Posted on May 23, 2013 in Drugs

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.

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 Posted on May 19, 2013 in American Psychiatric Association

The New York Times recently reported on new data from the Center of Disease Control (CDC) which reveals that nearly one in five high school age boys in the United States have received a medical diagnosis of attention deficit hyperactivity disorder (A.D.H.D.).

A.D.H.D. is a result of abnormal chemical levels in the brain that impair a person's impulse control and attention skills. About two-thirds of those with a current diagnosis receive prescriptions for stimulants like Ritalin or Adderall, which have been shown to lead to addiction, anxiety and occasionally psychosis.

The CDC also reports that an estimated 6.4 million children, between the ages 4 through 17, have been diagnosed with A.D.H.D., an increase of 16 percent since 2007 and 41 percent over the past ten years.

Medical experts predict the numbers will increase even more dramatically as the American Psychiatric Association plans to change the definition of A.D.H.D. which will allow more people to receive the diagnosis and treatment. There is growing concern in the medical community that the diagnosis and medications used for treatment are being overused in children.

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 Posted on May 16, 2013 in Drugs

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.

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 Posted on May 13, 2013 in Drugs

Azithromycin, also known as Zithromax, Zmax, or Z-pack, is a best-selling antibiotic used to treat many ailments. It is most frequently prescribed to treat middle ear infections, pneumonia, typhoid, bronchitis, strep throat, and sinusitis. It has also used for treatment of certain sexually transmitted infections (cervicitis, nongonococcal urethritis, and Chlamydia). Its primary use in recent years has been to aid in fighting bacterial infections in infants or people who have weaker immune systems.

Every drug package lists its side effects, and the ones reported most often with the use of azithromycin were diarrhea, abdominal pain, nausea, and vomiting. However, a new finding by the FDA in 2013 shows that this drug may cause changes in a heart's electrical activity—which in turn may lead to a deadly heart rhythm. The patients that face this risk the most are those with existing heart conditions—slower-than-normal heart rate, an arrhythmia (or those taking certain medications for their arrhythmia —existing QT interval prolongation, and those with low blood levels of potassium and magnesium.

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 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.

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 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.

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 Posted on April 28, 2013 in Drugs

The U.S. Food and Drug Administration (FDA) recently issued an update to a prior warning they issued regarding the administration of codeine to children.

In August 2012, the FDA warned that there were some children that shouldn't be prescribed codeine after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome because it could lead to rare, but life-threatening adverse events or death.

Codeine is an opioid pain reliever and is converted to morphine by the liver. Some children are “ultra-rapid metabolizers of codeine” and this can cause the liver to convert codeine into life-threatening amounts of morphine in the body, leading to a fatal morphine overdose.

At the time of their original warning, the FDA had received three reports of children's deaths and one case of severe respiratory depression. The children were between two and five years old.

Since then, a review of the FDA database has determined that from 1969 to May 1, 2012, there were ten deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.

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 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.

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 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.

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 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.

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