Physicians Pharmaceutical Industry

News & Analysis as of

Healthcare Transactions: Year in Review - January 2017

Healthcare transactional activity continued unabated throughout 2016, continuing a years long trend of sustained growth. This activity is due to a number of factors: innovative technology, pharmaceuticals, and services that...more

Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

This is a guest post from Michael Salimbene, an associate at Reed Smith. It’s about learned intermediary causation, and the need for prescriber testimony. Not infrequently, in mass torts with lots of solicited plaintiffs,...more

DEA Tweaks, Walks Back Changes to Renewal Process

DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be...more

Attorney-Client Privilege Held Not to Apply to Nonreporting Employee/Expert

Many years ago, we represented a client in a quandary. (We know, we know: that’s pretty much always the case.) The product had been sold for many decades, the early history was important in marshalling a defense, and there...more

Survey Finds Need for Biosimilars Education

On November 2, the Biosimilars Forum released the results of a survey in an article titled “Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians,” published in Advances in Therapy. According to the...more

Warning Causation Potpourri in New Jersey Mass Tort

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving. The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super....more

California's New End of Life Option Act Impacts Insurers

California's "End of Life Option Act" (the Act) went into effect June 9, 2016—making California the fifth state (behind Oregon, Washington, Vermont and Montana) to allow terminally ill adults with fewer than six months to...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants...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

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

Pennsylvania Enacts Biosimilar Substitution Law

On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable...more

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more

Pharmacy Settles Claim for Filling Forged Rx’s, as Trend Continues

There was a time when liability—criminal or civil—for drug abuse or forged prescriptions usually lay only with the abuser or the forger and those who actively helped them. Those days are long gone. First, we had PDMPs...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more

Docs in Jersey, Dixie rake in pay from Big Pharma, medical device makers

Big Pharma is not just whistling Dixie, as Southern, for-profit hospitals lead the nation in rolling out the welcome mat so doctors can take meals, consulting, and promotional payments from drug and medical device companies,...more

Prescribing Pain

Each year more than 1.25 million Americans suffer from medication errors made by physicians, hospitals, and pharmacies. With the rise in the number of Americans taking prescriptions, the number of errors will only continue to...more

Twenty Bucks Says Your Doctor’s Prescription Pad Is for Sale

A primary care physician in the United States receives an average, total, annual compensation of roughly $195,000, and likely will take in more than $6.5 million over a lifetime of practice. Ask most Americans and that’s a...more

Pharmaceutical Industry-Sponsored Meals and Prescribing Rates: New Research Shows Link

A new report published in the Journal of the American Medical Association (JAMA) has noted a link between pharmaceutical industry payments to physicians and prescribing rates for brand-name medication. Specifically, the study...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

Big Pharma flooded West Virginia with millions of addictive pain-killing pills

Big Pharma should hang its head in shame over recent revelations of its nasty role in inundating rural West Virginia with tens of millions of prescription painkillers. So many pills were shipped in that every man, woman, and...more

Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier

As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of...more

Massachusetts Legislature Reaches Compromise on Opioid Legislation

On March 10, the Senate voted unanimously to pass a bill that offers long-awaited measures aimed at tackling the state’s growing opioid abuse crisis. After House approval the previous day and seven weeks of conference...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

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