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According to a recent news article from Syracuse.com, two customers from Wal-Mart had purchased a package of Marketside Organic Spring Mix brand salad and discovered what the authorities first called “extraneous animal matter.”  As it turns out, that is a nice way of saying was part of a decomposing bat that had found its way into bags of prepackaged salad mix sold primarily in southern U.S. Wal-Mart stores.

batThe two alleged victims of this defective product reported having eaten some of the salad before finding the bat parts, and, for this reason, there was a threat of rabies and other pathogens.  The bat material was sent to the U.S. Centers for Disease Control (CDC) for testing to determine if the bat had rabies or any other serious pathogens that could affect a human, but the bat was too deteriorated to perform any of the tests.  Continue reading

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According to a recent news article from NASDAQ, Medtronic has begun to voluntarily recall all unused units of their StrataMR product lines.  StrataMR is a line of adjustable valves and shunts that patients and doctors have been complaining about lately.  These complaints range from minor issues to potentially deadly adverse events.  One person has died, but the company has yet to determine the exact cause of the death.xray

The medical devices are used to treat a medical condition known as hydrocephalus, which involves the buildup of fluid on a patient’s brain.  If this fluid is allowed to build up, it presses against the inner layer of skull known as the dura, and this creates a tremendous amount of pressure.  If untreated, this can result in permanent brain injury or even death. Continue reading

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Many people are familiar with transvaginal mesh products.  They have likely seen the many commercials and magazine ads for transvaginal mesh implants and have also read about the many products liability lawsuits filed against medical device companies that manufactured these defective products.

handsHowever, transvaginal mesh (TVM) is not the only potentially problematic surgical mesh implant being used. All surgical mesh is a woven sheet of either organic or inorganic material that is implanted into the patient for the purpose of supporting tissue or organs. It can be for temporary use, where it will eventually dissolve, or it can be a permanent implant like the ones use in TVM surgery.
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Lawsuits against Atrium Medical Corp. for its C-QUR hernia mesh product alleging these devices were not safe for use by humans. hands

One of the most recent cases is one filed in Florida Middle District Court in Orlando just this past month. In his filing, which alleges negligent manufacturing and strict product liability, plaintiff alleges he underwent surgery in April 2013 to repair multiple hernias. His surgeon used the C-QUR product. Subsequently, plaintiff alleges, he suffered injury.

Although the recent Florida Record article reporting the filing does not offer specific details on the man’s injury, we can make the inference based on previous claims, the type of liability asserted here and also what we know about the company’s history.  Continue reading

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The Journal of the American Medical Association (JAMA) recently published a large series of studies that primarily involved the risks and benefits of testosterone replacement therapy.  A recent article from Star-Telegram examined the results of these and discussed what they mean to those who are considering taking testosterone replacement therapy (TRT) drugs, or have already begun taking them and are worried about possible adverse effects and complications.

syringeThe first thing to understand is that while hundreds of thousands of men are taking testosterone replacement therapy drugs every year, the medication was first developed in the 1960’s to treat a relatively rare medical condition known as hypogonadism.  This condition involved extremely low levels of testosterone in men due a glandular defect and would affect normal development.   Continue reading

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When you go into a hospital on the day of your surgery, you have likely met with your surgeon and discussed the risk and benefits of the benefits of whatever procedure you are scheduled to have that day, assuming you are not brought into the emergency room and rushed into an operating room.  You are likely confident that surgeon has the skill and experience to do his or her job properly, and while this is very likely true, if your surgeon is unknowingly using a defectively-designed medical device, the chance of a complication may be exceedingly high.

surgeonIn a case from the Washington State Supreme Court, a surgeon who had used a defendant’s surgical assist robot on numerous occasions spoke to the patient about his intention to use the relatively new device to operate on the patient’s prostate cancer. The doctor obtained informed consent from the patient, who was considered severely obese at the time of his surgery.   Continue reading

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A recent case from the Supreme Court of New Jersey involved a products liability action filed against the major pharmaceutical maker that is now known as Roche in connection with its Accutane drug.  Accutane is the brand name for the drug isotretinoin. The drug was originally developed by Hoffmann-La Roche labs and was used to treat a severe skin condition known as nodular acne.  It was also used in some cases to treat a form of skin cancer.

pillsWhile the drug was effective at treating acne, it had some serious side effects associated with it.  In some cases, it would lead to severe birth defects.  For this reason, women taking the drug had to be counseled against becoming pregnant while taking it, and also needed to either abstain from sex entirely or use what were considered effective contraceptives.  Condoms were not considered sufficient when not used in conjunction with another method of birth control.  For this reason, Accutane is considered a teratogen, meaning it can cause birth defects. Continue reading

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In one recent case from the U.S. Supreme Court for the Fourth Circuit, a plaintiff, along with her husband, filed a lawsuit against Eithicon, the makers of a of popular transvaginal mesh medical device that has been the subject of numerous products liability lawsuits.

sadIn this case, plaintiff testified that after having the Ethicon (Johnson & Johnson) device implanted, she started to experience serious complications that resulted in significant pain and suffering.  In this case, the device was known as a Tension-Free Vaginal Tape-Obdurator. This device is typically referred to by its abbreviated name, TVT-O.   Continue reading

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Hernia mesh manufacturer Atrium Medical Corp. will face multi-district litigation (MDL) in a federal New Hampshire court, after a  judicial panel surgeryagreed to centralize all federally-filed claims against the company for its C-QUR product. More than a dozen claims are pending at this juncture.

Atrium’s C-QUR hernia mesh was produced for use in reinforcing the abdominal wall as a permanent solution after hernia surgery. The company has said its unique Omega-3 coating lowers the risk of adhesions to internal organ tissue – which had been a major problem with other hernia mesh devices. However, plaintiffs in these pending lawsuits say the polypopylene patches were negligently designed and the company fraudulently convinced doctors the product was safe when executives and scientists with the firm knew it wasn’t.

Specifically, plaintiffs allege the netting of the product is “biologically incompatible” to be used with human tissue. This resulted in an unreasonable risk of serious medical complications, including infections.  Continue reading

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The U.S. Food and Drug Administration is a federal regulator without a key regulatory power: Recall. blindinglight

That’s why when investigators with the agency confirmed there were high levels of a potentially lethal toxin in toddler teething tablets, there was really nothing they could do other than announce it. The manufacturer of the tablets refused to issue a recall, and the FDA was powerless to force them to do so.

This could soon change. At least, that is the hope of lawmakers supporting the Recall Unsafe Drugs Act. This measure, H.R. 1108, would give the FDA the authority to order mandatory recalls on dangerous drugs and homeopathic products. The measure would revise the current law for the FDA to be allowed to issue mandatory recalls for products it does not directly regulate. The proposed law would also give the agency the power to issue mandatory recalls of pharmaceuticals that have been shown to cause serious health consequences and/or death.  Continue reading