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Over the past few months, the Task Force on Drug Importation has held its so-called "listening sessions" with groups and individuals that would be impacted by drug importation, should it be legalized. At the meetings, U.S. Surgeon General Richard H. Carmona served as the chairman over a panel of representatives from the Department of Health and Human Services, as well as from other departments of the federal government with an interest in drug importation issues (see sidebar on page 5). The task force's members are being asked to offer recommendations to Health and Human Services' Secretary Tommy Thompson by December 2004 concerning how best to address key questions posed by Congress as part of the Medicare Prescription Drug Act, such as how drugs can safely be imported, what the impact of such imports would be on incentives to drug research and development, and how much the policing of imports would cost the government.
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The latest rulings of importance to you and your practice.
The truth is apparently no defense for the state when it comes to issuing warning labels for nicotine gums and patches. Recently, the California Supreme Court unanimously ruled in <i>Dowhal v. SmithKline Beecham Consumer Healthcare</i>, 04 C.D.O.S. 3259 that federal regulations trump state statutes when it comes to putting pregnant women on alert about the possible dangers of Nicorette' and other nicotine-replacement therapies -- even if the state warnings are legitimate. "Whether a label is potentially misleading or incomprehensible is essentially a judgment of how the consumer will respond to the language of the label," Justice Joyce Kennard wrote. "A truthful warning of an uncertain or remote danger may mislead the consumer into misjudging the dangers stemming from the use of the product, and consequently making a medically unwise decision."
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In a decision issued March 9 in the case of <i>Pharmaceutical Care Management Ass'n v. Rowe</i>, No. 03-153-B-W, 2004 U.S. Dist. LEXIS 3758 (D. Maine 3/9/04), U.S. District Judge John A. Woodcock Jr. delayed enforcement of a novel Maine law whose intent is to make the business practices of companies that negotiate drug prices on behalf of health plans more transparent. The preliminary injunction has at least temporarily prevented the state of Maine from implementing Maine's 2003 "Act to Protect Against Unfair Prescription Drug Practices (M.R.S.A. ' 2699), known as UPDPA, against pharmaceutical benefits managers (PBMs).
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Without disease and illness, there would be no need for life science companies or the products that they develop. Some modern maladies and ailments present more challenges than opportunities for biotech and medical device firms. Severe Acute Respiratory Syndrome (SARS) and comparable pathogens present medical device and life science manufacturers with new and daunting risks. One such peril lies in the realm of product liability.
In last month's newsletter, we discussed the financial burdens pharmaceutical and biotech firms face due to the Patent and Trademark Office's (PTO) policy of restriction practice -- the restriction of a patent application to prosecution of a single claimed invention per filing fee. Now we look at ways potential patentees can economically work with these restrictions.
Health and Human Services Secretary Tommy G. Thompson announced on Feb. 26 that a task force had been created to advise and assist HHS in determining whether and how drug importation into the United States could be conducted safely. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) directed the HHS to lead a comprehensive study to be completed by December 2004, gauging both the positive and negative effects that can be expected on the health of American patients, on medical costs and on the development of new medicines if pharmaceutical products are imported into the United States from countries with lower drug prices.
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The latest rulings of interest to your practice.
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As most pharmaceutical and medical device products liability cases are based on state law claims, diversity jurisdiction may be the only way to obtain a federal forum. Plaintiffs often join non-diverse defendants, such as local doctors, hospitals, pharmacies, employees and/or sales representatives, in an attempt to defeat diversity jurisdiction and prevent removal of cases to federal court. Defendants -- who generally prefer to proceed in federal court -- may be able to remove such cases for fraudulent joinder using some of the following arguments.