Medical Devices

News & Analysis as of

Second Circuit Summarily Affirms Denial Of Petition To Vacate Arbitration Award Based On Partiality Claim

Late last month, the Second Circuit Court of Appeals summarily affirmed denial of a petition to vacate an arbitration award where a party was arguing that the arbitrator was biased. The case involved a dispute between an...more

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

Health Alert (Australia) - November 23, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments: Commonwealth. Federal Court - 17 November 2015 - Burnett v Eastern Health [2015] FCA 1247 The Federal Court of Australia...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

Reflexion Health’s Digital Medicine Therapy Tool Receives FDA Clearance

San Diego-based company Reflexion Health announced that its motion-tracking based physical therapy tool Vera received FDA 510(k) clearance on October 30, 2015 (510(k) number K150462)....more

Areas of Unique Legal Concerns and Solutions in Device M&A

With medical device related acquisitions at all-time highs, and regulatory interest from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of Inspector...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

China Regulatory Enforcement Quarterly - Q3 2015

On August 12, a series of explosions in the northern port-city of Tianjin killed over one hundred people and injured hundreds of others. The explosions were allegedly caused by hazardous chemical materials in shipping...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

ClearCorrect Ruling Keeps ITC From Policing 3D Printing and Other Digital Data Transmission

3D printing has been a common topic of discussion of the blog. We’ve written about it and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September...more

Medical Device Manufacturers as "Health Care Providers"

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more

Medical Devices a Target for Online Hackers

In the past few years, medical devices have become a major target for online criminals. Not only are medical devices considered to be one of the easiest and most vulnerable points of entry into a health care enterprise, they...more

Health Alert (Australia) - November 16, 2015

In This Issue: -Judgments; Legislation; and Reports. - Excerpt from Judgments: Commonwealth. Federal Court 11 November 2015 - Ramsay Health Care Australia Pty Ltd v Compton [2015] FCA 1207 The Federal...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case

We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post. It is a beautiful fall day where we have a relative lull in our slate of...more

Endologix, Inc. To Merge With TriVascular Technologies, Inc.

According to a recent press release, Endologix, Inc. and TriVascular Technologies, Inc. have entered into a definitive merger agreement. The merger, in which TriVascular will survive as a wholly-owned subsidiary of...more

OIG Releases FY 2016 Work Plan

On November 2, HHS OIG released its FY 2016 Work Plan. The Work Plan summarizes new and ongoing OIG reviews with respect to HHS programs and operations, providing an advance notice to the industry, policymakers, and the...more

Federal District Court Issues Split Decision On Admissibility Of Evidence Bearing On Punitive Damages

As we have observed in a prior post, defendants in punitive damages cases often fail to develop evidence in mitigation of the amount of punitive damages, enabling the plaintiff to focus the jury on evidence about the...more

Allergan Acquires AqueSys for $300 Million

Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will...more

Essure Medical Device Faces Attacks on Multiple Fronts

The threat of a hunger strike against the Food and Drug Administration, a Facebook page titled “Essure Problems Lawsuit” and a congressional bill calling for a recall of the female contraceptive manufactured by Bayer have...more

Top takeaways from 33rd Annual IAHA Annual Meeting

On Oct. 27, 2015, the Annual Meeting of the Illinois Association of Healthcare Attorneys was held at Navy Pier in Chicago. Hundreds of health care attorneys attended, including several from Thompson Coburn. The symposium was...more

Punitive Damages – How Much Increased Risk Is Enough?

Back in 2009 – when the blog was still a Bexis/Herrmann operation – we wrote a catch-all punitive damages post entitled (oddly enough) “On Punitive Damages.” That post identified and briefly discussed a variety of punitive...more

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