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Class 1 Recall: Hospira Inc., GemStar Infusion System

The FDA has republished a Class 1 recall, the most serious, for the Hospira Inc. GemStar Infusion System. The GemStar pump by Hospira is designed to deliver fluids via IV, to lower back or spinal areas, and in other parts of the body.  It is small, lightweight and can be portable when using battery power.… Continue reading

Recall of Medtronic Cardiac “Guidewires”

The FDA has classified the Medtronic cardiac “guidewires” recall as a Class 1, the most serious category. Medtronic issued a voluntary recall of the “guidewires,” the wire connectors used to connect cardiac devices that help regulate heartbeat and other functions and facilitate heart surgery because the coating on the wire may disintegrate causing the wire… Continue reading

Leukemia Drug Iclusig: Deaths and Serious Injury

The leukemia drug Icusig that was given rapid approval by the FDA in December 2012 is now off the market and clinical trials are halted. The FDA received an alarming number of reports of more than a dozen deaths and a still-to-be-counted tally of serious injury from blood clots, heart attack, stroke, lack of blood… Continue reading

Verdict in Talcum Powder and Ovarian Cancer Lawsuit

A South Dakota jury sided with a woman claiming her ovarian cancer was linked to her use of Johnson & Johnson talc-based body powder. After a two week trial and nearly twelve hours of deliberations, the jury said J&J should have warned consumers of the risks. According to the Sioux Falls, South Dakota newspaper the… Continue reading

Medtronic MiniMed Paradigm Insulin Pump: Lawsuit Filed

The Harman Law Firm has filed a complaint against the manufacturer of the Medtronic MiniMed Paradigm MMT 722 Insulin Pump following the death of a young woman who was using the device The MiniMed Insulin Pump is designed to deliver insulin continuously into the body, making multiple injections per day unnecessary. The young college student… Continue reading

Tylenol Investigation: ProPublica Exposes Deadly Risks and Depth of Deception

This week, ProPublica in conjunction with the radio program “This American Life” released a Tylenol investigation, a blistering report on the popular over the counter drug and the manufacturer’s failure to adequately warn of the serious, deadly risks despite long-held concerns of the FDA and the medical community. New warnings are being placed on Tylenol… Continue reading

Stryker OASYS Spinal Surgery Device Recalled, Australia Issues Hazard Alert Following Reports of Device Failure and Patient Injury

A Class I recall has been issued in the United States for the OASYS Midline Occipital Plate, part of the OASYS Occiptito-Cervico-Thoracic System. The device is used in cervical spinal fusion surgery. Class 1 recalls are the most serious, which the FDA says are “situations in which there is a reasonable probability that use of these products… Continue reading

Levaquin Drug and Rapidly Occuring Nerve Damage: FDA Requires New Warning Label

Harman Law LLC is investigating patient nerve damage injuries related to fluoroquinolone drugs The FDA issued a drug safety alert that the agency is requiring the manufacturer of the antibiotic Levaquin (levofloxacin), Ortho-McNeil-Janssen Pharmaceuticals, and of other fluoroquinolone drugs revise the labeling to warn patients of the risk of serious side effects including nerve damage.  Previously, these drugs… Continue reading

Tylenol Safety Update: J&J to add warnings on bottle cap

Following up on the Harman Law LLC Tylenol and Liver Failure blog post from July 22: The Associate Press reports today that Tylenol manufacturer Johnson & Johnson’s McNeil Healthcare unit announced plans to add extra warnings on the over the counter pain reliever’s packaging. Starting in October of this year, the cap on Extra Strength… Continue reading

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