Lilly set for Cymbalta lawsuit showdown
pharmafile | August 5, 2015 | News story | Research and Development | cymbalta, duloxetine, lawsuit, lilly
Lilly is contesting the first in a series of lawsuits brought by patients who say the company failed to inform them about the withdrawal symptoms of its antidepressant drug, Cymbalta.
The first trial begins this week in a federal court in California. A similar case is also set to be heard in California, along with two more due to start in Virginia, later this month. Overall there are about 5,000 claims that Lilly downplayed the effects of serious withdrawal symptoms caused by stopping treatment with Cymbalta (duloxetine), including neurological symptoms such as electrical shock sensations, anxiety, nausea, vomiting and insomnia.
According to court documents, former Cymbalta users say Lilly downplayed the withdrawal risks on the drug’s warning label. Lilly says that only about 2% of people who took the drug experienced side effects when coming off the medication.
However, the lawsuits claim that some studies have found more than 40% of Cymbalta patients have at least one withdrawal side effects after stopping the medicine, according to a 2005 study published in the Journal of Affective Disorders. It also claims that Lilly disclosed on warning labels in Europe that 45% of users reported experiencing withdrawal symptoms after they stopped taking the drug,
The early cases could be a critical test of litigation over the drug. R. Brent Wisner, a lawyer for the plaintiff in the first California case, told Reuters: “The success or failure of these cases will give us a good sense of how they are playing to these juries. Even if we lose, we have every intention of moving forward with the litigation.”
Cymbalta brought in $3.9 billion in sales in 2013, before losing patent protection at the end of that year. It posted $561 million revenue during the first half of 2015 – a 36% decline so far this year.
Lilly’s latest financial results show the company’s revenue increased by 1% with the inclusion of higher volume sales of several products, including Cyramza (ramucirumab) and Trulicity (dulaglutide). But the firm says these factors “were largely offset by the unfavourable effect of foreign exchange rates and the residual impact of Cymbalta and Evista (raloxifene) patent expirations…. in December 2013 and March 2014, respectively.”
In the second quarter of 2015, Cymbalta generated $274.1 million of sales, a decline of 32% compared with the second quarter of 2014. Overall Lilly’s second quarter revenue was $4.98 billion, up slightly from $4.94 in the second quarter of 2014.
Nonetheless John Lechleiter, Lilly’s chairman, president and chief executive, remained upbeat. “Lilly remains on track to return to growth in 2015, driven by strong underlying business performance, including uptake of our recently launched products – Jardiance, Trulicity and Cyramza”, he says.
“With tangible results from launches of new medicines and continued progress in our pipeline, along with careful control of operational expenses, we are confident that our innovation-based strategy will continue to provide the basis for solid growth in the years ahead.”
Lilian Anekwe
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