Monday, September 7, 2015

Lawsuit By Orange County Against Pharma Companies for Fraudulently Marketing Addictive Painkillers Dismissed On Grounds FDA Had Exclusive Jurisdiction

On August 27, 2015, a California state court dismissed a groundbreaking lawuit filed last year by Orange and Santa Clara counties accusing the companies of fraudulently marketing addictive painkillers to undermine the effect of warning labels required by the U.S. Food and Drug Administration. The counties say that the efforts boosted sales of the dangerous drugs at the expense of public health. See Los Angeles Times article on this ruling.

In Thursday's hearing before Orange County Superior Court Judge Robert J. Moss, the companies asked that the case be dismissed on the grounds that the FDA had exclusive jurisdiction over the matter. The court ruled that the FDA had exclusive jurisdiction.

The 105-page lawsuit, filed in Orange County by District Attorney Tony Rackauckas, alleges five pharmaceutical companies spent millions of dollars to convince the public that drugs meant only for short-term use by cancer patients should be taken for chronic pain.  The marketing campaign changed prescription opioids from a niche drug to an $8 billion industry by 2010 and contributed to more than 16,000 overdose deaths that same year, putting profits above health, the suit states.

The rise in highly addictive painkillers also created an atmosphere where doctors made life-and-death decisions based not on science but on hype and marketing by the company to doctors directly, the suit states. Orange County was hit particularly hard by this epidemic. 

Rackauckas stated in prior interviews that the pharmaceutical companies are like the tobacco industry. “What we’re after is to make these companies stop the practice of false advertising and false claims that these drugs are benign,” he said. “The effort is to require them to be truthful.” The Orange County DA also apparently wanted to capitalize on the fact that Purdue and its executives plead guilty in 2007 to illegally marketing OxyContin.

The lawsuit was filed after an extensive series of Orange County Register columns over 3 years blaming much of the epidemic on drug companies. The lawsuit named Purdue Pharma (maker of OxyContin), Teva Pharmaceutical Industries, Janssen Pharmaceuticals – a subsidiary of Johnson & Johnson, Endo Health Solutions, and Actavis, as well as affiliated companies.

One reason why the lawsuit was filed is that Purdue, which makes the best-selling painkiller OxyContin, has never gone to trial on a case of OxyContin abuse. It has won dismissals in more than 400 personal-injury lawsuits related to the drug. And while it has settled some product-liability cases related to OxyContin under secret terms, Purdue has defeated more than 10 efforts to wage class-actions against it. 

All the companies were accused of false advertising, unfair competition and creating a public nuisance. With the state court dismissal, Orange County and Santa Clara will have to determine whether an appeal will be filed.  The marketing was not geared to patients but to family practice doctors who treat non-cancer patients. 

One of the issues is that FDA only has limited jurisdiction over the marketing of prescription medications directly to physicians. That is left to the Federal Trade Commission. When Purdue Pharma introduced OxyContin in 1996, it was aggressively marketed and highly promoted. Sales grew from $48 million in 1996 to almost $1.1 billion in 2000. Ultimately, the high availability of OxyContin correlated with increased abuse, diversion, and addiction, and by 2008 OxyContin had become a leading drug of abuse in the United States. 


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