The United States Supreme Court will soon consider whether the due process clause of the Fourteenth Amendment prohibits a state from requiring that a corporation consent to personal jurisdiction in order to conduct business...more
On April 4, 2022, the U.S. Supreme Court decided Thompson v. Clark, No. 20-659, holding that a plaintiff who brings a Fourth Amendment claim under 42 U.S.C. § 1983 for malicious prosecution must show that the underlying...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
On February 24, 2022, the Supreme Court decided Unicolors, Inc. v. H&M Hennes & Mauritz, L.P., No. 20-915, holding that an inadvertent mistake of law in a copyright registration applicant’s application does not render the...more
As we ring in the new year, it is time, once again, to reflect on the most significant legal developments for our drug and device clients this year. Below is a brief recap and assessment of our top-five developments impacting...more
A recent Pennsylvania Supreme Court opinion provides out-of-state corporations more protection from litigation tourists, bringing the state’s general personal jurisdiction rules in line with U.S. Supreme Court precedent. In...more
The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more
12/9/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight ,
Regulatory Standards
The global pandemic has accelerated the Food and Drug Administration’s (FDA) encouragement of real-world data (RWD) and real-world evidence (RWE) (the clinical evidence derived from analysis of RWD), particularly as the FDA...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more
11/4/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more
A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe...more
On March 25, the U.S. Supreme Court decided Ford Motor Co. v. Montana Eighth Judicial District Court, revisiting the issue of due process limitations on the exercise of personal jurisdiction, most recently addressed by the...more
On March 25, 2021, the U.S. Supreme Court decided Ford Motor Co. v. Montana Eighth Judicial District Court, holding that a state’s courts can exercise specific personal jurisdiction over a manufacturer in a product liability...more
On March 4, 2021, the U.S. Supreme Court decided Pereida v. Wilkinson, holding that noncitizens who seek to cancel a lawful removal order have the burden of proving they have not been convicted of a disqualifying crime, even...more
Practicing law at a socially appropriate distance has forced many litigators to broadly consider the value of face-to-face interaction—and what may be lost in its absence. A recent Pennsylvania Supreme Court opinion...more
5/18/2020
/ Appeals ,
Appellate Record ,
Bias ,
Impartiality ,
Judges ,
Jury Selection ,
Jury Trial ,
Local Rules ,
Motion To Strike ,
PA Supreme Court ,
Peremptory Challenges ,
Reversal ,
Right to a Fair Trial ,
Right to a Jury ,
Standing Objections ,
Trial Attorneys ,
Trial Practice Guidance ,
Voir Dire ,
Waivers
As companies continue to produce, modify, and/or distribute essential medical equipment and supplies to support efforts to fight the COVID-19 outbreak, questions about whether these companies may be subject to liability...more
“In the age of COVID-19 and other public health challenges, supply levels in the medical industry occupy a prominent place in our national consciousness,” an Illinois federal judge noted earlier this month while dismissing a...more
The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more
The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
9/26/2019
/ Data Collection ,
FDA Approval ,
FDA De Novo Clearance ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Patient Access ,
Premarket Approval Applications ,
Transparency
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more
Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions, and multidistrict litigation. Most of this scrutiny has focused on...more
6/11/2019
/ Anti-Assignment Clauses ,
Appeals ,
Class Action ,
Class Members ,
Commercial Loans ,
Disclosure Requirements ,
Federal Rules of Civil Procedure ,
Litigation Fees & Costs ,
Litigation Funding ,
Mass Tort Litigation ,
Multidistrict Litigation ,
NFL ,
Null and Void ,
Reversal ,
Rules of Practice ,
Settlement Agreements ,
Third Party Funding