Justia Drugs & Biotech Opinion Summaries

Plaintiff filed suit against Novartis, manufacturer of Zometa, alleging products liability, negligent manufacture, negligent failure to warn, breach of express and implied warranty, and loss of consortium. On appeal, plaintiff contended that the district court erred by excluding the causation testimony offered by her expert when it found the testimony to be irrelevant and unreliable. The court concluded that the expert's testimony was relevant because it indicated that plaintiff's bisphosphonate use was a substantial factor in her development of bisphosphonate-related osteonecrosis of the jaw. The court also concluded that the expert's testimony was reliable where he used a differential diagnosis grounded in significant clinical experience and examination of medical records and literature. Accordingly, the court concluded that the expert's testimony created a genuine issue of material fact regarding the specific causal link between plaintiff's bisphosphonates treatment and her development of osteonecrosis of the jaw. The court reversed the district court's summary judgment in favor of Novartis and remanded. View "Messick v. Novartis Pharmaceuticals Corp." on Justia Law

Plaintiff, after being diagnosed with tardive dyskinesia (TD), filed suit against Lilly, manufacturer of the antipsychotic drug, Zyprexa, alleging personal injury and product liability claims. The district court concluded that Lilly adequately warned plaintiff's treating and prescribing physicians of the risk of developing movement disorders like TD. On appeal, plaintiff argued, inter alia, that the district court erred in excluding his expert opinion testimony that 15% of Zyprexa users will develop TD after three years of use. The court concluded that the district court was well within its substantial discretion to conclude that plaintiff had not provided sufficient scientific support for the opinion and to exclude the opinion. The court also concluded that the district court properly applied the learned intermediary doctrine in dismissing the failure-to-warn claim. Finally, assuming Arkansas law recognized an overpromotion exception, the exception would not apply in this case because plaintiff presented no evidence that any representation by a salesperson affected a prescribing doctor's decision to continue plaintiff on Zyprexa and because there was no reliable evidence that Zyprexa had significantly more risk of movement disorders than the drug reps allegedly said it had. Accordingly, the court affirmed the district court's dismissal of plaintiff's complaint. View "Boehm v. Eli Lilly & Co." on Justia Law

Pauline and her doctors were aware of Pauline’s allergy to heparin, an anti-coagulant; she wore a medical bracelet listing her heparin allergy and her medical records noted the allergy. Her estate alleges that on several occasions, the hospital’s medical staff injected Pauline with heparin “in direct contradiction to her specific directive,” which proximately caused her death. The district court dismissed, for failure to comply with the notice and heightened pleading requirements of the Tennessee Medical Malpractice Act. The court concluded that under Tennessee law the injections were not “procedures” or “treatments” for the purposes of medical battery, but were only component parts of her treatment process, which did not require consent and could form the basis for medical malpractice but not medical battery. The Sixth Circuit reversed, holding that the complaint plausibly alleged medical battery, which is not subject to the Act. View "Shuler v. Garrett" on Justia Law

Shirley Gross filed suit against PLIVA after her long-term use of the generic drug metoclopramide, produced by PLIVA, caused her permanent injuries. On appeal, plaintiff, as the personal representative of the estate of Gross, challenged the district court's denial of Gross's request to amend her complaint and her state common law tort claims against PLIVA for injuries sustained as a result of her use of a drug it manufactured. Federal Food, Drug, and Cosmetics Act, 21 U.S.C. 301 et seq. The court affirmed the district court's denial of leave to amend and held that none of plaintiff's claims regarding PLIVA's alleged failure to update its warnings were before the court on appeal; the court found that the complaint did not allege any violation of the federal misbranding laws or parallel state duties, and to the extent these claims were made on appeal, they were waived; and all of Gross's causes of action were preempted by the FDCA. Accordingly, the court affirmed the judgment of the district court. View "Drager v. PLIVA USA, Inc." on Justia Law

Mylan manufactures generic Duragesic, a drug to treat pain. It consists of fentanyl (active ingredient) and a “transdermal system” (patch that delivers the drug). Kelly’s estate claimed that the patch caused Kelly’s death by delivering an excessive amount of fentanyl, alleging strict products liability, negligence, misrepresentation, fraud, warranty, and violation of the Michigan Consumer Protection Act. The district court dismissed, based on Mich. Comp. Laws 600.2946(5), which provides that “drug” manufacturers are immune from suit. The Sixth Circuit reversed and remanded. Michigan defines “drug” using the federal definition, 21 U.S.C. 321: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). Michigan’s definition provides that a “drug” is not a “medical appliance or device.” Immunity might not apply to a product, like the patch, that has mechanical (rather than chemical) effect on the body. Under the federal definition a product might be neither “drug” nor “device” but a “combination product.” Whether a combination product is regulated as a drug or a device is left to the Secretary’s discretion. View "Miller v. Mylan, Inc." on Justia Law

Plaintiff filed a complaint seeking damages and injunctive relief, alleging that defendants violated, inter alia, the Lanham Act, 15 U.S.C. 1125(a)(1), and New York General Business Law 349 when defendants published a scientific article reporting research results related to plaintiff's production of surfactants. The court concluded that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate could not give rise to liability for damages sounding in defamation. The court also concluded that the secondary distribution of excerpts of such an article could not give rise to liability, so long as the excerpts did not mislead a reader about the conclusions of the article. Therefore, the district court correctly concluded that plaintiff failed to state a claim based on publication of the article itself because the challenged statements were protected scientific opinion and plaintiff failed to adequately allege that defendants Chiesi and Cornerstone distributed misleading excerpts of the article. Accordingly, the court affirmed the judgment.View "ONY, Inc. v. Cornerstone Therapeutics, Inc." on Justia Law

Plaintiff brought claims of negligence, strict liability, breach of warranty, misrepresentation and fraud, and negligence per se against defendants, alleging that she developed tardive dyskinesia after taking generic metoclopramide manufactured by Defendant Teva for a period of greater than 12 weeks, contrary to administrative guidance issued by the FDA. The court affirmed the district court's dismissal of plaintiff's claims against Teva as preempted by federal law and because, preemption aside, the learned intermediary doctrine prevented her from stating a claim upon which relief could be granted under Florida law; affirmed the district court's grant of summary judgment in favor of Defendant Brand Manufacturers because Florida law did not permit an injured consumer to recover from the brand manufacturer of a prescription drug if the consumer is known to have ingested only the generic form of that drug; and noted that, insofar as plaintiff sought redress for her injuries, such redress lies with Congress or the Florida legislature. Accordingly, the court affirmed the judgment.View "Guarino v. Wyeth, et al." on Justia Law

Plaintiff filed suit against Novartis alleging that Novartis negligently failed to provide adequate warnings for two drugs she took, Aredia and Zometa, after having two of her teeth extracted. Plaintiff developed osteonecrosis of the jaw (ONJ) after the extraction. Plaintiff was awarded $225,000 in compensatory damages and Novartis appealed. The court concluded that a jury could reasonably find that plaintiff's injury was the natural and probable consequence of Novartis's behavior and rejected Novartis's arguement that plaintiff did not establish that her injuries were proximately caused by inadequate warnings; the district court did not err in applying Missouri law where Missouri had the most significant relationship to the punitive damages claim; and Novartis correctly reasoned that the MedWatch checkmarks were inadmissible hearsay, out-of-court assertions offered for their truth but Novartis failed to demonstrate the prejudice required for a new trial. The court concluded, however, that the district court abused its discretion in awarding plaintiff full costs for depositions conducted as part of multi-district litigation. Accordingly, the court affirmed in Case No. 12-3121 and vacated in Case No. 12-3409. View "Winter v. Novartis Pharmaceuticals Corp." on Justia Law

OMJP appealed from the district court's denial of its motion for relief from judgment under Federal Rule of Civil Procedure 60(b)(2) and (3). In Levaquin I, the court upheld a jury award in compensatory damages against OMJP for Achilles tendon injuries plaintiff suffered while taking OMJP's prescription antibiotic Levaquin. In this appeal, OMJP contended that the district court abused its discretion in denying OMJP relief under Rule (60)(b)(2) based on the delinquent and belated disclosure of an expert's calculation regarding the relative risk of Achilles tendon rupture to certain patients. The court concluded that the district court did not abuse its discretion in denying relief based on OMJP's claim of "newly discovered evidence" where the evidence was merely cumulative or impeaching and OMJP had not demonstrated that it was probable it would produce a different result. In regards to OMJP's misconduct claim under Rule 60(b)(3), the court concluded that the district court did not abuse its discretion in finding that the lack of the expert's calculation did not prevent OMJP from mounting a vigorous defense and that any misconduct did not warrant a new trial. Accordingly, the court affirmed the judgment of the district court. View "Schedin v. Ortho-McNeil-Janssen Pharmaceuticals" on Justia Law

Plaintiff alleged various causes of action against the maker of the generic drug (Pliva), brand defendants, and others after she was injured by the prescription medication metoclopramide. On appeal, plaintiff challenged the district court's grant of summary judgment in favor of brand defendants and dismissal of her claims against Pliva. The court denied plaintiff's motion to supplement the record, finding no compelling reason to allow plaintiff to do so; the district court did not err in determining plaintiff's claims against brand defendants failed as a matter of law because she stipulated that she had not ingested a product manufactured by brand defendants; reversed the district court's dismissal of plaintiff's non-warning design defect and breach of implied warranty claims and remanded for further consideration; and because there was no causal link between Pliva's failure to incorporate the 2004 labeling change and plaintiff's injury, the district court's dismissal of that claim was not error. Accordingly, the court affirmed in part, reversed in part, and remanded for further proceedings.View "Bell v. Pfizer, et al." on Justia Law