Apothecure's Voluntary Relinquishment in Florida, Reprimand from Texas, New Pharmacy at Same Address--Thank you Dr. Kenneth Woliner for the Research, Information and Your Comments

Here is Apothecure's voluntary relinquishment. (If anyone needs a copy that is easier to read, email me at stuckrichmond@gmail.com and I will email you the information).

http://ww2.doh.state.fl.us/DocServiceMngr/GetImage.aspx?documentid=MTc0ODExNTQ=&enc=1

APOTHECURE, INC
LICENSE NUMBER: PH21213	Printer Friendly Version

Profession PHARMACY License/Activity Status DISCP-RELINQ/ Qualifications Special Non-Resident License Expiration Date License Original Issue Date 2/28/2015 03/28/2005 Discipline on File Public Complaint YES  Link To Discipline YES  Link To Complaint Address of Record If further information is needed, please contact the Department of Health at (850) 488-0595.

Here is the "reprimand" Gary Osborn, the owner of Apothecure, got from Texas:  

http://www.tsbp.state.tx.us/abo/detail/140606%20R26249%20%20%20%20Osborn%2C%20Gary%20Douglas%20%20ABO%20%23J08026A.pdf

Now that was before he plead guilty to violating the FFDCA, perhaps they'll go back and do something similar to what the Feds did against Thomas Bader of College Pharmacy (revoke his license, make him sell all his shares in the pharmacy to a non-family member): http://www.fda.gov/ICECI/CriminalInvestigations/ucm200282.htm (note well: his conviction was upheld, but the $4.8 million forfeiture was reversed due to an instructional error by the judge). 

Washington Post Article: Compounding pharmacies have been linked to deaths, illnesses and safety failures for years

Founded in 2003, PharMEDium has four plants and annual sales of more than $100 million, officials said. The company says it uses only sterile, FDA-approved ingredients for the intravenous and epidural medications it supplies to more than 2,000 hospitals, including Johns Hopkins Hospital.

Company President Rich Kruzynski said the incidents are a fraction of the “tens of thousands of batches” provided to hospitals. The record, he said, demonstrates PharMEDium’s commitment to be the industry’s “gold standard” for quality, patient safety and regulatory compliance.

 

Continue reading here

Apothecure, Inc. and Gary Osborn Get No Jail Time: $100,000 Fine Imposed

The judge has sentenced Gary Osborn on Counts 1-2 to 1 year of probation and imposed a $100,000 fine.  The judge has sentenced Apothecure Inc., Counts 1-2 to 5 years of probation and imposed a $100,000 fine.

Gary D. Osborn and Apothecure Inc. Sentencing Continued to 10/3/2012

09/14/2012

54

ELECTRONIC ORDER as to Gary D Osborn, Apothecure Inc: Sentencing CONTINUED to 10/3/2012 02:00 PM in US Courthouse, Courtroom 1570, 1100 Commerce St., Dallas, TX 75242-1310 before Judge Barbara M.G. Lynn. (Ordered by Judge Barbara M.G. Lynn on 9/14/2012) (chmb) (Entered: 09/14/2012)

District Court Denies Gary Osborn and Apothecure's Motion to Preclude Raising the Fine Ceiling As Moot Since Government Agrees $100,000 Is Reasonable Fine

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Additional Briefs That Have Been Filed in U.S. v. Gary D. Osborn and Apothecure

To view Gary D. Osborn's Brief Relating to Apprendi/Fine argument click here.
To view Government's Response Brief to Osborn's Apprendi/Fine argument click here.
To view Government's Reply Brief click here.

Recent Docket Entries in US v. Gary Osborn and Apothecure

07/06/2012	32	REPLY filed by USA as to Gary D Osborn, Apothecure Inc re: 28 MOTION Preclude Raising the Fine Ceiling Based on Judge-Found Facts (Claud, John) (Entered: 07/06/2012)
07/09/2012	33	MOTION for Leave to File Reply Brief filed by Gary D Osborn, Apothecure Inc (Attachments: # 1 Exhibit A) (Shields, Robert) (Entered: 07/09/2012)
07/09/2012	34	NOTICE of Intent to Travel Internationally as to Gary D Osborn. (Shields, Robert) Modified filers on 7/10/2012 (axm). (Entered: 07/09/2012)
07/10/2012	35	RESPONSE by USA as to Gary D Osborn, Apothecure Inc re: 33 MOTION for Leave to File Reply Brief (Claud, John) (Entered: 07/10/2012)
07/12/2012	36	ORDER granting 33 Motion for Leave to File Reply Brief as to Gary D Osborn (1), Apothecure Inc (2). Replies due by 7/20/2012. (Ordered by Judge Barbara M.G. Lynn on 7/12/2012) (cea) (Entered: 07/12/2012)
07/13/2012	37	REPLY filed by Gary D Osborn, Apothecure Inc re: 28 Motion to Preclude Raising the Fine Ceiling Based on Judge-Found Facts (Man, Christopher) Modified doc. linkage on 7/16/2012 (ctf). (Entered: 07/13/2012)
07/17/2012	38	NOTICE OF ATTORNEY APPEARANCE by Abbe D Lowell appearing for Gary D Osborn, Apothecure Inc. (ctf) (Entered: 07/17/2012)

Judge Accepts Gary Osborn and Apothecure Pleas of Gulity

The judge in the Northern District of Oklahoma has accepted Gary Osborn and Apothecure plea of guilty.  The orders accepting the plea can be viewed here and here.

DOJ Press Release: Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with

Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Tuesday, April 24, 2012

Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with
Misbranded Drug Shipment, Shipment Led to Three Deaths in Pacific Northwest

Gary D. Osborn and his corporation, ApothéCure Inc., pleaded guilty today in the U.S. District Court for the Northern District of Texas to two misdemeanor criminal violations of the Food, Drug and Cosmetic Act (FDCA). The pleas are in connection with ApothéCure’s interstate shipment of two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.

ApothéCure, which is located in Dallas, is a compounding pharmacy. Compounding Pharmacies create particular pharmaceutical products to fit the unique needs of patients by combining appropriate ingredients.

Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults, and to relieve the pain of gout attacks when they occur.

The government’s charges were based on ApothéCure’s February 2007 shipment of 72 vials of compounded colchicine to a now-defunct medical center in Portland, Ore. On March 19, 2007, a patient in Yakima, Wash., who received colchicine from this shipment, died after receiving the infusion. The medical examiner determined that the cause of death was multiple organ failure and acute colchicine toxicity.

On March 30, 2007, colchicine from ApothéCure was administered to two other patients who were suffering from back pain. Within hours of receiving the colchicine injections, both patients became seriously ill, were taken to local hospitals, and died shortly thereafter. The medical examiner in Oregon determined colchicine toxicity to be the cause of death for both patients.

FDA testing of vials selected from the lethal shipment revealed that some of the vials were super-potent, containing 640 percent of the level of colchicine declared on the label. Other vials were determined to be sub-potent, and contained less than 62 percent of the declared levels on the labels.

“This plea shows that the Department of Justice will enforce the Food, Drug and Cosmetic Act against responsible corporate officers of companies that fail to control the quality of their products,” said Stuart F. Delery, Acting Assistant Attorney General of the Civil Division of the Department of Justice. “The drugs mixed by Mr. Osborn’s company were not merely misbranded, but lethal. Drug makers of all sizes, from large corporations to small compounding pharmacies, have a duty to ensure their products are safe.”

Sentencing is scheduled for July 27, 2012.

This case was investigated by Food and Drug Administration’s Office of Criminal Investigations, which referred this matter to the Justice Department. The case is being prosecuted by Trial Attorneys John Claud and Patrick Runkle of the Civil Division’s Consumer Protection Branch.

Previous State Court Proceedings and Other Pending Civil Court Proceedings against Gary D. Osborn and ApotheCure

Before the federal government brought criminal charges against Gary D. Osborn and ApothéCure, there were state proceedings in Oregon and Texas.  The Pharmacy Board of the State of Oregon filed a Notice of Proposed Civil Penalty. The board reviewed the case and voted unanimously in 2007 to issue a civil penalty not to exceed $1,000 per violation. Click here to see press release.

Oregon's Attorney General filed a complaint in Marion County Circuit Court.   ApothéCure, Inc., was not registered with the Oregon Board of Pharmacy as required by law. Oregon's lawsuit alleged that the unlicensed company unlawfully sold dangerous prescription drugs in Oregon including Colchicine, a highly toxic drug that must be used with great care to avoid injury and death.  In this Oregon case, Osborn and ApothéCure entered into a Stipulated General Judgment, which provided that ApothéCure was out-of-business in Oregon until all necessary licenses were obtained and a $500,000 penalty was paid.   

In November 2010, the Texas State Board of Pharmacy reprimanded Osborn's pharmacist license because he had failed to ensure that an error did not occur during the making of the compounded preparation of colchicine.  The board fined ApothéCure $125,000 and placed its license on probation for one year with the condition that the pharmacy develop and implement a continuous quality improvement program for preventing and handling dispensing errors.  The Texas States Attorney General also filed a lawsuit against ApothéCure and Osborn. Click here to see petition and here for press release.

The families of two of the colchicine victims filed wrongful death lawsuits and reached confidential settlements with ApothéCure.  The third family is negotiating a settlement with the company
On February 19, 2008, Hartford Lloyds Insurance  Company filed a civil action against Osborn and ApothéCure in the Northern District of Texas in case number 3:08-cv-00288-P.  This case is still pending. 

Cheryl A. Thompson has written an article posted on the The American Society of Health-System Pharmacits' website entitled Criminal Charges Not Necessarily Criminalization of Medication Error. Click here to read this article.

Gary D. Osborn's Plea in Criminal Case

Today, a magistrate judge in the Northern District of Texas recommended that the district court accept Gary D. Osborn's guilty plea to a two-count information, charging violations of  21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. Click here to see Report and Recommendation of magistrate judge.  As noted in previous blogs three people died because of misbranded colchicine injectable solution compounded at ApothéCure, Inc., where Osborn was a pharmacist.  Osborn was released on conditions that are typical of this type of case.  The next step is that the district court will most likely accept the magistrate judge's report and recommendation, thus accepting Osborn's guilty plea and then impose sentence.

Readers feel free to comment on whether pharmacists and companies that compound medications should be held criminally responsible in these types of cases?  Should criminal charges be brought only in cases where death or serious bodily injury results?  Does it matter if the death or serious bodily injury is that of an animal instead of a human?  Should a company be shut down if a death or serious bodily injury results?

Plea Hearing in ApothéCure and Gary D. Osborn Criminal Case

A hearing in the criminal case of ApotheCure and Gary D. Osborn is scheduled for 10:30 a.m. today.  It is expected that ApothCure and Gary D. Osborn will plead guilty to the two-count information, charging violations of  21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. The defendants were responsible for introducing into interstate commerce two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.  Updates on the hearing will be posted as soon as the information is available.

Gary Osborn and Apothecure are Scheduled to Plead Guilty in Compounding case Charging Misbranded Drug Violations

On April 18, 2012, the United States, Gary D. Osborn and Apothecure filed a plea agreement and factual resume in the Northern District of Texas. Pursuant to the plea agreement, Osborn and Apothecure have agreed to plead guilty to the two-count information, charging violations of  21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors.   ApothéCure and Gary D. Osborn are admitting that they introduced into interstate commerce a misbranded drug with a false and misleading label.  The defendants face up to a year of imprisonment.  Most likely, the defendants will receive probation and be ordered to pay a fine of $100,000.  The parties, while not agreement on the amount of the fine, have agreed that $100,000 would be a reasonable fine in this case.  Nevertheless, the United States' position is that the maximum fine can be imposed up to $250,000 for each count in the information.  The defendants have also agreed to pay restitution to the victims or community, which is mandatory under federal law.  The rearraignment and entry of the plea of guilty are scheduled for April 24, 2012, at 10:30 a.m.

ApothéCure and Gary D. Osborn Criminal Case: Hearing Set

A Rearraignment/Guilty Plea hearing has been set in the ApothéCure and Gary D. Osborn criminal case for April 24, 2012, at 10:30 in the Northern District of Texas.  See Notice filed by district court.  Most likely with the filing of a criminal information, instead of the grand jury issuing an indictment,  and this notice of rearraignment, a plea agreement has been reached between the parties and at the rearraignment the defendants will enter a plea of guilty.


Prior State Proceedings:


  In November 2010, the Texas state board reprimanded Osborn's pharmacist license of Osborn because he had failed to ensure that an error did not occur during the making of that compounded sterile preparation of colchicine.  The Texas state board fined ApothéCure $125,000 and its license was placed on probation for one year with the condition that the pharmacy develop and implement a continuous quality improvement program for preventing and handling dispensing errors.

Criminal Charges in a Compounding Case: Exercise of Federal Authority

The Criminal Information filed against ApothéCure, a major compounder in the United States, and Gary D. Osborn charges violations of 21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors.  Basically, the information charges that  ApothéCure and Gary D. Osborn introduced in interstate commerce a misbranded drug in that its label was false and misleading.  Criminal misdemeanors under the federal system are criminal offenses eligible for terms of imprisonment that do not exceed one year but are more than six months in length by federal statute. See 18 U.S.C. 3559(a)(6)  Under the federal system, the district court also uses the advisory United States Sentencing Guidelines to determine the range and actual punishment.  Both the criminal charges in ApothéCure and the attempt to obtain an injunction in Franck's show the FDA and DOJ attempting to exercise its federal jurisdiction to regulate and punish compounders who step out of bounds.  It will be interesting to see how far the federal courts allow the FDA and DOJ  to exercise this power against other compounders who violate the law.   The appeal  in Franck's while only binding on those states in the 11th Circuit Court of Appeals--Alabama, Florida, and Georgia--will be precedent setting with the possibility, no matter the outcome, of making its way to the United States Supreme Court.  The other possibility if DOJ/FDA loses the appeal is for there to be a legislative fix attempting to define the parameters of federal jurisdiction to regulate this area of the law.