Pharmaceutical/Medical Device

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 MicroRNA Therapy Delivers Positive Result in Early Mesothelioma Treatment Test

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 are typically more complex than conventional pharmaceutical drugs. Continue Reading FDA Issues Final Guidance on Biosimilars

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 action is created by statute and therefore must be read as written.  The two statutes at issue, the Wrongful Death Act (740 ILCS 180/2) and the statute of limitations for actions against physicians (735 ILCS 5/13-212(a)), both use the date of death as the determinative date for the accrual of a cause of action.  Because the Moon case was a medical malpractice case, the specific statute related to claims brought against hospitals or physicians applied rather than the general two-year statute for personal injuries. Continue Reading Illinois Court Adopts Bright Line Rule for Statute of Limitations in Wrongful Death Suit

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 “amphetamine-like” qualities. A recently published study led by Dr. Pieter Cohen of Harvard Medical School found BMPEA in eleven supplements on the shelves at various vitamin or supplement stores.

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

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 decision Pliva v. Mensing. Continue Reading Supreme Court Declines to Weigh in on Generic Preemption

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 bulk over the internet.  According to Laura MacCleery, an attorney with the Center for Science in the Public Interest, a consumer rights advocacy group, powdered caffeine is the most dangerous dietary supplement on the market.  The FDA reports that symptoms of caffeine overdose can include “rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity.” Continue Reading Lawsuits Fuel Debate About Powdered Caffeine

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 held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.
Continue Reading FDA Reopens Comment Period for Drug Labeling Rule

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 February 19, 2015 and updated on February 23rd.  The communication includes a summary and scope of the problem, as well as recommendations for facilities and staff that reprocess ERCP duodenoscopes.  While the intended audience of the safety communication is health care providers (gastroenterologists, surgeons, nurses, health care facility staff) and patients, the alert underscores the importance of the design, warnings and instruction manuals for these devices. Continue Reading The FDA Warns Common Medical Device May Spread “Super Bugs”

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 with FDA’s “good guidance practices” regulation (21 CFR 10.115) and will, when finalized, “represent the Agency’s current thinking on the development of drugs for the treatment of alcoholism and appropriate endpoints for clinical trials of drugs to treat alcoholism.”  The guidance “does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”

For years, abstinence from any alcohol consumption has been the common goal of clinical trials to develop drugs to treat alcoholism.  According to the FDA, however, abstinence has been considered an “unattainable threshold” and “a hindrance to clinical development for drugs to treat alcoholism.”  The FDA’s new draft guidance, entitled Alcoholism:  Developing Drugs for Treatment Guidance for Industry, recognizes that other outcomes besides sobriety (called “surrogate endpoints”) may still be effective at treating alcoholism.  Thus, the draft guidance provides that drugs to treat alcoholism may be approved if they are clinically proven to help patients:

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

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 in causing a majority of cancers.  The article, “Variation in cancer risk among tissues can be explained by the number of stem cell divisions,” was published in the 2 January 2015 edition of Science.  The study has caused quite a stir (see e.g., NY Times, CBS News, and 2020 Science blog) by suggesting that the majority of cancers are caused by normal cellular processes and cannot necessarily be “blamed” on something, or someone. Continue Reading New Study Suggests Need For Rethinking Cancer Causation