Zantac – the medication often seen on television commercials and long touted as one of the leading over-the-counter remedies for heartburn – has been pulled from all shelves by the U.S. Food And Drug Administration (FDA) due to the confirmed presence of a carcinogenic (cancer-causing) compound. The nationwide recall will go into effect immediately, and as a result all manufacturing of Zantac will cease.

Because Zantac was so popular and so heavily advertised for so many years, it is possible that millions of Americans were potentially exposed to a carcinogenic compound. Even worse, tests have shown that there could be tremendously high amounts of this cancer-causing compound in each dose of Zantac. If you believe that yourself or a loved one has contracted cancer as a result of repeated use of Zantac, contact an attorney from Altman & Altman LLP right away to discuss possible legal action.

What is dangerous about Zantac?

Zantac is simply a brand name used to market the medication. The active compound in Zantac is ranitidine, which is used to fight acid buildup in the stomach and esophagus – the cause of heartburn. However, recent tests have confirmed that Zantac also contains N-Nitrosodimethylamine (NDMA), which has long been classified as a potential carcinogen in humans by the FDA.

Exposure to NDMA has been linked to various diseases, from multiple types of cancer (including the most potentially deadly forms and less severe forms) to liver failure. Although testing the effects of NDMA on humans has been limited in scope, the FDA and independent studies have long identified NDMA as potentially harmful to humans through observation of its negative effects on lab mice. More pointedly, NDMA is a compound commonly found in industrial grade pesticides and even in high octane fuels.

How much NDMA is in Zantac?

According to Valisure, the Connecticut pharmaceutical company that made the initial discovery of NDMA, there were extremely high levels of the compound in the batches of ranitidine they tested – regardless of the dosage or where the drug was manufactured. They reported that there was as much as 3 million nanograms of NDMA in each Zantac tablet – which is over 31,000 times more than the recommended daily intake of 96 nanograms set by the FDA.

Unfortunately, the FDA did not immediately take heed from Valisure’s testing, and Zantac continued to be manufactured and sold to people across the country. It was only until this week that an independent investigation from the FDA finally convinced them to act.

What is the status of Zantac now? Should I stop taking it?

As of this week, the FDA has officially called for a full recall of Zantac products – meaning that manufacturing and sale of all variants of the drug must come to an end. This adds to a series of voluntary recalls that have occurred over the years from various manufacturers of the drug – as well as retail chains such as Walmart, Walgreens and CVS, which previously halted sale of Zantac and its generic forms.

This new recall means that anyone who regularly uses Zantac for heartburn relief should instantly stop doing so, as there is good reason to suspect it may negatively impact your health – especially if you rely on it regularly to treat heartburn and indigestion issues. As always, contact your healthcare provider with concerns you have, and with questions about what medication might work in place of Zantac. There are multiple medications, such as Pepcid, Nexium and Prilosec which have not tested positive for the presence of NDMA.

Did drug manufacturers know about this health risk?

There is some evidence to suggest that Sanofi – the manufacturer of Zantac – could have reasonably known about the possibility of Zantac being an unstable drug as far back as 2002, and that such instability could potentially result in the production of NDMA. In fact, the FDA’s most recent findings included the fact that improperly stored Zantac – for example, if it was stored at high temperatures – could especially lead to the production of NDMA.

Prior studies have found that patients taking ranitidine had large increases in the concentration of NDMA in their urine following tests. Others showed that ranitidine is a possible “precursor” to NDMA. This essentially means that the study found ranitidine is a chemical building block to the more harmful NDMA compound.

These findings suggest that there was always a chemical instability in Zantac that could potentially lead it to being dangerous, and if drug manufacturers were aware of this possibility but failed to warn consumers about it, that could mean they are liable for damages that have occurred due to the drug’s widespread use. Continue reading

Pharmaceutical giant Johnson & Johnson (J&J) has been ordered by a Texas federal jury to pay out over $1 billion in punitive and compensatory damages after a lengthy trial ultimately decided in the favor of six plaintiffs who claimed to have suffered severe consequences after being fitted with J&J’s “Pinnacle” hip implants, which are manufactured and distributed by Depuy Pharmaceuticals.  The Pinnacle hip implants are a type of implant that utilizes metal-on-metal components, meaning the artificial hip ball, socket and shaft pieces are all made of metal; usually a combination of titanium, nickel, cobalt and/or chromium. In many cases before, including about 93,000 different hip implants also distributed by Depuy and J&J, the metal-on-metal implants have been observed to cause serious health consequences for some users.

Why are these hip implants potentially dangerous?

Metal-on-metal hip implants have been observed to corrode over time and use, releasing microscopic pieces of metal into the patient’s blood stream, which can cause a type of blood poisoning known as metallosis.

Signs of metallosis can include:

• General skin hypersensitivity that results in rashes
• Cardiomyopathy (heart complications)
• Sensory changes such as complications with vision or hearing
• Depression or other unusual mental changes
• Kidney complications
• Thyroid issues such as a throbbing, painful neck, weight gain, fatigue or feeling cold constantly

Aside from these symptoms, the implants can degrade to a point where they can actually break, slip or otherwise malfunction, causing potentially horrible consequences. The plaintiffs in this case also specifically cite suffering from bone and tissue death as a result of the implants.

What if I have a metal-on-metal hip implant?

If you or somebody you love has received a metal-on-metal hip implant from any of these companies:

• Depuy
• Stryker
• Smith & Newphew
• OMNI
• Biomet

Then do some research into the type of hip implant was given. It may very well be one of the hip implants that has been subsequently recalled, and may explain health problems that have emerged after the hip installation.  In the case of J&J and their most recent legal scandal, they plan to appeal the decision and maintain that they are not liable for the pain and suffering their devices have caused. The jury disagreed, and felt that J&J and Depuy did not do enough to warn patients of any potential risks associated with the hip implants. Although the enormous sum of over $1 billion will likely be reduced by the courts, the message to the huge companies is clear: you are not untouchable.

At Altman & Altman LLP, we feel the same way. No company, regardless of how big or how valuable, is above the law or above the moral standards and ethics that all medical device manufacturers, distributors and parent companies must adhere to. The responsibility to properly protect patients is far too great to accept anything less than perfection.  J&J and Depuy’s lengthy list of lawsuits proves that something is not right with these implants. This case was just one of over 8,000 similar lawsuits surrounding the hip implants, meaning this is not an anomalous problem, but more likely a design flaw which, again, is simply unacceptable. Continue reading

Another jury has concluded that talcum powder does, indeed, cause ovarian cancer. This multimillion-dollar verdict is the third of its kind for Johnson & Johnson this year. Deborah Giannecchini of Modesto, California, was awarded more than $70 million last week, as a result of her 2012 ovarian cancer diagnosis. According to Giannecchini, she had been using Johnson’s Baby Powder for more than four decades.

Many women have used talc-based products, such as Johnson’s Baby Powder and Shower to Shower, for personal hygiene for decades. Talcum powder contains particles of talc, a mineral that can cause health complications when used in the genital area. Talc particles can travel through the fallopian tubes and become embedded in the ovaries. When this happens, the talc particles can cause inflammation, which can result in the development of cancerous cells. All cancer can be deadly, but ovarian cancer has an especially high mortality rate. If you have developed cancer after using talcum powder or baby powder, contact a Boston personal injury lawyer today.

What is Ovarian Cancer?

One of the most aggressive forms of cancer, ovarian cancer causes about 14,000 deaths every year. Symptoms are hard to detect, and often don’t appear until the disease has advanced beyond successful treatment. As with most cancers, once ovarian cancer has spread to other organs and tissues, it is extremely difficult to treat.

Symptoms of Ovarian Cancer

As previously mentioned, symptoms are not often immediately apparent. Furthermore, the following symptoms can be related to other, non-life threatening medical conditions. However, if you develop any of the below symptoms, it may be wise to contact your health care provider. It’s always better to be safe than sorry.

• Abdominal bloating
• Abdominal pain
• Feeling full even though you haven’t eaten much
• Back pain
• Pelvic pain
• Constipation
• Chronic indigestion
• Menstrual problems
• Pain during intercourse
• Fatigue

Despite compelling evidence that long-term use of talcum powder causes ovarian cancer, J&J continues to claim that its product is safe and is currently appealing all three rulings. But the manufacturing giant is estimated to face another 2,000 lawsuits from customers who developed ovarian cancer after using its products. Continue reading