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Cantwell, Capito Introduce Bipartisan Legislation to Guarantee Equal Pay for American Athletes Competing on the Global Stage

U.S. Senators Maria Cantwell (D-WA), the Ranking Member of the Senate Commerce, Science, and Transportation Committee, and Shelley Moore-Capito (R-WV) today introduced their bipartisan plan to ensure equal pay for Americans who represent our country in global athletic competitions, like the World Cup or the Olympics. Currently, men and women can be paid differently for representing Team USA in the same sport. 

“When American athletes represent our country on the worldwide stage, they deserve to be compensated equally – because a gold medal is a gold medal, no matter your gender,” Senator Cantwell said. “The U.S. Women’s National Soccer team has done so much to raise this issue, but it impacts top athletes in every sport. It’s time for us to work together to right this wrong and get this done.”

“The skill and success of the U.S. Women’s National Soccer Team at this year’s World Cup evoked a tremendous sense of pride and excitement in our country, but their performance also served as a reminder that women representing our country in global athletic competitions do not receive the kind of pay or benefits their male counterparts do,” said Senator Capito, a member of the Commerce, Science, and Transportation Committee. “While this is currently a very visible and talked about issue, it’s not a new one; and it’s time that we made sure all athletes representing our country on the global stage are equally compensated. As a woman, a sports fan, and the mother of a female athlete, I’m proud to join with Senator Cantwell on this bipartisan legislation.”

The Equal Pay for Team USA Act, pursuant to the Commerce Committee's jurisdiction over the United States Olympic Committee (USOC), would require that all athletes representing the United States in global athletic competitions receive equal compensation and benefits for their work, regardless of gender. Cantwell and Capito’s legislation also requires equal payment for medical care, travel, and expenses. 

The bill applies to 50 different sports national governing bodies, and it requires the USOC to conduct oversight to make sure they all come into compliance with the legislation.

You can read the full text of Senator Cantwell and Senator Capito’s bipartisan plan HERE

Subcommittee to Hold Hearing on Waterfronts

U.S. Sen. Cory Gardner, R-Colo., chairman of the Subcommittee on Science, Oceans, Fisheries, and Weather, will convene a hearing titled, “America’s Waterfronts: Addressing Economic, Recreational, and Environmental Challenges,” at 2:15 p.m. on Tuesday, July 23, 2019. This hearing will focus on the current state of our working waterfronts, how we can balance stakeholder needs, and maximize the benefits from our water and coastal resources. Witnesses will also discuss the current challenges, highlight management and development successes, and provide suggestions on how our waterfronts could be further improved.

Helping Small Businesses Compete: Challenges and Opportunities in the Federal Procurement Marketplace

House Small Business Committee News - Tue, 07/16/2019 - 10:00am

The Committee on Small Business Subcommittee on Contracting and Infrastructure will meet for a hearing titled, “Helping Small Businesses Compete: Challenges and Opportunities in the Federal Procurement Marketplace.” The hearing is scheduled to begin at 10:00 A.M. on Tuesday, July 16, 2019 in Room 2360 of the Rayburn House Office Building.

As part of the Subcommittee’s ongoing effort to improve the competitive viability of small businesses, the hearing will examine a variety of issues affecting small contractors. It will allow Members to look at some of the common challenges faced in the federal contracting arena. The hearing will also allow small contractors the opportunity to explain how these issues directly impact their daily operations and bring forward some of the potential solutions to address them.

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 

Witnesses 

Ms. Belinda Guadarrama
Founder & CEO
GC Micro
Petaluma, CA
*Testifying on behalf of GovEvolve
Testimony 

Mr. Bruce Lansdowne
President & CEO
Trinity Technology Partners
Greenbelt, MD
*Testifying on behalf of the Montgomery County Chamber of Commerce
Testimony 

 

*Witness testimony will be posted within 24 hours after the hearing’s occurrence



 

WCOE submits comments on SBA Proposed Rule on WOSB Certification

WCOE News - Mon, 07/15/2019 - 5:43pm

WCOE submitted comments to the SBA on its proposed rule which would eliminate self-certification for Women-Owned Small Businesses (WOSBs) and Economically Disadvantaged Women-Owned Small Businesses (EDWOSBs). WCOE supports a full certification program. Read the WCOE comments here. The comments support the Department of Transporation (DOT) certification program and advocate that any other authorized third-party certifiers, including state DOT programs, be required to use federal DOT criteria with no self-certification, under any circumstances. Other standards suggested by WCOE include a reasonable time limit for the certification process (180 days), the establishment of an appeal process, certification validity for 3–5 years but with a requirement that material changes to businesses affecting eligibility be reported. The comments also noted that DOT certification is free and suggests third-party certifiers that do charge, engage in a sliding scale fee based on the size of the business with a cost not to exceed $1,000. If you have any questions or comments about WCOE's comments to SBA, please feel free to contact WCOE President, Sheila Ohrenberg at sheila@sorellagroup.com or WCOE's Washington Representative Dana Thompson at dthompsonwcoe@outlook.com

Categories: Latest News

WLF Asks High Court to Stop Lower Courts from Rewriting the ADA

WLF Legal Pulse - Mon, 07/15/2019 - 11:09am

“Whether and how to impose a federal accessibility regime on America’s vast digital economy is a question of such political and economic magnitude that only Congress can answer it.”
—Cory Andrews, WLF Senior Litigation Counsel

Click HERE for WLF brief

(Washington, DC)—Washington Legal Foundation (WLF) today asked the U.S. Supreme Court to review, and ultimately overturn, a decision of the U.S. Court of Appeals for the Ninth Circuit that essentially rewrites the Americans with Disabilities Act of 1990 (ADA).

Congress enacted the ADA in 1990, before the cyberspace era. Title III of the ADA forbids “public accommodations” from discriminating against the disabled. Yet the Ninth Circuit extended the scope of Title III liability to Domino’s Pizza—not for its brick-and-mortar restaurant, but for its Internet website and mobile app.

Rather than phone his local Domino’s for pizza delivery or pick up, Robles sought to order pizza via Domino’s website and mobile app. Contending that Domino’s website and app lacked adequate written descriptions for every digital image, Robles sued Domino’s under the ADA for preventing him from completing an online order. The district court dismissed the suit. On appeal, the Ninth Circuit decided that Title III extends to Domino’s website and mobile app, allowing the suit to go forward. That holding conflicts with the decisions of at least three other federal appeals courts.  

In its amicus curiae brief, WLF argues that the Ninth Circuit’s decision amounts to an impermissible rewrite of the ADA. Under our constitutional system, only Congress—not courts or federal agencies—may amend federal law. And because the Supreme Court expects Congress to speak clearly if it wishes to regulate new matters of vast economic and political significance, the Supreme Court’s review is crucial to ensure that courts do not fill any statutory void in the ADA with judge-made legislation.

Celebrating its 42nd year as America’s premier public-interest law firm and policy center, WLF advocates for free-market principles, limited government, individual liberty, and the rule of law.

The post WLF Asks High Court to Stop Lower Courts from Rewriting the ADA appeared first on Washington Legal Foundation.

Categories: Latest News

SBA Management and Oversight of SCORE

House Small Business Committee News - Thu, 07/11/2019 - 11:00am

The Committee on Small Business Subcommittee on Investigations, Oversight, and Regulations will meet for a hearing titled, “SBA Management and Oversight of SCORE.” The hearing is scheduled to begin at 11:00 A.M. on Thursday, July 11, 2019 in Room 2360 of the Rayburn House Office Building. 

The SCORE Program was established in 1964 as a national, volunteer nonprofit organization. It provides face-to-face counseling at nearly 350 chapters nationwide with more than 11,000 SCORE volunteers. SCORE volunteers provide a full range of business consultation services, such as business plan development, strategic marketing, and financing ideas. The Small Business Administration Office of Inspector General released an audit of the program in April 2019 examining the SBA’s oversight of the program’s awarded federal funds and the measurement and achievement of program goals. The hearing provides an opportunity to discuss the audit report and what steps the agency is taking to resolve the recommendations.  

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 

Witnesses 

Mr. Hannibal “Mike” Ware
Inspector General 
United States Small Business Administration 
Washington, DC
Testimony 

Mr. Allen Gutierrez
Associate Administrator
Office of Entrepreneurial Development 
U.S. Small Business Administration
Washington, DC
Testimony 

 

*Witness testimony will be posted within 24 hours after the hearing’s occurrence



 

Court Appropriately Blocks HHS’s Audacious Power Grab on TV-Ad Drug-Price Disclosure

WLF Legal Pulse - Thu, 07/11/2019 - 9:05am

In the immediate aftermath of a U.S. Supreme Court Term that featured stirring debates on administrative agencies’ proper place in the Constitution’s separation-of-powers scheme, it’s fitting that Judge Amit P. Mehta invalidated an ultra vires agency action. On July 8 in Merck & Co., Inc. v. U.S. Department of Health and Human Services, he held that a rule mandating drug-price disclosure in TV ads exceeded the implementing agency’s statutory authority. Three pharmaceutical manufacturers and an advertising trade group had challenged the rule on both administrative-law and First Amendment grounds.

We have written previously here about HHS’s idea to require disclosure of drugs’ “sticker price” in TV ads, which the agency floated in a “blueprint” on how government could lower prescription drug prices. Our analysis focused on the Food & Drug Administration’s lack of authority to impose such a rule and the mandate’s violation of drug makers’ and consumers’ speech rights.

We were quite taken aback when HHS announced through the proposed rule that the Center for Medicare and Medicaid Services, not FDA, would implement the mandate under its power to administer the Social Security Act (SSA). CMS openly admitted in the proposal that Congress had never granted it express authority to regulate the advertising of drugs subject to Medicare or Medicaid reimbursement. But the agency claimed that its power to mandate price disclosure fit comfortably within the SSA’s broad language.

HHS argued that because Congress granted it such sweeping authority to carry out the SSA, the court should evaluate the plaintiffs’ Administrative Procedure Act claim under the Supreme Court’s 1973 Mourning v. Family Publication Services, Inc. decision. Judge Mehta was nonplussed, replying (we’re of course paraphrasing here), “thanks, but I’ll use the standard from a more recent Supreme Court decision on Congress’s delegation of rulemaking authority. You didn’t cite it in your reply to plaintiffs’ motion, but it’s called Chevron v. NRDC.”

The opinion goes on to meticulously detail why the government’s claim of authority doesn’t make it past Chevron Step One:

Text of the SSA. The SSA, Judge Mehta explains, grants CMS the authority to “administer” Medicare and Medicaid, which means CMS can promulgate rules for “‘running’ and ‘managing’ the federal public health insurance programs.” Pharmaceutical manufacturers do not play a direct role in carrying out Medicare or Medicaid. Pricing decisions, Judge Mehta reasons, at best “impact program costs in an indirect way.” The SSA’s text thus doesn’t support HHS’s argument of implied authority to mandate price disclosure.

Congress’s Grant of Drug-Advertising Oversight Authority. Congress has addressed direct-to-consumer drug advertising not in the SSA, but in the Food, Drug, and Cosmetic Act (FDCA). The FDCA empowers FDA to draft rules on drug advertising, which the agency has done. Congress also amended the FDCA several times to specify what is and is not appropriate for drug ads. As Judge Mehta states, “Congress knows how to prescribe the content of drug advertising when it chooses to do so.”

Magnitude of the Subject Dictates Need for Specific Delegation. In 2016, “CMS and its beneficiaries spent $238 billion on prescription drugs.” In 2015 “Americans spent $457 billion on prescription drugs.” A rule that moves HHS and CMS into regulating “the marketing of products that comprise ‘a significant portion of the American economy,'” Judge Mehta reasons, cannot be based on general rulemaking authority. He also adds that “HHS has never before attempted to use the SSA to directly regulate the market for pharmaceuticals.”

The Executive Branch as a whole is clearly determined to force down the cost of prescription drugs. But as we’ve argued here previously, many proposed cures risk doing far more harm than good. A misleading price forced into a TV drug ad can distract consumers from vital safety and effectiveness information or reduce treatment utilization, outcomes that could harm patients and increase Medicare and Medicaid costs. In addition, legal arguments that would vastly expand the power of one administrative agency are at odds with the laudable ongoing efforts to reduce government mandates and return respect to the separation of powers. 

HHS will no doubt appeal to the D.C. Circuit. Despite the thoroughness of Judge Mehta’s opinion, perhaps the agency could prevail. It would then have to return to Judge Mehta’s court and defend the rule against claims that it was promulgated in an arbitrary and capricious manner and that it violates the First Amendment. The plaintiffs, in our opinion, have solid arguments on both those claims. The wise choice, for HHS, for consumers, and for the rule of law, would be for the agency to withdraw the drug-price mandate and pursue other, lawful, avenues.

Also published by Forbes.com on WLF’s contributor page.

The post Court Appropriately Blocks HHS’s Audacious Power Grab on TV-Ad Drug-Price Disclosure appeared first on Washington Legal Foundation.

Categories: Latest News

Cantwell to Commerce Committee: Dickson is the Wrong Man for the FAA

At a Senate Commerce, Science, and Transportation Committee mark-up today, U.S. Senator Maria Cantwell (D-WA), the Ranking Member of the committee, delivered remarks opposing Stephen Dickson’s nomination to become the next Administrator of the Federal Aviation Administration (FAA). Senator Cantwell cited serious concerns over Mr. Dickson’s handling of a safety whistleblower case involving First Officer Karlene Petitt, a Washington state resident, during his time as a Delta Air Lines executive.

“But since our investigation it is very clear that Mr. Dickson did know, was involved with this pilot, did know what was happening, and failed to disclose it to this committee,” Cantwell said.

While Mr. Dickson was in charge of the flight safety regimen at Delta, Petitt raised a number of safety concerns, including lack of pilot training and pilot rest, to Dickson and other Delta officials. Instead of taking these concerns seriously, Dickson and other executives forced her to undergo a mandatory psychiatric evaluation and removed her from duty.

In her remarks, Cantwell raised concerns with this process and the psychiatrist chosen by Delta:

“And I don’t mean a general retaliation, I mean an absurd retaliation – a retaliation in which she was sent to a psychiatrist who then claimed, just because she juggled marriage, children, and being a pilot, that somehow she must be manic. And she was, because of that action by Delta, removed from flying, even though she had been a pilot for many years – decades,” Cantwell said.

This psychiatrist’s evaluation was later overturned by two exams performed by outside experts, including by a panel of eight doctors from the Mayo Clinic, and First Officer Petitt has returned to duty.

Yesterday, Captain “Sully” Sullenberger, the Hero of the Hudson, announced his opposition to Dickson’s nomination due to this retaliation. Cantwell highlighted Captain Sullenberger’s statement in her remarks to the committee.

“We certainly can’t have organizations who threaten pilots with this kind of retaliation to actually stop them from flying, when in reality they are just reporting what they think are the needed improvements to a safety management system,” Senator Cantwell said. “That is why this nomination has also been objected to by Captain Sullenberger, who has come to the aid of this whistleblower to simply say: ‘pilots have to be listened to.’”

Citing these concerns, among others, Senator Cantwell first announced her opposition to Mr. Dickson’s nomination in a statement last Friday.

Committee Announces Hearing on Deep Space Exploration

U.S. Sen. Roger Wicker, R-Miss., chairman of the Committee on Commerce, Science, and Transportation, will convene a hearing titled, “Moon to Mars: NASA’s Plans for Deep Space Exploration,” at 10:00 a.m. on Wednesday, July 17, 2019. This hearing will examine the future of the National Aeronautics and Space Administration (NASA) human spaceflight program. Witnesses will discuss NASA’s plans for the Artemis Program and returning U.S. astronauts to the lunar surface by 2024. The hearing will also highlight policy, regulatory, or technological challenges the agency faces in their efforts to achieve that goal.

Committee Advances FAA Administrator Nomination to Full Senate

The committee also approved a nomination to the Surface Transportation Board, Coast Guard promotions, and 10 legislative items....

<p>Good morning and welcome to the

Good morning and welcome to the Commerce Committee’s sixth executive session of the 116th Congress. Before we take up today’s agenda, let me provide a short update on the committee’s activities.

So far, we have reported nearly 20 bipartisan bills – and we intend to add another 10 to that count today.  

Bills already reported reflect this committee’s broad jurisdiction and include measures to: 

  • Combat illegal robocalls
  • Strengthen the maritime industry
  • Protect America’s oceans
  • Encourage STEM education
  • Expand rural broadband

We have also made progress on one of our top priorities -- consumer data privacy.  I hope to preview a bipartisan product in the coming weeks, and I look forward to continuing to work with my friend Ranking Member Cantwell and other members of the committee to accomplish this goal.

Today’s agenda includes several bipartisan legislative proposals to protect children from risk in hot cars, support veterans, and advance the Internet of Things.  

The committee will also vote on two nominations and several Coast Guard promotions.

One of today’s nominees is Stephen Dickson to serve as the Administrator of the Federal Aviation Administration. 

Mr. Dickson was chosen for this important position based on his strong qualifications, which include almost 40 years of combined service in the U.S. Air Force and the commercial air transportation sector.

Mr. Dickson is a 1979 Distinguished Graduate of the Air Force Academy and graduated magna cum laude from Georgia State University College of Law in 1999, where he earned his J.D. He served in the U.S. Air Force as an F-15 fighter pilot, including assignments as a Flight Commander, Instructor Pilot, and Flight Examiner.  

From 1991 until October of 2018, Mr. Dickson was employed by Delta Air Lines as a pilot and management executive. He retired after rising through the ranks to become Delta’s Senior Vice President of Flight Operations.

On May 15th, the committee held a hearing to consider Mr. Dickson’s nomination, and he clearly demonstrated the experience and leadership abilities necessary to lead the FAA.

After Mr. Dickson’s hearing, new information came to the committee’s attention that involved employees reporting possible safety violations at Mr. Dickson’s former employer while he was serving as a senior vice president. These matters merited further investigation. The committee has since conducted an extensive review, including multiple follow-up conversations and meetings with Mr. Dickson. We have studied hundreds of pages of legal documents. It is clear that Mr. Dickson was not a named party in any of these matters and was not personally alleged to have retaliated against any of his fellow employees who raised safety concerns.

Mr. Dickson’s responses to post-hearing Questions for the Record demonstrate that his commitments to safety and the protection of employees who report concerns are paramount. In fact, Mr. Dickson unequivocally stated in his written responses that he was never named as a party to any judicial, administrative or regulatory proceedings and he was never accused of retaliation of any sort during his tenure at his former employer.  

The FAA is the gold standard in aviation safety. It is vital to have a Senate-confirmed Administrator at the helm of the FAA at this crucial time for the agency. I believe Mr. Dickson is an excellent nominee for this position. I think he will bring the commitment, experience, and expertise necessary to lead the FAA and fulfill its mission. I will be voting for his nomination and I urge all of my colleagues to do so.

Continuing to Serve: From Military to Entrepreneur

House Small Business Committee News - Wed, 07/10/2019 - 11:30am

The Committee on Small Business will meet for a hearing titled, “Continuing to Serve: From Military to Entrepreneur.” The hearing is scheduled to begin at 11:30 A.M. on Wednesday, July 10, 2019 in Room 2360 of the Rayburn House Office Building.
 
While facing challenges in transitioning to new jobs after time in the military, returning service members possess leadership skills that naturally translate to entrepreneurship. The purpose of the hearing will be to discuss the role of veteran entrepreneurs in growing the economy and examine legislative efforts to foster veteran entrepreneurship.

To view a livestream of the hearing, please click here. 

Hearing Notice 

Hearing Memo 

Witness List 

Witnesses 

Mr. Davy Leghorn 
Assistant Director 
The American Legion 
Washington, DC
Testimony 

Mr. Scott M. Davidson CPT. USA, Retired  
Managing Principal & CEO
The GCO Consulting Group
McLean, VA
Testimony 

Mr. Torrance Harrington Hart  
Owner 
Teak & Twine 
Springfield, VA
Testimony 

Ms. Laurie Sayles
President and CEO
Civility Management Solutions
Greenbelt, MD
Testimony

*Witness testimony will be posted within 24 hours after the hearing’s occurrence



 

Executive Session

U.S. Sen. Roger Wicker, R-Miss., chairman of the Committee on Commerce, Science, and Transportation, will convene an executive session on Wednesday, July 10, 2019 at 10:00 a.m. in Hart Senate Office Building 216 to consider the following legislative measures and nominations.

Inherently Risky but Socially Beneficial: Court in PA to Rule on Strict Liability for Medical Devices

WLF Legal Pulse - Tue, 07/09/2019 - 3:40pm

Because it is impossible to design a prescription drug that provides the desired health benefits with zero risk of harm, courts have long held that manufacturers of prescription drugs are not strictly liable for injuries these drugs cause. In recent years, courts around the country have begun to determine whether prescription medical-device makers merit the same treatment when confronted with strict liability claims.

The United States District Court for the Eastern District of Pennsylvania recently asked the U.S. Court of Appeals for the Third Circuit to answer whether Pennsylvania recognizes a strict liability claim for a manufacturing defect of a prescription medical device. Rosenberg v. C.R. Bard, Inc., — F. Supp. 3d —, 2019 WL 2596358 (E.D. Pa. 2019). This case is similar to one currently pending in the Utah Supreme Court, Burningham v. Wright Medical Group, which will answer a Certified Question from the United States District Court for the District of Utah of whether implanted medical devices fall under the “unavoidably unsafe” exception to strict products liability in design defect claims recognized in comment k to Section 402A of the Restatement (Second) of Torts. (Washington Legal Foundation filed an amicus curiae brief in that case, urging the court to apply comment k categorically to prescription medical devices.)

Section 402A of the Restatement as adopted by many state courts imposes strict liability on one “who sells any product in a defective condition unreasonably dangerous to the user or consumer, or to his property” regardless whether the seller “exercised all possible care in the preparation and sale of his product.” Restatement (Second) of Torts § 402A (1965). Comment k, however, creates an exception to strict liability for “unavoidably unsafe” products. Products are deemed unavoidably unsafe if they “provide an exceptionally important benefit” yet pose a “substantial and unavoidable” risk to their users. Grundberg v. Upjohn Co., 813 P.2d 89, 93 (Utah 1991).

Both the Pennsylvania Superior Court and the Pennsylvania Supreme Court have barred strict liability claims in prescription drug cases for design defect and failure-to-warn claims based on the policies directly expressed in comment k. See Hahn v. Richter, 543 Pa. 558, 560-63 (1996). The Superior Court determined that comment k excludes prescription drugs from strict liability claims because prescription drugs are “inherently dangerous products which benefit society.” Hahn v. Richter, 427 Pa. Super. 130, 151 (1993) aff’d, 543 Pa. 558 (1996).

In Rosenberg, Judge Robreno relied on the language of comment k and Pennsylvania case law to support the prediction that Pennsylvania would extend its comment k jurisprudence to strict liability manufacturing-defect claims.

Comment k specifically “contemplates its application to prescription” drugs that a doctor must prescribe. “[C]omment k’s plain language appears to include prescription medical devices because ‘prescription’ medical devices, by definition … require a physician’s prescription.” Rosenberg, 2019 WL 2596358, at *3. The court therefore found “no meaningful distinction” between prescription drugs and prescription medical devices. Id.

Pennsylvania state courts have also concluded that the reasons for applying comment k to prescription drugs apply equally to medical devices. See, e.g., Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006). In Creazzo, the Superior Court expanded comment k’s reach categorically to implanted medical devices. It agreed with the trial court’s finding that, given the utility and unavoidably unsafe nature of implanted medical devices, there was no significant difference between such devices and prescription drugs from the Hahn decision. Creazzo, 903 A.2d at 31.

Based on those considerations, the court concluded that there is “no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Id. But notably, Pennsylvania has not specifically prohibited strict liability claims for manufacturing defects in the prescription-product context. So the Pennsylvania district court needed to predict whether Pennsylvania law would extend to bar such claims.

The court noted that a split has developed among the lower Pennsylvania courts regarding the applicability of strict liability to manufacturing-defect claims. But it concluded that the Pennsylvania Supreme Court has determined that “strict liability claims are not cognizable in the prescription drug context.” Rosenberg, 2019 WL 2596358, at *6 (citing Lance v. Wyeth, 624 Pa. 231, 242-43 (2014)). Based on case law and “the lack of a meaningful distinction between the legal treatment of prescription drugs and prescription medical devices,” Judge Robreno predicted that the “Pennsylvania Supreme Court would not recognize a strict liability claim for a manufacturing defect of a prescription medical device.” Id.

Acknowledging that the availability of a strict liability claim in the manufacturing-defect context is open to debate and is a controlling question of law in Rosenberg, the court certified the question to the Third Circuit for interlocutory appeal.

It is likely the Third Circuit will certify the question to the Pennsylvania Supreme Court, rather than itself also guessing what that court would hold. But if it chooses to answer the question itself, the Third Circuit should follow Judge Robreno’s lead and “extend comment k’s mantle of protection both to prescription drugs and prescription medical devices” to preclude strict liability claims based on manufacturing defects. Id. at *7. The Food and Drug Administration (FDA) thoroughly analyzes prescription medical devices’ risks and benefits when clearing such products for public release. Further, doctors prescribe devices on an individual, case-by-case basis. If courts refuse to consider prescription medical devices as “unavoidably unsafe,” juries will step into the shoes of FDA and patients’ physicians.

Strict products liability litigation alleging defective design could force manufacturers to cease production or alternatively to increase prices and pass those costs on to consumers. The public suffers when medical devices become unavailable or unaffordable.

Also published by Forbes.com on WLF’s contributor page.

The post Inherently Risky but Socially Beneficial: Court in PA to Rule on Strict Liability for Medical Devices appeared first on Washington Legal Foundation.

Categories: Latest News

NASA Exploration Plans: Where We’ve Been and Where We’re Going

U.S. Sen. Ted Cruz, R-Texas, chairman of the Subcommittee on Aviation and Space, will convene a hearing titled, “NASA Exploration Plans: Where We’ve Been and Where We’re Going” at 3:00 p.m. on Tuesday, July 9, 2019. The purpose of this hearing is to honor the upcoming 50th anniversary of the National Aeronautics and Space Administration’s (NASA) Apollo 11 mission and the United States landing the first man on the moon. The hearing will examine NASA’s plans for future human spaceflight missions.

<p>Fifty years ago exactly one week

Fifty years ago exactly one week from today, at approximately 9:30 a.m., three astronauts, sitting atop a rocket the size of a Navy destroyer packing 7.5 million pounds of thrust, took off from Kennedy Space Center in Florida. Roughly a million people had gathered on the ground to watch this historic event, including half of the United States Congress. These three astronauts, as one newspaper put it at the time, carried with them ‘the hopes of the world.'

The year was 1969, the astronauts were Neil Armstrong, Buzz Aldrin, and Michael Collins, and the mission was Apollo 11. Armstrong and Aldrin would go on to make history a little over 100 hours later when, with more than a third of the Earth watching or listening live, they became the first humans to ever set foot on the Moon. The Apollo 11 Mission would go on to make history again, a little less than 100 hours after that, as the first mission to not only put men on the Moon, but bring them home safely as well. Although President Kennedy hadn’t lived to see it, the goal he had set 8 years earlier had been met. To steal a line from the Flight Director of that mission, we had shown that, ‘What America will dare, America will do.’

Today, we rightfully celebrate the momentous occasion that is the upcoming 50th anniversary of Apollo 11. As President Nixon said in a phone call to Neil Armstrong and Buzz Aldrin while they were still on the Moon, because of what they had done ‘the heavens have become a part of man's world.’ Indeed, not only did we succeed in putting men on the Moon and returning them safely to Earth, but we’ve gone on to put robotic rovers on distant planets, celestial observatories in orbit that can literally peer into the beginnings of the universe, and established a human presence in low-Earth orbit that is there still today.

However, while it is tempting to focus only on the historic achievement that was Apollo 11, as some of our witnesses today will highlight, the Moon landing, and the entire Apollo Program for that matter, didn’t happen in a vacuum. It was the result of visionary leadership, national unity, and old-fashioned American tenacity.

The success of Apollo 11 and our national space program was also due in large part to the tireless contributions of countless women who were working behind the scenes, and whose stories have only recently become household names. One of our witnesses today, Dr. Christine Darden, was one of the famed “human computers” at NASA. Without her work and the work of other “computers,” many of them African-American women, we never could have sent astronauts into space, let alone brought them back safely. Unfortunately, Dr. Darden’s and the other computers contributions were hidden for far too long, relegated to the background for a time, despite the critical nature of their work. Her story, and the story of others like her, serves as a reminder of the lessons we need to learn from to ensure that we are cultivating, and elevating talent and leadership, not based on race or gender, but on merit, demonstrated skill, and passion. After the movie Hidden Figures came out, I introduced legislation to rename the street in front of the NASA Headquarters as Hidden Figures Way. The DC Council took up the idea, and just a few weeks ago, I was proud to join Dr. Darden and the families of other human computers at the dedication of the new street sign.

As we look out over the space landscape today, what we see is far different from the landscape of 1969. America and the Soviet Union are no longer the only players in space. Government space programs are no longer the only game in town. And our technological capabilities, both in terms of our ability to plan missions and what we are able to put in space and for how long, are, for better and worse, exponentially greater than they were when the space race began. But to truly succeed we must let our past lessons inform and help guide our future endeavors.

What do the next 50 years in space exploration look like, and what should we seek to accomplish?

First, I firmly believe that we need a bold vision that takes concrete action to secure our supremacy in space. Space is no longer just an uninhabited void or scientific novelty that it was 50 years ago. From GPS and communications satellites to weather and imaging satellites, space has become an integral part of the world economy and of our everyday lives.

The importance of space is certain to grow as space further establishes itself as not only the next frontier of exploration, but international commerce, and economic growth. By some estimates, the space sector will grow to nearly $3 trillion in value in the next three decades alone.

In the next 50 years we will see companies continue to take concrete steps that further expand upon manufacturing in space, developing new life-saving cures, and engage in asteroid mining, in which a small asteroid can contain rare materials such as platinum worth billions. These ventures are in part, why I believe the world’s first trillionaire will be made in space.

The United States will return to the Moon as part of the Artemis program, Artemis is the twin sister of Apollo, and this time when we return to the Moon, NASA has committed that we will land the first woman on the Moon, an American astronaut. On behalf of my two young daughters, let me say, thank you and it’s about time!  From there, we will pave the way towards establishing a more permanent presence on the Moon.

We will also look to use our return to the Moon to not only establish commerce but use it as a launching pad to send American astronauts to the surface of the Red Planet, and beyond. I was proud to author and pass the bipartisan NASA Authorization Act of 2017, in which Congress unanimously laid out going to Mars as the critical objective for space exploration.

We must also use the next 50 years to further the search for life within our solar system. This will include a detailed exploration of Earth-like planets like Jupiter’s Moon, Europa.

In short, the next 50 years in space have the potential to be even more consequential than the last, but this will require a serious, sober look at the road ahead of us. Our goal for the next 50 years should be to emphatically establish the United States of America as a true, space-faring nation. 

That’s why I am glad to be engaged with Ranking Member Sinema, Chairman Wicker, and Ranking Member Cantwell on a NASA Authorization that will help establish a long-term, sustainable vision for space exploration.

I look forward to hearing from out witnesses today about what those steps might look like, how we might best coordinate our actions, and how we in Congress can act to ensure the next 50 years, and beyond, are even more consequential and impactful than the last. To paraphrase the Astronaut Jim Lovell as he discussed seeing ‘Earth Rising’ for the first time, God has given mankind a stage upon which to perform. How the play turns out, is up to us.'

Following Hearing on Amtrak, Cantwell Calls for Analysis of Gaps in Positive Train Control Implementation

After pushing rail officials to make safety a top priority at a Senate hearing last month, U.S. Senator Maria Cantwell (D-WA), the Ranking Member of the Senate Commerce, Science, and Transportation Committee, sent a letter to the Federal Railroad Administration on the implementation of Positive Train Control (PTC) technology for rail safety and what measures FRA requires in areas where Amtrak operates without PTC.

“I am writing to seek more information about how the Federal Railroad Administration (“FRA”) ensures the safety of intercity passenger rail service on over 1,400 miles of track where Positive Train Control (“PTC”) safety technology is not implemented,” Cantwell wrote in her letter to FRA Administrator Ron Batory.

Last month, an investigation by the National Transportation Safety Board found that, had PTC been deployed, it could have prevented the fatal 2017 derailment of Amtrak 501 near DuPont, WA.

“While taking the train is generally a safe way to travel, in December 2017 tragedy struck near DuPont, Washington when the Amtrak Cascades 401 derailed and fell onto the highway below, claiming three lives and injuring 65 people. The National Transportation Safety Board found that PTC would have prevented this tragedy,” Cantwell wrote.

“Since the development of PTC technology nearly 50 years ago, there have been more than 150 accidents that this lifesaving technology could have prevented,” Cantwell continued. “At a recent Senate hearing, witnesses representing Amtrak and the NTSB expressed concerns about ensuring intercity passenger rail safety where PTC is not installed.”

Cantwell’s letter also seeks information from FRA on additional rail safety measures the agency requires for areas where Amtrak operates without PTC technology, including requirements for crewmember training, speed limit action plans, and other operational risk mitigations. 

In her role on the Commerce Committee, Cantwell has been a consistent advocate for increasing accountability and investment in rail safety in the United States. In July of 2015, as the Senate considered the DRIVE Act, Senator Cantwell expressed concern that the bill would delay PTC implementation and roll back safety protections. In December of 2017, Cantwell joined her Senate colleagues from the Pacific Northwest to demand railroads be held accountable for PTC implementation. In January 2018, Cantwell led members of the Washington Congressional delegation in calling for a comprehensive update from the Federal Railroad Administration on the nationwide implementation of PTC. And in March 2018, after calling for a hearing in the wake of the DuPont derailment, Cantwell pressed Amtrak CEO Richard Anderson on rail safety and PTC implementation.

The full text of the letter can be found HERE.

Cantwell Opposes Confirmation of Stephen Dickson as FAA Administrator

Senator Cantwell, the Ranking Member of the Senate Committee on Commerce, Science & Transportation, today released the following statement regarding the nomination of Stephen Dickson.

“Stephen Dickson has had a long career in both the Air Force and at Delta Air Lines. I have no doubt he has the basic knowledge and technical qualifications to serve as FAA Administrator. Indeed, I was inclined to support his nomination based on this experience and expertise.

But at this time of unprecedented challenges involving aviation safety, we also need to be absolutely certain that the person chosen to lead the FAA has a clean record on safety, and the ability to help restore the public’s trust in the FAA. Unfortunately, information brought to our committee in recent weeks calls into question the safety culture that existed under Mr. Dickson that allowed a safety whistleblower to be retaliated against. The nominee’s lack of candor about the issue was also troubling.

I recently met with a Delta Air Lines pilot, First Officer Karlene Petitt, who has been flying for 40 years. First Officer Petitt told me she repeatedly raised concerns about the safety culture at Delta to a number of executives, including Mr. Dickson. 

Instead of being celebrated for her potentially life-saving diligence, First Officer Petitt was sent for a compulsory mental health examination with a company-approved psychiatrist who incorrectly diagnosed her with bipolar disorder. This incorrect diagnosis cost her 18 months of flying. The doctor Delta chose for this compulsory exam has a record that includes serious red flags, which deepens my concern about this case.

Mr. Dickson described the decision to refer First Officer Petitt for a compulsory mental health examination as “sound” in his deposition and continued to defend it as recently as last month in written responses to our committee.

In the course of following up on First Officer Petitt’s allegations, Mr. Dickson has answered further questions from our committee, both in writing and verbally, about this case. In these answers, he repeatedly sought to minimize his role in this extremely troubling episode. However, the written record produced by First Officer Petitt and her legal team contradicts the picture Mr. Dickson has sought to paint of minimal involvement.

Given the urgent need for stronger safety culture and transparency throughout the FAA, these incidents do not paint the picture of the type of leadership that we need. Mr. Dickson’s oversight of these matters raises serious questions about his leadership, and therefore I will not support his nomination.”

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