A bit of interesting news has been flying under the radar involving a legal skirmish between Japanese drug maker Daiichi-Sankyo, manufacturer of the hypertension medication Benicar, and a couple of upstart companies that would like to produce and market their own generic versions. A federal judge's recent ruling on non-infringement of patent will allow Apotex, Inc. to enter the generic market earlier than it would have otherwise – but given the ongoing controversies over the drug, it's hard to know why it would want to.
Presently, allegations that olmesartan, used to treat high blood pressure, has been resulting a life-threatening intestinal condition known as sprue-like enteropathy, continues to spawn legal actions across the nation. The primary symptom of this condition is servere, ongoing diarrhea and severe, sudden weight loss. This is the result of the victim's system being unable to absorb nutrients. In essence, the patient can literally starve to death (and some have). According to a French research study in May of 2014, the increased risk of developing sprue-like enteropathy starts about twelve months after treatment begins; after two years, the risk factor goes up by over 950%. Plaintiffs allege that Daiichi-Sanyo failed to warn doctors and patients about the possible side-effects of the medication. Indeed, clinical trials lasted only three months, though most patients are prescribed Benicar for much longer periods.
If true, chances are good that Daichii-Sankyo, like so many other Big Pharma corporations, are willing to risk a few million dollars in judgments and human lives to preserve its profit margins. Appallingly, this happens. A manufacturer of a product realizes there is a problem, and the bean-counters analyze how much it would cost to fix the problem as opposed to having to pay out settlements in court. If the latter figure is smaller, the product goes to market, profits are made, people get hurt or killed – and the money paid out to settle the lawsuits are considered the cost of doing business.
This Japanese pharmaceutical giant is also not above breaking the law in order to get sales. Recently, Daiichi-Sankyo had to fork over $39 million in order to settle allegations that the company had paid kickbacks to physicians as incentives to prescribe its products – including Benicar – in violation of the federal False Claims Act.
Recently, the U.S. Judicial Panel on Multidistrict Litigation transferred 15 Benicar lawsuits to a federal court in New Jersey, where Daiichi Sankyo and Forest Laboratories maintain their U.S. headquarters. It is more likely that witnesses and documents relative to the case will be more easily accessible the defendants' home state, where forty additional Benicar lawsuits have been consolidated before the state Superior Court.
For more information on the Benicar litigation, visit Levin Papantonio's Benicar Lawsuit web site.