An Atripla lawsuit is a legal claim against pharmaceutical company Gilead Sciences, Inc. for the hazardous side effects of the HIV drug. Atripla is a brand name for tenofovir disoproxil fumarate (TDF), the active ingredient 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.
In this article, our Atripla lawyers answer these frequently-asked-questions:
- 1. What is the basis for an Atripla lawsuit?
- 2. What are the long term side effects of Atripla?
- 3. Where are the TDF lawsuits being filed?
- 4. When will Gilead settle?
- 5. Is this a recall on Atripla?
1. What is the basis for an Atripla lawsuit?
There are two main claims in the Atripla lawsuits against TDF drug manufacturer Gilead:
- Gilead was negligent by defectively designing the TDF drug; and
- Gilead purposely withheld a safer drug to make all the money it could from TDF first
And depending on the specific case, plaintiffs may also be able to claim that Gilead failed to warn patients about TDF’s serious side effects.
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 medications 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 healthcare experts draw a direct connection between taking TDF and suffering bone loss and kidney injuries. Plaintiffs just need to produce their medical records showing that they experienced kidney and/or bone damage after taking TDF. Other helpful evidence would include:
- expert medical testimony
- photographs or video of the plaintiff’s injuries
- eyewitness testimony of the plaintiff’s pain and suffering1
Note that there may also be a viable legal claim against Gilead for a manufacturing defect: Various lots of Atripla have reportedly contained: “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”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 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 drugmaker 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 the defective drug TDF was worth before introducing a safer alternative it already had to the market. The drug maker got rich while HIV patients got sick.
2. What are the long term side effects of Atripla?
Patients who take Atripla may suffer various bone problems and kidney damage. And these patients may be eligible to bring suit against Gilead for causing these often permanent injuries.
Bone injuries from Atripla
Kidney injuries from Atripla*
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|*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 an Atripla lawsuit. The stone or fracture would need to result from one of the conditions listed above.
Note that Atripla users may suffer such additional side effects as skin problems, liver problems, seizures, and depression.4
3. Where are the TDF lawsuits being filed?
Primarily in California, which is where Gilead is based. Presently, we are bringing suit in the Northern District of California (federal court) through an MDL (multidistrict litigation). This is where similar lawsuits are consolidated to speed up litigation and a settlement. The Truvada MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.5
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. The first “bellwether trial” is scheduled for June of 2022.
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 diagnostic-, treatment-, and rehabilitation expenses,
- Lost wages, lost earning potential, and professional setbacks,
- Pain and suffering, and
- Loss of consortium
To prove these damages, plaintiffs may need to show past paychecks, doctor’s bills, and other relevant bills and invoices.
Nearly all cases settle without a trial. But if an agreement cannot be reached, our attorneys will take these cases to trial in pursuit of the biggest judgment available under the law.
5. Is there a recall on Atripla?
No, Atripla has not been recalled despite its toxic effects on patients’ kidneys and bones. Though many doctors now are proactively prescribing TAF-based medications instead of TDF-based drugs like Atripla.
- 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).
- Sydney Lupkin, When Medicine Makes Patients Sicker, Kaiser Health News (January 4, 2019).
- 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. See Andrew Hill et al., Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety? Journal of Virus Eradication, Volume 4, Issue 2, April 2018, Pages 72-79.
- Some TDF victims have filed a class action against Gilead: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).