GDPR – Data Protection

On the 25th of May 2018 the European Data Protection Laws took affect.  In Germany a external Data protection officer is called an Externer Datenschutzbeauftragter.  Although companies had two years for get ready many companies are still struggling to comply even months afterwards. There is still a lot of uncertainty as to how the compliance is defined and what exactly has to be done to do so. What is certain though is that the Data Protection authorities are taking Data Protection very serious. They have warned companies that failure to comply would lead to have fines that could definitely hurt a company.  In case of a breach of the Data Protection laws, companies could face fines of up to four percent of their yearly gross turnover.

Many feared that Law firms would take the opportunity to go after companies that do not comply merely for the sake of making fast money. This, however, has not been the case until now. Because of the uncertainty and high potential fines many small bloggers have given up their websites out of fear of been sued.

Many companies are now relying on external experts to help solve their data protection problems.  AGIDAT is a company that offers seminars and lectures on Data Protection.  For companies that rely on their own personnell to handle Data security they even offer schooling at very affordable prices. For more Information on Data protection please contact someone at www.agidat.de

Acupuncture for Pain relief

Acupuncture has become increasingly popular in Germany for the treatment of various ailments. Acupuncture is a form of chinese medicine which more and more doctors are using to treat patients .
Health insurance companies have now also recognised it as a legitimate form of pain treatment and therefore these costs are now covered by the medical insurance. Before only naturopaths and physiotherapists and used acupuncture as a treatment for there patients, but the school medicine has had considerable success with this form of treatment.

Where to buy acupuncture needles

Acupuncture needles come in different forms of metal mainly stainless steel and copper. In the past therapists and doctors used needles that needed to be sterilised after use, but ever since the arrival of disposable needles these have become almost extint, disposables have become very popular and fewer and fewer other needles are in use. The advantages of such needles are obvious since it reduces the risk of infection from dirty needles and of course the trouble of sterilising the older forms of needles. One of the companies specializes in the production of  different forms of needles for humans and animals is the Wandrey Med a Berlin based company.

Click here for more Information on acupuncture needles

Could you be laid of for being sick in Germany

We often hear of horror stories concerning the laying off of workers on the account of them being continuously sick. Labour laws are particularly tough when it comes to the firing of employees.  Smaller companies have an advantage if they need to reduce their workforce. Often laying off of employees requires only a good reason.

Larger companies with more than ten employees, however, it is a whole different story. Unless someone has just starting working,  it is very difficult to layoff an employee. Bester Anwalt für Arbeitsrecht Berlin. For those that are in their first six months, they can be sacked with 30 days notice. Anyone who is guilty of severe breach of contract could be fired without notice regardless of the size of the company.

Larger companies will find it very difficult to reduce staff. In general the works council must be heard before anyone could be laidoff. Exceptions can be made when a branch or a section close there will also be a settlement.

For more information on Labour laws und for Assistance in Germany you may contact.

Rechtsanwälte Dr. Breuer

 

 

National Joint Registry Finally Underway

National Joint Registry Finally Underway in the U.S.

The American Association of Orthopaedic Surgeons estimates that around 800,000 joint replacements take place in the United States each year, and the time has finally come for the U.S. to establish a joint registry, The American Joint Replacement Registry. The United Kingdom, Australia, and Sweden are just a few of the countries that have national joint registries, which monitor the performances of devices.

A national joint registry is used to gather a patient’s basic information, hospital and surgeon information, the procedure and device used, as well as note if a patient has a revision surgery. The registries are extremely useful in identifying a device that is defective or malfunctioning and is not working on par with other competitive devices. Such was the case with the Australian National Joint Replacement Registry, which reported as far back as 2007 high revision rates for the DePuy ASR hip replacement device. The 2007 report showed the ASR resurfacing device as having twice the revision rate compared to other resurfacing devices, and then from 2008 until the DePuy ASR recall in 2010, the Australian data identified the ASR resurfacing device and ASR XL, used in total hip replacement, as having higher revision rates than competitive devices. When the Australian registry reported the problems with the ASR, most Australian surgeons stopped using the device, and DePuy withdrew the device from the Australian market in December 2009, before the issued Field Safety Notice in March 2010, and well before the actual recall in August 2010.

The United States did not have a national joint registry when the DePuy ASR was being implanted in patients; therefore the statistics regarding the high revision rates for the ASR reported in the Australian National Joint Replacement Registry and then the UK National Joint Registry were available if American surgeons searched for them.

Just this January, the AJRR began a trial of collecting information for three months from 16 various institutions, such as academic centers and private orthopaedic practices. After this pilot run, the AJRR staff will have a better understanding of the challenge of hospital personnel to submit data and also develop a method that works best to report data, as well as create a uniform system for collecting information and monitoring the outcomes of total joint replacements. The AJRR aims to collect data from 90% of U.S. hospitals where hip and knee joint replacements take place over the next five years.

Data from other registries have show a 10% reduction in revision rates, and with the vast amount of joint replacements performed in the U.S., even a 2% decrease of revision rates would lead to a savings of $65.2 million in one year, and a potential of $1 billion in savings over a span of 20 years. The creation of a national joint registry in the United States is long overdue and its establishment will not only help determine early on which devices are not performing to the standards of joint replacement devices, but also reduce revision rates and make the manufacturers more accountable for their products. This will be helpful in avoiding incidences such as the continued implantation in the U.S. of the defective ASR despite reports from other countries showing the problems with the DePuy ASR. Once surgeons will have available to them data showing the performance of a device, they will be able to choose the best prosthesis for patients

Recall of DePuy Hip Replacement

David Floyd, president of DePuy Orthopaedics, manufacturing knee and hip replacements sold worldwide, has resigned his post amidst growing company struggles in the wake of the DePuy hip replacement recall.

A spokeswoman confirmed on Monday that Mr. Floyd had tendered his resignation in the last week of February, citing the pursuit of interests outside of DePuy Orthopaedics. Mr. Floyd will continue as president at DePuy Orthopaedics, a position he assumed in 2007, through a transition period which will end in late March.

This resignation follows a particularly tumultuous year for DePuy Orthopaedics. In August of 2010 DePuy recalled its ASR hip replacement device, when research revealing a 13% early failure rate was reported. This recall resulted in the filing of hundreds of lawsuits on behalf of recipients of the DePuy ASR hip replacement system against DePuy Orthopaedics and Johnson & Johnson.

In addition to the damage inflicted on the company’s reputation, this recall was especially difficult for the company economically, exasperating the already hostile economic environment. Patients who did have the money to move forward with an expensive hip replacement procedure and their doctors were unwilling to purchase their hip prosthesis from a company whose hip replacement has just been so infamously exposed. Also, DePuy took a $280 million dollar charge in order to pay for testing and treatment of those who had been implanted with the ASR, a huge figure which many say will still be insufficient to cover the costs of the recall.

DePuy Orthopaedics is suffering the consequences of its carelessness in promoting the DePuy ASR despite evidence of its failing. The company received approval for marketing without having performed extensive testing of the device. Also, the company failed to respond to growing concerns over the safety of the device until recently. As a result of this carelessness, the defective hip implant, manufactured by DePuy, was implanted in thousands of patients worldwide. The implant is failing at rates higher than competing devices within the first five years after implant, and further, many of those implanted with the defective device require painful revision surgery to remove the ASR.

If you are one of those who fell victim to DePuy Orthopaedics’ inadequate policies regarding the safety of its products, and were implanted with the defective DePuy ASR hip replacement, call us today at 1 (888) 444-2336 for FREE advice regarding your legal rights to compensation from DePuy and Johnson & Johnson. You can also complete the form on the right side of this page and we will personally contact you.

Recall Sheds Light on FDA Medical Device Approval Process

The Senate Special Committee on Aging held a hearing on April 13th regarding how medical devices are approved for sale by the FDA. The hip replacement recall of the DePuy ASR was also discussed at the hearing, placing emphasis on the importance of the testing and better post-market surveillance of medical devices.

The government agency has two processes to approve medical devices: the Premarket Approval Process requires clinical trials, while the fast-track process, the 501(k), only requires that a product is similar to other approved products already on the market. The DePuy ASR hip replacement was approved through the 501(k) process, which required minimal testing of the device. The FDA’s fast-track process has come under scrutiny because hip implants, which are considered a high-risk device, are cleared through the non-rigorous 501(k) process.

The hearing included testimony from patient-safety advocates, industry representatives, and a ASR hip implant recipient. The patient disclosed that her doctor had received $600,000 in consulting fees from DePuy Orthopaedics. The amount, unfortunately, is consistent with the bribery complaint Johnson & Johnson, DePuy’s parent company, recently settled for $70 million. The company admitted to bribing European doctors and health-care providers in order to sell their products, including the DePuy hip replacement device.

Mass Device website, which published an article regarding the hearing, quoted DePuy’s Director of Communications as stating that the company supports efforts to improve patient safety, the establishment of a national joint registry in the U.S., and that DePuy would work “…with the FDA to strengthen an already-robust process that has worked well for three decades and evolved, when appropriate, to better serve patients.” Considering the amount of recalls of 501(k) approved products, it is troubling that DePuy would call the process ‘robust,’ especially because the company had its own product recalled. Although there is pressure from the medical device industry to lighten the approval burden, patient safety should not be neglected in order to make money, only to have the device recalled later. DePuy not only designed a faulty device, but also failed to timely warn surgeons and patients of the health risks of the device. The hip replacement recall of the ASR, which was implanted in over 30,000 patients in the U.S., helped shed a light on the importance of clinical trials and tougher FDA approval process to ensure patient safety.

DePuy ASR XL Failure Rates Nearly 50%

Important statistics presented at the British Hip Society Annual Conference in early March showed an even higher than anticipated revision rate for the DePuy ASR XL. Data collected from four surgeons in the U.K. showed a 21% revision rate at 4 years and 49% revision rate at 6 years for the recalled DePuy ASR XL hip device. Various reasons for failure include loosening of the acetabular or femoral component and metal reaction leading to death of tissue. In most cases, patients have high cobalt-chromium ion levels and fluid collection around the joint.

The surgeons’ results also indicated that revision rates could increase to 35% at 4 years if all the patients who are currently having pain with their implants need a revision. In the DePuy recall of the ASR XL Acetabular System and ASR Hip Resurfacing System in August of 2010, the company’s recall letter stated revision rates of 13% at 5 years for the ASR XL Acetabular System, with particular concern for patients who were implanted with ASR head sizes of less than 50 mm in diameter. The data presented at the Conference however showed high revision rates even for patients implanted with large diameter size cups, and the panel recommended avoiding the use of large diameter metal-on-metal bearings.

This new information regarding the DePuy hip replacement device affirms the problems and high revision rates associated with the ASR hip device. A hip replacement device with only a 50% survivorship rate is very unheard of, and with these statistics, it is anticipated that more patients implanted an ASR hip replacement device will need a revision surgery.

FDA Could Have Warned Patients Sooner

The FDA Could Have Warned Patients Sooner About the Defective ASR

When DePuy Orthopaedics recalled the ASR XL Acetabular System and ASR Hip Resurfacing System last August, it did so voluntarily, without any warnings from the Food and Drug Administration. By this time, there was ample amount of data and reports, accumulated through a few years, which showed the unusually high revision rate associated with the ASR hip implant. The New York Times article published after the announcement of the recall, titled “Johnson & Johnson Recalls Hips Implants,” noted that by the time of the issued recall, the FDA had received 400 complaints about the ASR since the beginning of 2008.

In the fall of 2009, DePuy announced it was discontinuing the production of the ASR, with plans to phase out sales of the device by the end of 2010. The reason for the discontinuation of production was declining sales–and not safety concerns. In December of the same year, DePuy pulled the ASR from the Australian market all together, yet continued to sell it in other countries. Then in March of 2010, the company issued a Field Safety Notice regarding the high revision rates for both versions of the ASR when used with head sizes smaller than 50 mm in diameter. The notice referenced the revision rates reported in the Australian National Joint Replacement Registry, and emphasized adhering to surgical technique, selecting the appropriate patients for the surgery and the importance of cup placement.

During this chain of events, beginning from when the FDA first began to receive complaints up to the recall in August, the Food and Drug Administration issued no warnings about the high revision rates for the ASR implant, despite available data and reports.

The Medicines and Healthcare Products Regulatory Agency, England’s version of the FDA, is responsible for the regulation of medicines and medical devices. Several weeks after DePuy’s Field Safety Notice, the MHRA released a medical device alert regarding all metal-on-metal hip implants and recommended surgeons to follow up on patients with these types of hip implants and conduct testing for cobalt and chromium ion levels in the blood. A month later, on May 25th, the agency released another Medical Device Alert specific to the DePuy ASR, reiterating the recommendation DePuy made in its March Field Safety Notice regarding cup inclination angle and following up on patients and conducting metal ion level tests and MRI or ultrasound scans.

The FDA however, made no recommendations, notices or alerts concerning the high revision rate and reports of patients with metallosis due to the defective design of the ASR. A new section on the FDA website informs patients about hip replacement surgeries and the various types of devices that are available, including warnings of the risk of metal-on-metal hip devices. Metal-on-metal implants inevitably shed metal debris due to the contact of the ball with the cup; the amount of debris though is dependent on the design of the device and how well the surgeon implants the device.

Half of the world’s joint replacements surgeries are performed in the U.S. and it is very unfortunate that the FDA did not issue a warning about the risks of the DePuy ASR hip implant earlier. The company could have recalled the device earlier, but instead continuously refused to address data from joint registries, studies, and concerns expressed by surgeons regarding the high revision rate for the ASR. In the circumstance in which a company shows negligence towards the under-performance of one of its products, the FDA is expected to step in and take appropriate actions when a device is not functioning properly. A careful overview of all the available data would have led the FDA to make a more prompt decision about the risks of the DePuy ASR hip implant

Australian Class Action Suit on Behalf of 5000

On Monday, February 28, 2011, a class action suit was commenced in the Federal Court of Australia against DePuy Orthopaedics. The suit centers around a recalled DePuy ASR hip implant which is manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The leading plaintiff in the action is Tammy Sanford, a resident of Hobart, Tasmania.

Ms. Sanford, a teacher and mother of two, is only 40 years old, but already had three operations since she had the DePuy ASR implanted in her hip five years ago. In her interview with Australia’s The Mercury news, Ms. Sanford described what was found in her body during her most recent January surgery:

“There was a lot of wear and tear in my body and he [the doctor] actually described what he had to scrape out as a black tar, gunky substance and the images of that were just terrifying, thinking that I had that inside me.”

The doctor also found that Ms. Sanford’s hip joint was inflamed, and that the tissue around her bone and joint had severely degenerated. The damage and pain are so severe, that Ms. Sanford is now unable to return to her teaching job. She walks with the aid of crutches and is reliant upon pain relief medications.

The Australian national joint replacement registry estimates that over 5500 patients have been implanted with the DePuy ASR metal hip systems in Australia between 2003 and 2009. The class action suit, led by Ms. Sanford, is on behalf of all these patients and seeks compensations for personal injury, pain and suffering, and economic damages.

DePuy Orthopaedics phased out sales of the ASR implant in Australia, the United States and other countries in late 2009 and early 2010. However, it did not officially recall the product in the United States until August 2010. Prior to the recall, it is estimated that more than 90,000 DePuy ASR systems were sold worldwide, and the latest data shows that 12-13%, or 1 in 8, of these implants may fail within 5 years. As doctors continue to monitor patients who received the ASR implant, the rate of failure is expected to increase past 30%.