The Latest ‘Federal Movement’ in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3239582

Right to Try Article

The link above will bring you to my forthcoming publication in the Indiana Health Law Review, Vol. 16, Issue 1, November 2018. The abstract is below.

Abstract

Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial.

This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?

Power Morcellators, Informed Consent, Laparoscopic Surgery, and Protocols …

 FDA ACTION

Power Morcellator

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

 Paying the Price of Not Being Fully Informed… Update 

Recently, the topic of laparoscopic hysterectomy or myomectomy for the treatment of fibroids and a procedure known as morcellation has become very controversial. What may seem like an everyday simple surgical procedure has become for some women the unwanted end result of invasive cancer.

The issues are quite complex. The purpose of this blog is to simply point out a few concepts to consider in the decision making process of whether a woman should undergo a full traditional surgical procedure or a  laparoscopic procedure. What may seem like a simple choice could potentially become a nightmare with a life changing outcome.

Today, more than ever, noninvasive surgery has become the “protocol” for many procedures. Yet, should it? The simple answer is that it depends on many factors. The single most important factor should be the patient and obtaining a valid informed consent. A valid informed consent should be videotaped. The patient must receive a “Plain English” explanation of the risks and benefits of such procedures.

It might sound “high tech” to use such a device approved by the United States Food and Drug Administration (FDA)  and the costs in terms of insurance might be beneficial to the to the insurer and insured. According to FDA: “Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”  MedWatch

Yet, the question remains at what cost?

An excellent example is the removal of fibroids and morcellation without the benefit of a biopsy prior to the morcellation. What this means is if the fibroids are cancerous, the “morcellation procedure” spreads the cancer throughout the patient’s body. How? Power morcellators use extended, tube-shaped blades to cut uterine tissue into little pieces. This permits the surgeon who performs a laparoscopic or minimally invasive hysterectomy, to remove the tissue through a small incision.

Does it all come down to dollars and lack of informed conformed? Apparently so, as the practice continues and is sanctioned in protocols. According to physician Amy Reed: Morcellation is done in at least 11% of the nearly 500,000 hysterectomies are performed each year. See: http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

Benefit: Easier removal of the uterus and speedier recovery time rather than traditional abdominal surgery which could result in a large scar.

Major Risk: Undiagnosed cancer may be present and the morcellation process spreads the cancer.

FDA Warning, Guidance and Alerts, FDA Medical Device Advisory Committee Recommendations and Lawsuits 

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

FDA had  issued an alert in April 2014 to discourage the use of power morcellation. Specifically, FDA set forth: “laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee was convened by FDA on July 10 and 11, 2014. The committee discussed the “safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.” According to FDA the purpose of the committee meetings was to  “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.” The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices.

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm  Quantitative Assessment of the Prevalence of Unsuspected Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids Summary and Key Findings April 17, 2014 http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf

See also: “New Cancer Risk Seen From Surgical Tool” in the Wall St. J. (July 23, 2014).

Lawsuits: Yes, lawsuits have been instituted. Yet, are lawsuits the solution? Here are suggestions to prevent what has occurred to date.

Recommendations

  • Medical Device companies who manufacture the device(s) used in these types of procedures should redesign the product and until that is done conduct a field correction recall of the medical device(s) in question. Ethicon Inc., a unit of Johnson & Johnson,  suspended the sales of several of its power morcellators and in July 2014 issued a market withdrawal.
  • Hospitals should consider a revised protocol and some hospitals have already temporarily banned morcellation until the risk can be more fully evaluated.
  • Physicians should offer “informed” options to the patient.
  • Informed consent should be just that- a plain language explanation of the benefits and risks of consenting to this type of procedure.

Stay tuned for more on this critical health medical-legal issue as the FDA Advisory Committee will issue recommendations pertaining to  appropriate use, premarket testing, labeling, and other risk mitigations such as containment bags) for these devices.

This blog was written by Roseann B. Termini, Esq. with insight and review by Desencia E. Thomas, M.D.