PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
Considerations for Biopharma Under a First-Inventor-to-File Regime
Hot Companies in Digital Health
Digital Health: Where is the Action for Entrepreneurs?
As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more
In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more
The Therapeutic Goods Act 1989 (Cth)(TG Act):
- Provides a national framework for the regulation of medicinal products.
- Provides a national system to control the quality, safety, efficacy and timely availability...more
In This Issue:
- The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities
- Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers
In this Presentation:
- Internet of Things - definition
- But what is it all about?
- But not just that...
- The IoT market in figures...
- Beecham Research - view of the World
- The Connected...more
On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more
Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more
CMS has released detailed Medicare inpatient hospital, outpatient hospital, and physician utilization and payment data for 2013, including data analysis such as spending breakdowns by specialty and region. The hospital data...more
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more
On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more
Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more
In Caplinger v. Medtronic, __ F.3d __ (10th Cir. 2015), the Tenth Circuit Court of Appeals affirmed dismissal of a patient’s state law tort claims against a medical device manufacturer as preempted by federal law. The Tenth...more
What follows is a guest post about a recent favorable development in Canadian drug/device litigation. We're not Canadian lawyers, so we gladly outsource Canadian developments to those who are, such as these guys - Mike A....more
On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more
Under a Connecticut law enacted in 2014, pharmaceutical and medical device manufacturers were required to begin reporting payments made to advanced practice registered nurses (APRNs) on July 1, 2015. ...more
The recent news that certain Lowe’s stores will offer customers the ability to custom-make 3D printed items has garnered a lot of attention. But perhaps even more exciting is that 3D printing (also known as additive...more
Sorin S.p.A. and Cyberonics, Inc. recently announced that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for their pending merger has ended. In February, the two companies...more
The price of liability can be extremely high. A medical malpractice lawyer in Lake County understands that when doctors, staff or manufacturers make medical mistakes, they are not likely to readily admit their errors. ...more
On April 13, 2015, in the case of Kathleen Hafer v. Medtronic, Inc., the United States District Court for the Western District of Tennessee issued a favorable opinion to a medical device manufacturer in the context of...more
Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs.
Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more
On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over...more
The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more
On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more
Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more
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