Tag Archives: FDA

Fake Doctor in Texas Accused of Injecting Patients with Silicone Instead of Botox

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A South Texas woman was charged on October 31, 2013, for allegedly injecting people with silicone, that she claimed was Botox. The phony health professional, described in some media reports as an “unlicensed plastic surgeon,” has been charged with practicing medicine without a license. According to Reuters, the unlicensed health professional could also be facing charges of manslaughter if investigators confirm that a woman’s death was related to treatments received from the imposter.

Click here to read the entire article from Reuters.

If convicted, the fake health care professional could spend up to ten (10) years in prison and have to pay up to $10,000 in fines.

Investigators Looking for More Victims.

Investigators say this phony health professional would travel to different spas and massage parlors along the Texas-Mexico border offering her services and leaving advertisements. She allegedly made injections in patients’ lips, buttocks and legs. The advertisements seized by authorities touted collagen treatments for $250.

According to Fox News, investigators learned of the underground practice when a victim allegedly received a series of injections in her legs in August 2013. The victim has allegedly been hospitalized since October 9, 2013. Authorities also say they are investigating the death of a woman who may have been a victim of the treatments. So far around 30 victims have been identified, but investigators say there could be more, according to Fox News.

To read the Fox News story, click here.

Underground Injections Happen All Over the Country.

This is by no means the first report we’ve heard of phony health care professionals injecting people with toxic chemicals.

In February 2013, a South Florida man was arrested for allegedly injecting people with silicone in a West Palm Beach motel room. According to police, this fake physician injected his patients with buttocks-enhancing silicone injections. He would then allegedly seal up the skin wounds with Krazy Glue. To read more on this, click here to read my previous blog.

As far as we know, there is no relationship between the Florida fake doctor and the Texas fake doctor. However, they could have attended the same medical school.

Practicing Without a License Is a Crime.

Practicing medicine without a license is a crime. Additionally, so is helping someone practice medicine without a license. As a practitioner, you may be asked to supervise or join a practice. Remember that your license may be at stake with any wrongdoing by your subordinates. Before you join a practice or agree to supervise others, check first with the Department of Health (DOH) that the other providers are legitimate. You can verify a license for free on the DOH’s website.

Also, remember that a license to practice medicine in Venezuela, Cuba, Mexico or anywhere else, is just that: a license to practice in that country. It does not allow a person to practice medicine in the United States. A specific license from the State of Florida is required to practice in Florida, except for certain military and federal physicians. Always check a physician’s license.

More Stories on Fake Physicians and Other Phony and Fraudulent Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health care professionals.

To see a blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Comments?

What do you think of all of these news stories of phony health care professionals? Please leave any thoughtful comments below.

Sources:

Taylor, Jared. “Phony Plastic Surgeon Accused of Using Silicone for Botox.” Reuters. (October 31, 2013). From: http://www.reuters.com/article/2013/10/31/us-usa-crime-texas-idUSBRE99U1CT20131031

Associated Press. “South Texas Woman Charged for Allegedly Injecting Client; Authorities Seek More Victims.” Fox News. (October 31, 2013). From: http://www.foxnews.com/us/2013/10/31/south-texas-woman-charged-for-allegedly-injecting-clients-authorities-seek-more/

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Settlement Reached in GlaxoSmithKline Healthcare Fraud Case

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

  • Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents; 
  • Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; 
  • Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
  • Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; 
  • Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea; 
  • Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
  • Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
  • Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK Will Also Plead Guilty to Criminal Charges as Part of Settlement.

As part of the settlement, GSK has will plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Florida to Receive Over $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state’s participation in the settlement on July 2, 2012.

Settlement Stems From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Historic Healthcare Fraud Settlement.” Florida Office of the Attorney General. (July 2, 2012). Press Release. From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. “GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement.” New York Times. (July 2, 2012). From: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

About the Author:  George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Investors can Continue to Bring Claims Against KV Pharmaceutical

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The ruling was reached on June 4, 2012.

To view the appeals court ruling in Public Pension Fund Group v. KV Pharmaceutical Company, click here.

Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit.

The appeals court has revived a securities fraud class action that was dismissed by a trial court in 2010. Investors pursued the fraud claims in a case filed in 2009 in U.S. District Court in St. Louis. In the lawsuit, investors allege that they suffered $1.5 billion in losses. The investors claim that the loss was suffered because KV allegedly misled the FDA in its compliance reports. KV then shut down its manufacturing operations in 2009.

Investors Allege KV Was Not Honest About FDA Compliance.

The lawsuit focused on FDA inspections of KV facilities over a six-year period. Results of those inspections were reported to the company’s management on a document called a Form 483. Investors alleged that information on the forms about KV’s compliance with FDA regulations contradicted statements KV made to investors. Allegedly, the forms stated that KV was not in compliance with FDA regulations.

However, KV said that the forms did not show the FDA’s final determination. The district court agreed with KV and dismissed the suit.

Appeals Court Decision May Have Ramifications for Other Drug Manufacturers.

The appeals court reversed the dismissal of the lawsuit. According to the appeals court, investors could have considered the Form 483 reports significant given the company’s assurance that it was in compliance.

The appeals court decision could have implications for other drug manufacturing companies. The decision represents the first time a federal appeals court has determined that FDA’s issuance of a Form 483 can be considered material under federal securities laws.

KV Has Recently Experienced Several Setbacks in Addition to the Investor Lawsuit.

The appeals court decision is the latest setback for KV. Starting in 2008, the generic drug manufacturer was subject to a series of recalls and investigations by the U.S. Department of Justice and the FDA. The investigations were related to KV’s manufacturing and distribution of oversized morphine pills.

In 2010, KV’s former subsidiary Ethex Corp. pleaded guilty to two felony counts of criminal fraud. Ethex Corp. agreed to pay $27.6 million in fines and restitution related to the charges. To view a press release from the U.S. Department of Justice regarding the charges against Ethex, click here.

In 2011, KV’s former chief executive pleaded guilty to misdemeanor violations of the Food, Drug and Cosmetic Act. He was sentenced to 30 days in jail and ordered to pay $1.9 million in fines and forfeitures.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Harris, Andrew. “KV Pharmaceutical Must Face Suit Over Quality Assurances.” Bloomberg News. (June 4, 2012) From: http://www.businessweek.com/news/2012-06-04/kv-pharmaceutical-must-face-suit-over-quality-assurances

Raymond, Nate. “U.S. Court Revives KV Pharmaceutical Investor Suit.” Reuters. (June 4, 2012). From: http://www.msnbc.msn.com/id/47681167/ns/health/t/us-court-revives-kv-pharmaceutical-investor-suit/

About the Author:  George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/