FDA Issues New Warning for Popular Type 2 Diabetes Drug

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

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.

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

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 © 1996-2015 The Health Law Firm. All rights reserved.

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The Fight for Medical Marijuana Lights Up in Florida and Across the U.S.

9 Indest-2008-6By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The fight to legalize medical marijuana seems to be spreading across the country. In Florida, a medical marijuana group said it cleared the first major hurdle to get a proposed constitutional amendment for medical marijuana on the 2014 ballot. In Illinois, the governor recently signed a law allowing marijuana to be used for medical purposes. Similarly, New Jersey’s governor also recently relaxed the state’s medical marijuana law for sick children.

Currently, twenty states plus the District of Columbia have effective laws that decriminalize medical marijuana.

Supreme Court to Review Florida’s Medical Marijuana Proposal.

According to the Miami Herald, People United for Medical Marijuana, a medical marijuana group, has collected at least 110,000 voter signatures in support of allowing the use of medical marijuana throughout the state. These signatures initiate the first step in getting the initiative on the 2014 November ballot, a Supreme Court review of the proposal language. The Supreme Court will review the proposal and will rule on its constitutionality.

To continue the group will need 583,149 more verified voter signatures by February 1, 2014, to get on the 2014 ballot, according to the Miami Herald. It will then need 60 percent (60%) approval from voters in order to be made a state constitutional amendment.

The People United for Medical Marijuana’s proposal only allows tightly controlled, medically prescribed marijuana. Florida attorney John Morgan of Morgan & Morgan recently jumped behind an effort to legalized medical marijuana in Florida. Morgan’s reputation throughout the community and his personal story on why he is lobbying for medical marijuana has people listening. To read a previous blog on Mr. Morgan’s support of medical marijuana, click here. If approved, Florida would be the 21st state to decriminalize marijuana.

Click here to read the Miami Herald article.

Illinois Allows Medical Marijuana.

On August 1, 2013, the governor of Illinois signed a law allowing marijuana to be used for medical purposes, according to Reuters. The law takes effect January 1, 2014, and allows patients diagnosed with one of 35 medical conditions to use marijuana. To receive the drug, a patient must have a recommendation from an Illinois licensed physician, must present a registered patient photo identification card, and the patient must be verified through an electronic system. According to Reuters, under the Illinois law patients will be limited to 2.5 ounces of marijuana every two weeks.

To learn more on the restrictions of this law, click here to read the Reuters article.

New Jersey Governor Allows Medical Marijuana for Sick Children.

Just weeks later, on August 17, 2013, New Jersey’s governor relaxed the state’s medical marijuana law, making it easier for chronically ill children to use the drug as part of their treatment. According to CBS News, the governor approved expanding the state’s medical marijuana program to allow the edible form of marijuana for children 18 years old and younger. To get medical marijuana, the young patients will be required to have approval from a pediatrician and a psychiatrist.

Click here to read the CBS News article.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its 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.

Comments?

Do you think marijuana should be legalized? Do you think Florida will legalize medical marijuana? Please leave any thoughtful comments below.

Sources:

Caputo, Marc. “Medical Marijuana Slows Petition Drive Until High Court Rules.” Miami Herald. (August 15, 2013). From: http://www.miamiherald.com/2013/08/15/3565544/medical-marijuana-slows-petition.html

Wisniewski, Mary. “Illinois Governor Signs Law Allowing Medical Marijuana.” Reuters. (August 1, 2013). From: http://www.reuters.com/article/2013/08/01/us-usa-marijuana-illinois-idUSBRE97018920130801

Brown, Terry, Burkholder, Amy, and Hirschkorn, Phil. “Christie Oks Medical Marijuana Bill for Ill Children.” CBS News. (August 17, 2013). From: http://www.cbsnews.com/8301-18563_162-57599009/christie-oks-medical-marijuana-bill-for-ill-children/

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.

“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.

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council for Pharmacists

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

We Will Work with Your Insurance Company.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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

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.

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.

United Parcel Service (UPS) Agrees to Pay Settlement for Online Pharmacy Shipping

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

United Parcel Service, Inc. (UPS) will pay $40 million to the Department of Justice (DOJ) to settle a probe related to its shipments on behalf of illicit online pharmacies. This announcement came on March 29, 2013.

Click here to read the press release from the DOJ.

UPS and FedEx Corp., have been the targets of a federal investigation to crackdown on illegal sales of prescription drugs.

UPS Had Previous Warning of Investigation.

From 2003 to 2010, the government warned UPS that internet pharmacies were using its services to distribute controlled substances and prescription drugs, according to the Orlando Sentinel. Federal law prohibits the purchase of controlled substances without a valid prescription from a physician. Even after being made aware, the government alleges UPS did not implement procedures to close these pharmacies’ accounts.

According to the Orlando Sentinel, because of the settlement agreement, the government agreed not to prosecute UPS. The company has also agreed to enhance its compliance policies with respect to shipments made from internet pharmacies. The company could have faced charges ranging from money laundering to distribution of controlled substances. Click here to read the entire article from the Orlando Sentinel.

FedEx Calls the Investigation a Threat to Privacy.

FedEx, has acknowledged it is under investigation, but called the probe a threat to customers’ privacy, and “absurd and deeply disturbing,” according to an article in the Wall Street Journal. FedEx has allegedly asked the Drug Enforcement Administration (DEA) to give the company a list of pharmacies it believes to be illegally operating so FedEx can shut down shipping services to those pharmacies. So far, FedEx is not facing any charges. To read the article from the Wall Street Journal, click here.

DEA Went After Doctors, Pharmacists and Pharmacies First.

Law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and the Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse, especially in Florida. These agencies have increased their efforts on doctors, pharmacies and pharmacists to crackdown on violators.

Click here to read a blog on an Orlando physician accused of prescribing painkillers to undercover agents. Click here to read a blog DEA’s investigation of six Walgreens pharmacies in Florida. Click here to read a blog on a Florida pharmacy owner who allegedly committed a $23 million health care fraud scheme. Check our website for similar blogs.

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 www.TheHealthLawFirm.com.

Comments?

What do you think of the government’s investigation into UPS and FedEx? Do you think it could possibly be an invasion of privacy? Please leave any thoughtful comments below.

Sources:

Barrett, Devlin. “UPS to Settle Web Pharmacy Case.” Wall Street Journal. (March 29, 2013). From: http://online.wsj.com/article/SB10001424127887323501004578390623687298836.html

Pavuk, Amy. “UPS Agrees to $40M Settlement in Online Pharmacy Shipping Probe.” Orlando Sentinel. (March 29, 2013). From: http://articles.orlandosentinel.com/2013-03-29/news/os-ups-dea-prescription-drugs-20130329_1_online-pharmacies-prescription-drugs-ups

Department of Justice. “UPS Agrees to Forfeit $40 Million in Payments from Illicit Online Pharmacies for Shipping Services.” Department of Justice. (March 29, 2013). From: http://www.justice.gov/usao/can/news/2013/2013_03_29_UPS.forfeit.press.html

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.

 

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.

California, Pennsylvania and Kentucky Move to Tighten Laws Related to Controlled Substance

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Details of the Prescription Drug Monitoring Program Possibly Coming to Your State.

According to the Los Angeles Times, California is looking to utilize its prescription drug monitoring program CURES to find physicians who are a little too loose with the prescription pad. Lawmakers are contemplating mining the data compiled by CURES to find physicians who are overprescribing and take action against them. Click here to read the entire Los Angeles Times article.

The Pennsylvania house recently forwarded a bill from committee to the floor for a final vote. The bill would establish a monitoring program like those in California, Florida and Kentucky. This monitoring program would be used to combat abuse and doctor shopping by identifying patients that have already received an adequate supply of medications.

Kentucky, already the home of some tough prescription drug laws, is looking to fine tune its regulatory scheme. According to The Courier-Journal, the new bill would clarify existing regulations by providing medical exemptions for patients that would otherwise be wrapped up in the enforcement provisions. To learn more on the proposed changes to Kentucky’s prescription drug laws, click here.

Most States Looking into Prescription Drug Monitoring Programs.

Lawmakers in all three states cited laws and regulations from other states as inspiration for the moves to consider new laws to monitor prescriptions of controlled substances. What this means is that whatever state you may be in, you should be aware that lawmakers are looking around the country at what works and are implementing similar programs and laws in their governments.

Databases Can Be Used as a Prosecution Tool.

Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

To read legal tips to manage pain patients, click 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, pain management doctors, 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 www.TheHealthLawFirm.com.

Opinions?

Does the state where you are located have a prescription drug monitoring program? Is it similar to any of programs we mentioned in this blog? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Girion, Lisa and Glover, Scott. “Atty. Gen. Kamala Harris Urges Funding for Prescription Tracking.” Los Angeles Times. (March 3, 2013). From: http://latimesblogs.latimes.com/lanow/2013/03/attorney-general-kamala-harris-funding-prescription-database-.html

Wynn, Mike. “Kentucky Legislature Overhauls Prescription Drug Law.” The Courier-Journal. (March 4, 2013). From: http://www.courier-journal.com/apps/pbcs.dll/article?AID=2013303040093&nclick_check=1

Associated Press. “Lawmakers Mull Prescription Drug Monitoring.” Associated Press. (March 4, 2013). From: http://meadvilletribune.com/local/x986702017/Lawmakers-mull-prescription-drug-monitoring

About the Author: Lance O. Leider is an attorney with 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 Avenue, Altamonte Springs, Florida 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.