Judicial Decisions

Pharmaceutical Company’s Failure to Warn Did Not Cause Plaintiff’s Injury, Court Rules

April 29, 2014 | Lebowitz & Mzhen

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.

Pharmacist Can Give Expert Testimony About Physician’s Duty to Obtain Informed Consent, Maryland Appellate Court Rules

January 22, 2014 | Lebowitz & Mzhen

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.

Court Finds Failure to Warn and Design Defect Claims Preempted in Lawsuit Against Generic Antibiotic Manufacturer

January 8, 2014 | Lebowitz & Mzhen

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.

Employment Lawsuit Reveals Potential Illegal Pharmacy Operation

December 26, 2013 | Lebowitz & Mzhen

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.

Court Sides with Plaintiff in Expert Testimony Prescription Medication Injury Case

December 5, 2013 | Lebowitz & Mzhen

The U.S. District Court for the District of Columbia reached an instructive decision regarding conflicting expert testimony in prescription medication injury cases where causation is at issue.

In the case, Patteson v. Maloney, Dist. Court, Dist. Col. (2013), the plaintiff was suing her prior psychiatrist for prescribing her Seroquel, which was an antipsychotic drug, in order to treat her insomnia.

After taking the medication, the plaintiff developed tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements and uncontrollable muscular tics. Her lawsuit thus claimed that the condition was caused by the Seroquel, on the basis of expert testimony. The defendant psychiatrist motioned to exclude all testimony linking Seroquel to tardive dyskinesia.

Supreme Court Affirms FDA Approved Drug Labels Do Not Shield Brand Name Drug Makers from Liability

November 20, 2013 | Lebowitz & Mzhen

In 2009, the United States Supreme Court handed down a seminal decision regarding the liability of drug manufacturers for failure to adequately warn of the risks associated with using a particular drug. The Court examined the argument of a drug manufacturer that it could not be held liable for a failure to warn, eventhough it would have been possible to issue a more updated warning label, because the FDA had already approved the drug, and its manner of uses, as safe.

The case, Wyeth v. Levine, 129 S. Ct. 1187 (2009), arose out of an incident whereby the injection of a drug caused a woman to suffer gangrene from a known side effect, which ultimately resulted in the amputation of her arm.

The drug at issue, Phenergan, is an antihistamine used to treat nausea. The injectible form of the drug can be administered two different ways. One way is through a traditional IV, and the other is more akin to a shot. If the drug accidentally enters an artery, it causes immediate and irrevercible gangrene. When the patient was given the drug, she was given it in the shot manner, and it somehow entered an artery, causing gangrene, which ultimately resulted in the amputation of her forearm.

Biotech Company Pleads Guilty to Illegal Marketing of Anemia Drug

January 10, 2013 | Lebowitz & Mzhen

A giant biotechnology company pleaded guilty in December 2012 to a single charge of illegally marketing a drug for uses expressly denied by the U.S. Food and Drug Administration (FDA), thus increasing the risk to patients of medication errors. A years-long investigation by the federal government, reportedly assisted by some company employees, led to a single misdemeanor charge. The guilty plea includes a sizeable criminal fine and civil settlement. The judge presiding over the case has delayed his decision on approving the settlement agreement, although he denied a whistleblower’s challenge to the settlement.

The FDA approved the drug in question, Aranesp, in 2001 to treat anemia in patients undergoing kidney dialysis and for cancer patients undergoing chemotherapy. The drug’s manufacturer, Amgen, is reportedly the world’s largest biotechnology company. Sales representatives employed by Amgen began reporting concerns about the company’s marketing of Aranesp and other drugs to the Department of Health and Human Services, which launched an investigation as early as 2004. Employees wore recording devices during meetings with Amgen managers, which provided evidence that the company was offering doctors financial incentives to prescribe Aranesp over other drugs, and promoting the drug for off-label uses.

Amgen allegedly promoted the use of Aranesp in cancer patients who were not undergoing chemotherapy. At least one study, reportedly sponsored by Amgen, showed an increased risk of mortality for non-chemo cancer patients. The company also allegedly promoted administering Aranesp less frequently but in larger doses, after the FDA refused to approve the drug for such a use. This was supposedly to encourage doctors to use Aranesp over a competing drug. The company allegedly profited $85 million from the misbranded drug.

Second Circuit Court of Appeals Holds “Off-Label” Promotion is Protected Free Speech – United States v. Caronia

December 11, 2012 | Lebowitz & Mzhen

Alfred Caronia, a pharmaceutical sales consultant for Orphan Medical, Inc., was convicted of conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act (“FDCA”). Caronia appealed the conviction and argued that the conviction rested solely on his speech in violation of the First Amendment. In a 2-1 split decision, the Second Circuit Court of Appeals agreed with Caronia and vacated the conviction.

Caronia promoted the drug Xyrem for “off-label” use. An off-label use is generally defined as using a drug for a purpose other than what has been approved for by the U.S. Food and Drug Administration (“FDA”). In this case, Xyrem is a powerful central nervous system depressant whose primary active ingredient is “GHB,” which is federally classified as the “date rape drug.” The FDA has approved Xyrem for only two medical indications.

Caronia was unknowingly recorded while promoting Xyrem for medical indications not approved for by the FDA, as well as subpopulations that had not been approved. The government alleged that Caronia was marketing Xyrem for medical indications he knew were not approved for by the FDA and that he knew Xyrem’s labeling lacked adequate directions and warnings for such uses. Thus, the government argued, Caronia conspired to introduce a misbranded drug into interstate commerce in violation of the FDCA.

On appeal, Caronia’s primary argument focused on the constitutionality of the misbranding provisions of the FDCA as interpreted by the government at trial. In addressing Caronia’s arguments, the court found that the FDCA provisions effectively regulate content, favoring one type of speech over another – “on-label” speech versus “off-label” speech. The court also found the provisions discriminated amongst speakers, penalizing only certain individuals — namely pharmaceutical manufacturers. These findings led the three-judge panel to examine the FDCA provision in question under the “strict scrutiny” standard of review.

Marketing of Drugs that Deviates from Voluntary Industry Standards Does Not Violate False Claims Act, Court Rules: United States of America et al v. Pfizer, Inc.

November 23, 2012 | Lebowitz & Mzhen

A federal court recently dismissed a lawsuit by the federal government alleging that a pharmaceutical company’s marketing activities violated the False Claims Act (FCA). The government claimed in U.S. ex rel Polansky v. Pfizer, Inc. that the company’s marketing of one of its drugs, which deviated from industry guidelines, constituted “off-label” marketing in violation of federal law. The court held that the industry guidelines were not legally-enforceable restrictions, and it further concluded that the government was trying to use the FCA to restrict marketing in a way that the regulatory agencies had chosen not to do. Since doctors often rely on pharmaceutical companies’ marketing to determine what drugs to prescribe and in what amounts, this decision could have a substantial impact on patient safety.

The pharmaceutical company Pfizer manufactures and markets the drug Lipitor as a treatment for high cholesterol. The company allegedly encouraged doctors, through its marketing materials and sale representatives, to prescribe the drug for patients whose cholesterol levels and heart disease risk factors were less than the guidelines established by the National Cholesterol Education Program (NCEP). The NCEP is a program of the National Institutes of Health, which works with a large number of organizations to raise awareness of the dangers of high blood cholesterol. The label produced by Pfizer in 2005 for Lipitor included the NCIP’s guidelines for drug intervention, but a new label introduced by Pfizer in 2009 did not include the guidelines.

VA Hospital Ruled Not Liable for Medication Error of Contract Anesthesiologist: Bethel v. US, Court of Appeals

November 18, 2012 | Lebowitz & Mzhen

A lawsuit, Bethel v. United States, sought to hold the federal government liable for a medication error at a Veterans’ Affairs (VA) hospital that allegedly caused a man severe and permanent brain damage. The anesthesiologist directly accused of the error was an employee of a state hospital who, pursuant to a contract between the two institutions, was working at the VA hospital that day. A federal district judge held that the VA was vicariously liable for the anesthesiologist’s negligence even without a direct employer-employee relationship, and ruled for the plaintiffs after a bench trial. The Tenth Circuit Court of Appeals reversed the finding of vicarious liability and remanded the case to the trial court to apportion liability among the other defendants.

David Bethel was admitted to the Veterans Affairs Medical Center (VAMC) in Denver, Colorado on September 10, 2003 for surgery. The anesthesiologist, Dr. Robin Slover, was an employee of the University of Colorado School of Medicine (UCSM) assigned to work at VAMC. A VAMC employee, first-year resident Dr. Nicole McDermott, assisted Slover during the procedure.

Prior to the procedure, Bethel began to complain of difficulty breathing. The court states that it is not clear what drugs, if any, he had received at this point. McDermott and another resident had to restrain him while Slover returned from another room. Slover administered a paralytic drug called Rocuronium and several other drugs in order to render Bethel unconscious. Bethel eventually needed a tracheotomy to allow breathing. He remained in the hospital until January 2004. Cardiac arrest and a lack of oxygen caused a hypoxic-ischemic brain injury, which has rendered him unable to provide for his own needs or care for himself. The trial court eventually concluded that the drug Rocuronium caused Bethel’s operating room symptoms, and that someone gave it to him by mistake after Slover prescribed a different drug.