Medical Devices

News & Analysis as of

Patent Appeals Board Denies Petition for Inter Partes Review of Medline Industries Patent

The Patent Trial and Appeal Board (“PTAB”) denied a petition by C.R. Bard, Inc. requesting inter partes review of claims 1 and 2 of U.S. Patent No. 8,488,786, entitled “Catheter Tray, Packaging System, Instruction Insert, and...more

What’s the Secret to Successful Medical Device IP?

Every medtech inventor is looking for the same things—to make a difference for patients, fill an unmet medical need…and maybe, just maybe, become a successful public company or an in-demand acquisition target....more

Product Liability Update - July 2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Allergan Announces Plans to Acquire Oculeve for $125 million + Milestones

Allergan recently announced that it has agreed to buy Oculeve in an all-cash transaction. The deal is expected to close in the third quarter of 2015. Press releases state that Allergan will pay Oculeve $125 million upfront,...more

House Passes Medical Innovation Bill That Would Revise HIPAA

On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

ABA Resolution 105 on Punitive Damages Is Dead for Now

On the eve of the ABA's Annual Meeting next week, the ABA's Standing Committee on Medical Professional Liability announced its withdrawal of proposed Resolution 105 from consideration by the ABA House of Delegates. The...more

Inside the Implied Conflict Preemption Box

Federal preemption in the drug and medical device world is a game of categories. Express preemption versus implied. Conflict preemption versus field preemption. Drugs versus devices, generic versus branded, premarket...more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Medtronic Announces Plans to Acquire RF Surgical Systems for $235 Million

Medtronic has agreed to acquire RF Surgical Systems Inc., for $235 million, according to a report by Nasdaq. According to the news article, Medtronic plans to incorporate RF Surgical’s surgical sponge tracking and detection...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

Recent Ninth Circuit En Banc Decision Makes It Easier for Relators to be an Original Source and the First- to-File

On July 7, 2015, the United States Court of Appeals for the Ninth Circuit issued an en banc decision that potentially makes it easier for relators to prevail on pending False Claim Act qui tam suits and bring new actions in...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...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

Congress Clears Bipartisan DME & Home Care Bills

On July 15, 2015, the House of Representatives approved by voice vote the following two bills...more

Washington Healthcare Update

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...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

China Tightens Advertising Rules for Life Sciences Companies

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

9th Circ. Relaxes Requirements for “Original Source” Whistleblowers

The False Claims Act makes it illegal to obtain government money through false claims. Under the Act a private party, known as a relator, may bring a civil suit on the government’s behalf against an entity that has allegedly...more

CMS Extends Medicare Prior Authorization for Power Mobility Devices Demonstration through August 2018

CMS has announced that it is extending its Medicare Prior Authorization for Power Mobility Devices (PMDs) demonstration for three years, through August 31, 2018. This demonstration was launched on September 1, 2012 in seven...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

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