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.
The Presumption of Legitimacy
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.
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, The New York Times 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.
A Business Expense?
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, inKokesh v. SEC, analyzed whether disgorgement in an SEC enforcement action was punitive or compensatory.
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.
Federal Circuit Resolves Circuit Split, Finds That Venue Is Not Waived Under Rule 12(h)(1)(A) for Cases Brought before TC HeartLand
Federal Circuit Reverses Award of Lost Profits Because Product Sold to a Single Customer Was an Available Non- Infringing Alternative
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
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.
