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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
Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more
The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more
Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more
Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more
In This Issue:
- Forum Non Conveniens: How To Avoid The Tide of Lawsuits Brought by Foreign Nationals
- Pro Te Solutio: Product Defense And FDA Compliance
- Health Care Strike Force: Uncovering Fraud In The...more
Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more
Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more
Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions.
On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more
How Does the DOMA Defeat Impact Healthcare Reform and Health Insurance Access? -
NOTE: The Supreme Court's 5-4 decision to invalidate the Defense of Marriage Act (DOMA) will affect more than 1,000 federal statutes—and...more
Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more
On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more
Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more
As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more
Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more
As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more
The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more
On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more
With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more
In This Issue:
- Diversity In Clinical Trials: The Need For Diversity To Ensure Safety And Efficacy
- Federal Removal Statutes: A Review Of The Federal Courts Jurisdiction And Venue Clarification Act Of 2011
Originally published in Medical Devices Law & Industry Report on 10/03/2012.
FDA’s New Plan -
The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more
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