Tag Archives: Food and Drug Administration (FDA)

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

–  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

–  “One who makes such a payment may be unable to explain and to justify it.”

–  “Such a firm or individual may well possess market power derived from the patent.”

–  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

–  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

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.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

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Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

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.

Comments?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

About the Authors: Carole C. Schriefer 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.

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.

Two National Recalls Prompt Food and Drug Administration (FDA) to Update Metal-on-Metal Hip Implant Safety Concerns

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. This comes after two recent hip replacement recalls that are sparking thousands of lawsuits. Click here to read the FDA communication.

In August 2010, Johnson and Johnson’s DePuy Orthopaedics implemented a DePuy ASR hip recall, withdrawing more than 93,000 hip implants from the market. (Click here to read the press release on the recall from DePuy.) In July 2012, Stryker Orthopaedics implemented a similar recall on the Rejuvenate and ABG II modular neck components. (Click here to read the Stryker recall press release.)

Updated Information on Metal-on-Metal Hip Implants From the FDA. 

According to the FDA, in metal-on-metal hip implants, metal can be released into the body when two connecting components slide against each other. This can happen during daily activities. Metal release will cause some tiny metal particles to wear off of the device and into the space around the implant. Wear and corrosion at the connections may also occur. Some of the metal ions from the implant can enter the bloodstream. If this happens, patients can suffer from muscle, nerve and bone damage.

Click here to read more on metal-on-metal hip implants from the FDA.

Second Trial Over DePuy Hip Implant in Progress.

The president of DePuy testified during the second DePuy ASR hip trial. According to an article in Bloomberg News, the DePuy president said that the metal-on-metal hip implants were recalled because of a high rate of corrective surgeries required in patients, not because the device’s design was defective. Click here to read the Bloomberg article.

You may remember on March 8, 2013, in the first ASR hip recall trial, a California jury awarded the plaintiff $8.3 million in compensation damages after finding the ARS’s design defective. This result will have significant impact in the 10,750 other lawsuits against DePuy. Click here to read a previous blog on the first trial over the DePuy hip implants.

Stryker Orthopaedics Facing Similar Lawsuits.

As of February 2013, more than 80 lawsuits against Stryker have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey. Stryker is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on any patient who had implants installed. Click here to read a previous blog on the Stryker lawsuits.

We’ve also learned some Stryker patients are being contacted by Broadspire. This company is trying to discuss settling with these patients. We want to encourage any metal-on-metal hip implant recipients to contact and experience attorney first, because there is still time to file a claim for injuries.

Contact an Attorney Experienced in Products Liability Litigation.

Although The Health Law Firm represents predominantly physicians and other health care providers, we are involved in products liability litigation. The Health Law Firm has recently undertaken plaintiffs’ products liability cases against the manufacturers of defective hip implants. We are now representing plaintiffs in a number of products liability cases involving both the DePuy hip and the Stryker hip implants. We are able to combine our knowledge of the health law industry with our litigation experience for the benefit of patients.

If you received a DePuy or Stryker hip replacement and have experienced pain, swelling, high levels of metal in your blood, a corrective revision surgery, or other complications, we may be able to help you.

To learn more about your legal rights, contact The Health Law Firm for a consultation by calling (407) 331-6620 or (850) 439-1001 or visit our website at www.TheHealthLawFirm.com.

Comments?

What are your thoughts on these recalls? Are you a Stryker or DePuy hip implant recipient? Please leave thoughtful comments below.

Sources:

Harris, Andrew and Voreacos, David. “J&J’s Ekdahl Says Hip Recalled for Clinical Reaons.” Bloomberg. (March 13, 2013). From: http://www.bloomberg.com/news/print/2013-03-13/depuy-chief-questioned-over-records-calling-asr-defective.html

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf

About the Authors: 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.

Carole C. Schriefer 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.

Hydrocodone Combination Drugs Could Be Reclassified to Schedule II Category of Controlled Substances

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA. If approved, hydrocodone combination drugs, such as Vicodin, will be harder for physicians to prescribe.

The advisory committee met because the Drug Enforcement Administration (DEA) is requesting the FDA to approve the reclassification of hydrocodone combination products. The DEA wants to help curb the growing number of people across the country addicted to painkillers.

Click here to read an FDA briefing document given to the advisory committee.

It is now up to the FDA to decide whether or not to implement the advisory committee’s decision as to whether hydrocodone combination drugs will stay labeled as schedule III controlled substances or move to schedule II controlled substances. If medications containing hydrocodone are moved to schedule II, they will be in the same category as the widely abused oxycodone.

Hydrocodone Abuse is Serious.

Currently, hydrocodone products are the most widely prescribed drugs in the U.S., according to an article on MedPage Today. Records show that painkiller abuse kills more people in America than heroin and cocaine combined. The DEA argues that since these drugs are so frequently abused, they should be more tightly controlled.

To read the MedPage Today article, click here.

What You Need to Know as a Health Care Provider.

This change would have wide-spread consequences for health care professionals, especially doctors and pharmacists. Under the schedule II category of controlled substances, physician assistants (PAs) and nurse practitioners would no longer be legally allowed to prescribe hydrocodone combination drugs.

If the recommendation is accepted, it would be more difficult for patients to obtain refills on hydrocodone combination drugs. Refills without a new prescription, faxed prescriptions and prescriptions called in by telephone would all be banned. Only written prescriptions from a doctor would be allowed.

If the recommendation is adopted, much stricter scrutiny on the purchasing, prescribing, retailing and use of these medications can also be expected. Prosecutions and administrative actions can also be expected to follow.

The FDA is also debating the DEA’s request to limit prescriptions of hydrocodone combination pills to a 90-day supply instead of the current regulations which permit five refills within six months.

Arguments Heard Against the Reclassification.

According to an article in The New York Times, many opponents spoke against the recommendation. Advocates for nursing home patients argued that weak and elderly residents with chronic pain would have to make a difficult trip to see a doctor just to get a prescription refilled. Click here to read The New York Times article.

Some committee members questioned if there was another option to consider versus changing the scheduling. They questioned whether greater use of e-prescribing and Prescription Drug Monitoring Programs, as well as better education efforts for clinicians and patients would be better solutions for the drug abuse epidemic.

Now it remains to be seen how the FDA will interpret the advisory committee’s recommendation.

Florida’s Prescription Drug Abuse Epidemic.

Florida law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse in Florida.

We have written a number of blogs on the abuse of narcotics in Florida. See our blog on a fake prescription ring busted in Osceola County, and a Central Florida nurse accused of illegally obtaining prescriptions for painkillers, for example. Check our website for similar blogs.

Pharmacists, pharmacies, legal distributors and physicians are often too caught up in the frenzy to stem prescription drug abuse and to eliminate “pill mills.”

Call Experienced Health Law Attorneys for Your Legal Needs.

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 Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), 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.
Sound Off.

As a health care professional, do you think hydrocodone products should be labeled as a schedule II controlled substance? What are the positive and negative effects of this decision? Please leave any thoughtful comment below.
Sources:

Fiore, Kristina. “FDA Panel Votes for Tighter Controls on Vicodin.” MedPage Today. (January 25, 2013). From: http://bit.ly/X8qlsu

Tavernise, Sabrina. “F.D.A. Likely to Add Limits on Painkillers.” The New York Times. (January 25, 2013). From: http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html?_r=0
About the Authors: 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.

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.