Category Archives: Pharmaceutical/Medical Device

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Who Won? The Verdict in the AndroGel Trial

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 … 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 … Continue Reading

Hacking Health Care: When Cybersecurity Can Mean Life or Death

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 … Continue Reading

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

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 … Continue Reading

More Publications Retracted Due to Suspected Fraud

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, … Continue Reading

FDA Approves First 3D Printed Pill

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, … Continue Reading

Scientific Articles and The Retraction Epidemic

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. … Continue Reading

MicroRNA Therapy Delivers Positive Result in Early Mesothelioma Treatment Test

Noting that the result is preliminary and must be evaluated in clinical trials, Australian researchers working with the Asbestos Disease Research Institute published a case report announcing significant improvement for a pleural mesothelioma patient treated with microRNA therapy.  The results were reported in the American Journal of Respiratory and Critical Care Medicine.… Continue Reading

FDA Issues Final Guidance on Biosimilars

Shortly after approving the first biosimilar under the abbreviated approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the FDA has recently issued 3 final guidances regarding biosimilars. Biological products, or “biologics,” are pharmaceutical products created from biological sources. Unlike chemically synthesized pharmaceuticals, biologics are isolated from natural sources, and … Continue Reading

Illinois Court Adopts Bright Line Rule for Statute of Limitations in Wrongful Death Suit

In Moon v. Rhode, 2015 IL App (3d) 130613, the Illinois Appellate Court announced a bright line rule: a wrongful death action against a physician must be brought within two years of the knowledge of the death, regardless of when the executor learned of an allegedly wrongful cause.  The Court noted that a wrongful death … Continue Reading

Bodybuilder Beware: Study Raises Concerns About Speed-Like Substance in Supplements

Whether you’re a bodybuilder trying to lose that last percentage of body fat or an average person looking to lose a few extra pounds, weight loss supplements can offer a quick fix. But a number of popular fat-burning weight loss supplements may contain the chemical known as Beta-methylphenylethylamine (BMPEA), a stimulant recently criticized for its … Continue Reading

Supreme Court Declines to Weigh in on Generic Preemption

The United States Supreme Court has decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground such claims were covered under the federal preemption memorialized in the 2011 U.S. Supreme Court … Continue Reading

Lawsuits Fuel Debate About Powdered Caffeine

Two recent deaths allegedly resulting from the use of powdered caffeine has led to litigation and a public alert from the FDA, warning consumers of the dangers of the substance. One teaspoon of powdered caffeine is roughly equivalent to 25 cups of coffee. The product is not available in stores, but can be purchased in … Continue Reading

FDA Reopens Comment Period for Drug Labeling Rule

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which … Continue Reading

The FDA Warns Common Medical Device May Spread “Super Bugs”

The Food and Drug Administration recently issued a “safety communication” warning that a common medical device used to perform procedures that over 500,000 Americans undergo annually, may put patients at risk for developing “super bug” infections.   The FDA communication, Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication, was issued on … Continue Reading

FDA Issues New Draft Guidance That May Ease Approval for Drugs to Treat Alcoholism

The FDA has issued new draft guidance that may make it easier for pharmaceutical companies to develop and market drugs to treat alcoholism.  The proposed guidance provides that the FDA may approve drugs that help patients improve their drinking behavior, even if the drugs do not help patients achieve complete sobriety.  The draft guidance is being issued consistent … Continue Reading

New Study Suggests Need For Rethinking Cancer Causation

According to a new study funded by the National Institutes of Health and published by Johns Hopkins University researchers, the majority of human cancers may be caused by the random genetic mutations that arise from normal DNA replication.  Put more bluntly, the research suggests that the “bad luck” of random mutations plays a predominant role … Continue Reading

New OSHA Rules Expose Companies to Higher Violation Fines

OSHA recently published a final regulation that requires manufacturers, distributors, importers, and employers to make changes to their Material Safety Data Sheets (SDS) pursuant to the Hazard Communication Standard (HCS) by June 2015. Failure to follow the new regulation may expose companies to OSHA fines up to $70,000 per violation, and to litigation from end … Continue Reading

Cigar Smoke Poses More Risk Than Previously Thought

A new FDA study finds that cigar smokers have higher levels of known or suspected carcinogens in their blood and urine than people who do not use tobacco products.  The study is significant because there have been few studies looking at the toxic constituents of cigar smoke and their intake in the body.  It has long … Continue Reading

Generic Pharmaceutical Litigation Continues Amid Preemption Uncertainty

Last week, the New Jersey Appellate Division added more uncertainty and unpredictability in generic pharmaceutical litigation when it allowed some failure to warn claims to proceed against generic providers of metoclopramide, a/k/a Reglan in the case of  In re: Reglan Litigation.   Most of plaintiffs’ claims were dismissed, but the Court allowed a claim based on an alleged failure to … Continue Reading

FDA Soliciting Comments on Regulatory Process For Drugs and Medical Devices

The Food and Drug Administration (FDA) wants to know your opinion.  More specifically, it wants to know how it can better regulate drugs and medical devices.  The Agency is creating a public forum for commentary on its activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. … Continue Reading
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