Risk Assessment and Post-Market Programs
February 09, 2004
How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a "best approach" to post-market co-vigilence.
New Pharmaceutical Agreement Notification Filing Requirements
February 09, 2004
As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice.
FDA Cannot Force an Over-the-Counter Drug Switch
February 09, 2004
Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will? The FDA is currently grappling with this issue, a dispute that has generated substantial controversy, including statements by FDA officials and coverage in leading newspapers.
Pennsylvania Remains a <i>Frye</i> State
February 09, 2004
Chief Justice Ralph J. Cappy of Pennsylvania's Supreme Court issued an opinion on Dec. 31, 2003, declaring that the State of Pennsylvania would remain a "<i>Frye</i> state" and would not follow suit with much of the rest of the nation in using the <i>Daubert</i> test to qualify expert witnesses.
Professional Fees: How to Get a Bankruptcy Judge's Attention
February 09, 2004
How does a bankruptcy professional get the court's attention on fees? Chief Bankruptcy Judge Mary F. Walrath of the District of Delaware answered the question with a detailed 33-page opinion on Dec. 23, 2003. <i>In re Fleming Companies, Inc., et al</i>, 2003 Bankr. LEXIS 1727 (Bankr. D. Del. 2003). Disposing of an objection by the United States Trustee to interim professional fee applications, Judge Walrath said she would "reduce the fees requested by the Debtors' professionals." <i>Id.</i> at 5. Not exactly the kind of attention any lawyer wants.
What Should You Know About the Rules of Evidence?
February 09, 2004
Bankruptcy lawyers who rarely visit a courtroom may think they do not need to worry about the rules of evidence. Yet evidentiary rules can provide critical protections. In a typical case or negotiation, lawyers create and circulate tremendous amounts of information -- much of which would be potentially damaging if obtained by other parties. To protect this information, bankruptcy lawyers need to be familiar with the rules of evidence and how courts have interpreted these rules.
Official Committee Members: Fiduciary Duty Liability
February 09, 2004
Members of official creditors' committees in Chapter 11 cases owe a fiduciary duty to the entire body of unsecured creditors. <i>See Woods v. City National Bank</i>, 312 U.S. 262, 268-69 (1941). As fiduciaries, committee members should have undivided loyalty to those they serve, free of any conflict of interest. <i>Id</i>. The imposition of such a broad duty to unsecured creditors generally might be otherwise unremarkable, except that committee members themselves obviously have significant selfish interests in the outcome of the bankruptcy case.
Render unto Caesar
February 09, 2004
A 70-year-old man was admitted to the hospital for a bowel resection. Following surgery, the patient's condition worsened considerably; He spent months in the ICU on a ventilator, was fed through a gastrostomy tube, and his mental status waned. After some time, it was suspected that his deteriorating condition might be related to sepsis from a bowel perforation. Subsequent surgery confirmed this diagnosis. Attempts to repair the perforation failed, and, ultimately the patient died. Medicare paid the patient's medical bills, which exceeded $500,000. The patient's family commenced a lawsuit, alleging that the surgeon's negligence caused the bowel perforation. During the litigation, the Medicare Trust Fund sent a correspondence to the patient's estate, asserting a claim of reimbursement for the benefits Medicare paid from any recovery that the estate might obtain.
