`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF MICHIGAN
`
`FEDERAL TRADE COMMISSION,
`
`Case No. 2:20-cv-11694
`
`COMPLAINT FOR
`PERMANENT INJUNCTION
`AND OTHER EQUITABLE
`RELIEF
`
`
`
`
`
`Plaintiff,
`
`v.
`
`PHYSICIAN’S TECHNOLOGY, LLC, a
`corporation,
`
`WILLOW LABS, LLC, a corporation,
`
`DAVID SUTTON, individually and as an
`officer of PHYSICIAN’S
`TECHNOLOGY, LLC, and
`
`RONALD SHAPIRO, individually and as
`an officer of PHYSICIAN’S
`TECHNOLOGY, LLC, and WILLOW
`LABS, LLC.
`
`
`
`Defendants.
`
`Plaintiff, the Federal Trade Commission (“FTC”), for its Complaint alleges:
`
`1.
`
`The FTC brings this action under Section 13(b) of the Federal Trade
`
`Commission Act (“FTC Act”), 15 U.S.C. § 53(b), to obtain permanent injunctive
`
`relief, rescission or reformation of contracts, restitution, the refund of monies paid,
`
`disgorgement of ill-gotten monies, and other equitable relief for Defendants’ acts
`
`or practices in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a)
`
`1
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.2 Page 2 of 51
`
`and 52, in connection with the manufacturing, labeling, advertising, marketing,
`
`distribution, and sale of low-level light devices under the brand name “Willow
`
`Curve” (herein referred to as “Willow Curve”).
`
`JURISDICTION AND VENUE
`
`2.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§
`
`1331, 1337(a), and 1345.
`
`3.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391(b)(1), (b)(2),
`
`(b)(3), (c)(1), (c)(2), and (d), and 15 U.S.C. § 53(b).
`
`PLAINTIFF
`
`4.
`
`The FTC is an independent agency of the United States Government
`
`created by statute. 15 U.S.C. §§ 41-58. The FTC enforces Section 5(a) of the FTC
`
`Act, 15 U.S.C. § 45(a), which prohibits unfair or deceptive acts or practices in or
`
`affecting commerce. The FTC also enforces Section 12 of the FTC Act, 15 U.S.C.
`
`§ 52, which prohibits false advertisements for food, drugs, devices, services, or
`
`cosmetics in or affecting commerce.
`
`5.
`
`The FTC is authorized to initiate federal district court proceedings, by
`
`its own attorneys, to enjoin violations of the FTC Act and to secure such equitable
`
`relief as may be appropriate in each case, including rescission or reformation of
`
`contracts, restitution, the refund of monies paid, and the disgorgement of ill-gotten
`
`monies. 15 U.S.C. § 53(b).
`
`
`
`2
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.3 Page 3 of 51
`
`DEFENDANTS
`
`6.
`
`Defendant Physician’s Technology, LLC (“Physician’s Technology”)
`
`is a Michigan corporation with its principal place of business at 23 East Front
`
`Street, Suite 200, Monroe, Michigan 48161. Physician’s Technology transacts or
`
`has transacted business in this District and throughout the United States. At all
`
`times material to this Complaint, acting alone or in concert with others, Physician’s
`
`Technology has advertised, marketed, distributed, or sold Willow Curve to
`
`consumers throughout the United States.
`
`7.
`
`Defendant Willow Labs, LLC (“Willow Labs”) is a Michigan
`
`corporation with its principal place of business at 747 South Monroe Street,
`
`Monroe, Michigan 48161. Willow Labs transacts or has transacted business in this
`
`District and throughout the United States. Since 2017, acting alone or in concert
`
`with others, Willow Labs has advertised, marketed, distributed, or sold Willow
`
`Curve to consumers throughout the United States.
`
`8.
`
`Defendant Ronald Shapiro is the Medical Director of Physician’s
`
`Technology and a managing member of both that company and Willow Labs. At
`
`all times material to this Complaint, acting alone or in concert with others, he has
`
`formulated, directed, controlled, had the authority to control, or participated in the
`
`acts and practices set forth in this Complaint. As co-founder and -owner of
`
`Physician’s Technology and Willow Labs and co-inventor of Willow Curve,
`
`
`
`3
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.4 Page 4 of 51
`
`among other things, Defendant Shapiro: (1) developed, managed, and controlled
`
`business and marketing strategy for Willow Curve; (2) was in charge of evaluating
`
`the scientific support for Willow Curve’s advertising claims; (3) actively
`
`participated in the creation, review, and approval of advertising concepts and ad
`
`copy for Willow Curve, including materials containing advertising claims that
`
`form the basis of this complaint; (4) personally made deceptive claims about the
`
`health benefits of Willow Curve to the public; (5) responded to inquiries from the
`
`media, potential investors, and others about scientific support for Willow Curve’s
`
`advertising claims and its compliance with regulations promulgated by the Food
`
`and Drug Administration; and (6) actively participated in and controlled decision-
`
`making with respect to whether and when to pay refunds to purchasers of Willow
`
`Curve.
`
`9.
`
`Defendant David Sutton is the Chief Executive Officer of Physician’s
`
`Technology and a managing member of both that company and Willow Labs. At
`
`all times material to this Complaint, acting alone or in concert with others, he has
`
`formulated, directed, controlled, had the authority to control, or participated in the
`
`acts and practices set forth in this Complaint. As co-founder and -owner of
`
`Physician’s Technology and Willow Labs and co-inventor of Willow Curve,
`
`among other things, Defendant Sutton: (1) developed, managed, and controlled
`
`business and marketing strategy for Willow Curve; (2) actively participated in the
`
`
`
`4
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.5 Page 5 of 51
`
`creation, review, and approval of advertising concepts and ad copy for Willow
`
`Curve, including materials containing advertising claims that form the basis of this
`
`complaint; (3) was responsible for developing and implementing refund policies
`
`for Willow Curve; (4) personally made deceptive claims about the health benefits
`
`of Willow Curve to the public; (5) responded to inquiries from the media, potential
`
`investors, and others about scientific support for Willow Curve’s advertising
`
`claims and its compliance with regulations promulgated by the Food and Drug
`
`Administration; and (6) actively participated in and controlled decision-making
`
`with respect to whether and when to pay refunds to purchasers of Willow Curve.
`
`COMMON ENTERPRISE
`
`10. Defendants Physician’s Technology and Willow Labs (collectively,
`
`“Corporate Defendants”) have operated as a common enterprise while engaging in
`
`the deceptive acts and practices alleged below. Corporate Defendants have
`
`conducted the business practices described below through interrelated companies
`
`that have common ownership, officers, managers, business functions, employees,
`
`and office locations, and that commingled funds relating to the marketing and sale
`
`of Willow Curve. Because these Corporate Defendants have operated as a
`
`common enterprise, each of them is jointly and severally liable for the acts and
`
`practices alleged below. Defendants Shapiro and Sutton formulated, directed,
`
`
`
`5
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.6 Page 6 of 51
`
`controlled, had the authority to control, or participated in the acts and practices of
`
`the Corporate Defendants that constitute the common enterprise.
`
`COMMERCE
`
`11. At all times material to this Complaint, Defendants have maintained a
`
`substantial course of trade in or affecting commerce, as “commerce” is defined in
`
`Section 4 of the FTC Act, 15 U.S.C. § 44.
`
`DEFENDANTS’ BUSINESS ACTIVITIES
`
`12. Willow Curve is a curved plastic device that applies low-level light
`
`and mild heat to the site of pain, via light-emitting diodes (“LEDs”) and heat
`
`resistors. To start a 24-minute “treatment” session, consumers select from among
`
`five different settings, which differ with respect to the parameters of the light
`
`emitted, such as angle, frequency, and sweep pattern. Willow Curve also includes
`
`sensors on its curved underside that purportedly measure skin-surface temperature.
`
`13. Since approximately 2014, Willow Curve typically cost $599 and, as
`
`of approximately January 2018, cost $799, plus an additional non-refundable
`
`charge for shipping and handling.
`
`DECEPTIVE ADVERTISING OF WILLOW CURVE TO CONSUMERS
`
`14. Since at least 2014, Defendants have labeled, advertised, marketed,
`
`distributed, and sold Willow Curve to the public, directly and through retailers and
`
`healthcare professionals, including Amazon and Active Recovery Essentials.
`
`
`
`6
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.7 Page 7 of 51
`
`Defendants have advertised and promoted Willow Curve to the public through
`
`national television campaigns, satellite radio, the Internet, including the websites
`
`willowcurve.com, trywillowcurve.com, and willomd.com, paid search ads,
`
`Facebook, in-bound telemarketing, and email and other correspondence. The core
`
`advertising messages are that Willow Curve relieves chronic and severe pain and
`
`reduces inflammation associated with such pain, is clinically proven to do so, and
`
`diagnoses and responds to individual consumers’ pain conditions.
`
`15. To induce consumers to purchase Willow Curve, Defendants have
`
`disseminated, or caused to be disseminated, ads and promotional materials for
`
`Willow Curve, including, but not limited to, the television ads attached as Exhibits
`
`A through D. These and other ads and promotional materials contain the following
`
`statements and depictions, among others:
`
`A. Excerpts from Willow Curve TV ad (Exhibit A (video) aired
`between approximately July 2017 and November 2017; posted to
`Facebook on February 14, 2019)
`
`ON SCREEN:
`
`
`
`ANNOUNCER: If you or someone you know takes opioids or other
`pain medications, please pay close attention.
`
`
`
`7
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.8 Page 8 of 51
`
`
`ANNOUNCER: Introducing the Willow Curve –
`
`ON SCREEN:
`
`
`ANNOUNCER: – an innovative drug-free medical device that is
`FDA registered and –
`
`ANNOUNCER: – proven to relieve pain and stiffness in minutes –
`
`ANNOUNCER: without harmful side effects or recovery time.
`
`ON SCREEN:
`
`* * *
`[Video depicts a person receiving treatment in a medical office]
`
`ANNOUNCER: Pain clinics across the country use therapeutic laser
`technology to treat pain and stiffness.
`
`ANNOUNCER: But, now, you can use Willow Curve’s smart
`technology conveniently at home or on the go for a fraction of the
`price.
`
`
`ANNOUNCER: The Willow Curve uses digital anti-inflammatory
`technology to provide –
`
`ANNOUNCER: – real, lasting, proven pain relief, without the costs,
`risks or inconvenience associated with elective surgery, prescription
`drugs or office visits.
`
`* * *
`
`8
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.9 Page 9 of 51
`
`
`
`
`
`ON SCREEN:
`
`
`ANNOUNCER: – to experience the soothing, deep healing pain
`relief –
`
`ON SCREEN: World’s #1 Digital Pain Relief Device
`
`
`
`* * *
`
`ANNOUNCER: – you can only get from the world’s number one
`digital pain relief device.
`
`ON SCREEN: Joe Wittenberg
`
` Willow Curve Owner
`
` * * *
`[Video of Mr. Wittenberg speaking]
`
`JOE WITTENBERG: I have rheumatoid arthritis primarily in my
`hands. The morning after I played golf, I could not open my hands.
`Frankly, I thought I was going to have to give golf up.
`
`JOE WITTENBERG: I started using the Willow Curve before I
`played golf and used it after I got home from golf. The next morning,
`my hands were fine.
`
`– The relief is, I think, nothing short of a miracle.
`
`
`
`
`
`
`9
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.10 Page 10 of 51
`
`ON SCREEN:
`
`
`
`[Animation depicting a red, inflamed knee joint that returns to a
`normal color after receiving treatment from the Willow Curve]
`
`ANNOUNCER: When applied, the Curve’s diagnostic sensors gather
`information that’s used to adjust the kinetic energy that stimulates
`your body’s own natural pain-relieving pathways.
`
`
`ON SCREEN:
`
`
`ANNOUNCER: It delivers a tailored digital prescription that can
`
`
`
`ON SCREEN:
`
`
`
`10
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.11 Page 11 of 51
`
`ANNOUNCER: – increase circulation and reduce inflammation –
`
`* * *
`
`ON SCREEN:
`
`
`
`ANNOUNCER: Call or log on now to try your very own Willow
`Curve risk-free for 60 days –
`
`* * *
`Get the proven high-tech pain relief you deserve with the
`Willow Curve.
`
`* * *
`
`B.
`
`Excerpts from Willow Curve TV ad (Exhibit B (video), aired
`between approximately February 2016 and May 2016)
`
`* * *
`
`ON SCREEN: Chuck Woolery
`
`
` Television Personality
`
`
` Willow Spokesperson
`
`CHUCK WOOLERY: – while [by] now you’ve seen me talking
`about the Willow Curve, the pain relief device that temporarily
`reduces joint pain, all without medication.
`
`
`
`
`
`
`
`11
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.12 Page 12 of 51
`
`ON SCREEN:
`
`
`
`CHUCK WOOLERY: Still people ask, does the Willow Curve really
`work?
`
`Well, the all-digital Willow Curve is so effective that it’s now used in
`doctors’ offices and, of course, by tens of thousands of people just like
`you.
`
`ON SCREEN: Tom U.
`
`
` Actual Willow Curve User
`
`
`
`
`
`
`
`
`
` Not a Paid Actor
`
`TOM U.:
`
`I could actually feel the meniscus tear –
`
`– My wife had heard about the Willow Curve. She got
`one. Within two or three days, just the pain relief was
`phenomenal. It really helped [me in] getting around and
`I was just amazed at how quickly I saw the change in my
`pain level. I couldn’t recommend it higher.
`
`* * *
`
`
`
`12
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.13 Page 13 of 51
`
`ON SCREEN:
`
`
`
`
`
`CHUCK WOOLERY: – there’s no need to wonder about the Willow
`Curve any longer. * * *
`
`ON SCREEN:
`
`
`ANNOUNCER: Order your Willow Curve today with a risk-free
`money-back guarantee by phone or online at TryWillowCurve.com.
`
`
`
`C. Excerpts from Willow Curve TV ad (aired between
`approximately November 2015 and March 2016)
`
`
`
`* * *
`
`CHUCK WOOLERY: The Curve is a non-invasive, drug-free digital
`pain relief device and it’s proven to help relieve pain and
`stiffness. * * *
`
`
`
`
`
`* * *
`
`ON SCREEN: Rob L.
` Actual Willow Curve User
`
` Not a Paid Actor
`13
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.14 Page 14 of 51
`
`
`[Video of Rob speaking]
`
`I can walk a mile now where [sic] I never used to be able
`ROB L.:
`to walk that far.
`
`* * *
`
`ON SCREEN:
`
`
`
`
`
`ANNOUNCER: Experience the same relief from pain and
`inflammation with the Willow Curve. * * *
`
`* * *
`
`
`
`CHUCK WOOLERY: People often ask how it works. On the Curve,
`there are diagnostic sensors that evaluate –
`
`ON SCREEN:
`
`
`
`CHUCK WOOLERY: – and respond to your body’s pain. This is
`amazing. The Curve’s smart onboard computer adjusts the protocol to
`your needs. It helps increase circulation with thermal energies and
`14
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.15 Page 15 of 51
`
`
`
`
`
`
`
`
`
`
`provides temporary, but effective, pain relief.
`
`* * *
`
`
`
`
`
`
`CHUCK WOOLERY: If you have knee pain, shoulder pain, wrist
`pain, arthritis, even leg pain, and you feel that other treatment options
`are not living up to their promises, it’s time to ask yourself if you have
`the courage to try a different kind of pain reliever.
`
`ON SCREEN: Kris Y.
` Actual Willow Curve User
`
` Not A Paid Actor
`
`
`
`
`
`[Video of Kris speaking]
`
`KRIS Y.: Burning, tingling, if you don’t have diabetes, you really
`don’t know what it’s like.
`
`
`ON SCREEN:
`
`
`
`
`KRIS Y.: After the Willow Curve finished its cycle, my foot felt
`better than it’s felt in over a year. It was just odd. I never realized
`how little I felt until I used the Willow Curve.
`
`
`
`
`
`
`
`
`
`
`15
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.16 Page 16 of 51
`
`ON SCREEN:
`
`
`ANNOUNCER: Order your Willow Curve today with a risk-free
`money-back guarantee by phone or online at YourWillowCurve.com.
`
`D. Excerpts from Willow Curve TV ad (Exhibit C (video), aired
`between approximately October 2015 and December 2015)
`
`
`
`
`
`* * *
`
`
`
`CHUCK WOOLERY: If I had said 20 years ago that one day we’d
`have computers in our pockets or driverless cars or you could wear a
`device that gets rid of your pain, you’d say I was crazy. Yet, all of
`those things are here, even the pain relief device. It’s called the
`Willow Curve.
`
`ON SCREEN:
`
`
`
`
`
`
`CHUCK WOOLERY: The Willow Curve is a non-prescription, drug-
`free, digital anti-inflammatory device. It’s proven to relieve pain,
`swelling, and stiffness in minutes.
`
`
`16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.17 Page 17 of 51
`
`* * *
`
`
`CHUCK WOOLERY: * * * The Willow Curve uses digital anti-
`inflammatory technology to provide real lasting pain relief without the
`risks or pain of surgery and without the side effects of drugs.
`
`* * *
`
`
`
`CHUCK WOOLERY: Just put the Curve on the painful area, push a
`button, and let the device relieve your pain.
`
`* * *
`
`
`ON SCREEN: Denise H.
`
`
` Rheumatoid Arthritis Patient
`
`
` Willow Curve User
`
`
`
`
`
`
`
` Not A Paid Endorsement
`
`[Video of Denise speaking]
`
`DENISE H: I was diagnosed with severe RA two and a half years
`ago. –
`
` So for the last two and a half years, I’ve been trying everything
`out there to get relief. My right hand was in a flaring state, so I tried
`the Willow Curve. After only 24 minutes of treatment –
`
` –
`
` – I could not only move my finger and joint area, but the
`inflammation was down tremendously.
`
`ANNOUNCER: * * * When applied, the Curve’s diagnostic sensors
`gather information from your skin. Then the smart device adjusts the
`photonic and thermal kinetic energies, stimulating the body’s natural
`pain-relieving and anti-inflammatory responses. It’s not science
`fiction. It’s a trusted, effective breakthrough in pain relief technology.
`
`* * *
`
`
`
`17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.18 Page 18 of 51
`
`E.
`
`Excerpts from Willow Curve TV ad (Exhibit D (video), aired
`between approximately January 2015 and March 2015)
`
`
`
`
`
`
`
`* * *
`
`
`
`CHUCK WOOLERY: Are you considering shoulder or knee
`surgery? Please pay close attention because this device, the Willow
`Curve –
`
`– has helped saved people from invasive surgery, like knee
`replacement.
`
`ON SCREEN:
`
`
`CHUCK WOOLERY: The Curve is a non-prescription, non-invasive,
`drug-free device that is proven to relieve pain, swelling, and stiffness
`in minutes.
`
`
`* * *
`
`
`CHUCK WOOLERY: Surgery is not guaranteed and it’s risky and it
`may not be your only option.
`
`ON SCREEN:
`
`
`
`18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.19 Page 19 of 51
`
`
`CHUCK WOOLERY: One Pro Football Hall of Famer found out for
`himself. He actually canceled his own knee replacement after using
`the Curve. Now, he’s off pain meds, too, thanks to this incredible
`device.
`
`
`* * *
`
`
`
`Excerpts from willowcurve.com website (captured May 1, 2019)
`
`Smart Pain Therapy to Fit Your Budget
`FDA Registered | Created and Endorsed by Physicians | Safe + Drug
`Free
`
`
`
`
`
`[Series of video testimonials in a tile design]
`
`
` * * *
`
`
`The commitment to help reduce the
`escalating cost of joint pain therapy. In
`some cases, for the cost of a single pain
`injection you could get a Willow Curve.
`
`Today, certain injections for pain can cost over $4,000 with an
`annual cost of nearly $40,000. The Cleveland Clinic recently
`reported on certain pain injection therapies that can cost up to $1,800
`per injection. * * * Digital technology like the Willow Curve can
`bring various efficiencies to certain aspects of health care costs.
`
`* * * The Willow Curve is an FDA registered, software controlled,
`handheld device for joint pain relief. It combines the documented
`benefits of safe laser, infrared, and LEDs in one device that produces
`19
`
`
`
`
`
`F.
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.20 Page 20 of 51
`
`safe medical grade pain relief at a fraction of the cost. READ MORE
`
`
` * *
`
`
`
` *
`
`
`
`Clinical Support
`
`The Willow Curve combines safe laser, infrared, and diode in one
`safe software controlled device.
`
`
`Low Level Laser Therapy (LLLT) is well researched and documented
`* * *. Now, safe advanced PT technology comes home. According to
`the National Institute of Health (NIH) there have been 400 randomized,
`double-blind, placebo-controlled trials published with over 4,000 basic
`science research and clinical studies of Low Level Laser Therapy
`(LLLT). Much of the landmark research was done by the National
`Aeronautics and Space Administration (NASA), providing the
`springboard for many additional studies. LEARN MORE.
`
`
`* * *
`
`Dr. Deb S., DC, RN
`
`“* * *. From a professional standpoint, it effectively reduces soft
`tissue inflammation, facilitates adjustments and provides a realistic
`way to help maintain the favorable result of office treatments beyond
`adjustments alone.”
`
`[left side of screen]
`
`Dr. Tiziano Marovino, DPT, MPH, RMSK, DAAPM Diplomat
`American Academy of Pain Management
`Key Opinion Leader
`
`“Patients using the Willow Curve are 2x more likely to reduce their
`pain by 3-10 pain scale numbers with a single treatment.”
`
`
`
`
`
`20
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.21 Page 21 of 51
`
`[center of screen]
`
`Dr. Eric P., MD, FACEP
`Emergency Medicine
`
`“I had a chance to try the Willow Curve and the results were
`absolutely incredible. I went from a limited 45 degree painful knee
`flexion before treatment to over a 90 degree pain free flexion after
`treatment. I’ve been able to walk with-out pain.”
`
`[right side of screen]
`
`Real People. MedTech Hanna
`
`[image of MedTech Hanna in softball uniform]
`
` I
`
` have had six major joint injuries and multiple sports accidents. I
`didn’t want to depend on pain medications, and physical therapy only
`gave me minimal relief. After 2-3 treatments in my injured areas with
`the Willow Curve, I received significant relief of pain and
`inflammation [sic]. I continue to use the Curve which has become an
`important treatment in my life to remain pain free and get back to my
`activities * * *
`
`Real People. Fireman Lt. Eric
`
`“Now, the pain is gone and my range of motion has improved over-
`[sic] thirty five degrees and my heel lifts have returned to near
`normal. My skin and scar have dramatically improved. It’s amazing.
`
`
`* * *
`
`[willowcurve.com>pages>how-to-select-the-right-product-for-
`your-joint-pain: Page that displays if visitor clicks “What’s right for
`you?” on home page]
`
`How to select the right product for your joint pain.
`
`The Willow Curve is a smart laser device, designed by physicians to
`relieve joint and arthritis pain. It is used effectively in clinics, at
`21
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.22 Page 22 of 51
`
`home, or gym.
`
`
`
`How is the Willow Curve a More Advanced Laser for Pain?
`
`* * *
`
`• Bigger is Better - * * *. This allows you to easily administer
`relief to joints and arthritis.
`
` Safer - * * *. Much safer than pain meds.
`
` •
`
` •
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Smart Artificial Intelligence - Patented smart laser technology
`optimizes pain therapy and results. Willow Curve is the smart laser
`for joint pain.
`
`* * *
`
`• Multi-Application - One advanced device treats 10 physical
`applications and 30 pain conditions.
`
` •
`
` Effective - Pain relief can start in as little as 12 minutes. Tens of
`thousands in use in (private and clinical).
`
` •
`
` Accreditations - FDA registered; ISO 13485; Arthritis Foundation.
`Ease of Use Commendation; American Medical Association assigned
`CPT code 0552T; patented; GSA Federal contract V797D-70038.
`
`[willowcurve.com>pages>frequently-asked-questions: Page that
`displays if visitor clicks “Frequently Asked Questions” link on home
`page
`
`* * *
`
`
`
`
`WHAT DOES THE WILLOW CURVE DO?
`
`The Willow Curve Smart Laser produces dynamic multi-band
`alternating pulse therapy (ATP) the body tissues absorb to:
`
`• Enhance central pain management systems function,
`
` •
`
` Spark the body’s opioid receptor,
`22
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.23 Page 23 of 51
`
` •
`
` Reduce inflammatory pain response and accelerate tissue healing.
`
` •
`
` Suppress sensory fatigue (adaptation), improving extended pain
`relief momentum and recovery.
`
` •
`
` The Willow Curve is not a conventional therapeutic laser; however,
`the resulting physio-biological changes in the treated area mimic what
`happens when therapeutic lasers are used.
`
`
`
`HOW IS THIS UNIT BETTER THAN ANY OTHER UNIT ON
`THE MARKET?
`
`
`
`* * *
`
`* * *
`
`• Physicians and patients report over a 90% favorable response rate
`when used as suggested.
`
`
`
`* * *
`
`HOW DOES THE CURVE WORK?
`
`• Sports, other trauma, and joint disease can create joint inflammation
`and pain.
`
` Published medical research reveals how inflammation can attack
`tissue structures and leave behind floating cellular debris that wear on
`delicate joint tissue and delay healing.
`
`* * *
`
`• The Willow Curve is a 100% drug free medical device designed to
`temporarily relieve pain and increase circulation, reduce stiffness, and
`help your body do what it does naturally to ease the pain and promote
`natural healing.
`
`
`
`
`
` •
`
`
`
`23
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.24 Page 24 of 51
`
`“IS THE WILLOW CURVE JUST A FANCY HEATING PAD?”
`
`* * *
`
`• While we cannot comment specifically on a heating pad, the Willow
`Curve is a digital smart low level laser therapy device (LLLT) that
`combines both patented bio-sensory and bio-therapeutic features.
`* * * [Willow Curve] reduces pain, swelling, increasing mobility
`while enhancing the healing process. Many of our patients comment
`on how the results of using a heating pad pale in comparison to the
`Willow Curve.
`
` •
`
` The Willow Curve produces a unique customized digital
`prescription. It utilizes a wide spectrum of energies, frequencies and
`delivery parameters that change thousands of times /sec. are adjusted
`in real time to your condition.
`
` •
`
` The Willow Curve joint scanning technology collects information
`from at and below your skin surface. Then the Curve calculates and
`digitally delivers multiple energy beams that change thousands of
`times/second * * *.
`
`
`
`* * *
`
`IS THE CURVE FDA APPROVED?
`
`• The Willow Curve® is FDA registered and has been determined to
`be a low risk device, and is registered for marketing in the United
`States.
`
`[willowcurve.com>Zero Down>30-Day Risk Free
`Plan>Installment Payments]: Page that displays if visitor clicks
`“Get Your Willow Curve” link on home page]
`
`Willow Curve Zero Down 30-Day Risk Free Plan Installment
`Payments
`
`30-DAY RETURN GUARANTEE
`
`We stand behind the Willow Curve. If you are not satisfied with your
`Willow Curve, you can return it for a replacement or refund. We must
`24
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.25 Page 25 of 51
`
`* * *
`
`receive your Willow Curve within 35 days after purchase. If you plan
`to return it call us at (800) 943-2802 for a Return Authorization
`Number. When returned it should be in “like new” condition free of
`damage along with all the accessories and in the original packaging.
`We do not pay return shipping charges. It is a good idea to keep the
`tracking number. Thank you.
`
`
`
`Willow’s guarantee does not cover ordinary wear and tear or damage
`caused by improper use or accidents.
`
`
`
`* * *
`
`G. Excerpts from willowcurve.com website (captured February 12,
`2019)
`
`[willowcurve.com: home page]
`
`[First of three rotating statements]
`
`
`
`
`
`
`
`* * *
`
`[Third of three rotating statements]
`
`25
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.26 Page 26 of 51
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FEATURES & BENEFITS [left side of screen]
`
`The Willow Curve delivers treatment specific
`to your condition, digitally activating many
`processes within the body that provide relief,
`detoxify the joint and promote healing.
`
`
`
`Drug-Free Pain Relief
`
`* * *
`
`The Willow Curve is a registered medical device with the
`FDA who has determined it to be 510-K exempt.
`
`PHYSICIAN-ENDORSED [right side of screen]
`
`Often, doctors are seeking alternatives to
`prescription medications for their patients.
`Now, they turn to the Willow Curve as a
`drug-free option for pain management
`
`
`* * *
`
`CAN THE WILLOW CURVE HELP WITH YOUR PAIN?
`
`THE NEXT EVOLUTION IN PAIN RELIEF —
`WITH NONE OF THE SIDE EFFECTS
`
`The Willow Curve has been clinically proven to temporarily relieve
`pain caused by various common conditions. Check out the full list to
`see if the Willow Curve would work for you.
`
`TREATABLE CONDITIONS [hyperlink]
`
`REAL PEOPLE. REAL STORIES.
`
`DENISE’S STORY
`
`“I can’t believe the difference. I’ve got myself back
`
`26
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.27 Page 27 of 51
`
`again. I’m able to move; I’m able to get out and function
`like a normal person again. * * *”
`
`After being diagnosed with rheumatoid arthritis, Denise felt that
`life was over as she knew it. Multiple ineffective
`treatment options left her hopeless –
`until she found the Willow Curve, and everything changed.
`
`CLICK HERE TO WATCH HER STORY
`PLUS OTHER REAL SUCCESS STORIES
`
`[willowcurve.com>conditions: Page that displays if visitor clicks
`“Treatable Conditions” link on home page]
`
`WILLOW CURVE® TREATABLE CONDITIONS
`
`* * *
`
`The Willow Curve has been used successfully to treat a number of
`conditions in thousands of hospitals and clinics nationwide, as well by
`the Navy SEALS and in professional sports training facilities.
`
`Some users experience relief and better range of motion from the very
`first use, while others require a few treatments before feeling a
`reduction in pain and inflammation. * * *
`
`THE WILLOW CURVE MAY BE ABLE TO HELP YOUR
`CONDITION
`
`CLICK BELOW TO LEARN MORE ABOUT THESE PAIN
`AREAS:
`
`[conditions listed include: Osteoarthritis, Rheumatoid Arthritis,
`Psoriatic Arthritis, Fibromyalgia, Plica Syndrome, Osgood-Schlatter,
`Patellofemoral Syndrome, Gout, Lupus, Plantar Fasciitis, Carpal
`Tunnel, Occipital Myospastic Headaches, Tension Headaches, and
`Muscular Headaches]
`
`* * *
`
`27
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 filed 06/25/20 PageID.28 Page 28 of 51
`
`
`
`
`
`[willowcurve.com>stories: Page that displays if visitor clicks “Real
`Stories” or Click Here to Watch Her Story Plus Other Real Success
`Stories” links on home page]
`
`REAL PEOPLE.
`REAL STORIES.
`
`
`* * *
`
`
`[Video testimonial of Eva B.]
`
`CASE STUDY: Eva B.
`
`CONDITION: Ankle Pain
`
`Eva broke her ankle and used the Willow Curve nightly to reduce pain
`and inflammation. Her medication upset her stomach, and the Curve
`offered her an effective alternative for relief.
`
`“I went ahead and used it faithfully, every single day, for the next
`couple of weeks, and the swelling went down. So that inflammation,
`when it went down, it reduced the pain.”
`
`[Video testimonial of Alvin F.]
`
`CASE STUDY: Alvin F.
`
`CONDITION: Ankle Pain
`
`Alvin injured his ankle over 20 years ago, and weight gain as he aged
`aggravated the pain. The Willow Curve has helped relieve that pain
`and increased his mobility.
`
`“I've been using it every other day, and I've been relieved of pain. It's
`been amazing, and I have greatly improved my quality of life.”
`
`[Video testimonial of Kristine Y.]
`
`CASE STUDY: Kristine Y.
`
`
`
`
`28
`
`
`
`Case 2:20-cv-11694-NGE-RSW ECF No. 1 fi