Archive for the ‘Product Related’ Category

Merck Coppertone Class Action Settlement

There has been a settlement in the Coppertone class action lawsuit issued on September 25, 2012. Merck & Co is going to pay in the region of $3 million to $10 million in settlement for false claims they made about their sunscreen products. This lawsuit has been ongoing for around ten years.

The original lawsuits was against Schering, but Merck bought Coppertone in 2009. Consumers had complained that the Coppertone products had exaggerated advertising related to them. The settlement comes about as a result of Merck wanting to put the case to rest. They also agree not to use terms such as sweatproof and all-day protection when promoting their sunscreens. Those involved in the lawsuit will be able to claim up to $1.50 per sunscreen purchased.

Merck stated that they are dedicated to follow U.S. Food and Drug Administration standards relating to their products and will carry information related to this to be included with each sunscreen product.

Transvaginal Surgical Mesh (TVM)

Transvaginal surgical mesh (TMV) is used during surgery for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).   The U.S. Food and Drug Administration (FDA) has put forth a safely warning to doctors and patients that use of TMV  through the vagina for  pelvic organ prolapsed (POP) may be exposing patients to additional risks.

This is a common surgical procedure amongst women and a third of these make use of mesh and three quarters are done through the vagina.  The lawsuit claims that woman as a result of the mesh surgery have experienced complications including:  erosion of the mesh into the vagina, infection, urinary problems, migration, vaginal pain, pelvic pain, urinary problems, skin split or mesh protrudes, pain during sex, vaginal scarring, narrowing of vaginal wall, mesh shrinkage as well as recurrence of the original problem, or the need for corrective surgery.

Manufacturers of TMV include Johnson & Johnson,  Boston Scientific,  C.R. Bard,  and American Medical Systems.

If you have suffered because of these types of surgery you should contact your doctor to be evaluated.  You should also contact a personal injury lawyer for their opinion.

What Products Does the Ingenix Class Action Suit Cover?

Ingenix, based in Minnesota, is a company that created a database to calculate ‘out-of-network’ payments and Ingenix also does consulting, billing, drug trials and many other data-crunching services for thousands of doctors, insurers and hospitals. Back in 2006 a fraud case was filed by the New York Attorney General, Andrew Cuomo against Ingenix, a small but fast-growing technology arm of UnitedHealthcare.

Cuomo charge Ingenix with posting phony rates in its database, for example: a $100 office visit might be reimbursed as a $72 visit, leaving the patient with a bill for the remainder. In January of 2009, UnitedHealthcare has settled out of court, a class action lawsuit brought on by the American Medical Association, in the amount of $350 million. Under the settlement, Unitedhealthcare will create a new database on ‘out-of-network’ rates.  But the repercussions across the medical industry has rippled across the technology industry and the insurance industry as well, which may result in the demise of Ingenix.

The technology issue is now there needs to be regular audits on key databases, audits that will maintain the accuracy of information the database contains, which will increase the risk of companies relying upon the databases. Risks such as databases that include value judgements, like quality of care, and how often the databases will be audited, how transparent should they be and when should patients and doctors be notified if changes are made in the database. A whole new industry in auditing database content will spring up, along with a whole new set of laws.

As for the insurance industry, there is still a heated debate about health insurance companies about how they are exempt for federal antitrust laws, the same laws that every private market must adhere to in order to keep the market competitive. The health insurance industry, unlike any other private industry in the country is allowed to engage in price fixing, market allocation and bid rigging. A bill was introduced in 2009, after the Ingenix debacle, which would repeal the antitrust exemption for health insurance providers.

Pacemaker

Pacemakers implanted medical devices that are used to electrically stimulate the heart. They are used in patients suffering from heart rate abnormalities. Pacemakers help to pump blood throughout the body. The devices contain small electronic circuits along with a battery. The pacemaker is attached to the heart with long wires that go through veins directly into the heart.

On July 18, 2005 Guidant Corporation announced a voluntary recall of their heart pacemakers. The reason being that the devices needed to be replaced due to faulty sealing components. At that time nine different pacemaker models manufactured by Guidant were recalled.

Prior to the recall there had been 69 reports of patient problems resulting from pacemaker malfunctions. These included both acceleration and deceleration of the pace which resulted in some cases of patients losing consciousness or heart failure.

As the FDA is making no recommendations about replacement of the pacemakers, rather they have left it up to the doctors as to whether replacement should be an option.

Knee Replacement Lawsuits

There have been problems associated with the manufacturing processes of knee replacement products.

Replacement surgeries are now a common procedure as they can give great relief to patients with arthritis or joint injuries. Replacement of joints reduces pain, as well as increasing mobility, and should last for 15-20 years. However there have been instances where faulty products have caused pain, distress and increased the need for additional surgeries.

Gamma irradiation has been used to sterilize the replacement parts. These parts are made with ultra high molecular weight polyethylene. However, it has been found that the sterilizing process has caused oxidation putting the devices at risk of breaking up after they have been implanted in the patient. This failure of the implants can cause the body to react against the parts and also to react against the actual bone causing a condition known as osteolysis. Patients then need the devices replaced.

Another condition known as metalosis is caused my metal fragments detaching from faulty implant.

Medical device manufacturers have stopped using gamma irradiation and moved to ethylene oxide or gas plasma as the sterilization process. This helps prevents oxidation.

Products manufactured by Johnson & Johnson, Biomet, Apex Surgical LLC, Encore Orthopedics Inc., Osteoimplant Technology Inc., Smith & Nephew Inc., Stryker Howmedica Osteonics, Zimmer Inc, Sulzer Orthopedics and Depuy have been associated with lawsuits.

Hip Replacement

Sulzer Orthopedics is a hip replacement device manufacturer. On December 8, 2000, they voluntarily recalled their Inter-Opacetabular shells as they contained traces of mineral oil. This interfered with the attachment of the device to the patient’s bone.

Sulzer’s hip replacement devices were found to be defective after implantation in more than 25,000 patients. This meant that in many cases the devices had to be replaced causing additional pain and distress for the patients. The cost of these surgeries can range from $20,000 -$50,000.

On May 8, 2002, $1 Billion settlement in the class action litigation was approved. During June of 2002 Sulzer changed it’s name to Centerpulse. On May 31, 2002, Centerpuluse announced approval of the settlement agreement.

Dialysis Machine

Dialysis is a treatment that replaces some of the function of the kidneys when they fail. Kidney dialysis is necessary when there is end stage kidney failure which results in the loss of approximately 85 to 90 percent of kidney function.

There have been reports of high fever and hospitalizations along with serious illness or death associated with the use of the Gambro Da Vita kidney dialysis machines. These reports suggest mechanical problems related to the handling of bacteria by the machine’s water treatment system as well as cleaning protocols.

There have also been reports relating to dialysis products manufactured by Baxter International and Medisystems Corporation. It has been reported that more than 50 deaths have been attributed to a particular combination of dialysis machine and blood tubing. Baxter informed customers to immediately discontinue the use of that combination of dialysis machine and tubing. The tubing referred to is the A, AF, and AX series blood filters. The FDA has launched an investigation.

Defibrillator

A defibrillator is a medical device that is implanted to regulate heartbeats. It is used on patients who have had heart related problems such as heart attacks, arrhythmia or other types of heart disease. When a patient’s heart begins to beat abnormally the defibrillator produces an electrical shock and this regains the natural cardiac rhythm of the patient.

Guidant Corporation manufactures cardiac defibrillators. During June of 2005 they recalled certain of their models as there were reports that they had the potential to malfunction. These malfunctions were reported to have led to the death of two patients. Patients who had the recalled product implanted needed to have them surgically replaced or reprogrammed. Of particular concern for patients was the fact that known defects in the defibrillators were not immediately reported to doctors or patients.

Up to 38,000 of the Guidant defibrillators have been implanted in US patients and it was reported that Guidant had failed to inform doctors or patients for three years that some of their defibrillators had a defect that caused the affected devices to short-circuit.

A week after the recall Guidant issued a 2nd safety advisory about its defibrillators. They instructed doctors to stop using certain models because they had a defective switch that could malfunction.

Guidant Corporation received FDA approval to re-launch their defibrillators on August, 2005 after they replaced the switch mechanism.

Medtronic also recalled two of its implantable defibrillators which were linked to four deaths. There units were said to have charging problems which resulted in a delay in delivering the shock to the patient.

There have also been problems associated with external defibrillators. During June of 2005 the FDA stated that Medtronic, a manufacturer of external defibrillators had failed to comply with the steps to eliminate flaws in their defibrillators.

Charite Spinal Disc

Charite Artificial Discs are used to replace deteriorating spinal discs in the lower back. The product is owned by Johnson & Johnson. Problems have arisen when some recipients of the disc have developed chronic lower back pain. To prevent disc failure, it is essential that correct sizing and positioning of the disc occurs. If the disc fails then potentially dangerous surgery needs to take place.

 

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