Articles Posted in Products Liability/Prescription Drugs

Post #4 image. 2012-10-29.jpgThe Food and Drug Administration recently announced that the agency launched an investigation concerning five deaths and one non-fatal heart attack linked to consumption of the Monster Energy Drink. The Monster Energy Drink is a heavily caffeinated soda that has grown in popularity in recent years among those eager for a boost, especially young people.

Reports indicate that several people suffered adverse reactions after consuming the drink which contains a whopping 240 milligrams of caffeine. To put that number into some perspective, one Monster Energy Drink contains about seven times the caffeine in a typical 12-ounce can of soda.

The FDA issued a statement saying that it was taking the reports of death seriously and will begin a thorough investigation to determine if any action should be taken. Although the FDA caps the amount of caffeine in soda at 0.02 percent, there is no such limit for energy drinks, something that may need to change in the future. Though a response from the regulatory agency is a good thing, the timing leaves something to be desired as reports first surfaced back in 2004. The agency says so far there’s no proof that the drinks directly caused the deaths or injuries.
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Post #3 image. 2012-10-29.jpgThe 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.
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Post #1 image. 2012-10-08.jpgThose 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.
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Post #1 image. 2012-08-29.jpgAccording a recent report, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company tasked with tracking food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

ExpertRecall pointed out that the number of device recalls is actually down slightly from the first quarter. However, the number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. An analysis of FDA enforcement reports found that the second quarter of 2012 saw some 242 medical device recalls, a drop of 13% from the 277 recalls seen in the first quarter of this year. Though there was a drop, the most recent numbers still represent an increase of 4% from the same time last year.

The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Though the gap may seem larger, stepping back in time reveals an even bigger difference. In the second quarter of 2011, only 16 million devices were recalled, about 1/8 as many as last quarter.

Though good news was hard to find in the report, one indicator showed some promise. Less than 7% of the recalls announced last quarter were Class I, meaning that the device carried a risk of serious injury or death. Moreover, these serious recalls accounted for less than 1% of the total units recalled in the quarter, thus affecting only a small number of patients.

It wasn’t just medical devices that saw millions of recalls last quarter, the group revealed that there were 69 pharmaceutical recalls in the second quarter of 2012. These 69 recalls amounted to a total of 12 million units of prescription drugs.

Companies affected by the recent recalls include Coviden PLC, which recently announced a voluntary recall of some DGPHP RFA high-power single use grounding pads. It also announced a voluntary global recall of some adult tracheostomy tubes.
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Post #1 image. 2012-08-14.jpgBayer AG, the maker of Yasmin birth-control pills, said that settlements related to U.S. lawsuits over its product have increased to more than $402 million. Bayer said it has resolved almost 1,900 cases in which it has been claimed that Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks and strokes. The company said that the payments have broken down to an average of about $212,000 per case.

Bayer also announced that it had more than doubled its financial reserve for future payments related to Yaz cases, setting aside an additional $610 million this quarter alone. The $610 million is to pay the company’s costs beyond what insurance will cover for legal fees, including cases that haven’t been settled yet. Even this huge figure may not be enough as drug-industry analysts have said that Bayer may end up paying out over $2 billion to resolve all the cases related to the birth-control problems.

Lawyers suing the company have brought forward FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The lawyers have argued that Bayer marketed the contraceptives for unapproved uses and misled women about their risks.

The suits follow a decision in April of this year by the U.S. FDA to order Bayer along with other drug makers to include stronger blood-clot warnings on their contraceptive products. Pills like Yasmin, which contain a synthetic hormone known as drospirenone, will now come with warnings that say researchers have found the drugs can triple a woman’s risk of blood clots.

Given the number of women taking Yasmin, which was the fourth most prescribed oral contraceptive in 2011, with 4.6% of the overall market, the suits have affected potentially millions of women. Bayer faced more than 12,000 lawsuits over the Yasmin line of contraceptives, including claims that they caused blood clots in some women and damaged gallbladders in others. Thus far, Bayer has agreed to settle 1,877 cases.
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Post #2 image. 2012-08-09.jpgA 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.

Hip implants should last for at least 15 years, but data indicates that the Wright Profemur Hip Implant often fails within just a few years of implantation. For example, 2009 data from an implant registry run by the Australian Orthopaedic Association found that one component, the Wright Profemur Z femoral stem, shows an 11.2% failure rate at the three year interval. This means that approximately one out of every 9 people who received the Wright Profemur Z hip implant experienced severe problems within a few years after their hip replacement.
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Post #1 image. 2012-08-09.jpgThe Food and Drug Administration just released some surprising news that it found poor software quality is to blame for many of the recalls that have been seen in the medical device industry. The FDA’s research revealed that such glitches were responsible for 24% of all such recalls.

Given this revelation, the FDA’s Office of Science and Engineering Laboratories will now begin dedicating significantly more time testing software quality and security. The goal will be to help reduce the failure rate cited in the most recent annual report which was just recently released. The agency will increase its efforts to avoid injury or death thanks to poorly designed or written software.

In a statement, the FDA said that it is developing “techniques and laboratory expertise to assist our review staff in identifying potential vulnerabilities and evaluating risk mitigation measures.” The procedures the agency will put into place are in line with those in other regulated industries and are intended to be rigorous. The statement continued saying, “Manufacturers are responsible for identifying risks and hazards associated with medical device software/firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety.”

There are multiple potential problems associated with software issues in medical devices. The first is obviously the risk such a failure can pose to a patient’s health and safety. The less obvious, but nonetheless important risk is to a patient’s privacy. Such devices can store vast troves of sensitive personal medical data that if compromised could reveal far more than a patient would feel comfortable with. There are even some devices that are connected to networks and which could conceivably be vulnerable to hacking attacks.

It was just this past month that Google reported disabling a hacked website that existed to distribute software updates for an array of medical devices. Among the devices receiving updates from the website include AVEA ventilators.
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Post #2 image. 2012-07-31.jpgA man from neighboring Tennessee has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa. The drug company is being sued by the man who claims his father died as a result of side effects he experienced as a result of his use of the blood-thinning prescription drug.

According to the suit, Melvin Giles’ father was prescribed the drug as a blood thinner. The medication typically is used to reduce the chance of blood clots developing and leading to a stroke in patients who are at risk for such issues. Giles’ father was given the medication in February of 2011 and in June of that same year suffered severe internal bleeding and died as a result. His son claims that the bleeding he suffered was the result of his use of Pradaxa.

Giles claims that the drug maker either knew or should have known about the potential for the dug to cause such serious complications. The suit cites as proof the 932 incidents reported to the FDA between October 2010 and March 2011 related to side effects of the medication. Some 120 of these reports involved death from Pradaxa bleeding, and 500 were severe and life-threatening bleeding events related to the medication. These numbers have gone on to spike and according to a new report from the Institute for Safe Medicine Practices, the U.S. Food & Drug Administration received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.

Pradaxa also led in reports of deaths (541), hemorrhage (2,367), kidney failure (291) and stroke (644), according to ISMP’s most recent report. Pradaxa was also a suspect in 15 reports of liver injury made to the FDA.
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Post #2 image. 2012-06-21.jpgRecent 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.

USA Today found that most retailers believe that the existing national recall system is flawed and that the country would benefit from a more uniform system. The FDA and USDA have different standards for recalls, each with its own unique set of requirements. These variances make it difficult for manufacturers and retailers to fully comply with all the specific rules for each recall. Though retailers are concerned about the safety of their customers, they are also worried about how they will protect their reputation and their bottom line. Jeanne Colleluori of Wegmans said, “Our concern is for our customers but we have to protect our name as well, and we are very much aware that when there is a recall if it is a Wegmans brand product our reputation is at stake.”
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