Justia Drugs & Biotech Opinion SummariesArticles Posted in Drugs & Biotech
Bridges v. Blackstone, Inc.
Bridges and Cunningham filed a putative class action, alleging that Blackstone (the owner of Ancestry.com) violated Section 30 of Illinois’s 1998 Genetic Information Privacy Act, which provides that no person or company “may disclose or be compelled to disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test,” 410 ILCS 513/30(a). Both plaintiffs had purchased DNA testing products from Ancestry and submitted saliva samples for genetic sequencing years earlier. Blackstone subsequently purchased Ancestry in a “control acquisition”— an all-stock transaction. Because Ancestry had allegedly paired the plaintiffs’ genetic tests with personally identifiable information—including names, emails, and home addresses—Bridges and Cunningham maintained that Blackstone, as part of acquiring Ancestry, had compelled the disclosure of their genetic identities in violation of Section 30.The Seventh Circuit affirmed the dismissal of the suit for failure to state a claim. The complaint focusing exclusively on Blackstone’s acquisition of Ancestry did not adequately allege any compulsory disclosure. View "Bridges v. Blackstone, Inc." on Justia Law
Onglyza Product Cases
In 2008, as part of the defendants’ application for approval of Onglyza and Kombiglyze XR, two diabetes drugs with saxagliptin as the active ingredient, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee required that defendant AstraZeneca perform a cardiovascular outcomes study. “SAVOR” was a randomized, double-blind, placebo-controlled study that consisted of 16,492 patients with type 2 diabetes who were at high risk of cardiovascular disease. The study concluded that saxagliptin did not increase or decrease the risk of these occurrences but noted a higher risk of hospitalization. Following SAVOR, the FDA required warning labels for medications containing saxagliptin, referring to the potential increased risk of heart failure. Researchers conducted additional studies and did not find an association between saxagliptin and an increased risk of hospitalization for heart failure.Patients who took drugs with saxagliptin filed approximately 250 related cases. Most of these cases were filed in federal court and consolidated into federal multidistrict litigation. A Judicial Council coordination proceeding (JCCP) was established for the California state court cases. The court of appeal affirmed summary judgment in favor of the defendants. The court upheld the exclusion of the plaintiffs’ general causation expert, who opined that saxagliptin can cause heart failure. View "Onglyza Product Cases" on Justia Law
Amgen Inc. v. Sandoz Inc.
Amgen produces apremilast and markets it as a phosphodiesterase-4 (PDE4) inhibitor, which is used for treating psoriasis and related conditions, under the brand name Otezla®. The 638, 101, and 541 patents cover Otezla. Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of apremilast. Amgen’s predecessor brought a Hatch-Waxman suit, asserting that Sandoz’s generic product would infringe the patents.The Federal Circuit affirmed holdings that claims 3 and 6 of Amgen’s 638 patent and claims 1 and 15 of Amgen’s 101 patent had not been shown to be invalid as obvious and that claims 2, 19, and 21 of its 541 patent”) were shown to be invalid as obvious in light of prior art. The court noted that varying a dose in response to the occurrence of side effects is a well-known, standard medical practice that may well lead to a finding of obviousness. View "Amgen Inc. v. Sandoz Inc." on Justia Law
KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC.
The Butter! Spray is a butter-flavored vegetable oil dispensed in pump-action squirt bottles with a spray mechanism. The front label on the product states that the Butter! Spray has 0 calories and 0 grams of fat per serving. Plaintiffs are a class of consumers who brought their lawsuit against the then-manufacturer, Unilever United States, Inc., contending that the product’s label makes misrepresentations about fat and calorie content based on artificially low serving sizes. The district court found that Plaintiffs failed to plausibly allege that Butter! Spray was not a “spray type” fat or oil under Food and Drug Administration (FDA) regulations. The district court further held that the FDCA preempted plaintiffs’ serving size claims. The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. The panel held that, as a matter of legal classification, Butter! Spray was a “spray.” In common parlance, a “spray” refers to liquid dispensed in the form of droplets, emitted from a mechanism that allows the product to be applied in that manner. In addition, the notion that Butter! Spray could be housed under the FDA’s legal classification for “butter” is implausible. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that because Plaintiffs’ challenge to the Butter! Spray serving sizes would “directly or indirectly establish” a requirement for food labeling that is “not identical” to federal requirements, the FDCA preempts their serving size claims. View "KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC." on Justia Law
Alliance Hippocratic Medicine v. FDA
The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement. Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions. The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law
UCB, Inc. v. Actavis Laboratories UT, Inc.
Rotigotine is used to treat Parkinson’s disease, which causes difficulty swallowing and slow transit times through intestines, which can frustrate oral treatments. Transdermal therapeutic systems deliver drugs through the patient’s skin and avoid those complications. In 2007, UCB invented and marketed Neupro®, the first FDA-approved patch treatment for Parkinson’s disease. Original Neupro® is covered by several UCB patents, including the Muller patents, which claim priority to an application filed in 1999. The Muller patents are listed in the FDA’s “Orange Book,” as covering reformulated Neupro®.In 2013, Actavis submitted an Abbreviated New Drug Application (ANDA) for FDA approval of a generic transdermal rotigotine patch. UCB sued for infringement. The district court granted UCB an injunction preventing approval of Actavis’s ANDA until March 2021, when the Muller patent expired. In 2018 UCB filed the patent application that matured into the 589 patent, claiming priority from a provisional application filed in 2009, entitled “Polyvinylpyrrolidone for the Stabilization of a Solid Dispersion of the Non-Crystalline Form of Rotigotine.” UCB again filed suit, asserting the 589 patent, to delay FDA approval of a generic for nine additional years.The district court found that the Muller patents anticipate all asserted claims and that the asserted claims would have been obvious in view of multiple prior art references, including the Muller patents. The Federal Circuit affirmed the judgment of invalidity of the 589 patent. The district court’s fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous, View "UCB, Inc. v. Actavis Laboratories UT, Inc." on Justia Law
Merck & Co., Inc. v. Bayer AG
In 2014, Merck and Bayer entered a Stock and Asset Purchase Agreement (SAPA) whereby Merck sold, and Bayer purchased, Merck’s consumer care business and consumer care product lines, including the Claritin, Coppertone, Dr. Scholl’s, and Lotrimin foot powder product lines. The transaction closed in October 2014. Bayer paid Merck more than $14 billion. After the transaction closed, both companies were the subject of lawsuits alleging injuries arising from consumers’ use of talc-based products that Merck used in foot powder product lines sold to Bayer; asbestos allegedly contained in talcum powder has caused fatal cancers.The Delaware Court of Chancery dismissed Merck’s suit in which it argued that Bayer breached the SAPA by refusing to assume liability for the claims. Both companies, as sophisticated participants in the pharmaceutical industry, understood that consumer products businesses face potential liability for torts associated with the sale of such consumer products. The SAPA clearly and unambiguously provides that Merck indefinitely retained substantive liability for the product liability claims related to products sold before the transaction closed. Merck attempted to argue that its liability for the product liability claims ceased in 2021; the court found that interpretation contrary to the SAPA's clear and unambiguous terms. Bayer’s interpretation of the SAPA is the only reasonable one. View "Merck & Co., Inc. v. Bayer AG" on Justia Law
Pacira Biosciences Inc v. American Society of Anesthesiologists Inc
Liposomal bupivacaine is a nonopioid pain medication that Pacira manufactures under the name EXPAREL; it is a local anesthetic administered at the time of surgery to control post-surgical pain. As of 2020, EXPAREL sales represented nearly all of Pacira’s total revenue. Pacira complains that the defendants, the American Society of Anesthesiologists, its journal, its editor, and authors published statements in a variety of forms, conveying their view that EXPAREL is “not superior” to standard analgesics or provides “inferior” pain relief.The Third Circuit affirmed the dismissal of Pacira’s suit for trade libel. Opinion statements are generally nonactionable. A “fair and natural” reading of the statements at issue shows that these are nonactionable subjective expressions. Pacira’s allegations boil down to disagreements about the reliability of the methodology and data underlying the statements; “a scientific conclusion based on nonfraudulent data in an academic publication is not a ‘fact’ that can be proven false through litigation.” Pacira failed to identify any aspect of the Articles, a Continuing Medical Education program, or a Podcast that “bring their conclusions outside the protected realm of scientific opinion.” View "Pacira Biosciences Inc v. American Society of Anesthesiologists Inc" on Justia Law
Osage Creek Cultivation, LLC v. Ark. Dep’t of Finance & Administration
The Supreme Court affirmed the order of the circuit court dismissing Appellants' complaint alleging that the Arkansas Medical Marijuana Commission had granted a marijuana cultivation license to a corporate entity that had been dissolved, holding that the circuit court correctly dismissed this appeal on the merits.Appellants, existing cultivation license holders, challenged the Commission's decision to allegedly grant a license to a dissolved corporate entity, arguing that the circuit court erred by holding that it lacked subject-matter jurisdiction and wrongly held that Appellants lacked standing. The Supreme Court reversed, holding that the circuit court (1) erred by not finding that it lacked subject-matter jurisdiction and that Appellants lacked standing; but (2) properly dismissed the complaint because it failed to allege facts sufficient to mount the State's sovereign immunity defense. View "Osage Creek Cultivation, LLC v. Ark. Dep't of Finance & Administration" on Justia Law
State v. Bristol-Myers Squibb Co.
The Supreme Court affirmed in part, reversed in part and vacated in part the judgment of the circuit court holding that Bristol-Myers Squibb and Sanofi had violated Hawai'i's Unfair or Deceptive Acts or Practices law (UDAP) by misleading the public about the safety and efficacy of their anitplatelet drug, Plavix, holding that remand was required.The circuit court concluded that Defendants misled Hawai'i consumers by failing to warn them that Plavix was less effective for poor responders, granted the State's motion for partial summary judgment, and imposed an $834 million penalty. The Supreme Court (1) reversed the circuit court's deceptive acts or practices holding, holding that the summary judgment ruling circumscribed Defendants' ability to present a full defense and affected the penalty award, requiring a new trial; (2) affirmed the holding that Defendants committed unfair acts under UDAP; and (3) held that Defendants' procedural arguments failed. View "State v. Bristol-Myers Squibb Co." on Justia Law