Cynthia Diaz Shephard

Wynn Hotel Security Measures Point to the Future of Security

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October 1st, 2017 – Las Vegas Shooting at the Mandalay Resort and Casino

At least 59 people were killed and another 527 injured by a lone gunman shooting down at a concert crowd from an upper floor at the Mandalay Resort and Casino in Las Vegas, Nevada late on October 1, 2017. The shooter later died from a self-inflicted gunshot wound. His motive for the shooting continues to remain unclear; however, the investigation is pointing to the fact that he acted alone, according to CNN.  Mandalay is owned by MGM Resorts International.

According to CNN, the shooting took somewhere between 9 to 11 minutes to complete and involved numerous weapons and 22,000 bullets. Injuries were due to both the onslaught of bullets, as well as the stampede. The gunman has been identified as Stephen Paddock. Various news sources note that this is the deadliest mass shooting to occur in modern United States history.

Paddock shot concertgoers attending the Route 91 Harvest Festival on the ground from the 32nd floor at the Mandalay. CNN notes that the attack seems to have been very carefully planned out. Paddock checked into the room in late September, bringing with him a number of weapons, setting up cameras inside the hotel suite, as well as in the hallway.

FBI Deputy Director Andrew McCabe told CNBC. “This individual … didn’t leave the sort of immediate thumbprints you find on these kinds of attacks,” adding that the FBI was considering all potential motives Paddock may have had. “We will look at every one of those lanes, pull every possible thread,” he said.

Meanwhile, Paddock had various weapons, as well as bump-fire stocks. These devices are legal and allow shooters to engage in rapid-fire shooting that is similar to what is used in automatic weapons. Paddock had installed these devices on 12 of his weapons, according to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), wrote CNN. Paddock also set up cameras within and outside of his suite. Police remain unclear if the cameras were transmitting elsewhere and the FBI continues to investigate for what purpose the cameras were used. The Clark County sheriff said he believes that the gunman may have been watching for anyone approaching his suite as one of the cameras was set up to view through the peephole.

Some 47 guns were recovered from the hotel suite at which Paddock was staying, as well as his homes in Verdi and Mesquite, Nevada. The weapons were purchased at multiple locations in California, Nevada, Texas, and Utah, Jill Snyder, special agent in charge of the ATF field division in San Francisco told CNN. Authorities discovered thousands of rounds of ammunition in the alleged shooter’s Mesquite home. Also found was an ingredient used in explosives found in Paddock’s car.

The attorneys at Parker Waichman LLP have long and successfully represented clients in personal injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit and who may have been injured in the recent mass shooting in Las Vegas.

The Wynn Hotel Discusses Current and Additional Planned Security Measures

Bloomberg News reported that the Wynn Hotel in Las Vegas announced changes it will be making to its security as well as existing security measures. The news outlet suggested that “all hotels should be doing this.”

As of the afternoon of October 2, 2017, every entrance to the Wynn resort in Las Vegas, Nevada was outfitted with guards scanning hotel visitors with metal detector wands. The guards were also inspecting guests’ bags. Bloomberg News wrote that the security measures led to a 10-minute wait to enter the hotel. Bloomberg News believes measures such as these may become standard operating procedures in various locations in Las Vegas.

Steve Wynn, CEO of Wynn Resorts, described Las Vegas as a so-called “target city,” and openly discussed the security measures previously taken at Wynn Resorts, according to Fox News. “Las Vegas is a target city. We have hardened the target at the Wynn,” Wynn told 13 Action News, Fox News reported. He added that, “This is the first time I’ve ever revealed this publicly … there’s a division in the Marine Corps of special people that are specially trained to guard the embassies. That’s a whole division with separate base, separate training. There are almost 40 of them at every opening of my building, plain clothes, armed, on the look-out, changing shift, and being relieved every two hours so they don’t get bored.” He also said he put “covert security measures” in place in the summer of 2016. “We have another group of a half a dozen Seals Team Six guys and CIA guys who are a counterterrorism unit that … relate on a daily basis to Homeland Security, the FBI, and Metro,” he said. “My company has metal detectors and devices at every entrance of the building for employees and guests that are non-visible to the public. We have done extraordinary things to make that sure we protect our employees and our guests at the hotel,” Wynn also said.

Las Vegas Shooting at the Mandalay Resort and Casino

Las Vegas Shooting at the Mandalay Resort and Casino

Casinos and other entertainment venues will likely have to take a more global look at security, considering potential shooting locations and at various angles, said David Shepherd, a former FBI special agent in counter-terrorism. Shepherd was also security director for Las Vegas Sands Corporation’s Venetian resort, according to Bloomberg News. “We have to start thinking like the Secret Service—start looking at tall buildings,” said Shepherd. Shepherd is also the co-author of the book “Active Shooter: Preparing for and Responding to a Growing Threat.”

Shepherd pointed out that the Las Vegas attack took place outside where there were no assigned exits; therefore, attendees who fell to the ground were at risk from the shots from above. Shepherd also noted that screening customers for weapons is not the only security measure to be taken, especially when a gunman is using weapons that have a range that exceeds one mile. Shepherd added that, “In this case he’s not even at the event,” according to Bloomberg News.

An executive from another casino operator, asking for anonymity, said that the security check at the door of Wynn Resort will likely be seen more and more at other locales going forward given that there are no other solutions for weapons screening.

Gambling locations worldwide also face security problems. For example, an arson attack at the Resorts World Manila in the Philippines in June 2017 led to a total of 38 fatalities. Now, the casino scans vehicles prior to their being permitted on premises and bags must be opened for security checks, noted Bloomberg News.

Filing A Lawsuit for Victims of Violence Associated with Mass Shootings

Parker Waichman has years of experience successfully representing clients in personal injury lawsuits. If you or someone you know is interested in filing a lawsuit, please contact one of our experienced lawyers today. Our firm offers free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/21370-2/

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JPML Approves Proton Pump Inhibitor MDL

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PPI Multidistrict Litigation Assigned in U.S. District Court New Jersey

The Judicial Panel on Multidistrict Litigation (JPML) entered an Order consolidating the Proton Pump Inhibitor (PPI) multidistrict litigation (MDL) 2757 (Nexium, Prevacid, et. al) on August 2, 2017. The PPI MDL has been assigned to Judge Claire C. Cecchi, United States District Court of New Jersey.

The consolidation was based on July 27, 2017 consolidation hearings held at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757. The case filings have significantly increased since the first JPML hearing took place on January 26, 2017 in Miami, Florida.

The medications at issue are Prilosec, Nexium, Protonix, and Dexilant as well as numerous generic versions of PPIs. The Order lists over 163 cases in 28 federal district courts. The defendants in the litigation are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc., and Pfizer subsidiary, Wyeth.

MDLs are created to help make complex litigation, such as this PPI litigation, more efficient. MDLs are a type of mass tort that centralizes lawsuits with common factual allegations. MDLs are organized in one court and are heard before one judge for consolidated, pretrial proceedings. Such centralization enables for more rapid movement of the legal process by streamlining litigation, eliminating the need for duplicate discovery, and eradicating inconsistent pretrial rulings. Lawsuits in an MDL remain separate and plaintiffs are treated individually. This is unlike a class action lawsuit in which the entire class is treated in the same way. In MDLs, plaintiffs share the same basic allegations; however, the seriousness of plaintiffs’ injuries may vary between cases.

Parker Waichman continues to offer free legal consultations to individuals who suffered kidney injuries, including acute interstitial nephritis, chronic kidney disease, and renal failure after taking a PPI product. Contact one of our experienced drug injury attorneys today for more information.

PPI Injuries, Research

PPI medications are used to prevent and treat acid-related conditions such as esophageal, duodenal, and stomach ulcers; nonsteroidal anti-inflammatory drug- (NSAID) associated ulcer; ulcers; gastroesophageal reflux disease (GERD); and Zollinger-Ellison syndrome (a rare condition in which gastrinomas [tumors that form in the pancreas or duondenum (upper small intestine) secrete the hormone, gastrin, causing the stomach to produce too much acid). PPIs in combination with antibiotics are also sometimes prescribed to patients diagnosed with helicobacter pylori, a bacterium that, with acid, causes ulcers of the stomach and duodenum.

The plaintiffs involved in this litigation similarly allege that PPI medication cause kidney injuries that include acute interstitial nephritis, chronic kidney disease, and end-stage renal disease.

In 2011, consumer advocacy group, Public Citizen, brought concerns about these drugs having harmful side effects for users’ kidneys to the attention of the U.S. Food and Drug Administration (FDA). The Agency mandated warnings about risks of acute interstitial nephritis on PPI medication labels in 2014, according to the plaintiffs’ MDL brief; however, the labels have never been revised to indicate any other potential kidney side effects. Plaintiffs also allege suffering renal failure due to taking a PPI. To date, more than 5,000 PPI cases are under investigation by plaintiff’s counsel. More are expected as awareness of the association between PPI use and kidney damage continues to increase.

More recent research have led to additional findings concerning a tie between PPI and kidney diseases and kidney failure. Over 15 million Americans used prescription proton pump inhibitors; however, estimates indicate that, between 25 percent and 70 percent of these PPI prescriptions have no appropriate indication. Meanwhile, research has revealed ties between proton pump inhibitors and various adverse side effect, including fractures, dementia, kidney damage, heart disease, and birth defects. The drug class first received FDA approval in 1989. The plaintiff’s brief indicate that several studies have made a tie between the use of PPIs and kidney damage over the past 25 years, including a 1992 study conducted by the University of Arizona Health Sciences Center and a 2006 study conducted at the Yale School of Medicine.

In 2016 and 2017, the following research was conducted:

  • 2016: Research published in the American Medical Association’s (AMA) journal JAMA Internal Medicine suggested that PPIs potentially increase risks for chronic kidney disease by as much as 50 percent. Research on proton pump inhibitor use, especially long-term PPI use, tied the drugs to increases in bone fracture, pneumonia, and Clostridium difficile. Researchers concluded that PPI use was associated with a 20-50 percent increased risk of developing chronic kidney disease.
  • 2016: Research published in CMAJ Open tied PPIs to an increase in the risk for acute interstitial nephritis by three times and a 2.5 times increased risk of developing acute kidney injury.
  • 2016: JAMA Internal Medicine published a research revealing that PPI use was tied to a greater risk of chronic kidney disease and that PPIs are associated with acute kidney injury. Researchers reviewed data from over 10,400 patients and conducted a 12-year follow-up for the study. The findings were replicated in a cohort of over 248,000 patients.
  • 2016: A Medical Daily report revealed evidence that tied PPI use to increased risks for developing chronic kidney disease, disease progression, and end-stage renal disease. The review of a national, comprehensive database revealed that, the proton pump inhibitor risks increased the longer the drug was taken. A prior observational study published by JAMA Internal Medicine and reported by Medscape Medical News revealed what was described as a significant 35 percent increase in developing chronic kidney disease risks associated with ever use of a PPI versus never use of a PPI.
  • 2016: A paper published in the Journal of the American Society of Nephrologyreported that long-term users of proton pump inhibitors may make patients 96 percent likelier to develop kidney failure and 28 percent likelier to develop chronic kidney disease when compared to patients taking H2-blockers.
  • 2017: Research published in Kidney International suggested that proton pump inhibitor users who develop chronic kidney disease may not experience any acute renal problems early on, leaving many PPI users unaware of the decline in their kidney function.

Filing a PPI Lawsuit

If you or someone you know is interested in filing a personal injury lawsuit involving a proton pump inhibitor such as Nexium, Prevacid, or Prilosec, please contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/jpml-approves-proton-pump-inhibitor-mdl/

PPI Lawsuits Allege Kidney Failure, Disease, Complications

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Proton Pump Inhibitor Lawsuits Centralized in New Jersey Federal Court

In August 2017, The United States Judicial Panel on Multidistrict Litigation (JPML) created a consolidated docket for all federally-filed proton pump inhibitor (PPI) lawsuits that involved allegations of kidney failure, chronic disease, and other serious renal complications.

In an Order dated August 2, 2017, the JPML transferred over 160 cases that were pending against a variety of PPI manufacturers, including Nexium, Prilosec, and PrevAcid to the United States District Court, District of New Jersey. The pending cases will undergo coordinated discovery, as well as other pre-trial proceedings; future, similar lawsuits that are filed in federal courts will be eligible for transfer to the new multidistrict litigation (MDL). The MDL is: IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II), MDL No. 2789.

MDLs are created to help make complex litigation, such as this PPI litigation, more efficient. MDLs are a type of mass tort that centralizes lawsuits with common factual allegations. MDLs are organized in one court and are heard before one judge for coordinated, or consolidated, pretrial proceedings. This centralization enables more rapid movement of the legal process by streamlining litigation, eliminating the need for duplicate discovery, and eradicating inconsistent pretrial rulings. Lawsuits in an MDL remain separate and plaintiffs are treated individually, unlike in a class action lawsuit in which the entire class is treated in the same way. In MDLs, plaintiffs share the same basic allegations; however, severity of injuries may vary between cases.

PPI medications are used to prevent and treat acid-related conditions, including esophageal, duodenal, and stomach ulcers; nonsteroidal anti-inflammatory drug- (NSAID) associated ulcer; ulcers; gastroesophageal reflux disease (GERD); and Zollinger-Ellison syndrome (a rare condition in which gastrinomas [tumors that form in the pancreas or duondenum (upper small intestine) secrete large amounts of the hormone, gastrin, which causes the stomach to produce too much acid). PPIs are also taken with antibiotics by patients who are diagnosed with helicobacter pylori, a bacterium that, with acid, causes ulcers of the stomach and duodenum.

Prescription and over-the-counter (OTC) drugs in this class include:

  • Aciphex, Aciphex Sprinkle (rabeprazole)
  • Dexilant, Dexilent Solutab, Kapidex (dexlansoprazole) [The brand name Kapidex was changed to Dexilent]
  • Nexium, Nexium IV, Nexium 24HR (esomeprazole)
  • PrevAcid, Prevacid IV, PrevAcid 24 HR (lansoprazole)
  • Prilosec, Prilosec OTC (omeprazole)
  • Protonix (pantoprazole)
  • Vimovo (naproxen and esomeprazole magnesium)
  • Yosprala (aspirin and omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)

Lawsuits began mounting soon after published research findings associated the use of PPIs to increased risks of developing kidney disease. Claims were filed on behalf of individuals who suffered kidney damage, including acute interstitial nephritis, chronic kidney disease, and renal failure and who also alleged these injuries were due to their taking a PPI.

Parker Waichman continues to offer free legal consultations to individuals who suffered kidney injuries, including acute interstitial nephritis, chronic kidney disease, and renal failure after taking a PPI product. Contact one of our experienced drug injury attorneys today for more information.

Research Ties Proton Pump Inhibitors to Kidney Damage

In 2013, over 15 million Americans used prescription proton pump inhibitors; however, estimates indicate that, between 25 percent and 70 percent of these PPI prescriptions have no appropriate indication. Meanwhile, research has revealed ties between proton pump inhibitors and various adverse side effect, including fractures, dementia, kidney damage, heart disease, and birth defects.

In 2014, the U.S. Food & Drug Administration (FDA) ordered that labels for Nexium and other prescription proton pump inhibitors be updated to include mention of acute interstitial nephritis. However, the labels have not been updated to indicate any other possible kidney side effects.

In 2016, research published in the American Medical Association’s (AMA) journal JAMA Internal Medicine suggested that proton pump inhibitors might increase the risk of chronic kidney disease by as much as 50 percent. Research on proton pump inhibitor use, especially long-term PPI use, tied the medications to increases in bone fracture, pneumonia, and Clostridium difficile. Researchers concluded that proton pump inhibitor use was tied to a 20-50 percent increased risk of developing chronic kidney disease.

In 2016, research published in CMAJ Open tied PPIs to a three-fold increase in the risk for acute interstitial nephritis, as well as a 2.5 times greater risk of developing acute kidney injury.

Also in 2016, JAMA Internal Medicine published a study revealing that PPI use was associated with an increased risk of chronic kidney disease. The report also indicated that PPIs are associated with acute kidney injury. Researchers reviewed data from over 10,400 patients and conducted a 12-year follow up for the study. The findings were replicated in a cohort of over 248,000 patients.

Other evidence has tied PPI use to increased risks for developing chronic kidney disease, disease progression, and end-stage renal disease, according to an April 2016 Medical Daily report. The review of a national, comprehensive database revealed that, the proton pump inhibitor risks increased the longer the drug was taken. Also, a prior observational study published by JAMA Internal Medicine and reported by Medscape Medical News revealed what was described as a significant 35 percent increase in chronic kidney disease risk associated with ever use of a PPI versus no PPI use.

In April 2016, a paper was published in the Journal of the American Society of Nephrology reported that long-term users of proton pump inhibitors may be 96 percent likelier to develop kidney failure and 28 percent likelier to develop chronic kidney disease when compared to patients taking H2-blockers.

In February 2017, research published in Kidney International suggested that proton pump inhibitor users who develop chronic kidney disease may not experience any acute renal problems early on, leaving many unaware of the decline in their kidney function.

Filing a PPI Lawsuit

If you or someone you know is interested in filing a personal injury lawsuit involving a proton pump inhibitor such as Nexium, Prevacid, or Prilosec, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/ppi-lawsuits-allege-kidney-failure-disease-complications/

Actemra Tied to Death, Serious Injuries

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Rheumatoid Arthritis Drug, Actemra, Associated with Significant Cardiac Side Effects

Roche/Genentech’s rheumatoid arthritis (RA) drug, Actemra (tocilizumab) has been tied to various significant adverse events, including heart attack, heart failure, stroke, pancreatitis, lung disease, and gastrointestinal perforation.

An investigation involving the rheumatoid arthritis drug revealed that hundreds of patient deaths were associated with the Actemra, according to PharmaLive.com. Actemra was approved in 2010 for the treatment of adults who have been diagnosed with moderate to severe active RA. To date, Actemra has been prescribed to more than 760,000 patients.

The Stat News investigation revealed that hundreds of patients taking Actemra died from cardiovascular and pulmonary complications and that Actemra carried no warning labels concerning these possible potential side effects. Stat News also pointed out that it reviewed more than 500,000 side effect reports for rheumatoid arthritis drugs and “found clear evidence” that the risk of adverse reactions, including heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.” The difference, according to Stat News, is that Actemra, unlike the other rheumatoid arthritis medications, does not carry a warning label for these side effects, according to PharmaLive.com; most competing drugs do warn about these potential adverse events on their labels.

According to the analysis, the U.S. Food and Drug Administration (FDA) received 1,128 reports of deaths in patients who had been taking Actemra. The FDA notes that it remains unable to determine if Actemra was the direct cause of the deaths; however, Stat News wrote that, “Though the agency is charged with monitoring the safety of prescription drugs, it doesn’t verify the side-effect reports it receives.” Stat News did cite various doctors’ reports that suggest Actemra was significantly involved in the deaths of the patients who were treated with Actemra. The doctors’ comments about a suggested link between the deaths and Actemra were included, as well. Identities were not disclosed.

Stat News also cited various experts who reviewed the analysis. The experts concluded that the FDA must consider adding a warning label to Actemra for heart failure and pancreatitis. According to PharmaLive.com, the experts also said that a failure to warn consumers “highlights the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved, and to act promptly when potential danger signs appear.”

Parker Waichman LLP has years of experience representing clients in lawsuits alleging injuries associated with medications. The firm continues to offer free legal consultations to anyone with questions about filing an Actemra defects lawsuit.

When Actemra was released to the United States market in 2010, it was promoted as not being tied to heart attacks, heart failure, of life-threatening lung complications as some other rheumatoid arthritis drugs have been, according to Stat News. Yet, hundreds of patients taking Actemra died and many other patients reported suffering injuries.

Actemra Side Effect Case Studies

Stat News’ probe found that risks to patients taking Actemra may be greater than patients realize.

In one example obtained through the Freedom of Information Act, a physician indicated that no factor—other than Actemra use—led to a fatal brain bleed suffered by 73-year-old man. The man was treated with Actemra intravenously two days prior to the bleed. In another case, a 62-year-old woman suffered a heart attack in 2014. “The company assessed fatal myocardial infarction as related to (Actemra).” Neither Roche nor the FDA made an attempt to change Actemra’s label to alert patients and doctors that potential risks are being seen in the reports and clinical studies completed after the medication was released to the market, according to Stat News.

In another case, according to a transcript of an Actemra meeting, Dr. David Felson, a Boston University rheumatologist, described patient blood test data that showed higher levels of the blood lipids cholesterol and triglyceride in people taking Actemra. This suggests that Actemra might be responsible for serious heart problems. Dr. Felson and all the other scientific advisers recommended Actemra approval, on one condition, that Roche sponsor a multi-year study to review for unobserved problems and cardiovascular events. Meanwhile, with no mention of these possible hazards on Actemra’s label, physicians and patients are unable to consider a drug’s risk-benefit profile. In a recent interview, Dr. Felson described Stat News’ findings as “noteworthy and concerning.” As for assertions that Actemra’s cardiovascular safety had been proved, he said that it “sounds like a drug company trying to defend themselves…. I just want it straight.”

In an injury case in which a woman, 40, said her physician told her that Actemra had minimal side effects when prescribing the drug to her for treatment of rheumatoid arthritis, she pointed out that she suffered from heart palpitations for days immediately after her first Actemra infusion. Heart palpitations are often reported by other patients and in complaints to the FDA. This symptom does not appear on Actemra’s warning label. When the woman sought help, her rheumatologist told her that he had not heard of this side effect and referred her to her general practitioner. She said that, “When I went to the [general] doctor, they offered me an antidepressant, but I said I’m not anxious,” she told Stat News. “If you give them a symptom they don’t know, they treat you like you’re a little crazy … I felt like I was dismissed.”

In another case, a 25-year-old woman said that, after starting Actemra, she experienced what she described as “brain fog.” She said that, “I’ve had moments where I’ve gone to start my car … and not remembered how to turn it on.” She also said that, at other times, she has forgotten how to put on makeup. These cognitive side effects are also not listed on the drug’s label but is a shared complaint among Actemra users. “It’s terrifying with a drug when you come to the realization that you haven’t been warned by your doctors,” she said. “It kind of ruins your life.”

Patients have also described other unlabeled side effects in interviews and reports to the FDA, including the heart-rhythm disorder, tachycardia; small strokes; and tremors. “I don’t want any sugar coating—I just want it straight,” said a 53-year-old woman. She suffered from another unlabeled, yet commonly reported, side affect— hair loss. “Why would you use something that would do that when there are 15 other drugs to try? That was really depressing,” she told Stat News. “[Actemra] has been a miracle for some people. But I think that on the whole, more people have serious side effects,” she added.

Filing an Actemra Lawsuit

If you or someone you know has questions about filing an Actemra lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/actemra-tied-death-serious-injuries/

FDA Reviews Hepatitis A Tied to Frozen Tuna

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Contaminated Tuna Originated in Vietnam and the Philippines

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), are collaborating with state and local officials to assess the risk of exposure to the hepatitis A virus tied to contaminated frozen tuna sourced from the Sustainable Seafood Company, Vietnam and the Santa Cruz Seafood Inc., Philippines. If unvaccinated consumers have consumed the recalled product in June 2017, post-exposure prophylaxis (action taken to prevent disease) may help prevent contracting the hepatitis A virus infection.

Prior to release of the FDA’s announcement, Hilo Fish Company sent out a direct alert to its customers and distribution partners on May18, 2017 to advise about the company’s recall of certain tuna products. The FDA indicated it had received records from the company or its distribution partners indicating that frozen tuna was sold to the establishments listed on the FDA’s website here.

The FDA indicated that it continues to work with Hilo and other distributors to ensure that the companies remove the contaminated tuna from the market. The FDA notes that it is Hilo Fish Company’s responsibility to advise its customers about the recall. Also, any company that received a recall notice from Hilo Fish Company is responsible to advise its customers. The establishments identified on the FDA’s website should have received a notice from Hilo Fish Company or their direct supplier. If not, they should reach out to their suppliers for additional information.

The first recall took place in Hawaii and involved imported raw frozen ahi tuna cubes sourced from PT Deho Canning Co. (JL. Raya Madidir, Bitung, Indonesia). That recall, by Tropic Fish, includes lot codes 609149 and 609187. No products are believed to remain on the market. The current recall resulted from follow-up after the Hawaii Department of Health advised the FDA of a frozen tuna sample, sourced from PT Deho Canning Co., which tested positive for hepatitis A on May 1, 2017. The initially recalled product has been removed from circulation and the newly recalled frozen tuna lots were not shipped to Hawaii; however, they were shipped to mainland United States.

The current recall, which began May 18, involves frozen yellowfin tuna steaks from Sustainable Seafood Company and yellowfin tuna cubes from Santa Cruz Seafood. The recall, implemented by Hilo Fish Company, includes Tuna Steaks in eight-ounce individually vacuum packed bags with production date code: 627152, lot number: 166623; expiration date: 2018-10-01. Frozen Yellowfin tuna cubes, random, were individually vacuum packed in 15-pound cases with the date code: 705342; lot number: 173448; and expiration date: 2019-04-01.

Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in food poisoning lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a contaminated food lawsuit.

What is Hepatitis A?

Hepatitis A is a contagious liver disease that is the result of an infection with the hepatitis A virus. The virus may range in severity from a mild illness that lasts a few weeks, to a severe illness that lasts several months. Hepatitis A may be spread when a person ingests the virus from contaminated food or water. The virus may also be easily passed from an infected person to other unvaccinated family members, sexual partners, and close contacts, according to the FDA.

The FDA points out that, symptoms of hepatitis A in adults include fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine, and pale stool; individuals with hepatitis A may not have symptoms until 15 to 50 days after consuming a contaminated food or drink. The CDC reports that, while the hepatitis A vaccine is recommended for all children, vaccination rates are lower than for other recommended childhood vaccines. Unvaccinated children may become ill and not have symptoms. Any unvaccinated person who consumed recalled frozen tuna is at risk of contracting the hepatitis A virus, noted the FDA.

The CDC recommends providing post exposure prophylaxis (PEP) for any unvaccinated people who have recently eaten any of the recalled raw or undercooked tuna products. People who have consumed this fish fully cooked are at reduced risk of exposure, but consultation with medical professionals is suggested.

PEP involves receiving the hepatitis A vaccine for people between the ages of one and 40 years or the hepatitis A virus-specific immunoglobulin (IG) for people outside of this age range. The hepatitis A vaccine may be substituted if the IG is not available. Those with evidence of previous vaccination do not require PEP

If you have never received the hepatitis A vaccine, getting a single dose within two weeks of exposure may protect against illness. If you are unable to determine if you have been vaccinated, receiving an additional dose of the vaccine is not harmful.

In the event that retailers and/or other retail locations are found to have handled recalled or other potentially contaminated food in their facilities, wash and sanitize display cases and refrigerators where potentially contaminated products are stored; wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products; and wash hands with hot water and soap following the cleaning and sanitation process. Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products must be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated products, according to the FDA.

The FDA notes that contaminated shellfish, fruit (berries), and salads are the most frequent foodborne sources of hepatitis A. Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Consumers should thoroughly wash their hands after using the bathroom and changing diapers to help protect themselves from contracting hepatitis A.

Filing a Food Poisoning Injury Lawsuit

If you or someone you know suffered injuries due to a contaminated food, you may have valuable legal rights. Our food poisoning lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/fda-reviews-hepatitis-tied-frozen-tuna/

IVC Filters May Fracture If Not Removed In Established Time Frames

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C.R. Bard May Have Known About Issues with Recovery and G2 Filters

At least 27 deaths have been tied to a C.R. Bard blood clot filter named the Recovery. Allegedly, C.R. Bard replaced the device with a modified version. Soon after the modified medical device was approved, C.R. Bard allegedly knew that it had similar problems to the initial version of the device, according to NBC News.

Despite that C.R. Bard was aware of complications associated with its blood clot filter, the device maker continued to sell the medical devices. According to NBC News, just four months after C.R. Bard released the G2 Bard blood clot filter, the device maker was concerned about failure reports. The G2 was created to replace the Recovery Bard blood clot filter and, since that time, the device has been tied to more than one dozen deaths and many injury reports.

Dr. William Kuo, a specialist in removing blood clot filters that have failed, told NBC, “All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications.” The Stanford radiologist also said that, “[t]he number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

The attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

C.R. Bard Recovery Filter Background

According to a prior NBC News report, IVC filters—sometimes known as blood clot filters—are implanted in approximately 250,000 Americans annually. In the last decade or so, millions of filters have been implanted in Americans.

C.R. Bard is one of 11 makers of IVC filters and had hoped to gain traction in the profitable filter market when it introduced the Recovery filter, receiving FDA clearance to market the device in 2002. It was then that reports of deaths and injuries tied to the device moving and breaking steadily mounted, according to NBC News. A confidential study commissioned by C.R. Bard revealed that the Recovery filter had increased rates of relative risk for death, filter fracture, and movement when compared to its competitors. An outside doctor hired to conduct the study wrote that “further investigation … is urgently warranted.”

C.R. Bard opted against recalling the Recovery from the market and, in 2005, after the device had been sold for three years, Bard finally replaced the Recovery with a similar device, the G2 series of filters. Internal Bard records and hundreds of reports to the U.S. Food and Drug Administration (FDA) reveal that that the G2 series did not resolve the IVC device’s issues.

A confidential memo written in December 2005 by a Bard vice president after the G2 was cleared by the FDA reveals his concern about “problems with … migration,” “tilting,” and “perforation.” He noted that Bard had another filter on the market with virtually no complaints. “Why shouldn’t doctors be using that one rather than the G2?” he questioned. Another later document includes data through 2010 that reveals that the G2 series filters experienced even more fractures, migrations, and reported problems than any of its competitors, according to NBC News. The C.R. Bard G2 series filters remained on the market until 2010.

In 2010, a man underwent implantation with the Bard G2 Express due to his body’s propensity to develop blood clots. The patient, 69, asked his physician in October 2015 to check on how the filter was doing and learned it had moved. His physician told him that the Bard filter was “dangerously close to your heart,’” according to NBC News. Two surgeons declined to remove the filter given its precarious position. The patient asked Dr. Kuo, whose team developed an advanced technique to remove failed filters and filter pieces. During emergency surgery, Dr. Kuo found that three legs broke off the filter, traveling to the patient’s lungs. Dr. Kuo said that two partially broken legs completely broke away during the operation. One, he said, could have killed the patient. “It floated off right in front of our eyes,” said Dr. Kuo. “First into the right atrium and then into the right ventricle. He’s very lucky.”

Kuo told NBC News that, in the prior 10 years he has removed 1,000 failed filters and noted that he has removed more Bard filters than any other single make of filter. Dr. Kuo said that, the Recovery and G2 series filters should have been pulled from the market and that, “Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled.” In addition with device companies, the FDA must take stronger action to protect patients. “What we’ve learned the hard way is that we can no longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices,” he said, according to NBC News.

What is an IVC Filter?

The FDA approved inferior vena cava (IVC) filters in 1979. The human body has large veins known as inferior vena cavas; these veins carry deoxygenated blood from the legs to the heart. The filters are “spider shaped” medical devices that look similar to a small cage, are approximately one-and-a-half-inches, are constructed of metal, and are inserted into the IVC. Once inserted, the filters are meant to capture blood clots that may travel to the heart, lungs, and brain.

IVC filters are typically prescribed for patients unable to take anticoagulants; when a patient is diagnosed with a recurrent pulmonary embolism (PE); a blood clot, especially a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); or if a patient suffered a significant accident or injury. Blood clots from the lower body may take place after knee or hip replacement surgeries.

For the most part, IVC filters are only meant to remain in the body on a temporary basis and should be removed when the threat of clots is over. Previously, some IVC filters were left in patients’ bodies permanently or for extended time periods, which may lead to life-threatening complications.

In 2010, the FDA warned that long-term use of IVC filters should be discontinued given risk of IVC filter damage, noted that IVC filters are intended as a temporary measure, and warned physicians to consider risks when discussing removal of these devices with their patients. The agency updated its warning in 2014, recommending that retrievable IVC filters be removed 29 – 54 days following implantation. Research shows that IVC filter risks outweigh their benefits when the filter remains in the body for more than two months. In one FDA warnings, it indicated that IVC implants may break in a patient’s body, potentially traveling through the bloodstream and into vital body areas with fragments potentially puncturing veins and organs. Pieces may become lodged in high-risk areas, according to NBC News.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/ivc-filters-may-fracture-not-removed-established-time-frames/

Recalls and Lawsuits Continue Over Metal-on-Metal Hip Devices

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Examples of Recent Recalls, Lawsuits, and Settlements

A number of device makers are having issues with their hip devices such as Accolade, Smith and Nephew, DePuy Orthopaedics, Zimmer Biomet, and Stryker. Over the past year, Stryker has been named as a defendant in another round of hip implant lawsuits. Also, its device, the LFIT Anatomic Cobalt-Chromium V40 Femoral Head, was recalled in October 2016 for the third time in five years. The device maker’s hip settlement expanded.

The latest Stryker lawsuit was filed in April 2017 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiffs, a couple, allege that injuries over failure of the implant in which the head of the stem was displaced and began to corrode. The plaintiffs are holding Stryker Orthopaedics responsible for failure to warn of the implant’s possible corrosion.

Another lawsuit was brought against Zimmer Biomet last spring. The plaintiff alleges that her Trilogy hip implant is defective and was unable to bond with her hip bone over an “improper pore size and/or porosity,” according to the lawsuit. The lawsuit was filed four years following implantation with the device. She underwent the surgery just prior to the device’s being recalled in June 2012. Federal Judge Wendy Beetlestone, in Pennsylvania, granted one strict liability claim to a plaintiff who brought a lawsuit against Stryker. The judge also allowed the plaintiff’s strict liability manufacturing defect, breach of warranty and loss of consortium claims to progress after Stryker’s motion to dismiss the plaintiff’s strict liability design defect and negligence claims.

According to The Legal Intelligencer, Judge Beetlestone ruled that the plaintiff’s allegations were sufficient to argue that the Stryker Gamma3 Nail System was defectively manufactured. The plaintiff was implanted with the device in March 2015. X-rays later revealed a broken nail in the implant. The plaintiff underwent a total hip replacement and suffered an infection following that surgery.

In another case, five patients implanted with metal-on-metal hips manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, were awarded $502 million. Because of a cap on punitive damages, the award was reduced to $150 million. According to Law360, the plaintiffs have complained to the Fifth Circuit that the cap is unconstitutional.

The nationwide attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip implant lawsuit.

New DePuy Orthopaedic Hip Implant Lawsuit

In May 2917, a new lawsuit was brought against DePuy Orthopaedics over its Pinnacle hip implant. The lawsuit was filed by a couple who alleged significant hip implant complications that required additional procedures to correct.

The plaintiff underwent a total right hip replacement on December 9, 2005, with a Pinnacle Device with an Ultamet liner. Soon after the procedure, the patient allegedly began experiencing severe pain, inflammation, and discomfort in the implant area. Testing revealed that the Pinnacle Device was experiencing wear and friction and was allegedly causing metal ions to be shed into the patient’s bloodstream, causing metallosis (blood metal poisoning), which compounded the damage in the area tissue and bone of the hip implant. The patient was left with no alternative but to undergo revision surgery on June 7, 2016, to explant and replace the Pinnacle Device. The woman chose to file her DePuy Pinnacle hip implant lawsuit after learning the manufacturing company may have been aware of potential complications tied to metal-on-metal hip implants.

As with other patients who opted for the DePuy Pinnacle device, the Pinnacle was recommended to the patient by her physician after reviewing the product’s packaging. All metal hip implants have been marketed to be overtly superior to ceramic and plastic models because of their durability and customizable features. The metal hip implants are particularly popular with younger orthopedic patients who live a more active lifestyle.

Metal-on-metal hip implants are composed of all metal components with no ceramic or plastic parts to prevent fretting. When the implant surfaces rub together, even during normal activities such as walking, the devices may release metal debris, leading to complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device.

Specifically, when the ball and socket joint of the metal device interact, nothing prevents metal ions from entering the patient’s bloodstream, which may ultimately lead to metallosis. This may impair the patient’s condition by potentially leading to infection, fretting, corrosion, tissue death, and the formation of pseudotumors. When this occurs, patients are generally forced to undergo revision surgery to explant the defective device and undergo implantation with a different device. Revision surgeries are considered risker, costlier, and more complex than the original surgeries and call for more intense and long physical therapy. In some cases, insurers do not cover revision surgeries. Despite the devastation to patients, DePuy allegedly failed to warn patients and physicians of these risks.

Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range-of-motion.

According to this DePuy Pinnacle hip implant lawsuit, the company either knew or should have known about the risks associated with its metal hip implants. At all times relevant, the woman involved in the lawsuit alleges that she only used the device for its intended purpose and did not deviate from medical instruction. She also noted that she would never have chosen the DePuy Pinnacle device if she had been aware of the potential complications associated with the DePuy Pinnacle metal hip. The woman’s husband joined her DePuy Pinnacle hip implant lawsuit with a claim for loss of consortium.

This DePuy Pinnacle Hip Implant Lawsuit is being heard in the U.S. District Court for the Northern District of Texas, Dallas Division.

Filing Defective Medical Device Lawsuit

If you or someone you know suffered injuries related to the use of defective medical device or device component, including metal-on-metal hip replacement device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/recalls-lawsuits-continue-metal-metal-hip-devices/