Pharmaceutical/Medical Device

Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference:  they typically cost a lot less. By FDA regulation, the two have the same active ingredients, dosage forms and strengths, and routes of administration.[1] And while federal law generally regulates pharmaceutical approval, states can regulate pharmaceutical distribution. Why is this significant? All states permit pharmacies to substitute generic drugs for the brand name equivalent, and some states require substitution in certain circumstances.[2] But a generic pharmaceutical company cannot change the brand company’s product label, so a person’s ability to sue a drug manufacturer is limited to the brand company who created the label.[3] Continue Reading Generically Speaking: Liability is Limited in Failure to Warn Claims

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually. Continue Reading New Legislation Gives More Time for Medical Device Reporting

A Chicago jury awarded a single plaintiff $150 million in punitive damages, finding that AbbVie, Inc. fraudulently misrepresented the safety risks of its drug used to treat low testosterone, AndroGel. But the jury also decided in AbbVie’s favor on the plaintiff’s strict liability and negligence claims—meaning that they determined that AndroGel did not cause the plaintiff’s alleged injury. As a result, the jury awarded no compensatory damages. Continue Reading Who Won? The Verdict in the AndroGel Trial

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring. Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring. Continue Reading Medical Device Manufacturers Face A Cybersecurity “Heartache”

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The interconnectivity between medical devices and clinical systems leaves wireless medical devices vulnerable to security breaches. Continue Reading Hacking Health Care: When Cybersecurity Can Mean Life or Death

Two partners from Schiff Hardin LLP’s Product Liability & Mass Torts Practice Group spoke about the future of mass tort litigation in the United States at the Lloyd’s Old Library in London on October 20, 2015.  Paul A. Scrudato and Edward Casmere discussed the state of mass tort litigation and its future with a group of London-based insurance professionals in the historic Old Library at Lloyds on Lime Street in London.  The topics included nanotechnology, pharmaceuticals and medical devices, e-cigarettes, wearable technology, and fracking.

Continue Reading Schiff Hardin Partners Present on the Future of Mass Tort Litigation at Lloyd’s Old Library in London

The string of retractions of published peer-reviewed medical and scientific articles due concerns about fraud or suspected fraud continues. This week a major publisher of scientific and medical articles has confirmed that it is retracting 64 articles from 10 of its subscription journals based on concerns that the peer review process was “compromised.”

The publisher, Springer, issued this statement: Continue Reading More Publications Retracted Due to Suspected Fraud

On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016.  Continue Reading FDA Approves First 3D Printed Pill

Warning: That scientific article you just read may be completely bogus. Scientific articles can be retracted for numerous reasons – errors in data, errors in calculation, plagiarism, duplication of publication, and fraud or suspected fraud. An unmistakable trend in the increase of retractions due to one of those categories has emerged, and it is disturbing. A 2012 Proceedings of the National Academy of Sciences (PNAS) article, “Misconduct accounts for the majority of retracted scientific publications,” found that the percentage of scientific articles retracted because of fraud has increased dramatically in the last 40 years.   Continue Reading Scientific Articles and The Retraction Epidemic