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Type 2 Diabetes and OnglyzaWith the rise of Type 2 diabetes in the United States, drug makers have attempted to meet the demand for treatments to lower blood sugar levels in patients. A variety of drugs such as saxagliptin, alogliptin, linagliptin, sitagliptin, exenatide and liraglutide were developed to help patients treat their Type 2 diabetes. Several of these drugs have resulted in unexpected problems. One specific drug in particular is saxagliptin, which goes by the trade name “Onglyza.”

What Is Onglyza?

Onglyza was co-developed by Bristol-Meyers Squibb and AstraZeneca and is a DPP-4 inhibitor. It works by increasing the levels of incretin (a type of hormone) in the body. Incretins lower blood glucose levels by reducing the amount of sugar the liver makes and increasing the amount of insulin released by the pancreas.

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An important trial is taking place over testosterone in Illinois. As part of the testosterone prescription multidistrict litigation, manufacturer AbbVie, Inc. is defending itself against claims that Androgel, a roll-on testosterone product, caused the heart attack of Jesse Mitchell in 2012 after years of taking the prescription medication. Let’s take a look at that case:

Mitchell v. AbbVie Inc. (1:14-cv-09178) 

AbbVie's Androgel TestosteroneIn 2007 Jesse Mitchell visited his doctor complaining of a constellation of symptoms, including fatigue and depression. He was 44. The doctor ran tests and discovered Mr. Mitchell’s testosterone levels were quite low, and prescribed Androgel, an easy-to-use roll-on testosterone product manufactured and (aggressively) marketed by AbbVie, Inc. Mitchell applied the roll-on testosterone to his upper body for several years. In 2012, at the age of 49, he had a massive heart attack. From trial and media reports, the heart attack permanently damaged his heart and almost killed him.

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SGLT2 Inhibitor Diabetes Drugs
Originally touted as a wonder drug, a new class of medications based on SGLT2 inhibitors promised to help those suffering from Type 2 diabetes by increasing their ability to lower and control their blood sugar, while also lowering body weight and blood pressure. Pharmaceutical companies were hoping that these new products could potentially become blockbuster drugs. Invokana and Farxiga are two examples of SGLT2 inhibitors.

But just a few years after the release of these drugs in the United States, the drug companies started facing stiff competition among themselves. Additionally, the public learned of the serious risks of taking SGLT2 inhibitors. The purpose of this blog post is to provide a quick overview of SGLT2 inhibitor drugs and the status of their litigation.

What Is a SGLT2 Inhibitor?

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Last week I wrote a timeline on the key events surrounding the failure of the Depuy ASR artificial hip. Today I want to take a similar look at the Depuy Pinnacle artificial hip. The Pinnacle was supposed to be the ASR’s more active and athletic brother. But it didn’t turn out that way.

1995: Study on Metal-on-Metal Hips Released

Study on Metal on Metal Artificial Hips
For all metal-on-metal artificial hips, we have to start with the central question: what did the manufacturer know, and when did the manufacturer know it? In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained that the performance of MoM hip implants was “unpredictable,” that the hips may work well for some time “before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics should have known about the metal-on-metal risk factors in 1995. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” That’s not good.

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I have written extensively about metal-on-metal (MoM) artificial hips. Specifically, I have covered the painful and sordid history of the Depuy ASR metal-on-metal (MoM) artificial hip. In this post I set out a timeline of important dates in the the journey of the Depuy ASR hip: from (quickly) finding its way into the market, then into thousands of patients, followed by thousands of revision surgeries, and ultimately to a massive multidistrict litigation (MDL) in federal court in Ohio involving thousands of injured people. Let’s take a look at the calendar of events of the Depuy ASR product failure.

1995

Doctor reviewing Depuy ASR hip X-ray
In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained how metal wear debris created from MoM hip joints was a serious problem because of poor design and manufacturing of the metal components. Dr. Isaac also stated that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were as “unpredictable as ever, working well for a period of time before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics most likely knew of the MoM risk factors in 1995, twenty-two years ago, and ten years before the company began selling the Depuy ASR artificial hip. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” I wrote more about what Depuy may have known about the serious risks of the ASR hip here.

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Patient Taking Taxotere Suffers Permanent Hair LossCancer is rough. It is a disease that has caused massive suffering, and virtually every family will be affected by it at some point. Doctors and scientists have tried to treat or cure cancer in patients ever since humans have existed as a species. In fact the name of this disease originates from ancient doctors who treated cancer and observed how a tumor’s appearance reminded them of crabs (cancer is Latin for crab).

Despite these efforts at fighting cancer over thousands of years, there is no complete cure and many current treatments, such as chemotherapy, have severe side effects.

Because of chemotherapy’s significant side effects and a general inability to completely cure the patient, a cost benefit analysis has always been important for cancer patients. Many cancer patients have to ask themselves if going through several weeks or months of misery is worth adding months or years to their lives. It’s an awful choice to make.

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Physiomesh Hernia Mesh
Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

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On June 12, 2017, a jury in New Orleans reached a verdict in favor of defendants in the second Xarelto bellwether trial. This verdict follows a defense verdict in the first bellwether trial. Let’s take a closer look.

The Second Xarelto Bellwether Trial  

Neoplastin PT Blood Test for Xarelto PatientsTo recap briefly, Xarelto (rivaroxaban) was first approved by the FDA for sale in 2011. As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. And it was easier to take than warfarin. In studies, however, Xarelto caused a higher rate of complications from internal bleeding; but unlike other anticoagulant drugs, there is no “antidote” for stopping internal bleeding in patients. People bleed and often can’t stop bleeding.

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Diabetes Drug InvokanaDiabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

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Pregnant Woman Taking Zofran for NauseaZofran is an anti-nausea drug. It works to prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that triggers nausea and vomiting. The drug was designed to help cancer patients dealing with the side effects of chemotherapy but it was also approved by the FDA for those suffering nausea due to radiation therapy, anesthesia and surgery. Nevertheless, GlaxoSmithKline (GSK) eventually pushed to market and sell Zofran to pregnant women. Women who are pregnant are often plagued by morning sickness, and some can suffer from extreme nausea. The problem is, the FDA never approved the use of Zofran for pregnant women; it’s an “unapproved” use of the drug. Unfortunately, “off-label drug use” is very common. I wrote about off-label drug use and its potential dangers here.

By 2013, 110,000 monthly prescriptions of Zofran were issued to pregnant women. If this were an approved use, we could rest easier, as an approved use means the drug has been thoroughly tested and evaluated, with the determination backed up by “strong scientific data.” For unapproved uses there is none of that. If a drug is approved for any use, a doctor can then use his best judgment to prescribe the drug for any other purpose.

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