We Need a No-Fault Compensation System for Drug Injuries
The FDA's approval of a prescription drug or biologic is the product of an often-delicate risk-benefit analysis of public benefit as opposed to individual safety. The therapeutic balance of these products must always be weighed against the risks inherent in their use. And there are always inherent risks associated with their use. Accordingly, while millions of Americans reap the benefits of prescription drugs every day, these same drugs may pose an unavoidable health hazard to a narrow, and often unidentifiable, subset of potential users. The American legal system currently regulates these risks by two means ' through the federal regulatory system as administered by the FDA, and through the common-law tort liability regime.
When Is Compliance Necessary?
The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.
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As discussed in the article 'Statewide Coordination of Mass Tort Cases Becoming Increasingly Popular,' <i>infra,</i> page 3, three states now provide statewide coordination of mass tort cases similar to the Multidistrict Litigation System (MDL) in the federal courts.
CASE NOTES
Highlights of the latest product liability cases from around the country.
Statewide Coordination of Mass Tort Cases Becoming Increasingly Popular
On January 24, 2002, the New York state courts adopted a rule that provides a procedure for the statewide coordination of mass tort cases that is similar to the Multidistrict Litigation System (MDL) in the federal courts. Uniform Rules for the New York State Trial Courts ' 202.69. With the implementation of Rule 202.69, New York is the third state, following California and Pennsylvania, to institute formal statewide coordination of mass tort cases that share common questions of law or fact (New York had previously followed an ad hoc coordination system). <i>See</i> Daniel Wise, 'New York Courts Adopt Federal Mass Torts Plan,' 2/22/2002 NYLJ 1 (col.5); Ca. Civ. Proc. '' 404.1, <i>et seq.</i>; Ca. St. Trial Ct. Rules 1501, <i>et seq.</i>; Pa. R. Civ. P. '' 213.1, 1041.1, 1041.2.
Inside the RIAA Suits
Until recently, it was generally believed that public relations and business concerns would prevent large copyright holders, such as record labels, from suing file sharers, who are also likely to be their consumers. Copyright owners have long avoided suing direct infringers for file-sharing due to obvious concerns: The cost and the negative publicity associated with filing multiple lawsuits against individual users would be overwhelming. However, this month, the Recording Industry Association of America (RIAA) filed 261 civil complaints against people who have allegedly distributed copyrighted music on peer-to-peer (P2P) networks.
Courts Turn Up Corporate Heat
The highly publicized accounting scandals at Enron, WorldCom and other large corporations have prompted a concerted legislative and regulatory response from Congress, the Securities and Exchange Commission (SEC), and the national securities exchanges. While there has been little in the way of legislative reaction at the state level, several recent court decisions reflect that state corporate law is not immune from the impact of these scandals. Using existing judicial doctrine, but applying it in a fashion that appears to indicate an increasing toughness with respect to corporate directors and officers who do not live up to their obligations, the judiciary has turned up the heat on corporate fiduciaries.
Out of Bounds: Radius Restrictions in Shopping Center Leases
A common restrictive covenant in shopping center leases is the so-called "radius restriction," a lease provision that prohibits a tenant from opening a competing establishment within a proscribed distance from the present location. Typically, a radius restriction goes hand in hand with a percentage rent provision, which allows the landlord to participate in the tenant's gross sales after a certain threshold or "break point" is achieved.
