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.
1. What are the grounds for a Complera lawsuit?
Complera lawsuits advance the following claims against TDF manufacturer Gilead:
- TDF is a defective design, and Gilead negligently created it; and
- Gilead purposely withheld a safer drug to profit more from TDF
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:
- Gilead was aware of Complera’s risk; and
- Complera caused the plaintiff’s kidney injuries and/or bone mineral density problems
A great deal of publicly-available paperwork exists that demonstrates that Gilead had full knowledge of the severe side effects of TDF. Namely, the drugmaker 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 the drug.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 the drugmaker 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 (tenofovir alafenamide fumarate) that was less toxic than Complera and other TDF drugs. However, Gilead kept this safer alternative 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. The drugmaker 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 the drugmaker did not start selling the safer version TAF to HIV patients 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
- Acute renal failure / kidney failure which requires hospitalization and/or dialysis
- Low kidney function which requires dialysis or has been diagnosed by a doctor or other major kidney damage or acute kidney injury
- 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 kidney disorders.
2.2. Qualifying bone injuries for a Complera lawsuit
- 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.
3. Where are the lawsuits being filed?
Presently, there is an MDL (multi-district litigation) out of the Northern District of California (federal court). An MDL is where similar lawsuits are consolidated to speed up litigation and a settlement. The MDL is called In Re. Tenofovir Disoproxil Fumarate Products Liability Litigation, MDL 2881.
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 lawsuit?
Individual lawsuits. But as discussed above, because these lawsuits involve victims with similar injuries, they are presently being consolidated into an MDL.5
- See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 61 (3d Cir. 2009). Complera is a once-a-day drug that contains 1) tenofovir disoproxil fumarate, 2) emtricitabine, 3) and rilpivirine. Complera is considered a nucleoside reverse transcriptase inhibitor (NRTI).
- 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).
- See Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018). Examples of TAF medications include Genvoya and Descovy.
- 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.
- There is a class action regarding TDF medications: Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).