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News from the FDA Image

News from the FDA

ALM Staff & Law Journal Newsletters

Agency news you need to know.

Reducing Frivolous Litigation Image

Reducing Frivolous Litigation

Michael R. McDonald, Kim M. Catullo & Michelle M. Bufano

Frivolous lawsuits are one of the most problematic issues facing drug and medical device companies today. Many frivolous lawsuits are either ultimately dismissed for lack of causation after years of litigation and the expenditure of exorbitant sums of money in defense costs, or settled by corporations that are not culpable, but "litigation-weary." This waste of time and resources easily could be avoided if plaintiffs were required to submit an affidavit of merit with respect to product defect and/or causation at the inception of the case. Part One of a Two-Part Article.

Features

Clinical Trial Transparency Image

Clinical Trial Transparency

Janice G. Inman

There's a newly urgent push from outside the pharmaceutical research and development community to get drug firms to disclose the results of all tests conducted on new drugs, even those that don't lead to the marketing of new medications.

Case Briefing Image

Case Briefing

ALM Staff & Law Journal Newsletters

Recent rulings of interest to you and your practice.

Features

Rogue Online Drugstores Image

Rogue Online Drugstores

Vivian Quinn & Jacob Herstek

In last month's newsletter, we looked at the problems posed by online pharmaceutical distributors that do not follow good pharmacy practice. These "rogue" pharmaceutical sites may be buying expired, substandard, contaminated or counterfeited products. Some sell without requiring customers to present prescriptions. The consumer may not be receiving proper medical oversight, which can result in administration of incorrect dosages, wrong or contraindicated drugs, or medication without adequate directions for use. These activities risk the reputations of pharmaceutical manufacturers and put them in greater peril of being sued by consumers whose adverse medical reactions could have been avoided. So, what can be done about it? Part Two of a Two-Part Article.

Features

In the Spotlight: Don't Leave 'Air Quality' Out of the Lease Image

In the Spotlight: Don't Leave 'Air Quality' Out of the Lease

William Crowe

Air quality standards are frequently not satisfactorily addressed in leases, if they are addressed at all. Most sophisticated office leases will require a landlord to provide certain temperature and humidity levels during specified times. A typical clause provides that the landlord will provide HVAC service from 8:00 a.m. to 6:00 p.m., Monday through Friday, and perhaps from 8:00 a.m. to 12:00 p.m. on Saturdays. Sometimes the actual dry and wet bulb temperature and humidity levels will be specified, and in other instances the lease will simply provide that temperature and humidity levels will be in accordance with first-class standards. These provisions, however, do not address air quality, including cooking odors or exhaust fumes which may infiltrate the building's air system and end up in a tenant's space.

Features

The Leasing Hotline Image

The Leasing Hotline

ALM Staff & Law Journal Newsletters

Highlights of the latest commercial leasing cases from around the country.

'Use Clauses' and the Bankruptcy Code: A Cautionary Tale Image

'Use Clauses' and the Bankruptcy Code: A Cautionary Tale

James A. Vidmar, Jr.

The recent Chapter 11 bankruptcy of Trak Auto Corporation ("Trak Auto"), the retail auto parts chain, has yielded a reported decision of the U.S. Fourth Circuit Court of Appeals that offers some insights for landlords on how "use clauses" in leases will be put under the bankruptcy microscope. <i>In re Trak Auto Corporation</i>, 42 B.R. 255 (4th Cir. 2004).

Features

It's Just a Phase: Issues and Answers for Landlords When Phasing a Project Image

It's Just a Phase: Issues and Answers for Landlords When Phasing a Project

Ira Fierstein

In today's larger community centers, the developer is often faced with the need to construct the shopping center in phases, either to ensure adequate tenancies before undertaking the next portion of the center or to negotiate a sale of a portion of the shopping center to a large department store user who has its own agenda on when to construct its store. In either case, it is necessary for the developer to address the construction timing of the various phases and to deal with the issue of whether certain phases will be built at all. This article focuses on certain provisions the landlord needs to incorporate into its leases to protect itself in these situations.

Some Less-Traveled Areas of Due Diligence for Commercial Tenants and Their Counsel Image

Some Less-Traveled Areas of Due Diligence for Commercial Tenants and Their Counsel

Jennifer Burton

In addition to focusing upon the oft-quoted mantra about location, sophisticated commercial tenants often recognize that a well-drafted commercial lease can be worth its weight in gold. On the other hand, when seeking legal input focused upon the lease document, commercial tenants (and perhaps their counsel) sometimes overlook the full range of value that counsel can bring to the property selection due diligence process.

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