On October 20, 2010, Dr. Enrique Rivera Mass pled guilty in the U.S. District Court of North Dakota to an Information alleging conspiracy to distribute a controlled substance via various online pharmacies.  Specifically, as part of the Plea Agreement, Dr. Rivera Mass acknowledged prescribing “at least 108,084 dosage units of a Schedule III controlled substance” and “at least 1,672,710 dosage units of a Schedule IV controlled substance” between January 2007 and April 2009 through internet pharmacies.  Dr. Rivera Mass also agreed to forfeit $100,000.  According to the Plea, Dr. Rivera Mass did not review medical records or contact any “customary primary physician” for his online pharmacy patients.

According to WDAZ in North Dakota:

Rivera Mass became involved with Internet pharmacies several years ago in his native Puerto Rico and continued while he was working in North Dakota, according to court documents. Officials with the Center for Psychiatric Care in Grand Forks say Rivera Mass worked there from Feb. 16 to March 18, 2009, and was fired after his Internet pharmacy dealings were discovered. He has since returned to Puerto Rico.

As part of the Plea, the parties agreed that Dr. Rivera Mass’s total offense level for the conspiracy count to which he plead under the Federal Sentencing Guidelinesis 22.  However, as part of the plea, the Government agreed to recommend a 2-level downward departure for acceptance of responsibility and 1-level downward departure for timely notification of Dr. Rivera Mass’s intention to enter a guilty plea.  The Government agreed to recommend a sentence within the guidelines. 

Assuming the offense level is determined to be 19 by the Court, the sentencing range under the Guidelines would be 30-37 months for an individual without any criminal history.  Of course, post-U.S. v. Booker, the guidelines are no longer mandatory and are merely advisory.  Instead, the Court must sentence according to the factors located in 18 U.S.C. 3553(a), which means the final sentence could be higher or lower than the recommended range under the Guidelines.  A conviction for conspiracy to distribute a controlled substance carries a maximum 10 year sentence.

The Ryan Haight Act, an amendment to the Controlled Substances Act, became effective in April 2009.  While the Information alleges that Dr. Rivera Mass’s conduct occurred between 2007 and April 2009, the language of the plea insinuates that all of the prescriptions occured prior to the effective date of the Ryan Haight Act.  As you might recall, the Ryan Haight Act makes it illegal to prescribe a controlled substance via an internet pharmacy without performing a face-to-face examination.  The language of the plea agreement, however, utilizes the pre-Ryan Haight Act language of the Controlled Substances Act and its associated regulations aimed at all prescriptions, not just those via an online pharmacy (i.e. the prescription must be for a “legitimate medical purpose” and issued in the ”usual course of professional practice”).  Consequently, though one can’t be completely sure, the prescriptions in question likely occurred before the Ryan Haight Act’s effective date. 

According to WDAZ, Dr. Rivera Mass’s medical license has been revoked.

The content on this post does not constitute legal advice and is for informational purposes only.  You should not act upon the information presented on this website without seeking the advice of legal counsel.  Should you wish to speak to an experienced white collar criminal defense lawyer knowledgeable and experienced in prescription, drug and online pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact one of us directly.

Yesterday, I wrote about the recent lawsuit filed by Google against certain internet pharmacy advertisers.  In the lawsuit, Google alleges breach of contract against Omar Jackman, John Doe “Simon” and John Does 2-50.

Specifically, Google alleges that  Jackman registered the domain name 4rx-online.com  and opened a Google AdWords account to run advertisements for his website, John Doe “Simon” opened a Google AdWords account to run advertisements for onlinedrpharmacy.com and John Does 2-50 are other individuals (to be identified later) who opened AdWords accounts to direct traffic to their online pharmacy websites selling prescription drugs.  Defendants’ internet pharmacies, Google alleges, are not certified by VIPPS, as required by Google policies; however, the defendants, nonetheless,

“attempted to and used AdWords to advertise prescription drugs for sale to consumers in the United States.  To get their ads running, defendants violated Google’s policies and circumvented technological measures Google takes to enforce its policies.”

For example, Google alleges that the defendants used advertiserments with misspelled prescription drug names:

“Although Google has created a system to block thousand of prescription drug related terms including misspellings, Jackman and other advertisers, including the Doe defendants, continue to create new misspellings.  The combination of misspellings of drug terms is virtually limitless.”

Google alleges that while the ads were displayed for a short time, Google eventually caught the advertisements and, consequently, Jackman and John Doe “Simon’s” AdWords accounts were shut down.

Google seeks injunctive relief and damages for breach of contract against the defendants, because

“[d]efendants’ breaches have damaged Google in that, among other things, Google has been forced to take significant steps to implement systems designed to protect, detect and take action against defendants’ actions.”

This is an unusual case.  Google will have to persuade the factfinder that the defendants were the proximate cause of the creation of these alleged cost-prohibitive “systems.”

The case is styled Google, Inc. v. Omar Jackman, et al., Case No. 5:10-cv-04264-LHK, and is presently assigned to Judge Lucy Koh in the Northern District of California.  It is set for a Case Management Conference on December 20, 2010.

Related Posts: Google Files Suit Against Internet Pharmacy Advertisers

The content on this post does not constitute legal advice and is for informational purposes only.  You should not act upon the information presented on this website without seeking the advice of legal counsel.  Should you wish to speak to an experienced white collar criminal defense lawyer knowledgeable and experienced in prescription, drug and internet pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact one of us directly.

In late September, Google filed a federal lawsuit, the first of its kind, against a number of “rogue” internet pharmacy advertisers and affiliates that Google claimed violated its Google Adwords policies.  Specifically, the lawsuit, against 50 unnamed “John and Jane Doe” Defendants, alleges that the Defendants circumvented Google’s Adwords restrictions, which require any advertising online pharmacy to be certified by the National Association of Boards of Pharmacy (VIPPS), by misspelling certain pharmaceutical terms and prescription names.  According to Google, it anticipates adding additional defendants as they are discovered.

Interestingly, Google’s lawsuit was filed the same day that eNom, a popular domain name registrar,  announced its collaboration with LegitScript.com.

The content on this post does not constitute legal advice and is for informational purposes only.  You should not act upon the information presented on this website without seeking the advice of legal counsel.  Should you wish to speak to an experienced white collar criminal defense lawyer knowledgeable and experienced in prescription, drug and internet pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact one of us directly.

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Dr. Charles McCool, a Pennsylvania doctor, was charged in Pennsylvania state court for prescribing controlled substances via an internet pharmacy to patients without a prior physical examination.  Specifically, McCool was charged with one count of “unlawfully administering/dispensing/delivery of a controlled substance by a practitioner unless done in good faith in the course of his professional practice or within the scope of the patient relationship.”

McCool allegedly prescribed narcotics to five different Pennsylvania residents without conducting a “physical examination.”  In one case, however, McCool conducted two 10 minute telephone consultations with a patient.  It is unclear whether the internet pharmacy in question required any form of a health questionnaire; however, it allegedly did not require the patient to submit medical records.

The language of the above-charge is somewhat similar to the ambiguous language in the Controlled Substances Act and its associated regulations, prior to the Ryan Haight Act amendment, which defined a “valid prescription” as a prescription issued for a legitimate medical purpose and in the usual court of professional practice.  One of the issues in Dr. McCool’s case will inevitably be what level of medical scrutiny is required under the Pennsylvania code.

The content on this post does not constitute legal advice and is for informational purposes only.  You should not act upon the information presented on this website without seeking the advice of legal counsel.  Should you wish to speak to an experienced criminal defense lawyer knowledgeable in prescription, drug and internet pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact one of us directly.

FDA Warns of Pet Internet Pharmacies

by dcooley on October 7, 2010

In March 2010, the FDA released a report warning users of the potentially “fraudulent” practices associated with internet pharmacies selling medication for pets, such as heartworm preventatives and nonsteroidal anti-inflammatory drugs (NSAIDs).  Specifically, the report warns that numerous veterinary internet pharmacies are selling expired or counterfeit drugs and selling drugs without a prescription.  The report expressly states “that a veterinarian should physically examine an animal prior to making a diagnosis to determine the appropriate therapy.”

While this is no doubt optimal, the issue is whether such a physical examination is legally required.  The FDA and DEA and very good about stating what should be done, but they sometimes tend to overlook what must be done in order to comply with the law.  Since I am unaware of any federal indictments on this matter, what level of medical scrutiny is required with respect to pet prescriptions remains unanswered.

The content on this post does not constitute legal advice and is for informational purposes only.  You should not act upon the information presented on this website without seeking the advice of legal counsel.  Should you wish to speak to an experienced white collar criminal defense lawyer knowledgeable and experienced in prescription, drug and internet pharmacy law, including the Controlled Substances Act, the Ryan Haight Act amendment and Federal Food, Drug and Cosmetic Act violations, please feel free to contact one of us directly.

Sorry for my absence.  I have been extremly busy over the last few weeks.  There have been numerous internet pharmacy law developments over the last month as well.  I intend to begin posting articles again on a regular basis this week.