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Exclusion of Evidence: The FDA's 510K Process
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. 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. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?
510(k) Approval
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Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Law Firms are Reducing Redundant Real Estate by Bringing Support Services Back to the Office
A trend analysis of the benefits and challenges of bringing back administrative, word processing and billing services to law offices.
Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
Risks of “Baseball Arbitration” in Resolving Real Estate Disputes
“Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
One Overlooked Element of Executive Safety: Data Privacy
Executives have access to some of the company's most sensitive information, and they're increasingly being targeted by hackers looking to steal company secrets or to perpetrate cybercrimes.