Physicians Medical Devices

News & Analysis as of

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

How Does a Bad Idea Get Implanted?

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway. The plaintiff bar is nothing if not persistent. ...more

Using Severance Under Rule 21 To Preserve Removal Jurisdiction

A recent pelvic mesh case in the District of Maryland, Sullivan v. Calvert Memorial Hospital, No. PJM 14-118, Memorandum Opinion (D. Md. July 30, 2015), offers an interesting and useful take on federal jurisdiction when...more

Medical Device Decision Plays PA’s Greatest Hits

When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

No Duty for Device Manufacturer to Provide Separate Warnings to Hospital, According to Washington Court of Appeals

We admit it. We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.” We tend...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

2014 CMS Open Payments Data Released

On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

CMS Releases Latest Medicare Hospital and Physician Utilization, Payment Data

CMS has released detailed Medicare inpatient hospital, outpatient hospital, and physician utilization and payment data for 2013, including data analysis such as spending breakdowns by specialty and region. The hospital data...more

Fraud So Complicated It Takes a Neurosurgeon

Generally, when a doctor is convicted for fraud, the misdeeds are limited to a single category of fraud. Maybe the doctor charged for procedures that weren’t performed; maybe there were kickbacks for referrals; or maybe...more

Health Alert (Australia) - April 28, 2015

In This Issue: Judgments; Reports; and Legislation. Excerpt from Judgments: Australia. Federal Court - 15 April 2015 - Australian Competition and Consumer Commission v ACN 117 372 915 Pty Limited (in...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more

The SGR Fix: Congress Charts a New Course for Physician Payments and Gainsharing

On April 16, President Obama signed into law the “Medicare Access and CHIP Reauthorization Act of 2015,” (“MACRA”) which repealed the Sustainable Growth Rate (“SGR”) payment formula used to limit annual updates to Medicare...more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

The Learned Intermediary Defense Advances in Nevada

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices. A learned intermediary is a medical expert, such as a...more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste. On Halloween of 2014,...more

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

New Jersey Federal Court Allows “Self-Help” Counterclaims Against Potential FCA Whistleblowers To Proceed

Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

What’s an MDDS? And Why Should I Care?

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

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