Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 1 of 14
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`U N ITE D STAT ES D ISTR ICT C O U RT
`SO U TH ER N DISTR ICT O F FL O R ID A
`
`CA SE N O .
`18 U.S.C. j 1349
`18 U.S.C. j 1001(a)(2)
`18 U.S.C. j 981(a)(1)(C)
`
`UNITED STATES OF AM ERICA
`
`VS.
`
`JESSICA PALACIO,
`
`D efendant.
`
`/
`
`IND ICTM EN T
`
`The G rand Jury charges that:
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`G EN ER AL A LL EG A TIO N S
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`A t various tim es relevant to this lndictm ent;
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`Clinical research trials, also know n as clinical investigations, w ere research studies
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`conducted on voluntaly human subjects designed to answer specitic questions about the safety
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`or effectiveness of new drugs. Dnlg developers, or ûtsponsors,'' initiated and took responsibility
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`for clinical research trials.
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`The United States Food and Drug Administration (1$FDA'') was responsible for
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`ensuring that dnzgs intended for hum an use were safe and effective. The FDA relied on the
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`truthfulness and accuracy of the results of clinical research trials to make regulatory decisions
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`about the approval of new drugs, with the ultim ate goal of ensuring that a11 FDA-approved drugs
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`w ere safe and effective for their approved uses in hum ans.
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`Before beginning a clinical research trial, sponsors w ere required to provide the
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`21-20301-CR-GAYLES/TORRES
`
`May 11, 2021
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`KS
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 2 of 14
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`FDA with extensive information regarding the proposed trial, including a detailed investigation
`
`
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`lan known as a ûistudy protocol.''P
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`The study protocol described, among other things, the
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`eligibility criteria for individuals to enroll as study subjects, schedules of tests and procedures,
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`drug and dosage regim ens, the length of the study, and the health outcom es to be m easured by
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`the study. Clinical research trials were required to be conducted according to the study protocol,
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`as well as any applicable laws and FDA regulations.
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`4. Sponsors generally retained contract research organizations CçCROs'') to oversee
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`and conduct various aspects of clinical research trials. Sponsors and CRO s typically contracted
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`with multiple research sites to perform clinical research trials. Under such an arrangement, each
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`individual research site was responsible for identifying study subjects, enrolling them into the
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`study, perfonning the study, gathering data, and reporting the data to the sponsor and/or CRO, in
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`accordance with the study protocol.
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`Each research site had a principal investigator, also known as a clinical investigator.
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`The principal investigator was the individual responsible for conducting the clinical investigation
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`at that site and ensuring that the clinical research trial was conducted according to the study
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`protocol and in com pliance with a11 applicable FDA regulations. Responsibilities of the principal
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`investigator included personally conducting or supervising the study, including all requirements
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`regarding the qualitication of the subjects, the dispensation of study medication, and the
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`collection and reporting of data; obtaining infonned consent from study subjects; reporting
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`adverse events that occur during the study; and ensuring that a11 em ployees w orking on the study
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`m eet those sam e obligations. Sub-investigators w orked tm der the direction of and assisted the
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`principal investigator in conducting clinical trials.
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`Principal investigators were also required, by regulation, to prepare and maintain
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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 3 of 14
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`records relating to clinical research trials.
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`These records, known as iûcase histories,'' included
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`adequate records of the disposition of the study drug, including dates and quantities of drugs
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`dispensed to subjects', informed consent fonns and medical records for each subject participating
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`in the clinical research trial; and records of al1 obselwations and other data pertinent to the
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`investigation for each subject administered an experimental drug.
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`The FDA had the authority to inspect clinical investigators to ensure that
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`investigators were complying with all applicable laws and regulations in conducting clinical
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`trials. The FDA'S inspection authority included the authority to review case histories and other
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`records m aintained by the clinical investigator.
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`Clinical investigators provided to the sponsor and/or CRO the infonnation about
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`each subject or ellrollee in the study, including his or her medical history, laboratory results, and
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`reaction to the drug under study. The sponsor then provided the inform ation to the FDA for its
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`use in evaluating whether the drug was safe and effedive and should be approved for its intended
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`use.
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`The D efendant and H er C o-conspirators
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`Unlimited M edical Research, LLC Cûunlimited M edical Research'') was a medical
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`clinic incorporated in M iam i, Florida that conducted clinical research trials of new drugs for
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`pharmaceutical companies and other sponsors. Unlim ited M edical Research's principal place of
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`business w as on G rand Canal Drive in M iam i-Dade County, M iam i, Florida.
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`Defendant JESSICA PA LA CIO w as a resident of M iam i, Florida. From in or
`
`around D ecem ber 2013 and continuing thzough in or around Septem ber 2015, PA LA CIO served
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`as a study coordinator at Unlim ited M edical Research.
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`1 1. Yvelice Villam an Bencosme was a resident of Hialeah, Florida, and licensed to
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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 4 of 14
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`practice as a m edical doctor in the
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`State of Florida. From in or around October 2013, and
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`continuing through in or around Novem ber 2016, Villam an Bencosm e served as a clinical
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`investigator at Unlimited M edical Research. Villam an Bencosme also operated a private m edical
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`practice in Pem broke Pines, Florida.
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`Lisett R aventos w as a resident of M iam i, FL. From in or around N ovem ber 2013
`
`and continuing through in or around M arch 2016, Raventos selwed as a study coordinator and
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`co-owner of Unlim ited M edical Research.
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`13. M aytee Lledo was a resident of Hialeah, Florida. From in or around December
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`1996 and continuing through in or around April 2016, Lledo w as em ployed as a receptionist at
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`V illam an Bencosm e's private m edical practice in Pem broke Pines, Florida.
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`14. Person 1 was a resident of M iam i, Florida. From in or around M ay 2012 and
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`continuing through in or around Septem ber 2017, Person 1 served as a co-ow ner of Unlim ited
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`M edical Research.
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`The Clinical Trial
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`Between at least in or around M ay 2012 and at least in or around Septem ber 2017,
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`Unlim ited M edical Research was contracted to conduct clinical trials on behalf of sponsors and
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`CROs located throughout the United States.
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`16. Am ong the clinical trials Unlim ited M edical Research was contracted to conduct
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`was a study (the çtstudy'') designed to evaluate the safety and effcacy of an investigational drug
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`intended to treat pediatric asthm a in children betw een the ages of 4 and 1 1 w ith persistent asthm a.
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`The Sponsor (sisponsor'') was a multinational pharmaceutical company with a headquarters in
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`the United States. The CRO (çûCRO'') was a contract research organization based in
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 5 of 14
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`M assachusetts that the Sponsor contracted with to monitor and oversee the Study.
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`17. Prior to beginning the Study, Unlimited M edical Research and Yvelice Villaman
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`B encosm e, as principal investigator, entered into a ççclinical Trial A greem ent'' w ith the CRO ,
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`which was acting as an independent contractor for the Sponsor. The Clinical Trial Agreement
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`required, am ong other things, that investigators follow the study protocol. At or around the sam e
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`tim e, Bencosm e, as the principal investigator responsible for conducting the trial, also signed a
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`Fonn FDA 1572, in which she agreed to com ply w ith the tenns of the study protocol and a1l
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`applicable FD A regulations.
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`18. The Study protocol required subjects to meet certain eligibility criteria to be
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`enrolled in the study. For example, nmong other things, the Study required subjects to be between
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`the ages of fotlr and eleven, and have docum ented asthma.
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`19. The Clinical Trial Agreement between
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`U nlim ited M edical Research, Yvelice
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`V illam an Bencosm e, and the CR O, also included a schedule of paym ents the Sponsor w ould pay
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`Unlimited Medical Research per study subject for each procedure, test office visit, or other event
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`required under the study protocol, in addition to other fees. The Clinical Trial A greem ent required
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`Unlimited M edical Research, in turn, to pay individual study subjects directly for their
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`participation in the clinical trial. Unlim ited M edical Research was generally required to pay study
`
`subjects upon successful completion of an office visit required by the Study protocol.
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`C O UN T 1
`C onspiracy to C om m it W ire Fraud
`(18 U.S.C. j 1349)
`
`The G enezal A llegations section of this lndictm ent is re-alleged and incorporated
`
`as though fully set forth herein.
`
`Begilm ing in or around Septem ber 2013 and continuing at least tluough in or
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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 6 of 14
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`around April 2017, in M iami-Dade County, in the Southern District of Florida and elsewhere, the
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`defendant,
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`JESSIC A PA LA CIO ,
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`did willfully, that is, with the intent to f'urther the object of the ccmspiracy, and knowingly combine,
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`conspire, confederate, and agree with Yvelice Villam an Bencosm e, Lisett Raventos, M aytee
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`Lledo, Person One, and with others known and unknown to the Grand Jury, to commit certain
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`offenses against the United States, that is, to knowingly, and with the intent to defraud, devise and
`
`intend to devise a schem e and artifice to defraud and to obtain m oney and property by m eans of
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`m aterially false and fraudulent pretenses, representations, and prom ises, knowing that the
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`pretenses, representations, and promises were false and fraudulent when m ade, and, for the purpose
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`of executing the schem e and artifice, did transm it and cause to be transmitted by m eans of wire
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`comm unication in interstate and foreign comm erce, certain writings, signs, signals, pictures, and
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`sounds, in violation of Title 18, United States Code, Section 1343.
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`PURPO SE OF TH E CONSPIRACY
`
`It was the purpose of the conspiracy for JESSICA PA LA CIO and her co-
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`conspirators to unlawfully enrich them selves by securing a contrad to conduct the Study, and
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`causing the Sponsor and/or the CRO to m ake paym ents on that contract, by making material false
`
`and fraudulent representations regarding, among other things, subject eligibility for and
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`participation in the Study.
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`M A NN ER AN D M EA N S O F TH E C O N SPIR AC Y
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`The m anner and m eans by which JESSICA PALACIO and their co-conspirators sought
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`to accomplish the object and purpose of the conspiracy included, among others, the following:
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`On or about October 25, 2013, Y velice V illam an Bencosm e entered into a Clinical
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 7 of 14
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`Trial Agreement with the CRO, which was acting on behalf of the Sponsor, to conduct the Study.
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`Villaman Bencosme agreed to conduct the Study at the Unlimited M edical Research site. As part
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`of that agreement, Villam an Bencosm e and Unlimited M edical Research agreed to conduct the
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`Study according to and in compliance with the Study protocol and all applicable laws and
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`regulations.
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`5.
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`To increase the payments received from the CRO under the Clinical Trial
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`Agreement, JESSICA PALACIO and her co-conspirators falsitied the participation of subjects
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`in the Study. The Defendant and her co-conspirators entered false inform ation in the case histories
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`of clinical trial subjects to make it appear that the subjects had, among other things, satisfied the
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`eligibility criteria to participate in the Study, provided infonned consent to participate in the Study,
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`received a physical exam ination from Villam an Bencosm e at Unlimited M edical Research in
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`relation to the Study, received and been adm inistered a Study drug, completed patient assessm ents
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`required by the Study protocol, reported data as required by the Study protocol, and received
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`paym ent for visits to Unlimited M edical Research as part of the Study.
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`JESSICA PALACIO and her co-conspirators recruited and enrolled subjects in
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`the Study that they knew did not m eet the eligibility criteria set forth in the Study protocol,
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`including subjects that they knew did not suffer from the medical condition intended to be treated
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`by the Study drug.
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`JESSICA PALACIO and her co-conspirators obtained and used personally
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`identifiable infonnation of third parties, including copies of identification doeum ents such as
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`drivers' licenses and birth certificates of the pediatric subjects and/or their parents or guardians, to
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`enroll and falsely portray children as participants in the Study at Unlim ited M edical Research. For
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`example, Yvelice Villaman Bencosm e and M aytee Lledo obtained personal identification
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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 8 of 14
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`infonnation, such as copies of birth certiticates and drivers' licenses, from pediatric patient
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`m edical records maintained at Villaman Bencosm e's private m edical practice. JESSICA
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`PALACIO, Yvelice Villam an Bencosm e, Lisett Raventos, and M aytee Lledo used this
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`identification infonnation to create and m aintain case histories which falsely portrayed Villam an
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`Bencosme's patients as subjeds who had consented to participate and in fact participated in the
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`Study.
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`8.
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`ln order to prevent the Sponsor, the CRO, and the FDA from learning that the
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`defendants had falsified the participation of subjects in the Study, JESSICA PALACIO, Yvelice
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`Villaman Bencosme, Lisett Raventos, and M aytee Lledo fabricated written case histories, so that
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`the case histories falsely and fraudulently represented that subjects had participated in the Study
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`according to the protocol, when, in truth and in fact, those subjects had not participated in the
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`Study according to the protocol.
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`9.
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`JESSICA PALACIO, Yvelice Villaman Bencosm e, Lisett Raventos, and M aytee
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`Lledo caused false information to be entered in the case histories for the Study, to make it appear
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`that subjects had, among other things, satisfied the eligibility criteria to participate in the Study,
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`provided inform ed eonsent to participate in the Study, received a physical exam ination from a
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`clinical investigator at Unlimited M edical Research, received the Study drug at Unlimited M edical
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`Research, returned Study drug containers to Unlim ited M edical Research, and received payment
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`for visits to U nlim ited M edical Research, w hen, in truth and in fact, and as PA LA C IO , V illam an
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`Bencosm e, and Raventos w ell knew , no such event had occurred.
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`10. To conceal the fact that the subjeets were not actually participating in the Study as
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`required by the protocol, one or more defendants discarded, without using, the Study dnzg provided
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`by the Sponsor, and JESSIC A PA LAC IO , Y velice V illam an B encosm e, Lisetl R aventos, and
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 9 of 14
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`M aytee Lledo caused false documentation to be placed in the case histories representing that
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`subjects were taking the Study drug as required by the protocol.
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`The Study protocol required subjects to place daily telephone calls into an e-diary
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`system , enter a contidential personal identitication number specific to the subject, and answer
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`questions to assess the subjects' drug usage, symptoms, and experience. ln order to conceal the
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`fact that the subjects were not actually participating in the Study as required by the protocol,
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`JESSICA PALACIO knew that, at the direction of Villam an Bencosm e and Person 1, M aytee
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`Lledo placed hundreds of telephone calls to the e-dialy system for the Study and provided false
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`and fictitious answers in response to questions about the subjects' daily drug usage and experience.
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`The CRO, acting on behalf of the Sponsor, paid Unlim ited M edical Research to
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`conduct the Study. The CRO 's payments, on behalf of the Sponsor, were deposited into the
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`U nlim ited M edical R esearch bank account, over w hich Lisett Raventos, Person 1, and others had
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`control. Unlimited M edical Research bank account funds were distributed to JESSICA
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`PALA CIO , Y velice V illam an Bencosm e, Lisett Raventos, M aytee Lledo, Person 1, and their co-
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`conspirators for participation in the clinical trial fraud schem e.
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`13. Betw een O ctober 2015 and D ecem ber 2016, Person 1, acting at the direction of
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`Yvelice Villam an Bencosm e, sent numerous electronic messages to the CRO, dem anding that a
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`final payment be issued to Unlimited M edical Research for the co-conspirators' purportedly
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`legitim ate work conducting the Study. ln tnzth, and as Person 1 and Bencosme well knew, the co-
`
`conspirators had falsified the participation of subjects in the Study and had not conducted the Study
`
`pursuant to the clinical trial protocol, and consequently no paym ent should have been made by the
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`CR O to U nlim ited M edical R esearch.
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`14.
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`To induce the Sponsor, through the CRO , to enter into a C linical Trial A greem ent
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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 10 of 14
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`with and provide m oney to Unlim ited M edical Research, JESSICA PALACIO and her co-
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`conspirators m ade and caused others to m ake numerous m aterially false and fraudulent statements
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`to the Sponsor, the CRO and/or the FDA, including, am ong other things, the following:
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`M aterially False Statem ents
`
`That Yvelice Villaman Bencosme and Unlimited M edical Research conducted the
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`Study in accordance with the protocol;
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`(b) That enrolled subjects satisfied the eligibility criteria for the Study;
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`That Villaman Bencosme conducted Study-related appointments with subjects at
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`Unlim ited M edical Research and in accordance with the Study protocol;
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`(d) That JESSICA PALACIO and Yvelice Villaman Bencosme obtained informed
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`consent from subjects prior to their emollment in the Study;
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`(e)
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`That JESSICA PA LA CIO and other U nlim ited M edical Research staff dispensed
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`the Study drug to subjects;
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`(9 That JESSICA PALACIO and other Unlimited M edical Research staff informed
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`subjects of the e-diary system and instructed subjects to create unique access codes
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`and PlN num bers for that system ; and
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`(g) That parents of subjects placed daily phone calls to the e-diary system as required
`
`by the Study protocol.
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`All in violation of Title 18, United States Code, Section 1349.
`
`C O UN T 2
`False Statem ents
`(18 U.S.C. j 1001(a)(2))
`The General Allegations section of this lndictm ent is re-alleged and incorporated
`
`by reference as though fully set forth herein.
`
`On or about A pril 25, 2017, in M iam i-D ade County, in Southern D istrict of Florida,
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`10
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 11 of 14
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`in a matter within the jurisdiction of the United States Food and Drug Administration, an agency
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`of the executive branch of the United States Government, the defendant,
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`JESSIC A PALA C IO ,
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`did knowingly and willfully make a false, fictitious, and fraudulent statement and representation
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`as to a material fact, in that the Defendant represented in a signed affidavit that she had perfonned
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`a screening visit for D .H . in the Study, when in truth and in fact, and as the D efendant then and
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`there well knew, she had not perform ed a screening visit for D.H., in violation of Title 18, United
`
`States Code, Section 1001(a)(2).
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`FO R FEITUR E A LLEG A TIO N S
`
`The allegations of this lndictment are hereby re-alleged and by this reference f'ully
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`incorporated herein for alleging forfeiture to the U nited States of A m erica of certain property in
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`which the defendant, JESSICA PALACIO, has an interest.
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`2.
`
`Upon conviction of a violation otl or a conspiracy to violate, Title l 8, United States
`
`Code, Section 1343, as alleged in this lndictm ent, the Defendant shall forfeit to the United States
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`any property, real or personal, which constitutes, or is derived from proceeds traceable to such
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`offense, pursuant to Title 1 8, United States Code, Secticm 98 1(a)(1)(C).
`
`If any of the property subject to forfeiture, as a result of any act or omission of the
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`D efendant:
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`cannot be located upon the exercise of due diligence;
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`has been transferred or sold to, or deposited w ith, a third person;
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`has been placed beyond the jurisdicticm of the Court;
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`has been substantially dim inished in value; or
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`has been com m ingled w ith other property
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`which cannot be subdivided
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`d.
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`C.
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`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 12 of 14
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`without difticulty,
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`the United States shall be entitled to the forfeiture of substitute property under the provisions of
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`Title 2 l , United States Code, Section 853û8.
`
`A11 pursuant to Title 18, United States Code, Section 98 1(a)(1)(C), and the procedures set
`
`forth in Title 21, United States Code, Section 853, as incorporated by Title 28, United States Code,
`
`Section 2461(c).
`
`A TRU E BILL
`
`F REPER SON
`
`12
`
`./ /
`
`)
`rAy ANTO 10 GONZALEZ
`
`JNG UN TE STATES ATTORNEYACT
`SO U THERN
`TM CT OF FLO RIDA
`
`GU STAV W . EYLER
`D IRECTOR
`CON SUM ER PR OTECTION BM N CH
`U .S. D EPA RTM EN T O F JUSTICE
`
`A -
`
`JOS UiD. ROTHMAN
`K AR A M . TR ASTER
`TRIA L ATTORN EY S
`CON SUM ER PRO TECTION BM N CH
`U .S. DEPA RTM EN T OF JU STICE
`
`

`

`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 13 of 14
`UNITED STATESDISTRICT CoIJRT
`SO UTHERN DISTRICT OF FLO RIDA
`
`UNITED STA TESO FAM ERICA
`
`CASE NO .
`
`JESSICA PALACIO,
`
`CERTIFICATE OF TRIAL ATTO RNEY.
`Superseding Case Information:
`
`/
`
`Defendant.
`New defendantts) I''-I Yes I--I No
`CourtDivision: (Select One)
`Numberof newdefendants
`1-17 Miami I--I Key West F-IFTL
`Totalnumberofcounts
`F-IWPB I--I FTP
`1. I have carefully considered the allegations of the indictm ent, the num ber of defendants, the number of proh ble
`witnesses and the legal com plexities of the lndictment/lnformation attached hereto.
`2. l am aware that the information supplied on this statem ent will be relied upon by the Judges of this Court in
`setting their calendars and scheduling crim inal trials under the m andate of the Speedy Trial Act,
`Title 28 U.S.C. Section 3161.
`lnterpreter: (Yes or No) No
`List language and/or dialect
`4. This case will take 10 days for the parties to try.
`5. Please check appropriate category and type of offense listed below:
`(Check only one)
`(Check only one)
`(71
`I 0 to 5 days
`Petty
`Izz
`I I 6 to l 0 days
`Mi nor
`I7r1
`lII 1 1 to 20 days
`Misdemeanor
`E7I
`IV 21 to 60 days
`Felony
`rql
`V 61 days and over
`6. Has this case previously been filed in this District Court? (Yes or No) Yes
`If yes: Judge Bloom
`CaseN o. 20-CR-20190
`(Attach copy of dispositive order)
`Has a complaint been filed in this matter? (Yes or No) No
`lf yes: M agistrate Cmse No.
`Related m iscellaneous num bers:
`Defendantts) in federal custody as of
`Defendantts) in state custody as of
`Rule 20 from the District of
`Is this a potential death penalty case? (Yes or No) NO
`7. Does this case originate from a matter pending in the Central Region of the U.S. Attorney's Office prior to
`August 9, 2013 (Mag. Judge Alicia 0. Valle)? (Yes or No) No
`8. Does this case originate from a m atter pending in the N orthern Region of the U.S. Attorney's Office priorto
`August 8, 20 l 4 (Mag. Judge Shaniek M aynard? (Yes or No) No
`9. Does this case originate from a matter pending in the Central Region of the U .S. Attorney's Oftice prior to
`October 3, 2019 (M ag. Judge Jared Strauss)? (Yes or No) No
`
`E1
`(71
`E1
`Ed
`
`*penalty Sheetts) attachi
`
`Jos ua D . Rot m an
`DOJ Trial Attorney
`Coud ID No.
`A5502447
`
`:?
`
`REV 3/l 9/2 1
`
`

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`Case 1:21-cr-20301-DPG Document 1 Entered on FLSD Docket 05/12/2021 Page 14 of 14
`
`UNITED STATES DISTRICT CO URT
`SOUTH ERN DISTRICT OF FLORIDA
`
`PEN ALTY SH EET
`
`JESSICA PA LA CIO
`
`D efendant's N am e:
`C ase N o:
`Count #: 1
`
`Title 18s United States Codes Section 1349
`
`Conspiracy to Com m it W ire Fraud
`
`*M ax Penalty; Twenty (20) years' imprisonment
`
`Count #:
`
`Title 1 8, United States Codes Section 1001(a)(2)
`
`False Statem ents
`
`feM ax Penalty:
`
`Five (5) years' imprisonm ent
`
`Count #:
`
`*M ax Penaltv:
`
`Count #:
`
`*M ax Penaltv:
`*Refers only to possible term of incarceration, does not include possible fines, restitution,
`special assessm ents, parole term s, or forfeitures that m ay be applicable.
`
`