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West Virginia Pharmaceutical Products Law Blog

Jury to decide negligence in robotic surgery wrongful death

A 12 person jury is now reviewing evidence and arugments from a five week trial over the death of a man who underwent surgery using the da Vinci robotic system. The man suffered from complications after a surgery by a doctor who had limited training and had only conducted several prior surgeries with the machine. 

The man's family sued both the company that makes the robotic system and the doctor for his wrongful death and settled a claim with the doctor out of court. The trial that is pending now is over the possible negligence of the company that makes the device, Intuitive Surgical Inc. 

FDA warns migraine meds could lead to birth defects

The Food and Drug Administration recentl reclassified a popular migrane medication from a category D to a category X, indicating that it is not safe for pregnant women to use. 

The drug, known as Depakote, is very effective in treating migranes but as a side effect for pregnant women would lead to a variety of injuries for their babies. The drug has been linked to lower IQs for babies born to mothers who used the drug while they were in utero. 

Drug company admits to selling tainted generics

The company responsible for distributing large amounts of defective generic Lipitor pleaded guilty recently in a federal court. The drug maker admitted to a total of seven criminal charges, including making intentionally false statements to the government, selling drugs with intent to defraud, and failing to report drugs that did not meet specifications.

The guilty plea comes after years of investigation by federal safety officials who took a highly unusual step of temporarily baring the company from importing drugs for a period of time in 2008 when quality concerns arose. Various other concerns by regulators lead to other restrictions over the past several years and then in 2012 the company had to recall 41 lots of their generic version of Lipitor when glass particles were found in the capsules.

Compounding pharmacies may face more regulation under new bill

U.S. senators on the health committee say that they are close to finalizing a bipartisan bill to increase regulation of compounding pharmacies under the auspices of the Food and Drug Administration. Compounding pharmacies made the news and gained public notoriety after a deadly meningitis outbreak lead to 53 wrongful deaths and over 700 illnesses.

The tragic outbreak brought attention to the fact that compounding pharmacies may ship large quantities of drugs to hospitals and clinics around the country without signficant oversight from state or federal governments, putting patients at serious risk of harm from contaminated drugs or improperly formulated medications.

Politician's surgery raises concerns about Lap Band

The medical device Lap Band has gained national attention this week after the news broke that potential presidential candidate Chris Christie had undergone gastric bypass surgery using the adjustable silicone band. Gastric bypass surgery using the Lap Band is associated with risks such as ulcers and infections and some patients can suffer from serious complications if the band malfunctions.

Doctors always have a responsibility to inform patients of the risks associated with a particular device or procedure, particularly when there have been documented incidents of death or serious injury associated with a device. At the same time, the device manufacturer and the FDA may be in a better position to assess the overall safety of a medical device because they have a bigger picture of uses in a variety of contexts.

Lipitor linked to Diabetes in women

The FDA has recently warned middle-aged and older women who take atorvastatin brand-name drugs such as Lipitor, Zocor, or Crestor to begin monitoring their blood-sugar levels on a frequent basis. A link to the official FDA announcement about label changes and risks can be found here. These drugs, Lipitor in particular, have all been linked to an increase in Type 2 diabetes, especially in women who have already experienced menopause. Experts in the field agree that if you are taking these drugs you should not stop until you have been checked out by a physician, but that it is important to consult your doctor as soon as possible. Over the past ten years or so, billions of dollars in settlements have been paid out to victims of diabetes that were caused by such as Lipitor. Most commonly, the consensus is that doctors and their patients were given misleading information in regards to drugs like Lipitor and their side effects.

Off-label Botox use caused botulism death, parents say

The parents of a teenage boy who died after contracting botluism say that the manufacturer of Botox is partially responisble for the wrongful death, according to a recent lawsuit. The teen contracted botulism when he recieved Botox injections for spasticity in his legs, after which the medication migrated from the injection site to other parts of the teen's muscles and legs. 

Botox has been approved by the Food and Drug Administration for primarily cosmetic uses such as reducing the appearence of lines between the eyes. It is also used for some therapeutic medical reasons but is not specifically approved for treatment of spasticity.

Antibacterial agent may cause fertility issues

Especially when flu season is in motion, many Americans turn to medical antibacterial gels to help rid their hands of germs. However, recent news looks at a chemical, which has been a staple to American's for many years. The chemical, commonly found in germ-killing agents, is now under the microscope for potential side effects.

The chemical is part of the billion-dollar anti-bacterial industry: tricolsan. Tricolsan is used in several antibacterial products - many of which are probably in your home. It might be in your hand soap, toothpaste and children's toys. In fact, sources suggest that approximately 75 percent of antibacterial liquid soaps and body washes sold in the U.S. include this potentially dangerous agent. The concern surrounds the potential side effects.

FDA issues recall for dangerous brain stimulating device

The Food and Drug Administration has issued a Class One recall of a device manufacturered by Medtronic to treat pateints with Parkinson's disease. A Class One recall is the most serious type of recall issued by the FDA and indicates that the defect is likely to cause serious injury or death. 

The device stimulates brain tissue to treat a variety of neuroligical conditions in addition to Parkinson's, including tremors and involuntary muscle contractions. The problem, according to Medtronic, is that the cap used to protect the wires can sometime damage the wires during the surgery to instert them. 

Pain from a faulty hip implant? There's an app for that

The Food and Drug Administration has recently introduced an application that allows patients to report possible problems with medical devices. The application, called MedWatcher, works with smart phones and tablets.

The FDA relies on patient complaints and consumer reporting in order to know which devices or medications are causing injuries. Only a fraction of actual injuries from defective devices are actually reported to the FDA, but patients who do take the time to make a complaint help show the FDA where the problem is and contribute to figuring out whether there is a need for a nationwide recall.

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