Michael D. Shalhoub
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A Farewell to 2020 and a Look Ahead at Life Sciences in 2021
What a year 2020 has been. The COVID-19 pandemic has been spewing death and economic destruction, and as scientists predicted, is now resurrecting itself in a second wave―just as it seemed there was light at the end of the tunnel. Now, we have news from the United Kingdom and elsewhere that the virus is mutating in a way that makes it more contagious. Yet, for the life sciences field, 2020 was a year of breathtaking achievement and innovation (e.g., ventilators, changes in standards of medical…HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures
The Department of Health and Human Services (HHS) recently issued Advisory Opinion 20-03 addressing vaccination-related issues and the Public Readiness and Emergency Preparedness (PREP) Act. The opinion is significant because we are moving toward approval of COVID-19 vaccines over the upcoming months. In its opinion, HSS believes that the PREP Act preempts state law in three specified circumstances to the extent that state law may be more stringent than activities authorized by the HHS secretary under the PREP Act. “Covered countermeasures” under the PREP Act…Should a Head-Spinning “Cure” and “Blessing From God” Abort Well-Established FDA Processes?
Whatever one’s political views, the COVID-19 diagnosis and treatment of the president, was certain to raise issues and questions. My original thoughts for this blog post were to discuss those. It is now focused on the potential effects and consequences due to the recovery of the president from his COVID-19 illness, if indeed that is what happened. As most people know, the president was given an investigational drug cocktail from Regeneron, an antiviral drug remdesivir, as well as steroids and perhaps other treatments unknown…FDA Warns: Hands Off for Some Sanitizers
The COVID-19 pandemic continues to raise a multitude of legal and practical issues in the midst of a terrible health crisis. The legal issues related to potential legal liability for actions during unprecedented public health crisis will continue to grow. This space has addressed product fraud issues, product immunity issues, immunity issues for reasonable actions taken in a time of incomplete, conflicting, and shifting information, nursing home issues, as well as concerns about whether efforts to prevent or treat the disease…Pennsylvania Supreme Court Reaffirms Fealty to Frye Standard
Although our nation and our courts are still very much in the midst of addressing the acute aspects and effects of the COVID-19 pandemic, there will come a time when our courts return to more “normal” operations. It is likely that this will coincide with an influx of new litigation relating to COVID-19 claims of many kinds, including, of course, personal injury and, tragically, wrongful death claims. For many of those claims, the use of experts and expert testimony to address issues of causation will…FDA’s Website a Worthwhile Source of Information
A trip through the FDA’s website is worth the time spent both for those heavily invested in the development of COVID-related diagnostic and treatment endeavors, and those with a causal interest. In this time of the politicization of response to the pandemic and reliance on traditional or social media for their spin (informed, or otherwise), it is worthwhile to either peruse or dissect FDA’s statements and guidance. Surely there is some PR in these materials, but they are the primary source for the content –…Mobile Medical Apps: To Be or Not to Be (Wellness or Medical)? That is the Question
The size of the mobile medical app market is massive. One report shows in 2017 the global market was $2.4 billion, with a forecast of $11 billion by 2025. The Apple App Store alone has more than 45,000 health apps. We believe that the COVID-19 crisis will accelerate that growth as the world has now become acclimated to the use of mobile technology for the provision and facilitation of health care and wellness. For years, FDA and industry grappled with the extent to which the…Legal Immunity and COVID-19–Controversy Continues
Earlier this month, we wrote about the looming debate over legal immunity against certain types of claims in lawsuits arising out of the COVID-19 crisis. On May 15, 2020, the New York Times published an opinion piece editorializing against the prospect of immunity from certain types of suits being contemplated by the Senate. Like many of the opponents of immunity, the Times fear-mongers, raises straw-man opposition, and is unmoored from the reality of what really happens in civil litigation, and will happen here. The headline…Legal Immunity and COVID-19 Recovery: Thorny Issues Abound
Want to start an argument? Start talking about COVID-19 immunity for people and companies. Anywhere in the nation. In Congress. In state legislatures and governor’s chambers. In hospitals and nursing homes. Indeed, even perhaps in your home. My goodness, people start talking past each other. Heartless companies who do not care about their customers or workers, they say. What? Greedy trial lawyers, they retort (no pun intended). Obviously, we are not talking here about viral (or herd) immunity, but legal immunity. Baby steps of limited…Medical and Scientific Literature is Crucial in COVID-19 Crisis
COVID-19 issues dominate the world. This post is being prepared remotely, and read by you remotely, because science dictated that to stop the spread of this terrible disease we needed to become isolated from each other. The tools to fight the virus, prevent its spread and treat the disease it causes for the most part will come from the life science sector. The tools have and will come from intuition, innovation and inspiration, and are based on quality science and medicine. We write from the…Eleventh Circuit Rejects Plaintiff’s Expert Evidence on Daubert Grounds
An important and interesting Daubert opinion was issued yesterday by the 11th Circuit which affirmed the trial court’s Daubert preclusion order against the plaintiff’s experts in litigation seeking to prove that the use of a denture adhesive causes neurological disease. The decision sets forth the infirmities in the plaintiffs’ expert evidence under Daubert standards. This blog post will be short and reportorial, rather than analytic, because the authors have worked extensively for the defense in the denture cream litigation, and on the Chapman case itself,…Keep Us Posted: FDA Updates Rules On Changes To Medical Devices
The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. To read the rest of this blog entry, authored by Jesse D. Rutter of Goldberg Segalla, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation.…First New York Court Rejects Controversial Drug Developer Liability Rule
In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…The Manufacturer Made Me Do It – One Claim By Negligent Surgeon Survives
California certainly breeds interesting cases. In the Chao case, available here, recently decided by a federal judge in the Southern District of California, the plaintiff was not an injured person. He was an orthopedic surgeon found to be negligent in his treatment of a patient by an arbitration panel, which awarded in excess of $2 million to the patient. The surgery was a hip replacement surgery during which the surgeon lacerated the patient’s femoral artery. Following the award, the orthopedic surgeon brought an indemnity action…D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments
The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado. In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here, a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…FDA e-Learning Course on Evaluating Drug Promotion
Off label promotion of drugs and devices is an issue that the FDA looks at very closely. Such off label promotion risks the product being viewed as misbranded which has significant regulatory and litigation risk. Companies and the lawyers that represent them in these kinds of cases are well aware of the importance of vigilance in preventing off label promotion. The FDA is now taking an educational role for consumers and health care providers. Together with Medscape, it is offering a continuing education course, intended…Congress to Codify FDA Recent Decision Not to Seek Enforcement of Low Risk Mobile Medical Apps
On September 25, the FDA released a guidance document related to Mobile Medical Applications (“MMAs”), which provided critical industry guidance as to which MMAs will be considered medical devices and subject to regulation by the FDA. On September 30 we reported on these new rules (click here) and on October 23 we also presented a webinar entitled “Mobile Medical Apps: FDA Regulation and Product Liability Implications” which was recorded and is available here. In particular, the FDA exercised its discretion not to enforce…Generic Drug Manufacturer Loses Battle on Preemption, But Wins War on Causation
Are state law claims against a generic drug manufacturer preempted where labeling of the generic drug differs from the brand name drug labeling? In a recent drug liability case decided in the federal district court in Arizona, the court said no and held that the plaintiff’s claims were not preempted. Nevertheless, the court concluded that the plaintiff’s physicians did not read or rely on the labeling and, therefore, Arizona law required dismissal of the plaintiff’s claim. The case is Carter v. APP Pharmaceuticals and can…Webinar: Mobile Medical Apps: FDA Regulation and Products Liability Implications
Sign up today for a free webinar on Mobile Medical Apps: FDA Regulation and Products Liability Implications The webinar will be held from 2-3 p.m. (EDT) Wednesday, October 23, 2013. Click here to register. This webinar will address:- An overview of the FDA’s final guidance on MMAs;
- Predictions for the level of oversight the FDA will exert over MMAs;
- How the traditional products liability theories of design defect, warning defect, and failure to warn, operate in the MMA context; and
- Ways in which creators of
New FDA Guidelines on Medical Device Mobile Apps
Scores of apps are available in the iTunes Store and the Android equivalent that are related to health and well being. This past week FDA issued a guidance (FDA Guidance for Mobile Apps) for Mobile Medical Applications which provides critical and much needed guidelines for industry as to which mobile medical apps are and are not going to be regulated by FDA as a medical device. Last Thursday the FDA also engaged in a Twitter chat meeting for a question and answer session…Court Refuses to Scrutinize the Sufficiency of Differential Diagnosis Analysis and Permits Causation Testimony in Absence of Controlled Studies
This past week, an Ohio federal court considered under Daubert the standard by which specific causation experts in drug and device cases are to be scrutinized. While the Court precluded the opinions of certain experts who did not engage in a differential diagnosis analysis before forming specific causation opinions, it stopped short of precluding one expert who engaged in what was essentially an incomplete differential diagnosis analysis, concluding the sufficiency of the analysis goes to the weight of the evidence and not its reliability under…Diflucan May Be Related To Increased Risk of Congenital Heart Defects in Children
This week, the New England Journal of Medicine published Danish Researchers’ findings on whether low doses of Diflucan (a Pfizer medication) carry the same risk of birth defects that long term, high doses of the medication have seen, as referenced here. In August of 2011, the FDA changed the designation of high doses Diflucan from a Category C to a Category D pregnancy drug, which means that there is positive human evidence of a risk of birth defects and issued a drug safety communication about…Consumer Fraud Class Action Rejected – Proposed Class Representative Inappropriate
Being close buddies with your lawyer does not always pay off – for the lawyer or the buddy. In a case against Pharmavite alleging that the labeling of its Vitamin E products is false and misleading, a California federal judge rejected a proposed plaintiff’s class action representative based on a close personal relationship between the plaintiff and plaintiff’s counsel. The court analyzed three issues: 1.) whether there is a conflict-of-interest between the class, and the plaintiff and her lawyer-friend,2.) whether plaintiff and her lawyer-friend…