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Xarelto Lawyer Ned McWilliams on the implications of FDA Xarelto decisions for users

Levin, Papantonio attorney Ned McWilliams answers client questions regarding Xarelto and the Xarelto lawsuit he recently filed against the drug’s manufacturer Janssen Pharmaceutical (a subsidiary of Johnson & Johnson) and its co-marketer Bayer Healthcare AG.

Q: Ned, what do you see as the central issue of the Xarelto lawsuit?

Ned McWilliams: The real key to the case – the central tenant – is that the drug company has a responsibility to advise doctors and patients on how to use their product in the safest and most effective way – and that means a blood test. Despite clear evidence of the opportunity to reduce bleeding events by way of a simple blood test (done as infrequently as once a year) in which they could identify patients at an elevated risk of a major bleed (relative to other Xarelto patients), its manufacturer has chosen not to provide this information to its customers.

Q: If Xarelto was approved for usage by the FDA and prescribed by my doctor, how could this risk develop now, so shortly after its introduction?

Ned McWilliams: Xarelto was created to offer a safer, easier alternative to warfarin for anticoagulation therapy, a drug which had been on the market for over 50 years and requires routine blood testing and dose adjustments. With strong concerns regarding who could and would benefit from drug testing, The United States Food and Drug Administration fast tracked the approval process for blood-thinning drugs that would not require regular testing and thus be easier to offer for greater wide spread use.

Q: Why wouldn’t Xarelto’s manufacturers and marketers simply ask users to take one test if it would have substantially improved Xarelto’s safety risks?

Ned McWilliams: Pharmaceutical companies like Janssen and its co-marketer Bayer work as for-profit corporations. In this case it’s questionable whether the potential marketing opportunity that the ease of product usage could provide actually drove the product development, not the other way around. Once a day or twice a day usage with no testing implies an easier product to use, one with less side effects than warfarin. So it appears that in the rush to get Xarelto to market and maximize its usage, the makers of the product have disregarded what matters most – the best interests of their customers.

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