Why the MGM lawsuit is wrong on multiple levels

MGM Complaint from mzamoralaw

By now many people have read with varying degrees of dismay that MGM (and a number of related companies) has decided to file a lawsuit seeking to limit any liability it may have as a result of the deadly massacre carried out by a lunatic during the Route 91 concert.  Stephen Paddock, the gunman, stayed at Mandalay Bay Resort and Casino and shot at concert-goers from a 32nd-floor window of the resort on Oct 1. 2017, killing 58 people and injuring hundreds more. In November 2017, 100's sued MGM and Live Nation, claiming negligence.

What is the lawsuit about?  The 57 page complaint lays it out. After identifying the Plaintiffs, the lawyers for them allege:

Named as defendants in this case are Claimants who have brought lawsuits (which they subsequently voluntarily dismissed) against the MGM Parties, alleging claims arising from Paddock’s attack, and persons who, through counsel, have threatened to bring such claims against the MGM Parties.

There is no pending litigation between Plaintiffs and Defendants relating to the attack. (Para 273). 

The Plaintiffs have attempted to utilize the SAFETY Act. According to the Complaint:

[Citing 6 U.S.C. §442(a)] the SAFETY Act expressly provides for original and exclusive federal jurisdiction over actions arising from or relating to acts of mass violence where technologies or services certified by the Secretary of Homeland Security were deployed. At the time of Paddock’s mass attack at the Route 91 concert, security services were provided by Contemporary Services Corporation as the Security Vendor for the Route 91 Harvest Festival. CSC’s security services were certified by the Secretary of Homeland Security under the SAFETY Act. (Para. 268). 

The SAFETY Act created liability limitations for claims resulting from an act of terrorism where Qualified AntiTerrorismTechnologies (QATTs) have been deployed.

Lawyers not linked with the case have claimed that law was intended to shield manufacturers of security equipment—such as airplane doors and metal detectors—under the cloak of U.S. sovereign immunity and by potentially capping damages. 

See http://www.abajournal.com/news/article/mgm_resorts_uses_an_obscure_law_to_sue_las_vegas_mass_shooting_victims 

Was it terrorism?  No. "When asked if authorities believed the massacre to be an act of terrorism, Clark County Sheriff Joe Lombardo said, “No, not at this point ..."(2017)

https://www.ajc.com/news/national/was-the-las-vegas-gunman-terrorist-under-nevada-law-possibly-under-federal-law-not-exactly/S3Gz798YQGe9mw1BUyek4O/

In January of this year, the LVMPD issued a preliminary report.   The initial conclusion? This was not an act of terrorism. From the report:

Paddock acted alone. Thousands of hours of digital media were reviewed and after all the interviews conducted, no evidence exists to indicate Paddock conspired with or acted in collusion with anybody else. This includes video surveillance, recovered DNA19and analysis of cellular phones and computers belonging to Paddock. 

* No suicide note or manifesto was found. Of all the evidence collected from rooms 32-135 and 32-134, there was no note or manifesto stating Paddock’s intentions. The only handwritten documentation found in either room was the small note indicating measurements and distances related to the use of rifles. 

* There was no evidence of radicalization or ideology to support any theory that Paddock supported or followed any hate groups or any domestic or foreign terrorist organizations. Despite numerous interviews with Paddock’s family, acquaintances and gambling contacts, investigators could not link Paddock to any specific ideology. 

The law enforcement agency assigned to this tragedy cannot come to the conclusion that the violence was terrorism. This report was issued nearly six months prior to the MGM filing.

What has the Department of Homeland Security said? Well, they haven't said it's terrorism: 


DHS Statement on Las Vegas Shooting
Release Date: 

October 2, 2017

For Immediate Release
Office of the Press Secretary
Contact: 202-282-8010

WASHINGTON – Acting Homeland Security Secretary Elaine Duke has been briefed on the horrific shooting in Las Vegas, Nevada last night. The Department is closely monitoring the situation and working with our federal, state and local partners in responding to and investigating this tragedy.

At this time, we have no information to indicate a specific credible threat involving other public venues in the country. However, increased security in and around public places and events may be experienced as officials take additional precautions.

Our thoughts and prayers are with all those affected by this incident as we work to support the Las Vegas community.

See: https://www.dhs.gov/news/2017/10/02/dhs-statement-las-vegas-shooting

The FBI also chimed in: 

The FBI said the deadly mass shooting in Las Vegas had no connection with an international terrorist group. "We have determined, to this point, no connection with an international terrorist group," an FBI special agent stated. 

See http://thehill.com/homenews/news/353426-fbi-las-vegas-shooting-has-no-connection-with-international-terrorist-group

The day before the lawsuit was filed, zero law enforcement on the local, state, or national levels had declared this heinous act one that was considered terrorism. 

The day before this lawsuit was filed, what is known about the SAFETY Act is what any person - lawyer or not- could find on the web: 

The purpose of the Act is to ensure that the threat of liability does not deter potential manufacturers or sellers of effective anti-terrorism technologies from developing and commercializing technologies that could save lives. Key to this act is  an “act of terrorism” is an act, determined by the Secretary of DHS. At the very least, in the absence of such a determination, reason and logic would suggest that some law enforcement agency would make that determination - not  a Judge.

Legal scholars have noted the limits of the SAFETY Act: If an incident is deemed by DHS to be an act of terrorism, an entity that has achieved this level an utilize the government contractor defense to all claims that may arise. The NFL received the distinction in December 2008, and its renewal runs through November 2018.Those benefits do not flow down to the teams or stadium owners.



Here, the legal reasoning is wrong. Was there some authentic effort to proceed in some other way? Was the only resort the filing of a lawsuit against victims, even if only seeking a declaration/limitation of rights? In the cases found on Pacer, such as Sheppard et al v. Mandalay Bay, LLC et al the Removal papers describe the SAFETY act as the basis for being before the USDCT. Would consolidation, and a stay have been the better course? Some won't ever know now. There are reports that some of the survivors are now dealing with another round of PTSD thanks to this.

Now, on to what is worse.

This is a huge business blunder in my humble opinion. By it's own admission, MGM states that there are no lawsuits pending, only a 'threat' of several. So what does it do? The Plaintiffs send out a summon to nearly 1,000 people. In some instances, there are estates established (undoubtedly). What will those people do? Ignore the lawsuit? Do they have enough money to retain counsel in Nevada? What happens if they do not answer? Is there a default? In theory, a victim who needed and received medical care incurred costs. That same victim may have lost time from work, or worse. Is this a second act that also victimizes a person who is truly innocent?

From a business perspective, MGM is getting skewered on Social Media:

Meanwhile, on Twitter:

In the quest to limit liability, common sense and reason should rule the day. In my opinion, both went out the window with that filing when it came to the victims. MGM is (in my view) clearly hoping for the entry of defaults by the hundreds. So, in a way that is best called perverse, victims will "lose" as defendants. I predict a Motion for SJ will be filed where the first few lines will state: "More than 300 Defendants have failed or refused to Answer the Complaint served."

Will the DHS Secretary be deposed? Will a retired "law enforcement expert" be hired to complete an affidavit that says yes, this was terrorism? I'll bet one person a nickel that happens. This cannot be what the SAFEY act authors envisioned. 


What do other say?

From the USA Today:

How any corporation could find the gall and lack of humanity to take such an action is beyond comprehension.The federal law was meant to protect companies, for example, that come up with new technologies to thwart terrorist attacks, but might be reluctant to market them for fear of liability if a terrorist attack occurred.

From CBS:

Nine months after the Las Vegas shooting, shooting survivor Lisa Fine's physical injuries have healed. Her emotional and psychological wounds have not. Fine is the co-founder of Route 91 Strong, a group for survivors of the concert shooting. Fine says MGM's latest legal maneuver makes her feel sick to her stomach. "It feels like bullets flying at my head right now," Fine said.

An attorney for several victims has been quoted: "I've never seen a more outrageous thing, where they sue the victims in an effort to find a judge they like,” he said. "It's just really sad that they would stoop to this level."

Agree? Disagree?


   

FDA working with manufacturers to withdraw Zinbryta from the market in the United States

Another recall, this one on Zinbryta:

On March 2, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta (daclizumab), a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile. As a result, FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment.  No new patients will start taking Zinbryta or participate in clinical studies. The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018.

Patients using Zinbryta should not stop their medication without talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms. Any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 1-800-456-2255 or the manufacturer’s website at www.zinbryta.com. We understand that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process.

The complex safety profile of Zinbryta has been recognized since the time of FDA approval. The drug’s safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more multiple sclerosis drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug only available through a restricted distribution program. FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available.

https://www.fda.gov/Drugs/DrugSafety/ucm600999.htm

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel

News of a recall of the product known as Limbrel. From the FDA:

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.

Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA's health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.

All lots within expiry of the following products are included in this recall:

• Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
• Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
• Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
• Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16

Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. Prior to marketing, Primus conducted clinical studies that support the efficacy and safety of Limbrel and compiled an extensive dossier providing an analysis of published data to support the medical food status of Limbrel and to establish how the product meets the distinctive nutritional requirements of OA.  Primus stands by the legal status of Limbrel as a medical food. Limbrel products have been distributed nationwide in the USA to wholesalers, pharmacies, and physicians as medical foods without challenge from FDA for over 13 years, with approximately 2 million prescriptions and physician samples dispensed to an estimated 450,000 patients.

https://www.fda.gov/Safety/Recalls/ucm594357.htm

Tasigna in the News

News across the web about Tasigna:

Tasigna (nilotinib) was approved by the U.S. Food & Drug Administration in 2007 to treat patients suffering from Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML). The medication belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which block a protein called Bcr-ABl to stop the growth of cancer cells. Since its approval, several studies have suggested that patients treated with Tasigna may be more likely to develop arteriosclerosis-related condition. For example, a 2016 study published in the American Journal of Hematology linked Tasigna to an increased risk for peripheral artery disease and sudden death.

In 2013, researchers writing in Leukemia reported that patients treated with Tasigna had higher rates of arterial disease compared to those prescribed imatinib. The Canadian label for Tasigna was updated in 2013 to note a potential risk of arteriosclerosis, after a review revealed that 277 reports of the condition had been logged with the Novartis global safety database between January 1st, 2005 and January 31, 2013. Canadian doctors were advised to closely monitor their Tasigna patients for signs of the life-threatening artery disease.

Here is the link for the Canada label changes made in 2013:

Subject: Updated information regarding the possible risk of developing atherosclerosis-related conditions with the use of TASIGNA* (nilotinib)

Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).

TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML).

• Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
• Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
• During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professional will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
• Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.

Atherosclerosis is a disease that occurs in arterial blood vessels (arteries) and occurs more frequently in older adults. In atherosclerosis the walls of the arteries become thickened and hardened by plaque buildup. Plaque is made from fatty deposits and cells that can build up in the walls of your arteries over many years. As plaque builds up, the arteries narrow and become less flexible and the blood flow through the arteries can be reduced. Possible complications of atherosclerosis include heart attacks and strokes.

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26659a-eng.php

Nuplazid in the News

The Food and Drug Administration (FDA) is re-examining the safety of a new drug after reports that it has potentially caused serious side effects and numerous deaths. 

The agency confirmed to The Hill it is “conducting an evaluation of available information” about Nuplazid, a drug approved in 2016 to treat delusions and hallucinations associated with Parkinson’s disease psychosis.

During a House hearing about FDA’s budget last week, Rep. Rosa DeLauro(D-Conn.) pressed FDA Commissioner Scott Gottlieb to answer why the drug was still on the market, even though there were 600 reported deaths associated with the drug in 2017.

http://thehill.com/policy/healthcare/384895-fda-re-examining-parkinsons-drug-after-reports-of-deaths

FDA recalls BBQ sauces with South Carolina roots

Two barbecue sauces with South Carolina roots are being recalled because of a possible allergic reaction to some ingredients.

Piggie Park Enterprises Inc. of West Columbia is recalling Maurice’s Southern Gold Honey Sauce and Gourmet Carolina Gold Honey Sauce, according to the U.S. Food & Drug Administration.

Read more here. https://www.postandcourier.com/business/fda-recalls-bbq-sauces-with-south-carolina-roots/article_9a1ffcea-2d0b-11e8-bef8-bf3f91e752ec.html

Arizona Woman Killed by Self-Driving Uber Car

From: https://www.ridesharelawgroup.com/arizona-woman-killed-self-driving-uber-car/

Uber has been testing self-driving vehicles on the road since December 2016, when it first became possible for Uber passengers to request a self-driving vehicle in San Francisco. In 2017, the company entered an agreement with Volvo to bring 24,000 self-driving Uber cars to rideshare passengers in the coming years. Now, all of the company’s self-driving vehicle testing has come to an abrupt halt.

Read more here.

http://stpete.attorney/injury-claims

FDA announces recall of dietary supplements after opioid declaration

From the FDA:

The U.S. Food and Drug Administration today announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market and submit any necessary evidence, as appropriate, to the FDA to evaluate them based on the applicable regulatory pathway.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, M.D. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption   to take swift action to remove these products from circulation to protect the public.” 

Read more here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597649.htm

Are Uber and Lyft Drivers Really Independent Contractors?

Rob Sach from PA has this excellent post on whether or not Lyft or Uber drivers are employees. 

In Rob's post, he summarized a recent decision, and wrote that a Court determined that individuals who are receiving unemployment compensation benefits often engage in temporary assignments to supplement their income or to assist them in finding full time employment.  

One of the most popular defenses that companies like Uber and Lyft try to use in accident cases is that the driver was an “independent contractor.”  The case summary that Rob writes about notes that Pennsylvania now has one of the first appellate cases which may persuade a court  that all the actions taken to become a rideshare driver do not create a relationship of somebody previously pigeon-holed as an “independent contractor.”  

Read more here: https://www.ridesharelawgroup.com/uber-lyft-drivers-really-independent-contractors/ 

Imprimis Gets a Warning Letter

WARNING LETTER

Mark Baum
Imprimis Pharmaceuticals Inc.
12264 El Camino Real, Suite 350
San Diego, CA 92130

Dear Mr. Baum:

This is to advise your firm that the U.S. Food and Drug Administration (FDA) has reviewed promotional materials disseminated by your firm, including the website at www.imprimisrx.com 1 where you take orders for the following compounded drug products:

• “Dropless” products

o Tri-Moxi (triamcinolone acetonide, moxifloxacin hydrochloride), 15/1mg/ml
o Tri-Moxi-Vanc (triamcinolone acetonide, moxifloxacin, vancomycin), 15/1mg/10mg/mL
o Moxi (moxifloxacin hydrochloride), 5mg/mL

• “LessDrops” products

o Pred-Gati-Nepaf (prednisolone acetate, gatifloxacin, nepafenac), 1/0.5/0.1%/mL
o Pred-Gati (prednisolone acetate, gatifloxacin), 1/0.5%/mL
o Pred-Nepaf (prednisolone acetate, nepafenac), 1/0.1%/mL

• “Simple Drops” products

o Tim-Brim-Dor PF 2  (timolol/brimonidine/dorzolamide), 0.5/0.15/2%
o Tim-Brim-Dor-Lat PF (timolol/brimonidine/dorzolamide/latanoprost), 0.5/0.15/2/0.005%
o Tim-Dor-Lat PF (timolol/dorzolamide/latanoprost), 0.5/2/0.005%
o Tim-Lat PF (timolol/latanoprost), 0.5%/0.005%

• “Klarity C-Drops” product (cyclosporine 0.1%/chrondroitin sulfate)

The claims on your website and other promotional materials establish that these products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the cure, mitigation, treatment or prevention of disease.  As explained further below, your firm’s website and twitter account make false or misleading claims regarding “Simple Drops” and “Klarity C-Drops” – specifically, they represent that these products are made with FDA approved components or are FDA-approved, when that is not the case.  In addition, your firm’s website makes false or misleading claims about your “Dropless,” “LessDrops,” and “Simple Drops” products by omitting important risk information, including side effects, contraindications, or consequences that may result from their use, and by presenting  efficacy claims about your “Simple Drops” products while omitting material information. 

Thus, the webpage and other promotional materials misbrand your “Dropless,” “LessDrops,” “Simple Drops,” and “Klarity C-Drops” products within the meaning of the FD&C Act and make their distribution violative.  21 U.S.C. 352(a), (bb); 321(n); 331(a). 

These violations are concerning from a public health perspective because they create a false or misleading impression about the safety and effectiveness  of these products.  This is especially concerning in light of the many known risks associated with several of the active ingredients in these products, as reflected in the prescribing information for FDA-approved products containing the same active ingredients 3,  and the technique by which your website indicates your “Dropless” products should be administered.  These risks include, but are not limited to, hemorrhagic occlusive retinal vasculitis (HORV) and ciliary body hemorrhage.  Appendix I to this Warning Letter includes descriptions of these and other known risks associated with the active ingredients in your products and the technique by which your website indicates your “Dropless” products should be administered.

In addition, your website and other promotional materials contain claims  regarding the effectiveness of your “Simple Drops” products that are not supported by the effectiveness data for the active ingredients in certain “Simple Drops” products.  The claims on your website and in other promotional materials suggest  that patients can treat elevated intraocular pressure with “One Simple Drop” according to “One Simple Regimen,” but fail to disclose that a patient would need to take more than one eye drop product pursuant to multiple, different dosing regimens in order for the active ingredients in those “Simple Drops” to be effective throughout the day.  This is concerning because patients can lose vision in the form of visual field loss (also known as glaucoma) if elevated intraocular pressure is not controlled thoughout a 24 hour period each day.  Appendix II to the Warning Letter includes information about the effectiveness of the active ingredients in your “Simple Drops” products that does not support and is inconsistent with your effectiveness claims.

False or Misleading Claims

Your “Simple Drops” brochure states that your products are “Compounded with FDA-approved drug components.” In addition, a press release, “Imprimis Pharmaceuticals to Launch its Simple Drops Combination Glaucoma Drops at Leading Cataract & Refractive Surgery Medical Meeting,” May 4, 2017, states, “Simple Drops consist of high-quality sterile FDA-approved components that are made and dispensed from Imprimis’ PCAB-accredited and FDA-inspected facilities.” Furthermore, on October 25, 2017, you tweeted the following on your Twitter account, @markbaum4:  “EyewireTV – Compounded Cyclosporine Introduced eyewiretoday.com/?v=mwloh #bauch lomb #dryeye #fdaapproval/clearance #imprmispharmaceuticals,” suggesting your compounded cyclosporine product – “Klarity-C drops” -- is FDA approved. Because your “Simple Drops” products are compounded using bulk drug substances, which are not FDA-approved, and your “Klarity-C drops” product is not FDA-approved, these statements are false or misleading. 

False or Misleading Risk Presentation

A drug is misbranded if its labeling, including promotional labeling, is false or misleading in any particular.  21 U.S.C. 352(a).  In addition, a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.  21 U.S.C. 352(bb).  In determining whether labeling or advertising is misleading, section 201(n) of the FD&C Act requires that it be taken into account whether the labeling or advertising fails to reveal facts that are material in light of representations made or with respect to consequences that may result from the use of the drug as recommended or suggested by the labeling or advertising or under such conditions of use as are customary or usual. 

Your firm’s website includes claims about the efficacy and use of “Dropless,” “LessDrops,” and “Simple Drops” products, each of which consists of multiple active ingredients.  According to your website, “Dropless” products are intended for intravitreal injection during ocular surgery to prevent infection and inflammation; “Less Drops” products are intended for topical use post ocular surgery to prevent infection and inflammation; and “Simple Drops” products are intended for topical use to treat elevated intraocular pressure.  Appendix III includes additional examples of claims made by your firm about the efficacy of your firm’s ophthalmic products. However, your firm’s website fails to communicate any risk information associated with these products. 

This is particularly concerning in light of the many known risks associated with the active ingredients in these products and the technique by which your website indicates that your “Dropless” products should be administered.  For example, one of your “Dropless” products includes triamcinolone, moxifloxacin, and vancomycin, and this product recently was associated with an incident of HORV, a rare, potentially blinding postoperative complication. 4  There are also many known risks associated with transzonular injection via cannula of “Dropless” products, such as floaters and ciliary body hemorrhage. 

By failing to present any information regarding the risks associated with these products, the website is false or misleading.  The omission of risk information suggests that the drugs do not bear the risks that are known to be associated with the active ingredients in these products and the technique by which your website indicates that your “Dropless” products should be administered.  The absence of risk information on your website is especially problematic from a public health perspective.  Because these risks are not described, the website does not enable healthcare providers to make informed decisions about whether the benefits of your products outweigh the risks for their patients or to inform patients of appropriate monitoring that could minimize consequences of these potential adverse events. 

False or Misleading Efficacy Presentation

Patients often take multiple eye drop products with different active ingredients and different dosing regimens (e.g., one drop or multiple drops at different times of day) to treat elevated intraocular pressure.  Your firm combines the active ingredients in those different eye drop products into single products, the “Simple Drops” products, and offers those products as treatments for elevated intraocular pressure. However, the effectiveness data for certain active ingredients in the “Simple Drops” products suggest that a patient would need to follow different dosing regimens for the various active ingredients in the “Simple Drops” products in order for each ingredient to be effective throughout the day.

In determining whether labeling or advertising is misleading, section 201(n) of the FD&C Act requires that it be taken into account whether the labeling or advertising fails to reveal facts that are material in light of representations made.  While your firm’s website and other promotional materials suggest that “Simple Drops” products are effective in treating elevated intraocular pressure, they do not disclose that an effective treatment regimen using the active ingredients in the “Simple Drops” products would require additional doses of certain products.  Instead, your firm’s website and other promotional materials contain claims  regarding the effectiveness of your “Simple Drops” products which are neither supported nor consistent with the effectiveness data associated with their active ingredients. 

Examples of these claims include:

• “One Simple Drop. One Simple Regimen.”
• “Imprimis Pharmaceuticals to Launch its Simple Drops Combination Glaucoma Drops at Leading Cataract & Refractive Surgery Medical Meeting,” May 4, 2017

o “Simple Drops preservative-free drops conveniently provide multiple glaucoma medications into a single bottle providing patients with a simple treatment option.  By providing multiple medications into one combination drop, Simple Drops may increase patient compliance and reduce costs.”
 

• “Simple Drops may simplify your patient’s treatment regimen by combining multiple glaucoma medications into a single bottle”
• “May increase patient compliance by reducing the number of drops taken per day”
• “Reduce compliance issues with multiple drop bottles. Simplify your patient’s treatment with one Preservative-Free Simple Drop”
• “Simple Drops include multiple medications into one drop bottle for your patient’s convenience”
• “Provides convenience of multiple medications into one combination drop”
• “May increase patient compliance by reducing the number of drops needed per day”

In addition, a video, “Eye Drop Instructions For Use,” states that “LessDrops” and “Simple Drops” products “may require fewer drops” and “may reduce post treatment confusion.”

The claims described above suggest that to effectively treat elevated intraocular pressure, a patient would only need to take one product (“One Simple Drop”) pursuant to one dosing regimen (“One Simple Regimen”), rather than multiple products pursuant to multiple, different dosing regimens.  They also suggest that the purported benefits of doing so include increasing the simplicity of the dosing regimen, reducing the number of drops taken per day, increasing patient compliance, and reducing post treatment confusion.  These claims are not accompanied by any additional information about the dosage regimen that would be necessary for each drug product in order to ensure effective treatment.

The false or misleading efficacy presentations for these products is particularly concerning because they may lead healthcare providers to prescribe only “Simple Drops” products to treat elevated intraocular pressure, when patients may not be receiving effective medications with certain “Simple Drops” products alone. Patients can lose vision in the form of visual field loss (also known as glaucoma) if elevated intraocular pressure is not controlled thoughout a 24 hour period each day. 

Conclusion

For the reasons discussed above, your webpage and other promotional materials misbrand the “Dropless,” “LessDrops,” “Simple Drops,” and “Klarity-C drops” products within the meaning of the FD&C Act, which makes their distribution violative. 21 U.S.C. 352(a), (bb); 321(n); and 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations associated with your drug products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.

In addition, we request that you include in your response copies of all labeling, including package inserts associated with the “Dropless,” “LessDrops,” “Simple Drops,” and “Klarity-C drops” products, and indicate which one of your facilities distribute each of these products. 5

Your firm’s response should be sent to:
 
CDR Steven E. Porter, Jr. 
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild
Irvine, California 92612
 
If you have any questions regarding any issues in this letter, please contact Jessica Mu, Compliance Officer, at Jessica.Mu@fda.hhs.gov, and reference unique identifier CMS 540678.
 
Sincerely,
/S/ 
Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

APPENDIX I

Technique-related risks

Risks associated with transzonular injection via cannula of “Dropless” products include 6: 
 
 Ciliary body hemorrhage
 Vitreous floaters
 Blurred vision

Active ingredient-related risks 7

Risks associated with “Dropless” products include:

Tri-Moxi (triamcinolone acetonide, moxifloxacin hydrochloride), 15/1mg/mL

Elevated intraocular pressure
Glaucoma
If a lens is still present, cataract formation
Allergic reactions
Vitreous floaters
Blurred vision

Tri-Moxi-Vanc (triamcinolone acetonide, moxifloxacin hydrochloride, vancomycin), 15/1mg/10mg/mL

Elevated intraocular pressure
Glaucoma
If a lens is still present, cataract formation
Allergic reactions
 Hemorrhagic occlusive retinal vasculitis (HORV)
Vitreous floaters
 Blurred vision

Moxi (moxifloxacin hydrochloride), 5mg/mL 

 Allergic reactions
 Prolonged use may result in overgrowth of non-susceptible organisms, including fungi.

Risks associated with “LessDrops” products include:

Pred-Gati-Nepaf (prednisolone acetate, gatifloxacin, nepafenac), 1/0.5/0.1%/mL

Elevated intraocular pressure
Glaucoma
Allergic reactions
Hyphema Keratitis
 Increased potential for corneal healing problems
 Corneal thinning
 Corneal erosion
 Corneal ulceration
 Corneal perforation
 If a lens is still present, cataract formation

Pred-Gati (prednisolone acetate, gatifloxacin), 1/0.5%/mL

Elevated intraocular pressure
Glaucoma
Allergic reactions
 Increased potential for corneal healing problems
 Corneal thinning
 Corneal erosion
 Corneal ulceration
 Corneal perforation
If a lens is still present, cataract formation

Pred-Nepaf (prednisolone acetate, nepafenac), 1/0.1%/mL

Elevated intraocular pressure
Glaucoma
Allergic reactions
 Hyphema
 Keratitis
 Increased potential for corneal healing problems
 Corneal thinning
 Corneal erosion
 Corneal ulceration
 Corneal perforation
If a lens is still present, cataract formation

Risks associated with “Simple Drops” products include:

TIM-LAT (timolol/latanoprost)

 Use of timolol, including topical ophthalmic timolol is contraindicated in patients with bronchial asthma or a history of bronchial asthma
 Use of timolol is contraindicated in patients with second or third degree atrioventricular block
 Use of timolol is contraindicated in patients with overt cardiac failure
 Use of timolol is contraindicated in patients with severe chronic obstructive pulmonary disease
 There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
 Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
 Masking of the signs and symptoms of acute hypoglycemia 
Increased pigmentation of the iris
 Increased pigmentation of the periorbital tissue (eyelid)
 Increased pigmentation and growth of the eyelashes
 Latanoprost should not be used in patients with active intraocular inflammation
 Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule
 

BRIM-DOR (brimonidine/dorzolamide)

 Hypersensitivity reactions
 Potentiation of syndromes associated with vascular insufficiency
 Fatigue/drowsiness
 Corneal edema in patients with low endothelial cell counts
 Lethargy/Coma in patients under two years of age

TIM-BRIM-DOR (timolol/brimonidine/dorzolamide)

Use of timolol, including topical ophthalmic timolol is contraindicated in patients with bronchial asthma or a history of bronchial asthma
 Use of timolol is contraindicated in patients with second or third degree atrioventricular block
 Use of timolol is contraindicated in patients with overt cardiac failure
 Use of timolol is contraindicated in patients with severe chronic obstructive pulmonary disease
 There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
 Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
 Masking of the signs and symptoms of acute hypoglycemia 
 Hypersensitivity reactions
 Potentiation of syndromes associated with vascular insufficiency
 Corneal edema in patients with low endothelial cell counts

TIM-DOR-LAT (timolol/dorzolamide/latanoprost)

Use of timolol, including topical ophthalmic timolol is contraindicated in patients with bronchial asthma or a history of bronchial asthma
 Use of timolol is contraindicated in patients with second or third degree atrioventricular block
 Use of timolol is contraindicated in patients with overt cardiac failure
 Use of timolol is contraindicated in patients with severe chronic obstructive pulmonary disease
 There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
 Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism.
 Masking of the signs and symptoms of acute hypoglycemia 
 Hypersensitivity reactions
 Corneal edema in patients with low endothelial cell counts
Increased pigmentation of the iris
 Increased pigmentation of the periorbital tissue (eyelid)
 Increased pigmentation and growth of the eyelashes
 Latanoprost should not be used in patients with active intraocular inflammation
 Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule

TIM-BRIM-DOR-LAT (timolol/brimonidine/dorzolamide/latanoprost)

Use of timolol, including topical ophthalmic timolol is contraindicated in patients with bronchial asthma or a history of bronchial asthma
 Use of timolol is contraindicated in patients with second or third degree atrioventricular block
 Use of timolol is contraindicated in patients with overt cardiac failure
 Use of timolol is contraindicated in patients with severe chronic obstructive pulmonary disease
 There are respiratory and cardiac contraindications because severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma have been reported following ophthalmic administration of timolol
 Masking of certain clinical signs (e.g., tachycardia) of hyperthyroidism
 Masking of the signs and symptoms of acute hypoglycemia 
 Hypersensitivity reactions
 Corneal edema in patients with low endothelial cell counts
Increased pigmentation of the iris
 Increased pigmentation of the periorbital tissue (eyelid)
 Increased pigmentation and growth of the eyelashes
 Latanoprost should not be used in patients with active intraocular inflammation
 Macular edema may occur particularly in patients with pseudophakia with a torn posterior capsule
 Potentiation of syndromes associated with vascular insufficiency

 
APPENDIX II

Efficacy information associated with “Simple Drops” products:

Timolol/Latanoprost 

This combination has been studied.  It was determined that giving timolol in the morning and latanoprost at night, i.e., splitting the timing of the dosing, was more effective than giving the combination once or twice a day.

Timolol/Brimonidine/Dorzolamide

Timolol is most effective when administered in the morning, and should not be given more than twice a day. In order for Brimonidine and Dorzolamide to be effective throughout the entire day, they must be administered three times a day because they only work for 8 hours.  As a result, any patient who uses this product would also have to use multiple other products that include Brimonidine and Dorzolamide in order for this product to be effective throughout the entire day. 

Timolol/Dorzolamide/Latanoprost

Timolol is most effective when administered in the morning, and should not be given more than twice a day.  Latanoprost is administered once per day, and is most effective when administered just before bedtime.  If Latanoprost is administered more than once a day, it can be less effective in lowering intraocular pressure than being dosed once a day or it can cause paradoxical elevations in intraocular pressure.  In order for Dorzolamide to be effective throughout the entire day, it must be administered three times a day because it only works for 8 hours.   As a result, any patient who uses this product would also have to use another product that includes Dorzolamide in order for this product to be effective throughout the entire day.

Timolol/Brimonidine/Dorzolamide/Latanoprost

Timolol is most effective when administered in the morning, and should not be given more than twice a day.  Latanoprost is administered once per day, and is most effective when administered just before bedtime.  If Latanoprost is administered more than once a day, it can be less effective in lowering intraocular pressure than being dosed once a day or it can cause paradoxical elevations in intraocular pressure.  In order for Brimonidine and Dorzolamide to be effective throughout the entire day, they must be administered three times a day because they only work for 8 hours.  As a result, any patient who uses this product would also have to use multiple other products that include Brimonidine and Dorzolamide in order for this product to be effective.

APPENDIX III

The following are additional examples of claims  made by your firm about the efficacy of your firm’s ophthalmic products:

Web content:

• “Dropless” products

o “Dropless Cataract Surgery”
o “Reduce issues with patient compliance”
o “Single Intraocular administration”
o “Quality sterile injectable compounded medications for use in ocular surgery” 
o “Ophthalmologists currently using Dropless Therapy formulations believe the optimal location for the injection would be the vitreous due to the depot effect. This is achieved by one of two approaches:

 Transzonular injection via cannula.
 Pars plana injection via needle”

• “LessDrops” products

o “Keep It Simple”
o “Provide fewer drops . . . with our proprietary topical ophthalmic compounded formulations for patients following LASIK, PRK, cataract, and other ocular surgeries (and non-surgical applications)”
o “Combination drop therapy may reduce the number of eye drops needed after ocular surgery”
o “Quality sterile compounded medications for pre and post ocular surgery”
 

• “Simple Drops” products

o “Simple Drops may simplify your patient’s treatment regimen by combining multiple glaucoma medications into a single bottle”

“Simple Drops” Brochure on website:

• “Reduce compliance issues with multiple drop bottles. Simplify your patient’s treatment with one Preservative-Free Simple Drop”
• “Simple Drops include multiple medications into one drop bottle for your patient’s convenience”
• “Provides convenience of multiple medications into one combination drop”
• “May increase patient compliance by reducing the number of drops needed per day”

Press releases posted on your website:

• “Imprimis Pharmaceuticals Secures First Key Composition Patent for Dropless Therapy Formulations,”  October 2, 2017
 

o “Imprimis’ Dropless Therapy compounded antibiotic and steroid formulations are available in single, injectable intraocular doses administered by physicians following ocular surgery. Dropless Therapy may substantially reduce or eliminate the need for patient-administered eye drops following surgery, thereby potentially eliminating patient non-compliance and dosing errors associated with post-operative care regimens.”

o “Dropless Therapy can simplify the post-operative care process, provide safeguards against bacterial infection and inflammation, and may decrease overall cost.”
 

• “Imprimis Pharmaceuticals Patent-Pending Dropless and LessDrops Formulations Exceed One Million Patient Eyes Milestone,” July 27, 2017
 

o “By eliminating or reducing the need for post-surgery eye drop regimens, Dropless injectable formulations…”
o “…Imprimis’ affordably priced LessDrops combination topical drops serve patients following cataract, refractive and other ocular procedures.”
o Mark L. Baum, CEO of Imprimis, stated, “Our innovative solutions, which all have come from the clinical experience of our physician-customers, have eliminated or reduced post-surgery drop regimens, provided better medication adherence and recovery, in addition to saving customers money compared to the standard of care.”
o “Two compounded antibiotic and steroid formulations currently available in single, injectable, intraocular doses administered during ocular surgery include preservative-free combinations of triamcinolone acetonide and moxifloxacin hydrochloride and triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin….Intraoperative administration of drugs has been shown to reduce both non-compliance and patient error, significantly lessening the surgeon's concern and elevating the patient's experience with cataract surgery. Physicians have prescribed Imprimis' proprietary formulations for use in thousands of cataract surgeries, and have reported advantages including reduction of compliance concerns and reduction of staff and chair time spent on instructions and follow-up with post-operative surgical patients and pharmacists.”
o “Imprimis' portfolio of combination drop therapy topical formulations may require up to 50% fewer drops to be administered by patients and may provide significant cost savings of up to 75% compared to current traditional post-surgery eye drop treatments.”
 

• “Imprimis Pharmaceuticals to Launch its Simple Drops Combination Glaucoma Drops at Leading Cataract & Refractive Surgery Medical Meeting,” May 4, 2017
 

o “Simple Drops preservative-free drops conveniently provide multiple glaucoma medications into a single bottle providing patients with a simple treatment option.  By providing multiple medications into one combination drop, Simple Drops may increase patient compliance and reduce costs.  Each formulation is provided in a uniquely-designed bottle with PureFlow technology, which allows for a one-way valve system preventing the risk of contamination.”

Investor materials posted on your website:

o Imprimis Fact Sheet, Q2-2017

o “Dropless Therapy compounded antibiotic and steroid formulations are available in single, injectable intraocular doses administered by physicians following cataract surgery. Dropless Therapy may substantially reduce or eliminate the need for patient administered eye drops following surgery, thereby largely eliminating patient non-compliance and dosing errors associated with post-operative care regimens.”
o “LessDrops combination topical eye drops may reduce the need for multiple post-operative eye drops following cataract, LASIK and other ocular procedures. This approach may help to cut medication costs, improve compliance and enhance the patient experience. It is estimated that LessDrops combination topical drops can require up to 50% fewer drops to be administered by patients and cost up to 75% less than current post-procedure eye drop regimens.”
o “Simple Drops are proprietary preservative free combination eye drops for patients suffering from Glaucoma. Our formulations may improve compliance by reducing the number of drops patients need to administer daily and simplifying their dosage regimen.”

o Investor Presentation

o “Dropless Cataract Surgery”
 “Substantially reduces or eliminates the need for post-operative eye drops”
o “LessDrops Combination Drop Therapy”
 “Up to 50% fewer eye drop applications”
o “Imprimis Dropless & MKO Melt Experience For Cataract Surgery”
 “No pre- or post-surgery drops prescribed”
 “Dropless Therapy intravitreal injection is administered following Cataract surgery”
 “Eye looks quiet, no infection, no inflammation”
 “Post-surgery drops eliminated or reduced”
o “Simple Drops Glaucoma Eye Drops”
 “Preservative-free, may reduce burning and stinging common in current drops”
 “Proprietary technology may increase corneal penetration and length of residence on the eye”
 

1 Last accessed on October 31, 2017.
2 Preservative free. 

3 For example, your Tri-Moxi products contain the the active ingredient triamcinolone acetonide.  The labeling for Triesence, an approved product which contains triamcinolone, contains the following risks: elevated intraocular pressure, glaucoma, cataract formation (where a lens is still present), potential to mask signs of infection, vitreous floaters, blurred vision.  See https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf. 

4 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm578514.htm. Furthermore, FDA approved on September 28, 2017, a supplemental new drug application that adds a subsection about HORV to the WARNINGS section in the labeling of Vancomycin Injection, USP. The warning states:
Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for prophylaxis of endophthalmitis.