Posted on May 27, 2013 in Defective Drugs & Treatments

According to a recent article published by Forbes, it has been discovered that dietary supplements have made up over half of all FDA Class 1 drug recalls between 2004 and 2012. "Class 1" means that the supplements contained ingredients that have a potential to "cause serious adverse health consequences or death."

The St. Michael's Hospital research team determined that between January 2004 and December 2012, 51% of drugs subjected to a Class 1 recall were in fact dietary supplements. Most of these recalls took place after 2008 for what was said to be unknown reasons.

The categories of supplements with the highest recalls were developed for (1) sexual enhancement, (2) bodybuilding, and (3) weight loss. Sexual enhancement supplements accounted for 40% of all Class 1 recalls.

What makes the supplement industry unique is that they do not require FDA approval before being sold. There are currently approximately 65,000 dietary supplements on the market in the United States.

Continue Reading ››

 Posted on May 23, 2013 in Defective Drugs & Treatments

A few short weeks ago, Allergan spent close to $1 billion on rights to a new drug for treating migraine headaches. However, the FDA has already rejected his product. A recent New York Times article has taken a closer look at the ordeal.

According to Allergan, the Food and Drug Administration rejected the new drug, called Levadex, due to concerns about the manufacturing of the inhaler that is required to dispense it.

Levadex is a unique kind of migraine drug that uses an inhaler. The inhaler is very similar to those used for asthma.

It was back in January that Allergan initially accepted the price of $958 million in order to acquire MAP Pharmaceuticals, which is the company that developed Levadex. This deal closed in March.

This wasn't the first time the FDA has rejected Levadex. In March 2012 it was also declined approval due to, again, concerns about the inhaler. MAP was confident that Levadex would be approved the second time around, as illustrated by Allergan's agreement to purchase the company before waiting for the FDA's official second decision.

Continue Reading ››

 Posted on May 16, 2013 in Defective Drugs & Treatments

A decade ago, Medicare experienced an expansion to make it easier for people to get the drugs that they need. In fact, Congress decided to increase funding to Medicare by billions of dollars to reach this goal. But it is possible that the fix worked too well.

Now Propublica has completed an investigation of this new system and found some interesting safety issues. By reviewing four years of prescription data, they have shown that large quantities of meds were given to Medicare patients without considering the possible side effects. There is also evidence of doctors continually prescribing medicines that they shouldn't according to FDA regulations.

Although Medicaid is good about policing the drugs given to its subscribers, Medicare does not do it at all. According to the director, Jonathan Blum, Medicare concedes to each physician's judgments rather than regulate the prescriptions given to seniors and disabled people.

Continue Reading ››

 Posted on May 07, 2013 in Defective Medical Devices

According to a story reported by Law360, expert testimony has began in cases regarding the lawsuits that are being levied against Johnson & Johnson. DePuy, Inc is a subsidiary of the Johnson & Johnson company.

Although the ASR XL metal hip has been recalled, Tony Nargol, testified that the prosthesis was safe and that the continued use of the product can be totally justified. Nargol is an orthopedic surgeon who was selected as an expert witness to testify in the case.

There are currently over 10,000 lawsuits that have been filed against the manufacturer alleging that the ASR products are defective and unsafe. The surgeon also testified that out of 243 surgeries where the ASR products were used, only three of those cases required surgical reentry. He also stated that the reentries were not because of the product itself but the way that it was used.

The first case went to trial in Los Angeles and the jury ruled against DePuy in the amount of $8.3 million. However, the jury refused to award any punitive damages to the people who had the surgery using these products.

Continue Reading ››

 Posted on May 03, 2013 in Defective Medical Devices

The ability to bring claims for defective medical device injuries will be possible again with the Medical Device Safety Act.

The 2009 supreme court case Wyeth vs. Levine also led to the reunion of the drug manufacturers and the device manufacturers. The case “confirmed that the Food and Drug Administration (FDA) marketing approval of all prescription drugs does still not (prevent) patients' state-law claims seeking damages for harm caused by those products.” The Wyeth court case touched on the main reasons for creating the Medical Device Safety Act.

The Medical Device Safety Act was in direct response to a 2008 Supreme Court decision in which the FDA's pre-market approval of medical devices would protect the manufacturer of the device for almost all liabilities through preemption, a legal doctrine. This decision also stopped an important protection of consumers.

In the Wyeth case, the court did not accept the foundation that a manufacturer is protected from liability because the product has received approval of the FDA. Although the court specifically addressed drugs, many of its observations also equally applied to medical devices.

Continue Reading ››

 Posted on April 24, 2013 in Defective Medical Devices

As if Johnson & Johnson didn't have enough problems with their hip implant device Articular Surface Replacement (ASR), now the U.S. Food and Drug Administration (FDA) has announced a Class I recall for another orthopedic device made by the manufacturer – LPS Diaphyseal Sleeve. The device is used in reconstructive knee surgeries and is being recalled because of the potential for fractures that the device poses.

A Class I recall is the most serious recall that the FDA can issue and typically involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. In its announcement, the FDA said fractures of the device that occur at the taper joint of the sleeve could cause soft tissue to become compromised and result in infection, function loss, limb loss, or death.

The FDA has received ten reports of the product malfunctioning. Reports included six fractures and 4 incidents where the product loosened up. DePuy, Johnson & Johnson's orthopedic medical device division, and makers of both this device and the ARS, has issued an Urgent Medical Device Recall to healthcare providers to stop using the recalled units immediately and return unused devises to DePuy.

Continue Reading ››

 Posted on April 20, 2013 in Defective Medical Devices

According to a recent article, Parker Waichman LLP filed a lawsuit on behalf of a New York woman. The woman was implanted with the Aris-Transobturator Sling System, which is a transvaginal mesh device intended to correct pelvic organ prolapse and stress urinary incontinence. It has been claimed that the device is defective and only caused more injuries. The Plaintiff is suing for pain and suffering, emotional distress, and economic loss.

Parker Waichman LLP is dedicated to protecting the rights of victims injured by defective medical devices. They have filed a lawsuit based on the fact that a transvaginal mesh implant, manufactured by Coloplast, caused injuries in a New York woman. Their lawsuit was filed on January 28th. The case is currently pending alongside many similar ones.

According to the Plaintiff's complaint, she received the Aris-Transobturator Sling System in February of 2008. Since then, she has suffered many complications, which she claims have been caused by the transvaginal mesh. The lawsuit claims that this device was defectively designed and poses a very serious risk of injury to women. The suit also alleges that the Defendants knew of the risks of the device but failed to adequately warn the Plaintiff, her doctor, or the public.

Continue Reading ››

 Posted on April 15, 2013 in Defective Medical Devices

Johnson & Johnson's DePuy orthopedic unit was ordered to pay $8.3 million in damages in a trial over artificial metal hips that were found to be defective, the Chicago Tribune reported on March 8. A Los Angeles jury ordered Depuy to pay over $338,000 in medical costs and $8 million for pain and suffering to Loren Kransky.

DePuy recalled the defective metal hips three years ago when it was found that the devices did not function as expected. Almost 100,000 ASR metal hips had been sold before the recall. “We believe ASR XL was properly designed, and that DePuy's actions concerning the product were appropriate and responsible,” said DePuy spokeswoman Loire Gawreluk. The company is planning to appeal the court's decision.

The defective metal hip resulted in increased levels of cobalt and chromium in Kransky, causing pain and suffering. Depuy's lawyers argued that it is not known what levels of metals may cause pain and harm to patients and claimed that Kransky's other medical problems, for example his diabetes and heart disease, were the actual source of his suffering.

Continue Reading ››

 Posted on April 12, 2013 in Defective Medical Devices

A new trend in operating rooms across the United States and the world is a robot named Da Vinci. This expensive multi-armed machine was approved by the FDA nearly four years ago to assist with highly dangerous surgeries like prostate removal, heart valve replacement and the transplantation of organs. In fact, nearly 400,000 surgeries have been performed with da Vinci across the United States, which is three times the number of robot assisted surgeries four years ago.

The robotic system is controlled by a surgeon who sits at a computer screen away from the patient. Advocates of using these robots have claimed that it removes the human element of shaky hands and also decreases recovery time for surgeries with large incisions.

But now, there has been a plethora of problems being reported about the da Vinci robot. Problems include times when a robotic hand wouldn't let go of a person's tissue during a surgery, or another incident when an arm of da Vinci repeatedly slapped a patient in the face. There have also been deaths that have happened during surgeries.

Continue Reading ››

 Posted on April 09, 2013 in Birth Injuries

In 1983, the FDA approved Depakote to treat certain issues with the central nervous system. It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior. This medicine can also be prescribed for migraine headaches. It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions.

After years of tests and research, there have been recent studies that have identified issues with this medication. Unfortunately, this is a far too common, because even the vigorous tests that were run by the FDA can miss potentially fatal side effects. In 2009, the FDA warned pregnant mothers about certain congenital birth defects such as a cleft palate, spina bifida, malformed hands and autism.

Continue Reading ››