Elbow Replacement Device Recalled After Patients Report Serious Injury
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 conditions that lead to elbow replacement.
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:
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 FDA plans to analyze self-reported, real-world data stored in the database of more than 350,000 members with more than 2,500 conditions according to PatientsLikeMe.
Increasing patient drug
safety through information gathering
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 FDA about how it could allow these drugs to be distributed. The answers weren’t that simple.
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 and provides the final approval to allow these products on the market.
As medical device manufacturers rush to market products designed to help patients experience a better quality of life, incomplete or deficient research and reports required to obtain FDA approval can put patients at risk.
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 issued a draft guidance for manufacturers of drugs and medical devices related to user-generated (independent third-party) internet content which addresses the correction of misinformation about an FDA approved product.
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, and company websites– is one area that the FDA has not specifically addressed until recently.
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.
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 adequacy of a drug’s warnings are pre-empted by federal law. Bartlett was an extension of the Court’s 2011 decision in PLIVA, Inc. v. Mensing, which found that state-law failure to warn claims against generic manufacturers are pre-empted under federal law.
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 their sex drive, and improve their energy. Options for testosterone replacement include an injection, patch, pellets, and a gel.
What does it mean to have low testosterone and how is it diagnosed?