Month: June 2013

Supreme Court: Federal law pre-empts state suits over drug label shortcomings

The Supreme Court has ruled that generic drug manufacturers cannot be sued in state court for potential warning label shortcomings in the generic version of a federally approved drug.In Mutual Pharmaceutical Co. v. Bartlett, the court ruled 5-4, agreeing with the generic drug manufacturer’s contention that federal law pre-empts a New Hampshire law that allowed a strict product liability lawsuit by Karen L. Bartlett.

Healio.com named Medical Marketing & Media 2013 award finalist

THOROFARE, N.J. — Healio.com, a website for specialty physicians published by SLACK Incorporated, has been announced as a finalist in Medical Marketing & Media’s (MM&M) 2013 Awards for “Best Healthcare Professional Media Brand.” The prestigious awards recognize health care marketing excellence in 23 categories.The gold and silver MM&M award winners will be revealed at a dinner ceremony in New York on Wednesday, Oct. 2.“Healio.com combines content from 18 medical and health specialty areas, which allows us to present a single platform that matches the breadth and depth of general medical (Read more...)

The Ahmed Versus Baerveldt Study: Three-Year Treatment Outcomes – Corrected Proof

Objective: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma.Design: International, multicenter, randomized trial.Participants: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy.Methods: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique.Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5–18 mmHg, with ≥20% reduction from baseline) for (Read more...)

Ophthalmic Surgery Simulator Training Improves Resident Performance of Capsulorhexis in the Operating Room – Corrected Proof

Purpose: To assess the effect of a Capsulorhexis Intensive Training Curriculum (CITC) on the rates of errant, continuous, curvilinear capsulorhexes (CCCs) during cataract surgery among resident surgeons at a teaching hospital.Design: Retrospective educational interventional case series.Participants and Controls: A total of 1037 consecutive cataract surgeries performed at Harbor-UCLA Medical Center during 4 consecutive academic years were considered. The baseline cohort consists of 434 cataract surgeries performed during the 2 academic years before the intervention. The postintervention cohort consists of 603 cataract surgeries performed during the following 2 consecutive academic years.Intervention: The principal intervention was the introduction of the CITC for (Read more...)

A Prospective Randomized Trial of Intravitreal Bevacizumab Versus Ranibizumab for the Management of Diabetic Macular Edema – Corrected Proof

Purpose: To compare visual acuity and spectral-domain optical coherence tomography (SDOCT) outcomes associated with intravitreal (IV) bevacizumab vs IV ranibizumab for the management of diabetic macular edema (DME).Design: Prospective randomized trial.Methods: Forty-eight patients (63 eyes) with center-involved DME were randomly assigned to receive 1.5 mg (0.06 cc) IV bevacizumab or 0.5 mg (0.05 cc) IV ranibizumab at baseline and monthly if central subfield thickness was greater than 275 μm.Results: Forty-five patients (60 eyes) completed 48 weeks of follow-up. At baseline, mean ± standard error best-corrected visual acuity (BCVA) (logMAR) was 0.60 (20/80) ± 0.05 in the IV bevacizumab group and 0.63 (20/85) ± 0.05 (Read more...)

BLOG: Supreme Court ‘pay-for-delay’ ruling hardly decides issue

On June 17, the Supreme Court handed down its decision in FTC v. Actavis, providing some clarity regarding the legal standard courts should apply to so-called “reverse payment” settlements. In these settlements, a brand drug company provides something of value to a generic drug company in order to resolve the parties’ patent litigation and clear the path for the generic product to come to market.

Split cornea donor tissue may be stored up to 1 week before DALK, DMEK

Anterior and posterior donor tissue that was stored up to 1 week before surgery showed no significant endothelial cell loss or complications 1 year after transplantation, according to a study.The retrospective, nonrandomized study included 110 eyes with anterior stromal disease that was suitable for deep anterior lamellar keratoplasty and 110 eyes with endothelial disease that was suitable for Descemet’s membrane endothelial keratoplasty. Best corrected visual acuity, visual and refractive outcomes, endothelial cell density, and complication rates were measured before surgery and at 1 day, 1 week, 4 weeks, and 3, (Read more...)