Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.
The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.
Glass Particles Found in Spray Bottle
“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”
With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.
“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”
Fluticasone Widely Used for Allergies
Fluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:
“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”
WebMD notes that the drug does not relieve symptoms immediately.
“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.
Precautions Necessary for Fluticasone Use
WebMD describes some of the precautions, as well.
“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”
Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.
“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”
Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at email@example.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.
In an age where data is widely available and almost everything is stored online, data breaches are becoming more common, and the outcomes of cases involving data breaches are unpredictable. Data involved in a breach can range from financial data, such as credit card numbers, to health data, such as treatments and medical history. Based on previous settlements reached, stolen health data typically has the most extensive damages due to the incredibly personal nature of the data, while stolen credit card data has the least damages. It is a lot easier to cancel and replace a credit card than it is to replace identifying information such as a Social Security number. When there is a breach of identifying information, continued alertness is necessary to prevent identity theft, adding to the costs.
The Type of Data in a Data Breach Matters
There are two cases that illustrate the disparity between settlements involving different types of data. An infamous hacker who goes by the name “Cumbajohnny” was responsible for hacking both T.J Maxx and Heartland Payment Systems. Data for approximately 130 million credit and debit cards was stolen from Heartland, and more than 45 million credit card5s were affected from the T.J Maxx breach. However, the Heartland settlement was $500,000, despite involving the breach of three times the amount of data. The T.J Maxx settlement was valued at $6.1 million. The court’s value was based on the type of data breached; Cumbajohnny and his cohort stole identification information from at least 450,000 customers of T.J Maxx, including Social Security and driver’s license numbers. Although the nominal value of credit card information was larger for Heartland, considering the threat of identity theft, the real value of the 455,000 people affected from T.J Maxx was much greater. In fact, eighty-six percent of the T.J Maxx settlement was from the much smaller number of identifying information stolen, and the other fourteen percent is attributed to the 45 million stolen card records.
Although identifying information is valuable in settlements, medical records often add the most value to a data breach settlement because they contain deeply personal information. For example, the breach of Advocate Health Care included unencrypted medical records, affecting 4.03 million patients. The case settled for $5.55 million, remaining the largest HIPAA settlement to date. This case exemplifies the need to keep up with the swiftly-evolving digital landscape to protect clients’ information. It may also demonstrate legislative attention to particularly personal and sensitive data. Due to the variation and uniqueness of each data breach case, it is important to evaluate the types of compromised data.
Identify Theft Also Important Factor
Generally, cases with elements identity theft will be stronger because it is difficult to prove standing without it. Some jurisdictions require the plaintiff to have suffered from identity theft to have standing. It can be difficult to prove that the hacker had malicious intention and/or sold the data they stole, and until they do sell it, some jurisdictions will not give the class standing. For large data breach cases, such as the T.J Maxx settlement, the plaintiff’s attorneys must be prepared to litigate the case under the standing rules of the federal court in any district because many cases filed all over the country can be consolidated into one federal district court for multidistrict litigation.
The value of data breach cases does not only include the monetary value of the breach. Protection against future losses, such as improved digital security and credit monitoring, are important to preventing identity theft and ensuring the affected company isn’t breached again. It can be beneficial to the plaintiff if the company at fault had a previous breach and did not take proper measures to increase their security.
What Happened After the Breach?
Before initiating a case, it is valuable to research what a company has already done after experiencing a breach. Oftentimes, the company will offer one-year free credit-monitoring for customers who experience ongoing credit risk. While credit-monitoring is helpful for preventing a breach, some companies may only monitor one of the three credit bureaus (Equifax, Experian, and TransUnion) to keep costs low, leaving customers vulnerable to fraudulent activity that shows up on other bureau’s credit reports.
Researching if the company bulked up its security after a breach is also useful. It can be difficult to find exactly what the company did in the aftermath because the discovery may not be accessible. Cybersecurity blogs can come in handy to get technical details of how the hacker was able to get into the company’s system in the first place and learn what, if anything, the company did to improve security. If there is a lot of room for security or credit-monitoring improvement, the value of the settlement may be greater, however the court can enforce this by either raising the dollar value of the settlement or mandating the company increases security. For example, after the Target data breach, which affected 41 million customers, the settlement required Target to employ a chief officer who manages security, to actively monitor its systems for security events, provide security training to its employees for five years, and perform routine security assessments. The case settled for $18.5 million, but the injunctive relief was much greater.
Third Party Vendors Can Play Role
Determining if the company or a third-party vendor is at fault for the breach can be challenging. The company experiencing the data breach often claims they have the most up-to-date security systems, however discovery usually reveals gaps that the hackers used to get in and out with the data. If a third-party could be responsible, it would be best to establish the relationship between the company and the vendor as soon as possible and determine if the vendor is primarily responsible for the breach.
An example where the vendor was unmistakably at fault is the case of the Stanford Hospital data breach. The hospital’s business associate (BA), Multi-Specialty Collection Services, LLC, posted 20,000 patients’ emergency room records, including hospital account numbers, billing charges, and emergency room admission and discharge dates, to a student homework website asking how to graph the patients’ data. Stanford Hospital properly encrypted the records before sending them to the vendor, but they were still responsible for paying the administration costs of the $4 million settlement. The hospital also agreed to train its vendors on how to most effectively protect patient data. Since vendors are typically smaller entities, they likely have fewer resources, and this could affect the settlement amount.
The U.S. Food and Drug Administration’s (FDA) slow and retroactive response to toxic chemicals found in cosmetics is being called into question. In the past year, there have been more protests urging the FDA to ban lead acetate, a compound found in hair dyes. It was banned in Canada and Europe nearly a decade ago for causing toxic levels of lead to build up in the blood, so what is taking the U.S. so long? Part of the reason why harmful chemicals aren’t banned from cosmetic products faster is that the FDA can only regulate products if it receives “reliable information,” as stated in the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Public protests, such as the petitions against lead acetate, are the beginning of the process that incites the FDA to begin research of the chemical, but this research can take years to complete. It is the responsibility of the FDA to find evidence that a certain product is harmful when used as intended because the manufacturer of the product is not required to submit their data. The research necessary to find such evidence takes time to complete. In the meantime, these dangerous chemicals will already have continued to harm many people.
Cosmetic Industry Also at Fault
The FDA’s response to toxic chemicals in cosmetics is not the only issue; there is no regulation of chemicals before the cosmetic products go to market. A company does not have to perform particular tests on products containing new chemicals, nor is it mandatory for the companies to publicize safety data they collect. Lack of accountability has allowed cosmetic manufacturers to use chemicals in everyday items, such as shampoo and toothpaste. Some cosmetics can contain formaldehyde, a byproduct of some preservatives put into cosmetics. The chemical is commonly used as a preservative for dead animal parts, such as the frog you may have dissected in science class. Formaldehyde was declared a human carcinogen by the National Toxicology Program at the Department of Human Health and Services in 2011 because it can cause cancers of the nasal cavity, myeloid leukemia, and rare cancers. About one fifth of cosmetics contain formaldehyde, a scarily high percentage.
Preventative Measures Are Ready For Congressional Passage
Henri de Toulouse-Lautrec’s “Woman at her toilette”
Consumers should not have to worry about using cosmetics which may have toxic effects on their bodies. One preventive measure the U.S. could enact is to ban chemicals based on preliminary toxicity data rather than the exhaustive data and research that is required. The Personal Care Products Safety Act is a piece of legislation recently introduced in Congress by Senator Dianne Feinstein which may help solve the problem. If passed, the bill will give the FDA the authority to take products off of store shelves immediately after receiving any reports of customers experiencing bad reactions. This will help close the gap between initial complaints and the years it takes the FDA to gather information before banning the chemical. Furthermore, the bill includes the mandate that manufacturers register their facilities and pay a fee to the FDA. The money will be used to determine the safety of at least five cosmetic ingredients a year. This preventative measure will help eliminate the inefficient process of removing harmful products from store shelves after they have gone to market.
While passage of this bill would be an excellent start to solving the problem, the FDA must enforce more thorough regulation of cosmetic products all around. Unfortunately, the laws on regulation of cosmetics do not require FDA approval before being put on the market, apart from color additives. The administration advises the manufacturers to consult available toxicological test data and perform any additional tests necessary to ensure the safety of the product. However the FDA has no legal jurisdiction to ban a product unless a law has been broken, such as the misbranding of a product. Implementing stricter regulations on companies will bring more peace of mind to consumers who should not have to worry about the toxicity of their cosmetics in the first place.
On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of Common Pleas’ mass tort program consolidating Xarelto-related injury lawsuits. Plaintiff, Indiana resident Lynn Hartman, sought damages after she was hospitalized in 2014 with a gastrointestinal bleed. She stated she required four blood transfusions to counter the injury. Ms. Hartman testified she took Xarelto for more than a year – to treat her atrial fibrillation – before her hospitalization. She blamed her Xarelto use for the hospitalization, noting that she subsequently used another blood thinner without incident. The jury agreed with her and awarded $1.8 million in compensatory damages and $26 million in punitive damages.
The plaintiff’s claims were based, in part, on allegation that Janssen and Bayer manipulated the clinical trials for Xarelto and failed to adequately warn patients of the bleeding risks involved with Xarelto use. Former FDA Chief David Kessler testified at trial that, in his opinion, the drug’s warning label did not sufficiently inform doctors or patients of the severity of the potential bleeding risks.
Janssen and Bayer responded to these allegations by arguing the warning label statement that Xarelto “can cause serious and fatal bleeding” was more than sufficient warning of the drug’s bleeding risks. Additionally, the defendants relied upon testimony of Ms. Hartman’s treating physician that she would still have prescribed Xarelto to the plaintiff even with the heightened warning, even though she felt additional information should have been included on the label.
Witness Tampering Allegations
This trial was not without its share of drama. At the beginning of trial, the plaintiff’s attorneys alleged witness-tampering by a Janssen sales representative. The representative had visited one of Ms. Hartman’s treating physicians, Dr. Aldridge, prior to the physician’s deposition. During the deposition, Dr. Aldridge testified that he did not believe the plaintiff’s gastrointestinal bleed had been cause by Xarelto; his testimony seemed to contradict his notes made during Ms. Hartman’s 2014 hospitalization.
Judge Michael Erdos, who presided over the trial, granted the plaintiff’s request to take Dr. Aldridge’s deposition during the trial. Granting a mid-trial deposition is an unusual event, to be sure. However, following the deposition, Judge Erdos denied Ms. Hartman’s request to use the doctor’s testimony during trial. The judge’s denial was grounded in what he determined to be a lack of evidence showing an attempt to influence Dr. Aldridge’s testimony.
Where Does Xarelto Litigation Go from Here
Lynn Hartman’s case was one of approximately 1,500 cases pending in the Philadelphia County Court of Common Pleas. The federal multidistrict litigation currently has around 20,000 cases. Three bellwether trials have concluded from the MDL. All three trials resulted in verdicts in favor of Janssen Pharmaceuticals and Bayer Pharmaceuticals. The next Philadelphia trial is scheduled to begin in January.
Johnson & Johnson and Bayer officials have stated they will appeal the December 5, 2017 Philadelphia verdict.
The next hearing session of the United States Judicial Panel on Multidistrict Litigation is scheduled for November 30, 2017 in St. Louis, Missouri. Eight matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters include trending issues such as Equifax’s massive 2017 data breach and the national opioid litigation against Big Pharma manufacturers and distributors. Ten matters will be considered for centralization without the parties making oral arguments.
What is the United States Judicial Panel on Multidistrict Litigation?
Multidistrict litigation is a mechanism for increasing efficiency in the federal court system. Created through an Act of Congress in 1968, 28 U.S.C. 1407, the law allows for the transfer of civil actions involving common questions of fact to one federal district court for coordinated or consolidated pretrial proceedings. To transfer a case, the Judicial Panel on Multidistrict Litigation must determine that the transfer will (1) be for the convenience of parties and witnesses; and (2) promote the just and efficient conduct of the related lawsuits. The efficiency in transferring cases to on federal court, or “centralization,” is accomplished through avoidance of discovery duplication, prevention of inconsistent pretrial rulings, and conserving resources of the parties, their attorneys, and the judiciary. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which Judge will handle the centralized proceedings.
The Judicial Panel on Multidistrict Litigation consists of seven sitting federal judges appointed to serve on the panel by the Chief Justice of the United States Supreme Court. Appointment is reflective of a judge being held in high esteem on the bench. The current Chair of the panel is Judge Sarah S. Vance from the Eastern District of Louisiana.
Currently, there are Multidistrict Litigation matters pending in disaster cases involving the September 11 terrorist attacks, the Deepwater Horizon oil spill; intellectual property; employment cases; securities litigation; and several others. Multidistrict Litigation is most frequent in cases involving products liability, antitrust, or marketing and sales practices. To date in 2017, Multidistrict Litigation has been formed in 9 products liability matters; 4 marketing and sales practice matters; and 2 antitrust matters.
Matters Set for Oral Argument
The following matters are scheduled for oral argument during the hearing session:
- MDL No. 2777 – In re: Michael Stapleton Associates, Ltd., Fair Labor Standards Act (FLSA) and Wage Hour Litigation
- MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation
- MDL No. 2801 – In re: Capacitors Antitrust Litigation (No. III)
- MDL No. 2802 – In re: Epipen (Epinephrine Injection, USP) Employee Retirement Income Security Act (ERISA) Litigation
- MDL No. 2804 – In re: National Prescription Opiate Litigation
- MDL No. 2806 – In re: McGregor-Mayweather Boxing Match Pay-Per-View Litigation
- MDL No. 2807 – In re: Sonic Corp. Customer Data Security Breach Litigation
- MDL No. 2808 – In re: Anthony Spencer Green, Sr. Litigation
Notable Motions to Transfer
MDL No. 2800 – In re: Equifax, Inc., Customer Data Security Breach Litigation. This matter involves over 300 cases filed against the consumer credit agency, alleging violations of state and federal laws for the company’s purported failure to use adequate safeguards to protect consumers. The alleged failures resulted in unauthorized individuals gaining access to Equifax, Inc.’s data network storing the private information of 143 million consumers. The Plaintiffs suing Equifax, Inc. moved for consolidation when only 22 cases were pending and noted numbers were likely to rise quickly given the amount of victims; by the morning of the hearing, over 300 cases had been filed. Equifax, Inc. acknowledged the data breach in September 2017; records accessed included names, Social Security numbers, birth dates and, in some cases, driver’s license numbers.
MDL No. 2804 – In re: National Prescription Opiate Litigation. Counsel representing several Plaintiffs filed for consolidation of the actions of state, county, and municipal governments and other agencies against opiate manufacturers Purdue Pharma, Teva/Cephalon, Janssen, Endo, Actavis, and Mallinckrodt and distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc. The lawsuits allege negligence as well as violations of public nuisance laws, state consumer protection statutes, and the Federal Racketeer Influenced and Corrupt Practices Act, 18 U.S.C. §§1961, et seq. Plaintiffs allege opioid manufacturers and distributors misrepresented the risk of addiction associated with opioid use to regulators, doctors, and patients and failed to report suspiciously large orders of their drugs, actions which allegedly contributed to the current nationwide opioid epidemic.