On March 13, 2003, Tommy G. Thompson, Secretary of the U.S. Department of Health and Human Services (HHS), announced two proposed rules from the Food and Drug Administration (FDA) that are intended to improve patient safety and are part of a strategic initiative by the FDA to reduce adverse events involving products that it regulates.

A settlement in principle has been reached between the FTC and giant drug manufacturer Bristol-Myers Squibb Company (whose total domestic net sales last year exceeded $13 billion). On March 7, 2003, the FTC announced the settlement. It resolves allegations filed by the FTC (In the Matter of Bristol-Myers Squibb Company) that the company violated federal antitrust laws and abused FDA's regulatory process in preventing generic drug manufacturers from competing against three of its widely prescribed products ' Taxol ' (paclitaxel) and Platinol (anti-cancer drugs), and BuSpar' (an anti-anxiety drug). The result of Bristol-Myers' conduct, according to the government, was that consumers were forced to pay hundreds of millions more than they needed to had generic products been available.

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In a recent article in this newsletter, we described a hypothetical situation about a publicly traded health care entity that was under attack by government regulators, disgruntled shareholders, and likely a qui tam relator. See, Michael E. Clark, Proffer Agreements May Be a Viable Strategy for Negotiating with Government, (Health Care Fraud & Abuse Newsletter, October 2002). This hypothetical situation continues in this article, as we illustrate some of the heightened compliance risks facing officers, directors, and attorneys who represent publicly traded entities as a result of The Sarbanes-Oxley Act of 2002 ('Sarbanes-Oxley'), Pub. L. 107-204, 116 Stat. 745 (2002), which ushered in major reform measures when signed into law on July 30, 2002 (and also in light of other proposals for strengthening corporate accountability from the major self regulatory organizations and exchanges: the National Association of Securities Dealers (NASD) (see NASDAQ Corporate Governance Proposals, September 13, 2002) and The New York Stock Exchange (NYSE) (see Corporate Governance Rules Proposals Reflecting Recommendations from the NYSE Corporate Accountability and Listings Standards Committee As Approved by the NYSE Board of Directors, August 1, 2002).

Highlights of the latest franchising news from around the country.

Highlights of the latest franchising cases from around the country.

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If a company ceases to expand its brand and market penetration through the sale of franchises as part of a plan to convert to an employee-based operation, is it exposed to liability for breach of the implied covenant of good faith and fair dealing? The answer is yes, according to one California appellate court. In <i>Sherman v. Master Protection Corp.</i>, 2002 WL 31854905 (Cal. App. 6 Dist. Dec. 18, 2002)(rev. den. April 9, 2003) [Business Franchise Guide (CCH) '12,503], a non-published decision, a unanimous three-judge panel of the California Court of Appeal for the Sixth District recently awarded damages and legal fees to a franchisee on that very basis.

Licensors, manufacturers, and other businesses that find themselves as unwitting franchisors face interesting issues when they attempt to enforce an arbitration clause. Most registration states will usually have statutory provisions that declare that the sale of an unregistered franchise or the sale of a franchise without the required disclosure is unlawful. <i>See, e.g.,</i> Cal. Corp. Code '' 31110, 31119; 815 Ill.Comp.Stat. ' 705/5; N.Y. Gen. Bus. Law ' 683.1; Wash. Rev. Code ' 19.100.020.(1). However, in the usual case, the sale is not declared to be void, but is voidable through an action for rescission. <i>See, e.g.</i> Cal. Corp. Code '' 31300; Wash. Rev. Code ' 19.100.190(2); N.Y. Gen. Bus. Law ' 691; 815 Ill.Comp.Stat. ' 705/26.

Highlights of the latest franchising cases from around the country.