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The National Law Forum - Page 508 of 753 - Legal Updates. Legislative Analysis. Litigation News.

Data Breach Developments in California (Part 2)

Morgan Lewis

Last week, we discussed three important changes to California’s data breach law that become effective January 1, 2015. Part two of this series looks at the data breach report recently released by the California Attorney General.

California Data Breach Report

In October, the California Attorney General’s data breach report presented key findings on breaches occurring in California and recommendations for lawmakers and affected industries. Notable findings and recommendations from the report are summarized below.

  • Data breaches are on the rise. Among other findings, the report found that the number of data breaches in California increased by 28% from 2012 to 2013, with “intentional unauthorized intrusions into computer systems” showing the biggest increase among breach categories and accounting for 53% of reported incidents.

  • Breaches of payment card data in the retail industry are most likely to result in fraud. The report found that from 2012 to 2013, the retail industry experienced 77 breaches, or 26% of all breaches, representing the largest share among industry sectors. Almost all (90%) of these breaches involved payment card data, which, according to the report, is the most likely data breach category to result in fraud.

  • Offers of mitigation services are on the rise and can be helpful to affected individuals. The report notes that after experiencing a data breach, entities are commonly offering mitigation services, such as free credit monitoring or other identity theft protection services, which can be helpful by providing advanced notice to individuals whose information is used fraudulently. However, the report found that no offers were made in 28% of incidents where the services would have been helpful. As discussed in part one, the new California law requires breach notices to include offers of mitigation services in certain circumstances.

  • Retailers should take action to “devalue payment card data.” Based on the finding that retail breaches involving payment card data are most likely to result in fraud, the report recommends that retailers take advantage of “promising” new technology, such as chip cards and tokenization, to enhance their security measures and “devalue payment card data.” The report also encourages retailers to implement tokenization technology for online and mobile transactions.

  • Lawmakers should clarify the roles of data owners and data maintainers in providing notices. Interestingly, the report recommends that the California legislature should clarify the notice obligations of owners and maintainers under the law. Specifically, the report explains that the law appears to require data maintainers to notify data owners of breaches, while the data owners must notify the affected individuals. Given this difference in responsibility, important breach notices may be delayed because the owners and maintainers may not agree on their respective obligations.

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FERC Approves Fourth Settlement for 2011 Southwest Blackout Against Western Area Power Administration

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On November 24, 2014, FERC approved a settlement with Western Area Power Administration – Desert Southwest Region  (Western-DSW) related to its involvement in the blackout in the southwestern U.S. on September  8, 2011.  This blackout left more than 5 million people in Southern California, Arizona, and Baja California, Mexico without power for up to 12 hours.  According to FERC’s press release on the Western-DSW settlement, this is the fourth settlement arising out of this blackout.

We have reported on two prior settlements, one involving Arizona Public Service Company on July  7, 2014 and one involving Imperial Irrigation District. A third settlement involved Southern California Edison Company and was approved on October 21, 2014. Two other investigations involving the California Independent System Operator and Western Electric Coordinating Council  remain outstanding.

The settlement with Western-DSW is unique in that it involves no monetary penalty.  This is in keeping with the DC Circuit’s recent decision in Southwestern Power Administration et al. v. FERC, 763 F3d 27 (DC Cir 2014) (SWPA). As we previously reported, the Court in SWPA held that FERC could not impose monetary penalties on a federal power marketing administration for Reliability Standards violations. This is in marked contrast to the $650,000 monetary civil penalty assessed against Southern California Edison Company and the $2,000,000 monetary civil penalty assessed against Arizona Public Service Company.  Similarly, the settlement with Imperial Irrigation District involved a monetary civil penalty of $3,000,000. FERC reached this settlement with Imperial Irrigation District three weeks before the SWPA decision was issued, and it is not clear whether that decision, which was based on federal sovereign immunity precedent, would extend to state public power entities like Imperial Irrigation District. As with the other three settlements, the Western-DSW settlement provided for investment in significant reliability improvements, but unlike the other three settlements, the Western-DSW settlement does not identify a monetary value for Western-DSW’s reliability improvements.

The Western-DSW settlement involved four alleged violations involving three Reliability Standards. These alleged violations arose out of a fault on a major transmission line owned and operated by Arizona Public Service Company and Western-DSW’s inability to handle the resulting increased flows on parallel transmission paths in which Western-DSW owns and operates transmission facilities. These increased flows resulted in voltage deviations and overloads on Western-DSW’s system which in turn required load shedding. After its investigation, FERC and NERC staffs found that Western-DSW had violated the following requirements:

  • TOP-004-2 R1, because Western-DSW did not operate its system within established system operating limits

  • TOP-004-2 R2, because Western-DSW did not operate its system to prevent severe low voltage conditions and loss of load that resulted from the loss of the Arizona Public Service Company line

  • TOP-008-1 R2, because Western-DSW did not operate its system to prevent system operating limit violations by identifying and studying the contingency related to the loss of the Arizona Public Service Company line

  • VAR-001-1 R9 because Western-DSW did not maintain sufficient reactive resources to support its voltage in the event of a contingency related to the loss of the Arizona Public Service Company line

While stipulating to the facts surrounding the September 8, 2011 event, Western-DSW noted in the settlement that it neither admits nor denies that it violated any Reliability Standards.

Although as noted above the settlement does not identify any monetary penalties, the “Remedies and Sanctions” section of the settlement describes at length several reliability improvements instituted by Western-DSW. To improve its operations within established system operating limits, Western-DSW committed to perform seasonal, next-day and real time studies to verify its system operating limits and interconnection reliability operating limits, to coordinate with its neighboring transmission systems and with its reliability coordinator on any areas of concern related to those limits, and to establish alarms, procedures and trainings related to real-time study of these limits. Western-DSW also committed to similar efforts associated with monitoring real-time voltage and reactive power support, and it joined with other facility owners to install a total of 90 MVar of reactive support. As with the other settlements arising out of the September 8, 2011 Southwest Blackout, the Western-DSW settlement included reliability improvements that do not appear directly related to the underlying alleged violations; these improvements addressed areas such as: situational awareness, long term planning, enhancing operational studies to predict system performance within appropriate phase angle limits.

Although the settlement makes clear that many of the reliability improvements committed to by Western-DSW are complete, the settlement provides that Western–DSW will submit status two semi-annual reports to FERC and NERC staffs regarding its mitigation activities and its ongoing compliance with the Reliability Standards.

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President Obama’s Executive Orders on Immigration – Interagency Cooperation and DOL Initiatives

Godfrey Kahn Law Firm

On November 20, 2014, President Obama announced a series of executive actions designed to reduce the strain on the country’s immigration system.  Many of these policies will have a direct effect on employers and the business community and demonstrate that the increased interagency cooperation and enforcement we have seen in recent years will continue.

Visa Application, Passport

The President has ordered the creation of an interagency working group consisting of U.S. Department of Labor (DOL), U.S. Department of Homeland Security (DHS), U.S. Department of Justice (DOJ), U.S. Equal Employment Opportunity Commission (EEOC) and the National Labor Relations Board (NLRB) to identify policies and procedures to promote the consistent enforcement of labor, employment and immigration laws.  Two of the topics the working group will review include 1) promoting worker cooperation with enforcement authorities without fear of retaliation based on immigration status, and 2) ensuring that employers do not use federal agencies to undermine worker protection laws by introducing immigration authorities into labor disputes.  DOL’s interagency working group fact sheet is available here.  This interagency group appears to be ready to continue the DOL-DHS discussions that began with the signing in March 2011 of a Memorandum of Understanding (which has since been revised) between those two agencies governing their coordination with respect to their various civil enforcement activities and avoidance of conflicts.

DOL has also proposed to review the permanent labor certification program (PERM), which is used to certify a shortage of U.S. workers who are able, willing and qualified to fill certain positions.  This certification is a necessary prerequisite for many employment-based legal permanent residence processes.  For example, DOL has reported that employers filed more than 70,000 PERM applications seeking to certify shortages of U.S. workers for specific positions in fiscal year 2014.  Among other key changes, DOL will attempt to modernize the PERM program so that it can identify worker shortages more effectively.  This part of the President’s directives will hopefully have a positive impact on employers trying to fill positions for which the pool of qualified applicants is limited.  DOL’s PERM fact sheet is available here.

Other initiatives flowing from the President’s announcement but whose details are not yet known include improved allocation of immigrant (legal permanent resident) visas; increased portability of work authorization without jeopardizing a pending legal permanent resident process; expanded work authorization for students, recent graduates and the spouses of certain professional-level workers; and efforts to increase the number of investors eligible to enter the country.

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Only one more week until the 2nd Annual Bank and Capital Markets Tax Institute West in beautiful San Francisco!

The National Law Review is please to give you information on the 2nd Annual Bank and Capital Markets Tax Institute WestBank and Captial Markets Tax Institute Dec 2-3 San Francisco, CA - Register Now!

Register today!

WHEN

December 2-3, 2-14

WHERE

San Francisco, CA

Due to the success of last year’s first ever west coast Bank and Capital Markets Tax Institute (BTI), we are proud to announce that BTI West will be coming back for a second year! For 48 years the annual BTI East in Orlando has provided bank and tax professionals from financial institutions and accounting firms in-depth analysis and practical solutions to the most pressing issues facing the industry, and from now on professionals on the west coast can expect the same benefits on a regular basis

The tax landscape is continually changing; you need to know how these changes affect your organization and identify the most efficient and effective plan of action. At BTI West you will have access to the same exceptional content, networking opportunities and educational value that have made the annual BTI East the benchmark event for this industry.

In an industry that thrives on both coasts, we will continue to offer exceptional educational and networking opportunities to ALL of the hard-working banking and tax professionals across the country. Join us at the 2nd Annual Bank and Capital Markets Tax Institute WEST, where essential updates will be provided on key industry topics such as General Banking, Community Banking, GAAP, Tax and Regulatory Reporting, and much more.

Immigration Developments for Highly Skilled Workers: Changes the Business Community Can Expect as a Result of President Obama’s Executive Action on Immigration Reform

Mintz Levin Law Firm

On Thursday, November 20th, coinciding with President Obama’s announcement regarding his forthcoming executive action on immigration, Department of Homeland Security (DHS) Secretary Jeh Johnson issued a memo to the directors of US Citizenship and Immigration Services (USCIS) and Immigration and Customs Enforcement (ICE) directing the agencies to take action on the president’s announcements. The DHS memo provides a framework for changes the government wishes to make, relating to skilled immigration, to alleviate some longstanding problems in our business immigration system.

Many of the suggested changes are laudable but regulatory rulemaking will be required for most of these changes to take effect. Unfortunately, whereas President Obama was very clear in his announcement about timelines for the changes he is taking to protect certain undocumented immigrants, timeframes for producing regulations or for most of the business immigration changes are lacking in the secretary’s memo. The business community is left to wonder when these announced changes will materialize and what specific forms they will take.

Modernize the Employment-Based Immigrant Visa System

There are caps (quotas) on various types of immigrant visas (green cards) that result in extremely long backlogs and delays for people born in certain countries such as India and China.  If two software engineers at the same company are sponsored for green cards at the same time, and one of them is from Germany and the other is from India, the German applicant will get his green card in about two years while it will likely take his Indian colleague ten years to conclude the process. During this excruciatingly long waiting period, the Indian software engineer is supposed to remain in the same position for which he was originally sponsored. This benefits neither the employer nor the software engineer.

The existing visa distribution is deeply flawed beyond the backlog problem. Every year tens of thousands of visas in some categories go unused. These unused visas go to waste because they don’t roll over from one fiscal year to the next. It’s like vacation days at a company – in many companies if you don’t use them, you lose them. Secretary Johnson directed USCIS to work with the Department of State to better understand immigrant visa availability over the course of the fiscal year and to rationalize the visa distribution system so available visas do not go unused.  Secretary Johnson also ordered the Department of State to modernize the currently unwieldy visa bulletin.

Reform “Optional Practical Training” for Foreign Students and Graduates from US Universities

Most foreign students on F-1 student visas are eligible for a year of post-graduate optional practical training (OPT) as long as the work experience that they gain is in a field that relates to their degree program. But 12 months of authorized OPT frequently is not enough time to bridge the time between the foreign student’s authorization to work on OPT and the granting of a temporary work visa status. The H-1B quota opens every year on April 1st, and the H-1B visas do not become effective until the following October 1st, at the beginning of the government’s new fiscal year. The quota has been exhausted immediately in the last several years, leaving no H-1B visas available until the next government fiscal year – resulting in a 17-month period with no H-1B visa availability.

This problem is less severe for F-1 foreign students who major in STEM (Science, Technology, Engineering or Math) fields. These students are eligible to apply to extend their OPT work authorization for an additional 17 months, as long as they are employed by US employers participating in the government’s E-Verify program. (E-Verify is a program that any employer can participate in, if it is willing to check its employees’ documents through a government database to ensure the employees are legally authorized to work in the United States. Some employers don’t have a choice: if they have certain federal government contracts, or operate in certain states, they must sign up for E-Verify.) Qualified foreign students who graduate with US STEM degrees are able to continue to work legally through multiple government fiscal years, increasing their chances of “winning” an H-1B visa before their OPT period expires.

The list of STEM “majors” that qualify a foreign student for a STEM OPT extension is limited, however, and the focus until now has been on the US degree program that the foreign student has just completed. It would be much more useful if the government would expand the program to allow for STEM-based OPT extensions for F-1 students who either graduate with a US STEM degree OR complete a STEM degree prior to studying in the United States. For example, many of our MBA students come to the United States with a STEM undergraduate degree. Furthermore, the list of STEM “degrees” should be expanded to be much more robust.

Accordingly, Secretary Johnson directed USCIS and ICE to “develop regulations for notice and comment to expand the degree programs eligible for OPT and extend the time period and use of OPT for foreign STEM students and graduates.”  The business community would like to see a significant expansion of STEM eligibility in the new rules. But the business community may not appreciate some OPT restrictions that the Secretary has suggested might be paired with expanded STEM eligibility. Currently there is great flexibility associated with OPT. F-1 graduates on OPT can be self-employed or work as independent contractors, and if they work as employees on a W-2, there is no prevailing wage requirement associated with their employment. The flexibility associated with OPT has proven extremely helpful to foreign entrepreneurs and inventors who use the post-graduation period to refine their inventions, products and business ideas, form companies, and find investors.

Promote Research and Development in the United States

In his announcement regarding executive immigration reform, the president emphasized the importance to the United States of the contributions of foreign entrepreneurs, researchers, start-up company founders and investors. Secretary Johnson’s memo recognizes that the existing immigration law does not meet the needs of these creative individuals who contribute to the vitality of the United States. In his memo, he directs the agencies to expand two existing immigration law provisions. The first, the National Interest Waiver provision, provides a pathway for a permanent immigration status. The second, the “parole” authority in the law, provides a temporary status.

The National Interest Waiver application allows people with “exceptional ability” to bypass the labor market test required for most employment-based green card applicants if the individual can demonstrate that his or her work is in the national interest. USCIS takes a narrow view of who can qualify in this immigration category and therefore its usefulness as an immigration vehicle has been extremely limited. Secretary Johnson recognized this in his memo and directed USCIS to “issue guidance or regulations to clarify the standard by which a national interest waiver can be granted, with the aim of promoting its greater use for the benefit of the U.S. economy.”  Hopefully we will see a significant expansion for eligibility, including for people who found companies and are stimulating the economy, even if it is a local economy. Stimulating the local economy is certainly in the national interest. Asking someone who founds a start-up company to demonstrate an immediate and obvious “national” impact across the entire United States would not be realistic and would run counter to the desire expressed in the memo to expand the reach and usefulness of the national interest waiver green card option.

The government’s parole authority in immigration law, which authorizes certain individuals to enter the United States without a visa, would be expanded by Secretary Johnson’s directive to accommodate entrepreneurs, inventors, and researchers. We have no viable visa option in the United States for entrepreneurs, researchers, and inventors. Over the past years, multiple “Start-up Visa” bills were introduced into Congress, only to languish and die there. Consequently, many of these brilliant individuals leave the United States and set up their businesses or engage in their research in more welcoming countries. This is a creative approach to solving the problem in the short term. It will be interesting to see the criteria that will be applied and the mechanism for implementing this change, especially for the applicants who may already be in the United States. In terms of eligibility criteria, we already know that applicants will understandably have to demonstrate that they have sufficient financial means to ensure that they will not become a burden on the US government.   Bring Greater Consistency to the L-1B Visa Program

Multinational companies in the United States use the L-1 visa program to transfer personnel to the United States from overseas offices. These transferees can either be “managers or executives” or individuals with “specialized knowledge” needed by the US employer. The Obama administration has heard the repeated outcries from the business community that the government’s interpretations of what constitutes “specialized knowledge” for L-1 intracompany transferee purposes are inconsistent, flawed, unreasonable, and unduly protectionist. Employers filing these petitions over the last many years have not been able to expect that a strong petition will be approved and have had to expend inordinate legal fees to fight and appeal incorrect government decisions and unjust denials. This has had a material negative impact on multinational US businesses.

Recognizing “vague guidance and inconsistent interpretation” of the term “specialized knowledge,” Secretary Johnson directed USCIS to “issue a policy memorandum that provides clear, consolidated guidance” for this visa category with the goal to “improve consistency in adjudications, and enhance companies’ confidence in the program.” Over the years, USCIS has issued plenty of policy memoranda regarding “specialized knowledge” but the accumulated guidance has been confusing. This time around the guidance must be crystal clear, reasonable, and consistent with the real-world business practices of multinational companies. But regardless of what the memo says, the guidance will be worthless if it is not actually implemented by the adjudicators in the field. At the end of the day, DHS must demonstrate a commitment to enforce the terms of the memo and USCIS officers who apply an inappropriate standard to their adjudications must be held to account by the US government.

Increase Worker Portability

It can take a decade for certain skilled immigrants’ green card applications to be approved.   These skilled workers find themselves “stuck” for years in the same position and with the same sponsoring employer. Their career development and job mobility are terribly hampered by the visa backlogs. Under current law, a green card applicant can only “port” his or her green card application to a new employer or accept a promotion with the same employer towards the very end of this lengthy green card process, which can take 10 years. In order for an applicant to take advantage of the green card “portability” provisions, he or she has to jump through many hoops: the first two (out of three) steps in the green card process have to be filed and approved, the third and final application must be lodged with the government, and on top of that, the new job must be “the same or similar” to the one for which the original employer tested the labor market. This “portability” rule has been particularly unhelpful, precisely because many of the affected green card applicants cannot take advantage of it. They can’t benefit from “portability” because of the ridiculously long backlogs: it takes them 8-10 years to reach the third and final step of the green card process, so effectively it does not help them at all.

Cognizant of the current limitations of green card “portability,” Secretary Johnson has directed USCIS to issue a policy memorandum clarifying the meaning of “same or similar” for this purpose. It remains to be seen how much flexibility will be built into the memo. The guidance in the memo should be designed to serve the needs of the business marketplace to facilitate career development and labor mobility.

Preregistration for Adjustment of Status

This development is quite radical. Dovetailing with the emphasis on facilitating worker portability, USCIS is expected to develop regulations to allow foreign nationals with an approved employment-based immigrant petition who are caught in the immigrant visa quota backlogs to preregister for adjustment of status in order to obtain the benefits of a pending application. This is expected to impact approximately 410,000 people. This is a marked departure from anything in the current business immigration regulations. It would not only benefit the employee who is the principal green card applicant, but would enable his or her dependents to obtain employment authorization and immediately enter the US labor market.  These impacted foreign nationals will be thrilled with this change.

Proposed Rule to Extend Work Authorization to Certain H-1B Spouses

The proposed rule published in May 2014 to extend work authorization to the spouses of H-1B employees with approved I-140 employment-based immigrant visa petitions is still outstanding, but is expected to be finalized in the next few months.

Summary

The Obama administration’s proposals to streamline and modernize key aspects of the country’s skilled immigration provisions are laudable and reflect that the administration has heard the lamentations and complaints from the users of these programs (employers and employees alike) that the current system is unworkable and archaic. Ultimately legislation must be passed to address the shortcomings in the US immigration system on a more fundamental and permanent basis. But no one knows how many more years it will take for the law to be changed.  Accordingly, the administration’s proposals for executive, administrative improvements may result in some significant temporary solutions and benefits for the business community in the United States. Now we must wait and see (a) what shape the concrete solutions will take, and (b) how long it will take to roll them out.

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Antares Pharma Bolsters the “Original Patent” Rule for Reissued Patents

Michael Best Logo

On November 17, the Federal Circuit decided Antares Pharma, Inc. v. medac Pharma Inc., holding reissued patent claims invalid for failing to comply with the “original patent” requirement of 35 U.S.C. § 251. The court’s decision casts a spotlight on the original patent rule and reinvigorates the little-used doctrine as an invalidity defense against reissued patent claims.

In Antares Pharma, the plaintiff alleged infringement of U.S. Patent RE44,846. Specifically, the plaintiff asserted four claims that had been added through reissue proceedings to broaden the original patent. The original claims were directed to various embodiments of a jet injection device, and the asserted reissue claims covered particular safety features for any injection device. The patentee sought a preliminary injunction, which the district court denied. The court found substantial questions of validity regarding whether the reissued claims impermissibly recaptured subject matter surrendered during prosecution to obtain the original claims.

On appeal, the Federal Circuit declined to address the recapture issue. The court instead decided the case by invoking the original patent rule, an issue that had been argued but not resolved below.

Section 251, which governs reissue applications, states in pertinent part that where a patentee has by error claimed more or less that it had a right to claim in a patent, the Patent Office will “reissue the patent for the invention disclosed in the original patent.” The italicized provision had previously been applied in a manner analogous to the written description requirement to require that reissue claims found adequate support in the disclosure of the original patent. In Antares Pharma, however, the Federal Circuit turned to Supreme Court precedents dating back as far as 1854 to read a more stringent standard into the “original patent” provision of § 251. In particular, the court held that whether or not the written description requirement was satisfied, “the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.”

Applying that standard to the reissue claims on appeal, the court not only affirmed the denial of a preliminary injunction, but also held the asserted reissue claims invalid as a matter of law. The court concluded that the safety features claimed during reissue were never described separately from the jet injector or disclosed in the particular claimed combinations. Because the original specification lacked “express disclosure” of the exact embodiments recited in the reissue claims, those claims failed to satisfy the original patent requirement.

The Antares Pharma decision provides guidance to potential reissue applicants and offers a significant new weapon for parties accused of infringing a reissued patent. For patentees, the decision expands the risks associated with using a reissue application to seek supplemental or complementary patent protection—the reissue applicant not only risks intervening rights and undesirable modification or loss of previously issued claims, but now faces a heightened requirement, not applicable to continuing applications, for clear and unequivocal disclosure of the newly claimed subject matter as a separate invention. To the extent practical, new applications should clearly set forth each potential invention with detailed examples. For parties accused of infringement, the exacting Antares Pharma standard will provide an additional, robust basis for validity challenges against asserted reissue claims during litigation.

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Health Resources and Services Administration (HRSA) Withdraws 340B Program Proposed Rule

Mcdermott Will Emery Law Firm

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the 340B Federal Drug Pricing Program.  The “mega rule,” which had been submitted to the White House Office of Management and Budget in April 2014, was expected to cover important 340B Program matters, such as patient eligibility, contract pharmacy arrangements, and eligibility for hospitals and off-site facilities.  Now, in lieu of the proposed rule, HRSA has announced its intention to release notice-and-comment guidance to “address key policy issues raised by various stakeholders committed to the integrity” of the 340B Program.  Additionally, HRSA plans to issue proposed rules related to civil monetary penalties for manufacturers, calculating the 340B ceiling price and administrative dispute resolution.

The decision to withdraw the proposed rule, coupled with HRSA’s intention to release regulatory guidance on similar issues, may be viewed as a response by HHS to a recent federal court decision limiting HHS’s ability to promulgate notice-and-comment rules.  In a May 23, 2014, decision, the U.S. District Court for the District of Columbia held that HHS did not have the requisite statutory authority to promulgate a notice-and-comment rule pertaining to the purchase of orphan drugs by certain Covered Entities.  Further, the withdrawal may indicate a decision by HRSA to scale back its issuance of notice-and-comment rules for the 340B Program, limiting formal rulemaking to areas where the statutory authority to do so is explicit.  The withdrawal of the proposed mega rule demonstrates HRSA’s position that it does not possess the broad authority necessary to issue a formal rule of this scope.

Without the proposed rule, important facets of the 340B Program remain uncertain.  Manufacturers and Covered Entities that sought guidance on key practical issues such as patient definition now must continue to wait for clarification.  As noted, going forward HRSA will seek to clarify “key policy issues” but has yet to announce whether the topics covered by the proposed rule will be addressed.  HRSA’s regulatory guidance on these issues may never come, however, if the U.S. District Court for the District of Columbia (which is hearing further briefing on the aforementioned case concerning HHS’s regulatory guidance on the orphan drug rule) further restricts HHS’s ability to issue guidance.

In the face of continuing uncertainty, 340B Program participants, including Covered Entities, should stay current and closely follow available guidance from HRSA and the 340B Prime Vendor (Apexus).  Until clear guidance has been issued pertaining to subjects such as patient definition and contract pharmacy compliance, 340B Program participants should continue to follow and document best practices to ensure compliance with all 340B Program requirements.

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Fifth Circuit Refuses Application of Bright-Line Test in FLSA Seaman Exemption Dispute

Proskauer Law firm

On November 13, 2014, the Fifth Circuit addressed the uncertainty stemming from its decision in Owens v. SeaRiver Maritime, Inc., 272 F.3d 698 (5th Cir. 2001), wherein the Court found that a plaintiff’s unloading and loading of vessels was considered “nonseaman” work subject to the Fair Labor Standards Act’s (“FLSA”) overtime requirements. Subsequent to that decision, plaintiffs have advocated for a broad application of Owens’s rule, and district courts struggled with Owens’s  application to what are often fact-driven cases.

The Fifth Circuit provided necessary clarity in Coffin v. Blessey Marine Services, Inc., No. 13-20144, 2014 WL 5904734 (5th Cir. Nov. 13, 2014), when it reversed the district court on an interlocutory appeal and held that vessel-based crewmembers tasked with loading and unloading vessels are seamen under the FLSA rendering them exempt from the FLSA’s overtime requirements under 29 U.S.C. § 213(b)(6). In so ruling, the Fifth Circuit limited its prior holding in Owens, by finding that the unloading and loading of vessels is not strictly “nonseaman” work, and that each individual and case must be analyzed under a facts-and-circumstances test. Significantly, in dicta, the Court intimated that the Department of Labor’s “twenty percent rule,” which states that an employee loses his seaman status when “nonseaman” work occupies over twenty percent of his time, is also not a bright-line test.

Plaintiffs are tankermen who lived and worked aboard Defendant’s vessels. Though the parties and the court agreed that most of Plaintiffs’ job duties were “seaman” work exempt from the FLSA’s overtime requirements, Plaintiffs filed suit alleging that their job duties related to the loading and unloading of vessels constituted “nonseaman” work for which overtime pay was owed. Plaintiffs and the district court relied on the Fifth Circuit’s prior holding in Owens, and the district court denied Defendant’s motion for summary judgment. The district court and the Fifth Circuit granted Defendant’s interlocutory appeal under 29 U.S.C. § 1292(b).

Following oral argument, the Fifth Circuit issued its decision, which disagreed with Plaintiffs’ and the district court’s interpretation and application of Owens. Importantly, the Fifth Circuit distinguished Owens and emphasized that the analysis under the FLSA’s seaman exemption is a fact-based and flexible inquiry not subject to bright-line, categorical rules. The Court reasoned that the analysis required the consideration of the character of the work performed and the context in which it is performed and not the consideration of where the work is performed or how it is labelled. Unlike in Owens where the plaintiff was a non-crewmember who was not tied to a vessel and who only sought overtime for land-based loading and unloading, the Plaintiffs in this case lived on Defendant’s towboats, and their loading and unloading duties undisputedly affected the seaworthiness of the vessels and were integrated fully with their other seaman duties. Therefore, considering the character and context of the work performed, the Court concluded that the Plaintiffs’ unloading and loading duties were seaman work, thus exempting Plaintiffs from the FLSA’s overtime requirements.  For these reasons, the Court vacated the lower court’s ruling and remanded the matter to enter judgment in favor of Defendant.

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3 Things You Need To Know About Penguin 3.0

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Penguin is an algorithm from Google that judges the quality of links that you have pointing to your site. Inbound links, sometimes called “backlinks,” to your website are one of the factors that Google’s algorithms use to rank websites in its search results. Google uses the Penguin algorithm (or filter) to punish link profiles that it sees as low-quality (coming from untrustworthy sites) or unnatural.  This is a response to linking practices used in the early days of search marketing, and still employed by some vendors, to show clients’ quick success.

3 Things You Need to Know about Penguin 3.0

In the early days of the Web and SEO, the sheer volume of links (and linking domains) to a website helped its rankings in Google Search results.  Many early SEO companies prospered by buying and selling links, creating directories and setting up other sites for the sheer purpose of creating content and supplying links. This was an exploit used for years by almost every search marketing vendor to gain rankings for their clients.  Since April of 2012, Google has used Penguin to dissuade webmasters from this practice for fear of losing all rankings for their websites.

As Google crawls the Web and finds a link to your site, it places them in a particular database of known links.  If you are bored, you can read through the original paper by Sergei Brin and Larry Page.  Penguin is a separate algorithm that is run periodically to parse through this database of links pointing to your site to check against known spam sites and known manipulative techniques.

In an explanation of Penguin 3.0 for Forbes magazine, Jayson DeMyers says Penguin “rewards sites that have natural, valuable, authoritative, relevant links.” It penalizes sites that have built manipulative links solely for the purpose of increasing rankings, or links that do not appear natural.

Penguin was introduced in April 2012 and updated twice that year with versions 1.1 and 1.2. Penguin 2.0 came out in May 2013 and an October update (2.1) had a fairly wide affect, causing Google ranking changes in about 1 percent of sites.

Penguin 3.0 was released in mid-October in what Google said could be a slow rollout. For some websites, Google said, it could be a few weeks until Penguin 3.0 had an effect, which would be about the time of publishing this article.

Here are the top 3 takeaways from the first days of Penguin 3.0:

1.  Penguin 3.0 may have little impact on quality websites.

Upon its introduction of Penguin 3.0, Google said: “(W)e started rolling out a Penguin refresh affecting fewer than 1 percent of queries in U.S. English search results. This refresh helps sites that have already cleaned up the Web spam signals discovered in the previous Penguin iteration, and demotes sites with newly discovered spam.”

This indicates that Penguin 3.0 will adjust rankings for sites that were adversely affected by earlier versions of the Penguin algorithm, but have since cleaned up offensive links.

But, if your site is still plagued by low-quality links, Penguin 3.0 will have an effect on you, and the impact – “demotes sites with newly discovered spam” – should be in line with earlier iterations of Penguin.  The word to note here (bolded) is that Google’s Pierre Far, called this a refresh, intimating that no new signals were added to this release.

2. Penguin 3.0 means you need to evaluate your links.

To avoid a penalty via Penguin 3.0 or to recover from it if Google has already penalized your site, you need to make sure you are not adding bad links that will hurt your site. You also need to rid your site of bad links pointing to it.

To avoid Penguin penalties, you want to review the type of links pointing to your site.  This can easily be done in Web Master Tools by using their tool to download a list of Sample and Latest links to your site.  Some of the items to look for are:

  • Links from foreign domains (ie. walre.co.pl)
  • Links sites that contain many hyphens (ie. best-personal-injury-lawyers-us.com)
  • Sites that are obviously off-topic (ie. a site about fishing would not normally link to an attorney’s site)
  • Large quantities of links from a particular domain.
  • Large percentages of commercial anchor text in the links pointing to your site.  (If you see anchor text that you would love to rank for in Google, then it is commercial.  Commercial should not make up more than about 10% of your anchor text.)

Removing bad links can be tedious and tricky. First you have to identify them and then you have to figure out how to get them taken down. You can simply contact the site that hosts them (if you can find a contact) and ask for it to be removed. Google also provides a “disavow tool,” by which you can ask Google not to take into account certain links when assessing your site.

But Google’s disavow tool come with two warnings: 1) “You should still make every effort to clean up unnatural links pointing to your site. Simply disavowing them isn’t enough.” And deeper on Google’s Webmaster tools site, 2) “This is an advanced feature and should only be used with caution. If used incorrectly, this feature can potentially harm your site’s performance in Google’s search results.”

3. If you’ve invested in a search marketing campaign, you need to know how your provider is obtaining links to your site.

Building links to your site cannot just be something you expect your marketing provider to do. How it is done can ultimately affect your business, and could adversely impact your overall revenue if your website is penalized by the latest Penguin update or by future Penguin updates.

The biggest takeaway from all Penguin updates is that you need to know how your vendor, your provider, is getting links for you. If they are not working directly with you, then it is likely a scaled process, meaning that their tactics are low quality and potentially harmful.

Instead, your vendor should be working to obtain links from sites that represent highly regarded authorities in your field. In addition to direct outreach to request backlinks, which may have limited cost effectiveness, firms may build links by community outreach, such as sponsoring organizations or public events in the community, which would publicize the firm. Or establishing a scholarship for local students and promoting it to area schools and school systems, which would link to scholarship information on your site. If a member of a law firm teaches at a local college or sits on a corporate or non-profit organization’s board, those organization’s sites may link back to that individual’s profile on your site.

Obtaining high quality backlinks is not always the easiest road, but it is the road well worth traveling, especially in the post-Penguin era.

Is Obesity the Next Pivotal Employment Discrimination Issue Within the European Union?

Greenberg Traurig Law firm

Introduction

Obesity is one of the greatest health challenges worldwide. During the last decade, the population that is overweight in the European Union (EU) Member States has increased significantly, which has resulted in more than half of the EU population being overweight or obese.1  According to a recent study published in The Lancet, more than one-third of the population worldwide is overweight or obese, of which 36.9 percent are men and 38 percent are women.2  The aforementioned development has led to a growing discussion on how to deal with obese (severe overweight) employees in the workplace. That discussion includes the question whether obesity is a ground for unlawful discrimination.

In 2013, the European Court of Justice (ECJ) was asked in a preliminary ruling in a Danish case – for the first time – which provisions of EU law, if any, apply to discrimination based on obesity. The ruling of the ECJ is expected at the end of 2014. Meanwhile the Advocate General (AG) delivered his opinion on the matter on 17 July 2014.3  The AG’s opinion basically revolved around two questions:

  • can obesity be considered as a self-standing ground of unlawful discrimination under EU law?
  • does obesity fall within the scope of the notion of disability as referred to in the Equal Treatment Framework Directive (Directive)?4

The aforementioned Directive has the objective of creating a level playing field, where equality in employment and occupation in both the public and the private sectors are concerned.5  Based on recent case law, the ECJ appears to have adopted, following the approach of the UN Convention, a social and not a (purely) medical model of disability.6

In this respect, it is important to understand that the Directive provides for minimum rules to be implemented by EU Member States with regard to their national laws. Member States are free to implement and execute provisions more favorable than the Directive so long as they are in line with the Directive, specifically and and EU law, in general. As a result, there are a variety of laws in place in the respective EU Member States regarding this topic, among many others, in combination with general EU law.

Given these developments, the topic of obesity in the context of employment discrimination is receiving greater scrutiny, and thus, the Danish case being closely watched by the employment law community in Europe. Indeed, obesity might be the next frontier in employment discrimination law.

This article is intended to highlight the most relevant aspects of the Danish case. It is likely that some of the issues will seem surprising to readers in the United States, inasmuch as, since the 2008 amendments to the Americans with Disabilities Act, the Equal Employment Opportunity Commission and the courts have already begun to rule that severe or morbid obesity is a disability regardless of whether or not it was caused by a psychological disorder.7

Facts

An employee, Mr. Kaltoft, has been employed since 1996 as a childminder (taking care of other peoples´ children in their own homes) in the Municipality of Billund, Denmark. Mr. Kaltoft has been obese during the entirety of his employment. Although he performed his job to everyone’s satisfaction, he was dismissed in 2010. According to the notice of dismissal, the termination was due to a decline in the number of children to be taken care of.

The dismissal followed an internal hearing in which the obesity of Mr. Kaltoft was discussed. The parties disagree as to whether and if so, how, his obesity constituted part of the basis for the dismissal. Mr. Kaltoft argued that his employment was terminated due to his obesity, and that this amounted to discrimination based on obesity.

Obesity as a self-standing ground of unlawful discrimination?

Mr. Kaltoft basically argued that the open-ended nature of certain provisions in the European Charter of Human Rights (ECHR), Protocol 12 of the ECHR and the EU Charter of Fundamental Rights of the European Union (EU Charter) as well as other general EU law principles, requires the conclusion that any form of discrimination should be protected.

The AG disagrees. In his analysis, he asserts that EU legislation prohibiting discrimination addresses specific grounds of discrimination within specific subject areas without an existing general prohibition on discrimination. Thus, since obesity  is not specifically mentioned as a prohibited ground of discrimination in the EU treaties, nor in any EU legislation, it cannot be seen as a self-standing ground of unlawful discrimination. If at all, according to the AG, obesity discrimination could only be grounded on Article 21 of the EU Charter, which prohibits ‘discrimination based on any ground such as (…).’ On this particular wording (such as) it might be argued that there is a general principle of non-discrimination in EU law covering grounds of discrimination not explicitly mentioned in the Charter. In this respect, the AG refers to an ECJ ruling in a previous case where the ECJ ruled that the discrimination within the scope of Directive 2000/78 should not be extended by analogy beyond those grounds listed- exhaustively – in Article 1 of the Directive.8  Therefore, the AG concludes that there is no general principle of EU law prohibiting discrimination in the labor market that would cover discrimination on grounds of obesity as a self-standing ground of unlawful discrimination.

Disability under Directive 2000/78

According to Article 1 of the Directive, discrimination on the grounds of disability is prohibited. The term ‘disability’ is not defined by the Directive, but a ‘notion’ of disability is being developed via case-law.  This case-law is consistent with the concept of disability as laid down in Article 1 of the United Nations Convention on the Rights of Persons with Disabilities (U.N. Convention), which is an evolving concept, and the U.N. Convention’s case-law. The U.N. Convention has been approved by the EU in its Decision 2010/48 and as a result the provisions of the U.N. Convention are an integral part of the European Union legal order.9  This means that EU legislation, such as directives, have to be interpreted, as far as possible, in a manner that is consistent with the U.N. Convention.

According to the ECJ, this notion of disability must be understood as referring to a limitation which results, in particular, from (i) long-term (ii) physical, mental or psychological impairments (iii) which in interaction with various barriers (iv) may hinder (v) the full and effective participation of the person in professional life (vi) on an equal basis with other workers.10

As to the scope of the term “disability,” the ECJ has held that disability cannot be defined by reference to the source of the impairment, because that would run against the very aim of the Directive, which is to implement equal treatment.11  Therefore, the notion of disability does not depend on whether the disability is self-inflicted or not. Disability can also include an illness, if the illness entails a limitation as described in the foregoing paragraph.12  In this respect it should be noted that an illness requiring particular attention, continuous medication and control may be a psychological or psychosocial burden to the person concerned, but that in itself does not necessarily hinder participation on an equal basis in professional life in general.13  Moreover, the protected disability may even be that not of the employee, but of a person in the care of the employee who seeks to rely on the Directive.14  The latter situation is described as ‘associative discrimination.’

According to the AG, it is sufficient that a long term condition causes limitations in full and effective participation in professional life in general on equal terms with persons not having that condition.  No link has to be made between the specific work concerned and the disability in issue as a precondition to application of the Directive.

With regard to the Danish case at issue here, one should note that the Municipality of Billund argued that it cannot be contended that Mr. Kaltoft’s obesity entails a limitation that may hinder his full and effective participation in professional life on an equal basis with other workers because he had already worked for 15 years as a childminder with the Municipality, and had participated in professional life on an equal footing with other childminders in the Municipality’s employ.  In other words, the Municipality asserts, Mr. Kaltoft’s obesity cannot be deemed to have impeded his work as a childminder. On the other hand, in light of the AG’s position, as set forth above, an employee such as Mr. Kaltoft could assert that it does not matter whether he could carry on his work as a childminder before he asserts a claim under the Directive; rather, if the disability, here obesity, causes limitations on his ability to participate in professional life generally, he can assert a claim of disability discrimination pursuant to the Directive.  Further, the notion of disability must be understood as referring to a hindrance to the exercise of professional activity, not only the impossibility of exercising such activity.15

Does obesity amount to a disability?

In addressing the question of whether obesity amounts to a disability, the AG refers to the Body Mass Index (BMI) classification of the World Health Organization.16  According to that measurement, persons can be divided in three categories: Obese class I (BMI of 30.00-34.99), Obese class II (BMI of 35.00 to 39.99) and Obese class III (BMI over 40.00). The latter category is also called ‘morbid obesity.’17  Although obesity is classified as an illness by the WHO, as set out above, an illness does not per se amount to a ‘disability’ as described in the Directive.18  With these categories in mind, the AG is of the opinion that most probably only WHO class III obesity (referred to by the AG as severe obesity) will create limitations that amount to a disability under the Directive and only when the situation fulfils all of the criteria set out in the ECJ’s case-law on the notion of disability. It is for the national Court to verify whether this is the case with respect to Mr. Kaltoft.19

Will the outcome matter for the Netherlands and the other EU Member States?

The Netherlands

The Directive was implemented in the Netherlands via the Equal Treatment Handicapped and Chronically Ill People Act (Act). According to this Act, discrimination on the grounds of handicap or chronical illness is prohibited. The terms ‘handicap’ and ‘chronical illness’ are not defined in the Act, and review of the legislative documents suggests that this omission was intentional, so as to be consistent with the Directive, which does not provide for a definition of ‘disability.’ Having said this, a handicap is considered to be irreversible and a chronical disease a long-term affliction.

As to the Dutch legal practice, it seems that the Act and the practice developed in the Netherlands are not completely in line with the ‘notion of disability’ in the sense of the Directive. There are elements that point in the direction of a wider scope, but there are also elements that seem to be narrower. The first (that is, a more expansive view) would be, as discussed earlier, permissible, while the latter (a narrower construct) would not. As an example, there are cases that seem to take the underlying (medical) cause into the equation in assessing whether the situation falls within the scope of a handicap or a chronic disease, which would seem to provide for analysis based on the source of the impairment, which, as described above, runs counter to the aim of the Directive.

Severe obesity is being interpreted as a chronic disease under Dutch case-law, by the Netherlands Institute for Human Rights (NIHR) as well as by the few courts that have rendered rulings on this topic so far. They all (directly or indirectly) refer to the aforementioned WHO classification regarding obesity and conclude that because morbid obesity is regarded as a chronical disease by the WHO it also qualifies as a handicap or chronical disease under the Act.20  Having said this, whether the outcome of the Danish case before the ECJ will change current practice will have to be seen, and may well depend on specific wording. If the ECJ rules in line with the AG’s opinion, the Dutch practice with regard to morbid obesity will not be affected; however, if the ECJ goes further, the ruling could broaden the nature of the protection.

Elsewhere in the EU

As described above, the EU Member States all have their own national legislation and in case of ECJ developments in this area, each will need to assess whether or not they fulfil the obligations that arise from the Directive and its case-law. By way of example, in the UK ‘disability’ is one of the protected characteristics under the Equality Act. There has been case-law, which held that while obesity is not a disability in itself, it may lead to an impairment which, if it meets the ‘disability’ test, would amount to a disability. If the ECJ rules that obesity per se amounts to a disability under the Directive, the UK courts may have to interpret ‘disability’ as including obesity or consider whether any changes to legislation are required.

Practical considerations

Just to be clear, the Directive does not impose an obligation to maintain in employment an individual who is not competent to perform the essential functions of the position concerned, notwithstanding the obligation for the employer, as laid down in Article 5 of the Directive, to provide reasonable measures where needed in a particular case to enable a person with a disability to have access to, participate in, or advance in employment, unless such measures result in the imposition of a disproportionate burden on the employer.21  This also applies to impairments such as alcoholism and drug addiction where these conditions amount to an illness. An employer may expect employees suffering from obesity to take reasonable steps themselves to ensure that they carry out their work properly. If that is or might become a problem, both the employer and the employee should address this in a timely and adequate manner to improve the situation, which will be a joint responsibility. In this context, looking at EU case-law as it currently stands, it is advisable for employers to consider reasonable adjustments (e.g., ergonomics of the workplace) where obesity leads to an impairment having an impact on an individual’s ability to perform their job. Furthermore, employers may also want to ensure a safe environment, addressing (in)appropriate behaviors toward those who are obese, not only because harassment based on obesity may in the future qualify as discrimination on the grounds of a “disability,” but more importantly to ensure that the employees feel good about themselves and their working environment, which will enhance their commitment to their colleagues and their employer and hence will create better results for all involved. With the latter, and the previously cited statistics in mind, employers might want to consider creating a healthy working environment that goes further than the regular health and safety regulations by, for example providing for healthy (lunch) food, health club arrangements, awareness programs and well-being programs among their workforces.


1 According to: Eurostat, Statistics Explained: Overweight and obesity – BMI statistics (data from November 2011)

2 Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013, The Lancet, Vol. 384, Iss. 9945, pages 766 – 781 (http://dx.doi.org/10.1016/S0140-6736(14)60460-8).

3 Karsten Kaltoft v. Municipality of Billund, Opinion of Advocate General Jääskinen 17 July 2014, Case C-354/13.

4 Directive 2000/78/EC of 27 November 2000.

5 ECJ 17 July 2008, Case C-303/06 (Coleman), EU:C:2008:415, par. 38 and 47.

6 ECJ 18 March 2014, Case C-363/12 (Z), EU:C:2014:159, par. 83-85.

7 Federal district courts in Louisiana and Mississippi and the Montana Supreme Court had already held that severe obesity not based on a physiological disorder can be deemed a protected disability (see EEOC v. Resources for Human Development, Inc., 827 F. Supp. 2d 688 (E.D.La. 2011); Lowe v. American Eurocoptor, LLC, 2010 U.S. Dist. LEXIS 133345 (N.D. Miss. Dec. 16, 2010); Feit v. BNSF Ry. Co., Op. 11-0436 (Mont. July 6, 2012).

8 ECJ 11 July 2006, Case C-13/05 (Chacón Navas), EU:C2006:456, par. 56.

9 Council Decision of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (2010/48/EC).

10 ECJ 11 April 2013, Joined Cases C-335/11 and C-337/11 (HK Danmark), EU:C:2013:222, par. 38 and 39.

11 HK Danmark, par. 41.

12 Kaltoft, par. 58.

13 Z, par 79 and 80.

14 Coleman, par. 56.

15 Z, par. 159.

16 Kaltoft, par. 50.

17 http://apps.who.int/bmi/index.

18 HK Danmark, par. 44.

19 Kaltoft, par. 56 and 60.

20 See for example NIHR 13 May 2011, 2011-78 (regarding a hiring and selection process).

21 Chacón Navas, par. 49 and 50