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The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall.
The article indicates...more
On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more
In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more
On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more
On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more
The past few years have seen 3-D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few...more
On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more
Debra Kilmer filed suit against Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics Corporation (“Defendants”), asserting that she had been injured by a defective knee implanted in her in Florida state...more
Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more
Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more
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
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
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