Pelvic Mesh MDL Closing to New Cases

(July 11, 2018) The pelvic mesh Federal Judge Joseph Goodwinmultidistrict litigation (MDL) court is closing to new cases.  Judge Joseph Goodwin, who oversees the MDL court in Charleston, W. Va., made the announcement last month.

Medical Mesh News Desk reports that the pelvic mesh MDL court was created in January 2012.  At its height, it was handling nearly 105,000 cases. Judge Goodwin issued orders on June 21, 2018 that no more cases would be filed in his federal court.

No More Cases Accepted in MDL 2327
With the MDL closing, any new case filings will need to be in state court, according to the order issued by Judge Goodwin. The judge issued the same order in each of the seven pelvic mesh MDLs filed in his federal court.

Charleston, WV MDL Court Closing
The largest MDL court was established for Ethicon (Johnson & Johnson).  Judge Goodwin wrote in Pretrial Order #304 in the Ethicon MDL #2327, that since January 2018, his court has requested cases no longer be transferred to MDL 2327.

Related:  Johnson & Johnson, Ethicon Mesh Losses Mount

On June 19, 2018, the Judicial Panel on Multidistrict Litigation entered a Minute Order:

“The court ORDERS that plaintiffs may no longer direct file claims against Ethicon, Inc. or Johnson & Johnson or any related entities in the Ethicon MDL (as set forth in PTO # 118) or in any other pelvic mesh MDL assigned to the court.”

The other six MDLs  with the same order include all of the major pelvic mesh makers – C.R. Bard MDL 2187; American Medical Systems MDL 2325; Boston Scientific MDL 2326; Coloplast MDL 2387; Cook Medical MDL 2440; Neomedic MDL 2511.

State Court Cases
Heretofore, it appears that any plaintiff’s lawyer wishing to pursue a newly-signed pelvic mesh case will need to file it in a state court venue, either in the state where the mesh maker is located or in the state where the plaintiff lives.

Mesh News Desk reports that it is not known whether the plaintiff will be able to share in the extensive MDL “Discovery” already gathered to support the MDL cases for trial.  Discovery costs can quickly reach half a million dollars or more in a single case, so the question is an important one. One advantage of an MDL court is that discovery costs can often be shared across several cases, so in theory at least, that cost savings is one advantage of the MDL court which could disappear in the face of any future pelvic mesh litigation pursued in state courts. The MDL system can also decidedly cut trial preparation time.

But before the doors close entirely, the federal West Virginia MDL court will host two Wave trials, Wave 7 and 8, against Ethicon.

Wave 7 and 8 Trials
Wave 8 cases in the Ethicon MDL, the last major trial by the federal MDL court, should be concluded with discovery by October 2018 and made trial ready in a June 13th order by Judge Goodwin.

Ethicon / Johnson & Johnson still faces Wave 7 trials of approximately 150 pelvic mesh-injured women whose cases will be heard in the West Virginia federal court. Final settlement conferences are scheduled for August 1, 2018, with trial set to begin August 14.

The West Virginia MDL once contained 104,749 cases representing plaintiffs filing pelvic mesh cases against seven mesh makers. New cases slowed to a trickle beginning in 2018.

Pelvic Mesh MDL Closing to New Cases

The cases of Carolyn Lewis v. Ethicon; Donna Cisson v Bard; Jo Huskey v Ethicon; Tyree v. Boston Scientific; among others, have all been heard in Charleston since 2012.

Thousands Dismissed with Prejudice for non-revision
In the Ethicon MDL, Medical Mesh News Desk also reported that Judge Goodwin just announced that he was dismissing thousands of cases with prejudice because they were non-revision cases.

In Pretrial Order #293, issued Wednesday, April 11, 2018, Judge Goodwin said that the court would dismiss more than 13,000 Ethicon mesh cases in which the plaintiff has a mesh in place but has not attempted any removal or revision.

That judiciary decision could prove unfortunate for several women. Many suffer from such compromised health that they fear any return to a doctor’s office could leave them in worse shape than if they took their chances with their current condition or injuries.  Any revision or removal surgery can sometimes leave a person in worse shape than she was in before she opted for the revision or removal.

As Jane Akre reports, “There are many reasons a woman may not have her pelvic mesh removed – compromised health, a risk of going under anesthesia, a new complication to her health, a warning from her doctor that the risks of revision outweigh the benefit – all might preclude having a mesh removal.  Now that may count against her.”

“Dismissed with prejudice” usually means that a plaintiff may not bring another legal action with the same claim. “Dismissed with prejudice” usually means that the case is dismissed permanently, with no future recourse for the plaintiff to seek compensation.

A possible silver lining, according to Mesh News Desk, is that Ethicon/JJ has reportedly agreed that plaintiffs with more than one office revision who have trigger point injections, vaginal physical therapy or vaginal Valium will be treated the same as those plaintiffs who undergo revision surgery within five years.

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Johnson & Johnson, Ethicon Mesh Losses Mount

(July 10, 2018) In 31 transvaginal mesh (TVM) trials so far, 22 have concluded with verdicts in favor of plaintiffs.  Eleven (or half) of those verdicts have gone against Johnson & Johnson and Ethicon, which has seen its mesh losses mount faster than any other TVM manufacturer.  J&J has lost five verdicts over its Gynecare Prolift mesh, three for its TVT-O mesh, one for TVT-Abbrevo, one for TVT-Secur, and one for its polypropylene tape used to treat stress urinary incontinence (SUI).

Related:  Transvaginal Mesh Lawsuit

In 2016, the FDA reclassified transvaginal mesh for prolapse repair (but not SUI) as Class III (high risk) medical devices. The reclassification made TVM implants ineligible for FDA’s 510(k) clearance program. That program had previously allowed mesh products on the market without prior clinical trial testing on human beings.  But 510(k) clearance does not amount to FDA approval.  TVM or pelvic mesh devices are not FDA approved.

Johnson & Johnson, Ethicon Mesh Losses Mount

Besides fighting TVM cases in the courts, Johnson & Johnson and other defendants have also quietly settled hundreds of them. As with most settlements, terms are not disclosed and the companies that pay admit no wrongdoing.

Johnson & Johnson (Ethicon) Trials have yielded at least eleven (11) wins for plaintiffs so far. These include:

March 8, 2018 – $35 Million for Plaintiff (Gynecare Prolift)
A U.S. District Court for Northern Indiana jury hit Johnson & Johnson’s Ethicon with a $35 million verdict over its Prolift pelvic mesh. ($10 million in damages and $25 million in punitive damages). Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012 after learning that the Prolift mesh her doctor implanted in 2009 to treat pelvic organ prolapse might be causing her low pelvic pain. The lawsuit petition accused J&J and Ethicon of concealing Prolift problems that included high failure, injury and complication rates, as well as “frequent and often debilitating re-operations.” Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” said the complaint.

The Kaisers also alleged that “[Ethicon] consistently under-reported and withheld information (about) Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”

The Kaisers also alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective. . .”

Dec. 14, 2017 – $15 Million for Plaintiff (Prolift)
A New Jersey woman was awarded $15 million by a Bergen County (New York) Superior Court jury in her transvaginal mesh lawsuit. The verdict followed 2 ½ weeks of trial testimony and nearly a day of jury deliberation. The woman testified that she had been in constant pain since receiving an Ethicon mesh implant. Jurors found the Johnson & Johnson subsidiary had failed to adequately warn her of the risks associated with Ethicon’s Prolift mesh implant. They awarded her $4 million in compensatory damages and $10 million in punitive damages, as well as awarding her husband $1 million for his loss of conjugal affection.

The jury also found Ethicon had failed to provide the woman with adequate safety warnings in regards to the TVT-O mesh implant, but they determined the Prolift mesh alone was responsible for her injuries. (Case No. L-13686-14)

September 6, 2017 – $57 Million for Plaintiff (TVT-Secur)
A Philadelphia jury awarded a woman $57.1 million in damages over a TVT-Secur mesh implant. Ella Ebaugh accused Johnson & Johnson unit Ethicon of making a defective pelvic mesh implant that scarred her urethra and left her incontinent. Her award included $50 million in punitive damages. The jury unanimously backed her claims that two negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.

May 26, 2017 – $2.16 Million for Plaintiff (Prolift)
A Pennsylvania jury awarded $2.16 million to a woman who suffered serious complications from Ethicon, Inc.’s Gynecare Prolift mesh. The verdict came in the Philadelphia Court of Common Pleas. It was the fourth straight loss for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)

April 28, 2017 – $20 Million for Plaintiff (TVT-Secur)
A state-court jury in Philadelphia ordered Johnson & Johnson to pay a New Jersey woman $20 million over a TVT-Secur pelvic mesh. The woman blames J&J’s vaginal-mesh inserts for leaving her in constant pain. The jury concluded that the TVT-Secur was defectively designed and caused Margaret Engleman’s injuries. They awarded her $2.5 million in damages and then hit J&J and Ethicon with $17.5 million in punitive damages.

February 2016 – $13.5 Million for Plaintiff (Polypropylene tape)
A jury in Philadelphia hit Johnson & Johnson subsidiary Ethicon with a $13.5 verdict in the second case involving its pelvic mesh products to go to trial in the city. The Philadelphia Court of Common Pleas jury awarded Sharon Carlino $3.5 million in compensatory damages, $10 million in punitive damages. It found Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective. It also found that Ethicon failed to adequately warn of its risks. Ms. Carlino required three revision surgeries to remove the eroded mesh.

March 4, 2015 – $5.7 Million for Plaintiff (TVT Abbrevo)
A California jury in Los Angeles hit Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict. The jury sided with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages. Ms. Perry had been implanted with Ethicon’s TVT Abbrevo mesh.

December 2015 – $12.5 Million for Plaintiff (Prolift)
A Philadelphia jury ruled Johnson & Johnson must pay $5.5 million to a Pennsylvania woman over its Ethicon unit’s Gynecare Prolift mesh implant. The jury found J&J liable based on the negligence of its scientists in relation to its Prolift pelvic mesh implant. They cited the mesh as the root cause of plaintiff Patricia Hammons’ inability to have sex after it was implanted. The jury later added $7 million in punitive damages.

A Pennsylvania state court judge ruled in 2014 that Johnson & Johnson and other pelvic mesh makers like Boston Scientific and Bard will need to challenge more than 860 product liability lawsuits on a case-by-case basis.

September 2014: $3.3 Million for Plaintiff (TVT-O)
In West Virginia, a federal jury in the MDL court hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling. The jury found in favor of plaintiff Jo Huskey on all counts, which included strict liability, design defect, failure to warn, negligence.

April 3, 2014: $1.2 Million for Plaintiff (TVT-O)
A Dallas jury ordered Johnson & Johnson to pay a Texas woman $1.2 million for a defective plastic sling – the TVT-O – which J & J’s Ethicon division makes and markets for stress urinary incontinence. Freese & Goss and Matthews & Associates represented the woman, Ms. Linda Batiste.

February 2013 – $11.11 Million for Plaintiff (Prolift)
A New Jersey jury awarded Linda Gross an $11.11 million verdict in her lawsuit against Johnson & Johnson’s Ethicon over the company’s Prolift vaginal mesh product. Ms. Gross suffered 18 surgeries in repeated attempts to remove the failed mesh and resultant scar tissue. The jury found J&J had failed to warn patients and doctors about the risks of its mesh products and that the company made fraudulent misrepresentations.

Johnson & Johnson TVM Court Wins
Johnson & Johnson settled at least one Prolift trial which had reached the MDL courtroom, and it has won two TVM trials so far. In February 2014, company lawyers were able to have Judge Goodwyn dismiss the case of a Texas woman against Ethicon and J&J (Lewis v. Ethicon/JJ) in a TVT-O case, and a Texas jury awarded nothing in a Nov. 2015 case over a Prosima device that reached trial (Cavness v. Ethicon/JJ). J&J also settled with the plaintiff in at least one TVM case which reached trial in March 2015 (Bellew v. Ethicon/JJ).

Transvaginal Mesh Lawsuits
Today, many thousands of TVM cases remain unresolved, parked in various state courts across the U.S. and in the federal MDL in West Virginia. The overseer of the federal MDL court, Justice Joseph Goodwyn, announced in June 2018 that he will no longer accept new mesh cases. Judge Goodwin has overseen several MDL trials and still has more than 100,000 cases on his books. He has urged the defendants to settle, some have occasionally obliged, but the sheer number of cases in the MDL makes it the largest federal court docket for mass tort litigation since asbestos.

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100,000 Women suing over Gynecological Mesh

(July 7, 2018)  The mainstream media has finally recognized that a huge number of women are suing mesh manufacturers over their plastic products.  A CBS news story reported last month that nearly 50,000 women are suing one mesh maker alone over gynecological mesh.  The polypropylene (plastic) mesh is often used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI),  which affect millions of women.  At least 100,000 women across the country are suing over gynecological mesh.  Many have filed their cases in the multidistrict litigation court in West Virginia.  Several other pelvic mesh lawsuits have been filed in various state courts throughout the country.

Related:  Transvaginal Mesh Lawsuit | Pelvic Mesh

Gynecological Mesh Makers

The CBS news story mentioned only Boston Scientific as a defendant in transvaginal mesh (TVM) cases, though several other gynecological mesh makers also face lawsuits.  Other defendants include Johnson & Johnson (Ethicon), American Medical Systems (AMS), C.R. Bard, Coloplast, and Cook Medical.

Sixty Minutes reported that Boston Scientific faces some 48,000 lawsuits in what has generated the largest multi-district litigation since asbestos. The suits claim mesh can inflict life-changing pain and injury.  Suits against Boston Scientific also claim the company used a mesh product never meant to be put inside the human body.

Related:  Johnson & Johnson Mesh Verdicts Mount 

More than two million American women have received gynecological mesh implants.  All the mesh makers claim their products are safe.

CBS News

CBS News reported the story of one woman implanted with a Boston Scientific gynecological mesh for stress urinary incontinence and also to lift organs that shifted after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.

Gwyn Madsen told CBS that the mesh “felt like a cheese grater inside of me.”

Ms. Madsen said she suffered pain which left her barely able to sit or play with her children.  She said, “It felt like the material was pulling on the muscles and I’d get shooting pains.  You almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk.”

Boston Scientific, which lost a $73 million verdict over  one of its TVM products following a 2016 trial in Texas, has fought allegations like Ms. Madsen’s for years.  The company told CBS: “Nearly one million women have been successfully treated.  (We) have extensively tested the [plastic] resin to confirm its composition, safety and performance.”

100,000 Women suing over Gynecological Mesh

The American Urogynecological Society – which has embraced the plastic mesh because it is easier to apply than the gold standard suture method for repairing POP or SUI – has also claimed plastic mesh is “safe and effective.”   Many doctors, however, disagree.

Dr. Michael Margolis testified for the woman who won a $73 million verdict in the Texas case.  He told CBS that the women’s mesh causes a chronic inflammatory reaction.  He has removed more than 350 mesh implants.

“The slings I’ve removed are substantially altered in their architecture,” Dr. Margolis told CBS.  “They are shrunk by at least 50% in width.  They are encased in scar tissue. The pores [in the mesh] shrunk substantially.”

Dr. Margolis showed CBS a mesh he removed which had been implanted.  It had shrunk substantially, he said, had folded, contracted, embedded in scar tissue, and was choking off the woman’s urethra.  He said it was half the size it had been upon implant.

Dr. Margolis told Scott Pelley the implant is “not supposed to change.”

Missing from the CBS story and interviews was the fact that Boston Scientific, as well as Johnson & Johnson (Ethicon, American Medical Systems (AMS), and Bard have all lost multi-million-dollar verdicts to women implanted with the companies’ transvaginal mesh products.

FDA:  Serious Adverse Events “not rare”

The story did include the fact that the FDA has issued a damning report regarding TVM mesh.  In 2011, the FDA said that it found mesh used to support organs after pregnancy had resulted in nearly 4,000 “reports of injury, death, and malfunction” and complications including “pain, infection, urinary problems, bleeding and organ perforation.”  The FDA wrote that, “Serious adverse events are not rare.”

Indeed.   At least 100,000 women would apparently agree with that statement.

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EPA helps Monsanto hide non-Hodgkin’s Lymphoma Link

(July 5, 2018)  The EPA helps Monsanto hide a non-Hodgkin’s lymphoma link with the only active ingredient listed in the chemical giant’s Roundup. That’s the story that emerged when we pull back the curtain and expose the EPA for what it is.  As with many governmental regulators (like the CDC with its giant conflict of interest in vaccination), EPA works ostensibly as a government watchdog to protect people from profit-driven corporations.  In reality, as this latest evidence shows, the EPA works first for corporations and secondarily (if at all) for U.S. citizens.

Related:  Monsanto EPA Ties Cancerous

A new report proves the EPA purposely ignored evidence showing a clear link between glyphosate (in Monsanto’s Roundup and other pesticide poisons) and non-Hodgkin’s lymphoma. The report shows the EPA obscured, cherry-picked, and/or simply ignored data presented by a Scientific Advisory Panel charged with reviewing the EPA’s glyphosate evaluation. The evidence shows the EPA deliberately misrepresented the opinions of the scientific panel.

Roundup Lawsuits
The EPA’s covering for Monsanto comes doubly into play, as many farmers, landscapers, agricultural workers, and homeowners have taken Monsanto to court over Roundup links to non-Hodgkin’s lymphoma. The plaintiffs accuse the chemical giant of lying about glyphosate’s safety profile.  Monsanto continues to claim that Roundup is “half as toxic as table salt.”  Hundreds of farmers and homeowners who have suffered with non-Hodgkin’s lymphoma after using Roundup disagree.  Many have filed Roundup lawsuits that accuse Monsanto of hiding Roundup’s cancer-causing effects.  The research obscured and/or ignored by the EPA shows the link between Roundup and cancer is real.

EPA ignored glyphosate cancer link – 2017
Bloomberg reported that a panel of scientists not connected with Monsanto assembled in 2017 to review the EPA’s glyphosate evaluation. Fifteen experts comprised the Scientific Advisory Panel. Nearly all of them took issue with the EPA’s conclusion on glyphosate.  Eleven of the 15 disagreed with the EPA’s hasty decision to give glyphosate and Monsanto a free pass over Roundup and glyphosate’s links with cancer.

Four of the six reviewers assigned to evaluate epidemiological data criticized the EPA for disregarding pertinent data regarding glyphosate’s potential link with cancer.  All four of the “dissenters” are biomedical researchers at leading research universities. The two who approved of EPA’s glyphosate evaluation are private consultants, which means they work almost exclusively for industry interests.

EPA officials inexplicably tossed out all but one meta-analysis of epidemiological data. They claimed the rest of the results were “statistically invalid.” But the panelists discovered that this specious claim simply was not true. They found the data was valid.

EPA Monsanto Collusion Unveiled
After taking a second look at the data, the panelists found the discarded meta-analyses were statistically significant. That data showed that farmers exposed to glyphosate had an increased risk ratio for non-Hodgkin lymphoma of 1.27 to 1.5. Those figures mean those farmers experienced a 27- to 50-percent higher risk of cancer than control groups.

One of the researchers pointed out that women in America stopped taking post-menopause estrogen because of a 22-percent increased risk in breast cancer. The risk association of glyphosate nearly doubles that risk.

EPA Assessment “Highly Imbalanced (and) “Seriously Flawed”
A University of Washington at Seattle biostatistician, Lianne Sheppard, said the EPA’s assessment on glyphosate was “highly imbalanced. She said the EPA clearly downplayed relevant findings.

“The agency’s conclusion is seriously flawed and needs to be strongly revised,” said Ms. Sheppard.

EPA obscured criticisms of Itself
Besides willfully disregarding statistically significant information regarding glyphosate’s potential to cause cancer and promote tumor growth, the EPA has also taken steps to downplay the Panel’s criticisms of the EPA itself.

The EPA’s report on the Scientific Advisory Panel’s peer review does everything possible to hide the fact that most of the panelists criticized the EPA and its handling of the glyphosate analysis.

The EPA not only failed to disclose the number of scientists who launched criticisms at the EPA, it repeatedly used a lying euphemism in an attempt to cover up its fraudulent work. The EPA’s’s report used the lie of a phrase “some panel members” an astounding 76 times. Any 12-year-old child can see that substituting the word “some” for “a majority” or even “most” is simply a disingenuous way to lie and mislead.

That majority of panelists who criticized the EPA’s pseudo science could also criticize its pseudo independence, the EPA glaring conflict of interest with the pesticide industry. The EPA’s Office of Pesticide Programs received nearly 30 percent of its funding from the pesticide industry last year. So who is this agency working for – the pesticide industry or the people targeted by the industry to buy pesticides?

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Quest Labs will pay $1.8 Million for overbilling scheme

(July 2, 2018)  Quest.8 Million for overbilling scheme"> Labs will pay $1.8 million for an overbilling scheme that defrauded Medicare and Medicaid.  That payment will likely not come as a surprise to the many Quest customers who level similar charges on the Quest review page at ConsumerAffairs.com.  There, some 267 Quest Diagnostics Consumer Reviews and Complaints (55 in the last year) average out to give Quest a dismal 1-star rating on a 1-5 star scale.  Those 267 reviewers are all verified, according to the web site.

Quest Diagnostics, Inc. and Quest Diagnostics Clinical Laboratories agreed to pay the U.S. $1.79 million, in April 2018, to settle claims of violations of the False Claims Act.

Echoing charges from many of the reviewers who question Quest’s billing practices on the Consumer Affairs web site, Quest was accused by the U.S. government of submitting duplicative claims to Medicare for several different tests.  Quest claimed its double billing was due to IT issues that affected some test codes in its system.  Quest denied any wrongdoing and said the problem won’t reoccur since the company updated its billing systems.

That said, we offer a typical example of the many one-star reviews of Quest Diagnostics.  One of the 267 verified reviewers, “S. Of Calif.”, published this statement on Jan 20, 2018:

“I have gone to Quest Diagnostics on my doctor’s recommendations since 2006. In that time I have had close to a million dollars in work performed by hospitals, clinics, and Quest labs. I have the entire time experienced with Quest only incorrect billing of my insurance on a consistent basis the entire time. I have multiple insurance overages. Quest not only billed my insurance companies but they, each time, have billed me forcing me to either pay the invoice or contact them to get it straightened out. This appears to be systemic with their billing practices. No other medical provider do I have this problem with. Now I am getting collection notices for bills that they were supposed to correct after alerting Quest that they had failed to bill it correctly. They refuse to correct the situation that they created causing me financial hardship and ongoing stress. With regard to the star rating if I could choose negative stars I would.”

Quest Diagnostic Whistleblower Lawsuit Settlement
Former Quest employee Eliza Martinez will receive $358,000 as her reward for blowing the whistle on Quest’s allegedly fraudulent billing practices.

Ms. Martinez testified that she saw Quest perform duplicate tests on the same patients on the same day, and then she saw Quest bill Medicare twice for that exact same test.

The U.S. Attorney’s Office for the Eastern District of California investigated after Ms. Martinez filed the complaint. The settled claims are only allegations, by law; the government established no determination of liability.

One would think Quest makes enough dough not to overbill people or the government.  Quest generated some $7.5 billion in revenue in 2016.  The company runs more than 2,200 patient service centers that conduct lab tests.  Quest’s website says Quest “[s]erves about half of the physicians and hospitals in the U.S.”

Many of the Quest reviewers also question whether a company can be trusted to do its lab work right when it offers terrible customer service (never answering the phone is another common complaint) and then not only double bills but also erroneously turns those bills over to a collection agency.

Quest Lawsuit
It’s a fair question to ask, especially now that we know Quest has missed some diagnoses.  Quest is being sued today for missing a cancer diagnosis in more than 200 women in Ireland.  Quest has settled with a woman involved in at least one of those cases.  More than a dozen of the women have reportedly since died of cancer, while their survivors and others who believe they were misdiagnosed are also suing Quest for damages.  Quest lawsuits are being filed as a result.

Given the whistleblower lawsuit and the 267 awful reviews of Quest Diagnostics, one can only wonder whether this company is performing its diagnostic duties with the due diligence its customers expect and deserve.

Related
•  Quest Lawsuit
•  Whistleblower Lawsuit| Lawyer
•  Quest Labs will pay $1.8 Million for overbilling scheme

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Parkinson’s Drug Nuplazid showed early Red Flags

The Parkinson’s drug Nuplazid showed early red flags. It’s approval by the FDA came with significant reservations from many of the reviewers who voted 12-2 to recommend FDA approve it for sale. A March 28, 2016 StatNews.com story came out just as Nuplazid gained FDA approval. It was titled “Parkinson’s Drug Nuplazid could reduce hallucinations, but at what cost?” It was a fair question then, and it looks prescient now. The real cost of Nuplazid seems clearer by the day. A reported 500 deaths have now been linked with the drug, though ultimate causation questions remain.

MSNBC reported that Nuplazid’s maker, Acadia, saw its stock plunge 22% in April 2018 when the FDA announced that it was reexamining drug.  An FDA spokeswoman told MSNBC the agency is conducting an evaluation of Nuplazid.

An Acadia spokesman, however, said the FDA review does not mean the agency has determined Nuplazid has a new risk, and that FDA has not suggested doctors stop prescribing the drug or that patients stop taking it.

Nuplazid was a hopeful drug for some people with Parkinson’s Disease who experience hallucinations. Parkinson’s can, for some, come with debilitating psychosis. Half of the million or so Americans diagnosed with Parkinson’s can experience hallucinations, illusions, and delusions. Symptoms are usually benign, but they can sometimes be very destructive.

Psychiatric disturbances often result from standard Parkinson’s drugs. That can leave patients choosing between physical and emotional stability. In desperation, some might try meds not designed for their condition.

In 2016, an advisory panel to the FDA voted 12-2 in favor of approving Acadia Pharmaceuticals’ Nuplazid, which was specifically designed for Parkinson’s psychosis. The FDA does not have to follow the panel’s advice, but it usually does, and it did in this case.

Nuplazid costs far more than existing antipsychotics, which are mostly used to treat schizophrenia and are available as generics. StatNews reported that in the votal trial behind Acadia’s marketing application, Nuplazid showed only modest improvements over placebo. It was also tested in a way that makes it difficult to compare against other treatments. (One might ask: Why?)

Nevertheless, physicians involved in the trial, some of who had financial ties to Acadia, stood by Nuplazid.

A neurologist at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Dr. Jeffrey Cummings, said he was struck by some of the patients’ “dramatic” responses, but he also acknowledged “families will also respond to placebos, and that’s why we don’t approve drugs based on anecdotal reports.” Dr. Cummings has taken consulting fees from Acadia. He called it “a pretty impressive study.”

Dr. Joseph Friedman, chief of the Butler Hospital Movement Disorders Program, also received consulting fees from Acadia in the past. Dr. Friedman also participated in the Nuplazid study. He noted that fear drives many Parkinson’s patients. He said patients can “start to worry about losing their mind.”

A smaller subset of patients suffers from paranoid delusions, most typically involving the fear that the person’s spouse is cheating on them. Studies have shown that psychosis, more than any other reason, causes Parkinson’s patients to move to nursing homes.

In an effort to help Parkinson’s patients with drugs, doctors often try to lower dosages of conventional Parkinson’s medications. These work to control tremors and other movement problems by targeting the same neurotransmitters in the brain that can also trigger psychosis.

The most common alternative is to give antipsychotic medications that are FDA-approved for treating schizophrenia or bipolar disorder but not Parkinson’s. Some doctors believe antipsychotics like Seroquel or Clozaril have some effect on Parkinson’s psychosis. Some doctors think they can also help ease anxiety and sleeplessness. But clinical studies have not shown any effect on Parkinson’s psychosis.

Nuplazid (also known as pimavanserin) was approved by the FDA in the middle of this already-dicey situation. Hope for Nuprazid rested mostly on a single Phase 3 trial lasting just six weeks.

Nuplazid Maker sponsored own studies
That trial was paid for by Acadia. It focused on 199 Parkinson’s patients. Half were given placebo, the other half Nuplazid. The Lancet reported that Nuplazid treatment showed a 37 percent improvement on a nine-point clinical scale, compared to a 14 percent improvement for those on placebo. It’s very hard to translate those numbers into any real concrete notion of the drug’s safety and effectiveness.

Another study participant with financial ties to Acadia, Dr. William Ondo, admitted that it is impossible to say whether that result shows Nuplazid is better than other kinds of antipsychotics. Director of movement disorders at the Houston Methodist Neurological Institute, Dr. Ondo has sat on Acadia’s scientific advisory board.

Nuplazid had failed to demonstrate a benefit in two previous Phase 3 trials. Both included international as well as US patients, which, according to Dr. Cummings, skewed the results. He claimed that people in other cultures carry different definitions of hallucinations.

The previous trials also evaluated the drug using the so-called Scale for the Assessment of Positive Symptoms, or SAPS, a traditional measure to gauge the extent of schizophrenia symptoms.

Acadia adapted that scale to better gauge the effectiveness in combating Parkinson’s psychosis specifically. Acadia adapted that scale to measure the sorts of hallucinations and delusions people experience with the neurodegenerative disease. The modified scale allegedly helped Acadia show Nuplazid was better than placebo at controlling symptoms in Parkinson’s patients. But since the Parkinson’s version of the scale hasn’t been used to test other drugs, some question the tool’s clinical validity.

Nuplazid uses a novel molecular approach. Other antipsychotic medications target both the dopamine and serotonin pathways in the brain; so they can interact with drugs that help regulate movement disorders Parkinson’s patients can suffer. By contrast, Nuplazid targets only the brain’s serotonin receptors. That may be why it was not found to worsen motor symptoms.

Nuplazid Side Effects
Since Nuplazid hit the market, many people have reported significant Nuplazid side effects. In all the Phase 3 trials of Nuplazid, 8.1 percent of patients on the drug experienced severe side effects, while only 4.8 percent who received placebo reported side effects. Symptoms included irregular heart rhythms, muscle injury, weight loss.

FDA: One adverse event for every two who benefit
The FDA noted in its own documents that for every two patients expected to achieve “much improved” status from taking Nuplazid, one patient experiences a serious adverse event.

Parkinson’s patients with psychosis can suffer abominably, as can their families and caregivers. But any answer for terrible suffering must not come with a price tag so high that it may be worse than the suffering itself. At this moment in time, it appears that Nuplazid may cause more problems than it solves.

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Firms request Shingles Vaccine Case Consolidation

(June 22, 2018)  Law firms representing people who have filed shingles vaccine cases have requested they be consolidated in New Jersey.  Law360 reported last month that the firms represent hundreds of people who allegedly suffered serious injuries after using Merck & Co. Inc.’s shingles vaccine.  A bar notice said the attorneys have asked the New Jersey Supreme Court to give the Zostovax cases a multicounty litigation designation (MLC).

Related:  Shingles Vaccine?  Really?

Plaintiffs in some 37 filed cases filed in one petition hail from all across the country. Their lawsuits all claim Merck failed to warn them that its shingles vaccine could cause maladies such as brain swelling, eye injuries, and other physical disorders.

One attorney representing 285 plaintiffs said that the people filing complaints claim similar injuries, so coordinating discovery for the suits “would be advantageous (and) promote convenience and fairness to all parties to these cases.”

Middlesex County is the best place for the cases, said the plaintiffs’ firms. According to Bern & Partners, Bergen and Atlantic counties are already handling 13 other mass torts between them, and two out of the seven mass torts now running in Middlesex are nearly finished; so Middlesex would be a good destination for the shingles lawsuit cases.

Bern & Partners argued that despite nearly identical issues of fact and law presented to the various judges now assigned to the cases, the rulings have not all been consistent. The Bern firm wants the Zostovax cases to go before Superior Court Judge James Hyland, who is overseeing mass torts for Middlesex County.

Bern & Partners attorney Thomas Joyce, who represents 569 plaintiffs, said, “We anticipate and presume that inconsistent rulings on substantively identical issues of law and/or fact will continue to occur. (Thus), MCL designation will be beneficial to preserve consistency throughout these similar cases, and will be fair and convenient for all parties and the court.”

The judiciary welcomed comments and objections to the applications through June 8, 2018.

Shingles Vaccine Lawsuits
Shingles vaccine lawsuits have been filed over Merck’s Zostavax vaccine.  Zostavax causes problems, according to plaintiffs, because it contains a live virus that can cause nerve-damaging inflammation throughout the body. Plaintiffs represented by Sadaka Associates claim that inflammation caused by Zostavax can lead to facial paralysis, encephalitis, meningitis and loss of dexterity.

Bern & Partners allege additional Zostavax shingles-related injuries that include post-herpetic neuralgia, retinol necrosis, keratitis (eye/vision injury) and acute myelitis.  Bern & Partners’ plaintiffs allege that the makers, marketers, distributors and sellers of Zostavax knew or should have known about its “dangerous propensity,” yet concealed the information to boost Merck’s shingles vaccine sales.

Judge Hyland Chosen
Merck also wants the cases to be heard by Judge Hyland, whom Merck recognizes as familiar with the company, according to a September 2017 letter from the drug and vaccine giant’s legal counsel, Fox Rothschild LLP.  That letter was included in the bar notice.

Plaintiffs’ lawyer Mark Sadaka told Law360 that he was hopeful the New Jersey consolidation would work hand-in-hand with the federal MDL.

The Zostavax shingles vaccine cases are in the Superior Court of New Jersey.

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Human Rights First helps Refugees

June 20 was World Refugee Day, which is somewhat ironic because the U.S. government’s “zero tolerance” policy has recently separated some 2,300 children from their parents.  Many are trying to escape to the United States to save their families’ lives.

Human Rights First is one organization singled out by ActBlue as one of a handful of organizations deserving support to help keep refugee families together.

Human Rights First helps Refugees

Human Rights First is one of the United States’ leading providers of pro bono legal services to refugees hoping to find safety in America.  With offices in New York; Washington; DC, Houston, Texas; and Los Angeles, Calif.,  HRF works with many of the country’s top law firms to win asylum and a path to citizenship for thousands of people escaping other countries.  HRF helped write the book on asylum reform.  The organization has been protecting refugees for four decades.

HRF also provides research and media outreach.  It works to push legislators to enact laws that reflect the ideals for which the U.S. was historically a global leader.  Human Rights First released a comprehensive report this week on unsafe refugee detention centers in Texas.  HRF continues its work to bring these issues to the press, U.S. legislators, and the executive branch of the administration.

Many of us want to do something proactive to help refugees.  Houston attorney David Matthews has been a longtime board member of Human Rights First.  He proudly supports the work of the organization and encourages everyone who can to donate in helping HRF help refugees and other peoples of the world caught in geo-political struggles that threaten their lives.

Mr. Matthews requests that his friends and supporters please consider making a donation to help Human Rights First help refugee families as they look to the United States for safety and a better life.

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Are Generic Drugs really the same as Brand?

Are generic drugs really the same as brand?  From a legal perspective, the answer is a resounding, “No, generic drugs are not the same as brand-name drugs.”  Not when it comes to liability for their respective makers, or the civil protections enjoyed by their users. Why is that? One might fairly ask. The answer is that five justices on the U.S. Supreme Court ruled in two landmark 5-4 votes that anyone injured by a generic version of a brand-name drug does not have the same civil protections as someone injured by the brand-name version of that same drug.  That can mean the difference between a $21 million jury award and nothing, which is what five members of the Supreme Court decided a woman’s injuries were worth after she was blinded and disfigured by a generic drug.

Supreme Court rulings on 5-4 votes in both Pliva v. Mensing (2010) and Bartlett vs. Mutual Pharmaceuticals (2013) gave generic drug makers virtual carte blanche to injure people at will without having to face the consequences of the drugs they make.  The latter ruling overturned a $21 million verdict for Karen Bartlett, who was blinded and disfigured by a generic version of sulindac, an anti-inflammatory drug.

Gross injustice like that in Ms. Bartlett’s case continues. The Supremes’ decision in favor of generic drug makers is a gift to drug companies that keeps on giving. Thanks to the high court, it is now either extremely difficult or virtually impossible for people hurt by the generic version of a drug to have their grievances heard in an American courtroom.

In addition to the fact that generic drugs fail to compare with branded ones in the American court system, there is much evidence to suggest that many generic drugs are not equivalent to brand name drugs from a medical perspective.

Fortune magazine reported in January 2013 on several controversies surrounding brand and generic drug “equivalence.”  Katherine Eban wrote a story which detailed how in 2012 the FDA took the rare step of declaring that a generic version of the antidepressant Wellbutrin – which the agency had previously approved – was not in fact “bioequivalent” to the name-brand version. In that case, the FDA withdrew its approval of that generic Wellbutrin.

Teva Pharmaceuticals (which made out like bandits in the Mensing v. Pliva decision over the generic version of Reglan), marketed the Wellbutrin generic in question.  Teva was forced to stop selling it.  Other drug companies are now testing their versions of Wellbutrin at the FDA’s request. Fortune reported that the episode brought momentum to a movement that was quietly building among many doctors and medical societies increasingly willing to ask whether generic drugs are in fact identical to the brands they try to copy.

Most people tend to think that generic drug versions are the same as their brand-name counterparts. Most people are happy to save some money at the pharmacy counter and not think past their pocketbook as they leave the drug store. Some people may be vaguely aware that generics are often much cheaper because generic drug makers don‘t have to spend as much money as brand-name drug makers to get their drug on the market. Most are likely unaware that the differences between brands and their generic versions can be significant.

The issue is a large one, because a whopping 80 percent of all U.S. prescriptions now dispensed are generic.  In 20112 alone, Americans saved $193 billion by buying generic drug versions, according to the Generic Pharmaceutical Association.

Generic drug makers may know some of the declared ingredients of a brand-name drug, but proprietary privilege helps the branders keep their processes secret. The patent that reveals the components does not explain how to make the drug. Consequently, generic drug makers must use reverse engineering to conjure their concoctions, hardly a panacea for perfection. The result is that a generic drug, is at best, an approximate copy, never a clean duplicate; and a generic drug will not behave in the same fashion as the branded drug will.

Though FDA rules acknowledge generic drugs’ duplication problems, the agency is a long way from solving them. The best the FDA can offer is a broad definition of “bioequivalence.” Fortune notes that “a generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.”

In addition, though the generic must contain the same active ingredient as the original, additional ingredients – excipients – can be different and are often of lower quality. Those differences can affect a drug’s bioavailability.  The American Heart Association has noted, “Some additives traditionally thought to be inert (may) alter a drug’s dissolution, thereby impacting its bioavailability.”

Are Generic Drugs really the same as Brand?

FDA standards also don’t regulate how quick medicine reaches peak concentration in the blood, and patients taking time-release drugs can be seriously affected by peak changes. Active ingredients releasing into the blood far more quickly can leave patients dizzy or nauseous.

The FDA is also somewhat hogtied by Chinese producers of generic drugs. The Chinese don’t allow U.S. FDA inspectors inside their plants. Officials from the U.S. can only show up at the plant, wait outside, and then accept (or not) whatever the Chinese generic drug makers give or tell them.

An estimated 80% of active drug ingredients and 40% of finished medications come from overseas, from some plants which the FDA has not inspected. In November 2013, generic Lipitor maker Ranbaxy Pharmaceuticals recalled some 480,000 bottles after tiny shards of glass were found inside pills. India’s largest generics company, Ranbaxy is the same entity for which the FDA granted permission to produce a version of Lipitor.  The approval came after a seven-year investigation in which the U.S. Justice Department concluded Ranbaxy had fabricated drug-approval data.  Ranbaxy agreed to pay $500 million and entered into a consent decree.

This is hardly the stuff which can help make people feel confident in filling their prescriptions with generic versions of brand-name drugs.

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Nexium, Prilosec Lawsuits Filed

(June 18, 2018)  Nexium, Prilosec, Prevacid and Protonix lawsuits are being filed in federal and state courts across the country. More than 4,250 proton pump inhibitor lawsuits have been filed in federal court as of June 2018.  The multidistrict litigation (MDL) court for PPI drugs was set up in August 2017 to help move similar cases through the legal process.

Nexium and Prilosec lawsuits lead by the numbers, though the MDL also includes Prevacid and Protonix lawsuits.  PPI lawsuits in the MDL claim these drugs used for stomach acid control have caused serious kidney problems, including chronic kidney disease (CKD).

PPI lawsuits were spurred in part by a study published in the Journal of the American Medical Association (JAMA) on February 1, 2016.  That study concluded:   “PPI use is associated with a 20%–50% higher risk of incident CKD. Future research should evaluate whether limiting PPI use reduces the incidence of CKD.”

Proton Pump Inhibitor Trials
There have been no proton pump inhibitor court trials as of June 18, 2018.  These PPI lawsuits are in the very early stages of planning.  They will likely culminate in bellwether trials.  The first trial in these PPI cases is slated to begin in May 2020.

Bellwether Trials
Bellwether trials are informally considered “test cases” for MDLs.  They can measure jury responses to arguments from both sides.  The results of bellwether trials can typically affect any eventual settlements.

PPI Lawsuit Timeline
May 2016:  The first Nexium kidney damage lawsuits were filed against AstraZeneca.

February 2017:  The federal MDL panel denied a motion to combine 39 PPI lawsuits into an MDL. Those lawsuits concerned several different PPI makers and named different drugs.

July 2017:  The federal panel reconsidered requests to create an MDL.

August 2017:  The MDL panel centralized 161 PPI lawsuits into one action in a New Jersey federal court. Five PPI makers were named in that action.

May 2018:  The total number of PPI lawsuits filed in the MDL grew to exceed 4,200.

May 2020:  Both plaintiff and defense sides requested that the first bellwether trial open in May 2020.

Because these drugs have been popular for a long time, plaintiffs’ attorneys expect the MDL could include several thousand more PPI lawsuits.

PPI Side Effects trigger Lawsuits
PPI lawsuits claim Prilosec, Nexium, Prevacid and Protonix cause kidney-related complications, including full-blown kidney failure.  Some people who have developed kidney complications have filed many of the lawsuits, but some have been filed by those who have lost a loved one to fatal kidney complications.

PPI Lawsuits claim the drugs caused:
•  Acute interstitial nephritis (AIN)
•  Kidney disease
•  Kidney failure
•  Kidney injury

Accusations Against Makers of Nexium, Prilosec, Prevacid, Protonix:

•  Negligence
•  Misbranding
•  Deceptive Advertising
•  Negligent Misrepresentation
•  Fraud
•  Failure to Warn
•  Accepting Kickbacks
•  Designing, Manufacturing, Selling Defective Products

PPI Brands and Manufacturers
The proton pump inhibitor MDL involves four different PPI brands and their manufacturers.

•  Nexium (esomeprazole) AstraZeneca
•  Prilosec (omeprazole) AstraZeneca
•  Prilosec OTC (omeprazole) Proctor & Gamble
•  Prevacid (lansoprazole) Takeda Pharmaceuticals
•  Protonix (pantoprazole) Pfizer

Proton Pump Inhibitor Lawsuit Help

If you or a loved one suffered kidney problems, including kidney disease, interstitial nephritis, kidney failure or other kidney injury after taking a PPI drug, contact an experienced drug injury lawyer for a free legal consultation regarding a potential Proton Pump Inhibitor Lawsuit.

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