Articles Posted in Judicial Decisions

Earlier this month, a federal appellate court issued a written opinion in a product liability case brought against the manufacturer of Zoloft, alleging that the medication causes birth defects. The court’s decision reviewed a lower court’s decision to prevent the plaintiffs’ expert witness from testifying. Ultimately, the court concluded that the lower court was proper to not allow the expert’s testimony.

The Facts of the Case

The plaintiffs were a class of people who collectively claimed that the medication Zoloft caused birth defects when taken early in a pregnancy. In order to establish their claim, the plaintiffs planned on presenting several witnesses to show that the ingestion of Zoloft actually caused the birth defects in their children. However, the court prevented one of the key witnesses from testifying, based on the novel method the expert used in arriving at her conclusion.

The plaintiffs then tried calling another witness in place of the one who was prevented from testifying. The drug manufacturer objected to this witness as well, and the court conducted a hearing to determine whether the expert’s testimony would be admissible.

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Earlier last month, an appellate court in Tennessee issued a written opinion in a case involving the death of a man who had overdosed on prescription medication. The court ultimately determined that the patient’s death was attributable to his own actions. The case was presented to the court as a workers’ compensation case, but the issue the court decided was relevant to personal injury cases involving allegations of pharmacy error and medical malpractice.

The Facts of the Case

The petitioner was the surviving wife of a carpenter who involved in an accident while on the job. As a result of the accident, the man’s doctor prescribed oxycodone, a powerful and addictive pain medication. The man took the medication as directed at first but then began abusing it. According to the court’s opinion, he would skip doses of the medication in fear that he would run out when he needed it. He eventually started to take the medication with alcohol to increase the medication’s effectiveness.

About two years after his accident, the man’s wife discovered her husband’s lifeless body in bed. The woman, through her deceased husband, filed for workers’ compensation benefits based on the fact that the original injury her husband sustained occurred while he was on the job. An autopsy reported the man’s cause of death as opioid toxicity, with contributing causes of hypertension, alcohol use, and tobacco use.

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The Supreme Court of Alabama recently released an opinion granting the appellant’s request for the state’s high court to intervene in the case and compel the trial judge to dismiss the plaintiff’s claim as time-barred. The statute of limitations for the plaintiff’s claim had expired shortly before the defendant’s motion was filed, and the motion was ultimately granted because the plaintiff had originally sued the wrong entity after an oversight was made. After the error was discovered, the complaint was not amended to include the proper defendant until after the limitations period had expired. Since the court found that the requirements for an amended complaint to “relate back” to an original filing and toll the statute of limitations were not met, the plaintiff will be unable to recover damages for his pharmacy error claim.

The Plaintiff Alleges That a Dangerous Mistake Was Made

The plaintiff in the case of Ex Rel VEL, LLC is a former customer of a pharmacy owned and operated by the defendant. In the events leading to the filing of the lawsuit, the plaintiff was allegedly given an antipsychotic medicine, Risperidone, instead of his blood-pressure medicine, Ropinirole. After taking the wrong pills for four days, the plaintiff allegedly experienced an adverse health event and was hospitalized, at which point the error was ultimately discovered. Claiming that he suffered permanent and serious harm as a result of the mistake, he pursued a pharmacy error claim against the pharmacy that made the mistake.

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Earlier this month, a court in Nevada heard a case involving an interesting legal issue that has recently come up in courts across the nation. In the case, Burton v. Walgreen, the issue was whether a pharmacy had a duty to preserve evidence of an error made by one of the pharmacists. The court determined that whenever a patient returns medication to a pharmacy that was given to him in error, the pharmacy does have a duty to preserve it.

The Facts of the Case

According to a summary of the case, the patient was prescribed Valsartan, which is a blood pressure medication. He filled the prescription at a local Walgreen’s pharmacy, and when he got home, he began taking the medication as instructed. After taking about five doses, the patient’s wife noticed that there were two different kinds of pills in the vial that her husband was provided. The patient’s wife then took the medication back to the pharmacy, where the pharmacist confirmed that the patient had been given unprescribed lithium pills in addition to his Valsartan.

After documenting the error, the pharmacist quarantined and destroyed the medication, pursuant to the company’s written policy. In a lawsuit later filed against the pharmacy, the patient claimed that the pharmacy had engaged in spoliation of evidence. Spoliation of evidence is the destruction or significant alteration of evidence by someone who knows or should know that the evidence will be used as evidence in an upcoming court case. A court can impose sanctions against a party for spoliation of evidence.

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Earlier this month, the Sixth Circuit Court of Appeals decided a case reinforcing the laws surrounding whom the manufacturer of a medication must warn about the potentially dangerous side effects of the medication. In the case, Yates v. Ortho-McNeil-Janssen Pharma., Inc., the Court ultimately determined that the duty to warn extends only to the physician, and not to the patient. Thus, the patient’s case against the drug manufacturer was properly dismissed by a lower court.

Yates v. Ortho-McNeil-Janssen Pharma., Inc.

The plaintiff was a sexually active woman who was suffering from extreme menstrual cramps and consulted her doctor about potential medications that may help her. The doctor told her of two choices, ORTHO-EVRA and Depo-Provera. The doctor warned the plaintiff that there was some risk of blood clotting and stroke with ORTHO-EVRA, and the plaintiff decided to first try Depo-Provera.

After a few months, the plaintiff noticed she had gained weight, which was a side effect of Depo-Provera. She consulted her doctor, who again advised her of the risks associated with ORTHO-EVRA, and this time she decided to give it a try. The plaintiff suffered a stroke during the application of her first weekly patch. The woman filed a lawsuit against ORTHA-EVRA’s manufacturer, alleging that the company did not adequately warn her of the risks involved with taking the medication.

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Earlier this year, the Supreme Court of Texas affirmed the dismissal of a woman’s case after she failed to provide the requisite expert opinion supporting her claim within the required time period. In the case of Randol Mill Pharmacy v. Miller, the court determined that the a claim alleging negligence in a pharmacy’s compounding services qualifies as a “health care liability claim” and must therefore comply with the applicable rules governing those claims.

The Facts of the Case

The plaintiff in the case was prescribed a special prescription by her doctor to treat her Hepatitis C. The prescription was not available in a mass-produced form, so a pharmacy had to create the medicine in a process called “compounding.” However, after a few weeks of taking the medication, the woman suffered a serious adverse reaction, resulting in several blood transfusions and ultimately ending in her losing sight in both of her eyes.

The woman filed suit against the pharmacy, alleging that the pharmacy “breached their implied warranties in the design, manufacture, inspection, marketing, and/or distribution.” She also filed suit against the doctor, but it was severed and tried separately.

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A federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.

The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.

The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.

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A pharmacist may offer expert testimony in a wrongful death lawsuit regarding a physician’s alleged failure to obtain a patient’s informed consent, according to a ruling by the Maryland Court of Special Appeals. Fusco v. Shannon, 63 A.3d 145 (Md. Spec. App. 2013). The trial court excluded testimony from the plaintiffs’ expert witness, a pharmacist, holding that he was not qualified to offer an opinion on a physician’s professional duties. The case went to trial without the pharmacist’s testimony, and the jury found in favor of the defendants. The appellate court reversed the judgment and remanded the case to the trial court.

The decedent, Anthony Fusco, Sr., was eighty-two years old when he received a diagnosis of “low-risk” prostate cancer in 2001. By early 2003, he and his doctor decided to begin a course of treatment that included radiotherapy. He met with a doctor who explained the nature and risks of radiation treatments, including possible inflammation of surrounding organs. The doctor referred him to Dr. Shannon to prescribe a protectant medication to reduce the risk of radiation damage. Dr. Shannon prescribed Amifostine, and would later claim that he explained the risks associated with the drug, such as nausea, skin reactions, and blood pressure issues.

The Amifostine treatments began in April 2003 and continued for about a month. He received twenty-three injections, seemingly without incident, but on May 17, 2003, the day after receiving his twenty-fourth dose, Mr. Fusco was hospitalized with a severe skin reaction. He was diagnosed with Stevens-Johnson syndrome, a rare but serious skin condition, which Dr. Shannon suggested was a reaction to the Amifosine. After several hospitalizations, Mr. Fusco died of a stroke allegedly resulting from Stevens-Johnson on December 4, 2003.

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A federal court dismissed most of the causes of action in a lawsuit alleging that a generic antibiotic caused a dangerous, potentially-fatal reaction. Wilson v. Amneal Pharmaceuticals, LLC, No. 1:13-cv-00333, order (D. Id., Dec. 31, 2013). The lawsuit asserted claims under Idaho state law, but the decision is similar to federal court decisions in other states involving generic drug manufacturers. Federal laws and regulations make recovery of damages difficult for injuries caused by generic drugs.

The plaintiff’s doctor prescribed Bactrim, a generic antibiotic manufactured by the defendant, Amneal Pharmaceuticals. After taking the medication for one week, the plaintiff reportedly developed Stevens-Johnson syndrome, a reaction to a medication or infection that causes painful rashes and blisters. It can be very difficult to treat, and in severe cases, can cause permanent injury or death. The plaintiff sued Amneal in state court, asserting seven causes of action including defective design, negligent manufacture, and failure to warn. Amneal removed the case to federal district court based on diversity jurisdiction. It attached various FDA documents to its answer, including formal approvals of changes to the drug label.

Amneal moved the court to take judicial notice of the documents it produced with its answer, and to dismiss the plaintiff’s complaint for failure to state a claim on which the court could grant relief. The plaintiff opposed the motion for judicial notice and moved the court to allow discovery to proceed. The court denied the plaintiff’s motion and granted the motion to take judicial notice. Judicial notice is proper, it held, when the evidence in question is widely available or a matter of public record. It found that all of the documents in question were easily obtainable online, and that no one disputed their authenticity. The court proceeded to decide the motion to dismiss without the introduction of any further evidence besides the pleadings.

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A federal employment termination lawsuit against a major corporation had the unintended consequence of revealing a potentially unlawful scheme of illegally operated pharmacies. Please note, however, that just because a former employee made allegations in his complaint doesn’t necessarily mean that they are true. Individuals can allege anything they want in a complaint, and may have a greater incentive following termination.

The case, Weidman v. EXXON MOBIL CORPORATION, Dist. Ct., ED Va. (2013), was filed in federal court following the plaintiff’s termination after nearly four years of employment.

The plaintiff was employed as a senior physician in a Virginia office, and claims that, after working for the company for two years, he discovered that it had been operating illegal pharmacies. Plaintiff claimed that large quantities of medication were being illegally stockpiled in the clinic in which he was working, as well as in other locations. Plaintiff did not state for what reason the medication was being collected. He further alleged that many of the senior managers were aware of the illegal activities, and that they requested he participate in a purported scheme involving a pharmacy which was allegedly distributing the stockpiled medications to ExxonMobil employees.

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