Johnson & Johnson is said to have marketed and sold an artificial hip replacement in overseas markets after its sale in the U.S. was rejected by the Food and Drug Administration. The U.S. regulatory agency decided in 2009 not to approve the hip replacement part know as an artificial surface replacement device (ASR), essentially a hip-socket cup, because J&J had not submitted enough clinical evidence of the safety and efficacy of the product. So after being on the market for approximately eight years, the FDA told J&J that they could not market this product any longer, as well as another similar model.
J&J continued to market and sell the other variation of the ASR because of a loophole in the regulations, but was prohibited from selling the other, which however they continued to market in foreign countries, particularly the U.K. Despite having both devices recalled by the manufacturing arm of J&J, DePuy orthopedics, because of the number of the devices said to be failing in patients that got that part when having a hip replacement, J&J still petitioned the FDA to gain approval to sell the product overseas. When the FDA declined the requests, J&J still sold the ASR outside of the U.S. due to the easier regulatory climate in other countries.
At no time is the FDA saying that J&J broke any laws in selling the ASR overseas, just that they were knowingly selling a device that both doctors and patients say is failing at very high rates. In addition, the U.K. regulatory agency overseeing such matters, the Medicines and Healthcare Products Regulatory Agency, said that J&J is not required by British law to advise them about any FDA refusal to sell the devices in the U.S.
J&J is bracing for heck of a legal battle stemming from the recall of the ASR as there are over 5000 lawsuits pending against the healthcare giant. The company has set aside a war chest of $3 billion in anticipation of the cost of fighting and perhaps having to settle these suits. In not disclosing the denial of the FDA to sell the device, and the use of a similar hip replacement part cleverly skirting the exact regulations, J&J also faces serious consumer dissatisfaction with their brand even though spokesmen for J&J insist that they violated no laws or regulations.
After the British regulatory agency had received a tremendous number of complaints about the ASR, DePuy issued a total recall of the device, which now puts the company in the middle of a serious legal battle..
How the heck do you recall a hip replacement part? its not like recalling a muffler for your car or some such thing that can be easily removed and replaced. Do these patients have to undergo surgery to have the parts removed and then send them back to J&J? Holy hanna, this seems like it’s going to be a much bigger problem that J&J ever imagined. I wonder, was it worth it to gloss over what they knew about the FDA not approving the device?
Bundling Insurance Together
The popular thing in insurance to do these days is to bundle a number of different programs together into one policy so that the person buying insurance can save some money and a Scottsdale State Farm agent would likely be able to combine a number of different types of insurance together for this goal. The great thing about insurance is that most large carriers do provide many types of insurance so bundling isn’t that difficult to do. It’s a worthwhile call to an insurance agent to see whether bundling and combining policies might offer a savings in money.
Changing a Personality
There are some interesting arguments at work in some areas of psychology which question whether or not various types of personalities that a person might possess naturally could be changed to accommodate a specific job or relationship and sometimes it’s important for an individual to consider taking a Myers-Briggs to confirm just what type of personality they have. Some people are of the opinion that obtaining a different personality just takes work while others suggest true personality can’t change and that if someone wants to become a different type of person, it will take constant work their entire life.
Issues that Impact Personal Injury
There are some things that happen in life which are pretty cut and dried as far as whether a person might be able to investigate the possibility of a personal injury lawsuit with the representation of Lynwood WA personal injury lawyers, but not all circumstances are that clear. A person might believe that they are entitled to some sort of restitution under the law after a particular type of accident or an incident, but it’s important to note that the motions of going through a personal injury lawsuit aren’t always appropriate for every type of circumstance and a lawyer can help with the decision to sue.
Stages of Care
When an individual requires assistance in the home for various and everyday projects such as cooking or light cleaning, it is likely that a few years after such services are required that more intensive Coconut Creek home care options might need to be considered. Generally additional options for care which might need to be included in future visits might include issues of bathing, getting dressed and even getting to the doctor for specific appointments and checkups. Often if a person lives alone, such visits are very important to ensure that a person is going to be able to be safe in their home.
Understanding Filter Needs
Some people are under the impression that because they have a well and that they don’t draw on the water from a city that they wouldn’t otherwise need a water filter, but one of the interesting things about the modern water supply is that city water is actually very often fine to drink and many people drink it for years without any sort of filter and do just fine in drinking it while people who have well water often remark that their water smells weird. This is often when a filter can come in handy as it can make the water taste better.
Engaging in Different Exercises
The best way to ensure that a woman is going to be able to ensure the health of her body throughout her life is to eat well and have a regular exercise program, but one facet of exercise that is extremely important is the idea that the same exercises shouldn’t be done over and over for a long period of time. For example, someone might want to spend a day or two in the gym to engage in some weight lifting, get Pilates teacher instruction for further core and strength training and then add either running, walking or swimming for an active workout.