NWCDN Members regularly post articles and summary judgements in workers’ compensations law in your state.
Select a state from the dropdown menu below to scroll through the state specific archives for updates and opinions on various workers’ compensation laws in your state.
Contact information for NWCDN members is also located on the state specific links in the event you have additional questions or your company is seeking a workers’ compensation lawyer in your state.
Terrence Preddie was employed from 2010-20This 11 as a fifth-grade teacher at Columbus Signature-Codrea Elementary School in Indiana. Dr. Diane Clancy assessed Preddie’s job performance in the first school term as effective in some areas and needing improvement in others. One specific area where improvement was needed was in leaving organized lesson plans for substitute teachers. Another concern was Preddie’s missing time from school in part to care for his son, who had Sickle Cell Disease. Preddie claimed that Clancy told him that he was missing too much time and asked whether there was anyone else who could pick up his son from the hospital or care for his son.
During the 2010-2011 school year, Preddie recorded 23 days of absence, five of which were for “family illness,” and seven of which were for “sick days.” Two days were missed for his own problems with diabetes and six were missed for his own hypertension and kidney failure. The Board recorded three of the absences as “personal days” and the other three as “leave without pay” because Preddie had already exhausted his allotment of paid sick days.
After Peddie used all his sick days, he spoke with Clancy who said that he could apply for leave under the FMLA but he would need to make a written application for that leave. Preddie never requested leave under the FMLA.
At the time of Preddie’s second semester review, Preddie said that Clancy advised he could not take any more time off for his son because it was affecting his classroom. On one occasion, Preddie called his wife to come down from Indianapolis to pick up their son since he was worried about his job. Preddie’s second semester review received lower grades as “needing improvement” in all categories. Clancy recommended non-renewal of Preddie’s contract, and the Board followed that recommendation.
Preddie sued under the ADA and FMLA. First he argued that the non-renewal violated his rights under the ADA. The federal court and the Court of Appeals rejected this argument for two reasons. The Court pointed out that attendance is an essential job function, and the ADA does not protect persons with erratic attendance. Additionally, Preddie was not entitled to reasonable accommodation because his sporadic attendance rendered him not a qualified individual under the law.
On the FMLA issue, Preddie argued that the Board interfered with his rights. The Court of Appeals disagreed with the federal court, which had ruled for the Board. The Court said that an individual need not mention rights under the FMLA or specifically ask for FMLA leave. The burden is on the employer to provide information about the FMLA once the employee provides enough information that he or she needs FMLA qualifying leave. The Court found sufficient evidence that Preddie had provided detailed information to the Board about his son’s Sickle Cell Disease and his need to care for him. That information should have caused the Board to provide Preddie with FMLA paperwork.
Of extreme importance was the Court’s comment that the Board may have used protected leave under the FMLA as a negative factor in evaluating Preddie’s performance. The conversation about Preddie’s need to spend less time caring for his son, if believed by a jury, could be sufficient for Preddie to establish interference with his rights under the FMLA. An employer cannot discourage an employee from using federally protected FMLA rights. The Court therefore permitted Preddie to bring his case before a jury on the FMLA interference issue.
Most employers know that they must provide information about the FMLA when an employee provides information that should lead the employer to realize FMLA rights have been triggered. However, some employers continue to misunderstand the difference between the ADA and FMLA. Under the ADA, the burden is on the employee to request an accommodation, but the employee under the FMLA does not have to specifically reference the FMLA. If an employee has provided sufficient information to the employer that a leave may be needed for FMLA reasons, the employer must provide FMLA information. This case can be found atPreddie v. Bartholomew Consol. Sch. Corp. 31 AD Cases 1761 (7th Cir. 2015).
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John H. Geaney, Esq., is an Executive Committee Member and a Shareholder in Capehart Scatchard's Workers’ Compensation Group. Mr. Geaney concentrates his practice in the representation of employers, self-insured companies, third-party administrators, and insurance carriers in workers’ compensation, the Americans with Disabilities Act and Family and Medical Leave Act. Should you have any questions or would like more information, please contact Mr. Geaney at 856.914.2063 or by e‑mail at jgeaney@capehart.com.
Paul Williams worked for ten years for the Township of Lakewood in the Department of Public Works (DPW). On March 28, 2013, the Township Manager received an anonymous letter concerning Mr. Williams. The writer said he was a co-worker and that he and other co-workers were in fear of their safety because Williams allegedly exhibited outbursts and tirades on a daily basis. The writer said three union stewards (initials provided for the stewards) witnessed such an outburst that very day. The writer claimed to have complained to a former Director, and the writer maintained that Williams was a time bomb waiting to explode and that co-workers feared for their safety.
The Township took no action on the letter for eight months. On December 2, 2013, The Township advised Williams that he must submit to a psychological fitness-for-duty examination, noting that failure to attend the exam would result in disciplinary action. Williams challenged the examination as not meeting the ADA standard of being “job related and consistent with business necessity,” and he refused to attend the examination.
On December 18, 2013, The Township served Williams with a Preliminary Notice of Disciplinary Action seeking to remove him from employment for failing to report for the fitness-for-duty examination. Williams requested a public hearing, which took place on January 6, 2014. The Township rejected Williams’s argument and then issued a Final Notice of Disciplinary Action terminating his employment.
Following an appeal, the Office of Administrative Law heard testimony from the DPW Director. He stated that Williams was sometimes confrontational and sometimes would walk away from someone who tried to speak with him. The Director stated that he did not fear Williams. He only wrote up Williams once over many years and never took any prior disciplinary action against Williams. He further stated that as far as his work, Williams was no different than any other employee.
The Administrative Law Judge reversed the Township’s decision to remove Williams, observing that the Township did not investigate the accuracy of the letter’s allegations against Williams. The ALJ also found no basis to connect the fitness-for-duty examination with Williams’ work duties. The ALJ also criticized the Township’s eight month delay in acting on the letter. Finally, the ALJ said that the Township could not discipline Williams for failing to attend an examination that the Township had no right to require.
Following the decision of the ALJ, the Township filed exceptions and on March 5, 2015, the Civil Service Commission reversed the ALJ’s determination. However, the Commission did not mention the ADA at all in its reversal but rather focused on the insubordination of Williams in not attending the exam. The Commission found against removal but imposed a six-month suspension. Additionally, the Commission ordered that Williams submit to a psychological evaluation.
On appeal to the Appellate Division, Williams argued that psychological examinations are the same as any other medical examinations in that there must be a showing that the exam is job-related and consistent with business necessity under 42.U.S.C.A. 12112(d)(4)(A). The Court commented that the EEOC further defined the “job-related and consistent with business necessity” standard as follows:
Generally, a disability-related inquiry or medical examination of an employee may be ‘job-related and consistent with business necessity’ when an employer ‘has a reasonable belief, based on objective evidence, that: (1) an employee’s ability to perform essential job functions will be impaired by a medical condition; or (2) an employee will pose a direct threat due to a medical condition.’
The Court further drew from 29 C.F.R. 1630.2(r) for the proposition that “direct threat means a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.” The Court went on to cite to EEOC Guidance that an employer may be given credible evidence by a reliable third party that an employee has a medical condition or the employer may observe symptoms that an employee has a medical condition which impairs job performance or may pose a direct threat of harm to the employee or others.
The problem in this case, according to the Court, was that the Township had no reliable information from a third party (the anonymous letter did not meet the standard without investigation) and had not made independent observations of Williams’ alleged behavioral problems at work. It said:
In other words, the employer must reasonably believe, either through direct observation or through reliable information received from credible sources, that the employee’s perceived medical condition is affecting his or her work performance or that the employee poses a direct threat. Then, and only then, may the employer lawfully require the employee to undergo a psychological fitness-for-duty examination.
When information comes from a third party about an employee, the employer should reflect on the EEOC Guidance, which suggests that employers focus on the following: “(1) the relationship of the person providing the information to the employee about whom it is being provided; (2) the seriousness of the medical condition at issue; (3) the possible motivation of the person providing the information; (4) how the person learned the information (e.g., directly from the employee whose medical condition is in question or from someone else); and (5) other evidence that the employer has that bears on the reliability of the information provided.”
In ruling that the Township violated the ADA, the Court noted that there was no objective evidence of any threat posed by Williams and that even the DPW Director stated his performance was satisfactory. The Court said the anonymous letter was not reliable. The identity of the writer was unknown, and there was no investigated done to confirm the allegations in the letter. The case was remanded to the Civil Service Commission for a calculation of back pay due to Williams upon his reinstatement to work at the Township.
This case is well reasoned and extremely helpful to employers in dealing with fitness-for-duty issues. Employers should keep this case at their desk when fitness-for-duty examinations are being contemplated because the case provides sensible guidance. It is among the best cases an employer will read on the rules for fitness-for-duty examinations.
The Appellate Division tried to explain that the Township could have solicited information from the DPW Director and other supervisors regarding Williams’ performance. That kind of credible information could have satisfied the job-related standard. Or the Township could have contacted the three union stewards named in the anonymous letter for information on the alleged outbursts that took place. In other words, the Township had to verify the allegations of the anonymous letter in order to reach a conclusion that the employee may pose a threat to himself or others. In this case, the Township failed to take these steps. Vague rumors or innuendos about an employee clearly do not suffice under the law to justify a fitness-for-duty examination. Direct observations by the employer are obviously the best evidence, but evidence from other employees that has been verified can also form the basis for a fitness-for-duty examination under the job-related and consistent with business necessity test.
This case can be found at In the Matter of Paul Williams, Township of Lakewood, 2016N.J.Super. LEXIS 15, (App. Div. January 25, 2016).
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John H. Geaney, Esq., is an Executive Committee Member and a Shareholder in Capehart Scatchard's Workers’ Compensation Group. Mr. Geaney concentrates his practice in the representation of employers, self-insured companies, third-party administrators, and insurance carriers in workers’ compensation, the Americans with Disabilities Act and Family and Medical Leave Act. Should you have any questions or would like more information, please contact Mr. Geaney at 856.914.2063 or by e‑mail at jgeaney@capehart.com.
Governor Appoints New Commissioner to Industrial Commission
Governor Pat McCrory announced today that Bill Daughtridge, formerly Secretary of Administration, has been appointed a Commissioner at the North Carolina Industrial Commission. The appointment is an emergency appointment which the General Assembly will need to confirm when they return to session in May.
Governor McCrory also has until February 29th to either reappoint Commissioner Linda Cheatham or make a new appointment for the seat. Commissioner Cheatham’s current term runs through June 30, 2016.
Updates from the Industrial Commission:
This follows a flurry of recent activity and changes at the North Carolina Industrial Commission, most notably the appointment of Charlton L. Allen as Chairman.
In January, Governor McCrory also announced the appointments of Brian P. LiVecchi, Dane Scalise and Tyler Younts as Deputy Commissioners, while re-appointing Thomas H. Perlungher and John C. Schafer as Deputy Commissioners as well.
On February 2, 2016, Alabama Republican Senators Orr, Sanford, Livingston, Scofield, Stutts and Melson introduced SB122. The bill seeks to revise sections of 25-5-57 to limit an employer's responsibility for permanent and total disability benefits and medical benefits. Similar revisions have been included in past bills that were unsuccessful. However, those bills included numerous other items resulting in them getting tied up by competing interests.
The first proposed revision in SB122 would limit the employer's responsibility for payment of permanent and total disability benefits. The employer's obligation to pay those benefits would be terminated upon either the date of the employee's 65th birthday or 500 weeks after the date of the injury, whichever is longer.
The second proposed revision would limit an employer's obligation to pay medical benefits. If the employee did not receive treatment related to the injury for 2 years there would be a rebuttable presumption that any subsequent treatment was unrelated. The employer would only be liable for the treatment upon a finding by clear and convincing evidence that the treatment was related. If the employee did not receive related treatment for a period of 4 years, then the employer's obligation to pay for medical treatment would conclusively end.
The article was written by Joshua G. Holden, Esq. a Member of Fish, Nelson & Holden, LLC, a law firm dedicated to representing employers, self-insured employers and insurance carriers in workers’ compensation and related liability matters. Mr. Holden is AV rated by Martindale-Hubbell, which is the highest rating an attorney can receive. Holden and his firm are members of The National Workers’ Compensation Defense Network (NWCDN). The NWCDN is a national and Canadian network of reputable law firms organized to provide employers and insurers access to the highest quality representation in workers’ compensation and related employer liability fields.
The Court of Appeals decided two workers’ compensation cases on February 2, 2016. In Falin v. The Roberts Company Field Services, Inc., the Court affirmed the Full Commission’s award of benefits to Mr. Falin. Temporary partial disability benefits were the only benefits at issue because Mr. Falin had returned to work with a different employer. The case centered on the plain reading of the statutory language defining suitable work under N.C.G.S. § 97-22(2). The statute requires that post-maximum medical improvement work be within 50 miles of the employee’s home in order to be considered suitable employment. In this case, the work The Roberts Company was contending was suitable was 338 miles from Mr. Falin’s home. The Roberts Company contended this job was suitable, despite the distance, because Mr. Falin’s pre-injury job was also hundreds of miles from home and in the same area. The Court ultimately held that the plain reading of the statute made the 50-mile consideration a requirement and not just a factor to be weighed; thus rendering the offered job unsuitable and entitling Mr. Falin to temporary partial disability benefits.
In Pickett v. Advance Auto Parts, Mr. Pickett sought benefits for psychological injuries after being the victim of an armed robbery while working as a salesperson at an Advance Auto store. He was held at gunpoint while the robber stole money and thereafter fled the scene. As a result, Mr. Pickett suffered psychological problems, including post-traumatic stress disorder. The issue before the Court involved challenges to Mr. Pickett’s credibility and to his doctors’ competency as experts. The Commission had previously found Mr. Pickett to be credible, so the Court would not consider questions regarding his credibility; which summarily resolved any challenges to the doctors’ opinions that were founded on Mr. Pickett’s credibility. In regard to challenges to the doctors’ competency as experts, the Court found no basis for finding either doctor incompetent as an expert. This holding also resolved Advance Auto’s challenge to the finding of disability as both doctors had written Mr. Pickett out of work. The Court thus upheld the Commission’s award of ongoing benefits to Mr. Pickett.
Risk Handling Hints: The decisions in Falin and Pickett provide reminders that parties should think carefully when considering whether to appeal a case to the Court of Appeals. Appeals from the Full Commission should not be pursued merely as a matter of course, but instead should be thought out given the facts and posture of the claim. Parties considering an appeal should remember that the Court of Appeals will not overrule the Industrial Commission’s “findings of fact” unless there is no evidence to support those findings.
Jennie Rosario worked for the State of New Jersey as a case worker for the Division of Youth and Family Services. She left the Division’s Maplewood office intending to get into a State-owned vehicle on May 23, 2006 to perform her duties as a field case-worker. As she was leaving the office, her ex-husband assaulted her with a knife, slicing her head. A fellow Division employee managed to distract the ex-husband, who then stabbed himself with the knife. Petitioner then filed a workers’ compensation claim for her injuries.
Days before the attack, petitioner Rosario had been granted a divorce judgment. Rosario had also previously obtained a domestic violence final restraining order against her ex-husband for attempting to murder her mother. Her supervisor had a copy of the restraining order. Security guards were notified of the threat posed to Rosario. Indeed, she asked for the transfer to the office in Maplewood from the East Orange Division office because she was worried about her ex-husband’s release from jail. She feared that he would come to the East Orange office location.
When Rosario’s ex-husband got released from jail, he devised a plan to reach out to her in order to apologize to her for his past criminal acts. On release from jail, her ex-husband contacted the Division’s East Orange office to find her. The receptionist told the ex-husband that she had just been transferred to the Maplewood office. That information led the ex-husband to travel to the Maplewood office where the assault occurred.
The Judge of Compensation held that this attack was a purely personal risk, not incident to Rosario’s employment, and therefore not compensable. Petitioner’s ex-husband testified that the reason that he went to see Rosario was both to apologize for his criminal behavior and to see if the two could reconcile. The Judge of Compensation reasoned that this assault could have occurred anywhere. The ex-husband tried calling petitioner on her cell phone first without success, and he only contacted the Division because he wanted to meet her in a public place.
Rosario argued that since the State disclosed her new location in Maplewood, this was no longer a personal risk. She contended that the State’s actions led to the likelihood that the assault would occur at work. Rosario’s contention was that the State had a duty not to disclose her location given that it was in possession of the restraining order.
On appeal, the court reviewed the case of Howard v. Harwood’s Rest. Co., 25 N.J. 72 (1957) for the proposition that when an attack arises out of a personal relationship, there is no right to workers’ compensation. The Court concurred with the Judge of Compensation that the attack stemmed not from work but from a personal relationship outside work. The Court disregarded the argument that the State had been negligent in offering petitioner’s new location. “Whether an employer actually commits a negligent act is irrelevant to determining compensability – the sole issue is whether the injury is work-related.”
This case is now the second in a few months in which the Appellate Division has found assaults that occurred at work were not compensable because of the personal relationship between the criminal actor and the petitioner victim. This case can be found atRosario v. State of New Jersey, A-4526-13T3 (App. Div. January 28, 2016).
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John H. Geaney, Esq., is an Executive Committee Member and a Shareholder in Capehart Scatchard's Workers’ Compensation Group. Mr. Geaney concentrates his practice in the representation of employers, self-insured companies, third-party administrators, and insurance carriers in workers’ compensation, the Americans with Disabilities Act and Family and Medical Leave Act. Should you have any questions or would like more information, please contact Mr. Geaney at 856.914.2063 or by e‑mail at jgeaney@capehart.com.
Charlton L. Allen Named Chairman of the North Carolina Industrial Commission
Governor Pat McCrory has selected Charlton L. Allen to be the next Chairman of the North Carolina Industrial Commission, effective February 1, 2016. Mr. Allen succeeds Andrew T. Heath who will become State Budget Director.
Uploading to the EDFP
The Industrial Commission will require electronic document filing effective Monday, February 1, 2016 pursuant to Rule .0108. All parties must submit documents electronically, except for pro se parties (who may submit by EDFP, e-mail, fax, U.S. Mail, private courier service, or hand delivery). If a fee is required, the document will not be considered filed until the fee has been paid in full. Some documents must be uploaded through the Electronic Document Filing Portal (EDFP). In order to upload documents to the Commission through the EDFP, parties have to first obtain a North Carolina ID (NCID), and then register with the Commission. Here is a link to instructions for registering for the EDFP provided on the Commission’s website: http://www.ic.nc.gov/EDFPregistrationInstructions.pdf. Here is a link to a tutorial for EDFP submissions also provided on the Commission’s website: http://www.ic.nc.gov/training.html.
The following documents must be uploaded through the EDFP:
The following forms are to be filed by e-mail to forms@ic.nc.gov:
Other Documents to Be E-Mailed
Other motions, responses, and additional documents not previously listed to be filed by e-mail as follows:
The Alabama Court of Civil Appeals recently released its decision in the case ofIn re: Henry Riley v. Reed Contracting Services, Inc. (Ala. Civ. App. January 29, 2016). In its opinion, the Court denied the petition for writ of mandamus filed by Reed Contracting Services, Inc., who was requesting that an Order from the Madison County Circuit Court be vacated. The trial court’s order directed Reed Contracting, Inc. to authorize surgeries, rejected that maximum medical improvement (MMI) had been reached, and further ordered the reinstatement of temporary total disability benefits (TTD) to include accrued benefits from the date the surgeries were initially denied.
Riley was an employee of Reed Contracting Services, Inc., who reportedly fell at work injuring his knees in 2012. Both knees also showed evidence of pre-existing arthritic changes. His authorized treating physician advised that the plan of care would not resolve osteoarthritic pain, which had been aggravated by his work injury. Riley declined further treatment at that time.
Two years later, in 2014, Riley returned to his authorized treating physician, who opined that the current knee complaints were not related to his 2012 injury, placed him at MMI with no impairment rating and released him to return to work full duty.
Riley requested a panel of four physicians, pursuant to §25-5-77(a), Ala. Code 1975. The new authorized treating physician opined that Riley had pre-exisiting arthritic changes in his knees, but that the 2012 accident made the condition worse and more symptomatic, which then warranted bilateral knee-replacement surgery. Reed Contracting Services, Inc., denied authorization for the knee replacement surgeries.
The trial judge found that, prior to the fall, Riley was capable of working as a tire technician, but had not been able to following his fall. The Court also found that both of Riley’s authorized treating physicians believed that the arthritic condition was aggravated as a result of the fall. The trial court held that the 2012 work-related fall caused a "permanent aggravation" of Riley’s arthritic condition and that the knee-replacement surgeries were medically necessary. It also held that the assigned MMI date was invalid, and ordered Reed Contracting Services, Inc., to reinstate TTD to include the payment of accrued benefits.
The Alabama Court of Civil Appeals held that substantial evidence supported the trial court’s finding that Riley’s fall produced a "permanent aggravation" of his arthritic condition and was therefore a contributing cause of the need for the recommended surgeries; making those surgeries compensable under the Act. It further held that substantial evidence supported the trial court’s finding that Riley had not reached MMI; and that the trial court had not erred when it ordered the reinstatement of benefits to include accrued benefits, from when the surgeries were denied.
MY TWO CENTS:
In cases involving a preexisting degenerative condition, the key issue is whether or not the aggravation is permanent. In many cases, you are simply dealing with a flare up which can be treated and returned to baseline. When that happens, the employer is only responsible for paying benefits during the flare up period. It is important to remember that returning to baseline does not necessarily mean returning to the same condition as before the work accident. A degenerative condition by definition gets worse over time. Therefore, returning to baseline simply means returning the employee to the condition he or she would now be in had the work accident not occurred.
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This blog submission was prepared by Karen Cleveland, an attorney with Fish Nelson & Holden, LLC, a law firm dedicated to representing self-insured employers, insurance carriers, and third party administrators in all matters related to workers’ compensation. Fish Nelson & Holden is a member of the National Workers’ Compensation Defense Network. If you have any questions about this submission or Alabama workers’ compensation in general, please contact Cleveland by e-mailing her at kcleveland@fishnelson.com or by calling her directly at 205-332-1599.
In Appeals Panel Decision No. 152184, decided December 29, 2015, t he Appeals Panel reversed
the hearing officer’s determination that the employer tendered a valid bona fide offer of employment
(BFOE) to the claimant, and rendered a new decision that the employer did not tender a BFOE to
the claimant. The hearing officer had found that the employer had issued two offers of employment,
both of which had complied with Rule 129.6.
The two offers, dated approximately one week apart, stated, “The position will entail the following
physical and time requirements” and then listed various work restrictions as noted on the DWC-73,
such as “No standing for more than 1 hour per day,” “No [kneeling]/squatting more than 1 hour per
day,” “No pushing/pulling more than 2 hours per day,” “Must wear splint/cast at work,” and “No
driving or operating heavy equipment.” The claimant appealed the hearing officer’s determination
that these were valid BFOEs, arguing that both offers of employment fail to comply with Rule
129.6(c)(4) because they merely list the restrictions given by the claimant’s treating doctor rather
than state the actual physical and time requirements that the position will entail.The Appeals Panel agreed, noting that Rule 129.6 sets out the requirements for a BFOE and
provides, in part, that “an employer’s offer of modified duty shall be made to the employee in
writing and in the form and manner prescribed by the [Division],” that “a copy of the [DWC-73] on
which the offer is being based shall be included with the offer as well as . . . a description of the
physical and time requirements that the position will entail.”
The Appeals Panel noted that it has previously held that the language in Rule 129.6 is clear and
unambiguous, and that the rule “contains no exception for failing to strictly comply with its
requirements.” In this case, neither offer of employment listed the physical and time requirements
the offered position would entail, nor did they state the specific job position that was being offered.
Instead, both offers of employment only listed restrictions of what the job would not entail, which
does not meet the requirement listed in Rule 129.6(c)(4). Accordingly, the employer did not tender
a BFOE to the claimant.
This decision is a reminder to carriers and employers to ensure their BFOEs to claimants include a
full description of the requirement of the offered position. It is not a bad idea to clarify that the
employee will not be required to perform duties that he/she is specifically prohibited from
performing as noted on the DWC-73; however, the job offer must also include the physical
requirements, time requirements, and state the specific job position that is being offered in order to
meet the requirements of a valid BFOE under Rule 129.6. Appeals Panel Decision No. 152184,
decided December 29, 2015.
At the request of the U.S. Food and Drug Administration (FDA), the Department of Justice filed a
complaint in the U.S. District Court for the Northern District of Texas on January 4, 2016, alleging
that Downing Labs LLC has been engaged in manufacturing drugs that, by virtue of their labeling and/or route of administration, purport to be or are intended to be sterile, but that fail to meet the
safety protections provided under federal law.
The complaint alleges, among other things, that Downing Labs and the individual defendants violate
the Act by introducing or delivering sterile drugs that are prepared, packed, or held under insanitary
conditions whereby they may have been contaminated with filth and/or rendered injurious to health.
The complaint also alleges the drugs are adulterated because the methods used in, or the facilities
or controls used for, their preparation do not comply with current good manufacturing practices
requirements. For example, during one of the inspections conducted by the FDA of Downing Labs
and its predecessor, NuVision Pharmacy Inc., test records showed excessively high levels of
endotoxins. Endotoxins are substances found in certain bacteria that can cause a wide variety of
serious reactions in humans, including high fever and shock. These products were not distributed.
In 2014, records showed that 19 lots of supposedly sterile drugs had tested positive for the pathogens
Staphylococcus haemolyticus and Nocardia nova. These products were not distributed, but the FDA
alleges that the company failed to adequately investigate the cause of these sterility problems. The
complaint alleges that Downing Labs has a long history of manufacturing drug products under
conditions that fall short of the minimum requirements to ensure safety and quality.
The permanent injunction requires Downing Labs and the individual defendants to bring their
processes into compliance with the law. Until then, the defendants are enjoined from manufacturing,
holding, or distributing drugs manufactured at or from their McEwen Road facility (located at
4001McEwen Road, Suite 110, Dallas, Texas). In addition, the FDA has been authorized to order
Downing Labs to stop drug manufacturing should it determine that Downing Labs has violated the
terms of the decree, and may also order Downing Labs to recall drugs or to destroy drugs that are
in the process of being manufactured.