Life Science Compliance Update

Search Results for: It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement

April

2018

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It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement

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Robert N. Wilkey, Esq.

In a closely watched matter culminating years of litigation, Medtronic in December 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry.


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September

2017

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Taking Center Stage – Washington State’s Medicaid Fraud Control Unit, the False Claims Act and Celegene

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

On July 26, 2017, the Washington State Attorney General Bob Ferguson announced one of the State’s largest recoveries against the pharmaceutical company Celgene for allegations involving violations of the Medicaid False Claims Act, in particular claims related to the company’s off-label marketing, fraudulent billing and providing kickbacks to doctors. The Washington State AG recovery represents a pivotal point in life science compliance, where State AGs, are actively seeking recoveries against companies that violate state and federal Medicare programs.


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October

2016

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GSK & China – The Latest FCPA Settlement Isn’t the End

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

GlaxoSmithKline(“GSK”) reached a settlement with the Chinese government in 2014 related to bribes and improper actions taken by company officials. Recently, GSK reached an agreement with the United States Securities and Exchange Commission for allegations that GSK violated the FCPA. While the SEC settlement is nowhere near the value of the 2014 Chinese settlement, they are both worth taking a look at.


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July

2016

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Pfizer: Another Settlement Down

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Kaitlin Fallon Wildoner, Esq., Staff Writer, Life Science Compliance Update

The agreement in principle reached between Pfizer, Inc. and the Department of Justice has been finalized. The deal includes $784.6 million in fines, but no provisions for Corporate Integrity Agreement updates. This article goes through the case, the settlement, and what it means for the future.


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September

2017

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Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain

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Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC; John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC; Teresita Weiss, Ph.D., J.D., Sr. Vice President, Regulatory Affairs and Compliance, for J. Knipper and Company, Inc.; Bryan Andrews, Director of Sales Operations, MedPro Systems LLC.

The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to the industry to form a new coalition to address state legislative and regulatory actions that have the potential to disrupt the entire supply chain.


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March

2018

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Uncle Sam Wants His Money – First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate in FCA Liability

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In October 2017, First Coast Cardiovascular Institute, entered into an almost $450,000 settlement with the DOJ to resolve allegations that it violated the False Claims Act by knowingly delaying repayment of more than $175,000 in overpayments. This settlement involving First Coast is a substantive example of how failing to make timely repayment can bring substantial, additional liability under the FCA. Therefore, it is crucial to ensure timely repayment to and reconcile any overbalances with the U.S. Government.


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January

2016

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Specialty Pharma in the Spotlight – Novartis Settlement Finalized

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By: Kaitlin Fallon, Esq., Staff Writer for Life Science Compliance Update

Novartis Pharmaceuticals Corporation recently signed an addendum to their September 29, 2010, Corporate Integrity Agreement. This article provides an in-depth side-by-side comparison of the nuances and new portions of the Corporate Integrity Agreement, especially as it relates to Novartis’ Specialty Pharmacy relationships.


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October

2017

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Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency

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Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.


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March

2017

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Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

We have seen many large False Claims and Anti-kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.


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July

2016

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The Olympus Settlement – What It Can Tell Us About the Compliance Officer

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Calisha Myers, Esq., Staff Writer – Life Science Compliance Update

When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement, however, provides us a rare glimpse into the nature of the Compliance Officer himself and how that can affect matters.


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December

2017

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Mylan’s “Banquet of Consequences” Ends for Now with the Latest EpiPen Settlement

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Mylan has been the subject of bad press for roughly a year now. Fortunately, it seems as though the firestorm surrounding the company – including the EpiPen price saga – may be over for now. This article outlines a recent suit filed by a Mylan competitor and the settlement and CIA that resulted. It concludes with insight from a prominent CEO about how compliance officers and other executives can avoid the negative press Mylan has endured.


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February

2015

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February

2015

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April

2016

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The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration (FDA) of medical devices for “single limited use” shields and otherwise immunizes manufacturers from product liability suits results from non-FDA approved uses.


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July

2016

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Valeant Finally Able to Close One Troubled Door with Salix Settlement

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Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update

Salix, a subsidiary of Valeant Pharmaceuticals International, Inc., recently settled claims involving Anti-Kickback and False Claims Act violations. Interestingly, while many of these agreements we have seen lately do not include any admission of guilt, Salix accepted responsibility for many the alleged activities.


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