Medical Devices

News & Analysis as of

ev3, Inc. v. Lesh, C.A. No. 515, 2013 (Del. Sept. 30, 2014)

In this en banc Memorandum Opinion, the Supreme Court reversed the Superior Court’s denial of the defendant-below’s motion for a new trial following a jury verdict and remanded the case for a new trial. The Supreme Court...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

Appealing Medical Device Patent Cases

Medical device patent infringement cases, like all patent infringement cases, must be appealed to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. People often refer to this Court as the “Federal...more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Blog: FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber...more

FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management

On October 2, 2014, the Food and Drug Administration (“FDA”) released the final version of a guidance document entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As discussed in a...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

Trade & Manufacturing - October 2014

In This Issue: - Export-Import Bank Is Reauthorized Through June 2015 - Roadblocks to Bali Package Implementation Remain As Summer Deadline Passes Without A Clear Path Forward - Customs Litigation: Federal...more

At Last – Long-awaited Health Reform Reconciliation Bill Released

Today House Democratic Leadership released the legislative text of the Reconciliation Act of 2010, sponsored by House Budget Chairman John Spratt. The bill amends a number of provisions in the Senate-passed “Patient...more

FDA Issues Draft Guidance for Laboratory Developed Tests

For almost 40 years the FDA has regulated in vitro diagnostics (IVDs) as medical devices. An IVD is a reagent, instrument, or system that is intended for the diagnosis of a disease or other condition, including the...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Make That First Bite A Big One

In Medtronic, Inc. v. Marital Deduction Trust, IPR2014-00695, Paper 18 (September 25, 2014), the Board denied Medtronic’s motion to join the IPR with a prior IPR 2014-00100, also involving U.S. Patent No. 5,593,417. The...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...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

Fighting Fraudulent Joinder: Getting Your Case Into Federal Court

Tort actions involving pharmaceuticals and medical devices usually involve state law claims, and therefore, diversity jurisdiction is often the only way to proceed in a federal court. Plaintiffs, however, may join doctors,...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Wisconsin Court Dismisses Hip Implant Suit Against Zimmer

On August 8, 2014, a Wisconsin federal court dismissed a case based on a defective hip implant because it found that it did not have jurisdiction over a case which did not state a basis for federal jurisdiction....more

Does Pennsylvania Permit Manufacturing Defect Claims Involving Medical Devices?

I am writing to report about a recent dismissal of a manufacturing defect claim made against a medical device manufacturer in the USDC for the Eastern District of Pennsylvania. This decision is favorable to our clients that...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

Misappropriation of Trade Secrets Warrants an Ongoing “Reasonable Royalty”

Sabatino Bianco, M.D., v. Globus Medical, Inc. - Comparing and contrasting Texas trade secret law to jurisprudence relating to patent infringement damages, the U.S. District Court for the Eastern District of Texas held...more

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