Justia Drugs & Biotech Opinion Summaries

Plaintiff filed a products liability suit against McNeil and its corporate parent, Johnson & Johnson, after he suffered a severe reaction after taking Motrin. The Court of Appeal held that the jury's verdict finding McNeil liable for negligent failure to warn must be reversed because it was fatally inconsistent with the verdict finding McNeil not liable for strict liability failure to warn; the negligent failure to warn special verdict was also defective because of the failure to include the necessary question whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger; the verdicts against McNeil for negligent and strict liability design defect, as well as against Johnson & Johnson for strict liability design defect, must be reversed, because the design defect claims were based on a theory—failure to sell dexibuprofen—that was impliedly preempted; the strict liability design defect verdicts must also be reversed because the jury found McNeil and Johnson & Johnson liable solely under the consumer expectation test, but that test did not apply when, as here, the question of design defect involved complex questions of feasibility, practicality, risk, and benefit beyond the common knowledge of jurors; and none of plaintiffs' design defect claims could be retried. View "Trejo v. Johnson & Johnson" on Justia Law

In multi-district litigation involving 315 product liability claims, plaintiffs alleged that Pfizer’s drug, Zoloft, a selective serotonin reuptake inhibitor (SSRI), caused cardiac birth defects. The Plaintiffs’ Steering Committee introduced several experts to establish causation. The testimony of each of these experts was excluded in whole or in part. In particular, Nicholas Jewell, Ph.D., a statistician, used the “Bradford Hill” criteria to analyze existing literature on the causal connection between Zoloft and birth defects. The district court conducted a Daubert hearing, excluded Jewell's testimony, and granted summary judgment to defendants, stating that Jewell: “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.” The Third Circuit affirmed, holding that the district court did not require replication of significant results to establish reliability, but merely made a factual finding that teratologists generally require replication of significant results, and this factual finding did not prevent it from considering other evidence of reliability. View "In Re: Zoloft t (Sertraline Hydrochloride) Products Liability Litigation" on Justia Law

The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud. They presented two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant; and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy. The district court rejected the Cervenys’ claims based on preemption. The Tenth Circuit held that the district court ruling was correct on the Cervenys’ first theory, because the undisputed evidence showed that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the Tenth Circuit found the district court did not explain why a state claim based on the FDA’s own proposed language would be preempted by federal law. The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted. View "Cerveny v. Aventis, Inc." on Justia Law

Hundreds of plaintiffs sued the drug manufacturer Merck, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary. The Third Circuit vacated. Preemption is an affirmative defense; Merck did not carry its burden to prove that it is entitled to that defense. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or to conclude that the odds of FDA rejection were less than highly probable. View "In Re: Fosamax Products Liability Litigation" on Justia Law

In July 2003, plaintiff Andrew McCarrell filed a products-liability action alleging that Hoffmann-La Roche, Inc. (Roche) had failed to provide adequate warnings about the risks and side effects associated with taking Accutane. Plaintiff timely filed this products-liability action within New Jersey's statute of limitations, but Alabama's limitations period had expired by the time of the filing. The issue is which state's statute of limitations applied under New Jersey s choice-of-law jurisprudence. Roche moved for summary judgment, citing Alabama's two-year statute of limitations. The trial court denied the motion, finding that the governmental-interest test set forth in "Gantes v. Kason Corp.," (145 N.J.478 (1996)), directed that New Jersey's statute of limitations governed the case. The jury found in favor of McCarrell on the failure-to-warn claim, but the Appellate Division reversed based on evidentiary issues. The Appellate Division approved the trial court's application of New Jersey's statute of limitations to the case, however, and the Court denied Roche's petition for certification. After a new trial, a jury found Roche liable for failure to warn, awarding McCarrell $25,159,530. Roche challenged the verdict on the ground that the governmental-interest test had been supplanted by the most-significant-relationship test of sections 146, 145, and 6 of the Second Restatement of Conflicts of Law and argued that, under this test, Alabama's statute of limitations applied. The trial court denied the challenge as untimely. An appellate panel expressly declined to apply section 142 of the Second Restatement, vacated the jury's verdict and award, dismissed McCarrell's complaint as untimely, and did not reach the remaining issues raised by Roche on appeal. McCarrell's petition for certification was granted. The Supreme Court reversed and reinstated the jury's verdict and award. Analysis under section 142 of the Second Restatement lead to the conclusion that New Jersey's statute of limitations was properly applied to this action. The matter was remanded to the Appellate Division for consideration of unaddressed issues remaining on appeal. View "McCarrell v. Hoffmann-La Roche, Inc." on Justia Law

In the 1990s, Stryker purchased a Pfizer subsidiary that made orthopedic products, including the “Uni-knee” artificial joint. It was later discovered that those devices were sterilized using gamma rays, which caused polyethylene to degrade. If implanted past their five-year shelf-life, the knees could fail. Expired Uni-Knees were implanted in patients. Stryker, facing individual product-liability claims and potentially liable to Pfizer, sought defense and indemnification under a $15 million XL “commercial umbrella” policy, and a TIG “excess liability” policy that kicked in after the umbrella policy was fully “exhausted.” XL denied coverage, arguing that the Uni-Knee claims were “known or suspected” before the inception of the policy. Stryker filed lawsuits against the insurers, then unilaterally settled its individual product-liability claims for $7.6 million. Stryker was adjudicated liable to Pfizer for $17.7 million. About 10 years later, the Sixth Circuit held that XL was obliged to provide coverage. XL paid out the Pfizer judgment first, exhausting coverage limits. TIG declined to pay the remaining $7.6 million, arguing that Stryker failed to obtain “written consent” at the time the settlements were made. Stryker claimed that the policy was latently ambiguous because XL satisfied the Pfizer judgment first, Stryker was forced to present its settlements to TIG years after they were made. The district court granted Stryker summary judgment. The Sixth Circuit reversed, finding the contract unambiguous in requiring consent. View "Stryker Corp. v. National Union Fire Insurance Co." on Justia Law

In 2001, BioEnterics obtained FDA approval for the Lap-Band, “designed to induce weight loss in severely obese patients by limiting food consumption" by creation of a small gastric pouch. The FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a postapproval study. BioEnterics's brochure states that surgeons planning laparoscopic placement must have specific experience, participate in a training program authorized by BioEnterics, be observed by “qualified personnel” during their first placements, have the equipment and experience necessary to complete the procedure via laparotomy if required, and report on their personal experiences using the device. In 2003, plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver; Lap-Band tubing became entangled with her small intestine. During surgery to remove the Lap-Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock, resulting in brain damage. More than nine years later, plaintiff filed suit. The court of appeal affirmed dismissal of her claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. View "Glennen v. Allergan, Inc." on Justia Law

Plaintiff was diagnosed with drug-induced lupus, allegedly a side effect from using Solodyn, a treatment for acne. Plaintiff sued Medicis Pharmaceutical Corporation, which manufactures and distributes Solodyn, alleging that Medicis knowingly represented and omitted material facts in connection with the sale or advertisement of Solodyn in violation of the Consumer Fraud Act (CFA). Plaintiff also alleged that Medicis failed to adequately warn her of the consequences of the long-term use of Solodyn. The superior court granted Medicis’s motion to dismiss. At issue on appeal was the learned intermediary doctrine (LID), under which a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the class of persons who may prescribe or administer the product. The Supreme Court reversed the superior court’s order dismissing Plaintiff’s complaint, holding (1) the LID does not prevent Plaintiff from suing Medicis; (2) Plaintiff alleged sufficient facts to survive Medicis’s motion to dismiss with regard to her products liability claim; and (3) the CFA applies to prescription pharmaceuticals, and therefore, Plaintiff alleged an actionable claim under the CFA. View "Watts v. Medicis Pharmaceutical Corp." on Justia Law

In 2004, Yates, 17 years old, was sexually active and was suffering from severe menstrual cramps. Smith, a licensed physician assistant, counseled Yates about various contraceptives, and the risks and benefits accompanying each. Yates admits that she was counseled concerning the risk of a stroke and clotting associated with ORTHO EVRA®. She decided to try Depo-Provera, which requires injections at three-month intervals. In 2005 she discontinued Depo-Provera due to weight gain and switched to the ORTHO EVRA® patch. Smith again discussed side effects. Yates admitted that she would have used ORTHO EVRA® even if she had read package warnings. Yates suffered a stroke while she was wearing her first weekly patch. A board-certified neurologist and neurophysiologist opined that Yates’s “use of the Ortho-Evra patch was the contributing cause of her stroke.” Smith’s suit was transferred for consolidated pretrial proceedings in connection with In re: Ortho Evra Products Liability Litigation. The district court dismissed her claims. The Sixth Circuit affirmed. The ORTHO EVRA® warnings in effect when Yates was prescribed the patch adequately warned her prescribing medical provider of the risk of stroke; there was no duty to directly warn Yates. The court rejected design defect, manufacturing defect, and negligence claims. View "Yates v. Ortho-McNeil-Janssen Pharma., Inc." on Justia Law

Whether a third-party payer (TPP) will cover the cost of a member’s prescription depends on whether that drug is listed in the TPP’s formulary. Pharmacy Benefit Managers prepare TPPs’ formularies of drugs approved for use by TPP members by analyzing research regarding a drug’s cost effectiveness, safety and efficacy. In 1999, the FDA approved Avandia as a prescription for type II diabetes. TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate. GSK downplayed concerns about Avandia’s heart-related side effects. In 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks. TPPs (union health and welfare funds) sued GSK on behalf of themselves and similarly situated TPPs. asserting that GSK’s failure to disclose Avandia’s significant heart-related risks violated the Racketeer Influenced and Corrupt Organizations Act based on predicate acts of mail fraud, wire fraud, tampering with witnesses, and use of interstate facilities to conduct unlawful activity. They also claimed unjust enrichment and violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law and other states’ consumer protection laws. The Third Circuit affirmed the district court’s finding that the TPPs adequately alleged the elements of standing. View "In Re: Avandia Mktg.,Sales Practices & Prod. Liab." on Justia Law