Category: Health Law Section (page 1 of 2)

Final FDA Guidance: Keeping the Surgical Suite from Becoming a Manufacturing Facility

By Justin M. Mann

An early focus of the U.S. Food and Drug Administration (FDA) under the new leadership of FDA Commissioner Scott Gottlieb, MD, has been regenerative medicines, which “hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.”  One of the areas of regenerative medicine that can be particularly difficult to regulate is treatments with human cells, tissues, and cellular and tissue-based products (HCT/Ps), because these treatments tend to be fairly individualized and there is a fine line of demarcation between medical practice and processes regulated by FDA.

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The UNC Cancer Pro Bono Legal Project Needs You!

If you have already volunteered as a supervising attorney with the UNC School of Law’s Cancer Project, you know how meaningful advance directive documents can be in bringing peace of mind to individuals facing daunting and difficult medical situations. If you have not had the chance to volunteer in this role, you are invited to participate now!

To learn more about this program, and about the substantive law which it provides, please register to attend the UNC Cancer Pro Bono Legal Project CLE, to be held at the UNC School of Law on January 26 at 9 a.m. This CLE will provide an overview of substantive law helpful to attorneys participating in the UNC Cancer Pro Bono Legal Project, a collaborative project sponsored by the UNC School of Law’s Pro Bono Program, N.C. Cancer Hospital, and Legal Aid of North Carolina. The CLE also will include a review of changes to the law surrounding advance directives documents, new for 2018.

While this CLE is provided free of charge — in hopes that you will volunteer (or continue to volunteer!) as a supervising attorney through the program — you will be responsible for paying your own CLE fee to the state bar ($3.50/hour).

Click here to register for the CLE program.



Fallout From the Sunshine Act 

By Richard S. Saver and MacKenzie Dickerman

All eyes are once again on health care reform. Amidst the present uncertainty, one law seems likely here to stay—the Physician Payments Sunshine Act (“Sunshine Act”). Part of the Patient Protection and Affordable Care Act, the Sunshine Act is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. As the law has moved beyond the implementation phase, with about three and one-half years of data accrued, it is an opportune time to evaluate its progress. In this post, we highlight what the Sunshine Act has revealed and its downstream effects.

Of particular interest to the health law bar, counsel in civil litigation are recognizing that the Sunshine Act serves as an important information resource.

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Asheville Area Members: Join Us For a Mixer At the Grove Park Oct. 18

As a reminder, on Wednesday, Oct. 18 starting at 6 p.m., the NCBA Health Law Section will host a “Mix, Mingle and Network” event at the Presidents Lounge, Omni Grove Park Inn, Asheville.  We are excited for an opportunity for our members and friends of the section to have a way to mingle in person and learn more about our section. The Health Law Section is an active chapter, and there are many ways that you can get involved, from CLE planning to pro bono.

Free parking for this event is available in the Sammons Wing Parking Deck. This a great opportunity for Health Law Section members in the Asheville area. For any questions and to RSVP, please contact:  See everyone Wednesday, Oct. 18!

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You Still Have Time to Sign Up For the NC Society of Health Care Attorneys Conference Oct. 6

It is not too late to join the North Carolina Society of Health Care Attorneys for its annual conference this Friday, Oct. 6, 2017, at the Rizzo Conference Center in Chapel Hill.

This year’s keynote address will be presented by Aaron McKethan, Ph.D., on the topic “Managing Change in Health Policy: State and Federal Perspectives.”

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Triple Canopy and Evolving Standards of Materiality Under the Civil False Claims Act (FCA)

By Joan H. Krause

In Universal Health Services v. United States ex rel. Escobar (UHS), the Supreme Court upheld the Civil False Claims Act (FCA) theory of “implied certification,” under which the submission of a claim for reimbursement “implies” that the claimant is in compliance with the statutes, regulations, and contract provisions necessary for that claim to be paid. Escobar was filed by the parents of a young woman who died after receiving Medicaid-covered mental health treatment from a Massachusetts clinic that violated state licensing and supervision regulations. Her parents alleged that the clinic’s claims were fraudulent because they implicitly (and falsely) represented that the facility was in compliance with the relevant provisions. A district court dismissed the suit, but the First Circuit reversed. In a unanimous opinion written by Justice Thomas, the Supreme Court held that where a defendant “makes specific representations about the goods or services provided, but knowingly fails to disclose . . . noncompliance with a statutory, regulatory, or contractual requirement[,] . . . liability may attach if the omission renders those representations misleading.”  But cautioning that such misrepresentations must be “material to the Government’s payment decision,” the Court reversed and remanded because the First Circuit had applied an impermissibly broad test.

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Health Law Section Charlotte Networking Breakfast Event

As a reminder, on Tuesday, Sept. 12 from 8 to 9 a.m, the NCBA Health Law Section will be hosting a networking breakfast.  We are excited for an opportunity for our members and friends of the section to have a way to mingle in person and learn more about our section. As you probably know, the Health Law Section is an active chapter, and there are many ways that you can get involved, from CLE planning to pro bono. There are also opportunities for reduced membership dues for law students, so join us to learn more!

The breakfast will be at Robinson Bradshaw’s Charlotte office, located at 101 N. Tryon St., Suite 1900.  Validated parking is available in the 101 Independence Center Garage (120 N. Church St.).

This a great opportunity for Health Law Section members in the Charlotte area.  For any questions and to RSVP, please contact:  See everyone on Tuesday!


Bioethics Master Strengthens and Expands Health Care Practice

NCBA Health Law Section / N.C. Society of Health Law Attorneys

The Wake Forest Bioethics Graduate program admits attorneys seeking to advance their knowledge of health care ethics and public policy, as well as joint-degree law school students who realize the career flexibility that comes with graduate training in the moral dimensions of health care policy. Bioethics education can deepen a health care lawyer’s understanding of the broader social context of various aspects of the life-sciences industry. In depth study of both classic and emerging bioethical dilemmas can sharpen lawyer’s skills in representing health care clients. Or, a graduate degree can be a springboard for a lawyer looking to move into management or public policy career paths.

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Legislative Update For May 10, 2017

NCBA Health Law Section / N.C. Society of Health Law Attorneys

On behalf of the North Carolina Bar Association Health Law Section’s Legislative Committee,  we are providing the following 2017 post-crossover legislative update.

The North Carolina General Assembly has been considering a substantial number of bills of potential relevance to health law practitioners this session. The Health Law Section’s Legislative Committee, with the help of NCBA staff, has been monitoring these bills on virtually a daily basis.

The General Assembly’s rules provide for a “crossover date” during the legislative session, which this year was April 27. The importance of that date is essentially that, with certain caveats, unless a bill has passed one chamber (House or Senate) by the crossover date, the bill will no longer be considered by the legislature. The following listing provides brief descriptions of current proposed legislation, in two categories.

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Court Of Appeals Helps Clarify Line Between Ordinary Negligence and Medical Malpractice Claims


Prognosis Blog

By Todd Hemphill and Matthew A. Fisher

Since the 2001 amendments to Rule 9(j), N.C.R.Civ.P. and other related statutes, the line between whether a medical provider’s actions constitute medical malpractice or ordinary negligence has become much more important. A relatively recent N.C. Court of Appeals decision demonstrates the impact of coming down on the wrong side of that line, upholding the  dismissal of the Plaintiffs’ case alleging ordinary negligence, when discovery revealed that the Defendant’s actions, if proven, would constitute medical malpractice, and there was no Rule 9(j) certification.

In Gause v. New Hanover Reg’l Med.Ctr., __ N.C.App. __, 795 S.E.2d 411, 2016 N.C. App. LEXIS 1358 (Dec. 30, 2016), Plaintiff Gause was seriously injured in a fall during an X-ray examination at Defendant hospital.  She and her family brought an action for ordinary negligence and negligence on a theory of res ipsa loquitur.  During pre-trial discovery, evidence revealed that the fall occurred when an X-ray technician was rendering services requiring specialized skill and clinical judgment.  The trial court granted Defendant’s motion for summary judgment on the grounds that the Plaintiffs’ claim sounded in medical malpractice and failed to comply with Rule 9(j), N.C.R.Civ.P., because there had been no certification of expert review prior to filing the claim. The trial court dismissed Plaintiffs’ res ipsa loquitur claim and dismissed her ordinary negligence claim without prejudice. The trial court also denied Plaintiffs’ motion to amend the Complaint to add a claim of medical negligence.  Plaintiffs filed a Notice of Appeal.[1]

The Court of Appeals affirmed the trial court’s ruling. In analyzing the X-ray technician’s actions, the Court relied upon prior Court of Appeals decisions distinguishing medical malpractice from ordinary negligence claims.  Those cases defined medical malpractice claims as ones “alleging injury resulting from activity that required clinical judgment and intellectual skill,” and ordinary negligence claims as those “alleging injury caused by acts and omissions in a medical setting that were primarily manual or physical and which did not involve a medical assessment or clinical judgment.” 2016 N.C. App. LEXIS 1358 at p. 9 (citations omitted).

Applying those decisions to the facts of this case, the Court of Appeals relied in part on the deposition testimony of the X-ray technician, who testified that in deciding that it was appropriate for the patient to stand for her X-rays, he was exercising his professional judgment in trying to give the radiologist an optimal image without compromising the patient’s safety and comfort.  Perhaps even more damning to Plaintiffs’ case were the statements in their interrogatory answers, which contended “that Defendant, through its agents and employees, was negligent in furnishing or failing to furnish the following services: assessing the patient, inquiring about and reviewing the patient’s medical history, and administering the X-ray.”   Id. at p. 12.  The Court found that each of these services involved specialized knowledge and skills which were predominantly mental or intellectual, rather than physical or manual. Thus, because Plaintiffs’ claim sounded in medical malpractice, rather than ordinary negligence, and because the Complaint contained no 9(j) certification, it was subject to dismissal.

On the trial court’s denial of the motion to amend the Complaint, the Court of Appeals determined that Plaintiffs had failed to perfect their appeal of that issue, and therefore concluded that it did not have jurisdiction to review that Order.

Todd Hemphill and Matt Fisher are both partners and members of the Health Law Section in the Raleigh office of Poyner Spruill LLP.  Todd’s practice focuses on health care strategic planning issues, assisting provider clients in developing health care development strategies under the Certificate of Need law, negotiating health care transactions, and litigating Certificate of Need awards and denials.  Matt’s practice also focuses on the representation of health care providers, with an emphasis on HIPAA compliance, privacy and information security matters and Certificate of Need litigation.

[1] There is no discussion in the Court’s opinion regarding the res ipsa loquitur claim, so presumably, Plaintiffs did not appeal that portion of the trial court’s judgment.

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