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Life Sciences
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May 17, 2013
Hedge Fund Sues For Proxy Fight Rematch With Digirad
Hedge fund Red Oak Partners LLC sued Wednesday seeking to force a rematch in its proxy fight with Digirad Corp., accusing the medical imaging company of numerous underhanded maneuvers that allegedly swayed a board election in its favor.
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May 17, 2013
MLB Suit Over Performance Boosters Falls Flat, Clinic Says
A Florida health clinic asked a state judge Wednesday to toss a suit filed against it by Major League Baseball alleging it provided performance-enhancing drugs to Alex Rodriguez and other players, saying the league failed to properly state its claim and include all the necessary parties.
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May 17, 2013
Drug Co. Scores Partial Win In Suit Over Botched Offering
A Delaware judge on Thursday granted a partial win to Emmaus Life Sciences Inc. in a suit over a botched public offering, ruling the drugmaker properly voided an agreement with an alleged check kiter and his company AFH Holding & Advisory LLC.
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May 17, 2013
Criminal Probes Await Top Health Cos.: Ex-DOJ Fraud Chief
The U.S. Department of Justice’s heavy focus on health care fraud in recent years is set to move into a new phase that will increasingly target major corporations and their executives with criminal investigations, said Sam S. Sheldon, a Quinn Emanuel Urquhart & Sullivan LLP partner who until recently headed up the DOJ's health care fraud unit.
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May 17, 2013
AbbVie Targets Hetero Over Generic Norvir Plans
AbbVie Inc. on Wednesday hit Hetero USA Inc. in Delaware federal court with allegations that the generics maker infringes several patents with its planned generic version of HIV treatment Norvir.
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May 17, 2013
Pa. Appeals Court To Reconsider $28M Knee Injury Suit
A Pennsylvania appeals court has announced it will grant an en banc rehearing, after having ordered a new trial in a case where a $27.6 million judgment was awarded to a woman who had allegedly reinjured her surgically repaired knee while filming a marketing video.
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May 17, 2013
Obama Budget Would Save $153B In Health Spending: CBO
The president's budget proposal for the 2014 fiscal year would save the U.S. government $153.6 billion in health care spending over 10 years, the biggest chunk of which would come from applying Medicaid's prescription drug rebates to dual eligible beneficiaries, the Congressional Budget Office said Friday.
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May 17, 2013
Galderma Settles Pimple Drug Patent Suit With Par
Swiss skincare company Galderma SA and Par Pharmaceutical Inc. told a Texas federal court Friday they had reached a settlement over allegations that the generics maker sought to market a knockoff of Galderma's Epiduo acne treatment.
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May 17, 2013
House Dems Seek Tougher Drug Trial Reporting Rules
A group of House Democrats, including the ranking member of the Energy and Commerce Committee, introduced a bill Thursday that would expand the federal clinical trials database, impose stricter reporting requirements for clinical trials and add information about foreign trials.
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May 17, 2013
European Panel OKs Bayer Acne Drug For Some Women
A European Medicines Agency committee on Friday backed the use of Bayer AG's acne drug Diane 35 in limited circumstances, months after France's drug watchdog halted sales of the medication over blood clot risks.
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May 17, 2013
FDA Details Approach To Expedited Medical Device Reviews
The U.S. Food and Drug Administration on Friday laid out its criteria for medical devices that qualify for speedier approval, saying technology must address life-threatening or irreversibly debilitating conditions and represent a leap forward in health care.
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May 17, 2013
GSK Says Comcast Ruling Kills Avandia Injury Class Action
GlaxoSmithKline PLC on Friday urged a Pennsylvania federal judge to reject two Humana Inc. units’ bid for class certification over costs borne by the insurers for treating Medicare patients harmed by the drug Avandia, contending that it is barred by the Supreme Court’s recent Comcast decision.
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May 17, 2013
Steptoe Nabs Trio Of Patent Litigators For Chicago Office
Steptoe & Johnson LLP has strengthened its intellectual property practice in Chicago with the addition of three patent litigators with experience in the medical device and energy industries, it announced Thursday.
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May 17, 2013
Allergan Targets Strides, Agila Over Generic Eye Drops
Senju Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd. and Allergan Inc. hit Strides Inc. and Agila Specialties Private Ltd. with a patent infringement lawsuit in Delaware federal court Wednesday over their plans to market a generic version of Allergan's Zymar and Zymaxid conjunctivitis eye drops.
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May 16, 2013
J&J To Stop Selling Metal Hips, Facing Thousands Of Suits
Johnson & Johnson subsidiary DePuy Orthopaedics Inc. announced on Thursday that it will stop selling its controversial metal-on-metal replacement hips, following the filing of more than 10,000 lawsuits nationwide over a related product line and fierce scrutiny by the U.S. Food and Drug Administration.
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May 16, 2013
Purdue Puts Generic OxyContin Suits To Rest
Purdue Pharma LP on Thursday settled its suits against KVK-Tech Inc. and Varam Inc. in New York multidistrict litigation over plans to market a generic version of painkiller OxyContin.
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May 16, 2013
5 Steps To Take Now For A Successful Recall Later
To ensure an effective recall, it's essential to plan ahead — a tough task for manufacturers when the production line is humming and the customers are smiling. Here are five steps to take immediately to avert disaster if and when a product defect emerges.
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May 16, 2013
J&J Unit Wants Ban On Rival's Use of IP, Logos in Ads
Johnson & Johnson unit Lifescan Inc. urged a California federal judge Thursday to block the maker of a generic test strip used in Lifescan glucose meters from using Lifescan's trademarked logo and other intellectual property in packaging and advertising, saying user difficulty with the strips will harm Lifescan’s brand.
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May 16, 2013
Axiom Wins Sanctions In Medical Device Trademark Row
A Florida federal judge on Wednesday issued sanctions against several affiliated Chinese companies accused of producing counterfeit versions of Axiom Worldwide Inc. medical devices, ruling that the companies, created by a former Axiom sales agent, have used the disputed trademarks and copyrights in the U.S.
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May 16, 2013
Medical Supplier BestMed Dodges $3.5M Verdict In IP Row
Colorado-based medical equipment firm BestMed LLC convinced a New York federal judge to reverse a $3.5 million verdict for its adversary, Israel-based thermometer maker Medisim Ltd., over a thermometer patent that she found invalid Wednesday.
Expert Analysis
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Rise Of The Machines — Predictive Coding Goes Mainstream
The pros of using predictive coding far outweigh the cons. Given the heavy pressure on law firms and in-house counsel to reduce discovery costs, as well as the Justice Department's recent stance on the subject, it appears predictive coding will continue to emerge from the obscure world of legal technology to the mainstream of legal practice, say Michael Moscato and Myles Bartley of Curtis Mallet-Prevost Colt & Mosle LLP.
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The Growing Problem Of Fishy Labeling
As evidenced by a recent study conducted by Oceana, mislabeled seafood appears to be a widespread problem that can adversely affect both the public interest and individual consumers’ wallets, health and socially responsible purchasing precepts, say attorneys with Arnold & Porter LLP.
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K-V Case Tests Limits Of ITC Jurisdiction
As illustrated by the recent K-V Pharmaceutical Co. case, the U.S. International Trade Commission will likely closely review complaints that could usurp the power of another federal agency and potentially undermine that agency's application of its own rules, say Eric Fues and Mareesa Frederick of Finnegan Henderson Farabow Garrett & Dunner LLP.
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Get Ready For Stricter RMP Enforcement
The recent $4 million settlement by Tyson Foods Inc. represents one of the largest penalties for a stand-alone risk management program enforcement case since the provision was added to the Clean Air Act in 1990. This case also exemplifies the U.S. Environmental Protection Agency’s increasing focus on RMP compliance and its intention to seek ever-larger penalties for RMP violations, say attorneys with Kilpatrick Townsend Stockton LLP.
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Dissecting The Rules Of Generic Drug User Fee Amendments
The Generic Drug User Fee Amendments, a part of the U.S. Food and Drug Administration Safety and Innovation Act, have changed the practice of generic drug sponsors in a multitude of ways. These requirements should be top of mind for abbreviated new drug application filers because they may ultimately impact a generic applicant’s eligibility for the coveted six-month marketing exclusivity, says Suchira Ghosh of Axinn Veltrop & Harkrider LLP.
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E-Discovery In The Cloud: Who Can Get Your Data?
Many lawyers are asking whether placing electronically stored information in the cloud could inadvertently waive the attorney-client privilege and whether the government or a civil litigant could obtain ESI directly from a cloud service provider. In answering these questions, there are a number of aspects of the cloud worth considering, say Timothy Broas and Matthew Saxon of Winston & Strawn LLP.
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5 Reasons For Optimism In The Venture Capital Community
Not every company can be the next Facebook. But thankfully, for many startups, generating one billion users is not the end goal, nor should it be. Enter “narrowcasting” — one of a few reasons to be optimistic about venture capital, despite the first quarter of 2013 being the slowest for fundraising since 2002, says David Kaufman of Thompson Coburn LLP.
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Preparing A Successful Daubert Motion
When preparing a Daubert motion, one of the things practitioners should remember is that there is no better way to succeed than to demonstrate to the trial judge that the challenged expert's own testimony has demonstrated that his methodology is deficient, says William Martin of Haight Brown & Bonesteel LLP.
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Lessons From Philips FCPA Settlement Over Polish Bribes
While Poland has not received particular Foreign Corrupt Practices Act enforcement focus over the years, the U.S. Securities and Exchange Commission's recent order against Koninklijke Philips Electronics NV over Polish bribes underscores the fact that, in given circumstances, any country can present high corruption risk, say attorneys with Fulbright & Jaworski LLP.
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How HIPAA Marketing And Sale Provisions May Apply To You
In light of the Health Insurance Portability and Accountability Act's new requirements on the use of personal health information for marketing and sale purposes, it is important to note that not just covered entities but also advertisers, data aggregators, market researchers and others who want access to PHI will be impacted, say attorneys with Duane Morris LLP.