Articles Posted in pharmaceuticals

levin perconti zantac injury

Zantac and Generic Ranitidine May Be Harmful

The U.S. Food and Drug Administration (FDA) recently revealed that Zantac and generic varieties contain a chemical that could be linked to cancer, called

N-nitrosodimethylamine (NDMA). Concern erupted when private lab Valisure found the contaminant and alerted FDA officials of a problem stemming from the composition of the drug. Several large pharmacy chains and stores such as Walmart, Rite-Aid, CVS and Walgreens have since suspended the sales of Zantac branded heartburn medicines and generic versions that contain active ingredient ranitidine. Three drugmakers – Apotex, Sandoz and GlaxoSmithKline – have recalled generic versions.

The FDA is often criticized for the amount of time it takes to test and approve a drug, a required step before a medication is able to be marketed and sold to the public. But behind the scenes, more and more pharmaceuticals are being quickly approved, bypassing the traditionally-required clinical trials that ensure a drug’s safety while providing the benefits they claim.

The Drug Approval Process

According to, the standard drug approval process is 3 phases:

Last year, Johnson & Johnson made constant headlines over their talc powder, sold for over 100 years and used by millions of women to keep undergarments and their body fresh and dry. When it was revealed that Johnson & Johnson knew that their product caused cancer and engaged in a decades-long cover up, many women suffering from ovarian cancer decided to sue the company, resulting in several large verdicts.

While the Johnson and Johnson crisis has blown the lid off the lengths manufacturers will go to sell a product (even with evidence indicating danger), they are hardly the first company to engage in such deceptive practices. The American Association of Justice (AAJ) recently released a report entitled “From Accutane to Zonite: A History of Dangerous Drugs and Devices Marketed to Women,” a thorough look into the ways women have been deceived by large corporations, paying big companies with their health and even their lives. The report comes at a time when the House is peddling the Protecting Access to Care Act (also known as H.R. 1215), a bill that would give significant legal protection to companies that are sued by those injured by faulty medical devices, dangerous drugs, negligent medical care, and abuse and neglect in nursing homes.

140 Years of Deceit & Claims of Curing ‘Women’s Problems’

Many of our loved ones and those in our community suffer from medical complications that require them to monitor their blood, among other vitals, on a daily basis. For instance, many of these people take blood-thinning medications after undergoing heart surgery, so they must monitor their blood coagulation levels. To do so, most rely on medical technology to help gauge the overall state of their health. However, when such technology fails them, a patient may receive an improper reading of their vitals, and therefore the wrong message about the state of their health.

Our lawyers believe that all patients should be able to trust the medical equipment they use to monitor their health. For those patients with already compromised health conditions, a wrong reading could mean the difference between life and death. In order to successfully monitor their medical conditions, patients rely on the products they use, and where companies and manufacturers provide defective or faulty medical products, a patient may be in grave danger and unable to take action without the accurate knowledge from wrong medical device readings. In these instances, patients and loved ones may be able to hold the companies and manufacturers liable in a product liability lawsuit

According to a recent article by Forbes, there is an urgent product recall for PT/INR test strips and monitoring system. This affects patients on blood thinners, such as the anticoagulant drug warfarin (Coumadin) or those who are given heparin injections . The company, Alere, has issued this urgent recall of their professional test strips with product number PN 99008G2. Patients and families should immediately check the brand of their monitoring devices.
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You are probably familiar with TV advertisements for new pharmaceutical drugs on the market, such as those for allergies or heart conditions, among many other ailments. These ads always include a cautionary list of warnings and side effects to consider. Although most viewers don’t realize it, these warnings are actually related to products liability law.

Under products liability law, manufacturers of products, such as food and drugs, must put safe products into the marketplace for consumers to purchase. This means that the manufacturer must abide by safety regulations and properly inspect the products for known dangers and not put any defective products into the market. Where a manufacturer is aware of dangers, they must warn consumers of proper use or potential hazards. This can include adhering a warning label for proper use to the packaging, such as that which we see on chicken at the grocery store. In the case of pharmaceuticals, not only must the drug be safe for use, but the manufacturer must warn the consumer and patient of all known dangers and potential side effects so that the consumer can make an informed choice about the drug they are purchasing and putting into their body. Where the manufacturer fails to warn about dangers of use, they can be held liable for injuries caused in a products liability lawsuit.

According to recent reports by the Cook County Record, one man is suing several drug manufacturers for failure to warn about Plavix’s dangers. The individual filed suit in Cook County Circuit Court against Bristol-Myers Squibb Co., Sanofi-Aventis US LLC, Sanofi-Aventis US Inc., and Sanofi-Synthelabo Inc. in a claim of strict product liability, manufacturing defect, negligence, and failure to warn. The man had been prescribed Plavix, and as a result of taking this drug he has suffered injuries, such as internal bleeding. He argues that the defendant drug manufacturers failed to completely and accurately convey the safety issues of Plavix and misled the medical community about the risks involved with the drug.

Olanzapine, a common anti-psychotic drug used to treat illnesses such as schizophrenia and bipolar disorder, has been recalled by its manufacturer in light of major defects in the drug’s packaging. Reports indicate that the United States Food and Drug Administration requested that the pharmaceutical manufacturer, Torrent Pharmaceuticals Ltd, recall their recent output of Olanzapine 10 mg tablets as a “precautionary measure” due to the fact that the drug is repackaged in the United States upon delivery from India. It is reported that upon repackaging of the drug in the United States, the filler material that is currently being used removes or blocks less moisture that was is approved under the FDA guidelines.

Reports from indicate that this particular recall has been classified by the FDA as a Class II – or one that implies that use of or exposure to the defective product may lead to temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Although this pharmaceutical recall may not lead to devastating consequences for those individuals who are prescribed Olanzapine, this is not the first time the pharmaceutical manufacturer Torrent has been in trouble with the FDA.

In early 2012, the FDA refused the importation of Torrent’s new product, Aripiprazole 5 mg tablets. Aripiprazole – a drug that has been classified by as a “new generation of dopamine system stabilizers, the first in a new class of antipsychotics and a major therapeutic advancement in the management of schizophrenia” was charged with numerous violations upon importation into the United States from India. The Food and Drug Administration charged Torrent with numerous violations cited under their Misbranding and Unapproved New Drug sections. Later that year, Torrent incurred a second import refusal for their drug Lamotrigine for violating the same sections.

The Food and Drug Administration (“FDA”) announced that Ameridose, the sister company of the Framingham pharmacy responsible for the meningitis outbreak earlier this fall, has recalled all of its products. Additionally, the Boston Globe reports that Ameridose will be shut down until at least next year due to an agreement by with Massachusetts state regulators. The fungal meningitis outbreak so far has infected 620 people, affected 19 states, and claimed a total of 39 lives according to the most recent Center for Disease Control statistics.

The Boston Globe reports that Ameridose initially agreed to close its doors back on October 10th but that its closure has been extended three times, leading many to believe the it suffers from the same deplorable conditions found at the New England Compounding Center. As a refresher, when the FDA entered the doors of the now shuttered New England Compounding Center back in early October, what they found was truly disturbing. They found bacteria, mold, fungus and bits of human hair within areas intended to be sterile. The FDA report on Ameridose is as equally gross. They found several types of vermin including bugs and even a bird flying around the sterile areas of the facility. It appears that it was only a matter of time until a major outbreak like the one we experienced this fall occurred.

While Ameridose and the New England Compounding Center are owned by the same entities, it is important to remember that they are only two of many drug-compounding pharmacies in the United States, including some in Illinois. These companies must be held to the highest standard of care, as they are responsible for much of the medicine offered to patients around the United States that rely on these drugs to keep them healthy, not make them sick or kill them. This negligence cannot go unpunished.

The American Bar Association (“ABA”) Journal reports that so far, over 100 cases have been filed in federal courts across the nation over bleeding risks associated with the blood thinning medication Pradaxa. According to the Pradaxa website, Pradaxa is a prescription blood-thinner used to resuce the risk of blood clots that cause strokes for persons with atrial fibrillation not caused by a heart valve issue. The Mayo clinic website defines atrial fibrillation as an irregular heartbeat.

The New York Times reports that Pradaxa, a highly successful drug that has generated over $1 billion in sales, has also been linked to over 500 deaths in the United States. Pradaxa, which was introduced in 2010, was the apparent replacement to Warfarin, a similar drug used to prevent strokes. The benefit to Pradaxa was that Warfarin required meticulous monitoring of the patient, including blood tests and dietary restrictions, while Pradaxa requires no such supervision. Many doctors and others in the medical community feel that the approval process was not rigorous enough because it was approved without an antidote in case of catastrophic side effects. Unfortunately, these side effects have caused hundreds of patients to bleed to death without any antidote to cure them. The patients at the highest risk of bleeding to death include those with kidney problems and the elderly and if you do experience internal bleeding due to Pradaxa, there is currently little to nothing doctors can do to save you.

The ABA Journal reports that so far, 131 Pradaxa cases have been filed, with 120 filed in the Southern District of Illinois alone. The lawsuits cite the lack of antidote and inadequate warnings of risk as the cause of wrongful deaths and injury. Due to the lack of antidote, this highly prescribed drug will likely see thousands more cases filed against it in the near future. Boehringer Ingelheim, the manufacturer of Pradaxa, cites in its defense a large clinical trial where patients died at roughly the same rate as patients prescribed Wafarin. The company also cites a Food and Drug Administration report that found that Pradaxa did not cause a higher risk of bleeding than Wafarin. Despite these defenses, it is likely that Pradaxa will at least have to increase its warnings and better inform doctors and patients about the bleeding risks associated with its drug.

Those who received a tainted steroid injection that caused the fungal meningitis outbreak were told that they had 42 days to wait to see if they contracted the disease. ABC News reports that the waiting period is over, but the meningitis threat is still a reality for some patients. The Centers for Disease Control and Prevention, the CDC, has stated that new cases will most likely continue to be diagnosed for at least a few months.

There were eighteen new cases reported last Friday alone, and despite the 42-day window coming to an end, more are likely to be reported soon. The fungal disease expert at the CDC, Dr. Tom Chiller said that meningitis outbreak “is a moving target.” The reason that the CDC publicized the 42-day period was to aid physicians in determining whether their possible infected patients should be placed on anti-fungal medications to combat spread of meningitis. However, the anti-fungal medications also placed patients at risk of other adverse health problems. Additionally, the 42-day period was only an average of the incubation period of fungal meningitis, which can last anywhere between 20 and 100 days, or even longer. Therefore, those injected by the tainted steroid product should remain vigilant and monitor their health and watch for any symptoms that may occur in the near future.

This outbreak continues to grow more frightening, the CDC reports that many persons infected with meningitis are now returning to their physicians with abscesses filled with fungus and puss, and some may actually relapse. Therefore anyone who received treatment should monitor their injection site and be aware that any growth in that area is dangerous and should seek medical attention immediately.

With the fungal meningitis outbreak rapidly spreading across the nation, many Americans are wary of drug compounding facilities, but they are not the only ones to be worried about. A recent article from the New York Times details just how dangerous the drug manufacturing business is as a whole, and how Americans should be vary wary of all drug manufacturers.

Unlike drug compounding pharmacies, which are not regulated by the Food and Drug Administration (FDA), major manufacturers of sterile injectable drugs are heavily regulated. The FDA regularly performs inspections using federal standards. As a result of these rigorous inspections, six of the major drug manufacturers have been warned by the FDA that they have seriously violated the rules just in the past three years. Some of these violations include rusty tools, mold in production areas, bug infestation and even a barrel of urine. As a result, four have closed their factories or drastically slowed production. Due to this decreased production, more and more drug compounding pharmacies, like the New England Compounding Center, have sprung up to fill in the void. These compounding pharmacies are just as dangerous for our nation, if not more so, as they are not subject to inspections by the FDA.

Apparently, those in the pharmaceutical industry are well aware how poorly the drug manufacturing business is maintained. In fact, Erin Fox, manager of the Drug Information Service at the University of Utah, stated that, “[i]n the industry, everyone knows that all of the factories are in terrible shape.” Our attorneys were shocked to read this and feel that it is unacceptable for the American consumer. These factories are all on American soil and are producing life saving injectable drugs that are used on thousands of ailing patients across the country.

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