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Life Sciences
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May 22, 2013
Ex-Watson Manager Says Homophobia Concerns Led To Firing
A former Watson Pharmaceuticals Inc. manager alleged Monday in New Jersey court that he was fired for protesting homophobic and sexist comments by another employee who later told superiors the manager had acted inappropriately on a business trip during which he visited gay bars.
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May 22, 2013
FDA Panel Clears Merck Insomnia Drug At Lower Dose
A U.S. Food and Drug Administration advisory panel on Wednesday recommended the regulator approve Merck & Co. Inc.’s proposed insomnia drug suvorexant, but only at the lower of two suggested dosages, finding the drug was unsafe at a higher dose.
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May 22, 2013
FDA Shows Deft Touch With 1st Mobile App Enforcement
The U.S. Food and Drug Administration's Tuesday move to rein in a developer of iPhone urinalysis software marked a perfectly balanced foray into stronger oversight of the fledgling mobile medical apps industry, experts say, addressing frustration among app makers that already work closely with regulators while taking care not to scare off potential innovators.
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May 22, 2013
Test Strip Maker Barred From Using J&J Unit's Logo In Ads
A California federal judge on Tuesday granted Johnson & Johnson unit LifeScan Inc.’s motion for a preliminary injunction blocking Shasta Technologies LLC from using LifeScan’s intellectual property in advertising its generic test strips for use in LifeScan glucose meters, saying the injunction would prevent customer confusion.
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May 22, 2013
Fen-Phen User Fairly Denied Extra Benefits, 3rd Circ. Finds
The Third Circuit on Tuesday ruled that the trust overseeing a national class action settlement over the drug combination fen-phen is correctly interpreting a key aspect of the agreement, rejecting a claim by a woman who sought to increase her level of benefits.
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May 22, 2013
Pfizer Plans Stock Swap To Exit Thriving Animal Health Biz
Pfizer Inc. on Wednesday outlined plans for shedding the rest of its majority stake in animal health unit Zoetis Inc. after a $2.2 billion initial public offering earlier this year, extending an offer for investors to swap their Pfizer stock for Zoetis shares at a discount.
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May 22, 2013
Senate Panel Advances Drug Compounder Oversight Bill
A U.S. Senate committee unanimously voted Wednesday to advance legislation that places the U.S. Food and Drug Administration solely in charge of regulating compounding pharmacies and also paves the way for added drug security along the supply chain.
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May 22, 2013
Nobel To Pay $1.3M To Settle Faulty Implant Suit
A California federal judge on Tuesday granted preliminary approval to a settlement resolving a $450 million class action accusing Nobel Biocare Holding AG of marketing defective dental implants that caused bone and gum problems, after the parties resolved a dispute over the deal.
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May 22, 2013
GSK Awarded Up To $200M For Bioterror Drug Program
The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority said Wednesday it has awarded GlaxoSmithKline PLC up to $200 million in a groundbreaking effort to help develop new drugs to fight antibiotic resistance and bioterrorism.
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May 21, 2013
Biotech Exec Indicted On Charges He Stole Investor Funds
A businessman whom New Jersey securities regulators sued for allegedly running a $9.5 million investment scam has been indicted on charges that he pilfered more than $230,000 from his biotechnology and medical device companies, the state attorney general announced Tuesday.
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May 21, 2013
Novo To Lay Down $700M For Antibiotics Specialist Xellia
Novo A/S, the holding company for Danish drugmaker Novo Nordisk A/S, has agreed to purchase majority venture capital-owned Norwegian antibiotic drug specialist Xellia Pharmaceuticals A/S for $700 million, the companies announced Tuesday.
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May 21, 2013
Herbalife Preys On Latinos, Nonprofit Tells FTC
A nonprofit on Monday urged the Federal Trade Commission to investigate Herbalife Ltd., claiming its vitamin distribution network — famously called the world’s “best-managed pyramid scheme” by activist investor Bill Ackman — preys on Latinos.
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May 21, 2013
Jury Convicts Atty Over Stock Fraud Scheme With Ex-NFLer
A Florida jury on Monday convicted a California attorney of conspiring with former NFL player Willie Gault and others to artificially inflate a heart-monitoring device company's stock through a series of fraudulent schemes.
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May 21, 2013
Herbalife Taps PwC As Auditor After KPMG Insider Scandal
Herbalife Ltd. said Tuesday it had chosen PricewaterhouseCoopers LLP as its auditor, replacing KPMG LLP after a partner at the firm was charged in early April with leaking confidential information about Herbalife and other clients to a friend who traded on the tips.
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May 21, 2013
Whistleblower Takes Takeda FCA Case To Supreme Court
A Takeda Pharmaceuticals North America Inc. sales leader has asked the U.S. Supreme Court to revive his whistleblower suit accusing the company of defrauding Medicare by overbilling for stomach acid drug prescriptions, arguing that it meets False Claims Act qualifications.
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May 21, 2013
Boehringer, Hospira Products Adulterated, FDA Warns
The U.S. Food and Drug Administration on Tuesday released warning letters it sent to generic-drug maker Hospira Inc. and German pharmaceutical company Boehringer-Ingelheim Pharma GmbH & Co. KG warning the companies of several products that are considered adulterated due to inadequate manufacturing processes.
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May 21, 2013
Deals Rumor Mill: Dish, Alere, Raytheon
Dish Network's chairman served up a $2 billion offer for wireless spectrum controlled by bankrupt LightSquared, while an activist investor is ratcheting up pressure on multibillion-dollar life sciences firm Alere to seek out a buyer.
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May 21, 2013
Reps. Urge Delay Of Medicare Competitive Bidding Program
Medicare should delay its controversial expansion of competitive bidding for durable medical equipment because unlicensed contractors have infiltrated the program and are greatly distorting prices, two congressmen wrote in a letter released Monday.
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May 21, 2013
Judge Disqualifies Whistleblowers' Attys In Kinetic FCA Suit
A California federal judge Monday disqualified the lawyers for whistleblowers accusing medical device maker Kinetic Concepts Inc. of violating the False Claims Act by falsely billing Medicare, ruling the attorneys knowingly and improperly used privileged documents in their clients’ pleadings.
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May 20, 2013
Pfizer Can't Shake Skelaxin Pay-For-Delay MDL
A federal judge on Monday refused to dismiss multidistrict litigation accusing Pfizer Inc.'s King Pharmaceuticals Inc. and Mutual Pharmaceutical Co. Inc. of keeping generic versions of the muscle relaxer Skelaxin off the market, finding Rite Aid Corp. and others had plausibly alleged a conspiracy.
Expert Analysis
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The Starstruck Medical Causation Trend
In the technical sense, medical causation answers whether an accused substance brought about some alleged disease. But rarely are the central causal allegations in major toxic torts purely courtroom affairs — publicity and politics now drive the litigation, with plaintiff verdicts begetting more publicity, says James Sabovich of Gibson Dunn & Crutcher LLP.
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Digging Into The Duty To Mine Big Data
Data mining has led, and will lead to, startling discoveries in the sciences. In the law, it may well lead to startling liabilities, especially if defendants are made to pay for harms foreseeable only by the most powerful software available, says David Oliver of Vorys Sater Seymour and Pease LLP.
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High Court Takes On Declaratory Judgment Burden Of Proof
With the U.S. Supreme Court granting certiorari in Medtronic Inc. v. Boston Scientific Corp., it will help clarify who bears the burden of proof in a declaratory judgment action. If the court affirms the Federal Circuit, the traditional patent law for this type of controversy will be turned on its head, requiring a licensee to disprove infringement, says Shashank Upadhye of Seyfarth Shaw LLP.
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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.