By: Jeff S. Gibson, Attorney Roughly 3,000 people in the U.S. have elbow replacement surgery each year. There are multiple conditions that can cause elbow pain and disability which lead patients and their doctors to consider elbow joint replacement surgery. Rheumatoid arthritis, degenerative joint disease, post-traumatic arthritis, severe fractures, and instability are the most common… Continue Reading »
Do Fast Drug Approvals by FDA Help or Harm Patients?
By: Jonathan A. Knoll, Attorney Two recent studies published by the British Journal of Medicine (BJM) raise concerns about the speed with which the Food and Drug Administration approves drugs for market in the United States. According to the FDA the stages of drug development and review necessary to gain marketing approval include: Pre-clinical Testing;… Continue Reading »
FDA Partners with Online Patient Network to Gather Post-Market Drug Safety Data
By: Jeff S. Gibson, Attorney The FDA announced an agreement with PatientsLikeMe, an online database where patients share healthcare information and experiences, to analyze data and provide new insights into drug safety. This agreement was created with the intent to provide better post-market surveillance of drugs and medical devices and increase patient safety outcomes. The… Continue Reading »
FDA Releases Rules and Requirements for Compounding Pharmacies
By: Jeff S. Gibson, Attorney Tainted steroid injections manufactured by the New England Compounding Center in 2012 cast a spotlight on compounding pharmacies and raised alarms. Hundreds of people across the United States were sickened and 64 people died after being exposed to fungal meningitis through contaminated steroid injections. The public demanded answers from the… Continue Reading »
Hip Replacements Gone Wrong: Lawsuits & Settlements
By: Jeff S. Gibson, Attorney The pharmaceutical and medical device industry seems to be on an endless search for the next advancement to improve patient care and quality of life. Whether existing designs are significantly altered by the addition of new materials or new products are created, the FDA continues its oversight of these devices… Continue Reading »
FDA Issues Guidance on Correcting Third-Party Misinformation About Prescription Drugs & Medical Devices on Internet and Social Media
by: Jeff S. Gibson, Attorney The internet and social media can provide a wealth of information for patients and consumers of healthcare services. However, due to the way that information is created and shared, it is possible for incorrect or incomplete information to be published online which can put patients at risk. The FDA recently… Continue Reading »
FDA Issues Draft of Social Media Guidelines for Medical Product Manufacturers
by: Jeff S. Gibson, Attorney The FDA is responsible for regulating the manufacture, sale, and distribution of drugs and medical devices in the United States including the oversight of the labeling of drugs and medical devices and the advertising of prescription drugs and restricted medical devices. Digital communication related to advertising, more specifically—blogs, Twitter, Facebook,… Continue Reading »
Concerns of Link Between Viagra Use and Melanoma
By: Jonathan A. Knoll, Attorney Erectile dysfunction drugs, like Viagra, have been on the market since the late 1990s. Conservative estimates place the market for these drugs at over $3 billion in annual revenue. Viagra leads the market for erectile dysfunction drugs with over $1 billion in annual sales. However, a recent study published online… Continue Reading »
Name-Brand Drug Manufacturer Could be Held Liable for Injuries Sustained by Generic Drug Says Court
By: Jonathan A. Knoll, Attorney In a previous blog article, I wrote about the impact that the United States Supreme Court’s 2013 decision in Mutual Pharmaceutical Co., Inc. v. Bartlett had on injured consumers of generic drugs. In Bartlett, the Court held that state-law design defect claims against generic drug manufacturers that turn on the… Continue Reading »
Low Testosterone Therapy Risks and Rewards
By: Jonathan A. Knoll, Attorney If you have been watching television lately, then you probably have heard about a treatment advertised as a way to boost men’s energy and health. This treatment, called low testosterone therapy, is being marketed to men over the age of 30 as a way to increase their muscle mass, boost… Continue Reading »
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