Fresenius Faces Another Lawsuit Involving GranuFlo

Facing another lawsuit due to its scandal-ridden product, Fresenius has to deal with a GranuFlo lawsuit an affected patient has lodged in court.  The plaintiff alleged to have been harmed by alkali dosing errors associated with GranuFlo. For pre-trial proceedings, a court has consolidated Fresenius lawsuits into a multidistrict litigation.

The lawsuit was lodged in court by, Ronnie Glasper.  He was prescribed Fresenius’s Naturalyte and/or GranuFlo in his dialysis treatments in a Louisiana Fresenius Medical Care center. Consequently, he suffered a heart attack and stroke.

The plaintiff in this lawsuit accuses Fresenius for allegedly hiding what it knows about the dangers that patients could suffer from Naturalyte GranuFlo (or Naturalyte).  The plaintiff also alleges in his lawsuit that Fresenius was negligent, with intent to defraud, with the product testing by saying that GranuFlo is safe.  Furthermore, the plaintiff questions the company as to whether proper testing has been conducted on the product in order to establish the risks associated with Naturalyte or GranuFlo.

On November 4, 2011, Ronnie Glasper’s claims relate, Fresenius issued an internal memo and sent it to Fresenius medical directors and physicians.  It was to warn on the health dangers a patient could be exposed to in using Naturalyte and GranuFlo.  However, this warning was not shared to the FDA.  Nonetheless, the risks linked to Naturalyte and GranuFlo were known in a case-control study involving patients of hemodialysis. It was noted in the memo, according to the plaintiff’s allegation, that the study revealed a tendency for an increased pre-dialysis bicarbonate levels to occur and also the risk of apparent alkalosis resulting with about six to eight times greater chance of fatal cardiac arrest.

Unfortunately, the problem with the memo, according to the plaintiff, is that Fresenius failed to send the memo to the facility where he received treatment, nor did his physician received it, though it was sent to some of other medical facilities. In some other reports, there were patients who suffered from the effects of high blood serum bicarbonate levels.  The condition can be fatal and may also result in cardiac arrhythmias, cardiopulmonary arrest, stroke and other serious health complications to those who received Naturalyte or GranuFlo.

Following the staggering court claims being filed against Fresenuis, personal injury law firms are starting to put up online legal centers catering to those who might want to lodge a lawsuit against the company over GranuFlo side effects.  Those who are alleging they were seriously harmed by the use of GranuFlo and Naturalyte may contact these law firms for free legal help, such as Rottenstein Law Group at www.rotlaw.com. There are now eleven federal lawsuits, as of this writing, reportedly consolidated to MDL 2428 in the US District Court, District of Massachusetts. The MDL is identified as In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation.

DePuy Pinnacle Lawsuits 2,700 and Growing

Johnson & Johnson (J&J) seems unable to keep its hands off some trouble over its metal-on-metal hip implants. Just when one thinks the recalled ASR hip lawsuits are currently being settled, here come DePuy Pinnacle lawsuits piling up at a speed not unlike its recalled predecessor. Last month registered almost 2,700 Pinnacle cases filed in federal court.

Although a multidistrict litigation (MDL) has been set up to consolidate these DePuy lawsuits, the product itself is largely out in the market. First trial for the Pinnacle MDL is set by May 2014. On the market front, approximately 150,000 patients utilize the Pinnacle, heralded as the successor of the DePuy ASR hip implant.

DePuy Setting Billions of Dollars for Recalled Hip Implants

There were about 96,000 patients affected by the DePuy ASR recall in August of 2010, a recall largely attributed to above-normal implant revision rates of 17 to 19 percent. Thus far, two ASR lawsuits have reached settlement of $200,000 each. At this rate and with 3,000 pending ASR lawsuits, DePuy’s mother company J&J is reportedly setting aside $3 billion for settlements alone. The company is helping patients shoulder the cost of revision.

However, it seems this is not the case for the Pinnacle. Spokesperson for the Pinnacle defends the hip implant vigorously as a totally different product in comparison the recalled ASR hip. On the contrary, the company is not helping Pinnacle patients with revision surgery.

But How Is It Different Really?

Reports from Reuters stipulate that 10 percent or more of all Pinnacle hip implants is going to fail in the next two to three years. With a 10 percent failure rate, this could translate into 15,000 lawsuits over DePuy Pinnacle in the U.S. alone. Worse, the British Orthopaedic Association estimates that the Pinnacle will exhibit a 49 percent failure rate after six years.

Today with the advent of internet, getting a case started over the Pinnacle is but a matter of taking a legal review in trusted online sites like www.rotlaw.com. Also, many plaintiffs have relied in the expertise of experienced personal injury lawyers (e.g. New York-based RLG or Rottenstein Law Group) to move their cases forward.

Remember at the onset, these metal-on-metal (MoM) hip implants were heralded as the sturdier devices designed for the younger, hipper, more active generation. Instead of lasting 15 years as predicted, they have acquired so bad a reputation surgeons are turning away from these MoM devices in general.

As a successor, the Pinnacle seems to be inheriting the same problems associated to the ASR hip: early revision rate, pain, swelling, limited mobility and dislocation. Then its complications also display the same culprit, metallosis or metal poisoning. Metallosis results from metal shavings or debris that gets deposited in the patient destroying bones and tissue and causing cardiovascular, neurological and renal problems.  In fact, one Mayo clinic orthopedic surgeon Dr. Mary O’ Connor aptly observed that we may be seeing but just the “tip of the iceberg” with regards to metal-on-metal failures.