Atripla® Lawsuit - Legal Claims for Bone Loss and Kidney Damage

Atripla HIV drug lawsuits

Personal injury attorney Neil Shouse talks about the dangerous side effects of Atripla and an ongoing lawsuit over the drug. There are a growing number of lawsuits directed toward Gilead Sciences, the maker of Atripla and Truvada, because of a dangerous component known as TDF. TDF is known to cause kidney disease and loss of bone density. The drug pools in the renal tubular, which causes kidney disease, and also it causes demineralization of the bones, which eventually leads to osteoporosis. Osteoporosis increases the risk of broken bones, and can lead to teeth falling out. There are allegations that Gilead Sciences had a safer drug called TAF, which does not cause these dangerous side effects. But for over a decade Gilead did not release TAF, most likely for financial reasons, as they were waiting for their patent on Truvada to run out. Patients who have taken the drug Atripla may have mixed feelings about suing the drug maker, since Atripla has saved many peoples’ lives. HIV used to be a death sentence, but because of drugs like Atripla, HIV is now a treatable condition. But whether or not the patients’ lives were saved by Atripla is not the real issue. The issue is that the safer and better drug could have been used, and if it had been, then none of the patients would be suffering from these horrible conditions. More info at https://www.shouselaw.com/torts/truvada/atripla or call (888) 327-4652 for a free consultation. If you or a loved one has suffered health complications from the HIV medication Atripla or Truvada, we invite you to contact us at Shouse Law Group. We can provide a free consultation in office or by phone. We have local offices in Los Angeles, the San Fernando Valley, Pasadena, Long Beach, Orange County, Ventura, San Bernardino, Rancho Cucamonga, Riverside, San Diego, Sacramento, Oakland, San Francisco, San Jose and throughout California.


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:

Atripla is one of several defective TDF 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.

pill
Using Atripla may cause bone loss and renal damage.

1. What is the basis for an Atripla lawsuit?

There are two main claims in the Atripla lawsuits against TDF manufacturer Gilead:

  1. Gilead was negligent in its defective design of TDF drugs; and
  2. 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 claim are:

  1. The manufacturer knew of the risk associated with the product; and
  2. 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 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. Gilead 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, Gilead wanted to extract every last dollar that TDF was worth before introducing a better drug it already had to the market. Gilead 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 or bone injuries. 

 Bone injuries from Atripla

 Kidney injuries from Atripla*

  • Osteoporosis,
  • Osteopenia,
  • Osteomalacia,
  • Bone fractures which a doctor attributed to bone weakening or demineralization,
  • Bone density loss,
  • Bone demineralization, or
  • Weakening of the bones
  • Chronic kidney disease,
  • Renal failure, which requires hospitalization and/or dialysis,
  • Low kidney function which requires dialysis or has been diagnosed by a doctor,
  • High creatinine levels,
  • Abnormal glomerular filtration rate (GFR), from levels 15 to 90,
  • Abnormal protein levels in urine (proteinuria), or
  • Fanconi Syndrome/ proximal renal tubule dysfunction4

 *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.

courthouse exterior
JCCPs are similar to MDLs, except they are California-specific and take place on the state and not the federal level.

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 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

Receptionists waiting for your call.
Call our mass tort Atripla attorneys at 855-529-3476 today.

Have you been injured?

The defective drug attorneys of Shouse Law Group represent Atripla victims from all over the U.S. who have been hurt by Big Pharma. There is a short statute of limitations (deadline) for filing a Truvada lawsuit or claim, so call us now at 855-LAW-FIRM (855-529-3476) to schedule a consultation. We take no payment unless we win your lawsuit.


Legal References

  1. See Sample Jury Instructions CACI No. 1222. Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual Elements.
  2. See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 61 (3d Cir. 2009).
  3. 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).
  4. 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.
  5. Some TDF victims have filed a class action against Gilead: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

Free attorney consultations...

The attorneys at Shouse Law Group bring more than 100 years collective experience fighting for individuals. We're ready to fight for you. Call us 24 hours a day, 365 days a year at 855-LAW-FIRM for a free case evaluation.

Regain peace of mind...

Shouse Law Defense Group has multiple locations throughout California. Click Office Locations to find out which office is right for you.

Office Locations

Shouse Law Group has multiple locations all across California, Nevada, and Colorado. Click Office Locations to find out which office is right for you.

Call us 24/7 (855) 396-0370