Bhambhani, M.D. v. Innovative Health Solutions, Inc.

CourtDistrict Court, D. Maryland
DecidedAugust 3, 2021
Docket1:19-cv-00355
StatusUnknown

This text of Bhambhani, M.D. v. Innovative Health Solutions, Inc. (Bhambhani, M.D. v. Innovative Health Solutions, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bhambhani, M.D. v. Innovative Health Solutions, Inc., (D. Md. 2021).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

RITU BHAMBHANI, M.D., et al., *

Plaintiffs, *

v. * Civ. Action No. RDB-19-0355 INNOVATIVE HEALTH SOLUTIONS, * INC., et al., * Defendants. *

* * * * * * * * * * * * MEMORANDUM OPINION Plaintiffs Dr. Ritu Bhambhani (“Dr. Bhambhani”) and Dr. Sudhir Rao (“Dr. Rao”) (collectively “Plaintiffs”), on behalf of themselves and others similarly situated, bring this putative class action lawsuit against Defendants Innovative Health Solutions, Inc., Innovative Healthcare Solutions, LLC, Acclivity Medical, LLC, DragonSlayer Strategies LLC, Coleman Certified Medical Billing & Consultant, LLC, as well as Joy Long and Ryan Kuhlam in their individual capacities, alleging civil violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. § 1962(c) (Count One); conspiracy to commit civil violation of RICO, 18 U.S.C. § 1962(d) (Count Two); fraudulent misrepresentation (Count Three); intentional misrepresentation by concealment or non-disclosure (Count Four); and civil conspiracy (Count Five) against all Defendants. (Third Amended Complaint, ECF No. 97.)1

1 The original Complaint in this case was filed on February 6, 2019 by Dr. Bhambhani on behalf of herself and others similarly situated. (ECF No. 1.) Dr. Rao was added as a Plaintiff in the Second Amended Complaint filed on August 28, Presently pending is a Motion to Dismiss filed by Defendant Ryan Kuhlman (“Kuhlman”), through which he seeks dismissal of all five counts filed against him. (ECF No. 102). The parties’ submissions have been reviewed and no hearing is necessary. See Local

Rule 105.6 (D. Md. 2021). For the reasons that follow, the Defendant’s Motion (ECF No. 102) is DENIED. The Plaintiffs have sufficiently alleged Kuhlman’s violation of the RICO statute,2 and this Court therefore has personal jurisdiction over him with respect to all five counts. Furthermore, the Plaintiffs have satisfied the pleading standard of Rule 9(b) of the Federal Rules of Civil Procedure with respect to all five counts of the Third Amended Complaint. Counts Three, Four, and Five are not time barred, as the relation back doctrine

applies.3 BACKGROUND When evaluating a motion to dismiss, this Court must “accept as true all well-pleaded facts in a complaint and construe them in the light most favorable to the plaintiff.” Wikimedia Found. v. Nat’l Sec. Agency, 857 F.3d 193, 208 (4th Cir. 2017) (citing SD3, LLC v. Black & Decker (U.S.) Inc., 801 F.3d 412, 422 (4th Cir. 2015)). Plaintiff Dr. Bhambhani is medical doctor

practicing in Abingdon, Maryland and is board-certified in both Anesthesiology and Pain Medicine. (ECF No. 97 ¶ 16.) Dr. Rao is a medical doctor practicing primarily in Mount Airy,

2020. (ECF No. 48.) The Third Amended Complaint was filed on May 21, 2021, and is the operative pleading in this case. (ECF No. 97.) 2 The Racketeer Influenced and Corrupt Organizations Act (“RICO”) provides a civil cause of action for acts performed as part of an ongoing criminal organization. Violation of RICO under § 1962 requires at least two acts of racketeering activity, commonly referred to as “predicate offenses.” In this case, the RICO charges in Counts One and Two are predicated on mail fraud and wire fraud. (ECF No. 97 ¶ 108.) 3 As discussed infra, Rule 15(c) of the Federal Rules of Civil Procedure permits a party to amend his pleading after the expiration of the statute of limitations if the amendment “relates back” to the original pleading, considering certain factors such as whether the party effected by the amendment had adequate notice of the proceeding and claims against him and will be prejudiced by the change. Maryland as well as other locations in Maryland, Virginia, and Pennsylvania. (Id. ¶ 17.) He is also board-certified in Anesthesiology and Pain Medicine. (Id.) Defendant IHS is an Indiana corporation alleged engaged in the marketing, selling, and distributing of a product known as

the Neuro-Stim System (“Neuro-Stim”). In 2014, Neuro-Stim was cleared by the Food and Drug Administration (“FDA”) for use in acupuncture. (Id. ¶ 2.) In the 510(k)-premarket clearance application4 submitted to the FDA, IHS specifically described the device as “an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.” (Id. ¶ 2, Exh. 1.) However, IHS allegedly sold and marketed the device throughout the United

States as a surgically implantable medical device. (Id. ¶ 3.) According to the Plaintiffs, IHS sold, marketed, and distributed the Neuro-Stim in this manner through exclusive-rights sales-agent distributors (“Sales Agents”), including co- Defendants Acclivity Medical, LLC (“Acclivity”) and Innovative Healthcare Solutions, LLC (“IHCS”). (Id. ¶ 3.) Acclivity was a Kentucky LLC, and prior to its dissolution in June of 2017, Acclivity was owned and controlled by its sole member, Defendant Kuhlman. (Id.) The

Plaintiffs also allege that Kuhlman served IHS as its “National Director” and has been employed by IHS since January of 2013. (Id. ¶ 21.) Dr. Bhambhani and Dr. Rao assert that IHS and its Sales Agents invested substantial sums in advertising and marketing the Neuro-Stim in a misleading manner throughout the

4 A 510(k) is a premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective as a legally marketed device. Applicants must compare their device to one or more similar legally marketed devices and make and support claims that their product is “substantially equivalent.” See Food and Drug Administration, Premarket Notification 510(k), https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k (last visited Aug. 2, 2021). United States, including on websites, at trade shows, in brochures, in newsletters, in video, on phone calls, in emails, and in on-site presentations at physician offices and ambulatory surgery centers. (Id.) For example, they allege that in a slide show used by ICHS in promoting the

device to Dr. Bhambhani and other medical providers, ICHS explicitly referred to the Neuro- Stim as being “FDA-approved,” claiming that it was the “first and only FDA approved electro- auricular, peripheral nerve stimulator currently on the market to treat acute and chronic pain.” (Id. ¶ 4. Exh. 2.) However, nowhere in the presentation did IHCS reference acupuncture or electroacupuncture. (Id.) Similarly, in a “[Frequently Asked Questions] Sheet for Clinicians” prepared by IHS and used by Acclivity and IHSC, the Neuro-Stim is referred to as “FDA

cleared for targeting acute and chronic pain,” but nowhere in the Frequently Asked Questions is the word acupuncture. (Id. ¶ 5, Exh. 3.) The Plaintiffs allege that as a means of enticing Dr. Bhambhani, Dr. Rao, and other medical providers to purchase the Neuro-Stim and implement it into their clinical practices, the Defendants promoted the billing of the device using a specific set of codes used to report implantable nerve stimulators. (Id. ¶ 7.) This set of codes provided for between $4,800.00

and $11,400.00 per patient in reimbursement from payers for a procedure to implant the device. (Id.) IHS and its Sales Agents allegedly employed the services of independent coding consultants (“Coding Agents”), including but not limited to co-Defendant DragonSlayer Strategies LLC. (Id. ¶ 8.) Dr.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

International Shoe Co. v. Washington
326 U.S. 310 (Supreme Court, 1945)
Christianson v. Colt Industries Operating Corp.
486 U.S. 800 (Supreme Court, 1988)
Tellabs, Inc. v. Makor Issues & Rights, Ltd.
551 U.S. 308 (Supreme Court, 2007)
Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
Wag More Dogs, Ltd. Liability Corp. v. Cozart
680 F.3d 359 (Fourth Circuit, 2012)
Bizzie Walters v. Todd McMahen
684 F.3d 435 (Fourth Circuit, 2012)
Consulting Engineers Corp. v. Geometric Ltd.
561 F.3d 273 (Fourth Circuit, 2009)
Goodman v. Praxair, Inc.
494 F.3d 458 (Fourth Circuit, 2007)
Kerby v. Mortgage Funding Corp.
992 F. Supp. 787 (D. Maryland, 1998)
Smith v. Isaacs
777 S.W.2d 912 (Kentucky Supreme Court, 1989)
Camelback Ski Corp. v. Behning
513 A.2d 874 (Court of Appeals of Maryland, 1986)
Mylan Laboratories, Inc. v. Akzo, N.V.
770 F. Supp. 1053 (D. Maryland, 1991)
Racing Investment Fund 2000, LLC v. Clay Ward Agency, Inc.
320 S.W.3d 654 (Kentucky Supreme Court, 2010)
Johnson v. Wheeler
492 F. Supp. 2d 492 (D. Maryland, 2007)

Cite This Page — Counsel Stack

Bluebook (online)
Bhambhani, M.D. v. Innovative Health Solutions, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/bhambhani-md-v-innovative-health-solutions-inc-mdd-2021.