Online: Web Site Advocates Health Care, Prescription Drug Access

The Community Catalyst created the Prescription Access Litigation Project (“PAL”) in 2001 to use class action litigation and public education to end pharmaceutical price inflation. The Community Catalyst is a national advocacy organization that encourages consumer and community participation in the molding of our health system to ensure quality, affordable health care for everyone. Visit the Web site at www.communitycatalyst.org.

According to PAL, prescription drug prices in the United States are the highest in the world and have become a significant barrier to increasing access to health care in the United States. Because of the drug industry's powerful legislative lobby, PAL chose the courts as a value-added, relatively level playing field through which the industry's alleged inflationary practices can be stopped.

PAL is a diverse coalition of more than 92 organizations, including state-based groups representing 35 states and the District of Columbia, as well as several national organizations. Three class action firms act as counsel in PAL's litigation efforts and AARP's Litigation Arm, AARP Foundation Litigation, serves as co-counsel on several cases.

PAL's cases challenge a variety of practices that are regularly committed by pharmaceutical industry players and that it considers illegal. It maintains that these lawsuits, which seek to bring an end to these practices, have great potential to change industry behavior and in turn increase consumer access to vital drugs. Some of the practices that PAL is challenging are:

1) Anticompetitive Practices: New drugs are subject to multiyear patent protections during which no other manufacturer can sell an equivalent drug. Brand name drug manufacturers often try to extend these patents beyond their legal limit because of the huge profit margins they generate by keeping less expensive (typically 30% to 70% cheaper) generics off the market. PAL and its partners have already reached settlements in several cases involving, eg, BuSpar, Relafen, Augmentin, Neurontin I and Wellbutrin. In addition, PAL has challenged alleged illicit anticompetitive agreements involving Cipro, K-Dur and Tamoxifen.

2) Improper Drug Promotions: A number of pharmaceutical companies promote “off-label” usage (those outside of specific indications approved by the FDA) of certain drugs. In so doing, they circumvent FDA safety and efficacy regulations requiring them to test and seek approval for each use. PAL has filed cases revolving around the off-label promotions of Bextra, Estratest and Neurontin (the Neurontin II case).

3) Price Manipulation: Drug manufacturers can inflate drug prices through use of the “average wholesale price. (AWP)” PAL has charged drug manufacturers with providing extremely inflated figures rather than an average wholesale price and then using these inaccurate price lists as the basis for sales to most large

buyers, including Medicaid and Medicare, to generate large profits. See, eg, the Lupron and the AWP megacase. Pharmacy benefit managers (PBMs) were created to save money for prescription drug buyers. PBMs negotiate prices with drug manufacturers. According to PAL, they typically do so in secret and only return a portion of the savings to the consumer. PAL has filed suit against the nation's four largest PBMs in order to challenge this practice and require them to comply with their fiduciary duty to consumers.

The PAL Web site includes links to all of the cases referred to, as well as to the law firms that represent plaintiffs. If you click on Neurontin, for example, you can learn about the drug, its patent background and litigation history. (See John Patrick Oroho, Howard J. Schwartz, and Elizabeth A. Brophy “Today's Pharmaceutical Investigation Is Tomorrow's Product Liability Lawsuit, infra page 3.) There is a link to a July press release about a settlement with GlaxoSmithKline Corporation over Augmentin. In fact, there are links to all of PAL's current cases, organized by the name of the drug. In addition, there's a link to an article discussing whether Medicare drug cards really provide discounts, a list of PAL's coalition members by state, and additional resources for consumers. The resources include press releases organized as Industry Background, Information on Drug Marketing Solutions and Policy Updates.

The Community Catalyst created the Prescription Access Litigation Project (“PAL”) in 2001 to use class action litigation and public education to end pharmaceutical price inflation. The Community Catalyst is a national advocacy organization that encourages consumer and community participation in the molding of our health system to ensure quality, affordable health care for everyone. Visit the Web site at www.communitycatalyst.org.

According to PAL, prescription drug prices in the United States are the highest in the world and have become a significant barrier to increasing access to health care in the United States. Because of the drug industry's powerful legislative lobby, PAL chose the courts as a value-added, relatively level playing field through which the industry's alleged inflationary practices can be stopped.

PAL is a diverse coalition of more than 92 organizations, including state-based groups representing 35 states and the District of Columbia, as well as several national organizations. Three class action firms act as counsel in PAL's litigation efforts and AARP's Litigation Arm, AARP Foundation Litigation, serves as co-counsel on several cases.

PAL's cases challenge a variety of practices that are regularly committed by pharmaceutical industry players and that it considers illegal. It maintains that these lawsuits, which seek to bring an end to these practices, have great potential to change industry behavior and in turn increase consumer access to vital drugs. Some of the practices that PAL is challenging are:

1) Anticompetitive Practices: New drugs are subject to multiyear patent protections during which no other manufacturer can sell an equivalent drug. Brand name drug manufacturers often try to extend these patents beyond their legal limit because of the huge profit margins they generate by keeping less expensive (typically 30% to 70% cheaper) generics off the market. PAL and its partners have already reached settlements in several cases involving, eg, BuSpar, Relafen, Augmentin, Neurontin I and Wellbutrin. In addition, PAL has challenged alleged illicit anticompetitive agreements involving Cipro, K-Dur and Tamoxifen.

2) Improper Drug Promotions: A number of pharmaceutical companies promote “off-label” usage (those outside of specific indications approved by the FDA) of certain drugs. In so doing, they circumvent FDA safety and efficacy regulations requiring them to test and seek approval for each use. PAL has filed cases revolving around the off-label promotions of Bextra, Estratest and Neurontin (the Neurontin II case).

3) Price Manipulation: Drug manufacturers can inflate drug prices through use of the “average wholesale price. (AWP)” PAL has charged drug manufacturers with providing extremely inflated figures rather than an average wholesale price and then using these inaccurate price lists as the basis for sales to most large

buyers, including Medicaid and Medicare, to generate large profits. See, eg, the Lupron and the AWP megacase. Pharmacy benefit managers (PBMs) were created to save money for prescription drug buyers. PBMs negotiate prices with drug manufacturers. According to PAL, they typically do so in secret and only return a portion of the savings to the consumer. PAL has filed suit against the nation's four largest PBMs in order to challenge this practice and require them to comply with their fiduciary duty to consumers.

The PAL Web site includes links to all of the cases referred to, as well as to the law firms that represent plaintiffs. If you click on Neurontin, for example, you can learn about the drug, its patent background and litigation history. (See John Patrick Oroho, Howard J. Schwartz, and Elizabeth A. Brophy “Today's Pharmaceutical Investigation Is Tomorrow's Product Liability Lawsuit, infra page 3.) There is a link to a July press release about a settlement with GlaxoSmithKline Corporation over Augmentin. In fact, there are links to all of PAL's current cases, organized by the name of the drug. In addition, there's a link to an article discussing whether Medicare drug cards really provide discounts, a list of PAL's coalition members by state, and additional resources for consumers. The resources include press releases organized as Industry Background, Information on Drug Marketing Solutions and Policy Updates.