Courtesy of Greg Monforton vice manufacturer should.”“These are people who have a life-
threatening condition to begin with, so on top of that, you're layering not only the risks and …

[Allowing claims against device manufacturers] will result in needless delays in patient
access to essential medical technologies, more lawsuits and ultimately higher healthcare …

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by
dangerous prescription drugs or medical devices can bring tort lawsuits against …

Congress enacted the Medical Device Amendments in 1976 (MDA) in order to protect
consumers from defective medical devices before these medical devices are marketed by …

Evergreen balloon catheter, a medical device approved by the US Food and Drug
Administration (FDA), into his patient's coronary artery in an attempt to dilate the artery, but …

Imagine you are sitting in your electrophysiologist's office, and she just informed you of a
new safety alert on the implantable cardioverter defibrillator (ICD) that lies beneath your …

A physician's decision to implant a medical device is governed by two bodies of conflicting
law. On the one hand, the law of medical malpractice allows professional choice-that is, it …

THE US FOOD AND DRUG ADMIN-istration (FDA) announced it has initiated a process
aimed at improving patient safety through better postmarketing oversight of medical devices …

IN 2008, THE US SUPREME COURT HELD THAT THE MEDI-cal Device Amendments
(MDA) bar common law claims challenging the safety or effectiveness of a medical device …

In late 2017, the US Food and Drug Administration (FDA) and Centers for Medicare and
Medicaid Services (CMS) jointly approved Foundation Medicine's FoundationOne CDx, a …