Drug Companies Abuse Free-Speech, Prioritize Profits

Casey Speer
NHS ’18

Pharmaceutical giant GlaxoSmithKline LLC recently agreed to plead guilty and pay $3 billion to resolve its criminal and civil liabilities stemming from the company’s unlawful promotion of prescription drugs.

Under federal law, it is mandatory for a company to specify each intended use for a drug in its application to the Food and Drug Administration. When the company begins promoting their drug, they are limited to only the intended uses approved by the FDA. Often times, however, these companies look to expand profits by misbranding, promoting unapproved or off-label uses of a drug.

The FDA’s policy that forbids misbranding has been called to question recently on the basis of free speech rights granted to all citizens in the First Amendment. Judge Paul A. Engelmayer of the Federal District Court of Manhattan argues that the First Amendment grants drug companies the right to promote unapproved uses as long as they are truthful claims.

The FDA recently struck down Amarin Pharma, a small drug manufacturer, from promoting off-label use of its cardiovascular health drug Vascepa. Using the free speech argument, Amarin Pharma sued the FDA for threatening to bring civil charges against them if they attempted to sell their drug for off-brand uses.

Those who oppose the FDA’s strict ruling on misbranding argue that the vast therapeutic value of off-brand uses has become the norm for patients as opposed to using drugs for intended and approved uses.

At what point will drug companies have enough? There are a plethora of pharmaceutical monopolies ruling the market and driving up prices simply because they can. With current patent laws these companies have all rights to their drug for years before any other company can attempt to make a generic counterpart at an affordable price.

Fortunately the Supreme Court Case Illinois v. Telemarketing Associates pointed out that the First Amendment “does not shield fraud“”.” Attempts to mislead doctors and agencies about the uses of drugs and medical devices are heavily challenged. In United States v. Harkonen, the conviction of a drug company executive was upheld due to misleading data that was published on the uses of a drug.

Drug companies should not be able to promote what is not approved by the FDA. If they were, why have the FDA in the first place?

I understand that unapproved benefits exist, but it is not the responsibility of the drug company to make me aware of them. The FDA allows doctors to inform patients of the alternative uses of drugs that the company itself was not allowed to promote.

Let’s keep our trust in the people who were specifically trained to treat us.

Drug companies want the additional profit of off-brand benefits yet they refuse to take the responsibility of adverse effects from their drugs. When promoting their drug, these companies inform patients to ask their doctor if the drug is right for them. In this way, they avoid any repercussions by placing all liability onto the doctor.  

Free speech is an undeniable right, however, these drug companies are abusing this right in order to turn a larger profit. I wish I believed that these companies were fighting to promote off-brand benefits in order to optimize patient care, but I’m smarter than that, and so is the FDA.

Notes

Peter J. Henning, F.D.A’s ‘Off Label’ Drug Policy Leads to Free Speech Fight, NEW YORK TIMES, Aug. 10 2015,  http://www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html?_r=0.

 

Raising the Bar: Retaliation in the wake of University of Texas Southwestern Medical Center v. Nassar

whistlehurter (1)

Sharon Mo
Columnist

“[F]ear of retaliation is the leading reason why people stay silent about the discrimination they have encountered or observed.” – Justice Ginsburg in dissent[1]

Retaliation claims are now the bread and butter of employment discrimination actions. In 2014, retaliation claims brought under Title VII of the Civil Rights Act of 1964 accounted for 34.7% of all charges filed to the U.S. Equal Employment Opportunity Commission (EEOC).[2] Following a line of pro-employee decisions that afforded broad protections to plaintiffs,[3] the Supreme Court’s decision in University of Texas Southwest Medical Center v. Nassar [4] is a surprising development that has left employees scratching their heads and employers cheering. Plaintiffs are now required to prove that an employer’s adverse employment action would not have been taken “but for” an employee’s protected activity.[5] This move imports a strict tort law causation test into the market of employment discrimination, with problematic consequences. The following note aims to provide a brief summary of retaliation law, break down the Supreme Court’s decision and discuss its implications.

Title VII and The Law of Retaliation

Title VII defines an unlawful employment practice as discrimination against any individual because of their race, color, religion, sex, or national origin.[6] Within Title VII is an anti-retaliation provision that prohibits employers from engaging in adverse retaliatory action in response to an employee’s objection to a prohibited practice or participation in a Title VII investigation or proceeding.[7] To be awarded damages, the plaintiff bears the burden of proving the following elements: (1) the plaintiff engaged in or was engaging in a protected activity; (2) the employer subjected the plaintiff to an adverse employment action; and (3) the plaintiff was subjected to the adverse employment action because of his or her participation in the protected activity.[8]

Shift from “Motivating Factor” to “But-For” Standard

Addressing the third element, the issue before the Supreme Court in, was the proper standard of causation for Title VII activity-based discrimination i.e. retaliation claims. A divided 5-4 bench determined in favour of the “but-for” threshold, over the lesser “motivating factor” standard applied to status-based discrimination claims.[9] The latter is less onerous on the employee for two reasons. First, while the “motivating factor” model would only require that retaliation be one motivating factor, amongst others, for an employer’s adverse action, the “but-for” test requires that it be the cause of the adverse action.[10] The second reason is that the “but-for” threshold rests the burden of persuasion entirely on the plaintiff, who often will not have the resources to investigate the employer’s deliberations.[11] In contrast, the “motivating factor” test places the initial burden on the plaintiff to prove that his or her protected activity was a motivating factor, before shifting the burden on the defendant to demonstrate that they would have taken the adverse action even in the absence of the protected activity.

The majority opinion, penned by Justice Kennedy, presented four arguments to justify the heightened standard.[12] The first was that retaliation is not identified in 42 U.S.C. §2000e-2(m) with other types of discrimination to which the “motivating factor” standard applies.[13] Secondly, the majority interpreted that “because” equated to “but-for” causation. In other words, if an action occurs “because of” another action, then that action is “the reason” for it.[14] The third argument aligned with policy concerns regarding the high volume of frivolous retaliation charges filed in the EEOC and the resultant resource inefficiencies, if the lesser standard was to be applied.[15] The majority’s final argument was that deference to generic EEOC guidelines favoring the “motivating-factor” test was not warranted.[16]

In a rather scathing opinion for the dissent, Justice Ginsburg favored the lesser standard. Specifically, she placed the meaning of “because” in the context of a multiple-motive decision, and countered that the omission of retaliation claims from 42 U.S.C. §2000e-2(m) did not automatically exclude employers from liability.[17] Justice Ginsburg denounced the majority’s divergence from both precedent and congressional intent to strengthen anti-discrimination laws in formulating Title VII.[18] In her closing remarks, she called out the majority for their unspoken motive and “zeal to reduce the number of retaliation claims filed against employers.”[19]

The Tortification of Retaliation

Perhaps the most significant layer to the Nassar decision is the majority’s importation of a tort law standard into the employment discrimination context. The tortification of employment discrimination law is not a new phenomenon,[20]with the transplant of vicarious liability to sexual harassment cases,[21] and the adoption of proximate cause to prove employer liability for subordinate bias.[22] Justice Kennedy is explicit in his treatment of Title VII retaliation claims as “textbook tort law”[23] and indeed, the Nassar opinion reads more like a tort decision than a case of statutory interpretation.[24]

However, imposing tort law’s strict “but-for” standard on retaliation claims is ill founded for two key reasons. The first reason is that in tort, the “but-for” test considers the cause and effect of physical forces to which reasonably common-sense and scientific theories of physical causation can be applied.[25] This is quite different to the mental investigation necessary in the context of employment discrimination to establish motive.[26] As Justice Ginsburg articulates, to apply the standard is to engage in a near-impossible “hypothetical inquiry about what would have happened if the employer’s thoughts and other circumstances had been different”.[27] The inquiry also fails to expose false reasons provided by the employer or uncover hidden motives.[28] The second reason is that the “but-for” standard asks the plaintiff to prove that his or her protected activity was the sole cause for the employer’s adverse action. Even in tort, the plaintiff faces similar problems pinpointing one “but-for” cause amongst a multitude of variables. It is therefore misguided to think that at any time within the dynamic setting of workplace relations, employers take adverse action based on a solely identifiable reason. Even Congress at the enactment of Title VII commented that a “sole cause” standard would render the Act “totally nugatory”.[29] Justice Ginsburg cites Senator Case, a key sponsor of Title VII who stated that “[i]f anyone ever had an action that was motivated by a single cause, he is a different kind of animal from any I know of.”[30] For all Justice Kennedy’s push for the tortification of retaliation, the employment discrimination context is, by its very nature, incongruous with the “but-for” model.

What now and where from here?

All this leaves a plaintiff bringing a Title IV retaliation claim in a tricky spot. Nassar’s “but-for” threshold asks employees to retrospectively speculate about employers’ motivations at the time of their adverse action, without the resources to do so.[31] Worse, it precludes remedies to employees who cannot prove that their protected activity was the reason for the adverse action, and protects employers whose actions were only partially motivated by retaliation.[32] The high bar contradicts the public policy behind Title VII to allow employees to engage in protected activity without fear of retaliation, and to deter employers against retaliatory action.[33] It would seem that Justice Ginsburg’s dissent was right to be as charged as it was.

Since Nassar, the Supreme Court has only further qualified that “but-for” means more than “contributing” and “substantial”, and exists where the retaliatory action is the “straw that broke the camel’s back”.[34] Thus, the best way forward is to, as Justice Ginsburg suggests, call on Congress to intervene and codify the “motivating factor” test through an amended Civil Rights Restoration Act.[35] Unlike tort law, employment discrimination and Title VII are creatures of statute, and best amended by statute. To recognize the distinction between tort and employment discrimination is to recognize that the “but-for” standard is ultimately unworkable in the workplace.

Notes

[1] University of Texas Southwestern Medical Center v. Nassar, 133 S. Ct. 2517, 2534-35 (2013) (Ginsburg, J. dissenting).

[2] EEOC, Charge Statistics FY 1997 Through FY 2014, EEOC (2014), http://eeoc.gov/eeoc/statistics/enforcement/charges.cfm

[3] See Burlington & Santa Fe Ry. Co. v. White, 548 U.S. 53, 67 (2006) and Thompson v. North American Stainless, LP 131 S. Ct. 863 (2011).

[4]  Nassar, 133 S. Ct. at 2517.

[5] Id. at 2533.

[6] 42 U.S.C. § 2000e-2(a).

[7] 42 U.S.C. § 2000e-3(a).

[8] United States Courts for the Ninth Circuit, Manual of Model Civil Jury Instructions – 10.3 Civil Rights—Title VII—Retaliation—Elements and Burden of Proof, United States Courts for the Ninth Circuit (2013), http://www3.ce9.uscourts.gov/jury-instructions/node/173.

[9] 42 U.S.C. § 2000e-2(a).

[10] Nassar, 133 S. Ct. at 2526.

[11] Gross v. FBL Financial Services Inc., 557 U.S. 167, 177-78 (2009)

[12] Garth E. Flygare, Title VII Retaliation Claims: But-For Causation Gets Back At Price Waterhouse In The Wake Of University Of Texas Southwest Medical Center v. Nassar, 39 S. Ill. U. L.J. 557, 563-564 (2015).

[13]Nassar, 133 S. Ct at 2526.

[14] Id. at 2527; Garth E. Flygare, Title VII Retaliation Claims: But-For Causation Gets Back At Price Waterhouse In The Wake Of University Of Texas Southwest Medical Center v. Nassar, 39 S. Ill. U. L.J. 557, 564 (2015).

[15] Nassar, 133 S. Ct. at 2531.

[16] Id. at 2533.

[17] Id. at 2546; Price Waterhouse v. Hopkins, 490 U.S. 228, 281-82 (1989).

[18] Darren Stakey, The Supreme Court’s Heightened Retaliation Standard In Nassar: A Prudent Limitation Or A Misguided Restriction To Title VII Claims? 30 TOURO L. REV. 923, 941 (2014).

[19] Nassar, 133 S. Ct. at 2547.

[20] Deborah L. Brake, Tortifying Retaliation: Protected Activity at the Intersection of Fault, Duty, and Causation 75 OHIO ST. L.J. 1375, 1381 (2014).

[21]See Faragher v. City of Boca Raton, 524 U.S. 775, 780 (1998)

[22] See Staub v. Proctor Hospital, 131 S. Ct. 1186 (2011)

[23] Nassar, 133 S. Ct. at 2525.

[24] Deborah L. Brake, Tortifying Retaliation: Protected Activity at the Intersection of Fault, Duty, and Causation 75 OHIO ST. L.J. 1375, 1381 (2014).

[25] Gross v. FBL Financial Services Inc., 557 U.S. 167, 190 (2009) (Breyer, J., dissenting). 

[26] Id.

[27] Nassar, 133 S. Ct. at 2546.

[28] Matthew A. Krimski, University Of Texas Southwestern Medical Center v. Nassar: Undermining The National Policy Against Discrimination, 73 MD. L. REV. 132, 144 (2014).

[29] 110 Cong. Rec. 2728, 13837–13838 (statement of Sen. Case).

[30] Id.

[31] Matthew A. Krimski, University Of Texas Southwestern Medical Center v. Nassar: Undermining The National Policy Against Discrimination, 73 MD. L. REV. 132, 148 (2014).

[32] Id. at 147.

[33] Kimberly A. Pathman, Protecting Title VII’s Antiretaliation Provision In The Wake Of University Of Texas Southwestern Medical Center v. Nassar, 109 NW. U. L. REV. 475, 479 (2015).

[34] Timothy M. Holly, The Causation Standard For Retaliation Claims Under Employment Discrimination Statutes: Ambiguity Of “Central Importance, 15 DEL. L. REV. 71, 75 (2014) citing Burrage v. United States, No. 12-7515, 2014 WL 273243 (U.S. Jan. 27, 2014).

[35] Nassar, 133 S. Ct. at 2547.

Why is it always the wrong time to talk about gun control?

Sydney Winkler
COL ’16

When ten people were killed and nine others were injured in a shooting at Umpqua Community College in southwestern Oregon this past Thursday, people criticized the President for making the issue “political.”  But there is no time to spare when it comes to saving lives from the next mass shooting.

Sadly, many predict that once again, nothing will be done.  Some have grown pessimistic of meaningful change in gun control.  Others have grown more protective of their right to bear arms.  Both sides refuse to meet in the middle and gridlock occurs.  So what is the result of our inaction?

Experts across the board believe that the consequence of America’s soft policy approach to guns is making more guns more accessible, which means more gun deaths.  Research has found that this is true for many types of gun violence: gun homicides, suicides, domestic violence, and even violence against police.

Looking at mass shootings in particular, like the one that occurred at UCC, there have been at least 986 mass shootings since Newtown in December 2012.  Mass Shooting Tracker, a crowd-sourced database, defines a mass shooting as “shootings in which four or more people were shot at all, not necessary murdered.”  This broader definition is essential to truly capture the threat of mass gun violence.

Some people argue that in order to respect those who have been affected by this tragedy we should not talk about gun control in light of the recent tragedy at UCC.  But if we always left time after a tragedy before bringing up a possible political solution, it would also lead to a conversation that never occurs.  According to Vox, “Under the Mass Shooting Tracker’s definition of mass shootings, America has nearly one mass shooting a day.  So if lawmakers are forced to wait for a time when there isn’t a mass shooting to talk gun control, they could find themselves waiting for a very long time.”[1]

Let me also just lay down some facts that people might find shocking… States with more guns have more gun deaths [shocker]. States with tighter gun control laws have fewer gun deaths [shocker].

But the second that I say “gun control,” half of you will stop reading this article.  It has become a buzz-phrase used by the left that causes the right to tune them out.

But what if I framed it in terms of how you obtain your driver’s license?  You go to the DMV, show proof of ID by presenting them with your Social Security number, date of birth, and residency.  Then you must pass a vision exam, written exam, and driving test.  Furthermore, drivers with vision, physical, or mental health issues must complete (along with their medical professionals) a Medical Report (Form DSD DC-163).  Oh, and you have to pay a fee too.

So what do I have to do to get a gun?  Nothing.

Federal law does not require any sort of licensing to own a gun. In most states, a license is not required to own a gun but is required to carry a gun on your person.

Some people will ask if permits will have any effect on gun homicides.  They argue that they are a hassle for law-abiding citizens and that criminals will still get their hands on guns.

Well, let’s look at a case in point: In the summer of 1994 in Connecticut, lawmakers passed a gun control bill in a special session after numerous gang shootings.  The bill requires a purchasing license before a person can buy a handgun. The state would issue these permits to people who passed a background check and a gun safety-training course.  Permit-to-purchase laws make it a crime for anyone to sell or give a gun to someone without a permit.

So what happened? Two decades later, researchers at Johns Hopkins University and the University of California Berkeley say that Connecticut’s law was actually a huge success for public safety.  They estimate that the law reduced gun homicides by 40 percent between 1996 and 2005. That’s an estimated 296 lives saved in 10 years.[2]

Permit-to-purchase laws make it harder for guns to enter the black market, too.  As Connecticut exemplifies, lower supply means higher prices.  If someone wants to get their hands on a gun through the black market, they will have to overcome a higher barrier to entry and invest more time and resources.

The process of acquiring a permit to purchase a gun is not to eliminate guns.  We don’t need to eliminate them; we need to make the process of owning them safer.  We require licenses to drive and we require seatbelts in cars.  Is it so different to require licenses to own a gun?  This is a public health issue and we should treat it like one.

It’s not clear that these steps would have prevented the Oregon shooting. But smarter gun policies could reduce murder rates by up to 50 percent, according to Dr. Daniel Webster, director of the Johns Hopkins Center For Gun Policy.

The difficult part is, while a couple states have permit-to-purchase laws, not all of them do.  And there is even a lack of credibility of permits between states.  For example, if you take your Idaho gun permit into Oregon, they won’t recognize it but Idaho will recognize an Oregon gun permit.   This type of system is disjointed and provides too many loopholes for individuals.  If an individual’s state doesn’t allow a purchase without a permit, they could just hop over to a neighboring state with more lax laws.

We need federal action.  We need Congress to act.

But we cannot only blame politicians for inaction.  It is our voices that grow silent mere weeks after a mass shooting.  If constituencies are not in favor of more gun control, then elected officials are stuck in a hard place.

After Newtown in December 2012, Pew Research Center found that “the public’s attitudes toward gun control have shown only modest change in the wake of last week’s deadly shooting at an elementary school in Newtown, Connecticut. 49% say it is more important to control gun ownership, while 42% say it is more important to protect the right of Americans to own guns.”[3]

Seriously?!  Were you silent after 9/11?  Did you say that it isn’t the right time to talk about homeland security or the threat of terrorism?

It may seem easier to just grow numb to the issue, to make it easier to deal with when the next mass shooting occurs.  But what if we could prevent that next time and the time after that?  Will you wait until the mass shooting affects your friend?  Your brother?  Your sister?  Your child?  How would you act then?

[1] http://www.vox.com/2015/8/24/9183525/gun-violence-statistics

[2] http://www.washingtonpost.com/blogs/govbeat/wp/2015/06/12/gun-killings-fell-by-40-percent-after-connecticut-passed-this-law/

[3] http://www.people-press.org/2012/12/20/after-newtown-modest-change-in-opinion-about-gun-control/