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Articles Tagged with mass tort

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Personal Injury -- Blackwell Law FirmA recent study estimated a significant percentage of medical studies are ghostwritten. The really troubling detail — Up to half of all medical studies may be ghostwritten by companies with a financial interest in the research.

Next time you see or read a medical article listing a researcher or physician as the author, take a step back. Did the listed author really write the article? Maybe. Maybe not. Maybe a drug company or medical device company funded and really authored the article.

Consider the revealing article published by former ghostwriter Linda Logdberg. The article is titled Being the Ghost in the Machine:  A Medical Ghostwriter’s Personal View. How does Ms. Logdberg now feel about her former career?

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Recent research shows a dangerous problem with many newly approved drugs. Life-threatening side effects are common in the years following FDA approval. An article titled “Study: Side effects emerge after approval for many US drugs” details the new research. The article’s opening paragraph sums it up:

Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications . . .

This new study followed all prescription drugs approved by the Food and Drug Administration (FDA) from 2001 through 2010. The drugs flagged because of serious post-approval problems included medications for common medical problems such as arthritis, infections, blood clots and depression. The study’s lead author (an associate professor at Yale University) said “the large percentage of problems was a surprise.” As for me — I’m not surprised.

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INVOKANA USE MAY LEAD TO FOOT AND LEG AMPUTATIONS

On May 16, the Food and Drug Administration (FDA) issued a new warning about the diabetes drug Invokana. Now, the FDA “has concluded” based on tests that the drug presents an increased risk of foot and leg amputations. Specifically, the FDA safety alert says:

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

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Did Johnson & Johnson fail to warn women of ovarian cancer risks related to the use of its talcum powder products? For years, Johnson & Johnson has marketed its talcum powder products for feminine hygiene. Yet, the company never warned that the use of talcum powder for feminine hygiene may be linked to ovarian cancer.

Since the early 1970s, numerous studies have indicated an increase in the risk of ovarian cancer with this use of talcum powder. So, why did Johnson & Johnson not warn consumers? Why did Johnson & Johnson continue to make money marketing these products as safe and effective for women? These are questions being raised by women who have suffered ovarian cancer after years of using talcum powder products.

For detailed information, take a look at our page on Talcum Powder Lawsuits located under the Hot Topics section of our firm website. We provide information about talcum powder and the history of its use by Johnson & Johnson. We are happy to answer additional questions as well.

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Our office has closely followed developments with the diabetes drug Invokana. Invokana is in a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. This is a relatively new class of drugs also including Farxiga, Jardiance, Glyxambi, and Xigduo XR. These drugs treat diabetes by altering kidney function to stop reabsorption of glucose into the patient’s blood stream. We have a page on our firm website discussing these drugs, how they work and their link to diabetic ketoacidosis. Despite being a new drug at the time we published our initial page, Invokana had already been linked to numerous adverse health reports. Since then, even more potential injury risks have emerged. You can read about these developments in several posts on this blog.

In its recent QuarterWatch report, the Institute for Safe Medication Practices (ISMP) calls Invokana a “dangerous gamble.” The ISMP report opens with the following paragraph:

The nation’s gamble in embracing new drugs for long-term use with only short-term clinical testing was most apparent in the rapid acceptance into clinical practice of a new class of oral diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. There are now three such agents, canagliflozin (INVOKANA), dapagliflozin (FARXIGA), and empagliflozin (JARDIANCE). Since approval, evidence of multiple safety problems has emerged.
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Invokana continues to be linked to serious health problems. Our office has closely followed developments with the diabetes medication Invokana since it was first approved by the Food and Drug Administration (FDA). Although relatively new to the market, many health injuries are already associated with this drug.

Invokana (canagliflozin) is marketed to treat Type 2 diabetes. The drug is one of a relatively new class of diabetes medications. This class of medications is known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other SGLT2 drugs include Jardiance, Farxiga, Glyxambi, and Xigduo XR. These drugs alter kidney function to prevent reabsorption of glucose into the patient’s blood stream. For more detailed information, please read the report on our firm website.

We have watched Invokana closely because of its association with the health problem diabetic ketoacidosis. This is a dangerous adverse health issue suffered by some patients taking Invokana. What is diabetic ketoacidosis? It is a build-up of acid in the blood. Symptoms can include abdominal pain, nausea, fatigue, difficulty breathing and confusion. In May 2015, the FDA issued a safety communication warning patients about the risk of ketoacidosis from Invokana.

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Consumer health and safety should be the NUMBER ONE GOAL of drug research. Yet, it’s not. The primary goal seems to be greed. Immediate greed for quick and massive profit. For some drug companies that means — conceal bad studies revealing drug dangers, give the FDA just enough positive information to get the drug to market, and then sell as much as possible until the dangers come to light. Because of this, many patients are needlessly injured each year by dangerous and defective drugs that should have never been sold. Often, it’s too late for the families harmed.

Below are just a few recent examples of how drug companies view real research and the documents that explore the safety of their products:

  • Transvaginal Mesh— My office represents numerous women in Huntsville and throughout northern Alabama who suffered injury from mesh products by manufacturers Boston Scientific, Johnson & Johnson’s Ethicon, Coloplast, and American Medical Systems. These companies marketed their mesh products through a loophole in our law that allows certain dangerous medical devices to be sold prior to proper testing. Basically, the process is turned upside down and sales come before safety testing. Thousands of women suffered serious, and often disabling, injuries after being implanted with these dangerous and defective products. We have worked closely with attorneys in other states. The dedication of the many excellent attorneys representing injured victims of these defective products is the only reason the truth about the dangers is now coming to light. Yet, some manufacturers continue to avoid producing the complete information which the public deserves. On February 4, 2014, the Court hearing the claims against Ethicon, entered an Order saying the following:
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Our firm represents many Alabama clients who suffered serious personal injury from drugs and medical devices. Our current cases in 2013 include claims involving the diabetes drug Actos and transvaginal mesh. If you want to see our current focus on defective products, you can read detailed reports under the Hot Topics section of the Blackwell Law Firm website. When we begin researching a drug or device, I will typically write a report for this section of our website. So, it is regularly updated to include only current topics.

We follow a different philosophy or approach with drug and device cases. Our approach is different than the mass advertising firms you see and hear on television and social media. Those firms typically approach claims by casting a wide net begging for calls. Their approach is to sign-up everything, see what happens, and settle a volume of claims. What is our approach? We focus only on a few products at a time. We know our clients. We work our cases. Why do we limit our approach to only a few products at a time? We want to study these products and gain expertise in their science.

I recently viewed an interesting discussion on an issue important in the medical research. The issue — Why are negative medical tests often concealed or not published? Many consumers (and even doctors) do not realize the extent of research bias. In most cases, your doctor is relying on the directions and warnings approved by the FDA. When the underlying tests are biased (because negative results were omitted), the doctor’s information is not reliable. When it comes to tests, negative results are very important to patient safety.

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