The National Law Review is pleased to bring you information about the ABA’s Upcoming Spring 2012 CLE National Institutes:
Learn and network at these in-person,full-day or multi-day seminars held live in various locations across the country that draw lawyers from across the nation.
The National Law Review recently published an article, Supreme Court Decision Opens Door for Possible Implied Conflict Preemption of Over-the-Counter Drugs, by David B. Sudzus, B. Todd Vinson, and Russell J. Chibe of Drinker Biddle & Reath LLP:
The United States Supreme Court’s most recentpronouncement on federal preemption, decided in the context of generic prescription drugs, appears destined to be at the forefront in future battles over unsettled questions regarding preemption in the context of nonprescription, over-the-counter (OTC) drugs. InPLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law preempted state law failure to warn claims asserted against generic drug manufacturers. The Court’s preemption holdings, couched in terms of “impossibility” borne out of federal regulatory requirements of “sameness,” could arguably have similar applicability in the context of OTC drugs regulated under the FDA’s “monograph” regime.
The doctrine of federal preemption is based on the Supremacy Clause of the United States Constitution. The Supremacy Clause provides that federal law is “the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. As such, any state law that conflicts with the exercise of federal power is preempted and has no effect. SeeMaryland v. Louisiana, 451 U.S. 725, 747 (1981).
State law is preempted under the Supremacy Clause where Congress has expressly preempted state law. See, e.g., Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, (1992). Preemption may also be implied to the extent that state law actually conflicts with federal law. English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). “Implied” or “conflict” preemption exists where (1) it is impossible for a private party to comply with both state and federal requirements; or (2) state law obstructs accomplishing and executing Congress’ full purposes and objectives. SeeMensing, 131 S. Ct. 2567 (citing Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). In Mensing, the Supreme Court addressed implied preemption based on impossibility.
Mensing involved state law failure to warn claims asserted against generic prescription drug manufacturers, and alleged the manufacturers failed to provide adequate warning labels. Plaintiffs claimed that state law required the manufacturers to use a different, safer label.
However, the Mensing Court determined that, under FDA regulations, generic drug manufacturers have an ongoing federal duty of “sameness” regarding their labels – namely, that the generic drug’s labeling must at all times be the same as the brand name drug’s labeling because the brand name drug is the basis for generic drug approval. Specifically, the Court found that the generic drug manufacturers could not strengthen their labels through the FDA’s “changes-being-effected” (CBE) process, as such action would constitute a unilateral change by the generic drug manufacturers violating federal regulations requiring a generic drug’s label to match its brand name counterpart. 131 S. Ct. at 2575.
The Court distinguished its prior 2009 decision in Wyeth v. Levine (holding that state law failure to warn claims were not preempted against a brand name prescription drug manufacturer) based on this difference in availability of the CBE process. The Court explained that Wyeth turned on its finding that it was not impossible for Wyeth to strengthen its product warnings because Wyeth could take advantage of CBE provisions applicable to brand name prescription drugs approved under the New Drug Application (NDA) procedure and change its labeling without first seeking FDA approval. Id. at 2581. Thus, the Mensing Court reasoned that, unlike the case before it, the availability of the CBE regulations permitted the brand name drug manufacturer to “unilaterally strengthen its warning” without prior FDA approval, and therefore “allowed the company, on its own volition, to strengthen its label in compliance with its state tort duty.” Id.
The Mensing plaintiffs nonetheless argued against a finding of impossibility by contending that, despite the federal requirement of “sameness” and lack of CBE availability, the generic drug manufacturers were still able to (or even were required to) propose stronger warning labels to the FDA if they believed such warnings were needed. Id. at 2575. The Mensing Court, however, reasoned that simply proposing label changes “would not have satisfied the requirements of state law,” but rather “federal law would permit the Manufacturers to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label.” Id. at 2578. This, according to the Court, “raise[d] the novel question of whether conflict preemption should take into account these possible actions by the FDA . . . .” Id. The Mensing Court held that it should not:
The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it. . .
***
If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express preemption, the Supremacy Clause would have any force. We do not read the Supremacy Clause to permit an approach to preemption that renders conflict preemption all but meaningless . . .
***
To consider in our preemption analysis the contingencies inherent in these cases – in which the Manufacturer’s ability to comply with state law depended on uncertain federal agency and third-party decisions – would be inconsistent with the non obstante provision of the Supremacy Clause . . .
Id. at 2579-80. The Mensing Court summarized the test for “impossibility” as follows:
[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for [preemption] purposes.
Id. at 2581.
The Mensing articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against OTC drug manufacturers. Specifically, manufacturers of OTC drugs regulated under the FDA’s “monograph” system could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.
An initial hurdle facing OTC drug manufacturers asserting implied preemption lies in reconciling the fact that Congress specifically carved out state product liability claims (including presumably, failure to warn claims) from the reach of an express preemption clause applicable to OTC drugs. The Federal Food, Drug and Cosmetic Act (FDCA) governing OTC nonprescription drugs contains an express preemption clause, but then sets forth a “saving clause” stating that “[n]othing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.” 21 U.S.C. § 379r(a), (e).
Nevertheless, the Supreme Court has recognized that the existence of an express preemption provision and saving clause does not foreclose application of the doctrine of implied conflict preemption. In Buckman v. Plaintiffs’ Legal Committee, the Court recognized that “neither an express preemption provision nor a savings clause bars the ordinary working of conflict preemption principles.” 531 U.S. 341, 352 (2001) (citing Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)).
The FDA regulates most OTC drugs under its “monograph” regime. A monograph is a set of regulations promulgated by the FDA through notice and comment rulemaking that describes the conditions under which a category of drugs may be marketed without a prescription.
The Final Monograph for a class of OTC drugs includes labeling requirements. The manufacturer of an OTC drug must use the warning language authored by the FDA. 21 C.F.R. § 330.1(c)(2). The FDA’s labeling requirements are designed to provide warnings reflecting known risks based on reliable scientific evidence. See generally 21 C.F.R. § 330.10(a) (procedure for establishing OTC monograph). Adequate warnings are those that, in the judgment of the FDA, are “clear and truthful in all respects, not misleading in any particular,” and that accurately communicate the benefit to risk ratio and the proper use of the product in terms “likely to be read and understood by the ordinary individual.” 21 C.F.R. § 330.10(a)(4)(v).
Compliance with the Final Monograph by the OTC drug manufacturer is mandatory. “Any product which fails to conform to an applicable monograph after its effective date is liable to regulatory action.” 21 C.F.R. § 330.10(b). Therefore, once a Final Monograph goes into effect, it is illegal to sell a drug described therein unless it conforms to the monograph. 21 U.S.C. §§ 332-334. If a drug is marketed without prior FDA approval or without complying with an applicable monograph, the United States may bring an enforcement action under the FDCA. Enforcement measures include seizure of the drug product, civil injunction against its sale and criminal penalties against the violator.
Mensing’s articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against Final Monograph OTC drug manufacturers. Specifically, manufacturers of Final Monograph OTC drugs could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.
Final Monograph OTC drug manufacturers could assert that federal regulations, providing for specific product labeling and making it illegal to sell an OTC drug unless it conforms to the monograph, make it impossible for the manufacturer to comply with the federal law and also provide the additional or different labeling sought under the state law failure to warn claims. Moreover, the OTC drug manufacturers would assert that the monograph regime does not contain any directly applicable CBE provision—a critical distinction made by the Mensing Court in distinguishing its holding from Wyeth.
Finally, the OTC drug manufacturers could argue that under Mensing, the fact that FDA regulations provide a mechanism to amend or repeal any final monograph based on consideration of new information related to the safety or effectiveness of OTC products in the category does not change the impossibility preemption result. As Mensing held, impossibility preemption does not take into account possibleactions by the FDA. As such, the OTC drug manufacturer could argue that the mechanism for potential amendment or repeal of a final monograph does not allow it to “satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency,” and thus it “cannot independently satisfy those state law duties for [preemption] purposes” through such means. 131 S. Ct. at 2581.
The law of federal preemption regarding claims against drug manufacturers—whether brand name or generic, prescription or over-the-counter—is constantly evolving, and promises to remain in flux in the immediate wake of Mensing. Key holdings in Mensing provide OTC drug manufacturers with plausible, though far from certain to prevail, impossibility-based preemption arguments to challenge failure to warn claims. Whether Mensing ultimately provides a path to preemption for OTC drug manufacturers should become more clear in the future as courts across the country begin to interpret Mensing’s impact in non-generic OTC drug contexts.
©2012 Drinker Biddle & Reath LLP.
The National Law Review is pleased to bring you information about the upcoming ICC Conference Masterclass Arbitrators:
Join us for an intensive 2 1/2 day training for professionals interested in working as international arbitrators!
June 4-6, 2012 at ICC Headquarters in Paris.
The Securities Litigation Group of Vedder Price recently had an article, SEC Speaks 2012, published in The National Law Review:
The US Securities and Exchange Commission (SEC or the Commission) held its annual SEC Speaks conference in Washington, DC from February 24–25, 2012. This past year was devoted to modernization initiatives and calls for renewed efforts to increase the unprecedented 735 enforcement actions filed in the fiscal year that ended September 30, 2011.
Chairman Mary L. Schapiro began the conference by noting the strides the SEC has made in improved modernization initiatives, including better hiring and training and more sophisticated technology, research capabilities and operational management. Schapiro specifically emphasized broadened hiring efforts to bring nonlawyer industry experts on staff, including traders and academics, as well as doubling the staff’s training budget and enhancement of the new agencywide electronic discovery program. Schapiro also lauded the staff’s increased ability to recognize threats and move rapidly to address them.
Robert Khuzami, director of the SEC’s Division of Enforcement, echoed chairman Schapiro’s remarks and emphasized the ongoing efforts to bring cases arising from the financial crisis, in addition to the nearly 100 actions brought to date against individuals and/or entities—more than half of which include CFOs, CEOs or other senior officers. Jason Anthony in the Structured and New Products Unit also addressed the SEC’s “very large focus” on financial crisis cases, reporting that the SEC has brought 95 actions against entities and individuals arising out of the financial crisis and has obtained almost $2 billion in monetary relief.
Matthew Martens, chief litigation counsel, discussed the SEC’s litigation record and settlement practices, in light of the uproar stemming from Judge Rakoff’s refusal last year to approve the SEC’s settlement with Citigroup. According to Martens, it is the SEC’s policy to accept settlements with recoveries that the SEC could reasonably expect to receive at trial, and he argued that it would be a mistake to reject settlements simply because they lack admissions of liability. Martens also noted that the use of detailed public complaints ensures that the public is adequately put on notice regarding any wrongful conduct that allegedly has occurred, and he stressed that out of approximately 2,000 cases settled in the past three years, judges have challenged settlements in fewer than ten instances.
Kara Brockmeyer, chief of the SEC’s specialized FCPA Unit, announced the December 2011 launch of the “FCPA Spotlight” page on the Commission’s website, which includes links to every FCPA action ever brought by the SEC and also provides FCPA case statistics going back five years. Brockmeyer noted that the SEC brought 20 FCPA actions in 2011 (19 companies, one individual) and collected $255 million in sanctions. Brockmeyer promised that “more will be coming,” including cases targeting the pharmaceutical industry. Indeed, in 2012, the SEC has already charged 14 individuals and five companies with FCPA violations. She also touched on various international developments in anticorruption enforcement, including recent antibribery laws passed in Russia and China, and noted that Switzerland recently brought its first foreign corruption case. Brockmeyer indicated that the SEC is seeing more and improved cooperation in connection with foreign corruption cases between regulators and across borders.
David Bergers, the SEC’s regional director in Boston, discussed Enforcement’s enhanced ability to pursue potential wrongful conduct based upon the delegation of formal order authority to senior officers in the Division, which permits the SEC to escalate an investigation more quickly and to compel testimony and document production. Bergers also noted that, under the streamlined Wells notice process, the SEC will allow only one post-Wells meeting so that settlement negotiations do not delay recommending an action to the Commission, which is consistent with Dodd-Frank’s requirement that an action be filed within 180 days of a Wells notice, with any extension requiring the Commission’s approval. Bergers stressed that the Enforcement staff is taking this deadline “very seriously.”
Commissioner Daniel Gallagher focused his comments on “failure to supervise” liability for a broker-dealer’s legal and compliance personnel. Although legal and compliance officers are not automatically considered “supervisors,” they can fall under this category when the facts and circumstances of a particular case reveal that they held the requisite degree of responsibility, ability or authority to affect the conduct of other employees such that they have become a part of the management team’s collective response to a problem. Gallagher acknowledged that “robust engagement on the part of legal and compliance personnel raises the specter that such personnel could be deemed to be ‘supervisors’ subject to liability for violations of law by the employees they are held to be supervising,” which then leads to “the perverse effect of increasing the risk of supervisory liability in direct proportion to the intensity of their engagement in legal and compliance activities.” Gallagher did conclude that the issue “remains disturbingly murky” and called upon the Commission to provide a framework that encourages such personnel to provide the necessary guidance without fear of being deemed “supervisors.”
Sean McKessy, chief of the SEC’s Office of the Whistleblower, reported that the new Whistleblower Program stemming from Dodd-Frank has resulted in hundreds of high-quality tips. McKessy stressed that his office has engaged in significant internal outreach to educate staff across the divisions to ensure they understand the type of information that should be captured from whistleblowers as well as how to process award payments, which Dodd-Frank directs the SEC to pay in amounts between 10 and 30 percent of monetary sanctions to individuals who voluntarily provide original information that leads to successful enforcement actions resulting in sanctions over $1 million. According to McKessy, the current priority is to improve and maintain communication with whistleblowers and their counsel, and he noted that the office has successfully returned more than 2,000 calls within 24 business hours of receiving the tip on the hotline.
In response to criticism that Dodd-Frank’s Whistleblower Program will stifle internal reporting, McKessy defended the approach as “balanced” because it includes “built-in incentives” that enable whistleblowers to report internally first yet still remain eligible for the award. McKessy also volunteered that his experience has been that a significant majority of the tips received were—according to the whistleblowers themselves—reported first internally within their respective companies, and said that he was “hard pressed” to think of an example in which the whistleblower did not first report internally.
Merri Jo Gillette, regional director in Chicago, commented on the expansion of aiding and abetting liability under Dodd-Frank, noting that the SEC now has more flexibility to assert aiding and abetting claims under the Securities Act and the Investment Advisers Act, as well as to seek civil monetary penalties. Prior to Dodd-Frank, the SEC was required to show that an aider and abettor knowingly provided substantial assistance, but now the SEC may prove the charge under a “knowing or reckless state of mind” standard. Gillette remarked that the SEC will continue to look at the application of aiding and abetting liability to so-called corporate gatekeepers, such as accountants and lawyers.
In terms of changes to civil penalties under Dodd-Frank, Gillette explained that the most significant development is the SEC’s authority to seek penalties in administrative proceedings as well as expanded authority to penalize secondary actors, as the SEC may now explicitly seek penalties against persons who commit direct violations and who were “causes” of direct violations.
Speakers at the conference continued to emphasize the importance of auditor independence. Because the SEC’s auditor independence standards are broader than those of the American Institute of CPAs (AICPA), the Accounting Enforcement panel cautioned that companies considering an initial public offering should carefully review the scope of their auditor’s services for compliance with the SEC’s more stringent requirements. Fraud enforcement in the context of financial reporting also continues to be a high priority for the SEC. The SEC warned that additional areas of focus will be cross-border transactions, disclosures, revenue recognition, loan losses, valuation, impairment, expense recognition and related-party transactions.
The revamped SEC now appears ready to expand upon its enforcement efforts in 2012, which is reflected within President Obama’s proposed budget for 2013, reflecting an 18.5 percent increase over the SEC’s 2012 appropriation, and which would permit the agency to increase its staff by 15 percent. This budget increase would support the Commission’s touted technology initiatives and continued expansion of the agency’s system to identify suspicious patterns and behaviors quickly and more effectively. The SEC appears engaged to exceed last year’s record number of enforcement actions, especially via the capabilities afforded by Dodd-Frank.
© 2012 Vedder Price
The National Law Review is pleased to bring you information about the upcoming Law Firm Marketing Boot Camp:
Have you ever gone to a seminar that left you feeling motivated, but you walked out with little more than a good feeling? Or taken a workshop that was great on style, but short on substance?
Ever been to an event that was nothing more than a “pitch fest” that left a bad taste in your mouth? We know exactly how you feel. We have all been to those kinds of events and we hate all those things too. Let me tell you right up front this is not a “pitch fest” where speaker after speaker gets up only trying to sell you something.
We have designed this 2 day intensive workshop to be content rich, loaded with practical content.
We are so confident you will love the Rainmaker Retreat that we offer a 100% unconditional money-back guarantee! At the end of the first day of the Rainmaker Retreat if you don’t believe you have already received your money’s worth, simply tell one of the staff, return your 70-page workbook and the CD set you received and we will issue you a 100% refund.
We understand making the decision to attend an intensive 2-day workshop is a tough decision. Not only do you have to take a day off work (all Rainmaker Retreats are offered only on a Friday-Saturday), but in many cases you have to travel to the event. As a business owner you want to be sure this is a worthwhile investment of your time and money.
Partners at Small Law Firms (less than 25 attorneys) Solo Practitioners and Of Counsel attorneys who are committed to growing their firm. Benefits you will receive:
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Solo practitioners who need to find more clients fast on a shoe-string budget. In addition to all the above benefits, solo attorneys will receive these massive benefits:
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Law Firm Business Managers and Internal Legal Marketing Staff who are either responsible for marketing the law firm or manage the team who handles the law firm’s marketing. In addition to all the above benefits, Law Firm Business Managers and Internal Legal Marketing Staff will also receive these benefits:
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Of Counsel Attorneys who are paid on an “eat what you kill” basis. In addition to all the above benefits, Of Counsel attorneys will also receive these benefits:
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Associates who are either looking to grow their book of new clients in the next 6-12 months or want to launch their own private practice. In addition to all the above benefits, Associates will also receive these benefits:
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1. Specifically Designed for Owners and Managing Partners at Small Law Firms and Solo Practitioners.While Associates, Of Counsel, and Partners at large firms (50+ attorneys) are welcome to attend and will receive benefit from attending, the Rainmaker Retreat is specifically designed to meet the needs, challenges, and financial budgets of solo practitioners and small law firms.
You won’t find any strategies that cost tens of thousands of dollars in this seminar. In fact, many of our strategies have little to no cost and with many of them we will tell you how to trade more of your time instead of spending your money if you’re marketing your practice on a shoe-string budget. Nor will you hear about generic marketing ideas that only work if you have a large staff or a separate marketing department.
2. This is an Advanced Legal Marketing Workshop. We work very hard to make the material easy to understand and simple to apply, but please understand this is an advanced, in-depth, hard-hitting law firm marketing course!
If you are just starting out or have never done legal marketing or business development before you will likely find the volume and depth of our strategies to be a little overwhelming at times.
A common remark we hear from experienced attorneys is that attending the Rainmaker Retreat is like “trying to drink from a fire hydrant” because we will provide you will dozens of time tested legal marketing strategies each day of the workshop.
At the Rainmaker Retreat, you will not hear any generic marketing advice like “just buy more Yellow Page ads” or “try to get more referrals from clients.” The Rainmaker Retreat focuses on in-depth discussions of cutting-edge strategies and revealing secrets of highly successful attorneys used by only an elite group of lawyers.
3. You will be taught How to Track and Measure Every Legal Marketing Effort! You will find a big emphasis on tracking the results of your attorney marketing efforts so if you are a numbers kind of person you will LOVE the Rainmaker Retreat!
There are 3 major areas you need to analyze and every one of your current challenges is directly related to problems in one or more of these 3 areas. We will teach you what the 3 areas are and how to use this tool to diagnose your problems and what “marketing treatment” you need to prescribe.
4. You will learn a Proven Lead Conversion System. The biggest area attorneys overlook in their legal marketing efforts is how to convert more prospects into paying clients. You will learn the 5 numbers you need to track in your law firm.
We will give you the tools and teach you how to use them so you can start tracking: (1) where every incoming lead is coming from, (2) how many of those leads turn into appointments, (3) how many appointments show up, (4) how many of those appointments retain at the initial consult, and (5) how many retain at a later date. We will introduce you to our Rainmaker Follow Up System that can be used to determine your Cost Per Lead (CPL) and Cost Per Client (CPC).
5. It is a Working Retreat. This means that several times each day you will be given specific marketing tasks to complete with step-by-step instructions. You not only come to listen, learn and discover, but also to practice and apply.
By the end of the Rainmaker Retreat you will:
6. There is a Strong Focus on Return on Investment (ROI)! Everything about this workshop is focused on one goal—helping you achieve the best possible results by finding more and better clients in the least amount of time using the least amount of money possible!
For most attorneys,landing just 1 new client as a result of this workshop will more than pay for your attendance. But that’s not our goal! Our goal is to teach you how to gain dozens of new clients in the next 60-90 days.
Please note, ethically we cannot guarantee those kinds of results, but we work hard to provide you with all of the tools you will need to find more and better clients on a consistent basis. With that kind of Return on Investment, can you afford not to attend?
7. 100% Money Back Guarantee! We are so confident you will benefit from the Rainmaker Retreat that we offer a 100% money back guarantee. If you are not completely satisfied at the end of the first day, just let us know, turn your materials in and we will refund your money.
We guarantee you will come out of these 2 days with a step-by-step Marketing Action Plan (MAP) to make very specific changes to your marketing and how you go about building your legal practice.
The National Law Review recently published an article by Martha J. Zackin of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Employee Emails:
Does an employer invade an employee’s privacy by accessing and reviewing the employee’s email? A recent Massachusetts Superior Court decision, Falmouth Firefighters Union v. Town of Falmouth, answers “no.”
For a two year period, the town of Falmouth, Massachusetts, used Google Gmail for its email. Falmouth entered into a contract with Google for use of Gmail, and the town purchased the domain names used for the email accounts. Each town employee was given a Gmail address and was responsible for managing the email sent to his or her address. Although Falmouth’s system did not save any emails on any computer, server, or disc, it was the administrator of the email accounts. The Gmail accounts were widely used by Falmouth employees for personal communications.
Falmouth published an email policy stating that the town maintained the ability to access any messages on or transmitted over the email system. “Because of this fact,” the policy stated, “employees should not assume that such messages are confidential or that access by the employer or its designated representatives will not occur.” Although there was a dispute over whether this policy was subject to collective bargaining between the town and the union representing Falmouth employees, it was clear that employees were never told that their emails were confidential.
The emails to and from the account of a Falmouth firefighter were reviewed and copied during the course of investigating a charge of sexual harassment brought against the town by a former employee. Some of these emails contained highly personal, intimate, and embarrassing emails. The firefighter sued, claiming that Falmouth had invaded his privacy in violation of the Massachusetts Privacy Act, which provides that “[a] person shall have a right against unreasonable, substantial or serious interference with his privacy.” To prevail, a plaintiff must show an expectation of privacy and an unreasonable and either serious or substantial interference with that privacy.
In a case of first impression, the Court found that the firefighter had no legitimate expectation of privacy in the emails and, therefore, no invasion of privacy. In a very interesting analysis, the Court did not reach the issue of whether the town’s email policy was properly implemented or even relevant. Rather, and importantly, the Court found that the firefighter “did not have a reasonable expectation of privacy in the emails he voluntarily sent over the Town’s email system absent any assurances that such communications were private or confidential.”
What does this mean for Massachusetts employers? We continue to recommend that employers implement electronic communications policies that clearly and unequivocally state that the employer has the right to access and review any and all information sent, received, or maintained on any employer-owned or maintained electronic devices or systems. However, at least in Massachusetts, the absence of such policies will not restrict the rights of employers to access employee emails.
©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The National Law Review is pleased to bring you information about the upcoming Canadian International Trade Compliance Conference:
Event Date: 21-23 Aug 2012
Location: Toronto, Ontario – VENUE TO BE CONFIRMED, Canada
Currently, international trade compliance professionals need to stay up to date on the changing regulations within Canada and also abroad. With the changes to the Export Controls List and the ever-complex nature of Canadian-U.S. cross border trade, companies need to be aware of how these changes affect their international trade compliance programs.
Canada’s relationship with the U.S. makes it imperative that the International Trade Compliance community is informed on the impact that U.S. rules and regulations can have on Canadian companies.
Building upon the success of the 2nd Annual International Trade Compliance Conference, the marcusevans Canadian International Trade Compliance conference addresses the Global Trade Compliance Concerns involving export controls, customs compliance and cross border trade in Canada.
By attending this event, industry leaders will be able to overcome any potential challenges in crafting and sustaining a comprehensive trade compliance program.
Attending This Conference Will Enable You To:
1. Dissect the latest updates from the Department of Foreign Affairs and International Trade with Research in Motion Limited
2. Comprehend the U.S. Export Reform Initiative and the impact upon Canadian companies with Public Works and Government Services Canada
3. Develop and understanding of import value and transfer pricing with Ericsson Canada Inc.
4. Focus on NAFTA and other Free Trade Agreements with Plains Midstream Canada
Industry leaders attending this event will benefit from a dynamic presentation format consisting of workshops, panel discussions and case studies. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking and exclusive online access to materials post-event.
Audience:
SVPs, VPs, Directors, Superintendents, Supervisors, Engineers, Specialists, Leaders and Managers from the Chemical, Petrochemical, and Refining Industries with responsibilities in:
On May 18, in Yankee Atomic Elec Co. v. United States, the Federal Circuit affirmed a damages judgment of $142.6 million, and added $17.0 million to the judgment by granting a cross-appeal, in a breach of contract action against the government arising from the Department of Energy’s failure to remove spent nuclear fuel from three reactor sites in New England. The decision came in three consolidated cases from among the 55 that have been filed in the Court of Federal Claims as a result of DOE’s breach of contracts it has with all nuclear utility companies under which the agency was required to begin removing spent fuel from reactor sites in 1998. Due to chronic delays with the DOE program, including controversy over the proposed Yucca Mountain, Nevada, repository DOE has never commenced any performance. The utilities have therefore been required to license and construct on-site storage facilities for the nuclear waste, the substantial cost of which constitutes the bulk of the damages claimed in the breach of contract actions.
Beginning in 2004 the government began settling some of these contract cases, and in recent years the pace of settlements has increased following utility victories on most contested issues. Settlements to date are estimated to exceed $2 billion, and only about 20 of the contract cases remain pending. However, separate litigation has arisen in the D.C. Circuit over DOE’s proposal to formally cancel work on the Yucca Mountain repository, and also seeking to relieve the utilities of the obligation to pay ongoing fees to DOE under the spent fuel contracts, fees that collectively cost the industry about $750 million per year.
Yankee Atomic was the first of these spent fuel damages cases filed, in 1998, and GT lawyers have represented Yankee Atomic as well as the other two companies involved in the May 18 decision, Connecticut Yankee Atomic Power Company and Maine Yankee Atomic Power Company, throughout the litigation, which has involved two trials and three appeals.
For the Legal Times of Washington’s take on this opinion, click here.
©2012 Greenberg Traurig, LLP
The National Law Review is pleased to bring you information about an upcoming conference:
The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.
Featuring case studies from leading generics experts, including:
Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments
Testimonials:
“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis
”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma
The National Law Review recently published an article by Charles H. Gardner of Much Shelist, P.C. regarding Social Media and Businesses:
In today’s diverse marketplace, social media sites, as opposed to a company’s own branded website, are poised to become a primary and potentially first point of contact with current and future generations of consumers. Techrevel.com recently reported that 56% of consumers who use Facebook, as an example, say that they are more likely to recommend a brand after becoming a “fan.” With the number of Facebook users approaching one billion, a strong social media presence has become a de facto mandate for businesses.
In response, start up and established businesses are growing more reliant on the Internet, and social media in particular, for marketing and sales. According to a recent Forrester Research study cited on Statistica.com, social media marketing expenditure is expected to grow to $5 billion in 2016, up from approximately $1.6 billion in 2011.
In this context, you may be exploring the possibility of making your company website more interactive. From a business perspective, creating a user experience on your branded website that is simpatico with social media reanimates the end user’s experience and revitalizes your brand. From a legal perspective, however, you may wonder how to enter (or expand your presence in) this pioneer media. How do you balance the advantages of interactivity with the added burdens of creating, maintaining and updating essential privacy, data security and other policies?
You can start by asking―and answering―the following questions:
Federal law (and several state laws) mandates that companies inform their users about the personally identifiable information (PII) they collect, how the company uses it, with whom the company may share it, and how users may “opt-out” of having their PII collected and shared. PII includes information such as name, social security number, biometric records, etc., that alone or when combined with other information such as date and place of birth, mother’s maiden name, etc., can be used to trace an individual’s identity. Because many states have regulations that are more restrictive than federal regulations, you should seek to comply with the laws of the most restrictive states. These laws may apply not only to information that you collect from your own company website, but also from your company social media pages.
Every company with a presence on the internet should have a privacy policy that is compliant, proactive and forward thinking. If you have a strong international presence, it should address issues of global compliance as well.
Consumers are likely to continue their use of third-party social media sites, including Facebook, as an interactive first point of contact with a company. However, as branded company sites begin to mirror the functionality of traditional social media sites, company sites are including interactive features from blogs and community chat rooms to video sharing and personalized profile pages that allow the posting of user-generated content (UGC). If your website includes these or similar features, then you are, in fact, also an interactive website.
There are two important legal protections for operators of interactive computer services. The Communications Decency Act (CDA) provides safe harbor (immunity from liability) for Internet Service Providers (ISPs). This shields an ISP from liability arising out of civil causes of action such as defamation, invasion of privacy, trade libel, etc. As a very general rule, as long as the provider is not a publisher of the content (importantly, they merely provide a place to post the content; they do NOT contribute to or edit it), they will not be held liable for the original posting of the offending UGC. While the term ISP is traditionally applied to services such as Yahoo!, Google, and AOL, recent case law suggests that if you operate an interactive computer service, you should, for the practical purpose of maintaining safe harbor protection, consider yourself a sort of ISP.
The Digital Millennium Copyright Act (DMCA) also contains important safe harbor provisions. Under the DMCA, “an operator of interactive computer services” is immune from liability for intellectual property (primarily copyright) infringement by a third party using the service provided that the provider follows certain registration, compliance and procedural guidelines.
One of the most valuable policies for a website owner is a terms of use policy (sometimes called “house rules” or a “user agreement”). Your terms of use tell your users what they can reasonably expect when using your site. For example, you may prohibit certain activities, such as hate speech, personal attacks, posting materials to which the user does not have the requisite legal rights, etc. By setting the ground rules of what you will allow on your site, you can monitor UGC for violations of the policy and remove or refuse to post such material objectively based upon your site’s posted terms and preserve your safe harbor protection. Remember, if an ISP edits or modifies content, it is treated as a publisher of content and can lose safe harbor protection. However, if an ISP removes content in its entirety for violating a documented policy, the ISP is not considered a publisher and is protected under the CDA for example.
A well-crafted terms of use policy, if correctly written and agreed to, also forms a “contract” between the end user and the website operator. For example, arbitration clauses can minimize the likelihood of class action lawsuits and the potentially negative publicity of high-profile trials. A transparent policy can also set reasonable expectations, engender goodwill and protect the company website owner.
As soon as reasonably possible, before or after your site goes live, you should discuss data security with your attorney and a qualified information technology (IT) representative. Like privacy policies, data security policies should comply with federal law and regulations, as well as the laws of the most restrictive U.S. state or territory. It is wise to have written procedures for data protection and breaches, which should be provided to any personnel who will be dealing with the company’s electronically stored information (ESI), particularly to the extent that the ESI contains end users’ PII.
You should also have a separate personnel policy that educates your employees and contractors about the use of company technology, social media and the Internet, and that protects your company without unreasonably or illegally restricting your employees’ activities.
As a practical matter, social media is no longer merely an optional business tool. It is a primary source of communication, information and advertising. Developing sound social media and technology policies as early as possible can reduce your liability and exposure and allow your company room to grow in this new online world.
© 2012 Much Shelist, P.C.
