Complera® Lawsuit - Compensation for Side Effects & Injuries

Complera HIV drug lawsuits

Personal injury attorney Neil Shouse talks about the dangerous side effects of Complera and an ongoing lawsuit over the drug. There are a growing number of lawsuits directed toward Gilead Sciences, the maker of Complera 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 Complera may have mixed feelings about suing the drug maker, since Complera has saved many peoples’ lives. HIV used to be a death sentence, but because of drugs like Complera, HIV is now a treatable condition. But whether or not the patients’ lives were saved by Complera 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/complera or call (888) 327-4652 for a free consultation. If you or a loved one has suffered health complications from the drug complera 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.

 

A Complera lawsuit is a mass tort legal action against Gilead Sciences, Inc., the manufacturer of the HIV-drug Complera. Complera contains tenofovir disoproxil fumarate (TDF), which Gilead's own studies show can cause major complications. These include:

  • Kidney problems such as renal failure from TDF's toxins building up in the body;
  • Bone damage such as osteoporosis and fractures, a direct result of damaged kidneys siphoning calcium from the bones; and
  • Lactic acidosis from when damaged kidneys result in a metabolic imbalance -- which can be fatal

Gilead had developed a safer HIV drug than TDF with fewer side effects. But Gilead kept this safer drug off the market in order to squeeze profits from TDF.

pill
Using Complera may result in bone loss and kidney problems.

1. What are the grounds for a Complera lawsuit?

Complera lawsuits advance the following claims against TDF manufacturer Gilead:

  1. TDF is a defective design, and Gilead negligently created it;  and
  2. Gilead purposely withheld a safer drug to profit more from TDF

These lawsuits concern Complera as well as Truvada, Atripla, Viread, and Stribild.

1.1 TDF was a negligent defective design

In order to prove that Complera is a negligent defective design, plaintiffs have to show two things:

  1. Gilead was aware of Complera's risk; and
  2. Complera caused the plaintiff's kidney and/or bone problems

A great deal of publicly-available paperwork exists that demonstrates that Gilead had full knowledge of the risks of TDF. Namely, Gilead knew that TDF had bad "bioavailability." That is the scientific way of saying that the body cannot absorb TDF well.

There also are a lot of medical experts willing to testify about this link between TDF and bone and kidney injuries. And individual plaintiffs can produce their medical records to show that they developed bone and kidney problems after taking TDF.1

Depending on when a plaintiff took Complera, he/she may also be able to bring a failure to warn claim against Gilead. Many patients would not have taken Complera had Gilead informed them about the risks. Even the U.S. Food and Drug Administration (FDA) warned Gilead against misleading the public about TDF's side effects.2

1.2. Gilead pushed TDF while withholding a safer drug

The plaintiffs claim that Gilead developed an HIV drug called TAF that was less toxic than Complera and other TDF drugs. However, Gilead kept TAF off the market in order to make as much money as it could from selling TDF.

Gilead finally started selling TAF-based drugs just when TDF was about to lose it patent protection from generic alternatives. Gilead urged people taking TDF-based drugs like Complera to switch immediately to its new TAF-based versions. And it cited TDF's side effects like renal failure and osteoporosis that it had previously insisted did not exist.

Gilead could have just gotten TAF approved by the FDA back in 2001, which was when TDF went to market. Instead, Gilead allowed patients to get sick from TDF for 15 more years. And Gilead did not start selling TAF until it was profitable for it to do so.3

2. Who qualifies to be a plaintiff?

Complera users who developed the following renal or skeletal injuries may have grounds to sue.

2.1. Qualifying kidney injuries for a Complera lawsuit

  • 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
  • Fanconi Syndrome/ proximal renal tubule dysfunction

A kidney stone is not grounds for a lawsuit unless it is accompanied by one of the above conditions.

2.2. Qualifying bone injuries for a Complera lawsuit

  • Osteoporosis
  • Osteopenia
  • Osteomalacia
  • Bone fractures which a doctor attributed to bone weakening or demineralization
  • Bone density loss
  • Bone demineralization
  • Weakening of the bones4

A fracture is not grounds for a lawsuit unless it is accompanied by one of the above conditions.

courtroom
JCCPs are like the California state version of federal MDLs. They temporarily combine similar cases against the same defendants to speed up litigation.

3. Where are the lawsuits being filed?

California, the state where Gilead's main offices are. Since there are so many similar TDF lawsuits against Gilead, they are being joined into a JCCP -- short for "Judicial Council Coordination Proceeding" (JCCP). The official court name for this JCCP is Gilead Tenofovir Cases and Coordinated Actions, JCCP No. 5043

Judge Kenneth R. Freeman of Los Angeles County Superior Court is presiding over all the pretrial motions. Then Judge Andrew Cheng of San Francisco County Superior Court will coordinate any jury trials.

Many TDF cases are also 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 are settlements expected?

It will be at least a year or two before TDF settlement negotiations will begin. The plaintiffs' attorneys are still in the discovery (evidence-gathering) process. And the judge has not scheduled any trials yet.

How these first trials -- called "bellwether trials" -- turn out will largely determine the size of the final settlement. Assuming the bellwether juries hold Gilead liable and order high punitive damages, Gilead will probably agree to a large settlement to resolve the remaining lawsuits.

During negotiations, each plaintiff's attorney will fight to recover enough compensation to cover the plaintiff's:

  • Doctors' bills (past and future),
  • Lost wages (past and future),
  • Pain and suffering, and
  • Loss of consortium

5. Is this individual lawsuits or a class action?

Individual lawsuits. But to minimize time and costs, these separate TDF lawsuits are consolidated into a "Judicial Council Coordination Proceeding" (JCCP).

JCCPs are like a state-level version of federal MDLs (multi-district litigations). Each case remains separate, but the plaintiffs join forces during the pretrial stage to reach a settlement quicker.5

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

Were you sickened by Complera?

Shouse Law Group's defective drug attorneys represent victims from all over the U.S. who have been harmed by TDF HIV drugs. But you must act now since there is a short statute of limitations for filing a Complera lawsuit or claim.

Phone us at 855-LAW-FIRM (855-529-3476) to see if you qualify for bringing a claim against Gilead Sciences, Inc.. And if so, we take no payment unless we win your case.


Legal References

  1. See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 61 (3d Cir. 2009).
  2. See Sample Jury Instructions CACI No. 1222. Negligence—Manufacturer or Supplier—Duty to Warn—Essential Factual Elements; Melody Petersen, "FDA's second warning letter to Gilead, Los Angeles Times," (May 29. 2016).
  3. 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. There is a class action regarding TDF medications: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

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