middle

By Brittany Buckley Salup

Chief Judge Brian Jackson issued an “Omnibus Order Suspending All Deadlines” for cases pending or to be filed in the U.S. District Court for the Middle District of Louisiana.  The Order explains that the court has been inaccessible—a key term in the Federal Rules of Civil and Appellate Procedure—since August 12, 2016 due to historic flooding in the region.  Until further notice from the Middle District, all deadlines and delays in cases pending or to be filed in the Middle District are suspended.  This suspension expressly applies to prescriptive and peremptive periods.  In addition, all pending criminal cases in the Middle District are temporarily excluded from the time requirements of the Speedy Trial Act.

The Middle District’s Order follows similar Executive Orders from Governor Edwards, which suspended deadlines in Louisiana state courts due to flooding.  More information about the Governor’s Orders is available here.

A copy of the Middle District’s Order (M.D. La. General Order 2016-10) is available here.

 

 

seal

By Claire Juneau

On August 17, 2016, Governor Edwards amended Executive Order JBE 2016-57 which had suspended the running of prescription, peremption, and all legal delays from August 12, 2016 until September 9, 2016. The amendment to Executive Order JBE 2016-57 modifies the suspension of deadlines as follows:

  • Liberative prescription and peremptive periods continue to be suspended throughout Louisiana until Friday, September 9, 2016.
  • Deadlines in legal proceedings currently pending in state courts, administrative agencies, and boards in Acadia, Ascension, Assumption, Avoyelles, Cameron, East Baton Rouge, East Feliciana, Evangeline, Iberia, Iberville, Jefferson Davis, Lafayette, Livingston, Pointe Coupee, St. Charles, St. Helena, St. James, St. John the Baptist, St. Martin, St. Tammany, Tangipahoa, Vermilion, Washington, West Baton Rouge, and West Feliciana, Parishes, continue to be suspended until Friday September 9, 2016. This suspension includes all deadlines set forth in the Louisiana Civil Code, the Louisiana Code of Civil Procedure, Title 9 (Civil Code Ancillaries) Title 13 (Courts and Judicial Procedure), Chapter 11 of Title 18 (Election Campaign Financing); Chapter 10 of Title 23 (Worker’s Compensation); Chapter 5, Part XXI-A of Title 40 (Malpractice Liability for State Services); Chapter 5, Part XXIII, of Title 40 (Medical Malpractice), and Title 49, Chapter 13 (Administrative Procedure) of the Louisiana Revised Statutes. This is a modification from the original Exeuctive Order JBE 2016-57 which suspended deadlines statewide.
  • Except for the suspension of prescriptive and peremptive periods and the suspension of deadlines in the parishes listed above, the suspension provided for in original Executive Order JBE 2016-53 shall end Friday, August 19, 2016. If a party can show an inability to meet the deadlines caused the flooding, the court, administrative agency, or board shall suspend deadlines specific to that matter until September 9, 2016.

A copy of the amendment can be found here: JBE-16-57-Amended-Emergency-Suspension-of-Deadlines-in-Legal-Proceedings

A copy of the original executive order can be found here.

medical

By Jennifer J. Thomas

On December 20, 2015, the Louisiana State Board of Medical Examiners’ (“LSBME”) published in the Louisiana Register the final rules for processing complaints against physicians and investigations regarding the practice of medicine.   The new rules are contained in Chapter 97 of LAC 46:XLV and are a result of Act 441 of the 2015 Legislative session, which amended  the Louisiana Medical Practice Act, La. R.S.  37:1261-1292.   The amendments required, in part, for the LSBME to promulgate rules for the investigation of complaints, notification to the physician being investigated, time limits for the investigation, and limiting the role of the LSBME executive director in the investigation.

When a complaint is submitted to the LSBME, it will be investigated by LSBME staff.  In accordance with the amendment to La. R.S. 37:1285.2(A), the executive director may not act as the lead investigator on any investigation regarding a physician.   The executive director does have the authority to issue subpoenas to obtain documentary evidence or require the appearance of witnesses.  A complaint can be anonymous and the identity of any complainant will be kept confidential unless the complainant waives confidentiality or the complainant is called as a witness at a formal LSBME administrative hearing.

The complaint process is divided into the preliminary review and formal investigation.  During the preliminary review, a determination is made as to whether sufficient cause exists to warrant a formal investigation.  The licensee may be provided the opportunity to respond to the complaint and has the right, at his/her own expense, to retain legal counsel to assist in responding to the complaint.   The preliminary review of the complaint is to be completed within one-hundred and eighty (180) days of receipt of the complaint; however, the LSBME can increase the preliminary review period for “satisfactory cause.”  The 180 day timeline does not apply to information received from local, state, or federal agencies relative to on-going criminal, civil or administrative investigations or proceedings.   After the preliminary review is concluded, a decision is made as to the whether there is sufficient cause for a formal investigation.  A complaint can be closed upon submission of a report and recommendation to the board.  If a compliant is closed after preliminary review, it is not considered an “investigation” and a licensee is not required to report the preliminary review as an investigation on LSBME renewal applications.

If there is sufficient cause, the board staff will submit a report and recommendation to the board to commence a formal investigation.  Within five (5) business days after the initiation of the formal investigation, written notice is to be sent to the licensee by registered, return-receipt-requested mail or by personal delivery.  The notice will contain a summary of the complaint and notice that the licensee can retain legal counsel.  The purpose of the investigation is to determine whether or not there is evidence to indicate that the law has been violated.  The LSBME can consider past complaints and investigations for the purpose of determining if there is a pattern of practicing or recurring conduct that is contrary to the accepted standards of the medical practice in Louisiana.  If the complaint involves medical competency, the board may, as part of the investigation, order the licensee to undergo an evaluation at an approved center.  Formal investigations are to be completed within thirty-six (36) months, but the time period can be increased for “satisfactory cause.”  The 36 month time period does not apply to any investigation already pending as of July 1, 2015.

If the investigation results in sufficient evidence to indicate that a violation of law has occurred, an administrative complaint may be filed with the board.  However, prior to filing the complaint, a draft administrative complaint must be mailed to the licensee along with a letter providing the licensee an opportunity for a conference to show compliance with all requirements to retain his/her license or to show that the complaint is unfounded.  If the licensee does not respond to the complaint or if the licensee does not satisfactorily demonstrate compliance with the law, the administrative complaint may be filed.  In emergency situations involving public health, safety and welfare, the administrative complaint can be filed with the board without prior notice to the licensee.  Once the administrative complaint is filed, the parties can engage in discovery including the identification of witnesses and exhibits.  The licensee can request the issuance of subpoenas by the LSBME for documentation, information, and the appearance of witnesses at the hearing.  At the administrative hearing, both parties will make opening and closing statements, examine witnesses and present evidence.  The burden of proof is by the preponderance of evidence.

The final rules provide for the opportunity for an informal resolution at any time during the complaint and investigation process upon the recommendation of the lead investigator and a majority vote of the board members.  Informal dispositions can be non-disciplinary in the form of an informal conference and letter of concern and are not considered disciplinary action and not a public record.  Whereas, formal disciplinary dispositions include consent orders and voluntary surrenders of licenses and are considered disciplinary action and public record.  The board is not required to offer an informal disposition prior to an administrative hearing.

With the adoption of the LSBME’s final rules, physicians should become familiar with the LSBME’s complaint and investigation process.  Because one day, despite all efforts to practice medicine in accordance with the law, a physician could be on the receiving end of a LSBME complaint and is entitled to due process throughout the complaint and investigation process.

 

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By Karen M. Fontana

William McDougald et al. v. St. Francis North Hospital Inc. No. 48,955 (La. App. 2nd Cir. April 9, 2014) 137 So.3d 1233 writ denied 2014-0815 (La. 6/3/14), 140 So.3d 1191.

In this medical malpractice wrongful death action, the plaintiffs contended that the defendant physician breached the standard of care in temporarily discontinuing the patient’s Plavix and aspirin in anticipation of orthopedic surgery without informing the patient of the associated risks. The patient died of a myocardial infarction several days after stopping the medications and just one day before the planned surgery.

Ms. McDougald was a 58 year old woman with a history of heart disease and smoking and had undergone placement of stents as her heart disease advanced. The patient had been maintained on Plavix and aspirin for over two years since her last stent placement in 2007. In 2009, Ms. McDougald planned to undergo knee surgery and was referred to defendant, her cardiologist, for a medical clearance.

Evidence was presented at trial that medical clearance was provided after the defendant’s head nurse (1) spoke with the patient’s primary care physician to confirm that the patient had not presented with any cardiac issues in the preceding year; (2) confirmed this with the patient directly as well; and then (3) discussed with the patient the need to temporarily discontinue the Plavix and aspirin seven days prior to the planned knee surgery. Nurse Gibson stamped the defendant physician’s signature on the clearance for the knee surgery. The patient was not seen by the defendant physician as part of this surgical clearance.

Ms. McDougald’s family filed a PCF claim alleging that the defendant physician committed malpractice by failing to inform Ms. McDougald of the risks associated with the cessation of Plavix and aspirin, including the possibility of death. Plaintiffs alleged that the physician had a duty to inform the patient of these risks pursuant to the Louisiana Uniform Consent Law (LUCL), La. R.S. 40:1299.40. Plaintiffs contended that the defendant physician never spoke to Ms. McDougald and therefore breached the standard of care by failing to obtain informed consent.

The Medical Review Panel found that the order to discontinue Plavix was appropriate because the accepted practice guidelines for Plavix therapy after stent placement called for 12 months of administration only and it had been two years since Ms. McDougald’s last stent. The panel further found that the standard of care did not require a doctor to discuss the discontinuance of Plavix because the risk of having a stent thrombosis due to discontinuation of Plavix was so minimal that it was not a material risk.

At time of trial, the court ruled that the Louisiana Uniform Consent Law did not apply to the decision to discontinue medications prior to surgery. However, the issue of informed consent was again raised during argument over jury instructions. Plaintiffs again sought a jury instruction regarding the LUCL and the general principles of its disclosure requirements.

Ultimately the trial judge accepted the defense argument that informed consent was not required when temporarily stopping medications such as Plavix or aspirin for surgery. Defendant successfully argued that physicians are not required to comply with the informed consent law when undertaking routine actions. Further defendant had argued that, even if the informed consent law were found to be applicable, a physician is only required to disclose a material risk, and plaintiff bears the burden of establishing materiality.

After jury verdict was returned for the defense, plaintiffs appealed arguing the trial court had erred in finding the LUCL to be inapplicable. The Louisiana Second Circuit affirmed the trial court decision, confirming that La. R.S. 40:1299.40 did not apply to the facts of this case and thus lack of informed consent was not an issue.

In rejecting the application of the informed consent statute to these facts, the Second Circuit cited with approval the Third Circuit decision in Novak v. Texada, Miller, Masterson & Davis Clinic, 514 So.2d 807 (La. 1987) which found that the administration of a flu shot did not fall within the scope of La. R.S. 40:1299.40 because it was a routine procedure not requiring written consent. The Second Circuit also cited the Third Circuit’s decision in Daniels v. State, through Department of Health & Human Resources, 532 So.2d 218 (La. App. 3d Cir. 1988) which held that the nonsurgical treatment of a closed wrist fracture was a routine medical procedure in which surgery was not involved and to which the informed consent statute did not apply.

Thus, in McDougal, the Second Circuit concluded that “the clearance of a patient for surgery and the recommendation that the patient should cease taking Plavix and aspirin seven to ten days prior to surgery is a routine, nonsurgical decision made on a daily basis. It is not a ‘medical or surgical procedure’ as contemplated in the LUCL to which the duty of informed consent applies.” Emphasis added. Thus the appellate court affirmed the trial court determination that the LUCL did not apply to the facts of this case and lack of informed consent was not an issue.

Plaintiffs often argue for the application of the LUCL requirements to physician decisions regarding selection of medications and other nonsurgical treatment decisions. This Second Circuit’s decision provides further support for limitation on the scope of the Louisiana Uniform Consent Law and its required disclosures. Where the challenged medical decision is a routine, nonsurgical decision such as the cancellation of a medication; or a decision to pursue nonsurgical treatment options, according to the Second and Third Circuits, physicians will not have to demonstrate compliance with the Louisiana Uniform Consent Law.

Of course there is no brightline as to what will be deemed a routine medical decision, and the materiality of risks of all treatment decisions must be assessed on a case by case basis. However, this Second Circuit opinion offers important clarification on the scope of the LUCL and its application in the clinic or non-operative setting.

 

 

 

By Karen M. Fontana

The effect of a physician’s decision to deviate from the pharmaceutical company’s dosage instructions contained in a drug’s FDA approved package insert has been a recurring issue in medical malpractice litigation with many claimants contending that any deviation from the manufacturer’s instructions constitutes malpractice. In a recent case the Louisiana Fourth Circuit has now specifically rejected that theory.

In Deroche v. C.B. Fleet Company et al., the Fourth Circuit stated:

We specifically hold that a manufacturer’s labeling and package insert standing alone is insufficient to establish the prevailing standard of care required by La. R.S. 9:2794. Similarly we find that a physician’s medical decision to deviate from a manufacturer’s labeling also does not ipso facto establish a breach of the standard of care.

No. 2013-CA-0979, (La. App. 4th Cir. 12/18/2013), 2013 WL6923718.

Thus the Fourth Circuit has now confirmed that deviation from FDA approved labeling and dosage instructions does not necessarily equate with a breach of the standard of care and does not relieve plaintiff’s duty to provide expert medical testimony to establish the prevailing standard.

The Fourth Circuit opinion is well founded. By the FDA’s own admission, the FDA has never had authority to regulate the practice of medicine. While the labeling and package inserts for drugs and devices are heavily regulated by the Food and Drug Administration, the FDA has made it clear that, with respect to its role in medical practice, the package insert is informational only. 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed. Reg. 59,820 59,821) (Nov. 18, 1994).

The FDA has also informed the medical community that “once a [product] has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling.” The FDA went on to state that: “unapproved” or more precisely “unlabeled” uses may be appropriate and rational in certain circumstances and may, in fact, reflect approaches … that have been extensively reported in medical literature. 12 FDA Drug Bulletin 4-5 (1982) (cited in 59 Fed. Reg. 59,820 59,821) (Nov. 18, 1994)(emphasis added).

Thus the decision whether or not to use a drug or device for an off-label purpose or in a different manner than described in labeling is a matter of medical judgment which must be evaluated by the trier of fact with the benefit of expert medical testimony. Package inserts and manufacturer labeling will be evidentiary, but they should not be considered de facto evidence of standard of care.

 

By Jason R. Cashio

The Louisiana Supreme Court has, once again, affirmed the constitutionality of the statutory cap for damages in Medical Malpractice cases.  On March 13, 2012, the Court reiterated its prior holding that the cap is constitutional and applicable to all qualified healthcare providers under the Medical Malpractice Act, including nurse practitioners.  The statutory cap on damages is $500,000.00, which includes a $100,000.00 limit for any qualified health care provider.

Read the majority opinion. 

 

 

By Linda G. Rodrigue

Act 337 of the Regular Session of the 2011 Louisiana Legislature enacted an amendment to Louisiana R.S. 37:1285(A) to add new subsection (A)(32), which provides an additional ground for physicians to be disciplined by the Louisiana State Board of Medical Examiners (the “LSBME”). The new ground relates to a physician holding herself/himself out to the public as being certified by a public or private board or using the phrase “board certified”. In order for a physician to use the phrase “board certified” with the public, all of the following criteria must be met:

(a) The full name of the board from which the physician received certification and the name of the specialty or subspecialty is included in the advertisement;

(b) The board that provides the certification meets any of the following qualifications:

(i) It is a member board of the American Board of Medical Specialties or an American Osteopathic Association certifying board;

(ii) The board has been approved by the LSBME;

(iii) The board requires an Accreditation Council for Graduate Medical Education or American Osteopathic Association approved postgraduate training program that provides complete training in that specialty or subspecialty.

(c) If the physician advertises and does not meet the criteria articulated above, the physician must list his or her qualifications for performing the advertised medical procedure or procedures.

The bill was signed by Governor Jindal on June 29, 2011. It will become effective August 15, 2011.

Complying with this new enactment is important, because failure to do so provides grounds for discipline of a physician, which may include refusal to issue, suspension, revocation, or other disciplinary action against the license of a physician by the LSBME.
 

By Deborah J. Juneau

In Oliver v. Magnolia Clinic, 2010-2785 (La. 3/25/11), 57 So. 3d 308, the Louisiana Supreme Court vacated a Third Circuit ruling that nurse practitioners were not covered by the Louisiana Medical Malpractice Act and did not benefit from the cap on damages. The Supreme Court remanded the case to the Third Circuit for an en banc consideration in order to obtain a majority opinion on the issues presented.

Upon original hearing, two judges of a five judge panel of the Third Circuit ruled the Medical Malpractice Act’s inclusion of nurse practitioners within its ambit violated the equal protection guarantees of the Louisiana Constitution and La. R. S. 40:1299.41(A)(1) and was, therefore, unconstitutional. Two judges on the panel ruled that the inclusion of nurse practitioners as health care providers entitled to the protection of the Medical Malpractice Act did not go into effect until the amendment of the statute in 2009. Because the alleged malpractice of the nurse practitioner occurred in 2000-2001, the statute did not cover the defendant nurse practitioner, and she was not entitled to a cap on the damages awarded at trial.
 

Continue Reading Unsettled Question of Medical Malpractice Act Coverage For Nurse Practitioners in Louisiana

By Jennifer J. Thomas

The United States Supreme Court on March 21, 2011 denied a writ application by a physician who was appealing the lower Federal court’s decision dismissing the physician’s civil rights action against the University of Illinois where the physician alleged numerous violations of his constitutional rights. See Abcarian v. McDonald, 617 F.3d 931 (7th Cir. 2010), writ denied, No. 10-913 (2011). The physician had been the head of the Department of Surgery at the University when he was notified that a lawsuit was being contemplated against him due to the death of a former patient. The physician alleged that when the University learned of the potential lawsuit it conspired with other defendants to discredit the physician’s reputation and executed a settlement agreement with the deceased’s family. The physician further alleged that the settlement agreement was a step in a conspiracy to destroy his reputation because the settlement agreement was entered merely so the defendants could report the settlement of the medical malpractice claim to the Illinois Department of Financial and Professional Regulation and the National Practitioner Databank. The physician filed suit alleging free speech, equal protection and procedural due process claims against the defendants.

Continue Reading Court Says No Violation of Physician’s Constitutional Rights When Hospital Settles Medical Malpractice Case

On March 21, 2010, the U.S. House of Representatives on almost a straight party-line vote passed two final healthcare reform bills late Sunday night. Initially, the House of Representatives passed H.R. 3950, the Patient Protection and Affordable Care Act, by a vote of 219 to 212.

Following the passage of H.R. 3950, the House of Representatives passed H.R. 4872, the Health Care and Education Affordability Reconciliation Act of 2010, by a vote of 220 to 211. This second bill by the House modifies the Senate bill (H.R. 3590), and H.R. 4872 will serve as the foundation for any changes made by Congress to the current healthcare delivery, payment and insurance system. Some of the insurance-related changes that may have immediate impact include: lifetime caps on coverage end; children can stay on parents’ policies until age 26, and insurance companies can’t cancel coverage except in the case of fraud. A significant issue of addressing the Medicare physician payment formula still remains unresolved, as well as medical liability reform.

The changes addressed in H.R. 4872, sought by House Democrats and President Obama, will be considered by the Senate under budget reconciliation rules requiring a simple majority to pass and send it to President Obama for his signature. Senate Republicans have stated their intention to offer numerous amendments and raise multiple points of order to the legislation. If the H.R. 4872 is changed in any way prior to Senate approval, it must return to the House for an additional vote before President Obama can sign it.