Join Us for a Webinar on “GDPR: Live”

The Global Data Protection Regulation (GDPR), the new European data privacy regulation that will have world-wide reach, goes into effect on May 25, and will significantly affect life sciences companies.

If you have been wondering what life is going to look like in a GDPR world, please join Reed Smith attorneys Cynthia O’Donoghue, Dr Andreas Splittgerber, Philip Thomas, Daniel Kadar, and Gerry Stegmaier at 9:30 a.m. on May 25 for a CLE webinar on “GDPR: Live.”

Topics covered will include expected developments in the coming months, an update on national legislation implementation, and prioritizing next steps in a GDPR world.

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

To register for this free webinar, please click here.

Upcoming Free Educational Opportunities for Life Sciences Clients

As the life sciences industry continues to undergo significant changes, Reed Smith is committed to offering high quality, free educational opportunities for its pharmaceutical, medical device, and biotechnology clients. We thus are pleased to shared two upcoming opportunities with you.

First, because the new import tariffs proposed by the current administration could significantly affect life sciences companies, Reed Smith partner Mike Lowell and associate Jeff Orenstein are offering a free CLE webinar that will provide practical information on the new tariffs and what they could mean for your business. 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. An application for 1.0 HRCI credit is currently pending. To register for this free CLE webinar, please click here.

Additionally, Reed Smith’s London office will be hosting a distinguished panel to discuss “Equity Capital Markets in the Pharmaceutical and Biotech Industry” on May 22. Speakers include Reed Smith’s James Wilkinson and Fiona McFarlane, as well as Mitesh Patelia of Crowe Clark Whitehill, Vadim Alexandre of Northland Capital Partners, and Dr. Dmitry Kuzmin of 4BIO Capital. To register for the event, please click here.

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also assuring the safety of the devices throughout their Total Product Life Cycle (TPLC). To that end, FDA intends to focus on the following five major areas:

  • Establish a robust medical device patient safety net in the United States by improving the quality and reliability of real-world evidence that manufacturers assess to support the safety and effectiveness of their products.
  • Explore regulatory options to streamline and modernize timely implementation of post-market mitigations.
  • Spur innovation toward safer medical devices.
  • Advance medical device cybersecurity.
  • Integrate the Center for Devices and Radiological Health’s (CDRH) pre-market and post-market offices and activities to advance the use of a TPLC approach to device safety.

The Action Plan builds upon existing programs that the Agency employs in the regulatory oversight of medical devices, including the Unique Device Identification System, use of real world evidence, and the National Evaluation System for Health Technology (NEST). For example, the Action Plan discusses FDA’s plans to seek additional funding and capabilities of NEST needed to realize its goal of establishing a robust medical device patient safety net.

FDA intends to streamline its process for requesting device manufacturers to implement post-market mitigations (such as, labeling, user training, and device features) by exploring the possibility of issuing umbrella regulations to identify devices that might require additional training or user education. Currently, FDA’s process for implementing mitigations through special controls requires rulemaking, which the Agency identifies as challenging and time consuming.

FDA’s Action Plan describes a multi-factor approach to spurring innovation toward safer medical devices. For example, the Agency plans to create opportunities for increased interactions between FDA staff and the device developers during the development, evaluation, and pre-market review phases of their products or by providing more streamlined pathways for comparative safety claims. Additionally, FDA released a draft guidance document, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria, on April 12, 2018, which establishes a voluntary, 510(k) pathway for demonstrating the safety and effectiveness for certain moderate-risk devices. In this guidance, FDA proposes to expand the 510(k) pathway to allow manufacturers of well-understood moderate-risk devices to use performance criteria to demonstrate substantial equivalence of their device to legally marketed predicate devices. Specifically under this pathway, if a new device meets or exceeds the level of performance relevant to the safety and effectiveness of a legally marketed device, then FDA could find that the new device is as safe and effective as the legally marketed device. Thus, rather than submitting data from direct comparison testing between the new device and the legally marketed predicate device, the manufacturer may establish substantial equivalence by demonstrating conformance to performance criteria established in FDA guidance, FDA-recognized consensus standards, and/or special controls.

In an effort to improve cybersecurity for medical devices, FDA will, among other things, consider seeking new pre-market authorities, such as requiring device manufacturers to build capability to update device security into a product’s design. Further, FDA intends to explore the development of a CyberMed Safety (Expert) Analysis Board (CYMSAB), a public-private partnership, which would assess cybersecurity vulnerabilities and evaluate patient safety risks at FDA or the manufacturer’s request.

Finally, FDA reiterates its previously announced plan to reorganize and streamline the structure of CDRH into one large office responsible for pre-market review, post-market surveillance, manufacturing and device quality, and enforcement actions relating to a device. The Agency believes this approach will enable its employees to have a more universal regulatory view of a device throughout its TPLC rather than at a specific stage of the product’s life cycle.

While it is difficult to gauge the full impact this Action Plan, it is clear that the medical device industry should plan for changes as the Agency further evolves its oversight of medical devices. Although device manufacturers stand to benefit from certain aspects of the Action Plan, particularly with respect to the abbreviated 510(k) pathway, other aspects may result in increased burdens and regulatory obligations. FDA is accepting comments on the Action Plan, which may be submitted through the public docket (FDA-2018-N-1315) at www.regulations.gov.

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.

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