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Wyeth Pharmaceuticals Agrees to Pay $490. 9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses
Borchardt Law Firm Team

Wyeth Pharmaceuticals Inc., (now owned by Pfizer) a pharmaceutical company has agreed to pay $490.9 million to resolve the unlawful marketing of the prescription drug Rapamune. The U.S. Food and Drug Administration (FDA) did not approve it as safe and effective, the Justice Department announced the other day. Rapamune is an “immunosuppressive” drug that prevents…

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Roll-A-Bout Walker Product Malfunction
Borchardt Law Firm Team

As a patient, being a health advocate is important. As our world progresses so does technology and the advancement in the medical field. Companies are making products so quickly, so the product can be sold in stores. Often products have not been tested to ensure the product works correctly. This therefore leads to severe consequences.…

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Two Dialysis Drugs Have Been Recalled; Granuflo and Naturalyte
Borchardt Law Firm Team

GranuFlo and Naturalyte are two dialysis products recalled by the Food and Drug Administration. Fresenius Medical Care, the world’s largest provider of dialysis clinics and products, manufactures both GranuFlo and Naturalyte. The FDA has issued a Class 1 recall – the most urgent type of recall – on both products. This recall is reserved for…

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American Medical Systems Settle Portion of Vaginal Mesh Suits for $54. 5m
Borchardt Law Firm Team

Transvaginal mesh was introduced in the 1990’s to help fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs drop into the vagina. These organs include the bladder, rectum and uterus. Stress urinary incontinence occurs from everyday activities that put pressure…

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Intuitive Surgical Inc. Failed to Report to FDA Correction on Devices
Borchardt Law Firm Team

Intuitive Surgical Inc., maker of the Da Vinci Surgical Robot broke procedures when it warned patients and surgeons about problems with the robot without first alerting regulators. The FDA noted four observations in a Form 483 letter following inspections at Intuitive’s facility. The Form 483 is a notice that informs a company about possible violation(s)…

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Benefits of Drugs Outweigh the Risks
Borchardt Law Firm Team

There has been a decent amount of coverage on the prescription drugs Januvia and Byetta. Januvia (sitagliptin) and Byetta are both injectable drugs, and provide a new way of treating type 2 diabetes. They both help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1). They have potential advantages…

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Rejuvenate Modular/Abg II Modular-Neck Stem Voluntary Recall
Borchardt Law Firm Team

In June 2012, Stryker, a medical technology company, decided to voluntarily recall its Rejuvenate and ABG II modular-neck hip stems. The modular neck-hip stems provide surgeons with the ability to correct certain aspects of a patient’s anatomy and his or her bio-mechanics. However they decided to recall these modular-neck hip systems due to the potential…

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