Posted on January 20, 2013 in Defective Medical Devices

In 2012, the Food and Drug Administration (FDA) passed a new act, the Medical Device User Fee Amendments, which went into effect on October 1. The new act, according to the FDA, “includes performance goals and user fees paid to the FDA by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S.” In the long run, the new act will help to shape with way that the FDA approves products, clinical trials, and also shorten timelines for scheduling appeals of meetings or decisions. It also will change the process for the reclassification of devices.

The provision that medical device manufacturers pay fees to the FDA when they register their establishment and list their devices first went into effect in 2002. They must pay fees whenever they submit an application or a notification to market a new medical device. The Medical Device User Fee Amendments (MDUFA III) that were passed in 2012, a decade after the fee schedule first went into effect, were meant to further regulate the approval and medical devices, despite fees that were being paid to the FDA. According to the FDA, MDUFA III “is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives.”

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 Posted on January 14, 2013 in Defective Medical Devices

Back in 2010, the FDA sent an open warning letter to DePuy Orthopaedics Inc., because the company had started producing and marketing their metal-to-metal joint replacement device Trumatch without an FDA approval. The company was also marketing a hip replacement device in cases where it had no approval for doing so.

In case of the metal-to-metal joint device, it was possible for people to get the device installed, because the company started offering the device for sale. However, since there was no FDA approval, this should have never happened. The warning letter to the company clearly explains that they had no approval, and thus they broke the law by offering the product for sale.

A product released to the public without FDA approval is a perfect example of a device that can cause serious problems patients who purchase such a product as part of their treatment. If a person were to suffer from serious problems with a medical device that was not FDA approved, this would certainly mean the victim would be a candidate eligible for compensation.

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 Posted on January 11, 2013 in Birth Injuries

Parents who had a baby with a serious heart defect sued a drug manufacturer and a number of others, saying medication prescribed to the mother caused the defect. Among others named as defendants are the local pharmacy and the mother's physician. The Montana Standard reported a story on this court case.

Lisa Rodney and Wayne Halvorsen are seeking compensation in the case where they allege that their daughter suffered serious birth defects as a result of the mother's Effexor XR medication. Effexor is an anti-depressant that the mother was ingesting before the child's birth.

The lawsuit names a number of defendants: Wyeth Pharmaceuticals Inc., Pfizer Inc., CVS Pharmacy, and a few others. The couple are also suing the physicians involved.

The filed lawsuit alleges that Wyeth failed to alert doctors, pharmacists, and the public on possible birth defects on babies if the mothers are ingesting Effexor before or during their pregnancy.

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 Posted on January 05, 2013 in Defective Medical Devices

Metal on metal hip replacements are called that because the two parts are both made of metal, the ball and the socket. When these two are put together they recreate the movement of a hip. Hip replacements are surgically implanted on deteriorated hip joints to combat pain and stiffness. This can be accomplished in one of two ways, either a hip resurfacing which reinforces the existing joint or full replacement. After being used for years, the FDA has researched claims that metal on metal hip implants are causing a variety of physical ailments.

Their research was initiated by a study conducted by British researchers at the National Joint Registry of England and Wales. Surveys uncovered that metal on metal hips require more maintenance than other types of hip replacements, be that ceramic or plastic. After being in use for five years, 6 percent of the over 30,000 metal on metal hips needed to be replaced or repaired. This is startling because only around 2 percent of the over 350,000 other types needed the same care after 5 years.

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 Posted on January 02, 2013 in Defective Drugs & Treatments

The on-going problem with an array of medication is that the side effects can be more damaging than the affliction being treated. That is the argument being made in the case of Barbara Jean Asher. The Asher family filed a lawsuit against Boehringer Ingelheim, makers of Pradaxa seeking damages for punitive damages, medical expenses, and other costs associated with her ailments. Pradaxa is a blood thinning medication which intends to stop people from having blood clots and reduce the risks of strokes for people with a certain kind of heart arrhythmia. The drug quickly cornered the blood thinner market because it didn't require regular blood tests to ensure correct dosage.

Barbara Jean Asher was prescribed Pradaxa after suffering a stroke. But after three months of taking the medication, she was rushed to a local hospital and treated for internal bleeding. When the doctors on duty could not stop the bleeding, Asher unfortunately bled out and died in June of 2011. Unlike other blood thinning medication, Pradaxa does not have an antidote which reverses the effects, which can led to patients not being able to coagulate when they are wounded. The death of Barbara left her husband and children looking for answers.

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 Posted on December 31, 2012 in Defective Drugs & Treatments

Birth control pills are very annoying as they need to be taken at the same time every day for three weeks at a time. While this is difficult for some women to handle, newer measures exist that are easier to maintain. That was the thinking that led to the design of Nuvaring, which is a self-administered contraceptive device in the form of a vaginal ring. The device has the added benefits of containing less estrogen exposure than the pill form of contraceptive. This low estrogen dosage can curtail estrogen induced side effects experienced with other contraceptive such as nausea, breast tenderness, and irregular bleeding.

The first problems with the vaginal rings included headaches, vaginitis, leukorrhea and discomfort according to a study conducted by John Hopkins University in 2010. Other side effects which were uncovered by the FDA included blood clots. Blood clots can result in serious diseases such as deep vein thrombosis up to more serious events such as heart attacks and strokes. The FDA released a report in 2011 that the risk of blood clots increased by over 50% for women who use Nuvaring. This report was corroborated by a report by the British Medical Journal which was released in May of 2012.

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 Posted on December 25, 2012 in Defective Medical Devices

Portable bed rails give the impression that they will be protective. Yet according to the Biomedical Safety & Standards, bed rails actually increase injury and death. The Federal Trade Commission has been asked to demand that manufacturers stop using false advertising. Consumers have filed 525 deaths to the U.S. Food and Drug Administration involving the bed rails. Another 155 deaths were reported separately to the Consumer Product Safety Commission. The Biomedical Safety & Standards also states that a fall with bed rails is worse for consumers than without them.

Even with all of these claims, the manufacturer still states that the bed rails will make any bed safer. Consumers have made a petition asking the FDA to order the manufacturer to stop advertising this statement. The market standpoint of safety that the bed rail manufacturers have taken are unproven, which continues to infuriate consumers more. Bed rails for children have lots of restrictions so that they will reduce injury or death. However, these restrictions are not the same for adults.

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 Posted on December 19, 2012 in Defective Medical Devices

Every year approximately one million people receive an artificial knee or hip, making it a $7 billion dollar industry. However, many patients eventually have to have a second surgery because the original replacement was faulty or recalled.

Because of this, a panel of medical experts believes the FDA should create a new process when approving devices. The current review is called a 501(k) and helps approve products that are similar to others already approved and on the market. The average time for a new device to be approved is 10 months—which the panel thinks is too short.

It was suggested that instead of the streamlined review, the FDA should mandate each device maker proves the moderate-risk (also known as Class II) products are safe and effective. Although this complex process may take more time, it could prove beneficial. Annually, 83 percent of the 700 devices recalled are Class II.

The top lobbying group in the artificial device industry does not believe a change is necessary. The FDA also states that the 501(k) is effective, mentioning in this ABC article that it has brought about a “robust medical device industry in the U.S. and…lower-risk devices to the market for patients who need them.”

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 Posted on December 17, 2012 in Defective Drugs & Treatments

A recent recall of the drug atorvastatin, the generic form of Lipitor, has left many consumers confused as to what they should do with the bottles of the medication they have sitting in their medicine cabinets. Ranbaxy Pharmaceuticals, which produces the drug, have directed pharmacists not to dispense the drug because it may contain specks of glass. But the recall was only directed at the retail level, and the company has given no direction to patients who may have bottles of the contaminated drug in their medicine cabinets. According to a statement issued on the company's website, the recall is being taken “with the full knowledge” of the U.S. Food and Drug Administration.

Headquartered in India, Ranbaxy Pharmaceuticals is one of the biggest pharmaceutical companies in the world. In the past, the FDA has accused the company of “a pattern of systemic fraudulent conduct” over a period of years for fabricating data in drug applications, taking shortcuts in crucial quality tests, and violating numerous additional manufacturing standards. In 2008, the federal agency banned Ranbaxy from importing over 30 different drug products into the U.S. That ban still stands today.

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 Posted on December 15, 2012 in Defective Medical Devices

Researchers that are from the Cincinnati Children's Hospital Medical Center have studied children that either have a pacemaker (40 patients) or an implanted defibrillator (133 patients). The researchers have been assessing the patients' quality of life compared to other children that have congenital heart disease and children that are healthy.

The children in the study, ages 8 to 18 years old, and their parents were each asked to complete a quality of life questionnaire. Children with heart devices and parents who have children with heart devices, when compared to the children and parents without heart devices, were reported to have significantly lower quality of life scores. Similarly, these parents' and children's scores were also lower than the scores for children and parents with children that have more severe heart disease, but no device.

Major factors that affect the quality of life for children, included things like self-perception, self-worth, and athletic capability.

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