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Exclusion of Evidence: The FDA's 510K Process Image

Exclusion of Evidence: The FDA's 510K Process

Janice G. Inman

In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.

Features

Children of a Married Same-Sex Couple Image

Children of a Married Same-Sex Couple

Janice G. Inman

<b><i>The Presumption of Legitimacy</i></b><p>In what is being hailed as a landmark decision, New York's Appellate Division, First Department, recently held that the presumption that a child born to a married couple is their legitimate offspring applies not only to biological children of both spouses, but also to children born through more modern means — even when the married parties are in a same-sex marriage.

Columns & Departments

Cooperatives & Condominiums

ljnstaff

Analysis of two key cases.

Features

Criminal Probe of Weinstein Role in amfAR Monies Image

Criminal Probe of Weinstein Role in amfAR Monies

The U.S. Attorney's Office for the Southern District of New York is conducting a criminal investigation into transactions connected to The Foundation for AIDS Research (amfAR) that were arranged by embattled film producer Harvey Weinstein, <i>The New York Times</i> reported. The transactions involved $600,000 raised at a May 2015 auction in Cannes on the French Riviera from a pair of fundraising packages arranged by Weinstein.

Features

The Deductibility of FCA Payments in Light of <b><i>Kokesh</i></b> Image

The Deductibility of FCA Payments in Light of <b><i>Kokesh</i></b>

Joseph F. Savage, Ezekiel L. Hill & Timothy H. Kistner

<b><i>A Business Expense?</i></b><p>In negotiating FCA or similar settlements with the government, one key consideration is the tax treatment of any payment. While not in the context of deductibility, the Supreme Court this year, in<i>Kokesh v. SEC</i>, analyzed whether disgorgement in an SEC enforcement action was punitive or compensatory.

Features

Defenses of Impossibility of Performance and Frustration of Purpose Image

Defenses of Impossibility of Performance and Frustration of Purpose

Thomas J. Hall

Parties in complex commercial cases that are accused of defaulting on or breaching a contract may invoke the defense of impossibility, arguing that performance of contractual obligations was rendered impossible by an intervening event. But under New York law, those arguments rarely make it past the motion stage.

Columns & Departments

IP News

Howard Shire & Michael Block

Federal Circuit Resolves Circuit Split, Finds That Venue Is Not Waived Under Rule 12(h)(1)(A) for Cases Brought before <i>TC HeartLand</i><br>Federal Circuit Reverses Award of Lost Profits Because Product Sold to a Single Customer Was an Available Non- Infringing Alternative

Columns & Departments

Development

ljnstaff

Discussion of a case in which a restaurant owner planned to demolish the existing building on a leased parcel to build a 5400-square-foot restaurant

Columns & Departments

Landlord & Tenant

ljnstaff

In-depth analysis of three major rulings.

Features

Chancery Approves Incorporation of Reference Condition in Section 220 Litigation Image

Chancery Approves Incorporation of Reference Condition in Section 220 Litigation

Brett M. McCartney

Books and records actions are heralded as the "tools at hand" for litigators pursuing shareholder claims against a corporation. In fact, the Delaware Court of Chancery has been critical of litigants who failed to take advantage of a shareholder's right to request the books and records of a corporation prior to commencing litigation against the corporation.

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