TDF HIV Drugs and Safer Alternatives

Florida Truvada injury lawyers know that this and other HIV drugs containing a compound called tenofovir disoproxil fumarate (TDF) have been the subject of an emerging wave of injury lawsuits against drug maker Gilead Science, Inc. One of the key arguments is that Gilead resisted the earlier release of known safer alternative drugs that could have reduced or avoided the risk of serious harm to patients – and did so to boost its own profits.

Specifically, plaintiffs in several lawsuits allege the drug company had the ability to bring safer TAF-based versions of this leading HIV/AIDS treatment to the market a full decade before it did, but stalled to run down the clock on its TDF drug patents, which expired in 2017 and 2018.

TDF medications, some of which are also prescribed to treat hepatitis B, are linked to numerous serious - sometimes fatal - side effects, including:

• Declining kidney function, chronic kidney disease and kidney failure
• Decreased bone density, osteoporosis, tooth decay/loss, bone fractures

Other minor side effects associated with TDF medications include:

• Dizziness
• Diarrhea
• Nausea
• Fatigue
• Headache
• Depression
• Insomnia
• Abnormal dreams
• Rashes

In several studies, researchers comparing TDF-containing medications like Truvada and Viread to those containing TAF (tenofovir alafenamide) found TAF drugs were just as effective, but on average were linked to fewer kidney injuries and bone mineral density loss.

One 2012 study conducted by the University of California in San Francisco found that for each year of exposure to TDF drugs, the risk of kidney damage spiked 34 percent, risk of rapid decline in kidney function increased 11 percent and risk of chronic kidney disease rose 33 percent. The risks remained elevated even more than a year after patients stopped taking the drug.

TAF drugs are typically dosed in much smaller quantities, which is believed to contribute to the reduced risks.

TDF drugs produced by Gilead include:

• Viread
• Truvada
• Atripla
• Complera
• Stribild

Another drug company, Mylan N.V., launched the release of two other TDF drugs for HIV treatment, Symfi Lo and Cimduo, in 2018.

Many of these are used in combination with other drugs. Truvada is the only one that is approved by the U.S. Food & Drug Administration for use as an HIV prevention drug.

• Descovy
• Genvoya
• Odefsey
• Vemlidy

Gilead began developing TAF drugs around the same time it released TDF medications. But despite early Gilead research indicating TAF was safer and more effective than TDF drugs, the TAF project was suddenly shelved without explanation - for 10 years. TAF drugs first became available in the U.S. in 2015, with Gilead marketing them as “novel.”

Some, like the plaintiffs in Lujano and Gary v. Gilead Sciences, Inc., assert the timing of this suspect because it coincided with the expiration of Gildead’s TDF drug patents. All the while, plaintiffs say, the company was downplaying the many health risks associated with TDF medications. (Gilead was in fact chastised repeatedly by the FDA for this).

Although TDF-based medications remained on the market when Gilead introduced TAF-based alternatives, the company quickly began encouraging patients taking TDF drugs to switch, marketing these as a novel, safer alternative. Plaintiffs, however, argue these medications weren’t “novel” because Gilead was aware of this alternative, but kept it on the back burner for years.

Although the U.S. District Court for the Northern District of California weighing an antitrust action found Gilead owed no duty to competitors to release TAF drugs earlier, that same court ruled in Holly v. Gilead Sciences, Inc. in 2019 that this conclusion “says nothing about any duties Gilead might owe consumers under state tort law.”

As Florida Truvada injury lawyers can explain, the claim of a safer reasonable alternative falls under the legal theory of defective design, a form of product liability.

As noted in The Yale Law Journal, plaintiffs alleging defective design of a prescription drug can establish defective design if they can show there were safer alternative drugs available that reasonable health care providers would have prescribed in place of defendant’s drug for all classes of patients.

Even in cases where no reasonable alternative design exists, pharmaceutical companies that fail to provide adequate instructions or warnings of a foreseeable risk of harm may also be held legally responsible for harm patients suffer.

In these cases, one must prove:

• The drug was defective by design;
• The design defect caused harm to the plaintiff;
• There was a feasible, reasonable alternative design whose adoption could have reduced or prevented plaintiff’s harm.

These cases are often complex, and require the dedication of an experienced product liability lawyer with experience taking on prescription drug companies.

For information on legal action, contact Fort Lauderdale Truvada injury lawyers at The Ansara Law Firm by calling (954) 761-4011 or (954) 761-3641.