Abstract
SCOTUS REJECTS ROUNDUP CANCER LAWSUIT
In a 7-2 decision that—oddly enough for the present Supreme Court of the United States (SCOTUS) did not break down along ideological or political lines—the nation’s high court overturned a $1.25 mm jury award in favor of a gardener who claimed that Bayer’s 1 Roundup weedkiller gave him the blood cancer non-Hodgkin lymphoma. The Supreme Court’s decision did not address the underlying science—that is, whether or not Roundup can cause cancer—but rather turned on pesticide labeling law and federal preemption.
Plaintiff John Durnell’s position, which had been accepted by a Missouri trial court, was that Roundup’s manufacturer (Bayer) was liable because it failed to warn users about the risk of developing non-Hodgkin lymphoma. Bayer’s defense, on the other hand, was that it legally couldn’t put a cancer warning on its pesticide. Bayer’s reasoning was that pesticide labels and their contents are strictly regulated by federal law, 2 which prescribes exactly what they have to and may say. The U.S. Environmental Protection Agency (EPA), the agency examining the pesticide’s safety, determined that it believed that Roundup and its active ingredient (glyphosate) were safe “when . . . used in accordance with its current label” and were “unlikely” to cause cancer in humans. Accordingly, the agency concluded, no cancer warning was required. Bayer argued that once the EPA found the label did not require a cancer warning, it was barred by law from unilaterally changing the label and adding such a warning. Therefore, Bayer could not be liable for not putting a cancer warning on its product when under federal law—which preempts state law—it was not allowed to add such a warning.
SCOTUS agreed with that position. The court’s position, written by Justice Brett M. Kavanaugh, found that the plaintiff could only have prevailed if a cancer warning were required on the Roundup label, which would, however, directly conflict with federal law. Therefore, since federal law preempts, there could be no liability. The ruling has significant implications for the thousands of Roundup suits pending in the United States in both state and federal court and represents a huge win for Bayer.
United States FOOD & DRUG ADMINISTRATION CITES DEFICIENCIES AT INDIAN BIOLOGICS PLANT
Dr. Reddy’s Laboratories Ltd. is a multinational Indian pharmaceutical company headquartered in the city of Hyderabad. The United States Food & Drug Administration (FDA) conducted an inspection of Dr. Reddy’s Hyderabad biologics plant in June 2026 and found a number of deficiencies, citing the plant with seven issues observed during the on-site visit. Without identifying the deficiencies with which it had been cited, Dr. Reddy’s stated that it will address them all within the stipulated time frame. These deficiencies follow the five manufacturing deficiencies found by FDA at the same plant a little less than three years ago, in October 2023, and, according to a filing by Dr. Reddy’s on the Bombay Stock Exchange, are a “continuation of the earlier inspections and corresponding disclosures.”
Dr. Reddy’s is no stranger to being cited for deficiencies by FDA. For example, its Bachupally research and development campus had three deficiencies flagged after an inspection in December 2023. FDA had observed deficient record-keeping procedures, poor employee training, and weak technical control procedures for reviewing technical data. That same year, another Dr. Reddy’s plant, in Pydibhimavaram, was cited for four quality control deficiencies, including a lack of proper testing. 2024 also saw the company’s Visakhapatnam formulation manufacturing facility cited with two observed deficiencies.
HEALTH & HUMAN SERVICES AND FOOD & DRUG ADMINISTRATION PROPOSAL TO SPEED CLINICAL TRIALS
The U.S. FDA, part of the Department of Health & Human Services (HHS) is in the process of seeking comments on a pilot program designed to speed clinical drug trials. Under the proposed program, drug sponsors will be able to collaborate with qualified external institutions to develop and review protocols for the critical first-in-human (FIH) clinical trials for investigational new drug (IND) submissions. FDA is also issuing draft guidance 3 to clarify when drug developers can rely on a single rigorous, adequate, and well-controlled clinical trial, supported by additional confirmatory evidence, in seeking drug approvals.
Both of these initiatives (the pilot program and the clinical trial guidance) were announced in June as part of HHS’s “Operation Trailblazer,” a multifaceted effort to speed up drug development from the early IND stage through late-stage clinical trials. The goal is to shorten the drug-development timeline, particularly with an eye toward keeping drug development in the United States and stemming the hemorrhaging of it to China. HHS Secretary Robert Kennedy Jr. stated, in discussing the new initiatives, that “America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas . . . [U]nder President Trump’s leadership, HHS is launching a coordinated department-wide effort to restore America’s leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the United States.” He went on to state that “America led the world in medical innovation before . . .[w]e will lead again.”
The new pilot program contemplates pharmaceutical companies partnering with qualified research institutions, such as academic medical centers or contract research organizations, in developing Phase I IND submissions for FIH clinical trials. They would use a rolling submissions platform, and the goal would be to minimize the need for clinical holds and their attendant delays.
UNITED STATES BIOFUEL PRODUCTION DRIVING SOYBEAN DEMAND
What a difference a Presidential Administration makes. According to Devin Mogler, President and CEO of the National Oilseed Processors Association, “Three or four years ago, we are exporting over 60% of our whole soybeans, most of which were going to China. We’re on pace this year, according to the USDA, 4 to crush over 62% of all soybeans grown in the U.S. right here at home.”
What’s changed? Two things. First, the imposition of tariffs by the Trump Administration, which has triggered retaliatory tariffs and cancelations of (or reductions in) orders by some other nations, such as China. The tit-for-tat trade war with China has reduced that nation’s orders for U.S. soybeans.
Second, higher U.S. biodiesel blend levels announced by the EPA this year, which has spiked domestic demand for soybeans and certain other crops as biofuel feedstock. According to Mogler, “Just a few years ago, the value of the oil a soybean, which is about 20% of the bean, it was about 30% of the value . . . [but] [i]t’s now 50% or more of the value,” due to the heightened biodiesel demand. Mogler went on to state that the enhanced biofuel demand is growing rural economies in soybean-growing regions as well as spurring the expansion or construction of new soybean processing plants.