Features

Exclusion of Evidence: The FDA's 510(k) Process
In a drug or medical device injury case, one of the defense's most potent arguments is often that the product in question underwent FDA approval, so the balance of its safety and efficacy has already been determined. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
Features

Physician Extenders or Liability Expanders?
For health care services to serve an influx of patients, so-called “physician extenders” now carry out functions previously performed by doctors. The aim of this article is to examine factors driving the growth in physician extenders, identify liability “hotspots” and offer tactics for health care providers to use in managing professional/medical liability risks.
Features

Paralysis Cases: Helping Your Client Cover Future Costs
<b><i>Part Two of a Two-Part Article</i></b><p>Your paralyzed client currently has many problems to deal with, but the future holds many more. In order to advocate for your client, you need to gain an understanding of his or her current and future challenges, and work to maximize the resources your client will need to deal with them.
Features

When Lack of Informed Consent Is Not the Issue
When an injury occurs, the first reaction of those in the medical office might be to ask, "Did the patient sign an informed consent form?" When the answer is "Yes," and the harm that occurred is listed as a possibility on that signed form, everyone can breathe a sigh of relief. Right? Not so fast.
Features

Maximizing Future Medical Damages in Paralysis Cases
<b><i>Part One of a Two-Part Article</i></b><p>When you take a catastrophic injury case involving paralysis, it is important to have a thorough understanding of the problems and pitfalls. In this two-part article, I will explore, from personal experience, the different types of future expenses the client can expect to incur.
Features

The Rise of the Travel Act
The DOJ continues to prioritize health care anti-fraud enforcement through the aggressive use of different statutes and investigative methods. Although the prosecutions and recoveries vary, between October 2016 and March 2017, "Strike Force" team efforts led to charges against 49 individuals or entities, 152 criminal actions, and more than $266.8 million in investigative receivables.
Columns & Departments
Drug & Device News
The U.S. Court of Appeals for the Second Circuit has upheld the summary judgment dismissal of the multidistrict lawsuit (MDL) against the maker of the intrauterine birth control device Mirena after finding that none of the experts proffered by the nearly 1,300 plaintiffs were reliable.
Features

Increased Scrutiny for <i>Cy Pres</i> Provisions in Class Action Settlements
Lawsuits against pharmaceutical and medical device manufacturers often come in the form of class actions, and sometimes the settlement or award amount exceeds the identified class members' claim amounts. In such cases, the excess funds may be distributed to a <i>cy pres</i> recipient, but courts are starting to question such moves more thoroughly.
Features

Defamation and the Disgruntled Defendant
<b><i>Anti-SLAPP Legislation and Defamation Claims</i></b><p><b><i>Part Two of a Two-Part Article</i></b><p>After defendants have established that their allegedly defamatory statements were made in furtherance of their right of free speech or petition under the United States Constitution or the California Constitution in connection with a public issue, the second thing that courts must question when a defendant seeks dismissal through an anti-SLAPP motion is whether the claimant has carried his burden of establishing a probability of success on the merits of his claim.
Columns & Departments
Case Notes
The U.S. Supreme Court is deciding whether to consider the case of Southern Baptist Hospital of Florida v. Charles, which pits a plaintiff against a hospital in the ongoing battle over which documents are privileged as adverse event records for the improvement of quality of care, and which must be turned over to aggrieved patients and their families.
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