Connect with us

National

Gilead hit with more lawsuits over harmful side effects of AIDS drug

AHF seeks $10 billion fund to compensate patients injured by TDF

Published

on

Gilead, gay news, Washington Blade

Michael Weinstein, executive director of AHF, said a large compensation fund would benefit both Gilead and the more than 1,000 patients that are plaintiffs in the multiple lawsuits against Gilead over the TDF issue. (Photo courtesy of AHF)

Another two lawsuits were filed last week in California against the U.S. pharmaceutical company Gilead Sciences, Inc. by several dozen patients who claim the company withheld from the market for more than a decade a drug for treating HIV that it knew was safer and more effective than the drug it promoted during that period.

The two personal injury lawsuits accuse Gilead of intentionally continuing to promote the HIV medication tenofovir disoproxil fumarate (TDF), which was known to cause serious kidney and bone damage, so it could profit from the drug before its patent on the medication was to expire in 2015.

At the same time, the lawsuits charge, Gilead withheld from the market a far safer version of the drug called tenofovir alafenamide (TAF), which it knew would more effectively treat HIV without causing any of the serious side effects caused by TDF.

The lawsuits charge that many patients taking one of five Gilead HIV drugs for which TDF was a key component needlessly suffered debilitating and sometimes fatal kidney and bone damage as well as damage to their teeth. Also adversely impacted by TDF, the lawsuits claim, were HIV-negative people taking the Gilead drug Truvada, which contained TDF, as part of the HIV prevention regimen known as PrEP.

In response to these and as many as a dozen or more similar lawsuits filed by HIV patients and PrEP users in state and federal courts in California over the past two years, the AIDS Healthcare Foundation on Monday called on Gilead to create a $10 billion fund “for victims harmed by its TDF-based drugs.”

Michael Weinstein, executive director of AHF, the nation’s largest AIDS advocacy and HIV/AIDS patient care organization, said a large compensation fund would benefit both Gilead and the more than 1,000 patients that are plaintiffs in the multiple lawsuits against Gilead over the TDF issue.

“We had two goals in putting this out,” said Weinstein. “One was to underline the significance of the liability that they are facing based on their conduct,” which could amount to billions of dollars, he said referring to Gilead.

“And second of all is simply to plant the idea in Gilead’s mind that ultimately the best resolution of this is to compensate the people who were harmed,” Weinstein said.

“For years, Gilead represented its TDF-based medications as safe and effective, misleading Plaintiffs, their doctors, and the medical community into believing that no safer alternative design existed that would have saved Plaintiffs from TDF’s dangerous effects,” says one of the two lawsuits filed July 12 in Alameda County, Calif., Superior Court.

“Indeed, it was Gilead that discovered and helped develop the safer design around the same time it developed TDF in the mid to late 1990s,” the lawsuit says. “Gilead, however, shelved TAF, the safer design, in 2004. Gilead marketed and sold only the dangerous and less effective design – TDF and TDF-based combination pills – for approximately 15 years,” the lawsuit continues.

“Then, when its monopoly on those TDF drugs was about to expire, Gilead sought and received approval from the U.S. Food and Drug Administration to sell, and market TAF-based drugs, allowing it to extend its exclusivity on tenofovir and keep its HIV drugs branded and priced high to increase its profits,” the lawsuit says.

A spokesperson for Gilead Sciences didn’t immediately respond to an email and phone message from the Blade asking the company to comment on this and other similar lawsuits filed against it during the past two years over the TDF and TAF drug allegations.

Gilead’s attorneys disputed the allegations that the company failed to adequately alert patients and doctors of the adverse side effects of TDF in a July 10 motion filed in the U.S. District Court for the Northern District of California in a motion calling for the court to dismiss yet another lawsuit filed against it over the TDF-TAF issue.

That case, Adrian Holley, et al vs. Gilead Sciences, Inc., was filed in March 2018 and is one of several TDF-related cases filed against Gilead in federal court in California.

In its motion to dismiss, Gilead argues that plaintiffs have failed to provide sufficient evidence that “newly acquired information” surfaced to that would have allowed Gilead to “strengthen warnings contained in TDF medication labeling after 2008.”

Gilead has stated in the past it has included warnings about possible harmful side effects of TDF for people who have a history of kidney or bone related ailments. The lawsuits, however, have charged the company with failing to issue an alert that TDF could cause serious kidney and bone damage for people who did not have a history of kidney or bone related problems.

‘Plaintiffs still have not alleged, inter alia, facts supporting when they or their doctors were exposed to any alleged misrepresentations, what misrepresentations they or their doctors were exposed to, or if or how their or their doctors’ conduct changed based on any such misrepresentations, as required by the Federal Rules of Civil Procedures 8(a) and 99(b),” Gilead attorneys state in their motion to dismiss the federal lawsuit.

The motion to dismiss makes no mention of the other key allegation in this and the other lawsuits – that Gilead withheld the release of the safer HIV drug TAF to enable it to reap its profits from TDF until its patent on that drug expired in 2015.

The lawsuit filed on July 12 in Alameda County, entitled Gary Smith, et al vs. Gilead Sciences, Inc. includes 41 plaintiffs who are seeking financial compensation for damages of an as yet undeclared amount on grounds that Gilead violated “Strict Products Liability – Failure to Warn” requirements; engaged in “Negligence and Gross-Negligence—Design Defect and Failure-to-Warn” related to the harmful effects of TDF; Fraud; and “Breach of Express and Implied Warranty.”

The Smith v. Gilead lawsuit was filed five days after a separate lawsuit accusing Gilead of the same allegations of failing to adequately alert patients to the harmful side effects of TDF and withholding the release of the safer drug TAF was filed in San Diego County Superior Court under the case name Timothy Williams, et al vs. Gilead Sciences, Inc., et al.

“This case is a shocking example of corporate greed,” said Elizabeth Graham, one of the lead attorneys with Grant & Eisenhofer, an Oakland, Calif.-based law firm that filed the San Diego case on behalf of the plaintiffs it is representing.

“Gilead owed its consumer patients the safest possible drug, but opted to withhold that drug from the market in the name of profit,” Graham said in a statement.

Liza Brereton, an attorney with HIV Litigation Attorneys, a law firm created to focus on personal injury and class action lawsuits filed against Gilead related to TDF, said judges with the multiple California state courts in which the pending lawsuits against Gilead have been filed have scheduled a hearing in Los Angles for July 30 in which the cases were expected to be consolidated into one large case.

“So it’s taken a while but pretty soon we’ll be all in front of one judge in one court and things will be moving pretty quickly,” Brereton said.

She said the cases in federal courts will continue as separate cases.

Continue Reading
Advertisement

U.S. Federal Courts

Indiana GSA sues school district that banned Pride flags over another ban

“The treatment aimed at PHGSA by administrators is unwarranted- these students must be treated in the same manner all others are treated”

Published

on

Pendleton Heights High School in Pendleton, Indiana (Screenshot via WTHR NBC 13 News)

INDIANAPOLIS – A student led Gay-Straight Alliance at Pendleton Heights High School in Pendleton, Indiana filed suit against their school and the South Madison Community Schools District for banning public announcements and adverts in-school for their club.

Last Spring officials in the Schools District, in this suburban community 30 miles northeast of Indianapolis, ordered faculty members at Pendleton Heights High School to remove Rainbow Pride flags from classrooms. The Schools District labeled the flags “political paraphernalia”  and instructed the Spanish, French and art teachers to get the flags out of their classrooms saying the flags violate their school district’s “political paraphernalia” policy.

In the suit filed last Wednesday by the American Civil Liberties Union of Indiana on behalf of the Pendleton Heights High GSA, in U.S. District Court for the Southern District of Indiana, the ACLU noted that the principal at Pendleton Heights has stated that the PHGSA cannot publicize its existence on school bulletin boards or on the school’s radio station, while other curricular and non-curricular clubs at the school are able to do so. 

“This group aims to create an environment that provides support to students, during a time that otherwise might be increasingly difficult for LGBTQ students,” said Kit Malone, advocacy strategist at ACLU of Indiana. “The differential treatment aimed at Pendleton Heights Gay-Straight Alliance by administrators is unwarranted and these students must be treated in the same manner that all other student groups are treated.” 

Pendleton Heights Principal Connie Rickert has the authority to decide what student groups are allowed to meet at the school and which ones are deemed to be “official.” Last Spring she deflected on the apparent anti-LGBTQ+ messaging the order to remove the flags sent telling one media outlet; ““Teachers are legally obligated to maintain viewpoint neutrality during their official duties to ensure all students can focus on learning and we can maintain educational activities and school operations,” she said. “Our counselors are trained to respond to any student who desires support.”

While she has allowed the GSA club to meet, her banning announcements and notifications for the GSA runs contrary to her statements last Spring that that her school prides itself on creating a welcoming environment for all. 

“Students at Pendleton Heights High School may participate in non-curricular clubs recognized by the school,” said Ken Falk, ACLU of Indiana legal director. “By creating additional hurdles for Pendleton Heights Gay-Straight Alliance such as censoring the group’s promotions and prohibiting fundraising, the school is infringing on these students’ rights.” 

The South Madison Community Schools District has declined comment.

Continue Reading

Texas

Alarming numbers of Texas Trans kids in crisis over litany of anti-Trans bills

“Under the guise of protecting children- Texas legislators are directly harming thousands of transgender & nonbinary youth”

Published

on

LGBTQ youth protest anti-Trans bills at the Texas Capitol building (Photo Credit: Equality Texas)

NEW YORK – The Trevor Project received nearly 4,000 crisis contacts from transgender and nonbinary youth in Texas in 2021, with many directly stating that they are feeling stressed and considering suicide due to anti-trans laws being debated in their state.

This new data comes during a year when Texas lawmakers have proposed nearly 70 anti-LGBTQ bills, including more than 40 bills that specifically target transgender and nonbinary youth — far more than any other state.

The Texas State Senate passed its anti-trans sports ban SB3 this week, and the companion bill HB10 is now moving forward in the Texas House. 

Republican Texas Governor Abbott has prioritized SB 3 and called for a third consecutive special session of the legislature to consider this bill, which would ban transgender student-athletes from playing on sports teams consistent with their gender identity.

“The Trevor Project’s crisis counselors have been hearing from transgender and nonbinary youth in Texas who are scared and worried about anti-trans laws being debated in their state — and some have even expressed suicidal thoughts. This is a crisis. We urge Texas lawmakers to consider the weight of their words and actions — and to reject HB10/SB3,” said Amit Paley, CEO and Executive Director of The Trevor Project.

  • Between January 1 and August 30, 2021, The Trevor Project received more than 10,800 crisis contacts (calls, texts, and chats) from LGBTQ young people in Texas looking for support. More than 3,900 of those crisis contacts (36%) came from transgender or nonbinary youth.
  • Crisis contacts from LGBTQ young people in Texas seeking support have grown over 150% when compared to the same time period in 2020.
  • While this volume of crisis contacts can not be attributed to any one factor (or bill), a qualitative analysis of the crisis contacts found that:
  • Transgender and nonbinary youth in Texas have directly stated that they are feeling stressed, using self-harm, and considering suicide due to anti-LGBTQ laws being debated in their state.
  • Some transgender and nonbinary youth have expressed fear over losing access to sports that provide important acceptance in their lives.

“As a transgender young person in Texas, this new data from the Trevor Project is not surprising, but it’s nonetheless harrowing and alarming to see this representation of the detrimental impact Texas Lege is having on our community — especially our kids. Lawmakers and proponents of bills like SB3 and HB10 should be alarmed by these statistics, too,” Landon Richie a Trans youth activist and GenderCool Youth Leader from Houston told the Los Angeles Blade.

“Under the guise of protecting children and promoting fairness, Texas legislators are directly harming thousands of transgender and nonbinary youth, denying them the dignity, respect, and childhoods that they deserve. It’s never an exaggeration to say that the passage — and merely debate — of these bills will cost lives,”  Richie added.

National mental health organizations like The Trevor Project and state LGBTQ equality groups including Equality Texas and Transgender Education Network of Texas (TENT) are raising concerns about the impact of such legislation on the mental health and wellbeing of transgender and nonbinary youth.

The Trevor Project’s 2021 National Survey on LGBTQ Youth Mental Health found that more than half (52%) of transgender and nonbinary youth seriously considered suicide in the past year and 1 in 5 attempted suicide. Further, Trevor released a new research brief earlier this month on LGBTQ youth participation in sports, which found that a majority of LGBTQ young people (nearly 66%) do not actively participate in sports — with many citing fear of bullying and discrimination as a key factor for not participating.

If you or someone you know needs help or support, The Trevor Project’s trained crisis counselors are available 24/7 at 1-866-488-7386, via chat at TheTrevorProject.org/Help, or by texting START to 678678. 

Continue Reading

Utah

2nd largest school district in Utah bans Pride & BLM flags as ‘too political’

“We have to have a politically neutral classroom, and we’re going to educate the students in the best possible way that we can”

Published

on

Davis School District Offices in Farmington Utah (Photo Credit: Davis School District)

FARMINGTON, Ut. – Administrators this week in the Davis School District, which is Utah’s 2nd largest school district with 72,987 students, banned LGBTQ Pride and Black Lives Matter flags, saying they are ‘politically charged.’

According to the Salt Lake City Tribune, Davis Schools spokesperson Chris Williams told the paper; “No flags fly in our schools except for the flag of the United States of America.” Williams later walked that statement back adding a clarification that some of the Districts schools have flags from sports team or international countries which are considered “unrelated to politics.”

“What we’re doing is we’re following state law,” said Williams. “State law says that we have to have a classroom that’s politically neutral.”

Amanda Darrow, Director of Youth, Family, and Education at the Utah Pride Center in Salt Lake City, told multiple media outlets the school district is “politicizing the rainbow flag” which doesn’t belong on a political list.

“That flag for us is so much more,” said Darrow. “It is just telling us we’re included in the schools, we are being seen in the schools, and we belong in these schools.”

KUTV CBS2 News in Salt Lake City checked with the Utah State Board of Education. In an email, spokesman Mark Peterson said, “There is nothing in code that specifically defines a rainbow flag as a political statement so it would be up to district or charter school policies to make that determination.”

The local Utah chapter of the American Civil Liberties Union also weighed in saying in a statement;

Whether or not a school district has the legal ability to ban inclusive and supportive symbols from classrooms, it is bad policy for them to do so,” the advocacy organization said in a statement. “Utah schools have an obligation to ensure that all students, regardless of their sexual orientation or gender identify, feel welcome inside a classroom. We urge school administrators and teachers to adopt policies that make all students feel safe and included.”

Williams insisted the policy is not meant to exclude anyone and that all students are loved and welcomed – they just want to keep politics out of school he told the Tribune and KUTV.

“We have to have a politically neutral classroom, and we’re going to educate the students in the best possible way that we can,” said Williams.

A Utah based veteran freelance journalist, writer, editor, and food photographer weighed in on Twitter highlighting the negative impact of the Davis Schools decision on its LGBTQ youth.

Davis County School District bans LGTBQ and BLM flags as ‘too political’

Continue Reading
Advertisement
Advertisement

Follow Us @LosAngelesBlade

Sign Up for Blade eBlasts

Popular