Januvia MDL Established

By Buck Daniel

May 1, 2014 – The judge managing the diabetes drug MDL has filed several orders shaping the next steps in the litigation. On Oct. 15, 2013, Judge Lloyd D. George filed an order scheduling a hearing on transferring several new cases to drugs Januvia, Byetta and Victoza pancreatic cancer MDL. This includes hearings to determine if several pending lawsuits will be transferred to the MDL. A second order was issued on Oct. 21, 2013. This order consisted of a transfer of eight individual lawsuits to the existing Januvia cancer MDL. Over 56 individual Januvia lawsuits have joined the MDL so far. The MDL is formally titled In Re: Incretin-Based Therapies Products Liabilities Litigation, MDL No. 2452, in the United States District Court for the District of California. The United States Judicial Panel for on Multidistrict Litigation is presiding over the transfers and managing certain other aspects of the case.

Januvia and related drugs work by interfering with the DPP-4 enzyme. While this can help control blood sugar, this enzyme is also involved in the suppression of tumor growth. So interfering with this enzyme may promote the growth and spread of cancer cells. Recently, this hypothetical risk has been supported by peer-reviewed studies, which indicate a link between the diabetes drugs and an increased risk of developing pancreatic cancer.

Supreme Court to Take Different Look at Generic Drug Manufacturer Liability

By Buck Daniel

March 20, 2013 – Two years ago, the Supreme Court severely limited the conditions under which consumers could sue generic drug manufacturers. The Pliva v. Mensing decision stated that generic manufacturers do not have control over a drug’s warning label content due to FDA regulations; and therefore, the companies cannot be sued for failing to alert patients to the risks of taking its drugs. However, a new case is before the Supreme Court testing a different theory of liability. The case, Bartlett v. Mutual Pharmaceutical Co., advances not a theory of  inadequate warnings, but one that claims the generic drug itself was defective. Bartlett comes to the Supreme Court on appeal regarding a decision by the United States Court of Appeals for the First Circuit that upheld a jury verdict for the plaintiff and argued that even if Mutual could not have changed the drug’s design, it had no obligation to continue selling a defective product. The results of this case has far reaching implications, because if the Supreme Court reverses the decision by the First Circuit patients will be left with very few options if they are injured by a generic drug. Which begs the questions, “Can you sue a generic manufacturer for any wrongdoing, no matter how disgusting their behavior?”

Affymax and Takeda Institute a Recall of OMONTYS

Posted by Buck Daniel

February 25, 2013 – On February 23rd, Affymax and Takeda instituted a recall of OMONTYS following serious adverse reactions, including life threatening and fatal events. Omontys is used to treat anemia associated with chronic kidney disease for patients on dialysis. Anemia, in which the body is unable to produce enough red blood cells to deliver oxygen to the body’s organs, is often found in kidney dialysis patients. The condition causes fatigue and sometimes heart attacks.

Omontys was produced as an alternative to Epogen, which has been a staple of kidney-dialysis treatment since 1989. However, despite having knowledge that the safety endpoint of cardiovascular events and death was worse for Omontys than for its alternative Affymax kept Omontys on the market. It was further proven, through two randomized controlled trials published in 2013, that Omontys was no more effective than its alternative despite having far greater risks.

About five patients were reported to have died after receiving Omontys, according to the figures provided by Affymax, and around 17 had severe allergic reactions requiring immediate medical help and, in some cases, hospitalization. The reactions could occur within 30 minutes of the first dose.

Bayer Warns Shareholders of Yaz Settlement Costs

Posted by Buck Daniel

September 6, 2012 – Bayer recently informed its investors of the potential costs that will be necessary to settle outstanding lawsuits regarding its birth control medication, Yaz. The company admits it faces no fewer than 12,325 lawsuits regarding the higher risks associated with its product. Nearly half of the lawsuits considered by Bayer have been brought for blood clot injuries only, while the other half includes heart attacks, strokes and gallbladder issues. However, in official statements, Bayer defends its products as carrying no greater risk than any other oral contraceptives, despite what studies suggest. The FDA has continued to push Bayer to strengthen its label regarding the dangers of Yaz, but the company has no intention of taking the birth control medication off the market.

Diabetes Drugs Linked to a Higher Risk of Macular Edema

June 12, 2012 – A ten-year study recently concluded that thiazolidinedione drugs, such as Avandia and Actos, may increase the risk of macular edema, a serious eye condition that can lead to blindness. It noted that the incidence of macular edema in studied patients on these drugs was more than double that of patients who were not on thiazolidinediones. At times during the study, there were more than six times the amount of studied patients who experienced macular edema after using a thiazolidinedione, compared to patients not on these drugs. Read more about this study at: Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes, JAMA

Drugs & Devices: How Big Pharma Puts Patients at Risk

June 1, 2012 – American Association for Justice Trial Magazine June 2012
Drugs & Devices: How Big Pharma Puts Patients at Risk

“Bad Actos” by Howard L. Nations and John M. Restaino

“The safety of Actos, an oral diabetes drug that increases the body’s sensitivity to insulin, has been increasingly called into question since 2010. That was when the FDA announced that it was “reviewing data from an ongoing, 10-year epidemiological study designed to evaluate whether Actos (piolitazone) is associated with an increased risk of bladder cancer.”  Read the rest of the article in Trial Magazine.