The Recall Lawyers

WARNING: If you cut yourself, you have a real risk that you may bleed to death. Go to the hospital immediately for a blood transfusion.

If the language above was in the Pradaxa label, would you buy it? I didn't think so. And neither does the maker of Pradaxa. If they included the language above, their sales would plummet. So what does the company do, they minimize the very serious risk of death and/or blood transfusions in the Pradaxa label.

Is that right? Is it fair? I don't think so. And lawyers across the country don't think so. In fact, Pradaxa attorneys across the country are hearing from the families of Pradaxa users who have suffered serious injuries and death because of this drug. Unlike it competitors, Pradaxa has no antidote for uncontrollable bleeding. There are no medicines that can cause the blood to coagulate and stop the bleeding naturally.

If you or a family member has been injured or killed because of uncontrollable bleeding caused by Pradaxa, contact Pradaxa attorney Larry Jones by clicking here.

What's a gallbladder worth? This is the question that I've heard over and over and over again as it relates to the Yas, Yasmin and Ocella settlement discussions currently taking place across the country. Bayer (the maker of Yaz, Yasmin and Ocella) says a gallbladder is worth zero, nothing, nada, zip. Bayer says that the woman who lost their gallbladders were fat, out of shape, old, and generally unhealthy. Bayer says that they are not responsible for gallbladder losses because there are no epidemiological studies showing an increased risk of gallbladder disease in Yaz, Yasmin and Ocella users.

What do I say? Bring it on. A gallbladder removal is a very serious injury. I represent teenagers, as well as middle-aged women, in the Yaz, Yasmin and Ocella litigation. They aren't all fat or old or out of shape. Indeed, there are thousands of young woman (pretty, thin, and in shape) who have lost their gallbladders. These women had no prior health history that would suggest gallbladder disease. These women never knew that they were at risk. The women never knew that a Canadian Medical Association published a study that found that there was a "statistically significant" increase in gallbladder disease for Yaz, Yasmin and Ocella users when compared to other oral contraceptives.

So what's it worth? I'm an experienced trial lawyer. I can try these cases. I can't imagine that a jury would not award six figure verdicts. So when Bayer comes knocking at my door, they better be ready to negotiate reasonable settlements. If not, I'll go to court and try my cases on behalf of my gallbladder clients. We don't plan on letting them get away with endangering our daughters, moms, aunts, and nieces who have used Yas, Yasmin and Ocella.

In a previous blog post http://www.the-recall-lawyers.com/2012/01/tekturna-recall-lawyer-says-la.html I detailed what Novartis did wrong. They marketed a drug to diabetics that was not FDA-approved for usage by diabetics. By marketing "off-label" to these users, Novartis engaged in conduct that was reckless, irresponsible and illegal.

There are many diabetics throughout the country who were convinced to use Tekturna, Valturna and TekAmlo by their doctors, who were led to believe that the drug would not only help their blood pressure, but that would also help with renal issues. The problem: there was no scientific evidence that showed it was safe to use with diabetics or that it actually helped with renal problems.

Novartis commenced clinical trials that tested the safety of diabetic usage. Unfortunately, they learned during the trials that the drug was not safe; indeed, it was dangerous. The trials were suspended because of the high number of diabetics who suffered strokes, renal problems, and other issues during the trials.

So what should happen to Novartis? Well, Novartis is a frequent offender. It is time for Novartis to be held responsible for their conduct. That's where we come in. Jones Ward PLC regularly files lawsuits against the largest pharmaceutical companies in the world. Some say that lawyers are after money. We feel otherwise. We believe in holding corporations accountable for conduct that puts our families and yours at risk every single day --and all in the name of profits. Of course we get paid. But that isn't what it is all about. The payments we receive from our work allows us to hire more attorneys that can help us get justice for our clients and accountability from the companies.

Day in and day out, I look at internal documents from pharmaceutical companies. I see how many of these companies blatantly cross the line, and break the law, all in the name of higher profits. The results? It puts all of us at risk.

So if anyone ever says that lawyers are greedy and no good. You tell them that without the lawyers the pharma companies would have no incentive to make safe products and they would never be held accountable.

For more information about Jones Ward PLC and what we do, contact Larry Jones at larry@jonesward.com.

Jones Ward PLC is actively litigating nearly 100 cases across the country (mainly in Boston, Philadelphia and St. Louis) related to the use if Reglan (metoclopramide) and its link to the tragic muscle movement disorder known as tardive dyskinesia. Much of the litigation is centered on the generic manufacturers of metoclopramide, who claim that they had no duty to contact the FDA and request a label change despite very clear evidence that the metoclopramide was linked to tardive dyskinesia. For more information from the FDA, check out this link: http://youtu.be/dum81RdFrhM

There is much more to this story. If you would like to know more, don't hesitate to send me an email at larry@jonesward.com

A recent study found new evidence that statins could increase women's risk factor for type 2 diabetes. Tens of millions of Americans take Statins to lower cholesterol levels. Crestor, Lipitor, and Zocor are the most popular of these medications that reduce the risk of heart disease and stroke. A recent study that followed more than 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Physicians do not know why statins increase diabetes, and the research does not implicate any single brand; however, these findings appear to confirm prior smaller studies.

Continue reading "Recent Study: Statins May Increase Chance of Diabetes in Women" »

In December forty medical products underwent label revisions, with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

The following medications have been affected:

• Multaq (dronedarone hydrochloride) tablets

• Dilantin-125 (phenytoin) Oral Suspension

• Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets

• Relenza (zanamivir) inhalation powder

• Tyzeka (telbivudine) tablets and oral solution

• Capoten (captopril) Tablets 

• Danocrine brand of Danazol capsules

• Desferal (deferoxamine mesylate) for injection

• Edarbi (azilsartan medoxomil) Tablets

• Eloxatin (oxaliplatin) for intravenous use

• Heparin Sodium Injection

• Isentress (raltegravir) scored, chewable tablets, film-coated tablet 

• Keppra (levetiracetam) Tablets and oral solution 

• Onglyza (saxagliptin) tablets

• Ovide (malathion) 0.5% lotion1 

• PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use

• Plavix (clopidogrel bisulfate) tablets

• Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating 

• Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules

The attorneys of Jones Ward PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by one of the above prescription drugs or any other type of product, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.

Novartis is looking at big trouble over the side effects caused by Tekturna (Aliskiren), a blood pressure drug sold by Novartis, after Tekturna's clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).

During the clinical trials, Novartis was testing Tekturna to see if it could be useful in the treatment of hypertension by diabetics. The results were disastrous. Rather than helping those who ingested Tekturna, Novartis that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.

As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched this week in Canada, where the medication is sold under the brand name Resilez.

Here's where Novartis went wrong. Long before testing the safety and efficacy of Tekturna on diabetic patients, Novartis engaged in extraordinary reckless behavior --all in the name of increasing its profits. Among other things, Novartis was instructing its sales representatives to engage in "off-label marketing" of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had "protective effects" on these patients even though it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.

Novartis announced the cancellation of the clinical trials via a December 20, 2011 press release. The trial, which was known as ALTITUDE, involved 8,609 patients from 36 countries. The ALTITUDE trial was a randomized, double-blind, placebo-controlled study of the drug's use in patients with diabetes and kidney problems. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE study found an increase in Tekturna side effects after 18-24 months. These dangerous side effects included not only strokes and renal complications, but also caused hypotension (low blood pressure) and hyperkalemia (high potassium), both of which can cause dangerous circulatory problems, such as a low pulse and heart rate. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE trial involved the use of Tekturna along with agiontensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). As a result, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

The ALTITUDE trials were cancelled after an independent Data Monitoring Committee (DMC), which was overseeing the clinical trial, became alarmed by the high rate of Tekturna health risks among the ALTITUDE trial subjects and recommended that Novartis immediately stop the study because of the dangerous side effects and the risk to the study's participants. See http://www.rttnews.com/1784537/novartis-reveals-termination-of-altitude-trial-with-rasilez-tekturna.aspx

Tekturna (Aliskiren) is an anti-hypertensive (blood pressure lowering) medication. Novartis claims it works by decreasing substances in the body that narrow blood vessels and raise blood pressure. Tekturna was launched by Novartis in April 2007. See http://www.drugs.com/tekturna-hct.html

Tekturna is indicated by the FDA for the treatment of hypertension, to lower blood pressure. See http://www.drugs.com/tekturna-hct.html

TekturnaHCT contains a combination of hydrochlorothiazide and Aliskiren. Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. TekturnaHCT is indicated for the treatment of hypertension, to lower blood pressure in: (a) patients not adequately controlled with monotherapy; or (b) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. See http://www.drugs.com/tekturna-hct.html

Valturna is a combination of aliskiren, a renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB). Valturna is indicated for the treatment of hypertension, to lower blood pressure: (a) in patients not adequately controlled with monotherapy; (b) May be substituted for titrated components; (c) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Novartis launched Valturna in January 2010. See http://www.drugs.com/pro/valturna.html

TekAmlo contains a combination of Aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker. Novartis launched TekAmlo in 2011. Amlodipine relaxes (widens) blood vessels and improves blood flow. TekAmlo is indicated for the treatment of hypertension, to lower blood pressure: (a) as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals; (b) in patients not adequately controlled with monotherapy; (c) as a substitute for its titrated components. See http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=28627

Amturnide is a combination of Aliskiren, amlodipine besylate (a dihydropyridine calcium channel blocker) and hydrochlorothiazide (HCTZ) (a thiazide diuretic). Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine besylate relaxes (widens) blood vessels and improves blood flow. HCTZ is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Amturnide is indicated for the treatment of hypertension, to lower blood pressure, and is not indicated for initial therapy. See http://dailymed.nlm.nih.gov/dailymed/mobile/drugInfo.cfm?id=56247

Novartis' Off-label Promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide

According to messages from sales representatives on CafePharma, Novartis engaged in an off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated. See http://www.cafepharma.com/boards/showthread.php?t=480316 See also http://www.cafepharma.com/boards/showthread.php?t=482965 See also http://www.cafepharma.com/boards/showthread.php?t=486183

In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince prescribers that these drugs had positive health effects for the diabetic patient population. The sales aid was known as the "flash card campaign." http://www.cafepharma.com/boards/showthread.php?t=486183 See also http://www.cafepharma.com/boards/showthread.php?t=486127

According to some, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.

On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB. See http://www.reuters.com/article/2011/12/20/idUS48151+20-Dec-2011+HUG20111220

What is Next?

Novartis has not yet released data from the study, but has informed all of the clinical trial's investigators to remove Tekturna products from their patients' treatment regimen. The company is also in consultations with governments worldwide about Tekturna health risks.

JONES WARD PLC partner Larry Jones says, "Given the level of misconduct associated with the marketing and off-label promotion of this drug, combined with the disastrous side effects, it is likely that Novartis will soon be taken to task for putting the desire for profits over the safety of consumers. We intend to be intimately involved with holding Novartis responsible for the lives it has damaged."

For another great article on the topic, look at Dr. Shezad Malik's blog http://fortworth.injuryboard.com/fda-and-prescription-drugs/novartis-tekturna-problems-study-cancellation.aspx?googleid=297374

For more information about Tekturna lawsuits, feel free to contact The Recall Lawyers or dangerous drug attorney Larry Jones by clicking here: larry@jonesward.com.

Sales of the Infuse bone-growth protein made by Medtronic Inc. are in a nosedive after reports that the U.S. Senate is investigating safety problems with the product.
Medtronic sold $800 million worth of Infuse in its latest fiscal year, but Infuse sales are now declining sharply in the wake of news reports about safety issues.

A recent analysis, for example, showed that when the growth protein is used in spine surgery there is a possible higher rate of cancer. The types of cancer cited in the study include, breast cancer, pancreatic cancer, and prostate cancer. If you or a loved one has been injured by Infuse, contact the attorneys at Jones Ward PLC for a free consultation. Call Jasper Ward at 502-882-6000 or email jasper@jonesward.com.

Evidence is mounting that Bayer's birth control pills are unreasonably dangerous, particularly in light of safer alternatives. Yasmin, Yaz, Beyaz and Safyral are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin. During the month of December, several FDA advisory groups met to review Bayer's warnings for these birth control pills.

Bayer's first drospirenone birth control pill, Yasmin, was developed and released in May 2001. With the approval of Yaz in 2006, Bayer's heavy marketing campaign took off. Bayer's advertisements targeted women's sense of freedom and individuality. It also directed Yaz and Yasmin for uses not FDA approved, including bloating, muscle fatigue, aches, and PMS. The campaign proved a huge success. In 2008 Bayer's Yaz and Yasmin profits were a staggering $998 million.

Then the problems surfaced. Women began having strokes and heart attacks due to venous thromboembolisms (blood clots) and pulmonary embolisms. Many healthy and young women with no other risk factors had their gallbladders removed. A significant number of studies and other evidence suggest a link between drospirenone and these gallbladder injuries. Additionally, these women share a common denominator: they all took a birth control pill in the Yaz-family. In response to the rising number of adverse events, the FDA ordered Bayer to spend $20 million on corrective advertising.

Continue reading "Yaz/Yasmin: FDA Reviews Bayer's Warnings" »

The controversy over the Infuse bone-growth protein made by Medtronic continues, with California's attorney general issuing another subpoena to Medtronic forcing the company to cough up documents.
Medtronic, based in Minnesota, already is under fire for allegedly downplaying the safety risks associated with Infuse. According to news reports and scientific studies, the potential dangers of the drug include uncontrolled bone growth, a heightened risk of cancer, and male sterility. If you or a loved one has been injured by Infuse, contact the attorneys at Jones Ward PLC for a free consultation. Call Jasper Ward at 502-882-6000 or email jasper@jonesward.com.

Drug maker Merck & Co. has agreed to pay $950 million and to plead guilty to a criminal charge. It was accused of marketing its painkiller Vioxx for off-label uses, uses for which the FDA had not approved the drug. While doctors may prescribe drugs for off-label uses, drug makers cannot market their drugs for such use. The allegations against Merck were that it illegally promoted the sale of Vioxx to ease the pain of rheumatoid arthritis prior to its approval to do so in 2004.

This is not the only legal trouble the drug company has faced over Vioxx. In 2004, Merck withdrew Vioxx from the market because of its link to increase in stroke and heart attacks. Merck previously agreed to pay a $4.85 billion settlement to individuals who were taking the drug and their families. It settled potential claims of unions and insurers for $80 million. It also agreed to pay $12.5 million to shareholders for their derivative claims against the company's officers stemming from the sale of the drug.

Continue reading "Drug Company Agrees to Pay Additional $950 Million" »

A U.S. Food and Drug Administration advisory committee recommended stronger warning labels for Bayer's birth control pills Yaz and Yasmin. By a 21 to 5 vote, the panel recommended changing the contraceptives' labels to reflect the possibility that the pills could lead to a higher risk for blood clots or deep vein thrombosis (DVT). Currently, the labels suggest the risk of blood clot is similar to those of other contraceptives that combine estrogens and progestins.

FDA spokeswoman Morgan Liscinsky said the panel acknowledged the conflicting data but "definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data." While some physicians do not believe this risk is enough to change their prescribing habits, others, including members of the FDA advisory committee, disagree. In an interview with the Wall Street Journal, committee member Sean Hennessy of the University of Pennsylvania stated physicians should use an abundance of caution because "these drugs ought to be rarely used."

Continue reading "FDA Panel Recommends Stronger Warning for Yaz and Yasmin" »

The U.S. Food and Drug Administration (FDA) remains concerned about the potentially higher risk of blood clots in women taking newer forms of birth control pills, such as Yaz, Yasmin and Ocella. These "fourth generation" contraceptive drugs contain drospirenone, a new type of synthetic progestin.

An FDA-funded study indicates that women taking contraceptive drugs containing drospirenone have a 50 percent increased risk of blood clots. Earlier this year two other studies appearing in the British Medical Journal found double to triple the risk. An FDA advisory committee is scheduled to meet in December after which the full findings of the study will be released.

A deep vein thrombosis (DVT) is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. A pulmonary embolism (PE) is a potentially fatal condition where the clot breaks loose and travels to the lung blocking a lung artery. DVTs and PEs are also known as venous thromboembolic events, or VTEs.

Continue reading "FDA Warns Yaz, Yasmin and Ocella Contraceptives Could Increase Clot Risk " »

The Food and Drug Administration (FDA) recently issued a safety warning on a group of drugs called 5-alpha reductase inhibitors (5-ARI). The drugs finasteride and dutasteride are included in the 5-ARI class and are marketed under the trade names Propecia, Proscar, Avodart, and Jalyn. The FDA revised the Warning and Precautions section of the drug labels to include new safety information on the increased risk of developing an aggressive form of prostate cancer. The label revision is based on the FDA's review of two studies, which showed that these drugs boost the chances of developing "high-grade" prostate cancer.

Propecia is FDA approved to treat male pattern hair loss. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate glad. Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.

Merk manufactures Propecia and Proscar. GlaxoSmithKline manufactures Avodart and Jalyn. Earlier this year, both companies requested the FDA to approve these drugs for use in preventing prostate cancer. The FDA denied their requests citing the increased risk of high-grade prostate cancer.

Continue reading "Propecia Increases Risk of Prostate Cancer - FDA Changes Label" »

In June of this year, the FDA announced that use of the diabetes drug Actos may be associated with a greater risk of bladder cancer. Based on its findings from the first five years of a ten-year study, the FDA recommended that Actos not be prescribed in patients with a history of bladder cancer or with active bladder cancer.

Actos has been used to control type 2 diabetes in adults. In the first ten months of 2010 alone, 2.3 million patients filled prescriptions for Actos or other drugs containing pioglitazone. Takeda Pharmaceuticals Co. Ltd., the maker of Actos, is already facing hundreds of lawsuits over the drug.

Continue reading "Diabetes Drug Actos Linked to Bladder Cancer" »