Thursday, August 17, 2017

Public Citizen Sues Trump Administration for Withholding Visitor Logs

Donald J. TrumpPresident Donald Trump’s Secret Service is violating the Freedom of Information Act (FOIA) and must release executive agency visitor logs, Public Citizen said in a lawsuit filed today in US District Court in Washington, DC.

Public Citizen filed three FOIA requests over the course of four months to obtain information from the Secret Service about visitors to four agencies housed in the White House complex. The Secret Service rejected or ignored each request. The responses indicate that the Secret Service has adopted an unlawful practice of withholding records, the lawsuit states.

The lawsuit asks the court to order the Secret Service to release the records and declare that withholding them is unlawful. Public Citizen is seeking visitor logs from the U.S. Office of Management and Budget (OMB), the U.S. Office of Science and Technology Policy (OSTP), the U.S. Office of National Drug Control Policy (ONDCP) and the U.S. Council on Environmental Quality (CEQ).

In response to Public Citizen’s first request, the Secret Service claimed that the documents were not subject to FOIA because they are under exclusive White House control. However, the U.S. Court of Appeals for the District of Columbia Circuit held in 2013 that visitor logs for offices that are not part of the president’s office, such as these four agencies, are subject to FOIA.

Trump wants to keep the public in the dark

“There is exactly one reason the Trump administration aims to keep secret the names of the people visiting the White House: It wants to keep the public in the dark about the corporate takeover of our government,” said Public Citizen President Robert Weissman. “Even so, the Trump White House’s refusal to turn over visitor logs that it knows it is legally obligated to release is particularly shameful, even by the standards of this administration.”

In denying Public Citizen’s first request, the Secret Service stated that it had transferred the requested records to the White House Office of Records Management, which is not subject to FOIA. Public Citizen therefore also is asking the court to issue a temporary restraining order and preliminary injunction (PDF) requiring the Secret Service to maintain a copy of all visitor logs and other records documenting visitors to the OMB, OSTP, ONDCP and CEQ since Jan. 20, 2017, until the lawsuit is resolved.

“The D.C. Circuit has already held that the records we requested are agency records subject to FOIA,” said Adina Rosenbaum, the Public Citizen attorney handling the case. “There is no legal justification for the Secret Service to withhold them.”

Learn more about the case.

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Wednesday, August 16, 2017

Nexium, Priosec and PrevAcid Mass Tort Litigation Consolidated in New Jersey

The US Judicial Panel on Multidistrict Litigation consolidated 161 proton-pump inhibitor (PPI) products liability lawsuits into new federal MDL No. 2789 in federal court in New Jersey.

It was the second, successful try by the plaintiffs. In January, the Panel denied a motion that also sought centralization of the claims. At the time, it cited the small number of filings (only 15), the differing heartburn drugs involved and the need to protect trade secrets among the various defendants.

Since then, the size of the litigation has grown. Further, two defendants, AstraZeneca and Pfizer, had also changed course, and now supported consolidation. There are 34 tag-along actions in addition to the 161 cases consolidated by the Panel.

US District Judge Claire C. Cecchi, who is already managing PPI cases in the district, will oversee the MDL litigation. Heartburn drugs in the MDL:

  • Nexium
  • Nexium 24HR
  • Prilosec
  • Prilosec OTC
  • PrevAcid
  • PrevAcid 24HR
  • Dexilant
  • Protonix

Causes kidney damage

The defendants are AstraZeneca Pharmaceuticals LP, Pfizer, Inc., Wyeth Pharmaceuticals Inc., Wyeth LLC, Wyeth-Ayerst Laboratories, Procter & Gamble Company, Takeda, Novartis Consumer Health, Inc., Novartis Pharmaceuticals Corporation, Novartis Vaccines and Diagnostics, Inc. and Novartis Institute for Biomedical Research Inc.

In the 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated with PPIs.

“Although several of the grounds on which we denied centralization in Proton-Pump I remain largely valid, we find that the significantly larger number 6 of involved actions, districts, and counsel, the concomitant increase in burden on party and judicial resources, and the opportunity for federal-state coordination, coupled with most defendants’ change in position to now support centralization, tip the balance in favor of creating an MDL,” the Panel said. “Centralization will facilitate a uniform and efficient pretrial approach to this litigation, eliminate duplicative discovery, prevent inconsistent rulings on Daubert and other pretrial issues, and conserve the resources of the parties, their counsel, and the judiciary,” the Panel said.

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Monday, August 14, 2017

Concussion Risks and Prevention

Football season is officially underway. Our own Atlanta Falcons had their first pre-season game against the Miami Dolphins last week and Georgia high school teams officially start week one of their schedules next week. Players have worked hard through spring and summer, so both they and fans of the game are excited that the season is officially underway.

Along with the excitement of the sport, it is also necessary to keep football safety concerns in mind - one of the most prevalent being that of concussions, which has been popular in the news recently. Concussions are most commonly associated with the NFL, but in fact occur at all levels of play. From little league to professional football, concussions are a serious issue. Some statistics show that high school players are twice as likely to sustain a concussion as college players.

One of the issues surrounding concussions is the lack of obvious symptoms often times present. A player doesn’t necessarily have to be knocked out to receive a concussion. A single hit can lead to a concussion without anyone realizing it. Over time, the continuous head impacts that football players experience can lead to serious consequences, such as concussions. Ultimately, they can lead to short- and long-term changes in brain function, as well as in serious circumstances, death.

An athlete’s well-being should be the most important aspect of sports, especially at younger ages where adults should look out for them. Not only should players be educated about the signs of concussions, but coaches, officials, and the training staff should be well-educated as well. Players that shows signs of dizziness, confusion, headaches, or issues with balancing should immediately be removed from participation. Until they are medically cleared by a health-care professional, they shouldn’t be allowed to return to the game. Ensuring compliance with regulations and guidelines such as these is the responsibility of the head coach and school administration. Not only are they responsible for being aware of concussion-like symptoms, but they should also equip players with proper functioning equipment to minimize the chances of concussions. If a player shows concussion-like symptoms and continues to play, they are at risk of further injury. The state of Georgia requires all coaches to participate in an online course on concussion management that is organized by the NFHS (National Federation of High Schools).

While sports can serve as an important recreation to adolescents, it is imperative that their safety remains the top priority. Concussions are serious, and science has continued to prove their significance in sports. As football is now underway, be mindful of potential injuries and help keep athletes safe. For more information on concussions and the responsibilities of the school, please visit the Georgia High School Association website.

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5 Deaths Tied to Weight-Loss Balloon Treatments for Obese Patients

The FDA reports that five patients died unexpectedly from 2016 to the present because of liquid-filled intragastric balloon systems used to treat obesity.

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

All five reports show those patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement.

“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices, e.g., gastric and esophageal perforation, or intestinal obstruction. The agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment — one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System,” the FDA says.

Spontanous over-inflation

The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation. Additionally, as part of the ongoing, FDA-mandated post-approval studies for these devices, the agency will get more information to help assess the continued safety and effectiveness of these approved medical devices.

In February 2017, the FDA first issued a letter to health care providers to recommend close monitoring of patients with liquid-filled intragastric balloon systems for the potential risks of acute pancreatitis and spontaneous over-inflation. Since issuing this letter, both companies have revised their product labeling to address these risks.

The FDA recommends that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

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Friday, August 11, 2017

Jury Awards $1.2 Million to Patient Injured During Spinal Surgery

A Washington state jury returned a $1.2 million verdict against Dr. Michael Thomas of Cascade Neurosurgical Associates for negligently performing a spinal surgery in 2011 that left his patient with a severe spinal deformity for three years before it was finally corrected by a second surgery.

The plaintiff, Emily Daley, 42, suffered from scoliosis since she was a teenager, but her back pain became insufferable in the summer of 2011. Dr. Thomas performed scoliosis surgery on Daley in July 2011 to assist with her pain. While the surgery initially provided some pain relief, according to testimony by medical experts during trial, Thomas’ substandard care and lack of adequate follow-up left Daley with severe, chronic pain, and left her spine in a forward and left leaning position.

After obtaining care from numerous providers and consulting with several local spine surgeons for more than three years, Daley’s forward and left lean was ultimately corrected in an August 2014 operation performed by Dr. Lawrence Lenke, an internationally renowned spine surgeon who was then practicing in St. Louis and is now in New York, New York.

According to Felix Luna, an attorney from Peterson Wampold Rosato Feldman Luna who, together with Tomás Gahan, tried the case on behalf of Mrs. Daley, the years between the botched surgery in 2011 and the 2014 procedure that resolved the problem were extraordinarily difficult for her.

Passed out from pain

“When I first met Emily, we were sitting and talking when the pain in her back became so severe that she passed out,” Luna said. “That was not uncommon and was the reality of her life, day in and day out, for more than three years.” Luna also stated that “Emily, her family, and our firm are all deeply appreciative to the jury for their thoughtful consideration of this case.”

Court records show that this was the first jury award for a plaintiff in a medical negligence case in Yakima, Washington, in many years, and according to Luna, underscores the severity of Daley’s injuries and the substandard care that she received.

“We hope this verdict leads to safer practices for future patients, by showing surgeons that they must always adhere to the standard of care.” Emily Daley agreed, stating that “I really hope this verdict helps to protect other patients in the future.”

Peterson Wampold Rosato Feldman Luna was founded in 1973 as a plaintiff’s personal injury firm as well as appellate, commercial litigation, insurance bad faith, construction accidents, and medical malpractice.

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Thursday, August 10, 2017

$300 Million Settlement for Benicar Blood-Pressure Drug

Daiichi Sankyo Company announced a $300 million settlement related to its blood pressure drug Benicar. Despite this, the company admitted no liability for any wrongdoing.

Patients who have been injured by Benicar can take part in the $300 million settlement if they have a retainer in place with a qualified Benicar attorney by August 23, 2017.

See our earlier report Picking 6 Winners in Mass Torts Litigation.

A total of 1,942 lawsuits have been filed in MDL 2606, IN RE: Benicar (Olmesartan) Products Liability Litigation, before US District Judge Robert B. Kugler in New Jersey as of July 15.

Benicar, Benicar HCT, Azor, and Tribenzor are angiotensin II receptor blockers that lower blood pressure associated with hypertension. It is also linked to severe gastrointestinal injuries, including:

  • Sprue-like enteropathy, which has symptoms similar to those of celiac disease.
  • Lymphocytic colitis, microscopic colitis, and collagenous colitis.
  • Patients may suffer from chronic diarrhea, vomiting, nausea, abdominal pain, kidney failure, and significant weight loss.

Starting in January 2014, plaintiffs began filing Benicar-related injury lawsuits, and in March 2015, the Judicial Panel on Multidistrict Litigation created the Benicar MDL. On August 1, 2017, Judge Kugler approved the $300 million settlement.

Patients who experienced Benicar-related side effects can still take part in the settlement, but only if they are represented by a Benicar attorney by the August 23, 2017, deadline.

According to the master settlement agreement, the fund will start to be paid out when 95 percent of all eligible litigants and claimants opt into the settlement under various conditions. Once the thresholds are met, claimants who meet specified criteria will receive compensation from the settlement fund.

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Wednesday, August 9, 2017

Construction Worker Recovers $2.7 Million Settlement in Scaffolding Collapse

A 35-year-old construction worker in California recovered a $2.7 million settlement for a severe brain injury he suffered when a defective scaffold he was working on broke apart, causing him to fall 20 feet.

Rosbil Nunez-Aguirre of Orange County, CA, was handing some wooden planks to his coworker when one of the brackets suddenly broke. He broke his jaw and ankle and lost consciousness when he hit the ground.

He was represented by Roger E. Booth, a member of The National Trial Lawyers Top 100 Attorneys, and Carly L. Sanchez of Booth & Koskoff in Torrance, CA.

The plaintiff suffered a profound frontal lobe traumatic brain injury in the 2013 collapse, causing a personality change that made him have fits of anger and destructive behavior. He did not want to leave the house, had difficulty with memory and concentration and was placed in an outpatient program at a rehab hospital for nine months.

The defendants included the distributor of the defective scaffolding — White Cap Construction Supply, Inc. — and its parent company HD Supply, Inc. This particular bracket scaffolding, called the Whalen-Jack, was designed by a contractor in South Dakota who had no background in engineering. He subsequently sold the design to JD Systems, a company that outsourced the manufacture to a facility in China. The defendants sold the bracket scaffolding nationwide.

Plaintiff’s contentions

The case is Nunez-Aguirre v. White Cap Construction Supply, Inc., Case No. 30-2014-00746710-CU-PL-CJC,
Orange County Superior Court. It settled on March 6, 2017.

Plaintiffs contended that the Whalen-Jack was defectively designed and manufactured.  The brackets were supported by two welds, with no redundancy or backup margin of safety, and the design was such that the welds could not be seen or inspected.  If the welds failed (as they did at the time of the incident), the entire structure would come down.  Moreover, the quality of the welding performed in China was poor.

During discovery, plaintiffs’ counsel uncovered the fact that the design of the Whalen-Jack was changed at some point prior to the subject incident, to provide some redundancy in case the critical welds failed.  Plaintiffs contended that this was done specifically to address the very design problem that led to the incident.  Moreover, discovery showed that, despite the design change, none of the old Whalen-Jacks were recalled, and, in fact, old units that were still sitting in warehouses continued to be sold, including the one involved in the incident.

Plaintiffs contended that White Cap and HD Supply) were liable, under strict liability principles, for having sold a defective product.  Moreover, plaintiffs argued that White Cap was negligent because it failed to perform any meaningful due diligence concerning JD Systems or the Whalen-Jack, but nevertheless represented the product as being “safe” and “rugged.”  The principals of JD had no prior experience manufacturing or selling products of any kind and exercised no control over the manufacturing process in China.  White Cap knew that JD’s methods for shipping Whalen-Jacks from China were shoddy and could result in damage to the product.

Defendants’ contentions

Defendants contended that the subject Whalen-Jack bracket was not defective in design or manufacture, as evidenced by the fact that there was no report of any other Whalen-Jack bracket ever failing.  JD Systems performed testing of the product before beginning to sell it in the early 2000’s, and defendants’ mechanical engineer performed testing of an exemplar bracket.  According to the defendants, this testing showed that the Whalen-Jack could withstand repeated use, under normal conditions, without failing.

Defendants contended that the subject bracket failed because of misuse and abuse by plaintiff’s employer, Circle M Contractors.  Defendants’ metallurgist opined that the failure was the result of Mr. Nunez-Aguirre jumping on to the scaffolding just before the failure.  Defendants’ mechanical engineer opined that the failure happened gradually over time, most likely as a result of Circle M employees hitting the bracket with hammers and/or dropping it to the ground when removing it from buildings.  Defendants asserted that there was visible damage to the bracket before the incident and that Circle M should have noticed this damage and removed the bracket from service.

In addition, defendants argued that, as a distributor, they do not have a duty to test every product that they sell or investigate every manufacturer with whom they do business and that they were not aware that there was a pre-incident change in the design of the Whalen-Jack.

Settled on the brink of trial

Mediations were held before Michael Moorhead at Judicate West in February and November 2016, which did not result in a settlement, but the case subsequently settled on the brink of trial through follow-up discussions with Mr. Moorhead.

Plaintiffs’ Experts were Lawrence Kashar, Ph.D., Los Angeles, metallurgy; Glen Stevick, Ph.D., Berkeley, mechanical engineering; H. Ronald Fisk, M.D., Los Angeles, neurology; Barry Pressman, M.D., Los Angeles, radiology; Marcel Ponton, Ph.D., South Pasadena, neuro-psychology; Richard Anderson, Westminster, vocational rehabilitation; Sharon Kawai, M.D., Fullerton, physical medicine/life care planning; Tamorah Hunt, Ph.D., Santa Ana, economics; Martin Breen, Tustin, toxicology.

Defendants’ Experts were Ramesh Kar, Ph.D., Anaheim, metallurgy; Scott Schroeder, Ph.D., Los Angeles, mechanical engineering; Sam Iler, El Cajon, construction safety; Steven McIntire, M.D., Rancho Cordova, neurology; Michael Brant-Zawadski, M.D., Newport Beach, radiology; Thomas Hedge, M.D., Northridge, physical medicine; Alfredo Sadun, M.D., Pasadena, ophthalmology; James Rosenberg, M.D., Woodland Hills, psychiatry; Ari Kalechstein, Ph.D., Los Angeles, neuro-psychology; Mary Jesko, Los Angeles, vocational rehabilitation/life care planning; Mark Cohen, Walnut Creek, economics.

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