AHF Calls on Gilead to Set Up $10 Billion Fund for Victims Harmed by its TDF-based Drugs

As pressure continues to mount on Gilead Sciences Inc., one of the largest manufacturers of HIV/AIDS drugs, from withholding improved HIV drugs from the public to increase profits, another foundation is taking the podium. AIDS Healthcare Foundation (AHF) is calling on Gilead to set up a $10 billion compensation fund for victims that took their TDF-based drugs as part of their HIV/AIDS treatment or preventative treatment (PrEP) programs.

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Gilead tries—and fails—to dodge lawsuit claiming it delayed safer HIV meds

After years of allegations directed towards Gilead Sciences regarding their decision to hold back the release of improved next-gen HIV drugs in order to maximize profits from their older generation drugs, a federal judge has finally allowed a key lawsuit to proceed. 140 patients in 31 states have claimed in the lawsuit that Gilead shelved their newly developed tenofovir alafenamide fumarate (TAF) drugs in 2004 to protect the profits from their existing and older franchise drugs tenofovir disoproxil fumarate (TDF). All the while knowing the TAF-based drugs were safer and better for patients.

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Jury awards $70 million to woman who blamed J&J powder for cancer

After only 3 hours of deliberations, a St. Louis jury awarded $70 million in compensation and punitive damages to a California woman who blamed her ovarian cancer on Johnson & Johnson’s talcum powder. This is the third straight trial Johnson & Johnson has lost over claims that its talcum powder can cause ovarian cancer. Earlier this year, juries awarded verdicts of $72 million and $55 million against the company in the first two talcum powder claims to go to trial. All three cases contended that J&J knew there was a risk of ovarian cancer linked to its Baby Powder and Shower to Shower products yet failed to warn customers of that risk. While the company plans to appeal the recent verdict, plaintiffs’ lawyers are hoping these two outcomes will motivate the company to try and settle the nearly 1,700 outstanding talc cases filed against J&J. The company denied any wrongdoing and stated that it takes questions about the safety of its products very seriously.

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J&J’s Janssen Pharmaceuticals Under Fire Again in Risperdal Trial

Johnson & Johnson’s Janssen Pharmaceuticals came under fire again when a Philadelphia jury awarded $70 million to the family of a boy who developed breasts while taking the company’s antipsychotic drug Risperdal. Apparently the jury found that Janssen intentionally falsified, destroyed or concealed evidence in the case in reaching its decision. These allegations come after J&J and Janssen already paid over $2.2 billion back in 2013 to resolve civil and criminal investigations by the U.S. Department of Justice into its marketing of Risperdal and several other drugs. The $70 million verdict here dwarfs the next largest jury award in a Risperdal case which was $2.5 million. Perhaps this could be a sign that people are tired of J&J and Janssen putting its revenues ahead of the health and well-being of its consumers. This trend in jury awards could be particularly troubling for the company as J&J is still facing over 12,000 claims regarding Risperdal.

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Jury Awards $70 Million in Risperdal Trial

In early July, a jury in a Philadelphia courtroom awarded $70 million to the family of a boy who developed breasts after taking the antipsychotic drug Risperdal. The jury found that the maker of Risperdal, Janssen Pharmaceuticals, failed to warn the boy’s healthcare providers that there was a risk of gynecomastia (breast growth in men) with use of the drug. The boy’s lawyers say he developed gynecomastia at the age of five as a result of taking Risperdal. A Janssen spokeswoman said the $70 million award was “clearly excessive” and said the company plans on asking the court to review it.

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Jury awards $55 million to woman who blamed talc for cancer

A St. Louis jury awarded a South Dakota woman who blamed her ovarian cancer on Johnson & Johnson’s talcum powder $55 million in compensation and punitive damages. A little less than two months earlier in the same courthouse, the company lost a $72 million verdict to the family of a woman who died of ovarian cancer. Both cases contended that J&J knew the risk of ovarian cancer was linked to its Baby Powder and Shower to Shower products yet failed to warn customers of that risk. While the company plans to appeal the recent verdict, plaintiffs’ lawyers are hoping these two outcomes will motivate the company to try and settle the nearly 1,000 outstanding talc cases filed against J&J. The company denied any wrongdoing and stated that it takes questions about the safety og its products very seriously.

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J&J’s Baby Powder Problem

Bloomberg released an investigatory report regarding the potential link between long term use of talcum powder in the genital area and ovarian cancer in women. J&J has been selling its Baby Powder for over 100 years, yet there had never been a discussion concerning ovarian cancer until a British study done in 1971 found talc particles “deeply embedded” in 10 of 13 ovarian tumors.

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Troubling Allegations in Risperdal Trial

The most troubling aspect of a recent case decided against Johnson & Johnson (J&J) concerning its antipsychotic drug Risperdal is the allegation that the company deliberately withheld data from the U.S. Food and Drug Administration. An expert witness testified that J&J knew about the risk of gynecomastia associated with Risperdal but failed to show the complete extent to which young people may develop it when using the drug. This is troubling because it appears to be proof that the company is putting its bottom line ahead of the health and wellbeing of our country’s children. Apparently J&J decided its revenues were more important than the psychological trauma suffered by young men who took Risperdal and had their lives turned upside down when they began to develop breasts. These companies should be held liable for their actions and it was good to see a Philadelphia jury decide accordingly.

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Jury Awards $2.5 Million in Risperdal Trial

The Wall Street Journal reported that a Philadelphia jury held Johnson & Johnson (J&J) liable for failing to warn that its antipsychotic drug Risperdal could cause gynecomastia and ordered the company to pay $2.5 million in damages. The family of an autistic boy who took Risperdal between 2002 and 2006 and later developed size 46DD breasts brought the suit, claiming J&J hid the risks of male breast development with the use of Risperdal in young boys and men. While J&J settled a number of these claims over the past few years, this was the first one to go to trial where J&J was accused of hiding data from the U.S. Food and Drug Administration as well as prescribing doctors and parents. One law school professor from the University of Richmond commented that the verdict “doesn’t bode well for the company,” but cautioned that J&J would most likely want to see more jury verdicts before seriously considering settlement negotiations for the 1,200 similar lawsuits filed against the company. For its part, J&J said it would consider its options going forward, including a possible appeal of the verdict.

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FDA Warns of Ketoacidosis with Certain Diabetes Drugs

An article on the American Academy of Family Physicians’ website discussed the FDA’s recent move to add warnings to the labels of diabetes drugs like Invokana to notify users about the potential risk of ketoacidosis. The article also cautioned physicians whose patients are on these diabetes drugs to watch for signs of ketoacidosis and to make patients aware of the symptoms so they can seek medical attention should symptoms appear. The FDA also noted that while a number of adverse events have been reported with this particular type of diabetes drug, the actual number of adverse events is most likely higher since the reporting is done on a voluntary basis only.

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No Legal Recourse for Injuries from Generic Drugs

When a person suffers injuries from a generic drug, there may be no recourse in a court of law. Unfortunately, one Massachusetts family had to discover this the hard way. A report done by a local CBS affiliate on the Steele family illustrates how patients taking generic drugs could be at risk due to a legal loophole. Alisa Steele was prescribed Ondansetron, the generic form of Zofran, for her morning sickness. The drug had never been tested for use in pregnant women and had only been approved for use in cancer patients to treat nausea while undergoing chemotherapy. Even though studies have linked Zofran to an increased risk of birth defects, current law does not allow generic drug manufacturers to be sued when their identical drug injures someone. Alisa Steele gave birth to a baby girl who was born with a congenital heart defect, one of the birth defects potentially caused by Zofran use during pregnancy. While the Steele’s are unable to pursue a claim against the makers of Ondansetron, they are hopeful that they can convince a judge that brand manufacturers should be held liable for their generic copies. and some

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Innovator Liability in Massachusetts

After reading this article I wanted to see how Massachusetts’ courts had ruled on the issue of innovator liability. A majority of them found that brand name manufacturers were not liable for injuries caused by use of their identical generic versions. The courts’ reasoning seemed to be summed up in its holding in Kelly v. Wyeth where it stated “a manufacturer of one product owes no duty of care to one who did not use their product.” Kelly v. Wyeth, 2005 WL 4056740, at 5 (Mass. Super. May 6, 2005)

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Xarelto Reversal Agent in Late Stage Trial

A drug developed to rapidly reverse the effect of new blood thinners during episodes of major bleeding has been effective in late stage trials according to an article on Reuters.com. The drug reportedly reversed the anticoagulant effect of the new blood thinners, including Xarelto, with no serious side effects being reported. This is an important development because currently there is no known antidote to blood thinners like Xarelto so serious bleeding events are difficult if not impossible to control. Portola Pharmaceuticals, the maker of the drug, was hopeful it would be able to file for approval with the FDA by the end of the year.

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