Products Liability/Prescription Drugs

November 5, 2012

Where do your drugs come from?

Post #3 image. 2012-10-29.jpg The recent outbreak of fungal meningitis has many people asking questions about the safety of compounding pharmacies and the origins of many of the medicines we put into our systems everyday. Something that many may not realize is just how hard it can be to track down the source of the drugs that you take on a daily basis.

So far the Centers for Disease Control and Prevention has said that the fungal meningitis outbreak has made 344 people sick in 18 states and caused 25 deaths. The outbreak was linked to a batch of injectable steroids that have since been recalled by the New England Compounding Center, a compounding pharmacy in Massachusetts. The facility has announced that as many as 14,000 patients have been treated with the steroids and may be at risk.

Compounders have recently played an important role in the medical field given the increasing occurrence of drug shortages. The pharmacies have been able to step in and provide some much needed supplies when the big manufacturers are down. Compounders are also useful as cheaper alternatives to the big name brands.

October 18, 2012

Fungal Meningitis Scare Reveals Trouble With Compounding Pharmacies

by Kilpatrick & Philley

Post #1 image. 2012-10-08.jpg Those who suffer from chronic pain often turn to steroid shots to help ease their discomfort. Normally, this is treatment is seen as safe and effective. Sadly, that perception has now changed due to the 105 people sickened across nine states and the eight who have died from fungal meningitis. Now, reports indicate that as many as 13,000 patients may have been exposed to fungal meningitis – a fungus that attacks the brain and central nervous system – from tainted spinal steroid injections.

It appears that all of the victims who have been infected were given steroids that had been produced by one Massachusetts pharmacy that issued a recall of the drug and has since closed. The pharmacy that issued the recall is the New England Compounding Center. Given the outcry since the recall was announced some lawmakers have called for bringing certain specialized pharmacies such as the one at the center of this case under greater regulatory scrutiny.

Three lots of potentially contaminated steroid injections were sent by New England Compounding Center to 75 health facilities in 23 states from July to September, according to officials. Despite the wide reach of the facility, oversight falls under the powers of the state, not the FDA. This is because NECC is considered a pharmacy and not a manufacturer.

August 13, 2012

Wright Medical Profemur System Presents All-Metal Hip Problems

by Kilpatrick & Philley

Post #2 image. 2012-08-09.jpg A terrifying statistic for the many thousands of patients who have undergone hip replacement surgery appeared in a Bloomberg article published in June of this year. The article explained that the FDA reported some 16,800 adverse events related to metal-on-metal hip implants in the U.S. between 2000 and 2011.

Another company is under the spotlight as the quality and durability of their products are in question. The Wright Medical Profemur Total Hip System is a line of hip replacement implants designed and manufactured by Wright Medical Technology. Problems have been reported with the device along the same lines of other all-metal counterparts.

One lawsuit was filed by a Michigan man in late 2011 which says the patient’s Wright Profemur hip replacement failed less than three years after implantation, leading to severe problems. Other similar lawsuits have been filed against the manufacturer, each alleging the design of the Wright Profemur Hip Replacement Implant is defective and prone to early failure. The fact that these hip implant systems may fail within a few years after surgery is bad because it results in additional hip revision surgery, a painful process that no patient should be subjected to a second time in such a short period.

June 25, 2012

Consumers increasingly tune out recall notices

by Kilpatrick & Philley

Post #2 image. 2012-06-21.jpg Recent figures from USA Today show that there is concern among manufacturers and regulators that consumers have grown tired of the constant recall notices arriving in their mailboxes. The increased numbers of recalls, while a good thing, is causing consumers to be exhausted and ignore some notices, possibly to their detriment. Last year alone there were some 2,363 product recalls in consumer products, medical devices, drugs and food. This number represents an increase of 14% from just a year before.

While the increased number of recalls is good in terms of notifying consumers of potential dangers, it creates a worry that consumers will tire of the repeated warnings, perhaps not taking them as seriously. The messages are increasingly reaching consumers, as regulators have been successful in spreading the word of product issues through social media and other forms of communication. Mike Rozembajgier, the VP of recalls at Stericycle ExpertRecall, said, “We’re experiencing recall fatigue in my mind at the consumer level and also perhaps at the business level, and we all have to worry about that.”

The problem is that if consumers are not paying attention to recalls then they become ineffective. The regulators then must come up with new ways to warn consumers about dangerous products that will somehow break through. As a result, consumer protection agencies are trying to vary the methods that they are using to contact consumers. Social media sites like Twitter and Facebook are now being used by government agencies to get the word out about potential recalls rather than simply mailing notices which are more easily discarded as junk mail. Authorities are not giving up on the more traditional means of contact like telephone calls.