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Complera HIV Medication Lawsuit | Get the Right Lawyer

Lawsuits recently filed charge Gilead Sciences, the maker of a widely-prescribed class of HIV medications that includes Complera (tenofovir disoproxil fumarate tdf), with bringing a defective HIV drug to market, and of unnecessarily exposing the public to a risk of serious side effects when there are a variety of safer, less dangerous HIV drugs available.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Free Confidential Complera Lawsuit Evaluation: If you or a loved one has been harmed by the side effects of Complera or another tenofovir disoproxil fumarate TDF medication, you should contact our law firm immediately for a free case evaluation and Complera Lawsuit review. You may be entitled to compensation by filing a Complera lawsuit against Gilead and our lawyers can help.

What is Complera?

Complera is a combination HIV medication that contains 3 active ingredients: tenofovir disoproxil fumarate, emtricitabine and rilpivirine.

It is prescribed for treating HIV in adults diagnosed with HIV infection and children over the age of 12 who meet certain medical requirements.

Complera HIV medicine components:

  • Tenofovir disoproxil fumarate – nucleoside reverse transcriptase inhibitors
  • Emtricitabine –nucleoside reverse transcriptase inhibitor
  • Rilpivirine – non-nucleoside reverse transcriptase inhibitor

What are Complera Lawsuits Against Gilead Sciences Alleging?

According to the LA Times, one recently filed lawsuit [1] claims that HIV medicine tenofovir patients suffered from up to a decade of “additional accumulated kidney and bone toxicity” from tenofovir disoproxil fumarate, an ingredient in Complera and its other HIV pharmaceuticals, while the manufacturer withheld an equally effective yet safer product from the public.

Lawyers claim that Gilead knew that their drugs had to be given in high doses to be effective, which meant they could damage the kidneys and bones, and cause lactic acidosis, yet the company failed to adequately warn patients or doctors about the side effects of Complera on the medicine’s label.

Gilead is now urging doctors to switch their patients to a safer drug to reduce possible bone injuries.

Complera Lawsuit

Complera Side Effects and Statistics

  • Bone injuries
  • Bone demineralization
  • Loss of bone density
  • Bone thinning
  • Bone fractures
  • Osteopenia
  • Osteoporosis
  • Declining kidney function
  • Kidney injuries
  • Kidney damage
  • Kidney toxicity
  • Chronic kidney disease (CKD)
  • Kidney failure (renal failure)
  • Fanconi syndrome
  • Abdominal pain
  • Lactic acid in the blood
  • Suicidal thoughts
  • According to the Web Med Specialist [2]

The other plaintiff in the personal injury suit is Jonathan C. Gary of San Diego County, took the drug for 10 years, beginning in 2001.

Gary was diagnosed with Fanconi syndrome, a rare kidney disorder, in 2010.

Last year, he was diagnosed with osteopenia and osteoporosis at age 59.

Adverse Effects

What’s the Problem with TDF Medications?

One lawsuit recently filed against Gilead Sciences alleges that HIV patients suffered from up to a decade of “additional accumulated kidney and bone toxicity” from tenofovir disoproxil fumarate, the active ingredient in Complera and other similar TDF medications, while the manufacturer withheld an equally effective yet safer product with patent protection to maximize profits.

Complera can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), severe skin rash and allergic reactions, liver problems, depression or mood changes, and new or worsening kidney problems, including kidney failure – said Debra Birnkrant, M.D., Director of the Division of Antiviral Products.

TDF lawsuits claim that Gilead knew that their HIV medicines were dangerous drugs that had to be given in high doses to be effective, which meant they could cause bone loss, chronic kidney disease (renal failure/kidney failure), and a buildup of lactic acid (lactic acidosis), yet the company neglected to adequately warn about the risk of patient health on the product’s labeling.

Judge Clears Suit Alleging Market HIV Medications Defectively Designed

According to the Clinical Info, U.S. District Judge Jon S. Tigar has greenlighted a strict product liability lawsuit filed by a group of patients seeking compensation who suffered bone loss, accusing Gilead Sciences Inc. of negligence, product liability, and a host of other allegations surrounding its tenofovir disoproxil fumarate- containing HIV medicines [3], but agreed to narrow the scope of the case by tossing allegations that Gilead hid knowledge that the medicines are “unreasonably and unnecessarily unsafe.”

Tigar cleared various other claims made in the suit, including design defect, negligence, and product liability claims.


Safer Drug

Which Other HIV Medications Have Been Linked to Kidney Failure?

In addition to Complera, other TDF medications that may cause the above side effects include:

What are Complera Lawsuits Alleging?

Complera lawsuits advance the following claims against Gilead executives:

TDF is a defective design, and Gilead negligently created it

To prove that Complera is a negligent defective design, plaintiffs have to show that Gilead was aware of kidney injuries linked to Complera and that Complera caused the plaintiff’s kidney injuries and/or bone mineral density problems.

If you were injured after taking Complera, you 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 FDA has warned the drugmaker against misleading the public about TDF’s side effects.

Gilead pushed TDF while withholding a safer HIV drug

Plaintiffs further allege that Gilead developed tenofovir alafenamide fumarate, which was less toxic than Complera and other TDF drugs. However, Gilead kept this safer alternative off the market to make as much money as it could from selling TDF.

Gilead then started selling TAF drugs just when TDF was about to lose it patent protection from generic alternatives. The drugmaker urged people taking TDF drugs like Complera to switch immediately to its new TAF-based versions.

It cited TDF‘s side effects like kidney injuries (renal failure) and osteoporosis which 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 of TAF to HIV patients until it was profitable for it to do so.

AIDS Healthcare Foundation Files Complera Class Action Lawsuit

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, helped file the lawsuit on behalf of Devin Martinez, Ricardo Wohler, and others who purchased Complera and other TDF drugs in May 2018.

This California lawsuit is separate from the individual injury lawsuits filed by people who suffered injuries from TDF, but it deals with similar issues.

According to the complaint, Gilead misrepresented TDF’s safety profile as early as 2001. The FDA even reprimanded Gilead in 2002 and 2003 for claiming the drug had no toxicities and would not cause bone or kidney damage, but the company continued to downplay the risks.

Allegations against Gilead in the class action include:

  • Failing to disclose that TDF had a significant risk for toxicity bone fractures and kidney damage
  • Failed to warn of the kidney and bone risks in all patients, not just those with preexisting kidney and bone problems
  • Gilead misrepresented the risks and benefits of its TDF drugs to sell them

What Makes Gilead Sciences Liable?

According to the American Bar Association (ABA), a defendant is negligent if he fails to act reasonably. This standard applies to civil lawsuits like yours. In the case of Gilead Sciences, we may argue that:

  • It would have been reasonable for Gilead Sciences to put your safety over their profits
  • It would have been reasonable for Gilead Sciences to replace the ingredient TDF with the safer alternative TAF
  • By failing to replace TDF with TAF as quickly as possible, Gilead Sciences was negligent

We will argue that Gilead Sciences should have known, or did know, that TDF was not completely safe. Manufacturing an unsafe product generally qualifies as negligence.

By exposing you to harm, Gilead Sciences may be financially liable for your medical problems.

Truvada, another HIV medication produced by Gilead, has been the subject of litigation for similar reasons. Potential Complera litigants should take note of this, as not a single Truvada lawsuit has been settled to date.

This makes it vital that you secure the services of an experienced attorney should you seek compensation from Gilead.

Related Article: Differences Between Intentional & Unintentional Torts

Is There a Class Action?

Our lawyers have opted against the filing of a class action lawsuit in the litigation involving Complera and the other HIV drugs in its class.

It has been our experience that class actions typically render many plaintiffs powerless over their cases, many of whom end up making bad decisions on behalf of the entire class, rather than on what’s best for them and their loved ones.

For this reason, the law offices of Schmidt & Clark, LLP, are only filing individual claims for our clients. Contact us today for a free case review.

Can I File a Suit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against Gilead Sciences, the maker of Complera, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect.

In the case of Complera, our attorneys suspect that patients may be able to take legal action in light of claims that Gilead failed to adequately warn doctors and patients about the risk of bone fractures and kidney damage.

Read More: Complera Class Action Lawsuit

See all related dangerous drugs lawsuits our attorneys covered so far.

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Have you or a loved one suffered from the adverse side effects caused by defective medication?

Do I have a Complera Lawsuit?

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Complera lawsuits. We are handling individual litigation nationwide and currently accepting new kidney injury and bone fracture cases in all 50 states.

Free Complera Lawsuit Evaluation: Again, if you suffered a bone fracture/break, or had any kidney problems after taking Complera, you should contact our law firm immediately for a free case evaluation / free case review. You may be entitled to a settlement by filing a suit for medical expenses and a free case evaluation can help.



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