Articles Posted in Recalls

The Children’s Hospital of Philadelphia (CHOP) has been conducting a study on polyethylene glycol 3350 (PEG 3350), the active ingredient in MiraLAX, and its effect on a child’s brain. The study came about after reports that children have been experiencing behavioral problems after taking MiraLAX.

What is MiraLAX and how is it different?

MiraLAX is a laxative that. MiraLAX has branded itself as being different from other laxatives by having fewer side effects. The medication’s own website notes that it works with your body’s natural process to provide relief from constipation. It claims that working with the body prevents harsh side effects. This contrasts from stimulant laxative pills, which forcefully stimulates nerves in your colon.

This is just crazy.  It what appears to be a rerun of a rerun, the FDA has once again updated its recall list of valsartan-containing products. If you are currently taking Valsartan, you must check that list to see your medication may or may not be on it. If you are unaware of the previous valsartan recalls, please inform yourself as this will help you become more informed on how these medications may affect your overall health. You must also know about the lawsuits involving NDMA-contaminated valsartan, as it shows what kind of hardships people might experience after taking these tainted drugs.

1. What was added to the recall list?

The FDA added valsartan-containing products under the brand name RemedyRepack to its recall list. Their tests determined that the valsartan brand contained N-nitrodimethylamine (NDMA), which is considered a carcinogen by both the Environmental Protection Agency (EPA) and the FDA. The pharmaceutical companies Prinston and Solco distribute this brand. Both Prinston and Solco are involved in class action lawsuits throughout the United States that involve their distribution of already recalled valsartan-containing products. This updated recall list highlights the extent of how many valsartan-containing products are contaminated.

If you have a Ethicon Physicomesh lawsuit, here are 8 things you want to know.

1. Ethicon Physiomesh

The Physiomesh was introduced in 2010 and had an absorbable film coating on each side of the mesh. It was designed to minimize inflammation and incorporate the patch into the body. Ethicon, a subsidiary of Johnson & Johnson, manufactured the Physiomesh.

On September 11^th, James Jones, a Missouri man, filed an MDL class action lawsuit in the U.S. District Court for the Eastern District of Missouri. This Valsartan lawsuit was filed against several manufacturers of the drug Valsartan, which is used to treat heart failure and high blood pressure.

What does this mean?  It means that the Valsartan cases are now moving forward very quickly.

In a few short months, we could have a full-blown MDL class action lawsuit with thousands of potential plaintiffs.

Yesterday, I wrote an article noting a Danish study that concluded that there were no long-term cancer risks associated with NDMA-contaminated valsartan tablets. While NDMA might not have long-term cancer risk effects, it is not the only impurity found in valsartan.

On September 13, Health Canada announced that another impurity, N-nitrosodiethylamine (NDEA), was found in valsartan that was manufactured by Zeijiang Huahai Pharmaceuticals (ZHP) in China.

The FDA also discovered NDEA in some ZHP-manufactured valsartan through testing. According to the European Medicines Agency (EMA), NDEA has been found in valsartan made by ZHP since they changed its manufacturing process in 2012. NDEA, like NDMA, is classified as a possible human carcinogen.

The date code range is the first 6 numbers of the serial number

The recall previously announced for the Series 503 Flushmate III Pressure Assist Flushing System has been expanded, affecting approximately an additional 351,000 systems.  This post discusses this recall and talks about how the jury is still out on whether a product is effective and safe even if is has been on the market for many years as these products were. Continue reading

The lawsuits involving Pradaxa have been proceeding along. We think these are high value cases that will ultimately settle for a lot of money. It is not surprising to see Xarelto, Pradaxa’s little brother, also in the sites of injury and wrongful death lawsuits.

Xarelto Problems Increase

Xarelto, a relatively new anticoagulant in the same class of medications as Pradaxa, has been climbing the charts when it comes to adverse reports and even deaths. With a reported increase of 240% in the use of Xarelto after just a year and a half on the market, the problems associated with the increased numbers seem to be comparable.  With 968 adverse events having already been reported in 2013, which includes 72 deaths, the numbers are way up from the 750 adverse events reported in all of 2012, which included 58 deaths.

Plaintiffs’ attorneys had known for some time that there were problems with DePuy’s ASR hip replacement because we generally pay attention to adverse reports and we hear from potential plaintiffs long before we even know there will be grounds for a suit in the first place.

But what put the whole thing into overdrive was the recall itself after J&J, who really owns DePuy, looked at the whole thing and said, we need to get out now while we can because (1) people are getting hurt (which I do think they care about to varying degrees), and (2) our legal liability is going to be through the roof if we don’t do something.   There are now nearly 7,800 suits and DePuy is going to be paying – I predict, anyway – a ton of money on these claims.  So they wanted to cut their losses.

With the first MDL trial around the corner, DePuy wants to keep the recall out of evidence.  Why?  Because it is pretty much game, set, match for the idea that the ASR metal-on-metal replacement was awful.

An initial conference for the parties involved in the multi-district litigation (MDL) of the dialysis injury lawsuits against Fresenius Medical Care has been scheduled for late next month. In April, the MDL panel that decides these things centralized all product liability complaints against Fresenius and the use of Granuflo or NaturaLyte dialysis treatments. Approximately 188 Fresenius Ganuflo lawsuits have been consolidated in Massachusetts before a judge who appointed a group of attorneys to serve leadership roles in the Fresenius Granuflo MDL. On August 30, 2013, the judge will meet with the lawyers involved to review any outstanding issues and pending motions. The purpose of the MDL is to avoid duplicative discovery given the number of cases, hoping to save money and providing the same justice to all parties. Ultimately, when the pre-suit discovery has been completed,  what will probably happen is a few of the cases will go to trial.  These bellwether help us all gauge the real settlement value of these claims.   If the cases don’t reach a resolution, they will get sent back to the courts around the country where they were originally filed. If settlement or other resolution is not reached following the MDL proceedings, each case may ultimately be remanded back to the U.S. District Court.

Fresenius Recall and the Suits That Followed…. and Will Follow 

Fresenius Medical Care, one of the largest providers of dialysis treatments in the United States, owns and operates thousands of clinics as well as manufactures many products used during dialysis treatment. In November 2011, Fresenius conducted an internal review of the use of Granuflo and NaturaLyte, products used during hemodialysis, not only in their clinics but in other dialysis centers across the country. During the internal review, Fresenius identified at least 941 instances in which patients suffered cardiac arrest during treatment in 2010. The company issued a warning memo to the doctors within their clinics but did not inform outside clinics that used their products. In March 2012, the memo was leaked to the FDA and pushed Fresenius to provide a warning to all health care providers. The FDA classified the issue as a NaturaLyte and Granuflo Recall. There are currently at least 188 complaints in the MDL, and that number is expected to increase to the thousands as product liability lawyers review Fresenius’s lawsuits. The cases involve similar allegations: sudden cardiac arrest, heart attack, or death after Granuflo or NaturaLyte dialysis treatments.  The plaintiffs’ attorneys have alleged that  Fresenius withheld information from consumers about the possible risk of problems during dialysis with their Granuflo and NaturaLyte products. According to the suits, both products contain sodium acetate that converts bicarbonate at levels that were just not safe.