Articles Posted in Pharmaceutical Litigation

Pharmaceutical LitigationIn what can be described as a less-than-surprising move, Takeda Pharmaceuticals and Eli Lilly are trying to get either a $9 Billion Actos judgment against them reversed or if that doesn’t work, they are seeking a new trial in the landmark case.

In April, a Louisiana federal agreed with two plaintiffs that the pharmaceutical giants withheld vital information from consumers about the diabetes drug Actos. They claimed the company knew about its potential for raising the risk of bladder cancer in those who used the drug, but failed to warn the public and health professionals. The jury ordered $1.5 million in compensatory damages, as well as $9 billion in punitive damages.

This trial was the very first in a series of bellwether trials that had been scheduled in the federal court system. There are several thousand Actos lawsuits still pending. The $9 billion punitive damage judgment was the highest ever in a drug liability lawsuit.

Attorneys for Takeda claimed that they should have a new trial because the multi-billion dollar punitive awards are excessive and unconstitutional.

Plaintiffs have claimed that Takeda Pharmaceutical executives were aware of the Actos bladder cancer risks before the drug was released to the public. Instead of warning consumers, they claim that the company downplayed the dangers and in some instances actually manipulated data to make it appear that the health risks of the diabetes drug were less than they actually were.

In an even more disturbing turn, a judge recently ruled that Takeda purposely deleted or destroyed evidence concerning the company’s knowledge of Actos’ side effects. She determined that Takeda knew of potential Actos bladder cancer litigation as far back as 2002.

If you believe you or a loved one has been harmed by Actos, please contact the pharmaceutical liability attorneys at Farah & Farah in Jacksonville. We can explain what your next move will be to assure that your legal rights are protected. Call us at (800) 533-3555 or contact us online today. Your consultation is free with no obligation on your part.

Pharmaceutical LitigationThe Florida fungal meningitis injury attorneys at Farah & Farah in Jacksonville have learned that the owners of the New England Compounding Center (NECC) and some associated medical companies have agreed to put nearly $100 million into a victim compensation fund for those stricken with fungal meningitis due to contaminated steroid injections.

The contaminated injections sickened 751 people nationwide in 2012 and early 2013 and killed at least 64 people. Investigators estimated that some 17,000 of the contaminated injections were distributed to hospitals and pain centers around the country. All told, 14,000 people may have been exposed to the contaminated shots.

In Florida, 25 people were infected with fungal meningitis and seven deaths were attributed to the contaminated shots.
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Testosterone DangersAccording to a study published in the Journal of Clinical Endocrinology & Metabolism, men are being prescribed testosterone medications in record numbers in the United States. The study’s researchers claim that testosterone use has quadrupled since 2000.

An even more frightening aspect of the study claimed that many men who do not meet the clinical guidelines for testosterone treatment or who have normal testosterone levels might still be getting the green light for testosterone treatments.

“We see a clear trend where more and more men being tested actually had normal testosterone levels. This is a cause for concern as research examines potential risks associated with testosterone use,” a co-author of the study stated.

Various studies have recently come to light that link the use of testosterone to heart attack, stroke, and other adverse health risks. The red flags raised in these studies have spurred the U.S. Food and Drug Administration (FDA) to investigate the serious health risks associated with testosterone therapy.
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Documents released during litigation against the manufacturer of the blood-thinning drug Pradaxa indicate that the company supplied U.S. Food and Drug Administration (FDA) regulators a more positive report regarding Pradaxa-related bleeding deaths, but withheld another report that painted a less rosy picture for the drug.

Concerned by growing adverse event reports linked to Pradaxa after the drug’s approval in 2010, the FDA had asked Boehringer Ingelheim GmbH to supply more data as part of a safety review the agency was conducting. According to the released documents filed in court, the German-based drug company gave the FDA one analyses that indicated Pradaxa-related deaths were actually less frequent than expected, while not providing the FDA with another analyses that showed a much higher death rate – nearly four times that of the analysis the company had forwarded to the FDA.

A Boehringer executive who oversees Pradaxa did not deny that the company withheld the more negative analyses, but told the court that he couldn’t say why that had happened.
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The Florida Chantix side effect attorneys at Farah & Farah have been letting our blog readers know about the dangers of Pfizer’s smoke-cessation drug Chantix for some time now. The U.S. Food and Drug Administration (FDA) has required a black box label for Chantix since 2009, warning of the risks of suicidal thoughts and depression associated with the drug.

Pfizer Inc., the manufacturer of Chantix, has entered into agreements to settle some 80 percent of the 2,700 lawsuits concerning the drug. It has cost the drug manufacturing giant around $273 million so far, and the company has set aside another $15 million to resolve all of the remaining claims. The company admits that amount may not be enough to cover future losses.

Most of the lawsuits brought against Pfizer claimed that the company knew of the psychological risks of Chantix, but failed to adequately warn doctors and patients. The announcement of the settlements came after two scheduled bellwether trials were canceled after Pfizer agreed to settle them both out of court for undisclosed amounts.
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FL Fungal Meningitis ContaminationAlthough the reported cases of a rare fungal meningitis outbreak linked to contaminated injections distributed by a New England compounding pharmacy have slowed, doctors are still worried more may appear – and the 620 survivors nationwide are still not out of the woods.

According to WebMD, many of the victims have been hospitalized for months, not only for fungal meningitis, but also for secondary infections – and patients may be looking at six months to one year before they are completely recovered. As of yet, nobody has been completely cured. Thirty-nine people in 19 states have died. Florida has had 25 confirmed cases and three deaths have been reported.
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The pharmaceutical litigation attorneys in Florida at Farah & Farah have previously warned about the potential dangerous side effects of Chantix – the smoking cessation drug manufactured by drug giant Pfizer Inc. – which has been linked in some studies to depression, aggression, and suicide. Pfizer recently settled a lawsuit filed by a widow whose husband took his own life after taking the drug.

Now, the U.S. Food and Drug Administration (FDA) is saying that smokers who take Chantix may be at a higher risk for stroke and heart attacks.

Last year, the FDA was concerned about heart risks linked to Chantix, so it ordered Pfizer to conduct additional safety studies on the drug. Pfizer’s study found that smokers who took Chantix for three months suffered more major cardiac events than a group that was given a placebo.

Since the risk of heart attack was fairly rare, it was suggested that the differences between the two groups might be simply be due to chance and not a result of taking Chantix. A recent report from the FDA disagrees with that assessment.
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FL Compounding Pharmacy LiabilityFlorida pharmacy regulators have ordered Florida’s approximately 7,700 pharmacies to complete a survey about their drug compounding practices.

This mandatory order comes in the wake of the deadly nationwide fungal meningitis outbreak linked to contaminated drugs made at a compounding pharmacy in Massachusetts. So far, 500 people have been sickened and 33 have died. There have been 24 confirmed cases and three deaths in Florida.

Earlier, the Florida Department of Health (DOH) had attempted to gather information on pharmacies’ compounding practices through a voluntary survey – a survey that 90 percent of pharmacists ignored.
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Florida Novartis LawsuitA woman who claimed that she suffered severe jawbone damage after taking the Novartis drug Zometa has been awarded $10.45 million by a federal jury.

In 2006, the woman alleged that she developed osteonecrosis, or “bone death,” in her jaw after being prescribed Zometa as part of her treatment for breast cancer. Zometa is a bisphosphonate used to treat bone complications that can result from cancer, according to Bloomberg News.

According to the plaintiff’s attorney, in May 2003 at least one Novartis marketing employee knew of a proposed report that linked Zometa to jawbone complications, and in an e-mail the worker described it as “quite damaging.” In another e-mail, which the attorney provided as evidence in the trial, the same employee proposed a strategy for damage control and proposed that a public relations effort be implemented to offset any negative news associated with the drug.
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When a 21-year-old Seffner, Florida man was given a prescription to fill after a hospital visit, little did he know that a prescription mix-up would land him right back in the hospital again. The mother of the man said that her son went to a local pharmacy to get the prescription filled, but he was given pills that belonged to someone else. When he mixed the two drugs – a pain medication and a muscle relaxer – he became violently ill.

He is expected to recover and the pharmacy is taking responsibility for the mix-up.

Benjamin Benoit, who runs Medicine Shoppe International in Pasco County (not the pharmacy involved in the mix-up), says that mix-ups happen, especially at larger pharmacies with many customers. Benoit suggested that customers always carefully look over the bottle and that pharmacists always confirm the name and even the address of the person picking up the prescription.

“Even with good systems there are things that slip through the cracks,” he told ABC News.
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