Drug Industry, Congress fuel Opioid Epidemic

A DEA whistleblower told CBS News that Congress derailed the DEA’s attempt to keep addictive opioids off U.S. streets.  Joe Rannazzisi ran the DEA’s office of Diversion Control during the worst drug epidemic in American history.  His division regulates and investigates the drug industry.  In a joint investigation by 60 Minutes and The Washington Post, Mr. Rannazzisi revealed how the opioid crisis was allowed to spread.  It was aided by Congress, lobbyists, and a drug distribution industry that shipped hundreds of millions of pills to rogue pharmacies and pain clinics.  Those loads fueled the opioid crisis that has killed some 200,000 people in the last 20 years.

People Die for Drug Profits

“This is an industry that’s out of control,” Mr. Rannazzisi told CBS’ 60 Minutes.  “What they wanna’ do, is do what they wanna’ do, and not worry about what the law is. And if they don’t follow the law in drug supply, people die.  That’s just it.  People die.”

Mr. Rannazzisi said drug distributors turned a blind eye and “allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices, that distributed them out to people who had no legitimate need for those drugs.”

A former DEA deputy assistant administrator armed with law and pharmacy degrees, Mr. Rannazzisi seemed most upset with the distributors, some of them multibillion dollar, Fortune 500 companies.  These blue-blood middlemen ship the pills from makers like Purdue Pharma and Johnson & Johnson to drug stores countrywide.  Mr. Rannazzisi accuses the distributors of fueling the opioid epidemic by pretending not to see pills being diverted for illicit use.

“This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices,” said Mr. Rannazzisi, “that distributed them out to people who had no legitimate need for those drugs.”

The Perps – Cardinal Health, McKesson, AmerisourceBergen

Mr. Rannazzisi said the three largest distributors are Cardinal Health, McKesson, and AmerisourceBergen.  They control some 85-90 percent of the drugs flowing downstream.  Mr. Rannazzisi said these companies knew they were pumping drugs into American communities and killing people.

Opioids Oxycodone, Hydrocodone

Opioids like oxycodone and hydrocodone became a routine medical treatment for chronic pain by the late 1990s.  Drug companies assured doctors and congressional investigators that the pain pills were effective and safe.  A Purdue Executive told Congress in 2001 that addiction was rare in the pain patient properly managed.

Many doctors were apparently convinced the opioids posed few risks (or apparently knew nothing about the long sordid history of opioid abuse); so prescriptions skyrocketed along with addiction.

Many who had become addicted to painkillers turned to what CBS news called “pill mills” – pain clinics featuring rogue doctors who would write fraudulent prescriptions and complicit pharmacists to fill them, one stop shops for legal drugs.

Drug Dealers in Lab Coats

Mr. Rannazzisi said many pain clinics popped up overnight.  The whole fiasco “made the crack epidemic look like nothing.”  He said, “They were just drug dealers in lab coats.”  But despite several arrests, opioids kept flooding the black market while the death toll kept rising.

Mr. Rannazzisi said that prosecuting crooked doctors and pharmacists failed to slow the epidemic, so he moved up the food chain.  He said the DEA saw hundreds of bad orders involving millions of tablets, so the agency started going after the distributors.

Distributors Required to Monitor Suspicious Orders

A distributor’s representative told CBS that doctors who overprescribe pain medication were the problem.  However, the distributors know exactly how many pills go to every drug store they supply.  The Controlled Substances Act requires distributors to report and stop what the DEA calls “suspicious orders.”  These include unusually large or frequent shipments of opioids.  DEA investigators said many distributors simply ignored that requirement.  (The better to profit, my dear.)

Former DEA man Jim Geldhof told CBS, “Their plan was to sell a lotta pills and make a lot of money. And they did both of those very well.  All we were looking for is a good-faith effort by these companies to do the right thing. And there was no good-faith effort. Greed always trumped compliance. It did every time.”

9 Million Pills for 392 People?

A 40-year DEA veteran, Mr. Geldhof ran pharmaceutical investigations from the Detroit field office.  Frank Younker supervised the DEA’s operations in Cincinnati.  Joe Rannazzisi was their supervisor. They saw distributors shipping thousands of suspicious orders. In one example, a pharmacy in tiny Kermit, West Virginia (Pop. 392) ordered nine million hydrocodone pills over two years.

With such obvious signs, Mr. Geldhof finds it ludicrous that the distributors now claim they didn’t see suspicious orders. He says the companies are culpable in the epidemic: “I can tell you with 100 percent accuracy that we were in there on multiple occasions trying to get them to change their behavior. And they just flat out ignored us.”

McKesson, Cardinal Health Fined Millions

In 2008, the DEA slapped McKesson, the country’s largest drug distributor, with a $13.2 million dollar fine. That same year, Cardinal Health paid a $34 million fine.  Both companies were penalized by the DEA for filling hundreds of suspicious orders – millions of pills.

Distributors fines have totaled more than $341 million over the last seven years. The companies complained to Congress that DEA regulations were vague and said the agency was treating them like a foreign drug cartel.  In a letter, the healthcare distribution alliance, which represents distributors, said they wanted to work with the DEA.  Effective enforcement, they wrote, “must be a two-way street.”

Drug Distributors flex Political Muscle

More than 17,000 Americans died from opioid prescription overdoses in 2011, the year Cardinal Health started pushing back at Joe Rannazzisi.  Cardinal’s attorneys called his bosses at the Justice Department, who called in Mr. Rannazzisi to explain his tactics.

Money and Influence

Joe Rannazzisi told CBS he was infuriated at having to explain his motives for going after corporations.  He told his staff they were in a war: “We’re going after these people and we’re not going to stop.”  But he was hamstrung by his own agency.

He said the drug industry used its money and influence to pressure top DEA lawyers to take a softer approach.  Former DEA attorney Jonathan Novak said it divided the litigation office. He said in 2013 that he noticed a sea change in the way prosecutions of big distributors were handled. Cases his supervisors once would have easily approved were no longer good enough.

Mr. Novak told CBS that they had achieved “incredible success in an almost unstoppable wave,” but suddenly his caseload dramatically slowed as his bosses began to scuttle the whole system, demanding unreasonable amounts of evidence.

Big Pharma minions in Congress then moved to further defang the DEA and save corporate profits at the expense of U.S. Citizens.  See the whole story at CBS News.

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FDA Recalls Johnson & Johnson Heart Device

The FDA has recalled a Johnson & Johnson heart device. The U.S. Food & Drug Agency announced Jan. 2, 2018 its strictest form of recall for a cardiac device made by Sterilmed.  A faulty valve in the device poses the risk of seriously injuring or killing a patient.

FDA Class I Recall: Its Most Serious
The FDA said the recall of Agilis Steerable Introducer Sheath devices – made by Sterilmed Inc. – is a Class I recall. That’s the agency’s most serious type of recall. This sheath device is used to insert and position cardiovascular catheters. It is sometimes used on the heart’s left side through the wall of tissue separating the heart’s right and left chambers.

Improper Seal
The FDA said the sheath’s hemostatic valve is at risk of failing because of an improper seal on the sheath’s hub. The valve is designed to keep blood from flowing back through the valve.

The FDA said, “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure or can create a difference in pressure that allows air into the circulatory system (air embolism).”

The improper seal happens when there isn’t enough glue used to reattach the sheath’s cap after use. But too much glue can also block the valve and make the device unusable, according to the FDA.

Fatal Flaw
FDA said, “The use of affected products may cause serious health consequences for patients, including death.”

Some 112 affected devices are included in the recall, which covers sheaths made between Jan. 1, 2017, and May 5, 2017, according to the FDA.

In addition, patients with a lower body mass index may be more at risk if there is blood loss, said the FDA. Smaller patients and those with a pre-existing lower lung capacity may also be more susceptible to air embolisms.
The FDA advised health care facilities and providers to search their inventories for the sheath and return any unused sheaths to Sterilmed. The agency said providers should also continue to monitor patients treated with the sheath, just as they would normally do.

FDA Recalls Johnson & Johnson Heart Device

A Sterilmed representative said that the company initiated the recall in June and that it has not received any reports of adverse events related to the devices.

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Failed Medical Procedures Proliferate

In November Cook Blood Clot Filter Lawsuits2017, new studies revealed that stents put into heart disease patients to keep arteries open work no better than a placebo. Hundreds of thousands of US patients receive expensive stents each year for the relief of chest pain. Americans pay anywhere from $11,000 to $41,000 for a stent procedure that, it turns out, is useless for most.  The wasteful and dangerous stent is just the latest in a long string of expensive and unnecessary medical treatments foisted on us all in recent years. Failed medical procedures proliferate in our profit-driven medical culture.

IVC Filters, Power Morcellators, Hernia Mesh Failures
To name just three others in recent memory, IVC filters have also been found to be almost completely unnecessary.  They are rarely, if ever, worth the risk of their implantation.  Power morcellators used for hysterectomy or uterine fibroid removal are another dangerous “improvement”; they can be lethal when used on women with undiagnosed cancer.  And finally, hernia mesh (plastic) is another unnecessary and dangerous “improvement” recently unmasked.  Lawsuits have been filed against the promoters and makers of all three of these “improvements,” because risk-benefit analysis shows that each is not worth the risk of its potential failure.

The Latest Technology Prejudice
The Western medical establishment, run on the sick-model-profit-motive, is decidedly prejudicial when it comes to using the “latest” technology. Most of us have also been unwittingly conditioned to embrace the latest gadget or device.  If it’s new, we almost instantly imagine that it must be better.  We are, at the least, encouraged to think so by television advertisements, the shiny new brochures that litter doctors’ offices, our own doctor’s own glowing recommendation that this is the “new great thing.”  New being the operative word, and sadly, if our doctor doesn’t know what “the latest” device, drug, or procedure is, we are conditioned to think she has failed to keep up with the times, and are apt to look for another, more “up to date” doctor model.

Money Prejudice

There is also a money prejudice at work.   Conditioned to pursue and worship money and to listen to those who have it, we sacrifice or denigrate our own skills and aptitude, as we genuflect to the money.  If some computer, phone, or medical device company spent millions developing this latest thing, it must be good, we imagine, because why else would they have spent all that money?  (Our money prejudice is a non sequitur we ignore at our peril.)  At the very least, we want to benefit from this great new thing, this new peachy pinnacle of money power.

We’re All Sales People Now
In our personal lives we act as (unwitting) sales people as we show one another the slickest features on the “new” cell phone, the bells and whistles on the latest model car, television, or “Smart” (Read: stupid) appliance.  Most of us embrace so-called Smart meters without a whimper of protest (or a single minute of research), even though they don’t save us anything and actually cost us all more for power in the long haul.  (But thousands of citizens have complained to Calif. PG&E; so some people are, fortunately, paying attention.)

Stents Unnecessary (for most), Expensive, Dangerous
As for stents, “Several randomized trials have clearly shown that stents and angioplasties don’t prolong life or prevent heart attacks in stable patients. Now, we know that they don’t reduce angina either,” wrote Dean Ornish, MD, clinical professor of medicine at the University of California of San Francisco.

IVC Filter Problems
No study has proven IVC filters are necessary or more effective than the treatment which preceded them – blood-thinning drugs and dietary and lifestyle changes. No study has demonstrated the efficacy of IVC filters. They have been shown by thousands of people, however, to be quite dangerous. They can be impossible to remove. They have likely killed thousands of people whose deaths were not attributed to the filters. They can break apart and migrate and perforate the heart and lungs, causing life-threatening conditions. IVC filter lawsuits have, consequently, been filed by the thousands against Cook Medical, Bard, Boston Scientific, Cordis, and other IVC filter makers. Even the AMA, virtually always friendly with medical device makers, has admitted these devices have proliferated despite any evidence of efficacy.

Power Morcellator Problems
Power morcellators have been used for performing hysterectomies and removing uterine fibroids. They’ve been marketed as a more convenient method for surgeons and as a less invasive method for women to undergo certain surgeries. The problem is that when they are used on women with undiagnosed uterine cancer (not entirely uncommon), they can spread that cancer throughout the body, and weaponize it so that it becomes lethal. As a result, power morcellator lawsuits have been filed against Johnson & Johnson (Ethicon) and other morcellator makers.

Hernia Mesh Problems
Hernias were fixed for at least 100 years with simple suturing, until some medical device maker got the bright idea to insert plastic mesh into the human body. The procedure is easier for surgeons or doctors who don’t have the chops to perform a good old fashioned suturing job, and it promises the patient a “less invasive” procedure with faster recovery times. The problem, however, is that once that mesh goes in, it “meshes” with the body’s tissues, grows into them in ways which can make it all but impossible to remove. When infection follows, as it often does in the body’s natural foreign body reaction, the mesh often needs to be removed; but it can be all but impossible to remove. The unlucky mesh implantee can then be doomed to a lifetime of pain. In the “old” method of simple suturing, any complications could be much more easily corrected or revised. The doctor could even remove all the stitching, if necessary, and begin again.  Not so with mesh.

Failed Medical Procedures Proliferate
Given all these failed or at best dubious devices and procedures, people would be wise to do their research before submitting to the latest, greatest procedure, pill or medical device. Discerning patients might be wise to start by looking very closely at their own ingrained prejudices concerning the latest, greatest anything.  Advertising dollars run what we call “the news,” which is often little more than the promotion of corporate products and corporate values, which is no values at all beyond the blind worship of profits.

Patient, beware.

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PPI Lawsuit Settlements

Proton pump inhibitor lawsuits are being filed for people who developed kidney problems after taking popular PPI drugs like Nexium, Protonix, Prilosec, Prevacid, and Aciphex. The lawsuits were spurred largely by a study published in 2016 which showed a link between PPIs and chronic kidney disease.

Chronic kidney disease can lead to kidney failure, requiring regular dialysis and possibly a kidney transplant.

In the latest study, researchers used data on self-reported proton pump inhibitor use among more than 10,000 people taking part in a national study on hardening of the arteries. Researchers also evaluated data on outpatient PPI prescriptions among nearly 250,000 patients of a Pennsylvania health care system.

The study noted PPI users in both groups were more likely to have health problems, such as obesity, high blood pressure and heart issues.

In both groups, researchers associated use of the drugs with an increased risk of chronic kidney disease over ten years.

The researchers also compared people using the drugs once a day with those who used them twice daily.  They found the latter linked with a 46 percent increased risk of chronic kidney disease, compared with a 15 percent increased risk in the once-daily users.

No one is sure how PPI drugs might damage the kidneys, though two theories lead the way.  One is that PPIs can cause magnesium levels to decline; a lack of magnesium can damage kidneys. The second theory is that kidneys might suffer damage if patients face repeated bouts of acute kidney inflammation from proton pump inhibitors.

Gastroenterologists are also cautious about using PPIs because they’ve been tied to other health problems such as bone fractures, infections of C. difficile, and pneumonia.

Because many people who take PPIs have other health problems, lawsuits against the makers of these drugs could be difficult to pursue, though several law firms are pursuing them, including Matthews & Associates.  Meanwhile, many makers of proton pump inhibitor drugs have already paid out millions of dollars in lawsuits related to these dubious drugs.  PPI lawsuit settlements reveal that these drugs have a checkered history:

PPI Lawsuit Settlements

2012 – $55 million: Pfizer agreed to settlement with U.S. government for promoting Protonix for unapproved uses.

2014 – Undisclosed amount: Takeda Pharmaceuticals settled a lawsuit claiming Prevacid was responsible for bone fractures.

2015 – $20 million: AstraZeneca agreed to a settlement in a consumer class action lawsuit over its marketing of Prilosec and Nexium.

2015 – $7.9 million: AstraZeneca agreed to settlement with U.S. government over alleged kickback scheme involving Nexium.

2015 – $24 million: Generic drug maker Teva Pharmaceuticals settled lawsuit claiming it took money from AstraZeneca to keep generic Nexium off the market.

Free Legal Case Evaluation
Our law firm is handling proton pump inhibitor lawsuits in which someone took a PPI and developed chronic kidney disease. Contact us for a free legal consultation if you have been diagnosed with kidney problems following use of PPI drugs.

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Xarelto Verdict $28M

On December 5, 2017, a Philadelphia jury delivered a Xarelto verdict of nearly $28 million in damages against Johnson & Johnson and Bayer. The jury found the companies had provided inadequate warnings about bleeding risks linked with the blood thinner Xarelto.

The case was filed by an Indiana woman who said she suffered a serious gastrointestinal bleed after using Xarelto. It was the first Xarelto verdict for a plaintiff. Juries in three previous federal multidistrict litigation trials in 2017 sided with the drugmakers.

Related:  Xarelto Lawsuit

The Lynn Hartman case is one of more than 1,500 pending as part of mass tort litigation in the Philadelphia County Court of Common Pleas.  Xarelto-related product liability claims were consolidated there, despite defense protests.

U.S. Patient Bleeding Events Misrepresented
Ms. Hartman’s trial centered around claims that J&J’s Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. failed to include vital information in Xarelto’s warning label.  The companies were charged in the lawsuit with failing to properly report the rate of bleeding events observed in a clinical trial.  The trial showed the rate was significantly higher among U.S. patients compared with patients elsewhere in the world.

According to evidence shown in the trial, the rate of bleeding events among people in the U.S. was 8.1 percent yearly versus 3.6 percent among people globally.

Ms. Hartman’s lawyers also accused the two companies of failing to adequately warn about the higher bleeding risks in using the drug with aspirin.  They also charged that the companies failed to inform doctors that some patients end up with significantly higher levels of the medication in their blood than others.

Higher Risk than Elizuis, Pradaxa
The woman’s lawyers argued that adverse event risks linked with Xarelto were significantly higher than that of Xarelto’s competitors, Eliquis and Pradaxa.

“Xarelto is the worst in class of the new blood thinners,” argued Ms. Hartman’s lawyer.  “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa, which are safer and far more effective.”

Ms. Hartman’s case was supported by testimony from former FDA head David Kessler.  He told the jury he believed that Xarelto’s warning label lacked key information concerning the severity of the drug’s potential bleeding risks.

Xarelto Defense Respose
The drugmakers’ lawyers focused Xarelto’s defense on the language included in the Xarelto label, which warned that Xarelto “can cause serious and fatal bleeding.”

The defense also pointed to testimony from Ms. Hartman’s doctor that she would not have changed her decision to prescribe Xarelto even with the additional information that she agreed (with the plaintiff) should have been included on the label.

Xarelto Verdict $28M

The case is Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

A Janssen spokeswoman said the company will appeal the verdict, which was not a shock to anyone, as no drug company has ever accepted any verdict against it without appealing to have it thrown out of court.  Hence the importance of corporations lobbying and bankrolling state and D.C. beltway politicians who then work endlessly to stack the appeals courts against citizens and their rights.

According to court records, a second Xarelto case is scheduled for a trial in Philadelphia in January 2018.

Stay tuned. . .

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•  Stay tuned. . .

 

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IVC Filter use decreases after FDA Advisory

Science Daily hasCook Blood Clot Filter Lawsuits noted IVC filter use has decreased following an FDA advisory.  IVC filter use began declining last year after the National Institutes of Health noted in June 2016 that IVC filters carry real risks.  IVC filter injury lawsuits may also be slowing down the sale and use of these blood clot filters.

The NIH paper which appears to have slowed the use of IVC filters was titled: “Permanent versus Retrievable Inferior Vena Cava Filters: Rethinking the “One-Filter-for-All” Approach to Mechanical Thromboembolic Prophylaxis.”

IVC Filter Dangers Soft Played
IVC filter dangers have been soft played by their manufacturers. The paper’s opening abstract notes: “Deciding which IVC filters to use, when to use them, and for how long they should remain in place remains a highly complex process with many variables to consider. At a minimum, it is important to recognize that mechanical thromboembolic prophylaxis is not entirely benign.” That’s fancy language for admitting that IVC filters can be dangerous.

IVC Filter Dangers Increase over Time
The NIH noted that the use of IVC filters, especially retrievable filters, “is associated with morbidity risks that increase over time.” In plain language, that means the longer an IVC filters remains in the human body, the more likely it is to cause problems. Pieces of the delicate little thimble-sized devices can break off and migrate throughout the circulatory system, including into the lungs or heart. The entire IVC filter can also tilt sideways or embed into a blood vein wall, causing other serious problems, including death.

NIH: Remove Filter after PE Risk Resolves
NIH cautions that IVC “filters should be removed when the patient’s risk for PE has resolved.” The problem is that many temporary filters are being left inside of a person far longer than they should be. To further complicate matters, many IVC filter patients are not told by their doctors that their temporary filters should be removed after a given time. In addition, as many IVC filter lawsuits charge, IVC filter makers such as Bard and Cook Medical have not given their doctor customers clear instructions for when the filters should be removed.

The NIH saysIVC Filters fail to improve Anticoagulant Therapythat, “Postplacement clinical follow-up is critical to optimizing retrieval rates. Given the increased adverse effects and cost difference when using IVCF in a permanent manner, an important goal for appropriate IVC filter selection should be selecting those patients best served with a permanent filter due to the patient’s unique clinical conditions. . .” That statement is as close as the NIH gets to criticizing IVC filter makers for promoting their filters for too many people, for not properly screening potential filter implantees.

NIH also recommends further development and validation of nuanced, large-scale mathematical modeling tools to determine how best to use IVC filters. The NIH never directly criticizes any medical device manufacturer, but the language makes it clear that current practices fail IVC filter implantees, or are at least inadequate.

The paper also notes that IVC filter implantation rates remain high compared to rates in Europe.

IVC Filter Background
IVC filters are used to prevent deep vein thrombosis (DVT), a medical condition in which blood clots develop in the deep veins of the body, often in the legs, thigh, or pelvis. These clots can break loose and travel to the lungs and can cause a life-threatening condition called pulmonary embolism (PE).  IVC filters are implanted in people at risk for PE when anticoagulant therapy is ineffective or cannot be used.  They are supposed to be use only in those for whom anticoagulant therapy is contraindicated.

IVC Filter Safety, Efficacy Questioned
IVC filter use has increased rapidly over the years, despite no real evidence that the filters are necessary or effective.   In 2010, the U.S. FDA issued a device safety communication after reviewing more than 900 adverse filter events over a five-year period.  Those problems include device migration, embolizations, perforation of the IVC, filter fractures.  Some led to adverse clinical outcomes, often with the filter remaining in the body long after the risk of PE had subsided.  The FDA safety communication recommended filter removal as soon as protection from PE was no longer needed.

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Third Hip Implant Verdict against Johnson & Johnson: $247 Million

(Nov. 17, 2017)  Johnson & Johnson was ordered by a Dallas jury to pay $247 million to six people who claimed J&J hid defects in its Pinnacle artificial hips.  It was the third multi-million-dollar verdict against J&J over its defective metal-on-metal hip implants.

The jury ruled yesterday that J&J’s DePuy unit officials knew the hip devices they made were defective, yet failed to warn doctors and patients about the risk that they would prematurely fail. The jury awarded $79 million in actual damages, plus $168 million in punitive damages to a group of six New Yorkers whose hips required surgical removal.

Nearly 10,000 lawsuits have now been filed against J&J and DePuy over the company’s mishandling of the metal-on-metal hips. J&J stopped selling the hip replacement devices in 2013 after the U.S. FDA toughened artificial-hip regulations.

A lawyer handling the cases called the medical device companies’ behavior “so reprehensible” as to demand “repeated punishment.”

In an emailed statement, J&J spokesmodel Stella Meirelles claimed the company acted “appropriately and responsibly” in developing and marketing the Pinnacle hips.  She said the company would “immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits.”

J&J 1-3 Record in Pinnacle Hip Cases
In October 2014, Johnson & Johnson won the first Pinnacle hip case to go to trial, when a federal court jury in Dallas rejected a Montana woman’s claims that the devices were defective and gave her metal poisoning.

$502 Million Verdict
In 2016, another Dallas jury ordered J&J to pay $498 million to a group of five people who accused the company of hiding defects in the artificial hips. In July 2017, a judge slashed that verdict to about $150 million.

$1 Billion Verdict
Earlier in 2017, a third Dallas jury ordered J&J and DePuy to pay more than $1 billion to six California residents whose hips had to be removed after failing. That award was later slashed by nearly half.

$2.5 Billion Settlement
The Pinnacle hip devices were not covered by J&J’s $2.5 billion settlement of claims over its ASR line of artificial hips. Johnson & Johnson recalled 93,000 of those implants worldwide in August 2010, admitting that 12 percent failed within five years.

The metal-on-metal Pinnacle hip cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges and test (or bellwether) trials. Judge Kinkeade agreed to combine the six cases in the most recent trial.

The six New York plaintiffs in the latest Dallas trial are a physician (88 years old); an elementary school teacher (67); a chauffeur (61); a housing official (60); a health-care aide (53); a financial analyst (52).

Plaintiffs in the latest trial argued that DePuy officials rushed the Pinnacle hips to market with little testing, and misled doctors about the product’s safety profile. They erroneously assured doctors that there was little risk of metal poisoning and tissue damage from the metal-on-metal hip device.

Metal on Metal Problem for Johnson & Johnson

The plaintiffs’ attorney in closing argument told the jury that the company “ran a grand seduction.”  He said, “Surgeons were seduced into using metal-on-metal” by DePuy executives’ false claim that the company had “solved the metal-on-metal problem.”

J&J’s lawyers argued that the hip devices failed because of routine wear-and-tear.  They denied that the hip device design was  flawed.  They argued that the company marketed the product properly.

Hip Implant Verdict against Johnson & Johnson: $247 Million

Jurors found that J&J and DePuy relied on “intentional misrepresentations” about the hip device’s safety profile to bolster sales. According to a verdict form, the jury found that J&J and DePuy engaged in “deceptive business practices” when they marketed the defective devices.

Hip Implant Lawsuit

If you or someone you love was implanted with a metal-on-metal hip implant that failed, contact our experienced medical device lawyers today for a free legal consultation.

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Proton Pump Inhibitor – Kidney Injury Lawsuits Consolidated

The U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed proton pump inhibitor (PPI) – kidney injury lawsuits on August 2, 2017. All the suits involve kidney failure, chronic kidney disease, and other kidney injuries. U.S. District Court, District of New Jersey will host the JPML.

The JPML’s Transfer Order affected 166 lawsuits filed against the makers of Nexium, Prilosec, PrevAcid, Protonix, and Dexilant. Any similar PPI lawsuits filed in federal courts in future will be eligible for transfer to the District of New Jersey.

Creating a multidistrict litigation court can help both plaintiffs and defendants. This one will allow all federal proton pump inhibitor – kidney injury claims to follow coordinated pretrial proceedings, including discovery and motion practice. The JPML process is designed to improve judicial efficiency, prevent inconsistent court rulings and duplicative discovery. It is also meant to preserve court resources and lighten loads on witnesses and others in the litigation.

Individual Cases Must Stand on Own Merits
Though pretrial proceedings will be coordinated, each proton pump inhibitor lawsuit in the multidistrict litigation will maintain its own identity and be decided on its own merits. All plaintiffs will continue to maintain control over important decisions affecting their own individual claims. That control includes whether or not to accept any future settlement offers.

Proton Pump Inhibitor – Kidney Injury Claim
The nationwide law firm of Matthews & Associates is handling lawsuits for people who took a proton pump inhibitor and then developed kidney problems. Chronic kidney disease, kidney failure, acute interstitial nephritis, or acute kidney injury have all been linked with popular PPI drugs: Nexium, Prilosec, Protonix, PrevAcid, Dexilant.

PPPI-Lawsuit | Lawyer

If you or a loved one has been diagnosed with any kidney issues that could be related to proton pump inhibitors, contact our office today. Protect your legal rights.  Email us for a free legal case review, fill out our short form or call us at (888) 520-5202.

What are proton pump inhibitors?
Proton pump inhibitors are a class of heartburn medications that include the prescription drugs Nexium, Prilosec, Protonix, and PrevAcid, as well as various over-the-counter (OTC) brands and generics. Those sold via prescription are approved to treat symptoms associated with GERD, ulcers and other problems linked with the overproduction of stomach acid. OTC proton pump inhibitors are often recommended for people who suffer from frequent heartburn (two or more episodes per week.)

An estimated 15 million Americans used proton pump inhibitors in 2013. Research suggests these drugs are often overused, and that many people use them far too long. Proton pump inhibitors are thought to be generally safe for short-term use, but long-term use has been linked to several serious side effects, including C. diff infections, certain bone fractures, low magnesium levels, B12 deficiency, and more. Research also suggests extended PPI use may increase one’s risk for dementia, heart attacks, chronic kidney disease, acute kidney injury, kidney failure.

What causes kidney failure?
Kidney failure is the final stage of chronic kidney disease. Also known as end stage renal disease, the condition occurs when the kidneys no longer function in a way that would allow a patient to survive, resulting in the need for dialysis or kidney transplantation.

Diabetes and high blood pressure are the leading causes of kidney failure. Other causes include:

•  Toxic exposure
•  Certain acute and chronic diseases
•  Severe dehydration
•  Kidney trauma

Other recent studies also suggest proton pump inhibitors may harm kidneys.

•  April 2015: A study published by Canadian researchers found older people who used PPIs were more likely to suffer acute kidney injury, a form of sudden renal failure.
•  April 2016: A paper appearing in the Journal of the American Society of Nephrology linked extended use of proton pump inhibitors to a 96% increased risk of renal failure compared to alternative medications.
•  January 2016: Research that appeared in JAMA Internal Medicine reported that proton pump inhibitors might increase the risk of chronic kidney disease by as much as 50%. The Journal of the American Society of Nephrology study also suggested PPI use was associated with a 28% increase in the risk for chronic kidney disease , compared to another class of heartburn drugs.

What is acute interstitial nephritis (AIN)?
Acute interstitial nephritis is a sudden inflammation of the kidney tubules often caused by a hypersensitivity reaction to a medication. AIN symptoms include:

•  Fever
•  Blood in the urine
•  Exhaustion, fatigue
•  Confusion
•  Nausea, vomiting
•  Rash
•  Water retention and weight gain
•  Swelling
•  Feeling bloated
•  Elevated blood pressure

When acute interstitial nephritis is caused by a drug, most doctors would cease treatment of that medication. If not recognized swiftly, the condition can progress to chronic kidney disease and renal failure.

FDA Label Warning Update
In 2014, the U.S. Food & Drug Administration ordered the makers of all prescription proton pump inhibitors to add information about acute interstitial nephritis to their product labels.

Proton Pump Inhibitor Settlements
Parties involved in the proton pump inhibitor litigation have not announced any settlements in kidney-related cases. The first such lawsuits were just filed in 2016. Pharmaceutical drug cases can take several years to come to fruition for plaintiffs, if they ever do. Anfyone suffering kidney injury after taking a protom pump inhibitor is encouraged to call our offices to discuss a potential case against the PPI maker.

Free Legal Consultation
Matthews & Associated drug injury lawyers offer free legal reviews to people who may have suffered chronic kidney disease, kidney failure, or other renal complications linked with Nexium, Prilosec, Protonix, or Prevacid.  Email for a free legal consultation or call us at (888) 520–5202.

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Hernia Mesh vs. Suture Repair

Most people considering surgery for hernia repair will find themselves facing a difficult choice.  Of course, one can always “wait and see” in the event of a hernia (more on that below).  And it is sometimes possible to use belts or trusses to help manage or simply live with a hernia.  Most people suffering from a hernia, however, will likely face a choice of surgical options.  Most will decide whether it is best to choose a plastic hernia mesh to repair a hernia, or to find a surgeon who can perform a more traditional hernia repair using sutures and/or natural tissues.

What is a Hernia?
A hernia occurs when an organ, intestine or fatty tissue breaches a weak spot or a hole in muscle or connective tissue.  Hernias often occur at the abdominal wall.  Sometimes a hernia can be visible as an external bulge, particularly when one strains or bears down.  There are many types of hernias, but inguinal hernias – in the groin area – are by far the most common.

Hernia Types
•  Inguinal: inner groin
•  Femoral: upper thigh/outer groin
•  Incisional: incision or scar breach in the abdomen
•  Ventral: general abdominal/ventral wall
•  Umbilical: belly button
•  Hiatal: inner abdominal, along the upper stomach/diaphragm

Hernia Causes
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue.  Pressure pushes an organ or tissue through the opening or weak spot.  The muscle weakness can be present at birth, but it usually occurs later in life.  Anything that increases abdominal pressure can cause a hernia.  Risk factors include obesity, heavy lifting, diarrhea, constipation, persistent coughing, sneezing.  The FDA web site notes that poor nutrition, smoking, and overexertion can also weaken muscles and contribute to hernia risk.

Hernia Treatment Options
The FDA reports that more than one million hernia repairs are performed each year in the U.S. About 80% involve inguinal hernias.  Treatment options are myriad.

1. Non-Surgical
Watchful Waiting – One can watch a hernia to see that it is not getting larger or causing problems. Though surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias.  Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.

2. Surgical
a. Laparoscopic – A surgeon makes several small incisions in the abdomen that allow surgical tools in for repair.  Laparoscopic surgery can be performed with or without surgical mesh.

b. Open Repair – A surgeon incises near the hernia and repairs the weak muscle area. Open repair can be done with or without mesh. Open repair using sutures without mesh is referred to as primary closure.  Primary closure, says FDA, is used primarily to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.  But one can use primary closure for other reasons, as well (such as fear of hernia mesh and its “side effects”), though the FDA does not say so.

The Problems of Surgical Mesh for Hernia Repair
The FDA on its web site seems solidly in favor of surgical mesh for hernia repair.  At the same time, it is worth noting that the agency also backed – at least in the beginning – the use of plastic mesh on women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The agency’s confidence in mesh appears to have been misplaced for many women.  More than 100,000 have filed lawsuits alleging they were injured by the plastic mesh used on them.  Many thousands of those lawsuits were settled, while many of them remain in the courts.  Just a few weeks ago, a jury awarded a woman several million dollars for a Johnson & Johnson mesh product that she testified badly injured her.  Several mesh trials resulted in large jury verdicts, including a recent $73 million award in Dallas.  The material used in the mesh on that injured Texas woman – along with thousands of others for POP or SUI – is the same material used in hernia meshes.

The FDA reports on its web site that mesh-based hernia repairs have increased since the 1980s.  By 2000, non-mesh repairs made up less than 10% of groin hernia repair techniques.  Does that mean that hernia mesh is safe?  Not according to at least one surgeon, who says that 10-20% of hernia mesh patients suffer complications.

FDA also says “the use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time.”  But FDA also cautions that recovery time depends on the type of hernia, the surgical approach, the patient’s condition before and after surgery.

The agency also says that the medical literature has “consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh.  For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair.”  But does that mean hernia mesh is safer than suturing, or superior to suturing?

FDA Cautions on Hernia Mesh
The FDA also admits that despite reduced rates of recurrence with hernia mesh vs. suture repairs, situations arise in which surgical mesh for hernia repair “may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.”

Hernia Mesh vs. Suture Repair

While the literature may indicate that using mesh for hernia repairs does have its advantages, the FDA categorically fails to state one glaring fact for those whom the mesh fails.  At least one prominent hernia surgeon says that the complication rate for hernia mesh surgery is a shocking 10-20%.   The FDA also fails to state, in its hernia mesh literature, what we saw with plastic mesh used on women for POP or SUI.  Namely, if the mesh fails the patient, for whatever reason, it can be difficult or impossible to remove it.  That unfortunate situation can lead to permanent pain for the person meshed.  This is one more instance, among an endless list of examples, where the FDA tends to err on the side of industry rather than on the side of the consumer, and safety.  In this instance and in many, many others, the FDA downplays the serious risks of a medical device (or drug), while promoting its alleged benefits.  Buyer beware!

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Hernia Mesh 10-20% Complication Rate, says Surgeon

Hernia mesh has a 10-20% complication rate, says a surgeon who has performed dozens of hernia mesh removals.  That’s much higher than the 1-2% complication rate that has been reported by mainstream doctors who parrot mesh makers’ claims.

Doctor will speak to UK Parliament

On Oct. 18, 2017, Dr. Robert Bendavid will tell the UK Parliament just how troublesome plastic mesh can be for hernia repair.  Dr. Bendavid works out of Shouldice Hospital in Toronto, Canada.  Jane Akre of Mesh News Desk reports that the surgeon is frustrated with the way plastic hernia mesh makers have downplayed the number of catastrophic events triggered by hernia repair that inserts plastic mesh into the human abdomen.

20% Hernia Mesh Failure Rate
Dr. Bendavid says 20% is likely a closer complication rate for the meshes used in hernia repair. He laments that, for about 20 years, synthetic meshes have become the mainstay of hernia surgery. The reason, he says, is not for efficacy.  Like plastic mesh put into women for pelvic organ prolapse (POP) or stress urinary incontinence (SUI), hernia mesh surgery has exploded in popularity primarily because mesh makers have so assiduously promoted it.  Mesh makers have doled out millions promoting mesh conferences, societies, and free surgical training sessions.  Those promotions have even formed a whole new generation of surgeons who were taught to favor mesh over traditional suture repair for hernias.  Meanwhile, the drawbacks of meshes, says Dr. Bendavid, “were always vague and nebulous.”

Today, mesh-based repairs are touted as the ideal in the guidelines of the European, Danish and Swedish Hernia Societies.  The American Hernia Society has gone right along with the mesh program.  Dr. Bendavid has not.

Shouldice Repair for failed Plastic Mesh Repair
The doctor notes: “Shouldice repair, a pure tissue repair, rated a mention only when infected mesh was removed!”  He adds that Shouldice repair was considered the “gold standard” 20 years ago, but today no one performs or knows how to perform it outside Thornhill. (editor’s note: We believe there are some American doctors and others in other countries who do perform Shouldice repair.)

Plastic Mesh spawns New Injury
Dr. Bendavid further notes that, “The world literature is now replete with publications on chronic postherniorrhaphy inguinodynia, a condition unknown before the introduction of mesh.  In 1964, in Nyhus’ classic hernia, postherniorrhaphy pain did not rate a mention in its index.  In Ponka’s equally excellent book, pain is mentioned in half a column as ‘uncommon’ and due to ‘scar tissue’ (1980).”

Hernia Mesh Complications
Many publications are now providing more up-to-date statistics on postoperative complications of mesh. Dr. Bendavid says that 11% of patients will have a “history of severe chronic postoperative inguinodynia severe enough to be detrimental to their quality of life.”

Mesh Pain Irreversible
Another group of patients (3%–4%) will suffer irreversible dysejaculation, which 20 years ago, sans mesh, had an incidence of 1 in 2500 cases and was reversible.  That is a hundred-fold (or 10,000%) increase.  Another 10% of patients will suffer severe testicular pain secondary to mesh erosion of the vas. This in some cases requires an orchidectomy. Additionally, transmigration of mesh into adjacent organs is commonly reported but not systematically quantified with any accuracy through industrial surveillance. Dr. Bendavid asks: “With such evidence, would a ‘duly informed’ patient consent to mesh-based surgery?

Mesh is now used in 90-97% of hernia surgeries around the world, but in just 3% of the cases at the Shouldice Hospital.

Professor Volcker Schumpelick, Editor in Chief of the Hernia, in his address to the American Hernia Society (2005) stated: “[D]espite the introduction of mesh and laparoscopy, there has been no reduction in the incidence of hernia recurrences in the last 30 years. That incidence worldwide is 14%.”  So Dr. Bendavid fairly asks: “Why are the European guidelines rushing to be launched as World guidelines?”

Dr. Bendavid has helped launch a study to pin down the percentages of complications resulting from hernia meshes used in hernia surgery.  He says the current hernia mesh surgery complication rate, “estimated at 10-20%, could be brought to a mere 5% with simple emphasis of anatomy. The Shouldice Hospital already demonstrated, 20 years ago, that 1%–5% is the magic number depending on the type of hernia.”

The doctor also notes that it takes surgeons 4-6 years to learn the necessary skills to safely and successfully perform hernia mesh surgery, while plastic mesh industry representatives, who are not always doctors, train doctors to perform plastic mesh surgery in minutes.  How many hernia sufferers would rather their hernia surgeon have trained for 4-6 years rather than for just a few minutes?

Hernia Mesh 10-20% Complication Rate, says Surgeon

How many people would rather have hernia surgery with a product (pure tissue) that can be safely and fully removed, rather than with a product that may be impossible to fully remove (plastic hernia mesh) and that could cause permanent, debilitating pain?

Ralph Nader, for one – who tends to do his research – chose to forego plastic mesh for his own hernia repair.  Mr. Nader chose Dr. Bendavid to perform his recent hernia surgery.  The man who started Consumer Reports may know a thing or two when it comes to safe products.

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