Upcoming Free Ethics CLE Webinar: “Privilege Protection: Tips for Working with Media Consultants Without Jeopardizing the Attorney-Client Privilege”

Involving any outside consultant in the attorney-client relationship gives rise to risks to the attorney-client privilege. Yet when a PR crisis erupts, good communications advice is essential, and a company’s media strategy can determine whether it is the subject of thoughtful, balanced articles or a maelstrom of misleading headlines – and whether unfair publicity infects any litigation that may occur.

That’s why my colleague Erica Yen and I are pleased to present this free Ethics CLE webinar, designed for in-house counsel at pharmaceutical and medical device companies, on “Privilege Protection: Tips for Working with Media Consultants Without Jeopardizing the Attorney-Client Privilege.”

Through discussion of case law and ethics rules, this webinar will analyze tips for working with media consultants that potentially can mitigate the risk that a company will have been deemed to have waived the attorney-client privilege.

This program is presumptively approved for 1.0 Ethics CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 Ethics credit under New York’s Approved Jurisdiction Policy.

To register for this free Ethics CLE webinar, please click here.

Analysis of Medicare, Medicaid, and Other Health Policy Provisions in Bipartisan Budget Act

The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers. Of particular note, the new law:  increases Medicaid rebate obligations with respect to line extension drugs; changes manufacturer discount obligations in the Medicare Part D “donut hole”; repeals the Independent Payment Advisory Board (IPAB); makes Stark Act revisions; and significantly increases penalties for violations of various anti-fraud statutes.  A Reed Smith Client Alert focusing on the major Medicare, Medicaid, and public health provisions of the Act is available here.

Upcoming Free CLE Webinar: “Multidistrict Litigation: What to Expect from JPML Consolidation Through Trial”

With more than half of all cases pending in the federal courts now docketed in multidistrict litigations (MDLs), pharmaceutical and medical device companies facing large-scale litigation should expect to find themselves before the Judicial Panel on Multidistrict Litigation (JPML) with an MDL on the horizon.

That’s why Melissa Geist and Jennifer Eppensteiner are pleased to present a free CLE webinar on “Multidistrict Litigation: What to Expect from JPML Consolidation Through Trial.” This webinar will provide in-house counsel at life sciences companies with an introduction to JPML and MDL procedures, including the latest trends and strategic tips for maximizing efficiencies where possible. You will also learn about the effect MDL litigation can have on pending state court actions, as well as about best practices for coordination among federal and state court actions.

This program is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy.

To register for this free webinar, please click here.

Join us for A Webinar on “Global Data Protection Regulation (GDPR) – Three Months to Go”

In three months, the new European data privacy regulation – with a world-wide reach and draconian sanctions for non-compliance – takes effect. Are you ready? Join Reed Smith on Thursday, February 22, 2018 for an informative CLE webinar discussing key priorities and strategies for compliance during the final three months remaining before the GDPR takes effect on May 25, 2018.

For more information, registration and topics of discussion please click here.  

No (Expensive) Lunch For You! New NJ Regulation Caps Payments To Doctors

Last month, New Jersey joined several other states in adopting a new regulation limiting payments and gifts that can be made by pharmaceutical manufacturers to health care providers. The regulation caps include a maximum of $10,000 per calendar year for a prescriber’s bona fide services, and $15 per meal.

Additional information about this new regulation is available in our client alert, or by contacting one of the authors.

DOJ Granston Memorandum May Promote Dismissal of Unmeritorious FCA Qui Tam Lawsuits

Michael Granston, the Director of the Commercial Litigation Branch within the United States Department of Justice’s Fraud Section, recently issued an internal memorandum affirming his prior statements that the Department of Justice (DOJ) should consider seeking dismissal of meritless False Claims Act (FCA) suits brought by relators in qui tam cases. Under 31 U.S.C. § 3730(c)(2)(A), the government can dismiss a qui tam action “notwithstanding the objections of the person initiating the action” by filing a motion with the court and provided the relator has had an opportunity to be heard. Historically, this authority has been used sparingly.

Last year, in a surprise announcement at a health care compliance conference, Granston indicated that the DOJ may seek to dismiss qui tam actions brought by FCA relators when it determines the actions lack merit. Following industry speculation that his statements reflected a policy shift by the DOJ, the DOJ disagreed and suggested Granston’s comments were simply a recitation of the status quo and description of the DOJ’s existing power to seek dismissal of unmeritorious FCA suits. The new DOJ memorandum, however, builds on Granston’s conference statements and could signal a more aggressive stance toward dismissal of unmeritorious whistleblower actions. At a minimum, it provides increased ammunition to defense counsel to request the DOJ seek dismissal of such actions. Continue Reading

Florida Court is Latest to Vacate FCA Judgment

As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the defendants’ motion for judgment as a matter of law.

This is part of a growing list of decisions that have resulted in dismissal of FCA claims or defense judgments based on a variety of factors, signaling a possible trend in the industry to clamp down on overreaching FCA cases.

This most recent decision comes only months after a Fifth Circuit case in which the court overruled a jury finding of FCA liability, and erased the damages award of more than $663 million, after trebling and inclusion of civil penalties. This case was discussed in depth in “Significant FCA Decision Affirms the Importance of Materiality.”

And in late 2017, we saw the high-profile HCR ManorCare case, in which the DOJ dismissed with prejudice an FCA lawsuit, after the court found that the DOJ’s main expert witness had lied in her deposition.

While the government continues to use the FCA to identify fraud and recover overpayments in government programs, these recent decisions highlight that the courts are looking long and hard at the merits of such cases to determine if any fraud was committed.

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an overview of the Guidance and answer questions. The presentation was a joint effort from several offices within the FDA’s organization and presenters included FDA employees, Matthew Di Prima, James Coburn (both of the Office of Science and Engineering Laboratories), Eric Horowitz (Office of Science and Engineering Laboratories), David Hwang, Joel Anderson (both of the Office of Device Evaluation) and Nooshin Kiarashi (Office of In Vitro Diagnostics and Radiological Health).

The webinar highlighted the technical assessments that manufacturers of certain 3D printed medical devices should consider when submitting a premarket application for a medical device that includes at least one fabrication step using additive manufacturing. As a helpful tool, the FDA used a hypothetical example of a 3D printed cranial implant device to walk through the information that the FDA would require in a premarket application for such a device. FDA has plainly put a lot of time into thinking about the unique technical aspects involved in 3D printing of medical devices and ensuring that the manufacturers of those devices consider these issues when submitting a premarket application.

The slides for the webinar are currently available on the FDA’s website. The webinar was also recorded and should be available here in the near future.

For more about the FDA Guidance, please see: Observations on FDA 3D Printing Guidance and FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices. For more on general legal issues involving 3D printed medical devices, please see: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, 3D Printing of Manufactured Goods: An Updated Analysis, and 3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”.

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a medical device. As explained in a statement by FDA Commissioner Scott Gottlieb, the new draft guidances “offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement.”

Section 3060(a) amended section 520 the Federal Food, Drug, and Cosmetic Act (“FDCA”) to remove certain software functions from the definition of device in section 201(h) of the FDCA.  The first draft guidance – Clinical and Patient Decision Support Software – focuses on the provision of the Cures Act that exempts certain clinical decision support (“CDS”) software from the definition of a medical device. The second guidance – Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – outlines FDA’s interpretation of other types of software that are no longer considered medical devices. Continue Reading

Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies

A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the security of IoT devices could be interpreted by courts as the minimal floor for any IoT product sold to the federal government and, potentially, sold commercially.

Given IoT’s increasing prevalence and importance in the life sciences field, this legislation could have significant impact on pharmaceutical and medical device manufacturers. For more information, please read our Reed Smith Client Alert, “Pending Legislation Seeks to Secure Federal Government IoT.”

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