By turning over sovereign prosecutorial-like power to contingency fee counsel in product-related litigation, a state effectively creates a new branch of government motivated by the prospect of private gain rather than the pursuit of justice or the public welfare. If not banned outright, this area needs "sunshine" reform, says Sean P. Wajert, co-chairman of Dechert LLP's mass torts and products liability practice group.
The plaintiffs' bar is vigilant in looking for medical devices and pharmaceutical products to indict. Television ads soliciting plaintiffs because of the alleged failure or defect of a medication or device and consumer expectations that a device or medication should work better than the human body help fuel such attacks, says C. James Zeszutek, co-chairman of Dinsmore & Shohl LLP's class action litigation and pharmaceutical and medical devices practice groups.
Legislation imposing responsibilities on financial institutions, with no promulgated regulations yet on the horizon, looks like a fertile field for plaintiffs to define specific obligations though litigation rather than through legislation, says Bart Friedman, leader of Cahill Gordon & Reindel LLP's white collar litigation practice group.
The debarment and suspension provisions of the False Claims Act need to be reviewed and modified. If convicted of even a small violation and prevented from doing business with Medicare and Medicaid, multibillion-dollar health care companies will quickly be faced with bankruptcy, says Julian Solotorovsky, chairman of Kelley Drye & Warren LLP’s white collar crime and investigations practice group.
Misconduct by prosecutors is as pernicious a development in the criminal justice system as I can imagine, says David M. Zornow, leader of Skadden Arps Slate Meagher & Flom LLP's white collar crime group.
We need clear guidance from the Federal Circuit to help the district court judges and the parties gain some predictability around patent litigation cases, says Sarah Chapin Columbia, head of McDermott Will & Emery LLP's worldwide intellectual property litigation practice group.
Although the outcome of Ariad Pharmaceuticals v. Eli Lilly appears to be an inside-the-Beltway kind of issue, it had broad implications in patent litigation, says James Galbraith, a partner and intellectual property litigation practice area member at Kenyon & Kenyon LLP.
Alternative energy, hands down, is where the next big wave is coming in corporate finance, particularly following the availability of matching funds from the U.S. Department of Energy, says Michael P. Drzal, chair of LeClairRyan's venture capital practice area team.
Many clients are looking to the global market for manufacturing, sales, marketing and strategic partnerships. This global reach forces companies to address international intellectual property issues, dispute resolution and other contract negotiation issues, says Josef B. Volman, co-chair of the corporate practice group at Burns & Levinson LLP.
The amount of time for oral argument is not well-matched to individual appeals cases: Some cases are better decided on the briefs, while others deserve more time for oral argument than the standard 15 minutes, says Robert S. Frank Jr., chair of the appellate practice at Choate Hall & Stewart LLP.
A successful appellate attorney must keep in mind the appellate audience: An appellate court is going to bring a more detached and broader perspective to its consideration of the issues than a trial judge who has been overseeing the matter for months, says Douglas S. Eakeley, co-chair of the appellate practice group at Lowenstein Sandler PC.
We need to pay judges adequately so that the best and most qualified people will want to serve, says J. Michael Jakes, leader of Finnegan Henderson Farabow Garrett & Dunner LLP's appellate practice.
One of the most challenging problems in international trade law today is that many clients must operate in a manner that serves the seemingly inconsistent regulations of several countries, says Stanley U. North III, a partner in LeClairRyan's corporate group who specializes in international trade.
The most significant problem in the U.S. appeals process is delay: It is often more important for the parties to obtain a decision — any decision — than to wait months or more for a great piece of judicial craftsmanship, says Robert N. Weiner, a partner in Arnold & Porter LLP's litigation and business litigation practice groups.
Memorandum decisions are now the norm and many are perfunctory. Last year, amazingly, the Eighth Circuit summarily affirmed without any substantive opinion over 30 percent of the time. That’s disturbing, and the problem may get worse now that unpublished opinions can be cited, says Dan L. Bagatell, appellate co-chair at Perkins Coie LLP.
Seeking broad discovery may be great, but can we review 10 million documents if all electronically stored documents are produced? People need to learn how to focus the request and production while still complying with the rules, says Gary M. Hoffman, leader of Dickstein Shapiro LLP's intellectual property practice.
A wave of litigation involving biologics and perhaps “personalized medicine” may be around the corner. The technology and rapid scientific advances in these areas are guaranteed to catch the attention of the plaintiffs bar, says Joseph M. Price, head of Faegre & Benson LLP's drug and medical device litigation practice.
All federal court litigation, and particularly antitrust litigation, has gotten much too expensive and cumbersome, says Barry Brett, head of Troutman Sanders LLP's antitrust practice group.
Investors are now looking at intellectual property as an asset class and will get more involved in monetizing those portfolios, says Amar Thakur, co-chair of Sheppard Mullin Richter & Hampton LLP's intellectual property practice group.
We could use fewer poor patents, a problem that is only exacerbated by the presumption of validity that a patent enjoys in litigation, says Luke Dauchot, a partner with Kirkland & Ellis LLP.
For the time being, patience and compliance are the only options for U.S. medicine and medical device manufacturers who require licenses to export their products to Iran. Waiting for an export license may be difficult, but the consequence of not having one can be a bitter pill to swallow, say attorneys at Reed Smith LLP.
No document review mechanism guarantees perfection, but the adoption of predictive coding has the potential to drastically alter the way in which documents are reviewed and produced in complex pharmaceutical and medical device litigation, says Jessica Sykora of Norton Rose Fulbright.
You might have heard this before — a cancer patient was treated with Aredia/Zometa, which, it is claimed, caused the patient to suffer from osteonecrosis of the jaw. A lawsuit is filed, the patient subsequently dies from the cancer, the plaintiff lawyers do not file the requisite paperwork to substitute in a new party, and the case is dismissed. But the defendant is not prejudiced by this kerfuffle, right? Wrong, says Stephen McConnell of Reed Smith LLP.
In light of the proposed e-discovery amendments to the Federal Rules of Civil Procedure, businesses need to set themselves up to efficiently respond to discovery and requests for information from their counsel by implementing and following document-control policies as part of normal business practices. The failure to do so will eventually consume vast amounts of employee time, say Steven Cvitanovic and Colin Murphy of Haight Brown & Bonesteel LLP.
While the technology at issue in Commil USA LLC v. Cisco Systems Inc. was not life sciences, the implications of the Federal Circuit's decision, and the trend in the law it reflects, likely will be significant for companies that often rely on method-of-treatment, mechanism-of-action and method-of-manufacturing patents as key value drivers. Such patents may be materially weakened, say Eric Marandett and Diana Huang of Choate Hall & Stewart LLP.
In Rowland v. Novartis Pharmaceuticals Corp., three Pennsylvania plaintiffs — merely because they were rousted to multidistrict litigation — received the advantage of the different choice-of-law rules for states to which they had no connection, rather than being bound by the choice-of-law rules of their actual domiciliary state. Where, as in Rowland, the plaintiff is a pure litigation tourist, this is an absurd result, says James Beck of Reed Smith LLP.
There are several unique defenses, depending on the state, available to defendant pharmaceutical companies which arise from the discord between consumer protection statutes and prescription drugs, say Yvonne McKenzie and Gabriel Vidoni at Pepper Hamilton LLP.
What is the thinking as to whether leaky air conditioner cases warrant multidistrict litigation treatment? On Dec. 5, the Judicial Panel on Multidistrict Litigation heads to Vegas to find out. This will bring a temperature shift in more ways than one from the September hearing, where the panel considered a potential MDL proceeding arising from allegedly defective clothes dryers, says Alan Rothman of Kaye Scholer LLP.
In addition to continued headline-grabbing litigation involving pharmaceutical companies in the wake of PLIVA Inc. v. Mensing, 2013 brought a number of important cases informing everything from class certification questions and product labeling trends to False Claims Act liability and fracking disputes, say attorneys at Weil Gotshal & Manges LLP.
China's Food and Drug Administration recently announced changes to its Drug Registration Rules, which, while demonstrating the agency’s determination to foster innovation, may not achieve a balance between multinational drug companies and domestic competitors in its current shape, says Katherine Wang of Ropes & Gray LLP.