Articles Posted in Products Liability/Prescription Drugs

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Anyone who has been paying attention has likely encountered hoverboards. They were the hot new gift this holiday season and can be spotted at your neighborhood mall grocery store or even street corner. Children and adults alike are fascinated with the new gadgets, treating them more as fun toys rather than a serious alternative mode of transportation.

The problem is that the hoverboards aren’t all fun and games. Thousands of YouTube videos are devoted to cataloging the ways riders can hurt themselves on the hoverboards. Videos of people flipping and falling and slipping off the devices have accumulated hundreds of thousands of views. While some of these accidents are comical, others are quite serious. People can suffer broken bones, fractures and concussions due to the sudden and violent accidents involving hoverboards.

Beyond the accidents, another even more troubling danger of the hoverboards has become apparent: fires. Reports of fires related to hoverboards are on the rise, with the Consumer Product Safety Commission recently announcing that it is investigating 22 such reported incidents. The fires occur while the boards are charging and even while the boards are in use. Several have caused damage not only to the boards and riders, but also the homes where the boards were being stored.

Post #2 image. 2013-10-10.jpgOfficials with the Mississippi State Fair say that a child was injured this past weekend after falling from a ski-lift type amusement known as the “Skyride.” According to officials, the accident happened around 11 p.m. when the seven-year-old boy fell more than 30 feet from the ride.

Emergency responders say the child was taken by ambulance to the University Medical Center where he has a compound fracture. Officials with the fair say that the incident is unprecedented and that the Skyride, long a fixture of the state fair, has never been involved in any other accidents.

Officials with the fair say the ride was closed immediately after the fall and has since been inspected by safety experts. The ride is now open after all equipment appeared to be in proper working order.

Post #1 image. 2013-04-19.jpgThe use of da Vinci robotic surgery systems has exploded in recent years according to one report, with 400,000 procedures being performed with the help of the robot last year. The corresponding growth in adverse events reports filed with the FDA has resulted in increased scrutiny by the agency over how safe the robots really are.

Use of the robotic surgery systems, namely da Vinci, the only system approved by the FDA for soft tissue operations, has increased threefold in only four years. Recently, the system has been linked with several deaths and a few troubling incidents in the operating room. The question that the FDA must now decide is whether the benefits of robotic surgery outweigh the obvious risks.

For years now hospitals have been advertising the supposed benefits of robotic surgery, in brochures, billboards and online. The goal is to attract new business and some claims used by hospitals have been misleading, citing unsubstantiated reports about the safety of such devices. As hospitals have fought for market share, particularly for lucrative surgeries, many have gone on a robotic buying spree. Numbers indicate that nearly four in ten hospitals have at least one such machine, a costly investment of nearly $1.5 million plus an additional $100,000 or more each year in service agreements. To help pay for the major investment hospitals have a huge incentive to bring in customers for the service, even if there may be no reason to use a robot at all.

Post #7 image. 2013-03-18.jpgDuring the middle of March 2013 a jury in Los Angeles decided that a former prison guard from Montana, Loren Kransky, was entitled to $8.3 million in damages for harm caused by Johnson & Johnson’s DePuy subsidiary’s metal hip implant.

The jury found that the ASR XL implant caused metal poisoning and other health problems for Kransky and were severe enough to cause the man to undergo painful revision surgery to remove the defective device. The jury found that DePuy knowingly marketed a faulty device and owed the injured patient millions as a result. However, the jury did not find that the company had acted with malice. This is important because it prevented Kransky from colleting punitive damages.

The major suit was the first of the more than 10,000 filed against J&J since the hip recall was issued two years, impacting more than 100,000 of the all-metal implants. The recalls were issued after studies showed unusually high rates of failure for the implants and incidents where patients had been left with metal poisoning, painful joints and other internal injuries due to metal shavings in the bloodstream released when the joints would rub against each other.

Post #8 image. 2013-03-18.jpgThe first of more than 3,000 cases filed against Takeda Pharmaceuticals over it’s once popular diabetes drug, Actos, is now underway. A witness recently testified that the pharmaceutical giant put sales ahead of consumer safety and allowed marketing concerns to trump patient health worries.

The witness, Howard Greenberg, was a clinical pharmacologist who had experience in the industry and based his testimony off emails sent between Takeda executives. The emails discussed the company’s possible response to a warning by regulators across Europe and the U.S. that warning labels might be applied to Actos that described the possible risks associated with the development of bladder cancer.

The executives who were discussing the matter did not appear terribly concerned about the potential health consequences of their drug, instead, worrying only about protecting the earning potential of the medication. The emails offered fairly clear evidence that the company only cared about protecting profits, not protecting the welfare of patients.

Post #1 image. 2013-01-03.jpgMississippi’s Governor Phil Bryant has been trumpeting the state’s tort reform laws as a major economic development according to papers filed in federal court. The governor made the claims in a filing before the court that will decide the constitutionality of the state’s $1 million cap on non-economic damages.

The case, which began in 2006, will decide whether the state’s cap on damages is unjust. The cap was put into place years ago after legislators complained that verdicts in the state had gotten too large, too fast and led to unfairly large awards for plaintiffs. The updated brief on the part of Governor Bryant filed in support of the measure was meant to inject life into the case after the 5th Circuit told attorneys for both sides that briefs needed to be updated.

The case is not expected to be resolved until sometime later this year. Attorneys have said the complexity of the case and possible further oral arguments may drag the matter out well into the New Year. It’s also possible that the 5th Circuit will ask for additional briefs on certain specific legal issues.

Post #2 image. 2012-11-21.jpgAccording to a recent article by the New York Times, the Food and Drug Administration has launched an investigation after reports that the 5-Hour Energy product may be linked to some 13 deaths over the past several years.

The FDA confirmed that it has begun an investigation into the 13 deaths which all occurred within the last four years. The investigation is similar to the one involving Monster Energy Drink and the five deaths that were related to its use.

A report by the New York Times revealed that since 2009, 5-Hour Energy has been named in some 90 filings with the FDA including 30 that involved life-threatening incidents. These include incidents of heart attack, convulsions and, in one especially tragic case, a spontaneous abortion.

Post #2 image. 2012-11-14.jpgA company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak is recalling all of its products after federal inspectors said it must improve its sterility testing process.

Officials with the FDA have said that a routine inspection turned up inadequate quality assurance related to Ameridose’s sterile products. The FDA was quick to say that it has not discovered any infections linked to the recalled products from Ameridose. In a statement, Ameridose declared it issued the recall “out of an abundance of caution.”

Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing fungal meningitis outbreak.

Post #2 image. 2012-10-31.jpgThe recent outbreak of fungal meningitis has many in the medical community desperate to get to the bottom of the cause. Possibilities abound and everyone appears to have a theory. Could it have been some moldy ceiling tiles? What about the dirty shoes of a careless employee? How about a contaminated ingredient?

There are many ways the fungus could have gotten inside the New England Compounding Center, a pharmacy in Massachusetts that has been blamed for the outbreak. The steroid injections made by the compounding pharmacy have already been recalled after leading to the death of 14 people and sickness in nearly 200 more.

So far regulators from both state and federal agencies have been quiet about what problem may have led to the contamination. It has been revealed that inspectors found fungus growing in more than 50 vials from the pharmacy. FDA investigators remain on the scene in Farmingham, Massachusetts in an attempt to better understand what went wrong.

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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