffs argued that the Act allows the appointment of a “health care provider” to the Panel, while defendants argued that, in effect, there was only one party defendant—the hospital—and, in such cases, the MMA mandates that all panelists be physicians. The Second Circuit agreed with defendants. La. Supreme Court Reverses Multi-Million Award to Attorney General Against Big Pharm in Misrepresentation Case Caldwell v. Janssen Pharm., Inc., 12-2447 (La. 1/28/14), 2014 WL 341038. The Louisiana Supreme Court reversed a jury verdict in favor of the Louisiana Attorney General (“AG”) for civil penalties in the amount of $257,679,500, attorney fees of $70,000,000, and costs of $3,000,200 in an action against defendant pharmaceutical companies for alleged violations of the Medical Assistance Programs Integrity Law (“MAPIL”), La. R.S. 46:437.1. Specifically, the AG alleged that defendants “knowingly misrepresented” that the drug, Risperdal, was “safer and/or more effective” than other antipsychotics; that defendants’ marketing misrepresentations affected the decisions of prescribing physicians; that defendants knew that many of the prescriptions written for Risperdal would be paid for by Louisiana’s Medicaid program; that the State would not have purchased, or reimbursed for, Risperdal had it known of the defendants’ misrepresentations; and that the State had suffered actual damages. The FDA required the manufacturers of Risperdal, years after its release, to place warnings on its label that its use was associated with an increased risk of hyperglycemiarelated adverse events. However, in its FDA-mandated letter to health care providers advising of the label change, defendants included additional statements minimizing Risperdal’s association with such events or diabetes. These additional off-label statements were the subject of the AG’s claim. Prior to trial, the district court found that “proof of false, misleading, misrepresentative, deceitful, intent (continued on page 9)
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to defraud type statements . . . that in and of itself is the causation [ ] needed” to impose civil penalties. After a jury found that such statements were indeed made, the court, without finding any evidence of actual damages sustained by the State, assessed a civil penalty of $7,250 per violation for 35,146 violations (7,604 letters and 27,542 sales calls). The Louisiana Third Circuit affirmed. The Supreme Court, in interpreting La. R.S. 46:438.3(A), held that the person liable under this provision must cause a health care provider or his billing agent to make a request or demand for payment from medical assistance program funds that the health care provider or his billing agent knows to be false, fictitious, untrue, or misleading. However, in this case, “[e]ven if the defendants misrepresented the efficacy or safety of their product to Louisiana doctors, there is simply no evidence in this record, and moreover no allegation, that this misrepresentation in fact caused any health care provider or his billing agent to knowingly present a claim for payment that is false, fictitious, untrue, or misleading in regard to any material information.” Plaintiff’s MSJ on Liability Affirmed Against Conclusory Affidavits of Defendant Health Care Provider Foster v. Patwardhan, 48,575 (La. App. 2 Cir. 1/22/14), 2014 WL 229834. After a unanimous Medical Review Panel opinion in his favor against defendant neurosurgeon, plaintiff filed suit and, shortly thereafter, filed a Motion for Partial Summary Judgment on liability and a like motion on damages. The trial court granted both, despite defendant’s introduction of his own affidavit, as well as the one-sentence affidavit of his retained expert witness in Neurosurgery. As to defendant, the trial court did not err in finding him unqualified to render an opinion under La. R.S. 9:2794. He is not Board-certified, he did not possess substantial training or experience in the subject area, and the Louisiana State Board of Medical Examiners had deemed him incompetent to practice Neurosurgery. His expert’s affidavit, stating only that the care provided was appropriate and demonstrated no breach, was conclusory and failed as summary judgment evidence. With respect to summary judgment on the damages, the Second Circuit reversed, holding that plaintiff failed to meet his burden that no factual dispute existed as to whether he suffered damages exceeding the statutory limit of $100,000.00. Specifically, because it was undisputed that the economic damages alone did not meet that limit, plaintiff had to prove that no material facts exist as to whether he suffers from a true right foot drop. Given conflicting medical records on that issue, plaintiff failed to meet his burden, and summary judgment on damages was reversed.
MRP Opinion Would Not Be Vacated Due to Alleged Conflicts of Interest of Panelists Elledge v. Williamson, 48,644 (La. App. 2 Cir. 1/15/14), 2014 WL 130939. The Second Circuit affirmed the trial court’s refusal to vacate the opinion of a Medical Review Panel, where it was, ex post facto, learned that one panelist taught defendant during his residency and was presently on staff at the same hospital as defendant. The panelist referred to defendant as “a good friend.” A second panelist became acquainted with defendant during their residency together. The court pointed out that Louisiana courts have previously found no potential bias when panelists were staff members at the defendant hospital, when a panelist supervised defendant during residency and were casual acquaintances, and when a panelist previously served on a panel that had exonerated defendant. There was no abuse in the trial court’s discretion in finding no conflict that prejudicially influenced the Panel. Moreover, the failure to inform the parties of a relationship did not automatically require the Panel to be vacated. Lastly, the fact that one of the panelists did not sign his oath until after the Panel meeting did not render the Panel’s Opinion inadmissible. Lack of Expert MSJ in Nursing Home Decubitus Case Pecue v. Plantation Mngmt. Co., LLC, 13-0977 (La. App. 1 Cir. 2/18/14), 2014 WL 667489. Plaintiffs filed claims under both the MMA and the Nursing Home Residents’ Bill of Rights (“NHRBR”), La. R.S. 40:2010.6 et seq. The 85 yearold resident allegedly died from an infection caused by an untreated decubitus ulcer. Defendant filed a Motion for Summary judgment based on plaintiffs’ lack of a medical expert qualified to testify as to any causal link between a breach of the standard of care and the resident’s injury. They also moved for summary judgment based on plaintiff’s lack of evidence to establish a factual basis for their NHRBR claims. Both motions were granted and affirmed by the First Circuit on appeal. The court rejected the plaintiff’s claim that they had established the applicable standard of care on their own through, 42 C.F.R. § 483.25(c), and, so, the burden then shifted to defendant to prove that the resident’s clinical condition demonstrated that the pressure sore was unavoidable. That federal regulation provides: (c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that— (1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual’s clinical condition demonstrates that they were unavoidable; and (continued on page 10)
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(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing. Further, the court found that the evidence proffered by plaintiffs failed to provide any factual support for their claims that the defendant violated decedent’s rights under the NHRBR, and their petition did not contain any specific factual allegations or instances of such conduct. More Lack of Expert MSJs Granted Reinke v. Kordisch, 13-1093 (La. App. 3 Cir. 3/5/14), 2014 WL 852636 (plaintiff’s reliance on her own affidavit was insufficient to defeat summary judgment by defendant who introduced a favorable Medical Review Panel Opinion and panelist’s affidavit); Smith v. Rapides Healthcare System, LLC, 13-1172 (La. App. 3 Cir. 3/5/14), 2014 WL 852361 (adversereaction-to-medication case did not fall under the res ipsa loquitur exception: “[E]ven if we acknowledge the factual discrepancy between [nurse’s] and [plaintiff’s] affidavits as to whether nurses checked on Mrs. Smith between the administration of the pain medication and the time she became unresponsive, this fact is not material to the case as there is still no evidence that the defendant violated any hospital protocol. Assuming that no nurse checked on Mrs. Smith as Mr. Smith contends, Nurse Ward’s affidavit indicates that the time period between the administration of the medication . . . was 39 minutes. While a lapse of 39 minutes in patient care may possibly amount to negligence in this circumstance, it does not indicate an obvious failure to attend to a patient. As these assessments of conduct are not apparent to a laymen finder of fact, who is not familiar
with proper medical protocol under these circumstances, expert medical testimony is required in this instance for the plaintiffs to prove that there was a breach of the standard of care.”); Spiewak v. Sightler, 13-1027 (La. App. 1 Cir. 2/14/14), 2014 WL 587141 (intraoperative complication of bladder laceration during hysterectomy was not subject to res ipsa loquitur doctrine, as case involved “a complicated medical procedure”); Rogers v. Hilltop Retirement & Rehab. Ctr., 13-867 (La. App. 3 Cir. 2/12/2014), 2014 WL 551056 (lack of causation expert MSJ filed two months after post-Panel action instituted and granted despite plaintiff’s protestations that he had not had sufficient time to conduct discovery and locate an expert); Lejeune v. LAMMICO, 13-0845 (La. App. 3 Cir. 2/12/14), 2014 WL 550927 (unsworn narrative attached to affidavit and which stated that defendant physician in failure to diagnose cancer case “could have” referred patient to oncologist who “might have” included him in a clinical trial was insufficient to defeat summary judgment). n
Focus on the Firm CURRY & FRIEND, PLC CONGRATULATES OUR LEADERSHIP IN LAW HONOREE Curry & Friend would like to congratulate Guy C. Curry, chosen by New Orleans CityBusiness as a recipient of the 2014 Leadership In Law distinction. Each of the 50 recipients were chosen by a selection committee and named as exceptional attorneys from the greater New Orleans area who have achieved success in their practice, made contributions to the community, and had an impact on the local legal industry. Guy and the other honorees were recognized at a cocktail reception at NOMA on March 24, 2014.
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TAR: IT’S STICKING AROUND
A REPORT FROM THE SEDONA CONFERENCE’S 8TH ANNUAL INSTITUTE ON EDISCOVERY Sarah S. Graham Associate Attorney This quarter we pause our e-discovery series for a special report from the recent Sedona Conference Institute on eDiscovery. We will resume our regular series in our next publication. The Sedona Conference held its 8th annual Institute on eDiscovery on March 13 and 14, 2014, in Houston, Texas. The faculty was comprised of members of the judiciary, inhouse counsel, and outside counsel, and the program was attended by attorneys representing all areas of law and all regions of the country. One topic of interest was TAR (technology assisted review). The following is based on information gleaned from the TAR discussion panel and the various materials associated therewith. TAR: Technology Assisted Review “TAR” (technology-assisted review), or predictive coding, as it is sometimes called, is rapidly replacing keyword searching and manual review. While there are many forms of TAR (one Sedona panelist noted that specific TAR tools can be “as different as a smart car and an RV”), the general concept is that an attorney familiar with the case reviews and codes a select set of documents (the “seed set’), thereby training the machine to distinguish between responsive/relevant and non-responsive/irrelevant documents. For those new to TAR, the concept is daunting, but for many it has become as customary as physically reviewing paper documents once was. According to the Sedona faculty, we are “past the stage where we’re deciding whether [TAR] is acceptable” and have moved on to more substantive issues, such as how
“seed sets” should be compiled and whether the opposing party should be allowed to participate in the process. The panel for the TAR discussion included Paul Burns (Senior Counsel; Procopio, Cory, Hargreaves & Savitch LLP; San Diego), Jerone “Jerry” English (Director of eDiscovery and Litigation Management Group; Intel Corporation; Santa Clara, CA), Hon. Andrew J. Peck (U.S. Magistrate Judge, S.D.N.Y.), Maura Grossman (Of Counsel; Wachtell, Lipton, Rosen & Katz; New York), Jason Baron (Of Counsel; Drinker Biddle &Reath, LLP; Washington, DC), Eric Schwarz (Principal; Ernst & Young LLP; Dallas). Early in the discussion, Judge Peck noted that a lack of public discourse regarding the use of predictive coding does not necessarily indicate that it is not being used. In fact, he suggested that TAR or predictive coding is likely used frequently, yet simply does not draw much attention because the issue of its use is settled outside of court. Those who are still uneasy with the TAR concept seem hesitant to trust the technology, but the panel raised an interesting point: we trust this type of technology every day in our personal lives, using Google and similar search engines to find answers to all of our questions, from the crucial to the trivial. Why, therefore, should we not trust it with discovery? Of course TAR has its limitations and imperfections, but so do its alternatives. To emphasize this point, the panel noted some of the drawbacks and shortcomings of more dated methods: • Visual document review requires hiring multiple lawyers, who likely know little about the pertinent area of law, much less the specific matter, and are only “trained” for one or two days. • Keyword searching results in many irrelevant documents (false positives) and misses many relevant documents. • Keyword searches are limited by language and human error: one can never possibly search for all synonyms, abbreviations, acronyms, and phrases or expressions that convey a similar meaning, while simultaneously accounting for misspellings and typographical errors, even with technology designed to account for such things. (The panelists shared several examples of misspellings thwarting keyword searches: in one instance, there were numerous misspellings of a company’s name within the company; in another, (continued on page 12)
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multiple variations on the spelling of “Kaddafi”; in a third, several departures from the proper spelling of “tobacco,” a term essential to the facts of the matter.) • Keyword searches are limited to the words you know to look for. Similarly, key players might have multiple email addresses, unbeknownst to those creating the search term list. • Early concept searching resulted in more documents overall, but that included more irrelevant documents. Nevertheless, the panel did not advocate for completely eliminating “older” methods of discovery. Instead, one should understand how each process works, what its strengths and limitations are, and decide how they can best be utilized in conjunction with one another; Grossman referred to it as “multi-modal searching.” The ideal process combines technology and people: technology can and should be used to eliminate the totally irrelevant documents, while human reviewers are invaluable for conducting in-depth analyses of key documents. The “squishy” documents (a term used by English to refer to those “potentially relevant” documents that fall into the grey area between relevance and irrelevance) that are hard for the computer to decipher in a TAR process are likely the same documents about which individual reviewers would have questions. Furthermore, such documents, while possibly relevant, are unlikely to relate to the issues most important to the case. An additional benefit of the TAR process is that the attorney with the most knowledge of the case can maintain almost complete control by choosing who will train the system, or perform the task himself or herself, eliminating any need to train other attorneys and reducing the potential for misunderstandings or multiple interpretations. TAR is becoming so well accepted that, while rare, there are scenarios in which it would be appropriate for a judge to compel a party to use TAR. For example, if a party claims that responding to certain requests will take too long or be too expensive (especially if that party is requesting costsharing), a judge could reasonably order the party to utilize TAR, thereby reducing both the costs and time that would have been associated with traditional document review. Nevertheless, Judge Peck asserted that it would be best to “suggest” the use of TAR before resorting to an order. Types of cases for which TAR is most suitable: • Those for which the time and costs associated with traditional review would be burdensome. • Those involving at least 50,000 to 75,000 documents (a threshold established by some vendors).
• Cases involving many classified files (as it is likely easier to obtain permission to utilize TAR than to obtain multiple security clearances for multiple contract attorneys to review files). • TAR is better with binary decisions, so, if a matter involves multiple issues, they should be addressed one at a time. Items for which TAR might not be the best option: • Visual documents, such as photographs or charts. If the majority of documents in a case are visual, the use of TAR would be inappropriate, as it is text-based. In matters where such documents are relatively few, however, they can be segregated and reviewed separately. • Potentially privileged documents. Some experts say it is difficult to use TAR accurately to identify attorney-client communication and attorney work product. Grossman, however, believes that it is possible, but that a “heavy” quality control process must be employed to ensure accuracy. It is important to remember that, while TAR is gaining momentum, it is, nevertheless, relatively new technology, and even those who use it regularly are “still experimenting.” As you delve into (or further into, depending on your level of experience) the world of TAR, be sure to research various tools, consider different options for different circumstances, and get information from multiple vendors. If you are unfamiliar with TAR, even inquiring about options can be intimidating. The panel emphasized, however, that it should not be. When discussing TAR tools and options with a vendor, do not accept the idea that you just don’t understand. The technology should not be a mystery, nor should the language be so highly technical that it is confusing. If you do not understand, keep asking questions until the vendor explains it in clear terms. Go beyond the salespeople and consult with those who handle the technology, even if you must sign a non-disclosure agreement. Resist the temptation to be impressed by a presentation based on a vendor’s own documents; instead, have them use your documents and compare what their system finds with what your human reviewers found. This is an area where you really cannot (continued on page 13)
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overdo research and preparation: the more, the better! In closing, the panel noted that the single best way to influence the process is not to get into a fight over TAR, but to cooperate as early and fully as possible with the other side, perhaps even providing opposing counsel with key words to use in identifying their seed set of documents. So, ready or not, here it comes! It appears that TAR is here to stay and is gaining momentum as it replaces more traditional
forms of document review. It is, like all methods of review, imperfect, but has proven to be as or more effective than its alternatives, accomplishes the same task in a shorter period of time, and costs significantly less. So take heart, technologically stubborn attorneys: with an open mind, ample research and preparation, and a sincere willingness to cooperate, you, too, can view TAR not as a scary, sticky mess to be avoided, but as another option in your toolbox to help discovery run smoothly and efficiently. n
Focus on the Firm Curry & Friend, PLC is pleased to announce that Lauren E. Godshall has been named Partner and Kathy A. Rito has become associated with the firm. Lauren E. Godshall has been named a Partner of the firm. Ms. Godshall handles environmental litigation, oil and gas law, toxic tort and Naturally Occurring Radioactive Material (NORM) defense. She is licensed in Texas, Louisiana and California and regularly practices in both state and federal court. She also has defended complex business disputes, class actions and multi-district litigation, insurance disputes, asbestos and products liability lawsuits. Ms. Godshall was recently selected to be a Fellow of the Louisiana Bar Foundation, sits on several committees in the Louisiana Bar Association, and is active in the Louisiana Air & Waste Management Association. She enjoys writing and leading seminars on various environmental law issues, ethics, professionalism, and the adoption of technology in the legal profession. She was named a “Rising Star” by Louisiana Super Lawyers in December of 2013 and was recognized for providing over 100 hours of pro bono service in 2010 by the New Orleans Pro Bono Project and the LSBA. Ms. Godshall is a member of the Krewe of Muses and serves as Secretary of the Board of Directors for the Down Syndrome Association of Greater New Orleans.
Kathy (Kat) Rito joined Curry & Friend in February, 2014, as a Senior Associate Attorney in the New Orleans office. Her practice areas include medical malpractice and nursing home litigation; health care; labor and employment; and professional liability and insurance defense. She represents various health care providers, as well as the Louisiana Patient’s Compensation Fund, in medical malpractice claims and litigation, and provides advice to providers and other entities on legal issues affecting their businesses. Ms. Rito maintains an active presence in her community. She has served as a CASA Child Advocate in the Greater New Orleans area, is a member of the NOLA Bulls Cycling Team, which fundraises to support multiple sclerosis research, and is a member and “running buddy” for Youth Run NOLA, which empowers underserved New Orleans youth through running. Ms. Rito also serves on the Healthcare Committee for the Louisiana Chapter of the Urban Land Institute, a multi-disciplinary coalition dedicated to the development of the Gulf Coast economy by developing business through better land use practices.
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Labor & Employment Law Corner
In this section, we will summarize recent developments in labor and employment law matters of interest to the health care community.
Presidential nominees, all of President Obama’s selections have been confirmed and the Board is going forward with new rules more favorable to union organizing.
PRESIDENT OBAMA WANTS TO AFFECT THE WORKPLACE Gerald “Jerry” J. Huffman, Jr. Partner Consistent with his stated intention to use his Executive powers when he and Congress cannot agree on new legislation, President Obama has recently announced many new initiatives to affect the workplace. As we advised you in last Fall’s newsletter, new regulations from the Office of Federal Contract Compliance Programs (“OFCCP”) went into effect last month requiring contractors to set goals and timetable for the hiring of the disabled and veterans. Other new directives have come from the: • Equal Employment Opportunity Commission (“EEOC”) regarding the use of conviction records in hiring decisions and discrimination against the unemployed, • Occupational Safety and Health Administration (“OSHA”) regarding the real-time reporting of workplace injuries (as described in our last newsletter) and • National Labor Relations Board (“NLRB”) regarding speeding up union representation elections and the regulation of employers’ policies concerning social media. With respect to the NLRB, you may recall that its attempt to require the posting of a notice informing employees of their rights under federal labor laws failed after court challenges. Other initiatives of the Board taken in the last few years are in legal peril due to its failure to have a quorum of members confirmed by the Senate – an issue to be decided in the Noel Canning case now before the Supreme Court. But since the Senate changed its’ rules to eliminate the filibuster on
Proposed Changes to Wage and Hour Laws Now, in this new year, the President has urged more new actions. In order to raise the pay of lowly paid workers across the United States, on February 12, 2014, he issued an Executive Order requiring that all new contracts beginning on January 1, 2015 between the federal government and contractors contain a clause mandating the contractor to pay a minimum wage of $ 10.10 per hour. The President has also proposed amendments to the Fair Labor Standards Act of 1938 (“FLSA”), 29 U.S.C. § 201 et seq. to raise the minimum wage applicable to all federal workers, but that effort does not seem likely to be enacted by this Congress. However, in an area the President can affect without Congressional approval, he has, on March 13, 2014, directed the Secretary of Labor, Thomas Perez, to change federal regulations now governing overtime pay to millions of American workers. Currently, under the regulations implemented by the Secretary’s Wage and Hour Division, employees who are engaged in executive, administrative and professional positions are exempt from the requirement that they be paid time and a half their regular rates of pay after 40 hours of work in any work week. Among the current regulations’ requirements for the establishment of such positions is a condition that the employee receive at least $455 per week (or $23,660.00 per year). Advocates for changes to the regulations contend that this threshold has failed to keep up with inflation and has left millions of low-paid salaried workers without the basic protections meant by the FLSA. The last time the regulations were increased was in 2004 when the basic salary requirement was raised from $230 per week to $455 per week under President Bush. In addition, the President directed Secretary Perez to consider revising the substantive test for the executive exemption, i.e. whether an employee’s “primary duty” consists of supervision. Currently, the test is based upon subjective factors regarding an employee’s working duties, regardless of the amount of time spent in managerial, as opposed to ordinary, working tasks. Proponents of the new rules contend that many “working supervisors” should in fact be treated as regular employees entitled to overtime pay. (continued on page 15)
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These changes, when final, will affect every workplace in the United States wherein supervisors receive relatively low pay. Due to the requirements under federal law with respect to regulatory changes, wherein proposed changes are subject to a public comment period, it is not expected that any changes will become final until the passage of at least twelve to eighteen months. Pay Equity Recently, the President has asserted that women are paid only 77% of what men are paid in the U.S. workforce. This figure has been widely disputed as a gross exaggeration with many economists asserting that non-discriminatory factors, such as education, career choices and maternity, explain the discrepancy. Nevertheless, on April 8, the President issued two more Executive Orders designed to increase pay equity in the workforce. The first order prohibits federal contractors from retaliating against employees who share salary information between themselves. Again, this Order falls on the heels of the failure of Congress to pass the “Paycheck Fairness Act” which would prohibit such retaliation by all employers. The second Oder directs Secretary Perez to develop regulations requiring contractors to report their salary practices to the Department of Labor on a yearly basis so the department can determine whether wage discrimination is occurring. We will keep you advised of all of these developments as the regulatory process goes forward. n
Health Care Legal Team Contributors Guy C. Curry Managing Partner, New Orleans firstname.lastname@example.org
Gerald “Jerry” J. Huffman, Jr. Partner, Covington email@example.com
Susan E. Henning Partner, New Orleans firstname.lastname@example.org
Meredith M. Miceli Partner, New Orleans email@example.com
Sarah S. Graham Associate Attorney, New Orleans firstname.lastname@example.org
Published on May 14, 2014
Every quarter we provide an update on select health care and medical malpractice developments. These updates are generally helpful as a quic...