Medical Devices

News & Analysis as of

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

In What Way is False Advertising False and Why it Makes a Difference

What is the difference between an advertisement that is literally false by necessary implication and one that is impliedly false? It may seem like a fine (and somewhat opaque) distinction, but determining the particular way...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

AGG Food and Drug Newsletter - September 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Stop them in their tracks: key points in seeking a preliminary injunction against medical device infringers

In 2006, the US Supreme Court reversed years of jurisprudence by eliminating the presumption of irreparable harm in patent litigations,1 which previously had resulted in virtually automatic grants of injunctions to prevailing...more

Is your cybersecurity upgrade FDA reportable?

In today’s marketplace, technology evolves at a rapid rate, and must adapt to changing circumstances, such as threats to cybersecurity. For device companies, some types of modifications to devices post-market - potentially...more

Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand...more

Health Alert (Australia) September 19, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: South Australia - 13 September 2016 - Dang Pharmacy P/L v Dang [2016] SADC 106 - This is a review of a decision by...more

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims...more

Stryker’s String of Acquisitions Continues with Ivy Sports Medicine

PRNewswire reports that Stryker‘s Endoscopy division has acquired Ivy Sports Medicine for an undisclosed amount. According to the press release, Ivy Sports Medicine’s portfolio includes: the only FDA-approved collagen...more

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on...more

11th Circuit Upholds Award of Summary Judgment in Mirena Lawsuit

In March 2014, Jenna Thurmond sued Bayer in the U.S. District Court for the Northern District of Georgia, alleging that her use of the Mirena contraception system caused her to develop pseudotumor cerebri. Her symptoms...more

Nestlé Continues Medical Industry Expansion

Nestlé Health Science S.A. recently announced that it will acquire Manchester, England-based Phagenesis Ltd. in a staged acquisition. Nestlé Health Science S.A., a subsidiary of Nestlé S.A., is the owner of more than a...more

Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies...

In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use?

Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba. After all, off-label use can be good medicine, even the best. Then...more

ZAG-S&W Provides U.S. Legal Advice to Medigus Ltd. in Offering of ADSs

A ZAG-S&W Team served as U.S. counsel to Medigus Ltd. (NASDAQ: MDGS) (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, in definitive...more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

The Fifth Circuit Rules Findings from SEC Civil Investigation are Admissible Evidence at Trial

The Fifth Circuit Court of Appeals appears to have handed white collar defendants a new tool for trial. In United States v. Gluk, — F.3d —-, 2016 WL 4150901 (5th Cir. Aug. 4, 2016), the court held that a little-noticed...more

FDA Announces Public Hearing on Manufacturer Communications Regarding Off-Label Uses

On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices, particularly...more

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

“World’s Smallest Pacemaker” Experiences Sizeable Success

Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples...more

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