Category: Alerts

Trump’s Actions Slow Down FDA

By Emily Cox

President Donald Trump’s hiring freeze, new regulations policy, and uncertainty surrounding his pick for FDA commissioner have had a negative impact on the FDA’s ability to perform at the rate Trump promised during his candidacy, Vox reports.

While a hiring freeze for the federal government is standard for new presidents, it’s difficult to speed up the review process without additional personnel.

However, his executive order requiring two regulations be cut each one a new one is introduced was far more disruptive than the hiring freeze as there are little provisions for how this measure would be implemented.

Trump’s promise to cut FDA regulations by 75 to 80 percent has introduced an unprecedented amount of uncertainty as to how the agency will continue to fulfill its function in keeping the general public’s food and drugs safe.
According to CNBC and Moneycontrol.com, Trump is expected to name the new FDA commissioner in the next week or two, but a couple of his candidates would be a massive departure from tradition. If Jim O’Neill or Balaji Srinivasan were to become commissioner, they would be the first ones without an MD or a PhD degree since the 1950s. It is uncertain how either of these candidates would fit into the framework of the FDA. O’Neill is a Silicon Valley investor who has indicated that the FDA shouldn’t have to prove that drugs work before they are approved – only that they are safe.

“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” O’Neill said. “Let’s prove efficacy after they’ve been legalized.”

Srinivasan, another Silicon Valley entrepreneur, has suggested that the U.S. would be better off if the FDA operated as a “Yelp for Drugs.”

Between the hiring freeze, drastic regulatory changes, and uncertainty regarding some of the FDA’s potential commissioners, Trump’s actions are bogging down the FDA according to Josh Sharfstean, former deputy commissioner of the FDA.

“Having uncertainty on three fronts at once is especially difficult, said Sharfstean. “People spend time worrying instead of doing their work. They spend time planning for different contingencies that may never happen.”

Researchers who study the FDA claim it’s already the fastest drug regulatory agency in the world and Trump’s actions regarding the agency could prove to be dangerous to public health.

American Students Name Trump in Suit Over Climate Change

Trump Photo by Gage Skidmore
By Emily Cox

Portland, OR – In a primarily procedural move, President Donald Trump replaces former President Barrack Obama as a defendant in a lawsuit brought by 21 youth activists, questioning the constitutionality of the government’s climate-change policy.

The students originally filed their constitutional climate lawsuit against the federal government in October
2015 in the U.S. District Court for the District of Oregon. The case, brought by 21 youths aged 9 to 20, alleges that the current climate change policy violates their constitution rights on a fundamental level by not protecting the planet’s future.

Their complaint indicates that government actions have contributed to climate change, violating the youngest generation’s constitutional rights to life, liberty, and property. It further asserts that these policies failed to protect public trust resources.

Dr. James E. Hansen, a world-renowned climate scientists, joins the youth activists as a plaintiff to protect “future generations and his granddaughter.”

Former President Obama’s administration and fossil fuel industry representatives filed to have the lawsuit dismissed this past year. But U.S. District Judge Ann Aiken denied the motion November 10, 2016, clearing the case for trial.

“Exercising my ‘reasoned judgement,’ I have no doubt that the right to a climate system capable of sustaining human life is fundamental to a free and ordered society,” Judge Aiken wrote in her opinion and order.

The Washington Post reported on Mary Wood’s reaction to the pending trial. Wood is a law professor at the University of Oregon and expert in public trust and natural resources law.

“It’s been called the biggest trial of the century, and it is,” said Wood. “Literally, when I say the planet is on the docket, it would be hard to imagine a more consequential trial, because the fossil fuel policies of the entire United States of America are going to confront the climate science put forth by the world’s best scientists. And never before has that happened.”

If the court finds for the plaintiffs, the federal government could be forced to develop and stick to aggressive carbon-cutting measures to preserve Earth’s climate for future generations. A similar case resulted in a landmark ruling, the only one of its kind, requiring the Dutch government to cut emissions by 25 percent within five years.

Trump once signed an open letter, along with U.S. business leaders and liberal representatives, to President Obama and Congress, calling for immediate and aggressive climate action.

“Please don’t postpone the earth,” the letter stated. “If we fail to act now, it is scientifically irrefutable that there will be catastrophic and irreversible consequences for humanity and our planet.”

The letter appeared in a full-page ad in the New York Times prior to the UN Climate Change Conference in Copenhagen in December 2009.

However, Trump’s strong opinions on climate change had shifted to the opposition by 2010. He has repeatedly spoken out against climate change since then, calling it a hoax and a con.

“The concept of global warming was created by and for the Chinese in order to make U.S. manufacturing non-competitive,” Trump posted on Twitter back in 2012.

While Trump being named as a defendant in this constitutional case is mainly procedural, the plaintiffs said they were disturbed by Trump’s expressions of doubt about the science behind climate change.

“I am hopeful that our case will reverse or prevent all damage our current president may inflict,” one of the plaintiffs, Aji Piper, 16, said in a statement.

It is believed that the trial could begin later this year.

Trump Travel Ban Hearing Yields Passionate Pleas but Little Evidence

By Emily Cox

San Francisco, CA — While today’s hearing, challenging the temporary restraining order (TRO) against President Trump’s travel ban, showed skepticism toward the validity of the executive order, neither side had facts to back up their claims.

While cases of this magnitude usually warrant in-court hearings, the Ninth Circuit District Court decided to expedite these proceedings due to Justice Department’s claims that national security was at risk. The hour-long phone conference was held today at 3pm PST.

Previous reports have indicated that this hearing was to overturn Judge James Robart of the U.S. District Court for the Western District of Washington State’s temporary TRO. August E. Flentje, arguing in defense of President Trump’s executive order, clarified that the Trump White House is only seeking a stay in the TRO to continue enforcement of the order until a more permanent resolution can be found.

The three-judge panel acknowledged that the seven nations affected by the travel ban were shown to “pose a special risk” by the Obama administration, necessitating additional Visa requirements, but it was also shown that no long-term residents who had met these Visa requirements have committed any violations.

Flentje argued that the executive order, banning entry to the U.S. by seven predominantly Muslim countries and limiting the U.S. refugee program, was “well within the President’s power” and that the TRO was “detrimental to the interest of the U.S.” When asked for evidence to support his claims, Flentje claimed that the quick nature of the hearing had hindered the Trump administration’s ability to produce evidentiary proof of its claims. However, it was Trump’s administration that had insisted on this immediacy in the first place.

While the weight of the judges’ scrutiny appeared to be focused on the representative for the Justice Department and White House, it did not escape their notice that the solicitor general for Washington, Noah Purcell, had no actual evidence beyond his impassioned claims of irreparable harm to Washington businesses and residents, as well as Washington state university students and faculty.

The judges are currently reviewing the arguments made today and will submit a determination as soon as possible. They indicated that this TRO may be remanded to be tried as an injunction against President Trump’s executive order as long as evidentiary proof can be provided by both sides.

Ninth Circuit to Hear Arguments Today on Trump Travel Ban

Photo by Gage Skidmore
By Emily Cox

San Francisco, CA – A three-judge panel will hear oral arguments in the challenge to President Donald Trump’s executive order on immigration today at 3pm PST.

The hour-long hearing will determine the validity of the nationwide temporary restraining order against Trump’s travel ban. It will be conducted via telephone and streamed live on the Ninth Circuit Court of Appeals website.

The nationwide temporary restraining order was issued this past Friday by Judge James Robart, a federal judge on the U.S. District Court for the Western District of Washington State. Lawyers for Washington state have argued that the executive order harmed Washington residents and businesses, as well as state university system students and faculty. They also claim the ban’s discrimination against Muslims is unconstitutional.

On Saturday, the Ninth Circuit Court denied the Justice Department’s request to stay the suspension of the ban to allow enforcement to continue. The Justice Department filed a brief Monday to the appeals court to reinstate the executive order, claiming that immediate action was needed to ensure the safety of the country. Justice Department lawyers wrote that the executive order is “a lawful exercise of the President’s authority over the entry of aliens into the United States and the admission of refugees.”

In its brief, the Justice Department claims that Robart’s decision was “vastly overbroad, extending far beyond the State’s legal claims to encompass numerous applications of the Order that the state does not even attempt to argue are unlawful.” The brief goes on to argue that Robart’s order would cause irreparable harm to national security.

In response, lawyers for Washington and Minnesota wrote that the Justice Department’s claim was without merit, as it indicates that the nation had always been subject to “some unspecified, ongoing irreparable harm” prior to the executive order signed January 27. The brief further argued that “preserving the status quo against sudden disruption is often in the interest of all parties.”

Washington and Minnesota attorney generals further claim that the restraining order should remain in place because President Trump “unleashed chaos” by signing the order in the first place.

President Trump is confident of a victory even though the Ninth Circuit Court is known as one of the most liberal courts in the U.S. “The opinion of this so-called judge, which essentially takes law-enforcement away from our country, is ridiculous and will be overturned!” President Trump posted Saturday morning on Twitter. No matter the outcome of today’s hearing, the Supreme Court will most likely be the next step in this challenge.

Several other federal judges and 16 state attorney generals have challenged the president’s executive order, blocking aspects of the executive order that suspended travel from seven predominantly muslim countries and limited the nation’s refugee program. It is also facing lawsuits from the American Civil Liberties Union and Council on American-Islamic Relations.

Trump Fires Acting Attorney General, Escalating U.S. Immigration Crisis

Photo by Gage Skidmore
By Emily Cox

Washington, D.C. – President Trump fired acting Attorney General Sally Yates Monday night after she publicly refused to defend his executive order banning entry to the U.S. by citizens of seven predominantly Muslim nations, questioning the order’s legality, according to multiple media outlets.

In a statement, announcing the dismissal, the White House said Yates had “betrayed the Department of Justice by refusing to enforce a legal order designed to protect the citizens of the United States,” denouncing her as “an Obama administration appointee who is weak on borders and very weak on illegal immigration.”

Matthew Miller, a former spokesman for the Justice Department during the Obama administration, found Yate’s termination troubling for the Department of Justice.

“It says that if you exercise your independent legal judgement, and it contradicts what the president want to do, he will fire you,” Miller said. “This is a major violation of Justice’s traditional independence that will send chills down the spine of everyone there.”

Until the Senate confirms Alabama Senator Jeff Sessions, longtime immigration hardliner, as attorney general, Dana Boente, the U.S. attorney for the Eastern District of Virginia, will be replacing Yates as the leader of the Justice Department. According to Joshua Stueve, a spokesman for the United States attorney’s office in Alexandria, VA., Boente has told the White House that he is willing to sign off on Trump’s immigration executive order.

Yates dismissal from the Department of Justice comes at the heels of three turbulent days after Trump signed a controversial immigration executive order that sent shockwaves throughout the world this past Friday. Trump’s order suspended the U.S. Refugee Admissions Program for 120 days, indefinitely banned admitting Syrian refugees, and temporary banned visa travel by foreign nationals from seven Muslim-majority countries. The abrupt order led to chaos throughout the immigration system and U.S. airports with U.S. customs officials detaining and deporting travelers without warning, including permanent green-card holding U.S. residents. Since then, masses of volunteer lawyers and demonstrators have gathered to protest the ban and help those affected by it. Federal judges in five states have issued orders preventing elements of the order from being executed.

Two members of Justice Department have said that Yates, like other senior government officials, was surprised by the executive order and deliberated over the weekend about how to respond. She told colleagues that she considered resigning but did not want to leave her successor to face the same dilemma. Monday night, Yates released a public letter to Justice Department lawyers and staff, instructing them not to defend Trump’s order, and exposing a deep divide throughout the government over Trump’s actions.

“At present I am not convinced that the defense of the executive order is consistent with [my] responsibilities nor am I convinced that the executive order is lawful,” Yates wrote. “Consequently, for as long as I am the acting attorney general, the Department of Justice will not present arguments in defense of the executive order, unless and until I become convinced that it is appropriate.”

Within hours of her letter becoming public, Yates was removed from her post. Many reports are likening Yates’ rebuke to Trump’s order and subsequent termination to the so-called Saturday Night Massacre in 1973 when President Richard M. Nixon fired his attorney general and deputy attorney general for refusing to dismiss the special prosecutor in the Watergate case.

In a statement, the Democratic leader, Senator Chuck Schumer of New York, said that the “attorney general should be loyal and pledge fidelity to the law, not the White House. The fact that this administration doesn’t understand that is chilling.”

The Democratic National Committee, heralded Yates as a heroic patriot in a statement released Monday.

“Donald Trump can try to silence heroic patriots like Sally Yates who dare to speak truth to power about his illegal anti-Muslim ban that emboldens terrorists around the globe,” the Committee said. “But he cannot silence the growing voices of an American people now wide awake to her tyrannical presidency.”

On the other side, many defend Trump’s decision and are saying that Trump was left with no choice but to dismiss Yates. Jack Goldsmith, a former official in the Office of Legal Counsel, responsible to determining the legality of executive actions, wrote in a Lawfare post that Yates’ reasoning was not persuasive and that her letter was “an act of insubordination that invites the president to fire her. Which he did.”

Scalia’s Legacy Could Block Trump’s Wall

By Emily Cox

New York, NY — One of late Justice Antonin Scalia’s last rulings could prevent President Trump’s Mexican border wall from becoming a reality, according to a New York Times’ op-ed by law professors Daniel Hemel, Jonathan Masur and Eric Posner.

Justice Scalia’s June 2015 opinion in Michigan v. Environmental Protection Agency blocked an E.P.A rule that would have limited mercury emissions from power plants, saying that EPA regulation of hazardous emissions should only be levied when “appropriate and necessary.” This phrase required the EPA to consider costs.

“No regulation is ‘appropriate’ if it does significantly more harm than good,” Scalia wrote. “…It is not rational, never mind “appropriate,” to impose billions of dollars in economic costs in return for a few dollars in health or environmental benefits.”

Trump signed an executive order Wednesday, mandating the immediate construction of the border wall, and is planning to rely on the Secure Fence Act of 2006 as statutory authority for the construction of the wall, preventing Democratic filibustering of new legislation in the Senate. The 2006 legislation authorizes the secretary of homeland security to only to actions to secure the border that are “necessary and appropriate.” Like the Clean Air Act, this language requires cost consideration before action can be taken.

Trump claims the wall would cost $8 billion; however, estimates put the cost as high as $25 billion. In terms of benefits, Trump says that the wall is necessary to block illegal immigrants who come into the U.S. and commit crimes, but there is no evidence that this population commit crimes at a higher rate others. Even if this evidence existed, the wall won’t stop most illegal immigrants, because they are in the U.S. on expired Visas. The wall also won’t stop smugglers from tunneling underneath.

According to the op-ed, any economic benefit the could be obtained by reducing illegal immigrants would be nullified by the fact that these immigrants pay taxes, spend money, and enhance U.S. productivity.

Consequently, Trump’s wall does not meet the cost consideration requirement of the 2006 legislation and Scalia’s opinion in his 2015 ruling at this time.

Multiple media outlets are reporting today that White House press secretary Sean Spicer said Trump plans to pay for the wall with a 20 percent tax on imports into the United States from Mexico. New legislation would be needed to impose the tax.

 

Trump Names Republican Miscimarra to Head Labor Board

By Emily Cox

Donald Trump has appointed Philip Miscimarra to head the National Relations Board, the government’s primary labor law enforcement agency. As the only Republican on the board, Miscimarra has been frequently critical of the actions of the Democratic majority on the board in the past.

“It is an honor to be named NLRB acting chairman by the president. I remain committed to the task that Congress has assigned to the board, which is to foster stability and to apply the National Labor Relations Act in an even-handed manner that serves the interests of employees, employers and unions throughout the country,”Miscimarra said.

He will replace current board president Mark Gaston Pierce. Pierce will remain on the board until his term runs out on August 17, 2018. Miscimarra was nominated to the board by Barack Obama in April 2013 and appointed to a four-year term that August. His current term expires December 16, 2017. Currently, the Board also includes Lauren McFerran, whose term expires December 16, 2019. Two Board Member seats are currently vacant. The NLRB traditionally consists of three Members of the president’s party and two Members of the opposition. Miscimarra’s appointment is Trump’s first move in shaping his NLRB.

Before joining the Board, Miscimarra was a Senior Fellow at the University of Pennsylvania’s Wharton Business School in the Wharton Center for Human Resources, and a labor and employment law partner with Morgan Lewis & Bockius, LLP, in Chicago. Previously, he also worked as a labor and employment attorney at Seyfarth Shaw, LLP, Murphy Smith & Polk, PC (now the Chicago office of Ogletree, Deakins, Nash, Smoak & Stewart, PC), and Reed Smith Shaw & McClay (now Reed Smith, LLP). Miscimarra received his Juris Doctor from the University of Pennsylvania Law School.

Trump Signs Directives to Revive Two Major Pipeline Projects

Photo by Gage Skidmore
By Emily Cox

Washington, D.C. — Despite considerable opposition, President Donald Trump signed legislation Tuesday to advance approval of the Keystone XL and Dakota Access oil pipelines, according to multiple reports.

During the election, Trump openly opposed to the Obama administration’s environmental policies that blocked construction of the two controversial pipelines. Trump promised that he would reverse these policies immediately upon being elected, streamlining the approval of the Keystone XL pipeline in the process.

The Keystone XL pipeline, a proposed 1,179-mile cross-border pipeline from Alberta to Nebraska, has been stalled since November 2015, when the Obama administration denied TransCanada the necessary permit to begin construction due to environmental concerns. Trump’s presidential memorandum, regarding the pipeline, issued a directive for TransCanada “to promptly resubmit its application.” The memorandum also ordered the secretary of State to make a decision within 60 days, expediting existing procedural requirements.

The Dakota Access pipeline is a 1,172-mile proposed pipeline from North Dakota to Illinois that has been protested by both Native American and environmental groups. Since the pipeline crosses waterways, it requires approval from the U.S. Army Corps of Engineers. In another presidential memorandum, Trump directed the secretary of the Army to review and approve the pipeline “in an expedited manner, to the extent permitted by law.” Trump owned stock in the company building the pipeline, Energy Transfer Partners. While his campaign claims Trump sold off all individual stock holdings in August 2016, he has not filed a financial disclosure report to confirm the sale.

Protestors of the projects immediately denounced Trump’s actions regarding the pipelines Tuesday.

“President Trump is legally required to honor our treaty rights and provide a fair and reasonable pipeline process,” said Standing Rock Sioux Tribe chairman Dave Archambault II in a statement. “Americans know this pipeline was unfairly rerouted to our nation and without our consent. The existing pipeline route risks infringing on our treaty rights, contaminating our water and the water of 17 million Americans downstream.”

The executive orders also caught the attention of environmental group and activists. Tom Steyer, the president of NextGen Climate is accusing the Trump administration of putting “corporate interest ahead of American interests.”

“The pipelines are all risk and no reward, allowing corporate polluters to transport oil through our country to be sold on the global market, while putting our air and water at serious risk,” Steyer said in a statement.

“President Trump will live to regret his actions this morning,” said Michael Brune of the Sierra Club, going on to say that Trump will face “a wall of resistance the likes of which he never imagined.

The Keystone XL pipeline still requires state approval, and Nebraska landowners have fought a legal battle for years against TransCanada, which withdrew its application with the state’s Public Service Commission when its permit was denied.

The directives signed by Trump on Tuesday included four presidential memoranda and one executive order.  In addition to the pipeline memoranda, Trump signed a memorandum that requires the secretary of Commerce to come up with a plan to mandate American-made steel for all future pipeline work in the United States within six months in order create more steel- working jobs.

“I am very insistent that if we’re going to build pipelines in the United States, the pipe should be made in the United States,” Trump told reporters.

In another memorandum for all federal agencies to review manufacturing regulations, Trump is requiring the secretary of Commerce to seek public opinion on how to streamline those rules for 60 days with a report to Trump containing proposals 60 days after that.

Trump’s executive order is to fast-track approval for “high-priority infrastructure projects,” claiming that the existing protocol was an “incredibly cumbersome, long, horrible permitting process.” Per the order, any Cabinet secretary or governor can request for a project to be designated as high-priority. If the chairman of the White House Council on Environmental Quality approves, the project goes to the front of the line for review and approval of the project by the necessary agencies.

“This is the expediting of environmental reviews and approvals for high-priority infrastructure projects,” Trump said. “We can’t be in an environmental process for 15 years if a bridge is falling down.”

“If it’s a no, we’ll give them a quick no, and if it’s a yes, it’s like ‘Let’s start building,’” he continued. “The regulatory process in this country has become a tangled-up mess, and very unfair to people.”

Risperdal Lawsuits Are on the Rise as Gynecomastia Settlements Are Reached in Bellwether Cases

Lawsuitupdate.com reports that lawsuits are increasingly being filed on behalf of young men and boys who were diagnosed with gynecomastia as a side effect of Risperdal, as the manufacturer of the atypical antipsychotic medication settles cases set for trial over their failure to warn about the risk of male users experiencing abnormal breast growth.

Currently, there are several thousand pending Risperdal lawsuits against Johnson & Johnson. Some of the older cases were set for trial during the past year to gauge juries’ reactions to evidence and testimony that will appear throughout the litigation.

Among the most recent plaintiffs is Nicholas Sheldon, who filed in the U.S. District Court for the South District of New York last week. Sheldon alleges that he developed gynecomastia following the use of Risperdal and a generic equivalent of risperdone between 1997 and 2012. He was diagnosed with abnormal breast growth in July 2010. Neither Sheldon or his doctors knew about the link between Risperdal and gynecomastia at that time.

Sheldon’s allegations reflect those in other claims, indicating that Johnson & Johnson and its Ortho-McNewil Janssen Pharmaceuticals subsidiary knew or should have known about the gynecomastia risk from Risperdal and willfully decided to hide this side effect from the general public and the medical community.

“The current warnings for [Risperdal] are still simply inadequate,” Sheldon states in the complaint. “The Pharmaceutical Defendants have failed and continue to fail in their duties to warn and protect the consuming public, including the plaintiff herein.”

Sheldon’s complaint was filed after Johnson & Johnson reached an agreement to settle a Pennsylvania state court bellwether case on January 6 in order to avoid a jury trial. In November 2016, Johnson & Johnson settled another Risperdal bellwether claim. The details of both agreements are confidential and have not been disclosed.

These settlements came after several recent large verdicts were awarded by different juries in Pennsylvania state court, which is where most Risperdal lawsuits are currently pending.  In July 2016, the family of a five-year-old Tennessee boy was awarded $70 million in damages. Prior verdicts include $2.5 million in February 2015, $1.75 million in November 2015, and $500,000 in December 2015. Since Johnson & Johnson has not been able to resolve many claims, additional bellwether trials are expected to be set for trial.

If you or a loved one has experienced abnormal breast growth or weight gain after taking Risperdal, you may be eligible for compensation. Please fill out the contact form on this page, call Arentz Law Group at 1-800-305-6000, or text 800-440-4400 to begin a free review of your claim.

FDA Panel to Review Essure Complaints

The US Food and Drug Administration has announced that it will order a meeting of the Obstetrics and Gynecology Devices advisory panel on September 24, 2015 to consider the data and other problems surrounding Bayer’s Essure implant as the number of patients reporting complications continues to rise. The FDA has received 5,093 reports of adverse medical events connected to the Essure device from it’s approval by the regulatory agency in November 2002 to May 31st, 2015. Most of the reports were made voluntarily by patients.

Bayer’s Essure implant is a form of long-term birth control provided to women on an outpatient basis through medical facilities and doctor’s offices. The procedure is executed by a physician placing flexible coils into a patient’s fallopian tubes; Essure coils then stimulate the formation of scar tissue sealing the tubes and preventing pregnancy.

However, patients report having encountered menstrual irregularity, headaches, fatigue, and weight loss and gain, and in at least four cases, death. Two of the deaths were directly linked to a uterine perforation and an air embolism caused by the Essure coils. The other two fatalities were caused by a secondary infection and a suicide. The death from uterine perforation was reported to the FDA by Bayer in February 2015 following the submission of a recall petition reached the FDA.

Bayer has attempted to mitigate the concerns of the Essure coils’ safety. If you or a loved one had Essure coils implanted and suffered injury, you may be eligible for compensation. Please fill out the contact form on this page, or call Arentz Law Group at 1-800-305-6000 for free review of your case. 

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