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For decades, Meshbesher & Spence has been helping clients across the country who have been harmed by defective medical devices and dangerous pharmaceutical drugs.
Current top medical device cases at Meshbesher & Spence:
Medical device company, Exactech, Inc., has issued recalls involving certain components used in its knee, hip, and ankle replacement systems due to an increased risk of premature failure.
Mayo Clinic Privacy Breach
On October 7, 2020, the Mayo Clinic in Rochester revealed that the private health information of over 1,000 patients was accessed illegally. The type of records accessed by the former employee included sensitive and private images taken during clinic appointments. Mayo Clinic became aware of this privacy breach on August 5, 2020 and has reported the incident to the Rochester Police Department and the FBI for further investigation. It is not yet known whether the former employee printed or retained copies of these private health records or provided copies to other parties. Mayo Clinic has notified affected patients about the privacy breach, disclosing the dates on which their medical records were inappropriately accessed, and the types of information viewed by this employee.
Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a digestive disease that impacts newborn children, often times premature babies. The bacteria enters the body and erodes the intestinal lining and causes infection.
What is Paraquat?
Paraquat (“Gramoxone”) is herbicide, or weed killer, and is primarily manufactured by Syngenta and Chevron Chemical Company. It was introduced to the market in 1961 and is used by farmers and agricultural workers throughout the United States as an all-purpose weed killer. Due to its toxicity, Paraquat is available for use only by commercially licensed users. Paraquat is sold in two forms – concentrate and granules.
Philips Respironics – CPAP Recall
On June 14, 2021, Philips Respironics issued a recall notification because of potential health risks associated with the polyester-based polyurethane (PE-PUR) sound reduction foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, as well as certain mechanical ventilators. Philips acknowledged that the PE-PUR foam may degrade or fall apart into tiny black particles that can enter the device’s humidifier, tubing and mask and be ingested or inhaled by the user. Testing by Philips also found that the foam can produce unsafe chemical levels that are released as gases.
What is Stevens-Johnson syndrome/toxic epidermal necrolysis?
Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a severe skin reaction most often triggered by the use of certain over-the-counter and prescription medications.
Most patients who have hip replacement surgery expect to have a new lease on life, with increased mobility and reduction in pain. Doctors and patients alike must trust the hip implant manufacturer to make and sell only devices that are safe and effective. Unfortunately, we’ve seen a host of hip recalls over the past ten years. What’s worse is that most patients have no idea whether or not the hip replacement they had is part of a recall.
Stryker Orthopedics voluntarily recalled its Rejuvenate and ABG II modular hip stems on July 6, 2012 due to fretting and corrosion. The neck components of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are coated with a proprietary titanium alloy. Corrosion of these implants can lead to dangerous cobalt ions being released into your tissues and blood stream resulting in severe damage to bone and muscle.
Multiple manufacturers have voluntarily recalled their Valsartan medication after the FDA issued its largest ever class 1 recall due to N-Nitrosodimethylamine (NDMA) in supplies that were produced by Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP). NDMA Is a known human carcinogen that can lead to serious health risks in high doses and through prolonged exposure. The FDA first initiated a recall of Valsartan, both on its own and in combination with other pharmaceuticals, in July 2018 and have since expanded the recall to include additional manufacturers as of January 2019.
Xeljanz, Xeljanz XR, Xeljanz ER (tofacitinib)
In 2012, the U.S. Food and Drug Administration (“FDA”) approved the above-named Xeljanz medicine in 2012 to treat moderately to severely active rheumatoid arthritis. It later approved the drug for ulcerative colitis, juvenile arthritis, and psoriatic arthritis.
Zantac is a drug taken for heartburn, acid indigestion, gastroesphogeal reflux disease (GERD), ulcers, and other stomach conditions. The FDA recently recalled Zantac and its generic formulation, ranitidine, due to an increased risk of cancer. Zantac’s active ingredient ranitidine, when exposed to chemicals in the body may produce dangerous levels of nitrosodimethlylamine (NDMA), a known carcinogen.
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