Category Archives: Drug Companies

With over 1.5 million drug and medical device related injuries each year, consumers are forced to take legal action. Find out if you have a lawsuit. Read news stories about dangerous medical devices and prescription drugs, health studies and pharmaceutical litigation.

Drug makers spend big to fight California price control referendum

Drug Companies To Pour $100M Into Battle Against California’s Price Control Ballot Initiative

The initiative, likened by one lobbyist to a “grenade being rolled into the conversation,” would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs, and the industry is gearing up to fight back. In other news, Novartis’ heart-failure drug is getting a warmer welcome in Europe than America, and the company is considering its options in selling its stake in Roche.

Politico: Drug Makers Spend Big To Fight California Price Control Referendum

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state. That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C. (Cook and Karlin-Smith, 4/25)

The industry is expected to pour $100 million into an effort to squash the November ballot initiative.

Donald Trump and Hillary Clinton give drug makers the jitters when they talk about Medicare negotiating the prices of prescription drugs. But the biggest near-term threat to the industry comes from a California ballot initiative that would test a version of that idea in the most populous state.

That ballot initiative “is a grenade being rolled into the conversation, and it is being taken very seriously,” says a Republican drug lobbyist in Washington, D.C.

Drug companies are expected to pour $100 million into an effort to squash the referendum in what will be a test of the industry’s strength at a time of growing consumer backlash against drug prices. The initiative would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs — one of the few federal agencies allowed to negotiate drug prices.

From the industry’s perspective, California could set a dangerous precedent. Besides having an economy the size of many small countries, the liberal bastion is often a laboratory for new ideas that take root and then spread east. That’s even more likely given that the presidential front-runners are pushing the federal government to negotiate drug prices for Medicare.

“This is the crack in the door” on drug pricing, said Jamie Court, president of Consumer Watchdog, a California nonprofit devoted to consumer protection issues. “If any Democrat in America wants bulk purchasing in Medicare, it will start with bulk purchasing for the most liberal state government in America.”

Which is precisely the intention of the initiative’s sponsor, Michael Weinstein, CEO of the Los Angeles-based AIDS Healthcare Foundation. “If we win, we hope it will start a national prairie fire,” he said.

Weinstein pursued the ballot measure after years of in-your-face activism on AIDS and after watching the California state legislature fail to do anything about drug prices — a big concern to people with HIV/AIDS who may be taking costly drugs for the rest of their lives.

Read more: http://www.politico.com/story/2016/04/drug-makers-california-referendum-222334#ixzz471Q9mg4k
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Zoloft (sertraline hydrochloride) Recall Info

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Sourced From Our Friends @ https://www.recallguide.org/drug/zoloft/

Zoloft® is an antidepressant medication classified as a selective serotonin reuptake inhibitor (SSRI), generally prescribed to adults to treat major depression and anxiety disorders and, less commonly, for vascular headaches and premature ejaculation. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Pfizer and is available in 25mg, 50mg, and 100mg capsules.

Side Effects & Adverse Reactions

Common side effects include fatigue, insomnia, nausea, dry mouth, headache, diarrhea, dizziness, weight gain, and sexual dysfunction (difficulty achieving arousal, erection and/or orgasm).

As with all antidepressants, Zoloft carries the FDA’s black box warning due to an increased risk of suicidal thoughts/ideation and actions, especially in children and young adults. (fda.gov)

The use of Zoloft during the first trimester of pregnancy is associated with increased risks of the following birth defects: omphalocele (abdominal wall defects), anal atresia (malformation of the anus/rectum), limb reduction, and septal (heart) defects.(ncbi.nlm.nih.gov)

Like many other antidepressant medications, the discontinuation of regular use of Zoloft can cause numerous unpleasant withdrawal side effects, including flu-like symptoms (nausea, vomiting, sweating, headaches, diarrhea), sleep disturbances (insomnia, nightmares, fatigue), sensory/movement disturbances (vertigo, dizziness, “zap” like electrical sensations in the brain or nerve paths), and mood disturbances (anxiety, dysphoria, agitation). Most cases of these withdrawal symptoms are mild and resolve themselves after 1-4 weeks.

Possible Adverse Interactions

Zoloft should not be taken with, or immediately after stopping use of, monoamine oxidase inhibitors (MAOIs), another class of commonly used antidepressants, as this can cause serotonin syndrome or serotonin toxicity, a condition that can be fatal.

It is also contraindicated for use with the antipsychotic medication pimozide (Orap) due to the risk of serious heart problems. The concentrated form also contains an alcohol solution, so it is recommended not to take it with Antabuse, a medication used to treat alcoholism. Grapefruit and grapefruit juice should also be avoided, as it can increase the levels of Zoloft in the body.

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Legal Issues

Pfizer has over 1,000 lawsuits pending against them regarding the use of Zoloft causing birth defects in pregnancy. In June 2015, a jury in Philadelphia, PA sided with the defendant (Pfizer) in a case wherein the plaintiffs alleged that Pfizer did not sufficiently warn patients of the potential for birth defects, finding that the drug’s label adequately warned physicians to weigh and discuss the benefits and risks of use before prescribing it (Robinson v. Wolters Kluwer Health Inc. and Pfizer, Inc.). This is the second such judgment in favor of Pfizer regarding birth defects and use of Zoloft in as many trials. (bloomberg.com)

Zoloft was also the subject of a consumer fraud class action lawsuit that was filed in 2013 in California. The case, Plumlee vs. Pfizer Inc., centered on claims by plaintiff Laura Plumlee that she had taken the drug as prescribed for 3 years with absolutely no effect. The suit alleged that Pfizer deliberately omitted from labeling that there had been studies conducted that found Zoloft to be no more effective than a placebo, and that their marketing and advertising regarding its effectiveness was misleading. The plaintiff’s first claim was dismissed in March 2014, not due to the argument of effectiveness or lack thereof, but due to time-barring. Plumlee had last used Zoloft in 2008, but did not file the lawsuit until 2013. She was given the opportunity to amend her claim and re-file, but the suit was ultimately dismissed with prejudice in September 2014.

FDA Safety Alerts

July, 2006

Food and Drug Administration Labeling Changes indicate several changes but this specific Alert was issued warning of increased risk of Neonatal Persistent Pulmonary Hypertension in mothers taking the drug (fda.gov).

December 14, 2011

The FDA warns of pregnancy risks in SSRI’s in general, including Zoloft. (fda.gov).

July 26, 2011

FDA warns of serious CNS reactions in patients taking the antibiotic linezolid (Zyvox) and certain psychiatric serotonin drugs, including Zoloft. (fda.gov)

Manufacturer Warnings

An undated warning letter from Pfizer alerts healthcare providers to the warnings and label changes regarding detrimental interactions of Zoloft with pimozide (Orap) and MAOIs (fda.gov).

FDA Labeling Changes

September 2014

A labeling adjustment was made to the drug interactions to remove previous additions of QT prolongation, Torsades de Pointes, and ventricular tachycardia – all types of cardiac arrhythmia (irregular heart rhythm) (fda.gov).

February 2013

Diabetes mellitus (scientific name for both Type 1 and Type 2 diabetes) was added to the list of events observed during the post-marketing evaluation of Zoloft. (fda.gov)

December 2012

Contraindications and warnings were added regarding the types of drugs or substances that will interact with use of Zoloft and possibly cause serotonin syndrome, expanding upon the warnings issued in January 2009 (fda.gov).

August 2011

Information was added to the packaging label to advise caution when co-administering Zoloft with drugs that may enhance serotonergic neurotransmission (transmission/absorption of serotonin) due to possibility for interaction. In addition, a precaution was added regarding laboratory testing: patients using Zoloft were reported to have received false positives on urine immunoassay screening tests for benzodiazepines(a class of frequently abused anti-anxiety medications) such as clonazepam (fda.gov).

January 2009

A warning was issued regarding the potential for the potentially fatal complication serotonin syndrome, also known as serotonin storm or serotonin toxicity, or a similar condition called neuroleptic malignant syndrome. Both of these conditions can occur when Zoloft is taken in combination with MAOIs (such as selegiline or phenelzine), or other drugs that alter the neurotransmission of serotonin (fda.gov).

March 2008

Precautions were added to the label making changes to the following subjects: abnormal bleeding as a potential side effect, and interactions with drugs that interfere with the clotting and flow of blood (Non-selective NSAIDs, aspirin, warfarin, etc.) (fda.gov).

Uses

Zoloft® is an antidepressant medication classified as a selective serotonin reuptake inhibitor (SSRI), generally prescribed to adults to treat major depression and anxiety disorders and, less commonly, for vascular headaches and premature ejaculation. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Pfizer and is available in 25mg, 50mg, and 100mg capsules.

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History

Sertraline was the result of many levels of experimentation by Pfizer chemists, beginning in the early 1970’s with the invention of multiple psychoactive compounds that were based on the structures of some of the earliest available antipsychotic medications. These experiments would eventually result in the development of many neurotransmitter reuptake inhibitors, the most potent and selective of which would go on to be tested in vivo (on living organisms, including human trials) and dubbed sertraline. None of the scientists responsible for its creation were anticipating the production of an SSRI type of antidepressant, so the discovery is considered a happy accident.

Zoloft was approved by the FDA on the recommendation of the Psychopharmacological Drugs Advisory Committee in 1991. It was also made available in the United Kingdom the previous year, and in Australia in 1994. It was only approved for prescription to adults over the age of 18 until 2002, when the FDA approved its use in children over age 6 to treat severe cases of obsessive-compulsive disorder. In 2005, the FDA issued a black box warning for all antidepressants, including sertraline, concerning suicidal thoughts and behaviors in children; this warning was amended in 2007 to include the possibility of suicidal tendencies in young adults aged 18 to 24.

The patent for Zoloft expired in the US in 2006, allowing for the availability of sertraline in its generic form. Other brand names for sertraline include Lustral and Asentra. In 2013, it was the most prescribed antidepressant and second-most prescribed psychiatric medication in the United States. (psychentral.com)

For Full Article – https://www.recallguide.org/drug/zoloft/

Jury to Decide if Monsanto PCBs Caused Plaintiffs’ Cancer

| March 15, 2016 12:45 pm

Monsanto’s controversial history with PCBs is being played out in trial in California state court this week, as the agrochemical giant has been accused of causing two retired plaintiffs to develop cancer.

The civil lawsuit, Dauber, et al. v. Monsanto Co., et al, regards plaintiffs Roslyn Dauber, 62, and John Di Costanzo, 87, who both claim that their non-Hodgkin’s lymphoma was caused by eating PCB-contaminated food for years, Courtroom View Network (CVN) reported.

PCBs, or Polychlorinated Biphenyls, are man-made chemicals once used to insulate electronics decades ago. Before switching operations to agriculture, Monsanto was the sole manufacturer of the compound, raking a reported $22 million in business a year. But when PCBs were found to be highly toxic, the company stopped production of them in 1977 over human health and environmental concerns.

Still, the pervasive legacy of PCBs remains. The U.S. Environmental Protection Agency (EPA)banned them in 1979, saying:

PCBs have caused birth defects and cancer in laboratory animals, and they are a suspected cause of cancer and adverse skin and liver effects in humans. EPA estimates that 150 million pounds of PCBs are dispersed throughout the environment, including air and water supplies; an additional 290 million pounds are located in landfills in this country.

Countless individuals, school districts as well as major U.S. cities have since slammed Monsanto with lawsuits for cleanup costs, environmental pollution and for claims that exposure to PCBs causes health problems to people and wildlife.

On Thursday, plaintiff attorney Scott Frieling of Dallas-based law firm Allen Stewart PC delivered an opening statement to jurors and Los Angeles County Superior Court Judge J. Stephen Czuleger about the history of PCBs, the difficulty in removing them from the environment and how these chemicals make their way into the food chain.

“They are virtually indestructible,” Frieling said. “Once PCBs are created, they will last a very long time.”

Frieling also touched on how Monsanto allegedly knew that PCBs were toxic for decades but continued production of the profitable compound anyway.

According to CVN:

Frieling showed jurors internal Monsanto documents dating back to the 1950’s that he claimed would prove the company knew for decades that PCBs posed a substantial public health risk but falsely represented them as being safe.

Freiling told jurors it was easy to link the PCBs in Dauber and Di Costanzo’s bodies to Monsanto, because the company produced 99 percent of the compounds sold in the United States. He claimed Monsanto intentionally avoided long-term safety testing on PCBs and instead publicized the results of short-term tests which didn’t allow enough time for negative health effects to become evident.

In response, Monsanto attorney Anthony Upshaw of Chicago-based law firm McDermott Will & Emery LLP argued that it could not be definitively proven that PCBs caused the plaintiffs’ cancer and that many people who have the same amounts of PCBs in their bodies never suffer any adverse effects, CVN reported.

“The evidence simply doesn’t support the assertion that the historic use of PCB products was the cause of the plaintiffs’ harms,” Monsanto spokeswoman Charla Marie Lord told CVN. “We are confident that the jury will conclude, as past juries have done, that the former Monsanto Company is not responsible for the alleged injuries.”

She also added that Monsanto’s involvement in the trial stems from contractual obligations associated with former chemical businesses that operated under the company’s name, and that Monsanto today is focused solely on agriculture.

The current trial is expected to run through the end of March. Previous rulings over PCBs lawsuits, however, have ruled in favor of Monsanto. CVN noted that a Los Angeles jury and a Missouri state court jury handed the company wins in 2014 and 2015, respectively.

Incidentally, a current House bill could give Monsanto permanent immunity from liability for injuries caused by PCBs. The New York Times reported last month that Republicans in Congress have inserted a clause into the Toxic Substances Control Act (TSCA) reauthorization bill that would effectively exempt Monsanto from liability for injuries caused by PCBs.

Environmental attorney Robert F. Kennedy, Jr., who has sparred over PCBs for three decades, wrote this week that the “so-called ‘Monsanto Rider’ would shield the chemical colossus from thousands of lawsuits by cities, towns, school districts and individuals, who have been injured by exposure to PCBs.”

“If Monsanto gets its way, the American people will pay a high price for corporate greed and political corruption,” Kennedy said.

Full Article – https://ecowatch.com/2016/03/15/jury-decide-pcbs-caused-cancer/

Texas Law Firm Investigating Potential For Talc Lawsuits Against Johnson & Johnson

Baron & Budd: “Seemingly Benign Product” Could Lead to Severe Health Complications Including Ovarian Cancer

ARTICLE | | BY DAVE SCHATZ

NEW BRUNSWICK, NJ–A Dallas-based law firm apparently wants to get in on the opportunity to represent women harmed by Johnson & Johnson’s (J&J’s) talcum-based products.

The law firm, Baron & Budd, says it is investigating potential legal action against Hub City-based pharmaceutical giant Johnson & Johnson (J&J) regarding a possible link between its talcum-based products and ovarian cancer, according to a press release issued by the firm on the last day of February.

Talc, a mineral, is contained in J&J products including baby powder.  It is imported from China, according to package labels.

The “national” law firm cites the recent $72 million verdict in Missouri, one that many media outlets have picked-up on.

The family of Jackie Fox will receive $62 million in a punishment award, plus $10 million in compensatory damages, as we reported.  J&J is expected to appeal the decision.

The release mentions that more than 1,000 other suits are pending against the company, but does not mention the 130 additional cases in the Garden State, consolidated in Atlantic County. The first New Jersey case is set to go to trial in July.

“It is extremely disturbing that such seemingly benign products could be linked to a devastating disease,” said Russell Budd, president and managing shareholder of Baron & Budd.

“We will thoroughly investigate this matter and make sure the rights of anyone harmed by talc-based products are protected.”

“Plaintiffs in the cases are claiming that [J&J] failed for decades to warn consumers that talc-based products such as Shower to Shower and baby powder posed a risk for ovarian cancer,” says the release, citing a report from Reuters highlighting the concern that women who use talcum powder on their genitals are at a higher risk for developing the disease.

Reuters also reported that many women traditionally, “spread talcum powder in the genital areas to help eliminate vaginal odors and keep the area comfortable and cool,” reads the release.

An epidemiologist at a Cancer Center in St. Louis is quoted in the Reuters Report as saying that inflammation increases the risk of a woman developing Ovarian Cancer, and it is a known fact that talcum powder increases inflammation, according to the release.

“The Reuters article also reported that a Harvard University doctor who testified in the Missouri trial has published several studies since 1982 linking talc-based products and ovarian cancer. According to the doctor, exposure to talc can increase a woman’s risk of developing the disease by as much as 30 percent,” says the release.

In 2011, J&J responded to consumer pressure concerning two harmful chemicals used to make its famous “No More Tears” baby shampoo: formaldehyde and 1,4-dioxane.

J&J ultimately reformulated the product, moving to its current hypoallergenic version, which is available on store shelves around the world. It looks and smells the same as the original formula. But, according to media reports it still contains very small amounts of formaldehyde.

J&J has said it was very costly to make the change. Now other makers of look-alike, golden-hued baby shampoos, including Wal-Mart Stores Inc., “Equate” label are also paraben, phthalate and quatemium 15 free.

Sourced From –http://newbrunswicktoday.com/article/texas-law-firm-investigating-potential-talc-lawsuits-against-johnson-johnson

New Xarelto Claim That J&J and Bayer Lied

Posted by Shezad Malik MD JD
March 8, 2016 7:03 AM

According to bombshell revelations in the New York Times, did two major pharmaceutical companies, in an effort to protect their blockbuster drug, Xarelto, intentionally mislead editors at one of the world’s most prestigious medical journals?

Several thousand injured plaintiffs have filed personal injury and product liability claims against Johnson & Johnson and Bayer over the safety of its anti-clotting drug Xarelto.

Now plaintiffs claim that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University deliberately left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies provided the very same data to regulators in the United States and Europe.

The New York Times article suggests that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.

Defective Medical Device Results Flawed

The heart of the controversy alleges that a key medical device that measures the levels of blood thinner in patients involved in the study was defective and that those running the clinical trial knew it, but failed to reveal that information.

The New York Times reports that documents produced by the drug makers during Xarelto lawsuits suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.

It is now confirmed that the measuring device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin.

Flawed Xarelto Medical Studies?

The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.

The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. An INRatio recall has since been issued after it was discovered that the device may show results that were falsely low.

The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.

The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism since Xarelto was approved, as the drug has been linked to a shocking number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have been unable to stop serious bleeding problems that occur, increasing the risk of severe injury or death.

Xarelto Lawsuits Over Bleeding Problems

Xarelto (rivaroxaban) is a new class of blood thinners released in recent years as a replacement for warfarin, which had been the gold standard blood thinner treatment for the past 60 years. Xarelto was approved in 2011, this new-generation treatment has been prescribed instead of warfarin to reduce the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Xarelto lawsuits, like http://sideeffectsofxarelto.org/xarelto-lawsuits/, allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. But, independent studies published after Xarelto was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

Undue Big Pharma Influence

Big Pharma is the nickname given to the vast and influential pharmaceutical industry and its trade group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars every year by selling drugs and medical devices.

Pharmaceuticals are HUGE business and these Big Pharma” companies stand to reap billions of dollars over the life span of a block buster drug. Big Pharma industry influence has led to the concealment of critical unfavorable data or ghost written medical articles (written by industry insiders) — when crucial clinical data went missing from journal articles, leading to embarrassing corrections and ethics policies to limit the influence of drug companies on medical literature.

Xarelto Billion Dollar Block Buster

Xarelto, is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace warfarin.

Last week, lawyers in the case against Johnson & Johnson and Bayer filed a legal brief in federal court in New Orleans, asking a judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

Read Full Article – http://fortworth.legalexaminer.com/fda-prescription-drugs/new-xarelto-claim-that-jj-and-bayer-lied/