Showing all posts written by Thomas Woodland

Thomas Woodland
Thomas Woodland
Thomas E. Woodland focuses on assisting with patent prosecution and litigation. Thomas received his law degree from the S. J. Quinney College of Law.
While serving as a Fellow for the Center of Medical Innovation, he experienced a wide variety of innovation. Prior to his legal education, Thomas received a Bachelor's degree in Physics from the University of Utah.
Thomas worked as a summer associate at the firm in 2015 and joined the firm in 2016.

$50 Million Lawsuit Filed Against FDA

On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was filed by Semler Research Center Pvt. Ltd., a contract research organization based in Bangalore, India.

The suit comes after the FDA notified a number of drug makers that marketing applications containing clinical trial data prepared by Semler would not be accepted due to concerns about the integrity of the data.

According to the FDA notification, the FDA inspected Semler facilities last fall. After the inspection, the FDA posted a notice on its web site saying that inspections found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”

According to the complaint, FDA inspectors ignored evidence that a “rogue employee” framed Semler by planting false data on the company’s computer network.

The complaint alleges that those employees were part of a scheme that involved contacting the FDA “to lead FDA inspectors to the fabricated information and raise suspicion regarding [Semler’s] procedures and the reliability of its studies.”

According to Semler, an independent audit showed that the purported data manipulation could not have occurred in the manner suggested by the suspect spreadsheet. Nonetheless, FDA officials “summarily disregarded the results” of the audit and produced the disciplinary letter.

According to Semler’s complaint, in response to the FDA’s actions, a $30 million sale of Semler collapsed, and various Semler clients are “demanding compensation” worth $20 million.

Semler’s lawsuit alleges violations of its Fifth Amendment right to due process, as well as intentional infliction of financial distress under the Federal Tort Claims Act, among other things.

The case is Semler Research Center Pvt. Ltd. v. U.S. Food and Drug Administration et al., case number 2:18-cv-00534, in the U.S. District Court for the Central District of California.

Netherlands Adopts US FDA-based UDI System for Medical Devices

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system.

According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceability of medical devices, and industry promised to place only UDI codes on device labels. According to the Emergo post, this means that every manufacturer that wants their devices used in Dutch hospitals now needs to provide UDI codes on those devices.

An article from Securing Industry cites to the the Dutch Ministry of Health as saying that the decision to use the FDA’s UDI system was made to avoid adding complexity for manufacturers by requiring a separate system. According to the article, the Netherlands is the first in the EU to adopt the FDA’s UDI system, a decision that some believe may increase the chances of the UDI system being adopted elsewhere in the region.

In 2013, the US published the rule requiring UDI codes to be assigned by device manufacturers to each version or model of a device. Under the published rule, the codes must be in both human and machine readable formats. According to the FDA, implementation of UDI codes improves patient safety, modernizes device postmarket surveillance, and facilitates medical device innovation.

 

 

Strategic Partnership Announced between BioSig Technologies and Mayo Clinic

Strategic Partnership Announced between BioSig Technologies and Mayo Clinic

BioSig Technologies recently announced a ten-year strategic agreement with Mayo Clinic and Mayo Clinic Ventures. According to the press release, the agreement aims to advance clinical features of BioSig’s PURE EP System, which BioSig describes as a novel platform designed to obtain and display important clinical data during procedures that test the electrical activity of the heart, through close collaboration with leading Mayo electrophysiologists.  BioSig intends the collaboration to result in the development of future technologies.

Speaking of the agreement, Greg Cash, President and CEO of BioSig Technologies commented:

“Adding innovation and intellectual property to the equation should raise this collaboration to a whole new level, likely resulting in better diagnosis and treatment of complex arrhythmias in many patients.”

BioSig Technologies describes itself as a Minneapolis-based medical device company developing a platform for cardiac electrophysiology.  According to Yahoo! Finance, BioSig is publically traded over-the-counter and has a current market cap of about $36 million.

Mayo Clinic describes itself as a nonprofit organization committed to clinical practice, education, and research.