Medical Devices

News & Analysis as of

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Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through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

New Jersey Federal Court Allows “Self-Help” Counterclaims Against Potential FCA Whistleblowers To Proceed

Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more

Medical Device Manufacturer Settles Trade Agreements Act Suit

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some...more

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

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

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

Opinion Underlying JMOL May Still Provide Basis for a New Trial, Even if JMOL Is Defective

Medisim Ltd. v. BestMed LLC - Addressing preservation of the right to submit post-trial motions, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s rulings on judgment as a matter of law (JMOL)...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Failure of Appellant to Appeal Damages Award Precludes District Court to Reconsider Damages After Partial Reversal

Retractable Techs., Inc. v. Becton, Dickinson, and Co. - The U.S. Court of Appeals for the Federal Circuit affirmed a district court’s denial of a motion to modify a damages award following the partially successful...more

New FCC Rules for Medical Body Area Networks

On August 21, 2014, the Federal Communications Commission (“FCC”) released an Order with new and clarified rules to foster the development and deployment of Medical Body Area Networks (MBANs). The Order provides more...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k)...

The U.S. Food and Drug Administration (FDA) has issued a final guidance document titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) (“SE Guidance”). The SE...more

Bundled Discounts Subject to Section 1/Clayton 3 Scrutiny In the Absence of Market Power and Substantial Foreclosure?

Bundled discount programs have received significant antitrust scrutiny over the past decade, even though these marketing programs may benefit both consumers and competition. Typically, bundled discounts have been evaluated as...more

Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process

On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Covidien and C.R. Bard Could Be Moving Toward Mesh Settlement

Covidien is not one of the large names associated with pelvic mesh lawsuits. There are 65,000 product liability lawsuits consolidated in a federal court in West Virginia filed by women alleging life-altering complications...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

CMS Shuts Down Sunshine Act Online Verification Process

On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more

Life Sciences Spotlight - Issue 4, 2014

Since our last edition, there has been a number of developments in the Life Sciences sector across the Asia Pacific region and we are pleased to be able to update you on these recent trends. It is evident that the...more

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