Blog Post

Supreme Court to Examine Patent Venue Shopping

Nick Dellefave

The Supreme Court is set to decide a case which may put an end to the widespread practice of forum shopping in patent cases. On December 14, 2016, the Supreme Court granted certiorari in TC Heartland v. Kraft to consider the question of whether the current patent venue statute, 28 U.S.C. § 1400(b), is the “sole and exclusive provision governing venue in patent infringement actions.”

Although predicting Supreme Court decisions is far from an exact science, many commentators have speculated that the Court is likely to reverse the Federal Circuit’s decision, and thus, impose limits on where patent infringement cases may be filed. Driving this speculation is the fact that, on grants of certiorari since 1999, the Court has reversed the Federal Circuit’s decisions in nearly 75% of the time, often unanimously. Furthermore, there has been a trend in recent years of the Supreme Court handing down decisions that limit plaintiffs’ access to federal courts.

Forum shopping is a prevalent practice in patent litigation. In 2015, nearly 65% of all patent infringement cases were filed in only five district courts, and 44% were filed in the Eastern District of Texas. The Eastern District of Texas has received much attention for the cottage industry of trial lawyers that has been propped up by the venue’s status as the most active patent forum in the country. Plaintiff-friendly local rules and even friendlier juries have made small communities like Marshall and Tyler hotbeds for patent litigation. Marshall’s courthouse has become well-known for its ice skating rink, which was donated by Samsung, a frequent defendant in patent cases.

Any change making forum shopping less prevalent is likely to gain support from the most frequent patent defendants. Amicus briefs were recently submitted by groups of technology companies and corporate financiers in support of the petitioner. If the Court does reverse, prominent patent forums like East Texas are likely to see a sharp decline in the number of cases filed, while districts where many companies are headquartered, such as the District of Delaware, Northern District of California, and Southern District of New York are likely to see more patent filings.

Rock Band Challenging Law Barring Registration of Disparaging Trademarks

Justin Farooq

On January 18, 2017 a majority of the U.S. Supreme Court looked to be amenable to arguments by a rock band that is challenging the federal law that bans the registration of disparaging trademarks.

The petitioners in this case are the Slants, an Asian-American band who claims the ban violates the First Amendment. According to reports by the Washington Post, New York Times and USA Today, members of the Supreme Court looked skeptical of the law during oral arguments.  The reaction is likely good for the Washington Redskins, a NFL team whose trademark was revoked due to the fact that its name is disparaging to Native Americans.  The Slants assert that they are using the name to regain an offensive term about Asians and use it “as a badge of pride.”

[1] Debra Cassens Weiss, Supreme Court Appears Skeptical of Law Barring Registration of Disparaging Trademarks, ABA Journal (Jan. 18, 2007, 4:44 PM CST), http://www.abajournal.com/news/article/supreme_court_appears_skeptical_of_law_barring_registration_of_disparaging.

[2] See Robert Barnes, Can Disparaging Trademarks be Denied? The Supreme Court is Skeptical, The Washington Post (Jan. 18, 2017), https://www.washingtonpost.com/politics/courts_law/supreme-court-skeptical-of-governments-withholding-disparaging-trademarks/2017/01/18/b97b6752-dd05-11e6-918c-99ede3c8cafa_story.html?utm_term=.047681dd22df.

[3] Adam Liptak, Justices Appear Willing to Protect Offensive Trademarks, New York Times (Jan. 18, 2017), https://www.nytimes.com/2017/01/18/us/politics/justices-appear-willing-to-protect-offensive-trademarks.html?smid=pl-share.

[4] Richard Wolf, Justices Dubious About Government Denials of ‘Derogatory’ Trademarks, USA Today (Jan. 18, 2017, 3:31 PM), http://www.usatoday.com/story/news/politics/2017/01/18/supreme-court-trademark-slants-redskins/96720748/.

[5] Tony Mauro, In ‘Slants’ Case, Justices Skeptical of Ban on Disparaging Trademarks, Law.com (Jan. 18, 2017), http://www.law.com/sites/almstaff/2017/01/18/in-slants-case-justices-skeptical-of-ban-on-disparaging-trademarks/?slreturn=20170027193816.

[6] Weiss, supra note 1.

Rock Band Challenging Law Barring Registration of Disparaging Trademarks

Justin Farooq

On January 18, 2017 a majority of the U.S. Supreme Court looked to be amenable to arguments by a rock band that is challenging the federal law that bans the registration of disparaging trademarks.[1]

The petitioners in this case are the Slants, an Asian-American band who claims the ban violates the First Amendment. According to reports by the Washington Post[2], New York Times[3] and USA Today[4], members of the Supreme Court looked skeptical of the law during oral arguments.  The reaction is likely good for the Washington Redskins, a NFL team whose trademark was revoked due to the fact that its name is disparaging to Native Americans.[5]  The Slants assert that they are using the name to regain an offensive term about Asians and use it “as a badge of pride.”[6]

[1] Debra Cassens Weiss, Supreme Court Appears Skeptical of Law Barring Registration of Disparaging Trademarks, ABA Journal (Jan. 18, 2007, 4:44 PM CST), http://www.abajournal.com/news/article/supreme_court_appears_skeptical_of_law_barring_registration_of_disparaging.

[2] See Robert Barnes, Can Disparaging Trademarks be Denied? The Supreme Court is Skeptical, The Washington Post (Jan. 18, 2017), https://www.washingtonpost.com/politics/courts_law/supreme-court-skeptical-of-governments-withholding-disparaging-trademarks/2017/01/18/b97b6752-dd05-11e6-918c-99ede3c8cafa_story.html?utm_term=.047681dd22df.

[3] Adam Liptak, Justices Appear Willing to Protect Offensive Trademarks, New York Times (Jan. 18, 2017), https://www.nytimes.com/2017/01/18/us/politics/justices-appear-willing-to-protect-offensive-trademarks.html?smid=pl-share.

[4] Richard Wolf, Justices Dubious About Government Denials of ‘Derogatory’ Trademarks, USA Today (Jan. 18, 2017, 3:31 PM), http://www.usatoday.com/story/news/politics/2017/01/18/supreme-court-trademark-slants-redskins/96720748/.

[5] Tony Mauro, In ‘Slants’ Case, Justices Skeptical of Ban on Disparaging Trademarks, Law.com (Jan. 18, 2017), http://www.law.com/sites/almstaff/2017/01/18/in-slants-case-justices-skeptical-of-ban-on-disparaging-trademarks/?slreturn=20170027193816.

[6] Weiss, supra note 1.

Science Does Not Lie: Increasing Global Temperatures

Lindsey Round

Regardless of political beliefs, scientific findings show that the Earth reached record high temperatures in 2016, exceeding previous records set in 2015 and 2014.[1] Three consecutive years of setting record temperatures is something that should at least cause individuals to question why this is happening. Scientists have attributed the increasing temperatures to both the El Niño as well as increasing levels of carbon monoxide and other greenhouse gases.[2] Even though El Niño has officially ended and scientists do not expect 2017 to be warmer than 2016, many species of plants and animals are in danger at the current temperatures.[3] However, this is not the first time in history that we have seen record setting temperatures three years in a row. In fact, in 1939, 1940, and 1941 the Earth temperatures reached what were record high temperatures at the time.[4] However, due to trending increasing temperatures on Earth, the record reached in 1941 is now only the 37th warmest year here on Earth.[5] So, while 2017 may not be warmer than 2016, the overall trend is indisputable science and it is imperative for everyone to take note of this change.

 

[1] Justin Gillis, Earth Sets a Temperature Record for the Third Straight Year, N.Y. Times (Jan. 18, 2017), https://www.nytimes.com/2017/01/18/science/earth-highest-temperature-record.html.

[2] Id.

[3] Id.

[4] Id.

[5] Id.

The Ants Go Marching One by One…But Do Humans?

Cecilia Santostefano

The fruit fly is one of the most well-known model organisms; it has been behind a vast amount of scientific research for over a century. Recently, though, another insect has intrigued scientists when it comes to answering the question of how human societies are organized. In a world where studying the brain and the complex organization of society is challenging, model species, like Dr. Kronauer’s raider ants, provide important insight.

Dr. Daniel Kronauer has been studying the biology, brain, genetics, and behavior or clonal raider ants out of his lab in Manhattan.[1] By manipulating his ant colony, Dr. Kronauer is studying its overall social system.[2] He explains, “by studying the neuromodulators that make ants so sensitive to their social environment, we could learn something fundamental about autism and depression along the way” because with such cerebral research, insights into human disease may be revealed.[3]

Dr. Kronauer has already observed similarities between his ant colony and human society. He has noted ants have inotocin, which is the equivalent of oxytocin, which triggers a caregiving response in humans and tells ants to leave the nest and find food for their young.[4] He has also observed that the ants that ignore the colony’s synchronized schedule and community cues “pay” for their behavior.[5] Dr. Kronauer’s research continues; he is still flipping over rocks “just to see what’s crawling around underneath.”[6]

 

[1] Natalie Angier, Gene Modified Ants Shed Light on How Societies Are Organized, NY Times, (Jan. 23, 2017), https://www.nytimes.com/2017/01/23/science/gene-modified-ants.html?rref=collection%2Fsectioncollection%2Fscience&action=click&contentCollection=science&region=rank&module=package&version=highlights&contentPlacement=1&pgtype=sectionfront&_r=0.

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] Id.

Pokemon Goes to Court; New Liability for New Technology

Robert D. Lang

This article was originally printed in the New York Law Journal on August 15, 2016. See the original article here.

lang-robert

Every generation has its own new fads, which can sweep across the country, if not the world, seemingly from nowhere, capturing the imagination and attention of millions.1 Why the crazes begin and why they end is beyond the scope of this article. With the exception of a few fads, these activities, however brilliant or mindless, do not create legal issues and potential litigation involving those who participate. Pokémon Go is one of those exceptions.2 This hot new enhanced reality game, produced by Niantic, Inc., has been installed over 100 million times and has more daily users than Twitter.3 The game allows its users to travel areas looking for Pokémons, collecting them and using them to conquer Pokémon Gyms. Players hatch Pokémon eggs by walking certain distances while playing, and obtain items needed to improve their collections by playing within a short distance from Pokéstops, which are denominated landmarks spread throughout the area.

Naturally, the game foresees the increased risks of having its users completely immersed in this parallel virtual reality and, as the application loads, it warns them to “be alert at all times” and to stay aware of their surroundings. Once the game starts, players have to acknowledge a message that warns them not to drive, trespass or enter dangerous sites while playing; but do these warnings fully satisfy Niantic’s legal duty?

Less than two months after its release on July 6, 2016,4 the new enhanced reality game already has a Pokéstop in court, this time, by a New Jersey man who filed a nuisance and unjust enrichment class action suit against the developer and distributor of Pokémon Go after at least five players knocked on this man’s door requesting access to his backyard to catch a Pokémon that had been virtually placed there.5 A second suit was filed last week in federal court in California by a Michigan couple living in a lakeside neighborhood, alleging that they are now unsafe due to hundreds of Pokémon-seeking people who have turned their park into a nuisance.6

A further question that personal injury attorneys will certainly raise is the game’s liability when minors are injured after being lured to dangerous premises. Although, in general, the attractive-nuisance doctrine is not applicable in New York,7 the law protects children by imposing upon an owner or occupier of a land a higher duty of care when it is foreseeable that minors will enter the property.8 The degree of foreseeability of minors entering private property in pursuit of Pokémons will be a fact-specific question, depending, among others, on the popularity of the game in the specific neighborhood. Furthermore, it can be argued that the high popularity of Pokémon Go imposes a duty upon a landowner, or its occupier, to give notice to the game distributor and producer of any unsafe premises, so that no special attraction is created therein.

Risk of Harm

To be sure, trying to catch all of the Pokémon characters while walking can be distracting. This raises to a new level the previously recognized problem of people walking while texting,9 since it is evident and obvious that people playing Pokémon Go can be distracted while doing so and as a result suffer serious personal injuries. Whereas the creatures in Pokémon Go are imaginary, the personal injuries resulting from playing the game are real. For one example, last month, two men who went to collect the virtual characters on their Smartphones fell off a 90-foot ocean bluff in California.10 Last month, the Auburn Police Department in New York issued an advisory reminding Pokémon players not to use the application while driving a motor vehicle or riding a bicycle, after a 28-year-old driver, distracted while playing the game, veered off the road and crashed into a tree.11

Nor is the problem limited to our country. Players in Bosnia have been warned, while roaming into areas looking to capture monsters on their Smartphones, that they should avoid mined areas because of unexploded land mines left over from the 1992-1995 war.12 The Israeli military has banned its soldiers and officers from playing the game on Israeli military bases due to security concerns, fearing that the game would activate cell phone cameras and location services that could leak sensitive information, such as army base locations and photographs of the bases, to users.13One of the unintended negative consequences of Pokémon is that it can increase tension between Israel and Palestine since, for Palestinians, it is a frustrating game to play as mobile high-speed internet services do not exist in the West Bank and Gaza Strip.14 Then, too, there is the issue of a Pokémon creature being placed in an off-limits building run by Hamas.15

Closer to home, last month in Florida, two teenagers looking for Pokémon creatures wound up instead being shot as potential robbers. The homeowner, hearing a loud noise outside his home at approximately 1:30 a.m., went outside and saw two teenagers, one of whom he overheard saying, “did you get anything?” Believing that the teenagers possibly broke into his home and stole his property, he took a gun and fired at them.16 In fact, the two teenagers were looking to “get” Pokémon creatures Marowak and Tauros.17

Although the producers of Pokémon Go are not present in the place where a Pokémon is virtually placed, the law recognizes that a defendant can act in concert with a co-defendant without being present at the place and time of the tortious act.18 In Kubert v. Best, a New Jersey court utilized this concept to find liable a person who sent text messages to another person, while knowing that the message recipient was driving a vehicle, and that driver was involved in an accident injuring the plaintiffs.19

The New Jersey court reasoned that although the text message sender was not present in the vehicle when the accident occurred, she was “electronically present” aiding and abetting the driver’s unlawful use of his cell phone while driving.20 It can be similarly argued that when Pokémon Go incites a player to catch a Pokémon in private property, it acts in concert and aids and abets the player to trespass into private property, thereby committing electronic trespass.

The Restatement takes this concept even further stating that “[a]n act is negligent if the actor intends it to affect, or realizes or should realize that it is likely to affect, the conduct of another, a third person, or an animal in such a manner as to create an unreasonable risk of harm to the other.”21 It can certainly be argued that when Pokémon Go virtually places a Pokémon in dangerous premises, it should realize that the conduct of the player will be affected in a way that could create an unreasonable risk of harm, inasmuch as the player will attempt to come close enough to the Pokémon to be able to catch it. This is especially true if a premise owner gives Pokémon Go specific notice of the danger.

Proceeding in Court

When faced with the litany of legal questions that arise as a result of the development of enhanced reality in general, and of Pokémon Go in particular, the courts should understand that their decisions will have ramifications. Reality is now often scripted, as in reality TV shows, and Pokémon Go blends reality and fantasy in a unique combination.

Enhanced reality has the capability of immersing its users in a parallel virtual reality that can lead them to reckless behavior. Therefore, courts will be tempted to force the development of this technology in a responsible path that protects the rights of our society. To do so, courts will place certain liabilities on the developers for wrongdoings that result from the use of their technology. However, courts should not bind innovation with burdens that will ultimately impede the advancement of this world-changing technology. Perhaps it would therefore be prudent for courts to wait and see before making consequential decisions.

As a practical matter, practitioners should be aware of the different, still unanswered, legal questions raised by enhanced reality and its different applications. Perhaps it would be cautious to advise landowners to put Niantic on notice of any dangerous premises and to request that they refrain from creating any attraction to their property. What if Pokéstop is at the home of a known sexual offender?22 Or a location dangerous for other reasons? For example, only last month, a 15-year-old high school student was struck by a car in Pennsylvania after the Pokémon game caused her to cross a major highway at 5 p.m. in the evening, during rush hour.23 There is also the possibility of mischief (Pokémischief?) of Pokémon creatures being purposely positioned at political rallies to swell the number of people apparently attending, thereby artificially boosting attendance at rallies of candidates who want to show a greater number of people present.24

While these different issues are considered by the courts, it would be prudent to inquire from personal injury plaintiffs whether their behavior was affected or distracted by any means of enhanced reality. It would be similarly frugal to question a defendant in a premises liability matter about their knowledge of Pokémon Go, and whether they were on notice of players entering their property while immersed in a parallel reality.

Until the courts rule, it would be wise for all of us to be on the alert for people, seemingly walking aimlessly in our general direction, appearing to swipe away imaginary creatures, in an effort to “get them all” and win the game.

Endnotes:

1. For just a partial list, consider: Candy Crush, Hula Hoops, Mexican Jumping Beans, Love Beads; Lava Lamps, Silly Putty, Ant Farms, “Baby on Board” signs, Trivial Pursuit, Mood Rings, Rubik’s Cube; Pet Rocks, Troll dolls, Slot cars, Swallowing Goldfish, Sea Monkeys, Tie-Dye T-shirts, Speed Dating, Pet Rocks, Slinkys, Care Bears, Pong, and (of course) Angry Birds.

2. Flash Mobs, Phone Booth Stuffing, Dance Marathons, and Flagpole Sitting are also exceptions.

3. Hern, “Pokémon Go Becomes Global Craze as Game Overtakes Twitter for US Users,” The Guardian, July 12, 2016.

4. www.pokemon.com/us/pokemon-video-games/pokemon-go.

5. Weiss, “New Jersey Man Plagued by Pokémon Go Players Files Nuisance Class Action,” ABA Journal, Aug. 2, 2016; Alcorn, “One Man Is So Annoyed That Pokémon Go Players On His Property That He’s Suing,” Fortune, Aug. 2, 2016; Kabateck and Pang, “Next Pokéstop: The Courtroom?” The Recorder, Aug. 3, 2016; Todd, “Take Your GPS Coordinates and Go, Pokémon!” The Recorder, Aug. 1, 2016.

6. The footnote citation for this is Mehrota, “Pokémon Sued By Couple Claiming Neighborhood Unsafe With Gamers,” Bloomberg, Aug. 10, 2016.

7. Morse v. Buffalo Tank Corp., 280 N.Y. 110 (1939) (explaining that the only duty which an owner of lands owes to a trespasser is to abstain from affirmative acts of negligence or not to injure intentionally).

8. 85 N.Y. Jur. 2d Premises Liability §23 (2016).

9. Lang, “Don’t Text, Talk and Walk: The Emerging Smartphone Defense and Personal Injury Litigation,” 77 Alb. L. Rev. 425 (2014).

10. Hernandez, “‘Pokémon Go’ Players Fall Off 90-Foot Ocean Bluff,” San Diego Union-Tribune, July 13, 2016.

11. Mason, “Auburn Police: Driver Crashes Into Tree While Playing ‘Pokémon Go,'” The Citizen, July 14, 2016.

12. F. Karimi “Pokémon Go Players at Risk of Landmines in Bosnia,” CNN, July 20, 2016.

13. Akram, “Israeli Army Identifies a New Threat: ‘Pokémon Go,'” N.Y. Times, Aug.1, 2016.

14. Id.

15. Id.

16. C. Hays, “Deputies: Man Shot at Teens Playing “Pokémon Go,'” (Orlando Sentinel, July 16, 2016.

17. Licata, “Florida Man Shoots Gun at Teenagers Playing Pokémon Go Outside his House,” Mommyish.com, July 17, 2016.

18. Restatement (Second) of Torts §876 (1979).

19. 75 A.3d 1214, 432 N.J. Super. 495 (N.J. Super. 2013); see also Lang, “Expanded Tort Liability Targets Those Who Send Texts, Vol. 250 N.Y.L.J. 95, pp. 4-7 (Nov. 14, 2003).

20. Id. at 1224.

21. Restatement (Second) of Torts §303 (1979).

22. McKinley, “In Pokémon Go, Lawyers Fear Unexpected Entrance of the Sexual Predator,” N.Y. Times, A18, July 30, 2016.

23, “Mom Says Teenage Daughter Hit by Car in Tarentum After Playing ‘Pokémon Go,'” WPXI, July 13, 2016.

24. Queenan, “Can Ivysaur and Psyduck Swing the Election?” C11, Wall Street Journal, Aug. 6-7, 2016.

Army Corps Orders Sioux Eviction

Cecilia Santostefano

The Standing Rock and Cheyenne River Sioux tribes have been protesting the Dakota Access pipeline for fear of water contamination as well the impact on sacred sites, including burial grounds.[1] The pipeline builder requires a final permit before the project may be underway. This permit would allow the pipeline to cross under the Missouri river, just north of the Standing Rock Sioux reservation.[2]

The Army Corps sent a letter to the Sioux tribes stating on December 5, the main camp will be closed due to “safety concerns” surrounding the approaching winter.[3] Additionally, the Corps will designate a “free speech zone” in which people may protest.[4] If anyone is found outside of that zone, it would be considered trespass and they would be subject to prosecution.[5]

This is not the first camp that will be closed. In October, law enforcement employed mace and arrests to clear Corps-managed property.[6] Over five hundred protesters have been arrested since August.[7] On November 20, the Standing Rock Medic & Healer Council announced twenty-six peaceful demonstrators were hospitalized and hundreds more were injured after law enforcement used tear gas, “less-than-lethal” munitions, and water cannons on the area.[8] With regards to these events occurring so close to Thanksgiving, a holiday that celebrates the the Native Americans and the first Europeans to enter America, Standing Rock Sioux tribal chairman David Archambault comments, “although the news is saddening, it is not at all surprising given the last 500 years of the mistreatment of our people.”[9]

 

[1]Associated Press, Standing Rock Sioux chairman says Army Corps to close camp access in pipeline protest, LA Times, (Nov. 25, 2016, 5:30 PM), http://www.latimes.com/nation/nationnow/la-na-north-dakota-standing-rock-20161125-story.html.

[2] Julia Wong, US Army orders eviction of Dakota pipeline protesters’ camp, tribe says, The Guardian, (Nov. 26, 2016, 8:07 AM), https://www.theguardian.com/us-news/2016/nov/26/us-army-orders-eviction-of-dakota-protesters-camp-tribe-says.

[3] Id.

[4] Id.

[5] Id.

[6] Id.

[7] Associated Press, supra note 1.

[8] Wong, supra note 2.

[9] Id.

Hashtag No-Filter: Instagram as a Platform for Art Dealers

Emma Fusco

Instagram has turned the art market on its head, especially for younger buyers.[1]  Matt Carey-Williams is a London-based deputy chairman for Europe and Asia at the Phillips auction house.[2]  By using Instagram as a marketing tool, art sellers are selling pieces for about 10 times its estimate all because the buyer had seen it on the auction house’s Instagram feed.[3]  For example, Sotheby’s sold a Fabergé silver, enamel and seed-pearl icon for £245,000, which is 10 times its estimate.[4]

Some say that the spike in prices is because the app allows users to understand the hearts and minds of collectors by creating a more intimate and friendly relationship because sellers are seen more as people rather than “a guy that sells paintings.”[5]

There is one area where Instagram has truly skyrocketed the sales platform: affordable collectibles.[6]  Mikki Towler is a dealer with 26 years in the business under her belt, specializing in antique kitchen items in Norfolk, England who averages two sales a day as a result of her Instagram feed.[7]  She has been so successful on Instagram that many people don’t ask the price of the collectible, “they just say, ‘I’ll have it.’”[8]

Transition from Nuclear Fission to Fusion

Aiden Scott

Venture capitalist such as Peter Thiel and amazon founder Jeff Bezos are attempting to take advantage of the long-delayed progress of nuclear energy. Theil has been funding a fusion start up called Helion Energy, and Bezos has invested in General Fusion Inc., in an attempt to take advantage of nuclear fusion’s potential capabilities to produce clean energy, at a low costs once proper technologies have been developed. Unlike nuclear plants that use fission, the classic splitting of atoms, companies such as Lockheed Martin, are working to create nuclear fusion generators that are small enough to be transported by truck. In response to this new flow of cash and enhanced research, General Fusion has acquired 10 patents, and has nine pending applications at the PTO. It is questionable as to how these advances will continue during Trumps presidency due to his statements concerning a return to coal power. However, if investment and research opportunities continue to grow we may also soon see numerous suits concerning compact fusion generators as well in the coming years.

See Eric Roston, Silicon Valley’s Peter Thiel’s Other Hobby Is Nuclear Fusion, 93 BNA Patent Trademark & Copyright Journal Vol 93 2362, 2363 (2016).

December FDA Update – Jardiance May Reduce Risk of Cardiovascular Death

William Salage

The U.S. Food and Drug Administration [FDA] today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Jardiance is marketed by Boehringer Ingelheim and Eli Lilly and Company. Risk of cardiovascular death is 70 percent higher in adults with diabetes compared to those without, per the Centers for Disease Control and Prevention. It is also the leading cause of death among adults with type 2 diabetes.

Jardiance had already been approved in 2014 for lowering blood sugar in adults with type 2 diabetes, but the FDA said that the drug was also “shown to reduce the risk of cardiovascular death.” Therefore, Jardiance was immediately put into a new clinical trial to prove its effectiveness for cardiovascular disease.

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME trial, which investigated the effects of Jardiance compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo; absolute risk reduction was 1.6 percent for Jardiance versus placebo. This primary finding was driven by a significant 38 percent reduction in the risk of cardiovascular death; absolute risk reduction was 2.2 percent for patients taking Jardiance versus placebo. There was no change in the risk of non-fatal heart attack or non-fatal stroke. The cardiovascular benefits of Jardiance were consistent among patient subgroups.