Food and Drug Administration | The Health Law Firm Blog

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.

By The Health Law Firm|2024-03-14T10:00:32-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: criminal fraud, drugs, enforcement, FDA, FDA compliance, federal securities law, Food and Drug Administration, inspections, investigation, investors, KV Pharmaceuticals, lawsuit, pharmacy, securities fraud class action, shareholders|2 Comments

FDA Issues New Warning for Popular Type 2 Diabetes Drug

By 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.

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Categories: Pharmacy Law Blog|Tags: defense attoryney, defense counsil, defense lawyer, drug side effects, FDA, Food and Drug Administration, health care attorney, health care lawyer, health law, Inkovana, ketoacidosis, plaintiff products liability attorney, products liability attorney, products liability lawyer, recall, safety announcement, safety warning, SGLT2 inhibitors, the health law firm, Type 2 Diabetes Drug|Comments Off

FDA Approves New Cholesterol-Reducing Drug

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

The first of a new class of cholesterol-lowering drug was approved by U.S. regulators on Friday. The new medicine is a highly anticipated medical advance that, unfortunately, will have the effect of escalating already growing drug costs. This will also offer new options for the millions of Americans who suffer from cardiovascular disease, the nation’s leading killer.

The new drug, Praluent, was developed by Regeneron Pharmaceuticals Inc and Sanofi SA.

It’s Available, but It’ll Cost You.

Praluent provides a desperately-needed option for the millions of high-risk heart patients who can’t get their cholesterol down with medicines known as statins. The problem however, is that drug companies are pricing this new drug much higher than other Cholesterol medications. In contrast, statins, which are the mainstay drug option for cholesterol reduction, can be purchased for just a few dollars a month.

Regeneron and Sanofi Defend the Product.

Regeneron and Sanofi defended the price of Praluent, saying the price is justified by the potential benefits to patients and savings to the health care system.

Praluent is an antibody that patients inject themselves with. It would prevent heart attacks and strokes, but the ability to do so has not been proved. However, in clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 percent or more. This was even among patients already taking statins, pills like Lipitor for controlling blood lipids.

To read the press release issued by the U.S. Food and Drug Administration (FDA), click here.

Comments?

Are you a health care professional who agrees with the distribution of this costly drug? Would you write prescriptions for it? Please leave any thoughtful comments below.

Sources:

Pollack, Andrew. “New Drug Sharply Lowers Cholesterol, but It’s Costly.” (July 24, 2015). The New York Times. From: http://nyti.ms/1LCiSPn

Winslow, Ron. “FDA Approves Cholesterol Drug from Regenron, Sanofi.” (July 24, 2015). The Wall Street Journal. From: http://on.wsj.com/1CVaO9n

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 attorney, defense lawyer, defense counsel, Praluent, cholesterol medication, cholesterol-reducing drug, pharmacy, pharmacists, physician, doctor, health care professional, health care provider, health care practitioner, prescriber, new medicine, Regeneron, Sanofi, medicine advances, cardiovascular disease, products liability attorney, products liability lawyer, health care attorney, health care lawyer, health law, health law firm, 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.

By The Health Law Firm|2024-03-14T10:01:19-04:00May 15, 2018|Categories: Pharmacy Law Blog|Tags: Food and Drug Administration|Comments Off

Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. v. Mensing case. The Court, however, left the door open when it added “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

In November 2013, the US Food and Drug Administration (FDA) began the process to do just that when it published a proposed rule that will require generic drug companies to update the labeling of their drugs in light of new safety risks even though the RLD labeling for those products has different information on warnings, precautions, contraindications, adverse reactions and the like.

Under the proposed regulation, when the ANDA holder has “newly acquired information” that presents “sufficient evidence of a causal association” between the unlabeled warning and the approved generic drug, the generic manufacturer must submit a Changes Being Effected (CBE-0) supplement to its ANDA and immediately change its label. Also, the ANDA holder will be required to send the NDA holder both the labeling change and a copy of the information supporting the change. Any changes ultimately approved by FDA would affect both the generic label and the RLD holder’s labeling.

The FDA has noted that “if this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.”

Interested parties wishing to provide input on the proposed rule must submit comments by January 13, 2014. The full text of the proposed rule is available at this link.

The Pliva v. Mensing, 131 S.Ct. 2567 (2011) decision is available at this link: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf.

About the Author: Alina Denis Jarjour is a business attorney, corporate governance / compliance professional and mediator. In addition to being a private practitioner, Alina has served in executive level legal, operational and governance/compliance roles within life sciences, telecommunications and technology companies. Her firm, Jarjour | Legal, works closely with clients engaged in the life sciences, tech / telecom, media, healthcare, consumer products and non-profit activities in and outside of the United States. Alina is an alumna of the University of Pennsylvania Law School, is bilingual (English/Spanish) and speaks frequently on business development, regulatory, compliance, conflict resolution and legal topics.

This article was originally published in the Florida Bar December 2013 Health Law Monthly Updates.

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Categories: Pharmacy Law|Tags: abbreviated new drug application, ANDA, brand name drug company, brand name prescription drugs, drug label, failure to warn, FDA, Food and Drug Administration, Generic Drug Cases, Generic Drug Labeling, generic drugs company, generic manufacturer, generic pharmaceutical manufacturer, generic prescription drugs, NDA, new drug application, prescription drugs, product liability, product liability action, reference listed drug, RLD|Comments Off

DEA Offers New Prescription Drug Return Policy

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

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address the rising number of injuries and deaths associated with controlled substance drugs, particularly opioids. Reducing the stockpile of unneeded prescription drugs from American homes will limit teenagers’ accessibility to their parents’ medications and reduce burglaries for such substances. According to The New York Times, this demographic is known to be the most prevalent abuser of such controlled substances.

To read the full story from The New York Times, click here.

Prior Methods of Prescription Drug Disposal.

Under the Controlled Substances Act, patients were only allowed to dispose of unused drugs themselves or surrender them to law enforcement. Personal disposal of controlled substances typically means flushing pills down a toilet or throwing them in the trash. Because this can pose a risk toward animals and clean drinking water, these methods are frowned upon by environmentalists and the Environmental Protection Agency (EPA).

Drug “take back” programs are another option when it comes to disposing of unused prescription drugs. These events are organized by the DEA and are held twice a year at local police departments across the country. During these programs, citizens can anonymously drop off any unused prescription drugs. According to The Wall Street Journal, the Department of Justice (DOJ) reported that a nationwide event in April 2014 brought in 390 tons of prescription drugs at more than 6,000 sites. In the past four years, these collection events have removed from circulation more than 4.1 million pounds of prescription medication from across the country.

Although these events prove successful, many healthcare professionals are optimistic for the bigger impact the pharmacy “take back” programs may have. Providing consumers convenient year-round access to medication disposals will be positive reinforcement to regularly dispose of unused prescription medications. This method is believed to be more likely to accomplish the mission of shrinking the pool of unused and potentially fatal controlled substances in American homes.

To read the full article from The Wall Street Journal, click here.

Ironing Out Details of the New Plan.

There are many logistics to consider to ensure these pharmaceutical “take back” programs will be successful. The programs will not be mandatory, as the decision to take part will be the under the sole discretion of each company. The pharmacies must voluntarily choose to register with the DEA in order to start receiving the leftover prescriptions. In the past, pharmacies have not generally wanted to accept the hassle of offering such a program. However, the DEA expects many pharmacies to jump on the bandwagon to showcase good-faith effort of keeping drugs out of the wrong hands.

DEA-approved organizations collecting the unused drugs will include hospital pharmacies, narcotic treatment programs, and companies contracted by other collectors to destroy controlled substances.

There are concerns circling the initiative. Some pharmacies do not have the resources required to accommodate incinerators, thus limiting the locations available to consumers. In addition, professionals are concerned with the lack of regulations listed in the new plan. There are no set requirements on how the prescriptions should be destroyed. The rules simply mandate that the drugs are altered into a permanent, irreversible state.

The burden of payment has also not been discussed or outlined in the new plan. Who will cover the cost of packaging and disposal has yet to be decided. Also, to be considered is the challenge of keeping the returned prescriptions safe until destruction. An unsecured, unmonitored return site containing stock piles of addictive drugs would be a gold mine for many addicts and criminals. Should a theft occur at one of these drop-off receptacles, who would be held liable? The American Pharmacists Association has already expressed concern of pharmacy legal liability.

The biggest obstacle of all, however, may be convincing the general public that returning unused pills is a necessary moral obligation.

Comments?

Would you participate in this type of prescription drug return program? As a pharmacist or someone who works at a pharmacy, what are your concerns with this take back program? Please leave any thoughtful comments below.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals. We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws. The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings.

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

Sources:

Barrett, Devlin. “U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs.” The Wall Street Journal. (September 08, 2014). From: http://online.wsj.com/articles/u-s-to-allow-pharmacies-to-take-back-unused-prescription-drugs-1410186602

Saint Louis, Catherine. “D.E.A. to Allow Return of Unused Pills to Pharmacies.” The New York Times. (September 08, 2014). From: http://www.nytimes.com/2014/09/09/health/unused-pills-return-to-pharmacies.html?_r=0

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.

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Categories: Pain Management, Pharmacist, Pharmacy, Pharmacy Law|Tags: controlled substance, controlled substance abuse, Controlled Substance Act, defense attorney, defense lawyer, drug abuse, Drug Enforcement Administration (DEA), FDA, Food and Drug Administration, health law, hospital pharmacy, medication, medication returns, opiods, pharmaceutical drugs, pharmacist attorney, pharmacist lawyer, pharmacy, prescription, prescription drug abuse, prescription drug returns, prescription drugs, prescription returns, retail pharmacy, unused medication, unused pills|Comments Off