We have been representing patients and their family in drug injury lawsuits for the past 16 years and this is our main practice area.
Drug injury legal compensation cases involve personal injury or wrongful death claims filed on behalf of people who, unfortunately, experienced a serious side effect, had an adverse drug reaction, or died from their use of a prescription medication.
Given our many years of experience handling these types of lawsuits we know drug injury cases deserve special attention.
Drug injury claims have a personal aspect which must be appreciated and respected by the attorney handling your case. At our law firm, we do not underestimate nor lose sight of the trust which is being placed in us by clients when they select us to represent them for their lawsuit against the responsible pharmaceutical company.
We will handle your drug injury case not only competently and professionally, but with genuine care and understanding. Any inquiries from our clients are responded to promptly, and telephone calls are always returned without delay.
If you, relatives, or friends need legal advice or legal representation for a personal injury lawsuit or a wrongful death lawsuit involving a drug side effect, the Law Offices of Thomas J. Lamb is here to help.
We encourage you to submit a Drug Injury Law Case Review — it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, or some other lawyer — about your case based on his many years of experience.
We handle these drug injury cases on a contingency fee basis, meaning that there is no payment for our legal services until we are successful in getting legal compensation for you.
While our office is in Wilmington, North Carolina, we have successfully handled drug injury lawsuits for people all over the United States.
It is important to note that we do not put our clients into large class actions. Rather we favor an individual lawsuit approach, which allows us to give personal attention to each of our clients, from start to finish.
Legal & Medical News: Featured Article
As background, Xarelto (rivaroxaban) belongs to a class of medicines known as the direct oral anticoagulants (DOAC), which also includes Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban). These still relatively new blood thinners have gained popularity in place of warfarin for the prevention of ischemic stroke in non-valvular atrial fibrillation because, as currently approved by the FDA, routine blood monitoring is not required.
According to this BMJ medical journal article, “Rivaroxaban: can we trust the evidence?”, published on February 3, 2016, a faulty medical device used in the clinical trial leading to the FDA’s approval of Xarelto (rivaroxaban) has called those results into question.
But in this letter to the New England Journal of Medicine (NEJM), “Point-of-Care Warfarin Monitoring in the ROCKET AF Trial”, also published on February 3, 2016, the medical researchers who conducted that Xarelto clinical trial conclude that the use of this device “did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial.”
However, going back to the BMJ article, we get this counterpoint:
In a letter submitted to the NEJM (as yet unpublished) and shown to The BMJ, former FDA cardiovascular and renal drug reviewer, Thomas Marcinicak, says: “The care for the warfarin control arm patients [in ROCKET-AF] appears to have been compromised.”
The medical device at issue, which was later recalled by the FDA, allegedly is prone to giving falsely low INR readings. In the context of this Xarelto clinical trial, such readings would have prompted higher doses of warfarin being given to participants — resulting in higher bleeding risks for those given that warfarin — making Xarelto seem comparatively safer.
Perhaps is the most interesting part of the February 2016 BMJ article, “Rivaroxaban: can we trust the evidence?”, is a possible unexpected result flowing from this current Xarelto controversy:
At the end of 2015, both the EMA and the FDA held meetings to discuss the need to measure blood levels of direct oral anticoagulants and adjust the dose accordingly to maximise benefit and minimise harm—despite all the manufacturers claiming that this is not necessary. The meetings were held after The BMJ revealed that Boerhinger Ingelheim, manufacturers of dabigatran, withheld analyses from the regulators that showed how many major bleeds could be prevented by monitoring anticoagulant activity and adjusting the dose.
A presentation to EMA last year by Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, suggests that the FDA believes there is a scientific argument for measuring the blood levels of these drugs and adjusting the dose.
However, the latest on this front is found in the February 16, 2016 Reuters news report, “Xarelto trial results reaffirmed despite faulty device”:
Europe’s drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer’s top-selling anti-clotting drug Xarelto did not distort the study’s main findings.
“Xarelto can continue to be used as before, in line with the current prescribing information,” the European Medicines Agency (EMA) said on its website.
While the EMA has now made its determination, we wait to see what this current Xarelto fiasco leads to in terms of possible action by the FDA and other drug regulators.
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