Manufacturers of Cymbalta and Risperdal Face Accusations of False Advertising
Drug manufacturers Eli Lilly & Company and Johnson & Johnson are facing expensive civil litigation for injuries caused by their drugs, Cymbalta and Risperdal. Lilly's Cymbalta is a popular anti-depressant that has been linked to severe withdrawal symptoms while Johnson's Risperdal is a anti-psychotic drug that has caused male breast growth. These cases are similar because both manufacturers have been accused of misleading doctors and consumers with false advertisements, inaccurate reports of risks, and statements that downplayed the the severity of side effects.
Lawsuits Accuse Misleading Advertisements Hid Cymbalta Withdrawal Effects
The central argument made by the plaintiffs in lawsuits against Eli Lilly is that that company mislead consumers with a series of aggressive advertisements that highlighted the positive effects of Cymbalta and downplayed, or ignored, the potential risks of withdrawal side effects. Recently, the US Food and Drug Administration (FDA) released results of an agency study that found:
- Clinical studies of abrupt discontinuation of Cymbalta show that withdrawal occurred in 44 to 50% of patients
- Of patients suffering withdrawal symptoms, 10% of those were severe
- Half of the patients who reported Cymbalta withdrawal had not resolved the side effects at the end of the two week study
The FDA’s study also pointed out that there had been “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],” which suggests that Eli Lilly was aware of the potential side effects from Cymbalta withdrawal and provided neither the FDA nor the American public with adequate warning of the risks.
The problems with Eli Lilly's Cymbalta advertising is nothing new. The company was fined in 2007 and 2009 by the FDA for unlawfully promoting Cymbalta through mailings that gave false statements that overstated the effect of the drug and downplaying clinical studies that revealed risks of Cymbalta withdrawal. Further, the company has been accused of selectively publishing study results that over-exaggerate the effect of Cymbalta and hide the risks. Citing the history of Eli Lilly’s fines by the FDA and the suspicion that the company provided misleading study results, plaintiffs claim that the company has established a pattern of falsified advertising to press Cymbalta on patients without adequate warning of the risks.
Risperdal Patients Claim Johnson & Johnson Failed to Provide Adequate Warning
Johnson & Johnson's anti-psychotic Risperdal has resulted in serious side effects among some youth and adult males. Some male users have suffered from gynecomastia - the growth of male breasts - and galactorrhea - milk leakage from the breasts. In addition to physical discomfort and the possibility of corrective surgery, young men suffering from Risperdal's side effects have reported severe emotional trauma as a result of their injuries. Like the Cymbalta plaintiffs, civil litigants seeking damages from Johnson & Johnson accuse the company of providing misleading information regarding Risperdal use - leading many people to take the drug unaware of the risks. Specifically, Johnson & Johnson is accused of:
- Failing to publish or report studies that found negative side effects associated with Risperdal
- Paying medical writers and scientists to produce favorable studies or to attach their name to reports written by Johnson & Johnson that downplayed Risperdal side effects.
- Failing to provide accurate reports to the FDA about the adverse effects of Risperdal
- Awardeding grants to doctors for promoting and prescribing Risperdal
- Marketing use of Risperdal beyond what was approved by the FDA. Specifically, the company promoted use of the drug for bi-polar disorder before the FDA approved.
- Providing health care professionals with misleading information to downplay the risks that the FDA required be added to Risperdal warning label.
In addition to pending civil litigation, Johnson & Johnson has paid significant fines and judgments to states across the country for unlawful marketing and promotion of Risperdal. The company has been fined $1.1 billion in Arkansas, and recently settled criminal accusations in 36 other states for $181 million. Additionally, the company is working out the details of a $2.2 billion settlement with the federal government to close a large scale investigation into Risperdal advertising. Whether or not the fines and lawsuits will impact the way either company does business or advertises its drugs remains to be seen, however, the publicity Cymbalta and Risperdal have received should serve notice to patients and physicians.