When to Pursue a Cymbalta Lawsuit

In the wake of studies that indicate anti-depressant medication Cymbalta is linked to potentially serious side effects and withdrawal symptoms, affected patients and their attorneys are turning attention to legal liability for the drug’s manufacturer, Eli Lilly & Company.  As lawsuits against Eli Lilly are prepared and filed, allegations have emerged that the company was well aware of the negative symptoms associated with Cymbalta withdrawal yet mislead consumers to hide risks and encourage sales.

Inadequate Warnings of Cymbalta Withdrawal Symptoms

Although the symptoms of Cymbalta withdrawal have become well documented by the Food and Drug Administration, Eli Lilly has not acknowledged in its marketing campaigns or drug warnings that the risk of withdrawal symptoms is severe.  Eli Lilly’s Cymbalta label reads, as of 2011, that “symptoms occurred at a rate greater than or equal to 1%” of users – a warning that, while technically true, makes it easy for Cymbalta users and health care professionals to be unaware that symptoms were present in 44 – 50% of users. 

While the label lists several potential symptoms of Cymbalta withdrawal, it is notably unclear on how frequent these symptoms occur to the point where plaintiffs in lawsuits against the company claim they were mislead into thinking the drug carried very little risk.  For more information about the risks and symptoms of Cymbalta withdrawal, click here.

Eli Lilly & Company’s History of Misleading Marketing

Cymbalta is marketed as a treatment for depression, anxiety, fibromyalgia, and even muscular or skeletal pain.  Primarily an anti-depression medication, risks associated with Cymbalta have been listed, but the frequency and severity of the side effects have not been made clear to potential consumers of the drug.  Eli Lilly’s marketing techniques have attracted the attention of the FDA and other medical professionals before:

• In 2009, the company was criminally prosecuted by the US Department of Justice for concealing the adverse side effects of its anti-psychotic drug Zyprexa.  Lilly ultimately pled guilty and settled for over $1.5 billion.
• In 2007, the FDA penalized Lilly for unlawfully promoting Cymbalta products through direct mailings.  The FDA issued the penalty because Lilly’s ad was “false or misleading [and] overstated the efficacy of Cymbalta” by suggesting results that had “not been demonstrated by substantial evidence of substantial clinical experience.”  The FDA penalty also cited Lilly’s failure to reveal material facts including precautions relating to abrupt discontinuation of Cymbalta.
• Lilly was penalized again in 2009 for illegally marketing Cymbalta by failing to include relevant risk information of side effects associated with use of the drug.

Eli Lilly & Company has developed a documented history of misleading, or potentially misleading, marketing campaigns that both overstate the effect of Cymbalta and downplay its risks.  With the drug being aggressively marketed on television, online ads, and mailers, users have been exposed to significant advertisement that may not provide the facts regarding Cymbalta withdrawal symptoms.

What Eli Lilly Knew About Cymbalta

A recent lawsuit against Eli Lilly & Company alleges that the manufacturer had conducted internal clinical tests to determine that the risk of Cymbalta withdrawal symptoms was between 44 – 50%, with up to 30% of patients experiencing “moderate to severe” symptoms.  The results of these clinical trials were submitted to the FDA in 2004 when the company was attempting to have the drug approved, however, these results were not made clear via drug labels or warnings in marketing campaigns.

Lilly has also been accused of selectively publishing studies and clinical test results to present a favorable impression the Cymbalta users were at very low risk for withdrawal symptoms.  A recent study published in the New England Journal of Medicine exposed “a bias toward the publication of positive results” that both downplayed the risks of Cymbalta by selectively reporting test results to the FDA and over-exaggerating the effectiveness of Cymbalta by up to 33%. 

The FDA has acknowledged “a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage [the side effects],” indicating that Lilly was aware of the severity of the risks and downplayed the side effects in its marketing campaigns and warning labels. 

Cymbalta Lawsuits Against Eli Lilly & Company

Plaintiffs and attorneys are preparing and filing lawsuits against Eli Lilly & Company that allege Cymbalta marketing has been misleading and failed to adequately warn patients of the drug’s risks and addictive qualities.  The degree to which Lilly was aware of the drug’s risks and hid the facts through misleading marketing campaigns can be a significant factor in the right of Cymbalta victims to recover financial damages for their pain and suffering.