Life Sciences

April 16, 2013
FDA Staff Has Concerns Over Endo Testosterone Replacement

An application for a new testosterone replacement drug by Endo Pharmaceuticals has serious safety risks that may outweigh its benefits, according to a report by U.S. Food and Drug Administration reviewers released Tuesday ahead of an advisory committee meeting on the new drug application.
April 8, 2013
FDA Isn't Cracking Down On Social Media Ads, Report Says

Rising use of social media and digital advertising among drugmakers and medical device firms hasn’t led to stepped-up enforcement by the U.S. Food and Drug Administration for improper promotional activities, despite uncertainty about how the agency will police such activities, according to a recent report.
March 28, 2013
Medicare Asleep On $70M Equipment Overpayments, OIG Says

Medicare has recovered just a sliver of as much as $70 million in overpayments to suppliers of durable medical equipment despite a mandate that such companies obtain bonds to guarantee taxpayers can recoup excessive reimbursement, according to a report issued Wednesday.
February 25, 2013
Shine Might Be Off Alt Fee Arrangements, GC Survey Shows

A significantly smaller percentage of in-house counsel used some form of alternative legal fee structures last year, according to a new legal survey from Fulbright & Jaworski LLP that defied previous years' upward trends and more vocal criticism in recent years of the billable hour.
February 25, 2013
GCs Brace For More Whistleblower Suits

The percentage of in-house counsel expecting an increase in whistleblower suits hit a three-year high in 2012, as companies braced for more tipsters to come forward under a potent new Dodd-Frank Act program, according to a survey released Tuesday by Fulbright & Jaworski LLP.
February 25, 2013
In-House Teams Expand To Keep Pace With More Suits, Probes

Corporations beefed up their legal departments in 2012 and expect to do the same this year, according to a new report, with mounting regulatory challenges and abundant litigation combining to boost the need for in-house expertise.
February 25, 2013
GCs Rate Fixed Fees Best Bang For Their Buck

In-house corporate lawyers last year rated fixed-fee legal pricing the most effective alternative fee model to the straight billable hour, according to an annual Fulbright & Jaworski LLP survey released Tuesday.
February 15, 2013
GCs Name Cream Of The Crop Litigators

Corporate counsel singled out nearly 100 litigators as the most client service-driven in their field thanks to their innate ability to deliver solid outcomes, effectively communicate litigation strategy and prioritize their clients' business interests.
February 12, 2013
Mass Tort Reforms Prompt Fewer Filings, Philly Judge Reports

An administrative judge for Philadelphia's trial court system reported Thursday that efforts to reduce a significant backlog of pharmaceutical and asbestos mass tort cases were succeeding, and ordered that reformed procedures for these cases continue.
January 7, 2013
FTC Often Forces Fixes In Pharma Probes, Stats Show

The Federal Trade Commission has taken enforcement action on nearly every pharmaceutical merger it has examined in depth since 1996, according to data the antitrust watchdog released Friday.
December 12, 2012
Pfizer Chantix Trials Show More Heart Troubles In Users: FDA

An analysis of clinical trials has shown that users of Pfizer Inc.'s smoking cessation drug Chantix had a higher occurrence of heart attacks, strokes and other cardiovascular adverse events compared to patients who took a placebo, the U.S. Food and Drug Administration said Wednesday.
November 8, 2012
Humana Failed To Monitor Drug Refills, HHS Report Says

For more than two years, Humana Insurance Co. failed to prevent unallowable partial fills of drugs with a high potential for abuse while under contract with the U.S. Centers for Medicare & Medicaid Services, according to a federal report released Thursday.
October 22, 2012
Meningitis Probe Could Cause Drug Shortages, FDA Says

The investigation into the causes and extent of a widespread meningitis outbreak could lead to drug shortages for providers that buy drugs from Ameridose LLC, a compounding pharmacy affiliated with the compounder blamed for the outbreak, the U.S. Food and Drug Administration said Saturday.
October 16, 2012
OIG Urges Medicaid To Lower Drug Payment Limits Quickly

An inspector general's report released Tuesday found Medicaid is still overpaying for some prescription drugs and recommended that the program quickly implement changes — opposed by the pharmacy industry — that would lower the maximum reimbursement for these drugs.
September 27, 2012
GAO Calls For Greater FDA Scrutiny On Device Hacking Risk

Implantable medical devices that need a power source to function could be prone to hacking attacks and other security threats and need more scrutiny by the U.S. Food and Drug Administration, the Government Accountability Office said in a report released Thursday.
September 11, 2012
Life Sciences Rise In Value Despite Venture Capital Dropoff

Valuations for life science companies have moved upward this year despite a falloff in venture capital investment, according to Fenwick & West LLP's survey of venture capital financings for 186 U.S.-based life sciences companies.
September 6, 2012
FDA Beats EU On Cancer Drugs, But Not Others, Study Shows

The U.S. Food and Drug Administration gets new cancer medicines to patients more rapidly than other pharmaceuticals, and the opposite is true for the European Medicines Agency, according to a study published Wednesday that adds to a growing collection of data comparing the two agencies.
August 31, 2012
4 Firms Feared Most By In-House Counsel

When dealing with high-stakes litigation, there are four top-notch firms that in-house counsel dread seeing on the other side of the courtroom, according to a new survey of corporate counsel.
August 13, 2012
ACA Unlikely to Change Employer Health Coverage, GAO Says

President Barack Obama's health care law will likely lead to little change in the number of people covered by employer-sponsored health insurance, although statistical studies and employer surveys vary widely in their predictions, according to a report released Monday.
July 16, 2012
FCA Recoveries On Steep Rise To Record Highs, Report Says

Riding a sharply rising tide of enforcement, recoveries under the False Claims Act will likely hit record highs in 2012, with most imminent claims likely to come from the health care industry, according to a report issued Thursday by Gibson Dunn & Crutcher LLP.

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Expert Analysis

How Monsanto Applies To Nonagricultural Biotechnology

The U.S. Supreme Court's recent decision in Bowman v. Monsanto Co. provides the biotech community some much-needed clarity regarding self-replicating inventions. Perhaps equally important, the court displayed a keen sensitivity to the negative implications of an overly broad exhaustion doctrine, say attorneys with Womble Carlyle Sandridge & Rice LLP.
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.
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.
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.
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.
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.
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.
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.
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.
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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