Posted on April 09, 2015 in Defective Drugs & Treatments

A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down.

Compounded Drug Recall

The NCBOP said in a news release that it was recalling all nonsterile and sterile products that were compounded, repackaged, and distributed by the pharmacy from September 10, 2014 to March 10, 2015. The listing of recalled products includes antidepressants, antibiotics, antiviral medications, immunosupressants, and others which were distributed to all 50 states and Canada. “This recall is due [to] the pharmacy's inability to ensure sterility, stability, and potency for these products,” the Board of Pharmacy said. While no complaints of injuries have been received by the board, the NCBOP and FDA are advising clinicians to quarantine any products from the Prescription Center and not to administer them to human or animal patients.

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 Posted on April 07, 2015 in Defective Medical Devices

When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.

Recall Classes

The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. A recall is categorized by the FDA as one of the following:

Class III Recall: Exposure to the device or drug is unlikely to result in adverse health consequences, but the product does not meet regulatory standards.

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 Posted on March 10, 2015 in Defective Medical Devices

Defective medical devices are not limited to those implanted in a patient's body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not. According to The Baltimore Sun, it is imperative to maintain wheelchairs and walkers as you would a car, as a lack of proper maintenance can result in unsafe conditions such as broken or bent parts. If the device is broken, it can result in the requirement of extra energy to get around, more pain, or—worst-case scenario—a devastating accident that can result in hospitalization.

The onus of maintaining these devices is not, however, solely the responsibility of the patient. Sometimes these devices, and machinery used in conjunction with them, are not properly built or vetted before it is put on the market. One such incident occurred earlier this year, when a California-based manufacturer was ordered to pay a $1.75 million civil penalty for continuing to sell faulty wheelchair lifts. The lifts were recalled by the National Highway Traffic Safety Administration (NHTSA), according to an agency report, as they had been labeled as potential fire hazards. Even after the recall was announced, the manufacturer, Rincon Corporation, continued selling the lifts to the public.

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 Posted on March 03, 2015 in Defective Medical Devices

When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them. Such is the case with a device that until very recently was used to aid with knee replacement surgery, the OtisKnee, distributed by OtisMed Corporation.

In December, according to The New York Times, the former CEO of OtisMed pled guilty in a New Jersey federal court to criminal charges of distributing adulterated medical devices. The OtisKnee was not cleared by the Food and Drug Administration before OtisMed began to distribute and sell the device to American hospitals, and 18,000 of the adulterated devices were sold and distributed between 2006 and 2009. The device was marketed as one that would speed knee surgery and aid in patient recovery, but many patients experienced the exact opposite. In one case, a woman experienced intense and lasting pain after the surgery, and ended up having to have a second knee replacement. Another patient said that the revelation that the device that had been used was likely at fault for her persisting knee problems made her feel like she "had been a guinea pig."

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 Posted on January 28, 2015 in Defective Medical Devices

In what will likely be the first of many settlements to come, Johnson & Johnson has agreed to resolve claims from four Missouri women that its Ethicon Prolift vaginal mesh implant caused serious injuries.

The settlements came almost literally at the courthouse door, as jury selection was scheduled to begin in late January 2015. Since the controversy over these devices began in 2012, J&J consistently denied that these devices are dangerous. Nevertheless, it currently faces about 23,000 liability lawsuits. One observer noted that "it's only four cases, but it's a start. There's still a long way to go to get the whole thing resolved." A J&J spokesperson emphasized that the company did not admit or deny liability as part of the settlement terms and that "the company may consider whether settlement is appropriate" in individual cases.

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 Posted on January 27, 2015 in Defective Medical Devices

Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury. According to the New York Times, these devices became popular in the late 1990s because they allowed patients to leave the hospital earlier while they received narcotic painkillers for recovery through the pump. While the pain pumps had received clearance from the U.S. Food and Drug Administration, the FDA had never cleared the devices for use in joints.

It was not long until several young patients returned to their surgeons suffering from chondrolysis, a rare ailment in which the cartilage dies, precipitating the painful condition of a bone grinding on an adjacent bone. One orthopedic surgeon told the Times that he had lost many hours of sleep trying to figure out what was causing the chondrolysis before several medical studies identified pain pumps as a likely culprit.

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 Posted on January 22, 2015 in Defective Drugs & Treatments

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan. The system was first introduced as a prototype more than five years ago, but only received approval from the U.S. Food and Drug Administration (FDA) last year.

The first da Vinci Intuitive surgical robot was introduced more than a decade ago. When the company first went public, 15 years ago, it posted $10 million in annual sales, though the robot had only been used on 600 patients worldwide. The machine was thought by the medical professional community to be a great symbol of technological surgical advance, and, according to ModernHealthcare.com, “one of the most coveted status symbols of 21st-century medicine.” Yet the $2.3 million machine caused serious side effects and even injury in several patients, due to a disregard for patient safety on the part of the manufacturer and aggressive marketing tactics that often preceded patient testing.

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 Posted on January 16, 2015 in Defective Drugs & Treatments

A federal multidistrict litigation panel has consolidated 21 Xarelto cases in the Eastern District of Louisiana. Eight of these cases were originally filed in the Southern District of Illinois. The others came from Louisiana, Florida, Kentucky, New York, Utah, Vermont and West Virginia. Writing on behalf of a seven-member panel, Judge Sarah Vance concluded that the cases all presented common factual issues, even though there were some differences, such as dosage amount and medical history. Therefore, Judge Vance ordered the cases to be consolidated, given the common facts and the “impractical[ity] of informal coordination.” Judge Vance consolidated the cases in Louisiana because both parties agreed that The Bayou State was an acceptable forum, it is centrally located, and the presiding judge is “well versed in multidistrict litigation.”

In addition to the pending cases, as many as 30 additional matters may be filed in the coming months, alleging that Xarelto causes significant health problems.

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 Posted on January 09, 2015 in Defective Drugs & Treatments

The product first hailed as a miracle weight-loss drug and subsequently pulled from the market when its dangers became apparent has resurfaced, albeit in another format. But the new drug has some of the same health concerns, and some new ones as well.

Fen-Phen

Fenfluramine was first introduced in the 1970s. Those who took it saw little or no results, so sales were quite weak until the early 1990s when it was combined with Phentermine. Its newfound success was short lived, however, as serious concerns about the link between Fen-Phen and primary pulmonary hypertension (PPH), one of the most serious heart-lung disorders, began to surface in the mid to late 1990s. The Food and Drug Administration recalled Fen-Phen in September 1997.

Qsymia

Fenfluramine was considered the more dangerous of the two drugs. Several years after the Fen-Phen recall, Vivus introduced a new drug pairing Phentermine with the anti-seizure drug Topiramate. The new anti-obesity drug, then known as Qnexa, initially faced some obstacles at the FDA because of its questionable heritage. But the agency eventually approved the drug for treatment of dangerously obese patients.

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 Posted on December 29, 2014 in Defective Drugs & Treatments

Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

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