Medical Devices

News & Analysis as of

$1 billion verdict in lawsuit against maker of metal-on-metal hip replacements

The pain and suffering that a flawed medical device can cause can last a long time. A Dallas jury provided a timely reminder of that, deciding six California plaintiffs should be paid more than $1 billion for the harm they...more

Blog: 21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act,...more

Live! From the ACI Drug and Medical Device Litigation Conference

I’m blogging from the American Conference Institute’s Drug and Medical Device session on International Mass Tort Litigation: Strategies for Handling the Increasing Interplay Between Domestic and Global Products Liability...more

Repealing and Replacing the ACA: Five Developments Likely to Occur in the Years Ahead

On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more

Stopping The Sale of Gray-Market Medical Devices

On November 3, 2016, the US Court of Appeals for the Second Circuit approved an injunction against about 200 importers and sellers preventing them from importing and selling gray market blood-glucose test strips. The case was...more

Capitol Hill Healthcare Update

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Just Wait Until the USPTO Lays Its Hands on These Single and Dual Color TM Applications

Back in 2009, we wrote about what was then Kimberly Clark’s pair of single color purple trademark registrations in connection with “gloves for medical and surgical uses” and “disposable nitrile gloves for general use,” now...more

Plaintiffs Withdraw Motion to Centralize Essure Birth Control Litigation

Essure birth control is a medical device designed to provide permanent sterilization. Since 2002, about 750,000 women worldwide have undergone Essure sterilization procedures. Although the device has been marketed as a...more

Health Alert (Australia) November 21 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 16 November 2016 - Page v Healthscope Operations Pty Ltd [2016] NSWSC 1608 - PRACTICE AND PROCEDURE...more

HALLOWEEN TREAT: Judge’s October 31 Order Adds $21 Million to Jury’s $70 Million Award for Trade Secret Theft

On October 31st of this year, a district judge in Massachusetts granted a motion for enhanced damages in a theft of trade secrets case, adding an additional $21 million to a $70 million jury award. The theft of trade...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened...

What follows is a guest post by Cara DeCataldo, a Reed Smith associate, who gamely stepped up to the plate to research one of a number of blogging topics that have been hanging fire for some time now. This topic is a type of...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Cybersecurity Threats May Impact Your Digital Health

As the healthcare industry continues to embrace the Internet of Things, cybersecurity may present unprecedented health and privacy risks to patients. Wireless-enabled medical devices are increasingly common. For some...more

Isto Holdings Acquires Arteriocyte To Form Isto Biologics

Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto...more

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

Insurance Recovery Law - November 2016

Asbestos Injury Continuous, Delaware Supreme Court Rules - Why it matters - In the latest ruling in the long running asbestos litigation involving pump manufacturers in Delaware, the state's highest court declared,...more

2016 Security of Things® Forum

The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

MDR Reporting Final Guidance

FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on...more

FDA to Study Social Media Promotion

On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have...more

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

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