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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J&J Talc Supplier agrees to Settle Lawsuits

(June 14, 2018)  A J&J talc supplier has agreed to pay at least $5 million to settle 22 ovarian cancer law suits, Reuters reported last week.  Imerys Talc America supplied Johnson & Johnson with talc for its Shower-to-Shower and Baby Powder products. Imery’s has agreed to the reported $5 million figure in order to settle a talcum powder lawsuit filed by 22 women.

The women all allege they developed ovarian cancer from regular, repeated use of J&J talc-based powders for feminine hygiene.  Their lawsuit against Johnson & Johnson is being heard now in Missouri’s 22nd Circuit Court in St. Louis.  Bloomberg News reported that Imerys agreed to the settlement just before the trial began.  A company spokesperson confirmed the agreement.

No Fault for Imery’s
Imerys has not admitted fault for any of the plaintiffs’ injuries. The company continues to deny its talc was tainted with asbestos, as does Johnson & Johnson.  No exact settlement terms will be made public.

Talcum Powder Mesothelioma Verdicts
Johnson & Johnson and Imerys are named in more than 9,000 lawsuits which allege talc used to make Baby Powder and Shower-to-Shower was tainted with asbestos. Lawsuit petitions all state that the talc caused regular users to develop ovarian cancer or mesothelioma.

Johnson & Johnson Talc Powder Mesothelioma Trials
A California jury ordered J&J and its talcum suppliers – including Imerys – to pay a woman $27.1 million for her claim that asbestos-tainted Baby Powder caused her mesothelioma. The jury also added $4 million in punitive damages. It found J&J acted with malice, oppression, or fraud.

In April 2018, a New Jersey’s jury in Middlesex County Superior Court awarded a man $117 million in compensatory and punitive damages. He had alleged his life-long Baby Powder use was the only possible explanation for his mesothelioma. The jury found J&J and Imery’s Talc 70% and 30% liable (respectively) for damages incurred by the plaintiff and his wife.

Johnson & Johnson prevailed in a California mesothelioma trial that concluded in November 2017, but it has lost other talcum-mesothelioma cancer lawsuits.

A third California case was declared a mistrial in May 2018, and a recent South Carolina talc-meso trial was also declared a mistrial after the jury deadlocked.

Talcum Powder Ovarian Cancer Verdicts
Plaintiffs have won four and lost two talc-cancer verdicts in Missouri’s 22nd Circuit Court.

•  February 2016: A jury ordered Johnson & Johnson and Imerys to pay $72 million* to the family  of an Alabama woman who died from ovarian cancer.
•   May 2016: A jury ordered J&J to pay $55 million to a South Dakota woman.
•   June 27, 2016: A jury ordered J&J to pay $70 million to California woman.
•   March 2017: A jury founds in favor of J&J against a Tennessee woman.
•   May 2017: J&J and Imerys were ordered to pay $110.5 million to a Virginia woman.**

*The $72 million verdict was later dismissed after a U.S. Supreme Court ruling in Bristol-Myers Squibb v. Superior Court of California. The high court held that a plaintiff must file suit where defendants are headquartered or else in the state where the plaintiff was injured.

**J&J challenged the $110 million verdict, but it was upheld. The trial court ruled jurisdiction was appropriate because J&J had used a Missouri-based company to label, package and distribute.

J&J Talc Supplier agrees to Settle Lawsuits

Johnson & Johnson is appealing the other four Missouri verdicts.  There has also been a concerted PR campaign from industry quarters to attack the Missouri court as unfairly favorable to plaintiffs.

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Parkinson’s Drug Death Reports should alarm FDA

Parkinson’s drug death reports should alarm the FDA.  At a time when Congress and the FDA are besieged by Big Pharma lobbying money to fast track “miracle” drugs to market, the story of Nuplazid shows what can happen when government regulators lower the bar too fast. A Nuplazid Lawsuit may be on the horizon.

People who see their loved ones stricken with Parkinson’s disease can be driven to desperate measures. They can become easy targets for a drug maker’s promises.  They might even be driven to try a drug that has not been proven safe or effective.

While San Diego-based Acadia Pharmaceutical company defends its Parkinson’s drug (see below), many red flags appear to be flying around Nuplazid.

Nuplazid Fast Tracked to Market
Nuplazid’s safety review process was expedited by the FDA because Nuplazid had been designated as a “breakthrough therapy.”  That meant Nuplazid demonstrated “substantial improvement” in patients with serious or life-threatening diseases compared to other treatments already on the legal drug market.  Spurred by Big Pharma lobbying money, the U.S. Congress created the breakthrough designation in 2012 to speed the FDA’s approval process.  Drug makers and their political friends in government have long criticized the FDA for being too slow in granting new drug approvals, though the agency is now, and has been for a long while, the fastest of its kind in the world.  The FDA has granted some 200 drugs this new designation since 2012.

To recommend approval, an advisory committee first has to find a drug’s potential benefits outweigh its risks.  Remember that word “potential,” which can be stretched an awful long way.

Since several people had said that their loved ones had been helped by Nuplazid, some FDA officials concluded Nuplazid’s public health benefit was enough to merit the drug’s approval.  But others in the test trials said there was no way for them to know whether they were on Nuplazid or a placebo.

Dr. Paul Andreason, who led the FDA’s medical review, warned that patients taking Nuplazid during the company’s clinical trials suffered serious outcomes, including death, at more than double the rate of those taking the placebo.   Dr. Andreason said the company’s limited testing had not convinced him Nuplazid’s benefits outweighed its risks.

The advisory committee voted 12-2 to recommend FDA approve Nuplazid for the treatment of Parkinson’s disease psychosis.  The majority based their approval vote on a six-week study of about 200 patients.  Dr. Andreason said three previous studies of Nuplazid had not shown it was effective, though they did show similar risk.  The hearing transcript also showed that some committee members who voted for Nuplazid did so with reservations.

CNN noted that one physician stated he thought the risks were “going to be small” (and) “the benefits for some of these people who are very sick and whose families are affected by this, I think they’re probably willing to take that risk.”

Another committee member said she wouldn’t have voted for Nuprazid’s FDA approval if there had been a safe and effective alternative on the market.  A third pleaded to the FDA to “consider a large observational study” to ensure benefits would outweigh risks.

Nuplazid hit the open market in June 2016, and sales reached roughly $125 million in 2017.

Nuplazid Adverse Events Reports
Shortly after Nuplazid’s release, patients’ family members, doctors, and other healthcare workers began reporting “adverse events” possibly linked to the drug.  Those “events” included deaths, life-threatening incidents, falls, insomnia, nausea, fatigue.   In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.

In November 2017, the Institute for Safe Medication Practices warned that 244 Nuplazid-linked deaths had been reported to the FDA between the drug’s launch and March 2017.  ISMP also noted hundreds of reports suggested Nuplazid was “not providing the expected benefit” or was even potentially worsening the condition.

Tracked by the FDA, these so-called “adverse event reports” document deaths, side effects, and other issues.  These reports can be made directly by consumers, caregivers and other medical professionals.  Reports are submitted to either the FDA or to the drug maker, which is required to pass along any it receives to the federal government.  Sometimes the person filing the report is convinced the side effects were caused by the drug.  Sometimes the reporter ascribes no cause, but notes the patient was taking the drug.

An adverse event report does not mean the medication in question has been ruled as the cause of harm.  The FDA uses the information to monitor potential issues with a drug and can take action as needed.  The agency may update a drug’s label, restrict its use, pull it from the market, or suggest or demand some other action from the drug maker.

Nuplazid: More Harm than Good?
The ISMP concluded that Nuplazid reports “reinforces the concerns of those who warned that (Nuplazid) might do more harm than good.”  A senior scientist for drug safety and policy for the nonprofit ISMP, Thomas Moore, said the deaths are an “important warning signal” that warrants further FDA review, and possible action.

Since ISMP released its analysis, FDA data shows reported deaths have risen to more than 700. As of June 2017, Nuplazid was the only medication listed as “suspect” in at least 500 of the death reports. Keep in mind that it’s also well known by drug and medical device safety experts that only 1-10 percent of actual adverse events are ever reported.

That’s a lot of potential Nuplazid-related deaths. Hindsight does tend to be 20-20, but physicians, medical researchers and other experts told CNN they worried that Nuplazid had been approved too quickly, based on too little evidence that it was safe or effective.  Based on these mounting reports of deaths, they say more must be done to assess Nuplazid’s true risks.

Acadia’s Response
Nuplazid’s maker, Acadia, has responded by saying, in part, that its “benefit/risk assessment of Nuplazid remains unchanged.”  Acadia says it carefully monitors and regularly analyzes safety reports from both ongoing studies and adverse event reports.  Acadia noted, for example, that since Nuplazid’s approval, two studies totaling more than 300 Alzheimer’s disease patients found no difference in the death numbers reported between Nuplazid and a placebo.

FDA commissioner Scott Gottlieb was asked by CNN’s Dr. Sanjay Gupta to give his thoughts on drugs that receive expedited reviews and then prompt concerns about safety once they become available.  While Mr. Gottlieb refused to comment on a specific drug, he said he is “familiar with the circumstances” and that it’s important for FDA to balance safety with medical need.  He also admitted this was a flexible standard and there may be more tolerance for risk when there is a significant need and patients don’t have an alternative.

Mr. Gottlieb may sound “reasonable,” but who is he kidding?  There are always alternatives, unless one lives in a world where doing nothing at all – or simply praying– is not an alternative.  Or one lives in a world where taking any path or action whatsoever that doesn’t involve swallowing a Big Pharma drug cannot be seen as an alternative.

Parkinson’s Drug Death Reports should alarm FDA

Time will tell, hopefully, and the truth will come out about whether or not any benefits Nuplazid may offer are worth its risks. We sincerely hope the FDA is paying attention for the sake of Nuplazid’s potential future victims, but also for the sake of the next 500 or more people who may be given a drug which has also not been sufficiently tested for safety and efficacy before being unleashed “on the market.”  One can only wonder how many of the 200 drugs the FDA has granted “breakthrough therapy” status to since 2012 has been worthy of that designation. One thing seems certain right now:  Whether Nuplazid is worthy of that status it was granted is highly debatable.

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J&J Talc Trial for 22 Women

( June 8, 2018)Talcum Powder Lawsuit  A J&J talc trial for 22 women began last week in St. Louis.  Six of the women plaintiffs have died of ovarian cancer.  The 16 still alive also have ovarian cancer, which they said they got as a result of their daily use of Johnson & Johnson talcum powder products – either J&J’s Baby Powder or Shower to Shower. Their lawsuit charges that  J&J willfully ignored evidence that the powder was tainted with deadly asbestos.

The 22 women hail from all across the nation.  The court anticipates hearing from each of them or from a surviving family member over the course of the trial.

Related:  J&J Talc Powder Cancer Lawsuit

Johnson & Johnson representatives and company lawyers say the talc in Johnson’s Baby Powder and Shower to Shower is a cosmetic grade that was, and is, free of asbestos.  J&J says many  scientific and governmental organizations that have investigated any talc-cancer link have not been persuaded.

But the women’s attorney, Mark Lanier, argued in opening statement that J&J worked furiously to keep the talc-asbestos evidence hidden from the public.

The Houston attorney told the jury of an Italian mine that supplied J&J’s talc for baby powder.  The Italians warned J&J that they had asbestos in their talc mines.  He said, “[T]he company sends two of their big dogs over to Italy to get in front of that company and say, ‘Please stop this English translation from going out until we can work on it and take out the asbestos section.’”

Rigged Talc Asbestos Tests?
Mr. Lanier told the jury he expected J&J’s defense attorney to show them “document after document” in his own opening in an attempt to prove the company performed hundreds of tests to rule out any possible asbestos in J&J talc products.

“They rigged the tests,” shrugged Mr. Lanier.  “They rigged the tests.”

Mr. Lanier called J&J’s baby powder the company’s “sacred cow.” He said talc mines are “marbled” with asbestos like streaks.  He said testing should be done on “concentrate” asbestos, like orange juice.  He said asbestos doesn’t reveal itself via “onion properties” like smell, visibility, sneezing or eye-watering.

The defense attorney did not fall short of performing as Lanier had anticipated for the jury. “Millions of women who’ve used baby powder have not gotten cancer,” he said.  “And most who have ovarian cancer did not use baby powder.”

“We believe and have always believed that there isn’t [asbestos in J&J talc],” said the defense lawyer.  “Independent laboratories said there’s no asbestos. Universities and research centers said there’s no asbestos. Government agencies, no asbestos. Johnson & Johnson’s testing, no asbestos. The talc suppliers’ certificates, no asbestos.”

He said at least one of the plaintiffs had brought her own bottle of baby powder to a deposition, and when asked to read the back of the bottle, read, “Pure cornstarch”– not talc.

He further alleged that every one of the 22 women had a family history of cancer.

“Asbestos is everywhere,” the defense attorney told the jury.  “[T]heir experts will say to you that everybody, you, me, everyone has asbestos in their tissue because of what is in the atmosphere. I don’t think there’ll be any dispute about that.”

Witnesses expected in this trial include materials scientist Bill Longo and mineralogist Dr. Alice Blount for plaintiffs.  Matthew Sanchez of R.J. Lee Group and gynecological oncologists Cheryl Saenz and Warner Huh are expected to testify for J&J.

The trial for the 22 women is expected to last a couple of weeks.  It comes on the heels of several previous talc-cancer trials over Johnson& Johnson’s Baby Powder and Shower-to-Shower. It has been a mixed bag of results so far, as plaintiffs have won some and J&J has prevailed in some.  In addition, some large verdicts for women have been overturned on appeal.

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Chuck Norris fights MRI Dye Gadolinium Makers

Chuck Norris fights bad guys in fictional dramas, but there’s nothing fictional about his fighting MRI dye gadolinium makers. After the action-star’s wife became stricken with mysterious mental confusion, deep muscle and bone pain, and strangely hardening skin, Mr. Norris and his wife Gena O’Kelley put two and two together. Gena had recently submitted to several injections of gadolinium prior to MRIs.

What is Gadolinium?
A chemical element and a heavy metal, gadolinium can be found on the periodic table as “Gd,” but most of us associate it with medical scans. It is often used as a contrast agent to make MRI or some MRA scans sharper. Some 30 million people are exposed to gadolinium every year, according to the American College of Radiology.

What’s the Problem with Gadolinium?
Most people are lucky and see no side effects after being injected with gadolinium dye. They apparently pass most of the gadolinium dye through urination. Others are not so lucky.

Gadolinium Deposition Disease
Sometimes the gadolinium dye does not exit the body quickly enough. Gena O’Kelley had apparently received more gadolinium than her body could abide. She and Chuck Norris consequently filed a lawsuit against several gadolinium-dye making companies. According to their lawsuit petition, Gena was stricken with gadolinium deposition disease. A law firm is representing Mr. Norris and his wife in a suit against three different companies for $10 million in damages. The two are suing MRI dye maker Bracco. Other MRI dye makers include General Electric (Omniscan) and Bayer (Magnevist).

FDA on Gadolinium MRI Dye
The FDA announced Dec. 19, 2017 that it was requiring a “new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.”

The agency was quick to add gadolinium retention has not been “directly linked to adverse health effects in patients with normal kidney function.” FDA also “concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.” (In every case? Apparently, for that agency.)

The FDA did, however, also throw patients a bone, stating that it was requiring “several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA. FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.”

Nephrogenic Systemic Fibrosis (NSF)
The FDA also claims the only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), which the agency says occurs only in people with pre-existing kidney failure.”

The FDA does, however, also admit on its gadolinium “safety alert” that it has “received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.”

Did you catch that? FDA admits seeing adverse events reports but sees no causality. So we are all to simply just accept the overarching announcement that the benefits of gadolinium injection outweigh the risks if we have “normal” kidney function?

Chuck Norris fights MRI Dye Gadolinium Makers
Chuck Norris doesn’t like it, and neither do we. Our law firm handled several NSF cases for people who died of that terrible disease, their bodies and their organs slowly shutting down until their lungs no longer worked. We saw the terrible results of gadolinium poisoning firsthand. But because gadolinium deposition disease shy of NSF is not yet recognized by the FDA, the fight Chuck Norris is taking on could be hard to win, but we sure hope he and his wife do win it. We’ve spoken to too many people in similar circumstances to theirs, people who also say they’ve developed a host of maladies following one or several MRIs’ with gadolinium dye.

Free Legal Consultation
If you or someone you love is suffering from the ill effects of gadolinium dye, contact our law offices for a free legal consultation regarding a potential MRI Dye Lawsuit.

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Cook Medical loses $1.2 Million IVC Filter Verdict

(May 25, 2018)  .2 Million IVC Filter Verdict">Cook IVC Filter AttorneyCook Medical must pay $1.2 million to compensate a man who was implanted with a Cook Celect IVC filter, said a Texas jury Thursday.  Following a three-week trial, the jury of 12 ruled Cook must pay for injuries following a Celect filter’s implantation in Jeffrey Pavlock on March 3, 2015.   A 35-year-old Houston-area firefighter,  Mr. Pavlock sued Cook after its Celect inferior vena cava filter became stuck inside him and required open laparotomy surgery to remove.

Cook promoted its Celect IVC filter as retrievable, but the filter put into Mr. Pavlock’s inferior vena cava tilted, perforated his IVC, duodenum and aorta, and was pressing against his spine and renal artery.  That situation made it impossible to remove without major surgery. Two previous removal procedures had failed.

Much conjecture from both sides argued about how much the results of the removal surgery affected Mr. Pavlock now and could affect him in the future. For the present, despite the scar hidden beneath the button-down shirts he favored during the trial, the appearance of the burly firefighter and EMT appeared unremarkable.  He moved freely throughout the proceedings, without any apparent pain or visible injury, in full view of the jury just a few feet away.

One plaintiff’s expert in the case testified that Mr. Pavlock had a 90% chance of suffering future spinal stenosis from the surgery which involved cutting the metal filter into several pieces and digging them out.

”Spinal stenosis,” according to the Mayo Clinic, “is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine.  Spinal stenosis occurs most often in the lower back and the neck. Some people with spinal stenosis may not have symptoms.”

Defense pounced on the Plaintiff side’s analysis that any spinal stenosis Mr. Pavlock may have is asymptomatic for now but could become symptomatic in the future. Nobody could say for certain whether or not Mr. Pavlock would suffer symptomatic stenosis in the future.

Attorney David Matthews argued for the plaintiff in closing that Cook knew its Celect had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway.  He showed the jury several independent studies which found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.  Mr. Matthews also reminded the jury that he had showed evidence that as few as one percent of adverse events are reported by doctors to a medical device company.

Concerning the large gap between independent- and Cook-sponsored study findings, defense attorney John Mandler said, “They have their favorite studies and we have ours.”  Cook’s lawyers had also refuted trial evidence of doctors reporting only 1-5% of actual adverse events related to medical devices.  In closing, Mr. Mandler called the low-reporting evidentiary studies a “conspiracy theory.”

Cook issued a press release the next day vowing to appeal the jury verdict.

Cook Medical loses $1.2 Million IVC Filter Verdict

Freese & Goss and Matthews & Associates Law Firm represented the plaintiff. Cook Medical was represented by Faegre Baker Daniels of Minneapolis.  The actual jury award was $1,240,500.

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