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Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Health Update - October 2016

Defining and Resolving the Provider Data Dilemma - Editor’s Note: Provider data drives the most fundamental processes in the healthcare system. Inaccurate provider data puts patient care and billions of dollars at risk....more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

GSK Settles SEC FCPA Case for $20 Million

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

Cybersecurity Awareness Month: Visits From the Ghosts of Claims Past and Claims Future

Cybersecurity awareness month is nigh upon us again, and thus perspective is in order. 2016 brought us the first collection and analysis of the nascent claims history of the burgeoning cyber-insurance market. On August 27,...more

The Oscar Meyer Wiener Theme and Revisiting GSK in China

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

EU Court Confirms European Commission’s Decision on Pay-for-Delay Agreements

On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...more

Deal Watch: Teva and Regeneron Announce Fasinumab Collaboration

On September 20, Teva Pharmaceutical Industries Ltd. and Regeneron Pharmaceuticals, Inc. announced an agreement to develop and commercialize fasinumab, an investigational NGF antibody currently under development by Regeneron...more

3 Essential Steps For Responding To Ransomware Attacks

Likely because most victims comply with their demands, the incidence of attacks by ransomware hackers has exploded in 2016. Guidance issued by the U.S. Department of Health and Human Services (“HHS”) in July notes that, on...more

FDA Announces Public Hearing on Manufacturer Communications Regarding Off-Label Uses

On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices, particularly...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Compounding Pharmacy’s Group Boycott Claim Survives Motion to Dismiss

On August 23, 2016, the District Court for the Eastern District of Missouri allowed claims by a compounding pharmacy to proceed, denying a motion to dismiss filed by the defendant pharmacy benefit manager (“PBM”). In...more

Top Trends in H1 2016 Digital Health Investments

A few months ago, following our fifth annual Digital Health Summit, the attendees made some predictions about product development and investment in the rapidly growing sector. Now that we are more than halfway through the...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Locky Ransomware Continues to Hit Health Care Entities

FireEye Labs has reported that the Locky ransomware continues to hit the health care industry hard, and has increased in the month of August. Although the telecommunications, manufacturing and aerospace/defense...more

Drug Companies and Charitable Patient Foundations

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

Texas Diagnostic Imaging Service Settles FCA Allegations for $3.5 Million; Whistle-Blower to Receive $596,700

A recent settlement illustrates the substantial recovery available to whistle-blowers under the FCA’s qui tam provisions. Those provisions allow a qui tam plaintiff to receive typically between 15 percent and 25 percent of...more

HIPAA News: HHS Getting Tough On ePHI Data Breaches

On August 4, 2016, the U.S. Department of Health and Human Services, Office of Civil Rights (OCR) announced a record-setting settlement with Advocate Health Care Network (Advocate) for multiple potential violations of HIPAA...more

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

OCR Announces First HIPAA Enforcement Action against a Business Associate

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health...more

Is There Coverage for The Pill Mill Lawsuits?

In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

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