Is Your FDA Regulated Product a Drug, Device or Combination?

Prevor v. United States Food and Drug Administration

Primary Mode of Action Determination is Critical in Combination Product

Introduction: At times, the United States Food and Drug Administration struggles with proper product classification. The case of Prevor v. Food and Drug Administration , D.D.C., No. 1:13-cv-01177 (September 9, 2014) provides a prime example. The major complex issue is whether the product should be classified as a drug, medical device or combination.

About the Product: The form of Diphoterine® Skin Wash (DSW) is a liquid substance in a canister propelled by pressurized gas. Intent is critical in the determination of product classification.

Background:  The drug, device and combination product classification issues stem back to 2009. Originally, back in 2009, FDA’s Office of Combination Products classified Prevor’s skin wash product, DSW as a drug primary mode of action rather than as a device as a primary mode of action. See 21 C.F.R. § 3.2(m).  FDA found the product had two primary intended purposes using the reasoning “to wash the chemical off the skin and neutralize the chemical that is on the skin.”

Prevor I: In 2012, the District Court found the FDA’s action classifying the DSW product as a drug primary mode rather than a device as a primary mode was both arbitrary and capricious.  The District Court vacated the FDA’s decision to classify  DSW as a drug-device combination product with a “drug” primary mode of action.  Yet, Prevor, a device maker,  has vigorously argued that the product is a device and not a drug. Alternatively, if deemed  a combination product, the primary mode of action according to Prevor would be a device. Prevor v. Food and Drug Administration (Prevor I ), 895 F.Supp.2d 90 (D.D.C.2012)

Prevor II: Fast forward to 2014 and this time, the District Court for the District of Columbia again vacated FDA’s decision to designate Prevor’s DSW as a drug-device combination product with a “drug” primary mode of action. Ultimately FDA reached the same conclusion, yet found only one primary purpose: “to help prevent and minimize accidental chemical burn injuries.” The Court clarified that “as the record now stands, the Court cannot affirm FDA’s classification decision because it was based on an erroneous and unreasonable interpretation of the law.” . The Court rejected Prevor’s argument to classify the product as a medical device and or a combination product with a medical device as the primary mode. Yet, the District Court found that FDA action arbitrary and capricious.

Court Leaves Door Open:   FDA must consider the issue yet again. In essence, the  Court left the door open for FDA to reconsider the issues again; that is, the court stated that the FDA “could find that DSW should be classified as a drug-device combination product with a drug mode of action if it also adopts a plausible construction of the relevant statutory language.”  Chemical action and intent remain critical as the court set forth that classification is dependent on whether its chemical action will prevent and minimize chemical burns. Therefore, the court “left open” and remanded the designation decision to the FDA.

Next Steps: There is no definite conclusion nor is there finality. FDA will need to reconsider the issue and provide a basis in accordance with what the District Court stated about a “plausible construction of the statutory language”. No doubt the legal saga will continue.

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.