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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 Posted on December 26, 2014 in Defective Medical Devices

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant designed to strengthen a weakened vaginal wall in the instance of POP or to reinforce the urethra to treat SUI. In 2011, the FDA issued a follow-up of its health notification from three years previous, which alerted people to the complications linked to transvaginal mesh when treating either of these medical conditions.

The updated safety alert identified additional concerns and growing numbers of reported difficulties involving surgical mesh devices. From the time between the initial communication in 2008 through to the end of 2010, the FDA recognized that complications were continuing at a high rate and were not considered a rare occurrence. More than 1,500 additional cases involving transvaginal mesh for POP repairs were documented and nearly 1,400 reports were linked to repairs for urinary continence.

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 Posted on December 17, 2014 in Defective Drugs & Treatments

The results from a new six year study may bring hope for those who have been forced to use dangerous drugs like statins to lower their cholesterol levels.

Whereas statins reduce LDL cholesterol by preventing it from being made, ezetimibe achieves the same result by preventing LDL cholesterol from being absorbed. The study, discussed at the annual meeting of theAmerican Heart Association, separated subjects into two groups – a group given statins and a group given the new drug ezetimibe. The statin group ended with an LDL of 69, while the ezetimibe group had an average LDL of 54. The second group also suffered 6.4 percent fewer cardiac incidents, such as heart attacks, strokes, and severe chest pain. One prominent observer called the outcome “fantastic” and “a truly spectacular result for patients.”

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 Posted on December 12, 2014 in Defective Drugs & Treatments

Thrombosis, or blood clots as they are colloquially known, tend to manifest naturally in men more than women. Women, however, are at risk for blood clots primarily because of pregnancy, birth control, and other hormonal therapies men do not generally take, according to StopTheClot.org.

Birth control pills are the most common form of contraceptive used in the U.S., and carry a high risk of blood clotting. Women who take birth control pills are generally three to four times more likely of developing a blood clot than women who do not take the pill.

It should be noted that the chance of a woman developing a blood clot as a result of taking birth control pills is still relatively small. Only about one in 3,000 women develop a blood clot because of birth control, but if a woman has a history of thrombosis in her family, the risk increases significantly.

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 Posted on December 10, 2014 in Defective Drugs & Treatments

Side effects of certain medication can put people at high risk for harm, increasing pain, and long-term medical conditions. It is the responsibility of drug manufacturers to make publicly known the severity of side effects its products may cause.

One of the highest-selling medications, Levaquin, secured record high sales in 2012 with $1.5 billion worth of prescriptions sold, according to Forbes. The antibiotic is prescribed to patients to treat conditions such as:

• urinary tract infections;
• pneumonia;
• acute bacterial sinusitis; and
• skin infections.

A little over a year ago, the U.S. Food and Drug Administration (FDA) issued a drug safety warning about the risks Levaquin carries. The administration required updates to drug labeling and medication guides to include a better description of one of the major side effects of taking the medication: peripheral neuropathy.

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