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.

Holding Generic Drugmakers Accountable

By Cindy L. Nations

UPDATE: March 24, 2014 : Ever since the 2011 Supreme Court ruling in Pliva, Inc. v. Mensing, the American Association for Justice has been working to close the generic drug accountability loophole which largely immunizes generic drug manufacturers from liability for injuries caused by their products. On March 13, AAJ filed comments with the FDA in support of the agency’s rule regarding generic drug labeling. The rule, as proposed, would effectively overturn the Mensing decision by allowing generic drug manufacturers to update their labels with new safety information without prior FDA approval.

AAJ’s efforts calling for accountability and increased safety were supported by more than three dozen members of Congress, a bipartisan group of State Attorneys General and a variety of consumer and health groups. In addition, a consumer petition signed by more than 20,500 people has been sent to the FDA.

(Original: November 11, 2013) – The FDA announced a proposed rule that would allow generic drugmakers to update labels with new information, just like the brand name manufacturers, potentially exposing them to liability.  Most people don’t realize this, but under the current laws, a generic drugmaker cannot be held liable for drug defects or failure to warn about such defects.  This is based on a 2011 U.S. Supreme Court ruling (Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142) which noted that under current FDA rules, only name-brand drugmakers are responsible for safety warnings.

So, essentially, what is taken by most as a casual decision made at the pharmacy (choosing generic over brand name) could potentially be the difference between someone being able to seek justice for an injury or have no remedy at all.  Since the Supreme Court decision in 2011, Attorney Howard Nations, working in conjunction with the American Association for Justice (AAJ) has met numerous times with key members of Congress and the FDA to discuss this issue and advocate for the rights of consumers.  This recent decision by the FDA is a move in the right direction.

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.