An Atripla lawsuit is a legal claim against pharmaceutical giant Gilead Sciences, Inc. for the hazardous side effects of Atripla, an HIV drug. Atripla is a brand name for tenofovir disoproxil fumarate (TDF), which can cause injuries in patients such as:
- Kidney damage or failure – a result of toxins pooling in the kidneys that cannot be filtered out;
- Bone damage, including osteoporosis and fractures – a result of the demineralization that follows from kidney damage; and
- Lactic acidosis – a potentially life-threatening metabolic condition that also stems from kidney damage
Atripla is one of several defective TDF HIV medications drugs manufactured and sold by Gilead, including Truvada, Viread, Stribild, and Complera. To make more money, Gilead continued to market these drugs even though it had already invented a safer HIV drug. In doing so, Gilead prioritized wealth over health.
1. What is the basis for an Atripla lawsuit?
There are two main claims in the Atripla lawsuits against TDF manufacturer Gilead:
- Gilead was negligent in its defective design of TDF drugs; and
- Gilead purposely withheld a safer drug to make all the money it could from TDF first
Depending on the specific case, plaintiffs may also be able to claim that Gilead failed to warn patients about TDF’s dangerous side effects.1
1.1 Negligent defective design
Two key elements of a defective design drug lawsuit claim are:
- The manufacturer knew of the risk associated with the product; and
- The product caused the plaintiff’s injuries
Here, Gilead’s internal documentation shows it was aware that the body cannot absorb TDF drugs like Atripla well. This poor “bioavailability” leads to toxins building up in the body instead of being filtered out.
In addition, several medical studies and experts draw a direct connection between taking TDF and suffering bone and kidney damage. Plaintiffs just need to produce their medical records showing that they experienced the kidney and/or bone damage after taking TDF.2
1.2. Gilead withheld a safer drug
Atripla lawsuits allege that Gilead delayed releasing its safer HIV drug called TAF (tenofovir alafenamide fumarate) in order to maximize profits from TDF. TAF — short for tenofovir alafenamide — is far less toxic than TDF because the body absorbs it better and causes less strain to the kidneys. Therefore, lower doses of TAF accomplish the same results as high doses of TDF.
Even though Gilead invented TAF around the same time as TDF, Gilead submitted only its TDF-based drugs to the FDA for approval. The drug maker even put obstacles in the way of other drug companies developing HIV drugs and announced that it was no longer researching TAF. This possibly was an attempt to convince other drug companies that there was no reason to develop a TAF-like drug.
Only when TDF’s patents were beginning to expire did Gilead roll out a new line of “revolutionary” HIV drugs based on TAF. Gilead also released extensive medical studies that showed it was more effective, less toxic, and safer than TDF-based drugs. Gilead then urged patients to switch to the new HIV treatments to avoid the side effects of TDF — like osteoporosis and kidney failure — that it had earlier denied.3
In short, the drug maker wanted to extract every last dollar that TDF was worth before introducing a better drug it already had to the market. The drug maker got rich while patients got sick.
2. Who is eligible to be a plaintiff?
Patients who took Atripla may have grounds to sue Gilead if they developed the following kidney problems or bone problems.
Bone injuries from Atripla
Kidney injuries from Atripla*
|*If an Atripla user died from renal failure, his/her estate should be able to file suit.|
Simply getting a kidney stone or breaking a bone is insufficient to bring a lawsuit. The stone or fracture would need to result from one of the conditions listed above.
3. Where are the TDF lawsuits being filed?
Primarily in California, which is where Gilead is based. To expedite settlement talks, these lawsuits are being consolidated into a “Judicial Council Coordination Proceeding” (JCCP) called Gilead Tenofovir Cases and Coordinated Actions, JCCP No. 5043.
The court that is handling all the pretrial motions is Los Angeles County Superior Court under Judge Kenneth R. Freeman. And the court that will coordinate any jury trials is San Francisco County Superior Court under Judge Andrew Cheng.
There are also several TDF cases pending in federal court in the Northern District of California under Judge Jon S. Tigar. The case number is 3:18-cv-06972-JST.
4. When will Gilead settle?
It may be several years before any settlement talks begin. The lawsuits are still in the evidence-gathering (“discovery”) stage. And once all the pretrial issues are resolved, the judge will order a few of the individual cases to go to trial.
How these “bellwether trials” turn out will dictate how settlement negotiations will go. If Gilead loses these bellwether trials and is ordered to pay large punitive damages, Gilead will likely make a generous offer to avoid any more trials.
In any case, the plaintiffs’ attorneys are fighting for compensation for:
- Medical bills, including anticipated future expenses,
- Lost wages, lost earning potential, and professional setbacks,
- Pain and suffering, and
- Loss of consortium
5. Is this a class action lawsuit or separate lawsuits?
Individual lawsuits that are joined into a JCCP. As discussed above in section 3, JCCPs are a way to streamline the litigation process for similar cases against the same defendant.
JCCPs are very similar to federal MDLs (short for multi-district litigation). The main difference is that JCCPs are in California state court.5
- See Sample Jury Instructions CACI No. 1222. Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual Elements.
- See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 61 (3d Cir. 2009).
- Melody Petersen, “FDA’s second warning letter to Gilead, Los Angeles Times,” (May 29. 2016); See Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018). Note that Atripla is an antiretroviral drug, and it is a three-drug combination of 1) efavirenz (EFV), 2) emtricitabine (FTC) and 3) tenofovir disoproxil fumarate (TDF).
- Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky, “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (2010); Willem D.F. Venter, June Fabian, and Charles Feldman, “An overview of tenofovir and renal disease for the HIV-treating clinician,” South African Journal of HIV Medicine 19(1):817 (2018); Pablo Rivas, Jorge Polo, Miguel de Górgolas, Manuel L Fernández Guerrero, “Drug points: Fatal lactic acidosis associated with tenofovir,” British Medical Journal 327:711 (2003); FDA Approval Letter for TDF.
- Some TDF victims have filed a class action against Gilead: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018)