US Supreme Court to Rule on California State Jurisdiction Over Plavix Litigation

Plavix bleeding side effectsThrowing a lifeline to Bristol-Myers as it tries to wriggle out of mass tort claims against its Plavix blood-thinner in California, the US Supreme Court agreed to review the state supreme court’s ruling taking jurisdiction over out-of-state plaintiffs.

In September the California Supreme Court ruled that its state courts can take “specific jurisdiction” over mass tort claims by out-of-state plaintiffs against Bristol-Myers Squibb (BMS) arising from the company’s national marketing and sales campaigns. Bristol-Myers Squibb Company v. Bracy Anderson, S221038, Super. Ct. JCCP No. 4748 (Sept. 29, 2016).

Bristol-Meyers Squibb (BMS) desperately wants the US Supreme Court to reverse the state court, and to apply a 2014 US Supreme Court ruling Daimler AG v. Bauman, 134 S. Ct. 746, that states may take “general jurisdiction” only over companies that are “at home” in the state. However, that case involved a California product-defect suit involving a German-manufactured vehicle that overturned in Poland and injured a Polish driver and passenger.

In contrast, BMS has 400 employees in California, has a registered agent for service of process and marketed and sold more than 180 million Plavix pills to distributors in California alone, generating sales revenue of $1 billion from 2006-2012.

The Trump factor

“Chief Justice Roberts has leaned left in high-profile rulings and away from his original conservative view the last two years and kept things in line,” said Mark A. York, Senior Consultant for Mass Tort Nexus. “Roberts may continue that path and it will be a 5 -3 ruling for the plaintiffs. But even if he goes right and there’s a 4-4 split, if it’s prior to Trump’s pick for a new Justice, the California court ruling stands, and BMS is out until the next chance comes in another case.”

“This may be a moral compass decision for Roberts at this point and a view down the road of what’s coming even if there is a conservative Trump appointee. If Trump successfully appoints a Justice who pulls the straight conservative line and Roberts goes right, then non-resident Plavix cases are done in California. But there will probably be a clarification of the original Daimler ruling as to how it applies to all parties who are US entities. If Roberts stays left on this, then non-resident cases will be able to proceed in state courts. But if he leans right, then the state court MDLs are up in the air,” York added. “I also noticed that there are several Amici filings supporting Bristol Myers including the US Chamber of Commerce, which shows that BMS is using leverage from outside the pharma-medical industry for support.”

At issue are eight complaints alleging identical facts filed in San Francisco in March 2013 by 86 Californians, and 592 residents of 33 other states. The resident plaintiffs allege the same acts by BMS in the state as the non-residents do, and BMY admits that it is subject to specific personal jurisdiction with respect to the claims of California plaintiffs.

“All the plaintiff’s claims arise out of BMS’s nationwide marketing and distribution of Plavix” that took place in California, says the brief in opposition by Thomas C. Goldstein and Charles H. David of Goldstein & Russell PC in Bethesda, MD.

Mass actions are different

While BMS marketed Plavix as safer than aspirin, it caused the plaintiffs to have heart attacks, strokes, internal bleeding, blood disorders or death.

“Mass actions are fundamentally different from traditional litigation, raising distinct questions about fairness to the litigants and to the states themselves. This is particularly true of mass actions where – as in this case – the non-resident defendant is indisputably subject to the personal jurisdiction of the forum’s courts for some plaintiffs; all the plaintiffs bring essentially identical claims; and the non-resident defendant will inevitably be a party to the litigation of the claims of the non-residents,” the plaintiffs argue.

“In such a case, there is no inherent unfairness to the non-resident defendant, and the nation’s judicial systems operate far more efficiently by adjudicating the indistinguishable claims together.”

The question presented is whether the Constitution immunizes BMS from the personal jurisdiction of the state courts regarding the claims of non-resident plaintiffs arising from the identical factual allegations of resident plaintiffs.

BMS attempts to manufacture a conflict in the courts that must be resolved.

  1. But for Cause. The Fourth, Ninth and Tenth Circuits and the highest courts in Arizona, Massachusetts and Washington arguably conclude that a plaintiff cannot establish personal jurisdiction over a defendant unless he shows that he would not have suffered an injury but for the defendant’s forum-related conduct.
  2. Proximate Cause or Foreseeability. The First, Third, Sixth, Seventh and Eleventh Circuits, as well as the Oregon supreme Court, have not settled on a precise standard, but arguably say that a plaintiff’s injuries must be proximately caused by the defendant’s forum-state contacts.
  3. No Causal Connection. The California, Texas, District of Columbia supreme courts and the Federal District found jurisdiction — paraphrasing here — where there is a substantial nexus or connection between the defendant’s forum activities and the plaintiff’s claim.

Three-part test

But the California court held it did have specific jurisdiction based on a three-part test:

  1. Whether the defendant has purposefully directed its activities at the forum state.
  2. Whether the plaintiffs’ claims arise out of or are related to these forum-directed activities.
  3. Whether the exercise of jurisdiction is reasonable and does not offend traditional notions of fair play and substantial justice.

Satisfying test 1, “BMS purposefully availed itself of the benefits of California” by marketing and advertising Plavix in California, selling 187 million Plavix pills in California from 2006-2012 resulting in sales revenue of $918 million, employing 250 sales representatives in California, contracting with McKesson, based in San Francisco, to be its pharmaceutical distributor, operating research and laboratory facilities in California, and even having an office in the state capital to lobby the state.

Satisfying test 2, BMS had extensive activities in California, including by marketing and promoting Plavix in the state, conducting research and development in California and targeting California as part of a nationwide campaign. “Because of the defendants‘ relationship with the forum, it is not unfair to require that they answer in a California court for an alleged injury that is substantially connected to the defendants’ forum contacts,” the court ruled.

Satisfying test 3, BMS had adequate notice that it was subject to suit in California. “BMS embraced this risk by coordinating a single nationwide marketing and distribution effort and by engaging in research and development in California. In that regard, BMS was on notice that it could be sued in California by nonresident plaintiffs. In fact, our courts have frequently handled nationwide class actions involving numerous nonresident plaintiffs.”

No date has been set for oral argument yet.

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New Lawsuit Filed in Xarelto Litigation, as Caseload Reaches 14,465 Actions

xarelto internal-bleedingAnother wrongful death action has been filed in federal court in Xarelto (Rivaroxaban) Products Liability Litigation, this time by a family of a Louisiana woman who was killed by unstoppable bleeding because the manufacturers concealed their knowledge of Xarelto’s defects, from the decedent, the FDA, the public and the medical community.

The case is Terrie Toups, Duane Rochelle, Patty Buras, and the Estate of Florence Bourgeois, Case No. Case 2:14-md-02592-EEF-MBN, in MDL 2592 supervised by U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana. The current caseload is 14,465 actions. For more information Update: Federal Court Revises Xarelto Product Liability Cases for Trial

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court

The defendants include:

Be sure to read:

Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?

  • Janssen Research & Development, Janssen Ortho LLC and Janssen Pharmaceuticals, Inc.
  • Johnson  & Johnson
  • Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG and Bayer AG

Florence Bourgeois began using Xarelto around September 23, 2013, up until about January 12, 2016. She suffered life-threatening bleeding, anemia, urinary tract infection, sepsis, renal failure and death on January 14, 2016.

151 deaths

The FDA approved Xarelto, also known as rivaroxaban, on July 1, 2011. The drug is used to reduce stroke and blood clots in patient with atrial fibrillation, a heart disorder.

In the U.S., about 1 million Xarelto prescriptions had been written by the end of 2013, when sales for Xarelto passed $1 billion. Meanwhile, for 2012 a total of 2,081 new Xarelto-associated “Serious Adverse Event” reports were filed with the FDA in its first full year on the market — and of those, 151 were deaths.

There is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning about the lack of antidote, but instead only mentioned this important fact in the overdosage section.

“Defendants also failed to warn emergency room doctors, surgeons, and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Xarelto, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto,” the complaint states.

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New Data Show Heightened Risk of Birth Defects with Antidepressants

SSRI-Antidepressants-Lawsuit-Birth-Defect-Side-Effects3A new Université de Montréal study in the British Medical Journal reveals that antidepressants prescribed to pregnant women could increase the chance of having a baby with birth defects.

The risk – 6 to 10 %, versus 3 to 5 % in women who do not take the drugs – is high enough to merit caution in their use, especially since, in most cases, they are only marginally effective, the study says.

“In pregnancy, you’re treating the mother but you’re worried about the unborn child, and the benefit needs to outweigh the risk,” said the study’s senior author, Anick Bérard, a professor at UdeM’s Faculty of Pharmacy and researcher at its affiliated children’s hospital, CHU Sainte-Justine.

Litigation is building against antidepressant manufacturers across the US:

Link to birth defects

A well-known expert in pregnancy and depression, Bérard has previously established links between antidepressants and low birth weight, gestational hypertension, miscarriages and autism. Her new study is among the first to examine the link to birth defects among depressed women.

Every year, about 135,000 Quebec women get pregnant, and of those, about 7 % show some signs of depression, mostly mild to moderate. A much smaller percentage – less than one per cent – suffers from severe depression.

In her study, Bérard looked at 18,487 depressed women in the Quebec Pregnancy Cohort, a longitudinal, population-based grouping of 289,688 pregnancies recorded between 1998 to 2009. Of the women studied, 3,640 – about 20 per cent – took antidepressants in the first three months.

“We only looked at the first trimester, because this is where all the organ systems are developing,” said Bérard. “At 12 weeks of gestation, the baby is formed.”

Antidepressant use during this critical time-window has the potential to interfere with serotonin intake by the fetus, which can result in malformations.

“Serotonin during early pregnancy is essential for the development of all embryonic cells, and thus any insult that disturbs the serotonin signaling process has the potential to result in a wide variety of malformations,” the study says.

Celexa, Paxil and Effexor

For example, when Celexa (the brand name for citalopram) was taken in the first trimester, the risk of major birth defects jumped from 5 per cent to 8 per cent, Bérard found. In all, 88 cases of malformations were linked to use of the drug.

Similarly, use of Paxil (paroxetine) was associated with an increased risk of heart defects; venlafaxine (Effexor), with lung defects; and tricyclic antidepressants (such as Elavil), with increased eye, ear, face and neck defects.

Depression is on the rise across the globe and is a leading cause of death, according to the World Health Organization. Depression is particularly serious during pregnancy, and doctors – especially psychiatrists, obstetricians and other specialists – are prescribing more antidepressants than ever to expectant mothers.

Over the decade or so that Bérard studied her cohort, the proportion of expectant mothers on antidepressants in Quebec doubled, from 21 users per 1,000 pregnancies in 1998 to 43 per 1,000 in 2009.

Those using the drugs tend to be older, live alone or be on welfare; they also may have other ailments such as diabetes, hypertension and asthma, the new study shows. The women generally don’t have the financial means, leisure time or support to seek other solutions, such as exercising regularly or consulting with a psychotherapist.

“There are a multitude of ways to get mild to moderate depression treated, but you need to have the time and money and also the encouragement to take advantage of them,” Bérard said.

“Given that an increasing number of women are diagnosed with depression during pregnancy, (the new) results have direct implications on their clinical management,” the study concludes.

“This is even more important given that the effectiveness of antidepressants during pregnancy for the treatment of the majority of cases of depression (mild to moderate depression) have been shown to be marginal.

“Hence, the need for caution with antidepressant use during pregnancy is warranted and alternative non-drug options should be considered.”

About this study

“Antidepressant use during pregnancy and the risk of major congenital malformations in a cohort of depressed pregnant women: An updated analysis of the Quebec Pregnancy Cohort,” by Anick Bérard, Jinping Zhao and Odile Sheehy, published in BMJ Open on January 12, 2017. doi:10.1136/bmjopen-2016-01337 Anick Bérard, PhD, is a professor at Université de Montréal’s Faculty of Pharmacy and a researcher at the CHU Sainte-Justine Research Centre.

This study was supported by the Canadian Institutes of Health Reseach (CIHR), and the Fonds de la recherche du Québec – Santé (FRQ-S).

Dr. Bérard is the recipient of a FRQ-S Research Chair on Medications and Pregnancy. She is a consultant for plaintiffs in litigations involving antidepressants and birth defects.

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After Science Day, Flouroquinolone Litigation Heads Toward Settlement

Peripheral neuropathy, a result of damage to your peripheral nerves, often causes weakness, numbness and pain, usually in your hands and feet.
Peripheral neuropathy, a result of damage to your peripheral nerves, often causes weakness, numbness and pain, usually in your hands and feet.

Opposing parties held a science day in Fluoroquinolone Products Liability Litigation on Jan. 17, one of the penultimate steps before a comprehensive settlement is reached in 713 actions against Bayer, Johnson & Johnson and its Janssen subsidiary.

Chief US District Judge John R. Tunheim in Minnesota, who is supervising MDL 2642, viewed Powerpoint presentations by the parties’ scientists, explaining the connection between the powerful fluoroquinolone antibacterial drugs (FLQs) — Cipro, Avelox and Levaquin — and peripheral neuropathy.

The nerve condition is irreversible and its symptoms include pain, burning, tingling, numbness, weakness, alterations of sensation affecting musculoskeletal, neuropsychiatric, sensory (e.g., vision or hearing), skin, and cardiovascular systems.

Admission of Liability

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.
John Ray has been a leading consultant to the Mass Tort industry for over a decade.

The MDL has steadily grown since it was created on August 17, 2015, when there were only 20 actions. An admission of liability by the defendants and other indications show that the cases are in the process of being settled. At the December 1, 2016 status conference, the parties asked the court to delay setting dates for bellwether trials so that they could seek a settlement.

FLQs are broad-spectrum synthetic antibacterial agents marketed and sold in oral tablet, IV solution, and ophthalmic solution, used to treat lung, sinus, skin, and urinary tract infections caused by certain germs called bacteria.

“The are trying to establish anything to mitigate damages,” said mass tort expert consultant John Ray. “I expect see a settlement based on a value based on the type of injury, mitigated by any any co-morbidity.”

  • Both the J&J and Bayer defendants have publicly acknowledged that FLQs can cause neuropathy. At the FDA’s joint advisory committee meeting in November 2015, Dr. Susan Nicholson, Vice-President of safety, surveillance, and risk management for the Johnson & Johnson, testified for all the defendants. She agreed that FLQs cause tendon ruptures, severe arrhythmia, and neuropathy.
  • The FDA issued a safety announcement on May 12, 2016, advising that “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.”  The FDA instructed that patients with these conditions should not be treated with a fluoroquinolone if alternative treatment options are available.
  • In an unusual expansion of liability, courts in California, Alabama, Illinois and Vermont have ruled that the brand-name manufacturers owe a duty of care to patients who took a generic version of an FLQ.

Defense strategy

“The defendants know they’re going to pay,” Ray said. “It’s a question of how much they’ll pay and how much they can get out of paying. They are giving individual cases more scrutiny.”

Illustrating this point, the plaintiff’s fact sheet, which is used instead of interrogatories, is double the usual length at 42 pages. It betrays that the defense strategy is to pick off cases one-by-one with fraud, statute of limitations and alternative cause defenses. It probes plaintiffs with questions in granular detail, including what Facebook groups a plaintiff belongs to. For example:

  • Have you every used a computer to look for information on the internet about any fluoroquinolone drugs?
  • Have you ever read or posted any weblogs (blogs), social networking sites (such as Facebook or LinkedIn), or message boards regarding any fluoroquinolone drugs.
  • Do you belong to any fluoroquinolone-related information or support groups, either online or elsewhere? (e.g. Floxie Hope; Facebook’s “Fluoroquinolone Antibiotic Toxicity Community;” Facebook’s “Fluoroquinolone Wall of Pain;” The Tropical Penguin Health Forum, etc.)
  • Please indicate whether your parents, siblings, children or grandparents have ever experienced to been diagnosed with peripheral neuropathy?
  • Were you ever given any written [or verbal] instructions, warnings or other information about any fluoroquinolone?”
  • Have you ever filed a lawsuit or made a claim relating to any bodily injury?
  • Have you been convicted of, or pled guilty to, a felony or a crime of fraud or dishonesty within the past ten years?
  • Have you ever been diagnosed with any of the following 47 conditions — starting with alcoholism to vascular disease.
  • Have you had any communications with your health care providers, orally or in writing, about whether your condition is related to your use of fluoroquinolones?

The case proceeds when the next status conference is held on February 21, 2017, at 2:00 p.m.

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Corrupt Congressman Invests in Zimmer Biomet, Then Sponsors Bill to Make Stock Price Go Up

Georgia Republican Congressman Tom Price
Georgia Republican Congressman Tom Price

According to CNN, Rep. Tom Price last year bought shares in a defective medical device manufacturer days before introducing legislation that would have directly benefited the company, raising new ethics concerns for President-elect Donald Trump’s nominee for Health and Human Services secretary.

Price bought between $1,001 to $15,000 worth of shares last March in Zimmer Biomet, according to House records reviewed by CNN.
Less than a week after the transaction, Price introduced the HIP Act, legislation that would have delayed until 2018 a Centers for Medicare and Medicaid Services regulation that industry analysts warned would significantly hurt Zimmer Biomet financially once fully implemented.
Zimmer Biomet, one of the world’s leading manufacturers of knee and hip implants, was one of two companies that would have been hit the hardest by the new CMS regulation that directly impacts the payments for such procedures, according to press reports and congressional sources.
Zimmer is facing nationwide litigation against it:
  • MDL 2158 Zimmer Durom Hip Cup Products Liability Litigation, where 463 cases are consolidated before U.S. District Judge Susan D. Wigenton in New Jersey. The plaintiffs charge the replacement hip was defectively designed or manufactured, and that Zimmer failed to provide adequate warnings about it.
  • MDL 2272 Zimmer NexGen Knee  Product Liability Litigation, where 501 cases are consolidated before U.S. District Judge Rebecca R. Pallmeyer in the Northern District of Illinois. Four cases have been scheduled for bellwether trials, where plaintiffs suffered loosening of the replacement knee or had to have it removed and replaced.

After Price offered his bill to provide Zimmer Biomet and other companies relief from the CMS regulation, the company’s political action committee donated to the congressman’s reelection campaign, records show.

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St. Jude Medical Recalls Implantable Cardioverter Defibrillators

Fortify Assura VR ICD, and a Quadra Assura CRT-D
Fortify Assura VR ICD, and a Quadra Assura CRT-D

St. Jude Medical Inc. on Tuesday said it would recall 400,000 implanted heart devices due to risk of premature battery depletion, a condition linked to two deaths in Europe. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

Recalled Products:

  • Fortify, Unify, and Assura Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
  • Model/Item Numbers: See “Full List of Affected Devices
  • Manufacturing Dates: January 2010 to May 2015
  • Distribution Dates: February 2010 to October 2016
  • Devices Recalled in the U.S.: 251,346 Nationwide

St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit.

If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.

Who May be Affected

  • Patients with a St. Jude Medical ICD or CRT-D device
  • Caregivers of patients with a St. Jude Medical ICD or CRT-D device
  • Health care providers treating patients with heart failure or heart rhythm problems using St. Jude Medical ICD or CRT-D devices

What to Do

On October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices.

Additionally, on October 11, 2016, the FDA issued a safety communication regarding this recall, and provided recommendations for health care providers, patients, and caregivers.

Full List of Affected Devices

  • Fortify VR: Model No(s). CD1231-40, CD1231-40Q
  • Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
  • Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
  • Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
  • Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
  • Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
  • Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
  • Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
  • Unify: Model No(s). CD3231-40, CD3231-40Q
  • Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
  • Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
  • Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
  • Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C

Contact Information

Customers with questions may contact St. Jude Medical Customer Service at: 1-866-915-5065.

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FDA Warning: Do Not Use PNC-27 for Treatment or Cure for Cancer

PNC 27 molecule
PNC 27 molecule

The FDA is warning consumers not to buy or use PNC-27, a product promoted and sold through http://PNC27.com, as a treatment or cure for cancer. An FDA laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation.

Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Consumers at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and people with weakened immune systems.

PNC-27 may be available in various dosage forms, such as a nebulized solution, intravenous solution, vaginal suppository, or rectal suppository. FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any form of cancer. The agency has not received reports of illnesses or serious adverse events related to PNC-27.

The FDA recommends patients with cancer discuss treatment options with a licensed health care professional. Patients who have used any PNC-27 product and have concerns should contact their health care provider as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The FAQ at the PNC-27 website says, “PNC-27 is a tiny, nontoxic protein molecule that attaches to specific receptors only found on cancer cells, causing them to die.

“PNC is a set of investigational proteins designed to attach to malformed cells and cause them to die via cell necrosis. PNC proteins were theorized, then created using a super computer in New York by Dr. Matthew Pincus and Dr. Joseph Michl of Suny Downstate Medical Center.

“PNC-28 was the first protein investigated, followed by its more effective counterpart, PNC-27. Multiple studies in laboratories and on humans have been successfully conducted. PNC is also the subject of several US Patents.”

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Plaintiff’s Executive Committee Named in California Essure Birth Control Litigation

Fidelma Fitzpatrick
Attorney Fidelma Fitzpatrick

California Superior Court Judge Winifred Y. Smith named the plaintiff’s executive committee in state litigation against Bayer in Essure Product Cases litigation, Judicial Council Coordinated Proceeding No. 4887.

Some 55 actions were consolidated in state court by some 900 women who alleged that they sustained injuries from Essure. The suits contend that the Bayer product, an FDA-approved medical device that has been on the market since 2002, caused a number of problems and physical injuries in thousands of women who have had the device implanted.

Plaintiffs’ Executive Committee

The court designated as Lead Counsel of the Executive Committee:

Fidelma Fitzpatrick
Motley Rice LLC
55 Cedar Street, Ste 1 00
Providence, RI 02903
Phone: (401) 457-7700
Fax: (401) 457-7708
E-mail: ffitzpatrick@motleyrice.com

As chair of the PEC, Fitzpatrick will lead a five-person Executive Committee, as well as two liaisons, in seeking compensation for alleged harms suffered by the women. The PEC is responsible for coordinating the activities on behalf of all Plaintiffs’ during all pretrial proceedings.

Thousands of women across the U.S. claim Essure  has caused serious and permanent injuries, including hundreds represented by Motley Rice. The FDA reports that more than 9,000 voluntary complaints have been submitted by women allegedly harmed by Essure. While Bayer has denied any wrongdoing, the FDA announced in February 2016 that it will require the company to conduct a clinical study and implement a patient decision checklist to make sure potential users of Essure understand the potential, serious risks implanting the device may cause. Additionally, in October 2016, the FDA added a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.

Reported Essure complications include life-threatening ectopic pregnancy, fetal death, migration of the device causing perforation or tear of pelvic organs, additional surgeries, including hysterectomy to remove the device and repair organs, and other severe side effects.

“We stand firm that our clients and all affected by Essure deserve to have their stories heard,” stated Fitzpatrick. “I welcome the opportunity to represent these women as lead, working closely with fellow members of the Plaintiffs’ Executive Committee, and will do all in my power to achieve justice on their behalf.”

The court also designated:

Erin Copeland
Fibich Leebron Copeland Briggs & Josephson
1150 Bissonnet Street
Houston, TX 77005
Phone: (713) 751-0025
Fax: (713) 751-0030
E-mail: ecopeland@fibichlaw.com

Kim Dougherty
Janet, Jenner & Suggs, LLC
31 St. James Ave., Suite 365
Boston, MA 02116
Phone: (617) 933-1265
E-mail: kdougherty@myadvocatcs.com

M. Elizabeth Graham (CA State Bar 143085)
Grant & Eisenhofer P.A.
10 I California Street
Suite 2710
San Francisco, CA 94111
Phone: 415-365-9585
E-mail: egraharn@gelaw.com

Edward A. Wallace
Wexler Wallace LLP
55 W. Monroe St., Suite 3300
Chicago, 11 60603
Phone: (312) 346-2222
Fax: (312) 346-0022
E-mail: eaw@wexlerwallace.com

Plaintiffs’ Co-Liaison Counsel

The court designated for the Plaintiffs’ Co-Liaison Counsel

William A. Kershaw
Kershaw, Cook & Talley
401 Watt A venue
Sacramento, CA 95846
Phone: (888) 997-5170
Fax: (916) 669-4499
E-mail: bill@kctlegal.com

M. Elizabeth Graham
Grant & Eisenhofer P.A.
101 California Street
Suite 2710
San Francisco, CA 94111
Phone: 415-365-9585
E-mail: egraharn@gelaw.com

Defendants’ Lead and Liaison Counsel

The court designated:

Alycia A. Degen,
Sidley Austin LLP
555 West Fifth Street, Suite 4000
Los Angeles, CA 90013
Telephone: (213) 896-6000
Facsimile; (213) 896-6600

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Federal Judge Joins Plaintiff Cases in Wright Profemur Hip Litigation

wright PROFEMUR-R1 hipAt the plaintiff’s request, US District Judge Christina A. Snyder in California combined two cases against Wright Medical Technology, Inc. in litigation over the defective Profemur Total Hip System. In both cases the hip implant broke during normal daily use.

The cases are Richard B. Sarafian and Kristin Biorn, new case No. 2:15-cv-07102-CAS, US District Court for the Central District of California in Los Angeles. The cases were already proceeding with joint discovery.

Separately, 575 hip implant lawsuits against Wright are pending in Georgia in MDL 2329 before U.S. District Judge William S. Duffey, Jr. IN RE: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

Recalled in 2015

The Profemur hip was designed in 1985 and has been implanted in more than 50,000 patients. Wright received a short-cut 501(k) FDA approval in 2000 to sell the device base on an earlier hip replacement. The FDA recalled the device in August 2015.

Sarafian had his left his replaced in 2012 and the implant’s neck broke 37 months later. Biorn had her left hip replaced in 2013 and it broke after 20 months. Both were performing the “normal and expected activity of daily living.” The revision surgeries were done as emergency procedures.

Wright objected to combining the cases, arguing that it would allow evidence in one case that may not have been allowed otherwise in the other. It also argued that having multiple plaintiffs would make it look inherently guilty.

Both actions appear to share common issues of fact and law,” the judge wrote. “On balance, plaintiffs have the stronger argument.”

Sarafian and Biorn are represented by Helen Zukin, Paul R. Kiesel, D. Bryan Garcia and Cherisse H. Cleofe of Kiesel Law LLP.

 

 

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Plaintiffs in DePuy Hip Cases Ask 5th Circuit to Hear Appeals Together

depuy-asr-hip-replacementEight successful plaintiffs in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation have called on the Fifth US Circuit Court of Appeals to consolidate all the appeals from two jointly-tried cases where juries found that the company knowingly sold a defective hip replacement.

Citing Fed. R. App. P. 3(b)(2) allowing appeals to be joined, the plaintiffs point out that the cases have the same MDL, defendants, lawyers, plaintiff injuries, evidence and witnesses. The appeals arise out of the second and third bellwether trials in MDL 2244 before US District Judge James Edgar Kinkeade in the Northern District of Texas. A total of 8,707 lawsuits are pending against DePuy in case No. 3:11-md-02244.

  • J&J prevailed in the first Pinnacle hip case to go to trial in October 2014.
  • In the second bellwether trial, a jury awarded $502 million to five of the patients in March 2016. The court cut the award to $150 million.
  • In the third bellwether trial, a jury awarded $1.04 billion in December 2016. The judge cut the punitive damages portion of the award in half.

The only difference is that the law of Texas governed the second trial, and the law of California governed the third.

Design flaws

The plaintiffs were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

The evidence demonstrated that:

(i) the Pinnacle Ultamet was defectively designed and marketed by Defendants.

(ii) Defendants failed to provide adequate warnings for the device.

(iii) Defendants failed to test the device in people before putting it on the market.

(iv) Defendants knew or should have known of the dangers of metal-on-metal hip implants.

(v) Defendants misrepresented or concealed material facts about the device.

(vi) Defendants polluted the scientific literature with fraudulent studies and biased doctors.

(vii) Defendants routinely used improper consulting agreements to induce orthopedic surgeons to use and market their products.

(viii) Defendants routinely prioritized marketing and sales over product safety.

The motion was filed by Kenneth W. Starr; The Lanier Law Firm, PC (W. Mark Lanier, Kevin Parker, M. Michelle Carreras); Fisher, Boyd, Johnson & Huguenard, LLP (Wayne Fisher, Justin Presnal); Neblett, Beard & Arsenault (Richard J. Arsenault, Jennifer M. Hoekstra); Simmons Hanly Conroy (Jayne Conroy, Andrea Bierstein), counsel for Plaintiffs-Appellees.

 

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