Hilliard Martinez Gonzales LLP: Gilead Sued For Intentionally Withholding Safer HIV Drug
Nov 17, 2018, 12:16 ET
CORPUS CHRISTI, Texas, Nov. 17, 2018 /PRNewswire/ -- Today attorneys Bob Hilliard, Steve Berman, and Ben Crump filed a lawsuit against Gilead, claiming the giant drug company intentionally kept a safer HIV drug from hundreds of thousands of patients so as to protect its multi-billion dollar patent on a less safe drug.
Gilead was aware that its less safe drug, Viread (also known as TDF), could damage patient's bones and kidneys, yet the company still decided to hold up the availability of TAF, Gilead's safer version of Viread.
Gilead’s 15-year delay in offering the safest drug to the HIV community served its intent to extend the profitable commercial life of Viread (TDF) which provided the company billions in profits.
Only when TDF was nearing the end of its patent term did Gilead start to pitch TAF as much safer than TDF and became critical of the dangerous and unnecessary side effects caused by TDF. By doing so, Gilead was able to stifle the generic versions of TDF and limit the potential market for TDF generics by other manufacturers. At the same time Gilead began to warn the medical community about the dangerous side effects of TDF it also began to tout what it said was the much safer option, TAF, a drug whose patent term was just beginning and would last for 20 years, allowing Gilead to continue its stranglehold on the billion dollar HIV market.
Hilliard states, "For nearly two decades, Gilead has been raking in billions of dollars each year from the sale of the TDF-containing drugs that are the subject of our lawsuit—medications used primarily for treatment of people living with HIV."
But Gilead knew even before it asked for and received FDA approval of its first TDF product in 2001, Viread, that TDF was toxic to the bones and kidneys, with potentially fatal consequences such as kidney failure.
Within the first month Viread was on the market, and over the next eleven years, evidence of TDF toxicity continued to mount through post-marketing data and adverse event reports—but Gilead continued to develop and market TDF-containing products, bringing four additional TDF-containing drugs to market by 2012, Truvada, Atripla, Complera and Stribld.
During those eleven years, Gilead downplayed the safety risks of TDF and had to be repeatedly warned by the FDA regarding its minimization or omissions regarding TDF safety risks.
And even as the risks of TDF began to come to light, prescribers and patients were faced with a knife at the neck and a gun to the back—they were forced to treat a potentially life-threatening condition with potentially life-threatening medication.
For years, Gilead continued to sharpen its double edged blade at the expense of the HIV community. To make the most profits possible it intentionally created a Catch 22 for those who needed the drug. Either don't take the drug and suffer terrible HIV medical consequences or take it and suffer terrible medical consequences of the side effects. All the while, this company's response to the growing concerns of the HIV community seemed to be similar to Col. Nathan R. Jessep's response in A Few Good Men "I'd prefer you just say thank-you and went on your way."
Even before Gilead's TDF-containing drugs were approved by the FDA, Gilead had already identified TAF as an equally effective but safer alternative to TDF.
Despite its knowledge of the risks of TDF and the safety benefits of TAF, Gilead ceased development of TAF based on an "internal business review" and an alleged inability to sufficiently differentiate TAF from TDF. These mistruths are borne out by Gilead's current marketing. Today, after withholding TAF for an entire decade and during which time Gilead made seven patent applications for TAF products it had purportedly abandoned, Gilead openly markets TAF as a safer alternative to TDF. We believe the evidence will show that Gilead withheld the equally effective but safer medication for one primary reason—billions in profits.
"If Gilead withheld TAF during its patent exclusivity with regard to TDF, Gilead could maximize its profits by monopolizing the market during the exclusivity period, releasing TAF prior to expiration of TDF exclusivity, and encouraging prescribers to switch patients from TDF to the safer TAF medications before entry of generic TDF into the market. This is what Gilead did do, and people living with HIV paid the price. Our lawsuit seeks recovery for those hurt by Gilead's greed, and to hold Gilead accountable for choosing profits over people."
The case is: Cause No. 3:18-cv-06972 Adrian Holley, et al. v. Gilead Sciences, Inc.
ABOUT HMG http://www.hmglawfirm.com/
Hilliard Martinez Gonzales LLP (HMG) has been successfully representing clients in the United States and Mexico since 1986. The firm specializes in mass torts, personal injury, product liability, commercial and business litigation, and wrongful death. Founding partner Bob Hilliard was named 2016 Elite Trial Attorney of the Year (Motor Vehicles) and 2015 Elite Trial Attorney of the Year (Product Liability) by the National Law Journal. His cases have been covered by The New York Times, Wall Street Journal, NBC, ABC, CBS and Fox News.
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