If you’re interested in learning about the Gilead Sciences TDF lawsuit, you’ve come to the right place. We’ve got the facts about TDF side effects, the HIV Business dilemma, and how the company may be liable for the problems it caused patients.
Gilead Sciences’ struggle with HIV business
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The company’s troubles are well known in the HIV community. In the past, the company has faced lawsuits and boycotts. In Florida, the company sued some clinics and labs for fraudulently claiming to offer HIV medications at a lower price. The lawsuit also targeted the company’s Advancing Access program, which provides HIV medicines to people without insurance.
The company is in the midst of a massive multi-year transition. Its flagship product, Filgotinib, was originally expected to make $5 billion, but its sales have been slowing down. Furthermore, the company has lost a lot of exclusivity in the HIV market. As a result, Gilead has had to invest heavily in other businesses. Its revenue from other businesses is growing, which may help it cope with the current challenges in the HIV market.
The company is attempting to address this by adopting a comprehensive approach to their business. This approach is important for all companies, not only in the HIV industry. To achieve behavior change, companies need to address underlying social issues. For example, the HIV epidemic is linked to many of the social determinants of health, such as racial equality, education, opportunity, and health literacy. The company hopes to expand its efforts by partnering with nonprofit organizations to make a difference.
Side effects of Gilead TDF drugs
A growing number of lawsuits have accused Gilead Sciences of failing to warn doctors and patients about the serious side effects of TDF drugs. The company had previously developed an alternative drug that was more effective, but deliberately delayed its release to increase profits. In March 2002, the FDA ordered Gilead to stop downplaying the risks of TDF drugs and instead disclose them more fully.
Gilead Sciences made its first TDF drug, Viread, available to people living with HIV in 2001. It was later expanded for use in chronic hepatitis B and in children. The company then introduced combination products containing TDF, including Truvada. These drugs are used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in people who are at risk for infection. HIV-positive individuals can also use these drugs to prevent HIV transmission to sexual partners.
While Gilead Sciences has not publicly acknowledged the occurrence of serious side effects of its TDF drugs, it was aware of these risks when developing the drugs. The company began research to develop safer alternatives to TDF in 2001. Eventually, it developed tenofovir alafenamide fumarate, which is less toxic to the kidneys and lowers the risk of bone and tooth loss.
Business dilemma with TAF
Gilead Sciences is facing a business dilemma because of its disputed TAF patent. The drug is patented for 20 years and Gilead has not been able to sell it without a patent. Gilead’s decision to shelve TAF development in 2004 stems from allegations that the drug was too similar to TDF, its competitor. The company also argued that obtaining two periods of exclusivity for TDF would give it an edge over its competitors. The company has faced similar allegations before and has prevailed.
After years of research, Gilead has published its research on TAF. It has also launched two TDF-based single-tablet regimens, including blockbuster drug Truvada. The company also has developed the similar drug Descovy, which replaces TDF in the Truvada regimen. While TDF-based products have proven themselves in the market, Gilead had to find a way to keep the TAF market growing even as its patents expired.
The company’s patents on Viread are set to expire at the end of 2018. TAF, on the other hand, has a long patent life. Gilead hopes to use TAF as the backbone drug for patients who cannot use Viread.
Liability of Gilead
The lawsuits filed against Gilead allege that TDF caused many patients to develop unnecessarily severe side effects. These claims are based on design defects, negligence, and product liability. Gilead denies liability and says it is protected by federal law. It also argues that it should have launched TAF drugs earlier, but didn’t.
The lawsuits filed against Gilead are separate and independent from other mass tort prescription drug cases filed against the company. They were not included in the federal class-action MDL that consolidated cases in this area. However, a consolidation motion was filed in the recent past, though it was withdrawn soon afterward.
TDF is an HIV medication developed by biopharmaceutical company Gilead Sciences Inc., which was granted FDA approval in 2001. It was initially viewed as a breakthrough in the fight against AIDS, and millions of patients were using it.