On March 28, 2019, the United States Judicial Panel on Multidistrict Litigation will hear arguments from attorneys representing individual service members across the country and attorneys from 3M Company regarding whether claims against 3M for hearing loss injuries stemming from use of the earplugs during active duty should be consolidated for pretrial proceedings. In these lawsuits, service members claim the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. Additionally, the lawsuits claim 3M misrepresented the effectiveness of its hearing protection devices to the military during the proposal process when seeking to procure a government contract to be the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.
Background of 3M Combat Arms™ Earplug Litigation
Military service members in training, standard military operations, and especially those in combat, are often exposed to high intensity noise of various types. Between 2003 and 2015, Aero Technologies and 3M Company (who acquired Aero Technologies in 2008) sold millions of the Combat Arms™ earplugs to the military for use by service members in active combat and otherwise. The earplugs are non-liner, or selective attenuation earplugs; this means there are two sides to give soldiers two options for hearing reduction in one product. When worn on the olive-colored side, or the “closed” position, the earplugs were intended to block noise like a traditional earplug. When worn on the yellow side, the “open” position, the earplugs were intended to block or significantly reduce loud noises while allowing the user to hear lower level noises, like communications from commanding officers.
In May 2016, Moldex-Metric, Inc. filed a qui tam lawsuit against 3M Company alleging violations of the False Claims Act for representations it made to the United States about the hearing protection afforded by the Combat Arms™ earplugs. The qui tam action followed lawsuits both 3M and Moldex-Metric, Inc. had previously filed against each other; news reports indicate 3M sued Moldex-Metric, Inc. for earplug patent infringement and Moldex-Metric, Inc. countersued for fraud and failure of 3M’s earplugs to pass safety tests, in violation of its contracts with the military.
A qui tam lawsuit is a lawsuit brought by a private citizen – here, a competitor earplug manufacturer – that alleges false statements in the performance of contract with the government or in violation of government regulation. In other words, the lawsuits allege fraud on the government. Here, Moldex-Metric, Inc. alleged Aero Technologies designed the Combat Arms™ earplugs in a manner that was too short for correct insertion, resulting in loosening without recognition by the person wearing them – and that Aero Technologies knew about the product defect as early as 2000. The lawsuit maintained Aero Technologies/3M did not disclose this defect to the United States. Notably, according to the U.S. Department of Veterans Affairs (VA), tinnitus and hearing loss are the two most common health conditions among military veterans. The qui tam lawsuit cited sources quantifying VA service member hearing loss treatment at over $1 billion per year.
In a qui tam lawsuit, the government has the option to join the private citizen as a plaintiff in the lawsuit or to opt out and have the private citizen pursue the fraud claims on his or her own. In July 2018, the United States joined as a party and publicly announced a settlement with 3M. As part of the settlement, 3M paid $9.1 million to the United States “to resolve allegations that it knowingly sold the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) to the United States military without disclosing defects that hampered the effectiveness of the hearing protection device.” The settlement resolved claims the U.S. government had against 3M; it did not resolve any claims of individual service members for injuries suffered as a result of 3M’s alleged false statements.
Following the announcement of the settlements and primarily starting in January 2019, individual service members who used the Combat Arms™ earplugs as instructed and suffered noise-induced hearing loss during their time in service began filing individual lawsuits against 3M. As of February 14, 2019, service members have filed over 150 lawsuits in various state and federal courts.
The United States Judicial Panel on Multidistrict Litigation and the Case for Consolidation of 3M Combat Arms™ Earplug Lawsuits
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. 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.
Attorneys representing one of the service member plaintiffs filed a motion seeking transfer of claims by U.S. military personnel and other wearers of the Combat Arms™ earplugs who suffered hearing-related injuries for coordinated proceedings on January 25, 2009. 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. If the Judicial Panel determines a case should be centralized, they will also determine at the hearing which judge will handle the centralized proceedings. General opinion is in favor of consolidation, given the similarity of all of the claims asserted and the number of claims filed – as well as the scores of lawsuits expected to be filed in the future. The real question may be which judge is appointed to oversee centralization – suggestions have included judges in the District of Minnesota (where 3M headquarters is located), the Eastern District of Louisiana, and the Western District of Missouri.
Searcy, Denney, Scarola, Barnhart & Shipley, P.A. is currently investigating and handling cases of service members who suffered hearing loss and tinnitus injuries arising from use of the 3M Combat Arms™ earplugs. If you have any questions about these cases, please give us a call.
The next hearing session of the United States Judicial Panel on Multidistrict Litigation (“JPML”) is scheduled for January 31, 2019 in Miami, Florida. Six matters are set for oral argument to consider motions to transfer each to one centralized district for coordinated pretrial proceedings. The matters set for this session include such hot topics as the massive Marriott data breach and litigation over Valsartan products contaminated with NDMA, a probable human carcinogen.
2018 JPML Year in Review
2018 saw a continuation of the pattern of decreasing motions for consolidation. Only 56 motions for centralization were filed in 2018, the lowest number in at least nine years and less than half of the 121 motions filed in 2009. However, the JPML centralized 28 of these new requests, an increase over the past two years. More actions were involved in those granted motions to centralize, the most in more than nine years. So, while requests to centralize are down, those actions that are centralized involve more lawsuits than in the recent past. MDLs continue to be dominated by products liability and antitrust cases. However, four new intellectual property MDLs were created in 2018.
Matters Set for January 2019 Oral Argument
The following matters are scheduled for oral argument during this first hearing session of the year:
• MDL No. 2875 – In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation
• MDL No. 2876 – In Re: Enhanced Recovery Company, LLC, Fair Debt Collection Practices Act (FDCPA) Litigation
• MDL No. 2877 – In Re: Air Crash at Durango, Mexico, on July 31, 2018
• MDL No. 2878– In Re: Ranbaxy Generic Drug Application Antitrust Litigation
• MDL No. 2879 – In Re: Marriott International, Inc., Customer Data Security Breach Litigation
• MDL No. 2880 – In Re: H&R Block Employee Antitrust Litigation
Notable Motions to Transfer
MDL No. 2875 – In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation. A class action plaintiff filed for transfer of at least fifteen consumer class action lawsuits and two individual lawsuits arising out of use of the generic drug Valsartan. The lawsuits were filed against manufacturers, distributors, and marketers of Valsartan – a prescription drug used primarily to treat high blood pressure and heart failure – following a July 2018 FDA announcement regarding voluntary recalls of several products containing the active ingredient valsartan after the products were found to contain NDMA, a probable human carcinogen. The moving plaintiff requested transfer to the District of New Jersey, where many of the actions are currently located and which serves to house the headquarters of at least three named defendants.
The main dispute over centralization between the parties in this case appears to be whether consumer class actions seeking solely economic damages and product liability cases requesting personal injury damages should be consolidated. Several of the defendants have opposed the transfer motion; while most defendants agree to transfer of the consumer class actions if the JPML feels it is warranted, they seek denial for the transfer of any individual personal injury claims.
MDL No. 2879 – In Re: Marriott International, Inc., Customer Data Security Breach Litigation. Data breach litigation continues trending in MDL requests for 2019; here, two motions for consolidation and transfer of litigation have been filed over the Marriott International, Inc. and Starwood Hotels & Resorts Worldwide, LLC data breach. The ten lawsuits that had been filed as of December 3, 2018 at the time of filing the motion to transfer has now grown to over 35 lawsuits. Plaintiffs allege Marriott failed to protect its customers’ private information, resulting in four years of hacker access to the reservation system of its hotel chains. Marriott disclosed the data breach on November 30, 2018, acknowledging that the names, addresses, credit card numbers, phone numbers, passport numbers, travel locations, and arrival and departure dates were exposed for up to 500 million customers. The two initial motions both requested transfer and consolidation to the District of Maryland, where Marriott headquarters are located, one alternatively suggesting the District of Massachusetts. Several briefs have subsequently been filed suggesting transfer to Florida, Connecticut, and New York.
MDL No. 2880 – In Re: H&R Block Employee Antitrust Litigation. This request to transfer and consolidate putative class action lawsuits centers around allegations that H&R Block violated the Sherman Antitrust Act by engaging in conspiracies not to compete for employees and to suppress employee wages. The lawsuits were filed on the heels of a July 2018 letter from 11 state attorneys general to eight national fast food franchisers requesting information about similar “no-poach” agreements in franchise contracts. The state attorneys general cited concern for such agreements limiting the abilities of fast-food and other low wage workers to seek raises and promotions in announcing the request for information. The current lawsuits allege that H&R Block has a policy in its own stores and require its franchisees to execute “no-poach” agreements, resulting in average wages of $10.86 per hour for H&R Block seasonal tax preparers as opposed to an industry hourly wage average of $22.67. H&R Block has opposed the transfer, citing only two jurisdictions where lawsuits have been filed as well as an arbitration agreement that it anticipates will remove at least two of the pending lawsuits.
For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves. Product Quest Manufacturing, a Florida company that manufactures the product, recommends consumers stop using it immediately and either discard or return the spray to the place of purchase.
On August 8, 2018, the U.S. Food and Drug Administration (“FDA”) announced a voluntary recall of the CVS Health 12 Hour Sinus Relief Nasal Mist. Product Quest Manufacturing found a specific lot of their spray was contaminated with bacteria Pseudomonas aeruginosa. According to Product Quest, “repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised.”
The recalled products can be identified by locating the side panel. The side panels are coded with “Lot 173089J” and “EXP 09/19.” 16,896 units are involved in the recall. The units were sold nationwide.
What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is the most common strain of the Pseudomonas infection to cause problems in humans. Infections with this type of bacteria are generally treated with antibiotics, although the Centers for Disease Control and Prevention notes that some strains – mostly in healthcare facilities – can be multidrug-resistant. Pseudomonas aeruginosa infections associated with healthcare facilities often cause bloodstream infections, pneumonia, urinary tract infections, and surgical wound infections. Exposure to Pseudomonas aeruginosa is seen in hot tubs and swimming pools. These mild exposures in normally healthy people result in ear infections or skin rashes. Symptoms can also mimic the common cold or flu and include sinus pain and pressure, fever and chills, body aches, light-headedness, rapid pulse and breathing, nausea and vomiting, diarrhea, or decreased urination.
Regulation of Over-the-Counter Medications
As an over-the-counter, or nonprescription, medication the CVS Health 12 Hour Sinus Relief Nasal Mist is sold directly to consumers without a prescription. In 1951, the Durham-Humphrey Amendment to the Federal Food, Drug and Cosmetic Act of 1938 established a legal framework for prescription and non-prescription drugs. The Amendment also authorized the FDA to make this prescription/over-the-counter distinction. The FDA states that medications designated as over-the-counter are generally safe and effective when used as directed. However, just because the FDA presumes over-the-counter drugs are safe does not mean they are free of defects. Being vigilant requires reading warning labels, taking medications as directed and watching for recalls such as this one for the CVS 12 Hour Sinus Relief Nasal Mist.
The FDA announcement directs consumers who have been injured by the nasal mist to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, by regular mail or by fax.
If you become ill or are injured by an over-the-counter medication, seek the assistance of a physician or health care provider.
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.
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.