Order by Bankruptcy Court for Pure Med Spa

Below is the text of the order by the bankruptcy court in the Northern District of Georgia for Pure Med Spa:

On the 17th day of December, 2009, came on to be heard the Motion to Dismiss Chapter 7 Cases of Non-Operating Debtors (the “Motion”) filed on behalf of Edwin K. Palmer, duly appointed Chapter 7 Trustee (the “Trustee”) for Pure Laser Hair Removal & Treatment Clinics Inc. (“Pure”), John Street Holdings LLC (“JSH”), GRF Medspa Broadway Plaza, LLC, GRF Medspa Redmond Town Center Mall, LLC, GRF Medspa Santa Ana, LLC, GRF Medspa Santa Clara, LLC, GRF Medspa Southcenter, LLC, GRF Medspa Washington Square Mall, LLC, GRF Medspa Village at Corte Madera, LLC, GRF Medspa Clackamas Town Center, LLC, GRF Medspa North Town Mall, LLC, GRF Medspa Alderwood Mall, LLC, GRF Medspa Bellis Fair Mall, LLC, GRF Medspa Fashion Show, LLC and GRF Medspa Sherman Oaks, LLC (collectively, the “Jointly-Administered Debtors”).

Pursuant to the Motion, the Debtor has represented that the Chapter 7 cases for each of the Jointly-Administered Debtors are to be dismissed, other than the Chapter 7 cases of In re Pure Laser Hair Removal & Treatment Clinics, Inc., Case No. 09-62038, and In re John Street Holdings LLC, Case No. 09-62039 (collectively, the “Remaining Cases”).

After reviewing the Motion and the pleadings on file, the Court is of the opinion, and so finds, that no written objections were filed with regard to said Motion and that good cause exists to grant the Motion. At the time the Motion was called for hearing, no parties appeared to object to the Motion. Accordingly, it is hereby ORDERED AND ADJUDGED as follows:

1.  The Motion is GRANTED as set forth herein;

2.  The above-captioned Chapter 7 case of GRF Medspa North Town Mall, LLC; Case No. 08-85315 is hereby dismissed.

3.  Upon entry of this Order, the Remaining Cases will no longer be jointly-administered and any future pleadings, motions or other filings that relate to either of the Remaining Cases must be filed in the applicable Remaining Case unless and until such Remaining Cases are jointly-administered or substantively consolidated by a future Order of the Court.

4.  Notwithstanding this dismissal, all orders previously entered in this Chapter 7 case or any of the Chapter 7 cases of the Jointly-Administered Debtors shall remain in full force and effect.

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3 thoughts on “Order by Bankruptcy Court for Pure Med Spa

  1. Now that they have filed bankruptcy does anyone know how to ‘get in line’ and try to collect? I called Consumer Affairs and that is basically the information they gave me. They said find out if Pure Med has filed bankruptcy and if so, get in line to try and collect.

    Is there any kind of class action lawsuit?

    Please keep me in the loop. I have a substantial gift card that was never used and I’m sure like every other person here, it breaks my heart.

    Thanks so much

    -Jackie
    therapywithcare@sbcglobal.net

  2. THIS IS A NEW WARNING LETTER FROM THE FDA TO JEFF NOURSE ET AL…

    Pure Med Spa 4/6/10

    Department of Health and Human Services Public Health Service
    Food and Drug Administration
    Silver Spring, MD 20993-0002

    WARNING LETTER

    April 6, 2010

    VIA FEDEX

    Mr. Jeff Nourse
    http://www.puremedspa.com
    301 Yamato Road
    Boca Raton, FL 33431

    Dear Mr. Nourse:

    The United States Food and Drug Administration (FDA) has reviewed your website, http://www.puremedspa.com. As explained below, your website contains false or misleading claims related to your LipoDissolve products, causing them to be misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 352(a), 352(n), and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5)(i) and (e)(6)(i).

    Your LipoDissolve products are intended to cure, treat, mitigate, or prevent disease in humans or to affect the structure or function of the body. Statements on your websites that document these intended uses include, but are not limited to, the following:

    • “The medications used in the LipoDissolve causes [sic] lysis of the fat cell wall. This allows the fat that is being stored in the cell to be released, and is taken by the lymphatic system to the liver where it is metabolized and excreted in the urine.”

    • “The main ingredient is Phosphatidylcholine, which is actually what causes the fat cell to break down.”

    • “LipoDissolve can also aid in the treatment of various medical conditions in both men and women. This includes fat deposits on the face and body, cellulite, lipomas, help with skin retraction, and more.”

    Because these LipoDissolve products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans, or to affect the structure or any function of the body of man or other animals, they are drugs, as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321(g)(1)]. In addition, your firm’s injectable Lipodissolve products are prescription drugs, as defined in section 503(b)(1) of the FDCA [21 U.S.C. § 353(b)(1)], because the method of their use is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. Under sections 502(a) and 502(n) of the FDCA and FDA’s implementing regulations, a drug is misbranded if its labeling or advertising is false or misleading. Section 201(n) of the FDCA [21 U.S.C. § 321(n)] provides that, in determining whether a drug’s labeling or advertising “is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts material in light of such representations . . . . ” Advertisements that contain a representation or suggestion that a drug is better, more effective, or safer than has been demonstrated by substantial evidence or substantial clinical experience are false or misleading.

    Pure Med Spa’s website contains unsubstantiated efficacy and safety claims concerning LipoDissolve products for the following reasons:

    1. Unsubstantiated Efficacy Claims

    Your website contains unsubstantiated efficacy claims concerning LipoDissolve products, including:

    • “Its [sic] not a question of whether Lipodissolve will work, but rather how many treatments it will take to attain a goal in reduction.”

    • “Generally, the average patient requires approximately 2-4 treatments with the goal of losing AT LEAST 1 inch of fat with each treatment.”

    • “The results from Lipodissolve will last permanently in the area treated.”

    FDA regards these claims as false or misleading. FDA is not aware of evidence that supports these claims.

    2. Unsubstantiated Safety Claims

    Your website contains unsubstantiated safety claims concerning LipoDissolve products, including:

    • “The main ingredient used to cause the fat cells to break down is not a synthetic medication, but rather a natural homeopathic ingredient, which has been used intravenously in Europe over 30 years to treat plaques in blood vessels with extensive research showing safety. In Lipodissolve, this same medication is just being used for a new purpose.”

    These claims imply that these products have been proven safe. Although intravenous phosphatidylcholine has been approved in some countries for the treatment of a variety of conditions, it has not been approved in the U.S. FDA is unaware of evidence to support the safety claims for your LipoDissolve products.

    As explained above, the claims made for your LipoDissolve products are false or misleading in that they are not supported by substantial evidence or substantial clinical experience. These claims cause your LipoDissolve products to be misbranded under the FDCA [21 U.S.C. §§ 352(a), 352(n), and 321(n)].

    Conclusion

    The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

    You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

    Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

    Your written response should be addressed to:

    Sudha Shukla, PharmD
    Consumer Safety Officer
    FDA/CDER/Office of Compliance
    10903 New Hampshire Avenue, WO51-5238
    Silver Spring, MD 20993-0002

    Sincerely,

    /Michael M. Levy, Jr./
    Michael M. Levy, Jr., Esq.
    Director
    Division of New Drugs and Labeling Compliance
    Office of Compliance
    Center for Drug Evaluation and Research

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