Please Join Us For Our Annual “12 Months in Health Care Law: A Roller Coaster Journey” Webinar

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory developments and court rulings in health care law over the past 12 months. This fast-paced program will provide an engaging look at the twists and turns of our industry’s legal developments, including:

  • Record-breaking false claims act/whistleblower recoveries
  • Yates memo in action: arrests of corporate executives
  • Cases combining kickback, Stark, false claims theories
  • Regulatory developments: overpayments, physician payment changes, CMS innovation models, lab cuts under PAMA
  • Judicial pronouncements on off-label marketing
  • Continued health reform battles
  • Testing the government’s authority to extrapolate false claims
  • Escalating HIPAA settlements
  • Intriguing health care items you may have missed

This webinar is also approved for 1 hour of general CLE credit in CA, IL, NJ, PA, TX and WV. To register for the free webinar, please click here.

Join Us for a Free CLE Webinar on Social Media Issues for Pharmaceutical, Medical Device Companies

The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it can also open up a Pandora’s Box of regulatory issues.

In this webinar, Reed Smith presenters Celeste Letourneau, Kimberly Chow Sullivan, and Jennifer Pike will look at how drug and device companies can use FTC and FDA guidance to avoid these pitfalls. The presenters will address FTC and FDA regulations and cover recent warning or other enforcement actions, product liability considerations and current best practices.

This webinar is approved for 1 hour of general CLE credit in CA, IL, NJ, PA, TX and WV. To register for the free webinar, please click here.

Reed Smith Attorneys to Speak at DRI’s November 10th Government Enforcement and Corporate Compliance Seminar

Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar.

This panel will examine recent government enforcement activities and legal decisions that might shape investigations, litigation, and resolutions of government claims. The criminalization of pharmaceutical and medical device FDA disclosure violations will also be addressed.

The DRI event will be held from November 10 to November 11 at the National Press Club, 529 14th Street, NW, 13th Floor Washington, DC 20045.

Other seminar sessions include:

  • The Foreign Corrupt Practices Act and Anti-Corruption Compliance
  • Data Breach: New Technology, New Challenges, New Risks
  • Health Care Fraud: Riding the Wave
  • Special Address: A Veteran’s Perspective on Key Principles of Professional and Personal Success
  • Anti-Money Laundering and Bank Secrecy Act
  • Special Address: Perspectives from a Federal Prosecutor
  • When the Client Is in the Crosshairs: Strategies for Responding to Government Investigations
  • Global Antitrust Enforcement
  • A False Claims Act Case Study
  • Environmental Dangers: Compliance and Ethics in Environmental Law

For full information on this informative DRI seminar or to register, please visit the event’s website. In-house counsel who are DRI members receive complimentary registration.

OIG Encourages CMS Claim Forms Which Will Allow For Better Tracking Of Implantable Medical Devices

On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”.  This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion of the “Unique Device Identifier” for implantable medical devices, and to encourage providers to make proper use of an existing two-digit field for reporting “device failures and recalls.”

According to the Early Alert, OIG decided to make this recommendation after it conducted an audit into “the Medicare costs associated with seven cardiac devices from three manufacturers.”  Because OIG “could not determine from the claims data alone the specific device implanted and whether the device replacement was due to a recall, a premature failure, or a necessary upgrade,” it “had to establish complex audit procedures and undertake the labor-intensive process of obtaining and reviewing the device recipients’ medical records to identify” Medicare payments it believed were due to “recalls or premature device failures.”

OIG says that “the lack of medical device-specific information in the claims data impedes the ability of CMS to readily identify and effectively track Medicare’s total costs related to the replacement of recalled or defective devices” and that its recommendations will “assist in identifying the costs to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds.”

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement.

Leaving aside the inevitable delays to the UPC project, there is a serious risk that Brexit means that the UPC will be diminished in the eyes of one of its major user constituencies, the international life sciences companies. These companies have extensive experience of the alternative to the UPC, the national country-by-country litigation route.

Counter intuitively, Brexit may make the UK a more important patent litigation venue than it would have been as part of the federal UPC system. The UK’s commercial significance means that companies will have to litigate in the UK as well as in Europe (whether in the UPC or in the national courts).

  • Brexit has, if anything, shifted the strategic balance. A diminished federal UPC system in Europe without UK participation runs the risk of being seen as less appealing by its potential users, especially the global life sciences and technology companies.
  • Brexit may increase the attractiveness of the current national litigation route as an alternative to the UPC for life sciences companies.
  • Brexit is likely to increase English patent judges’ willingness to grant pan-European declarations of non-infringement, paving the way for more complex and disruptive patent litigation strategies.

Please click here to read the full article drafted by London IP partner, Jonathan Radcliffe on this topic (originally published in August 2016 by Bloomberg).

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist.

The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person attendance is via pre-registration, written comments are accepted via (and should reflect the docket number “FDA-2016-N-1149”), and the meeting will be webcast as well.

Even more recently, on September 19, 2016, the Medical Information Working Group (MIWG) filed an amicus brief on these issues with the District of Massachusetts in United States v. Facteau in support of the defendants’ motion for a judgment of acquittal or new trial.

As the MIWG brief explains:

In particular, the MIWG has sought to address concerns that the current enforcement scheme is at odds with fundamental First and Fifth Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about off-label uses of their products.  The unclear rules that characterize the regulatory framework, and the Government’s expansive and ad-hoc approach to enforcement, provide inadequate notice of the line between permissible and impermissible speech and, as a result, manufacturers’ constitutionally protected speech is chilled.

Id. at 1.

This MIWG brief should be a useful resource for anyone addressing off-label promotion issues, regardless of whether those involve alleged regulatory violations (as with the criminal prosecution in Facteau) or allegations of tort liability in civil litigation.  And, it cites to our colleagues over at the Drug and Device Law Blog for their post about how long it has taken to get clarity from the FDA about the First Amendment free speech issues with its regulation of off-label promotion.


FDA Mandates Black Box Warnings For Opioids And Benzodiazepines

The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants called benzodiazepines.

Opioids are a class of powerful, pain-reducing medications that include oxycodone, fentanyl, and morphine.  Certain prescription cough suppressants also contain opioids.  Benzodiazepines, such as Xanax and Valium, are typically prescribed to treat neurological or psychological conditions such as anxiety, insomnia, and seizures.  Both classes of drugs suppress the central nervous system and can cause drowsiness, dizziness, nausea, and slow or difficult breathing.  Using these types of drugs together heightens those risks.

FDA’s new mandate comes after the Agency concluded that physicians increasingly prescribe both classes of drugs to the same patient, and that the rate of emergency room visits involving non-medical use of both drug classes had increased significantly from 2004 to 2011, with the rate of overdose involving both drug classes having tripled in that time.

While both opioids and benzodiazepines already carry warnings about the risks of combining the two types of drug, the new black box warnings are intended to catch the attention of the physicians and patients and underscore the seriousness of the threat.

The FDA’s mandate is one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan.  This plan focuses on policies aimed at reversing a growing prescription opioid epidemic while continuing to allow patients to effectively manage their pain.  Manufacturers of opioid and benzodiazepine undoubtedly are already in the process of  revising their labeling, including patient information, to comply with the new mandate.

Boosts in Ransomware Attacks Spark Multiple Government Agency Responses

Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released new Health Insurance Portability and Accountability Act (“HIPAA”) guidance on ransomware.  In addition to OCR’s guidance, the Secretary of HHS sent a letter to chief executive officers of companies in the health care sector stressing the importance of robust security compliance to combat ransomware attacks.

Ransomware, as explained by OCR, is a type of malware (i.e., malicious software) that most often attempts to deny access to a user’s data, usually by encrypting the data, until a ransom is paid. Hackers may also deploy ransomware in conjunction with other malware that destroys or transfers data from the infected information system.  Indicators of a ransomware attack could include, for example, an inability to access certain files, or a user’s realization that a link or file attachment that was opened may have been malicious in nature.

Continue Reading

Privacy Shield to Enter into Force Immediately in EU, on August 1 in U.S.

The EU-U.S. Privacy Shield has been adopted by the European Commission. On July 12, 2016, following a positive vote from the member states (the Article 31 Committee) on July 8, the EU College of Commissioners formally adopted the Privacy Shield. The Privacy Shield enters into force immediately in the EU. In the U.S., the Privacy Shield will be published in the Federal Register, becoming effective on August 1.

To learn more about this development, please read the recent Reed Smith Client Alert, “EU-U.S. Data Privacy Shield adopted – a phoenix rising from the ashes of Safe Harbour?” written by Cynthia O’Donoghue, Kate Brimsted, Philip Thomas, Paul Bond, and Gerard M. Stegmaier.

Reed Smith Attorneys to Speak at Upcoming “Women Leaders in Life Sciences Law” Conference

Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 3rd Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 27-29, 2016.

On July 28, Reed Smith partner and co-chair of the firm’s LSHI group, Melissa A. Geist will discuss some of the most cutting-edge legal challenges in the life sciences space in a panel entitled, “What Women Leaders in Life Sciences Law Must Know About Products Liability, Mass Torts, and ‘Bet-the-Company’ Litigation.” On July 29, Reed Smith partner Gail L. Daubert will be speaking on building a pricing and reimbursement strategy during the panel presentation, “Key Regulatory and Pricing Developments Affecting How Life Sciences Companies Bring Products to Market.”

The “Women Leaders in Life Sciences Law” event was created to increase the prominence of women in the life sciences legal community through substantive legal discussion, professional development and woman-to-woman networking. This year’s program features an impressive lineup of women leaders throughout the life sciences community poised to discuss key legal developments for pharmaceutical, biotech and medical device companies as well as engage in candid discussion of gender stereotypes and other implicit obstacles to advancement.

As a proud sponsor of this event, Reed Smith is able to offer a 15 percent registration discount for clients who would like to attend. To obtain the discount, enter the code P15-999-RSH16 while registering online. (Your discount will be manually applied at the end of the registration process by American Conference Institute customer service staff.)