Philadelphia Jury Awards $20 Million against Johnson & Johnson in Vaginal Mesh Case

Tension-free vaginal tape (TVT)
Tension-free vaginal tape (TVT)

A Philadelphia Court of Common Pleas jury returned a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after receiving a vaginal mesh device.

The verdict was the third consecutive eight-figure award against J&J in a mesh case in the Philadelphia courts.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—was recovered by Peggy Engleman, 56, of Cinnaminson, PA. She charged that the Ethicon TVT-Secur medical device was defective and that the company failed to warn of its risks, and continued to market the device while they knew about the damage it caused to patients.

In related litigation:

Polypropylene mesh erodes

Doctors implanted the device into Engleman in 2007 to relieve stress urinary incontinence, a leakage caused by exercise or coughing. But within a month the TVT-Secur failed and Engleman’s stress urinary incontinence returned.

She began to suffer pain and discomfort when the polypropylene mesh started to erode inside her body. Doctors were unable to remove it all even after three more surgeries. As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

The TVT-Secur vaginal mesh product was introduced in September 2006 but J&J had already had many reports of high failure rates from countries all over the world.

“This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated,” lead plaintiff’s counsel Benjamin Anderson told Fox 29.

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Zofran Fraud Claims Can Proceed against GSK

Plaintiff attorney Tobias L. Millrood of Pogust Braslow & Millrood LLC.
Plaintiff attorney Tobias L. Millrood of Pogust Braslow & Millrood LLC.

US District Judge F. Dennis Saylor IV shot down a defense motion and allowed fraud claims filed by 365 plaintiffs to proceed, charging that manufacturer GlaxoSmithKline (GSK) marketed Zofran to pregnant women, knowing it would cause birth defects.

The judge is overseeing litigation in  In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.

“[b]ecause plaintiffs adequately pleaded the content, time, and place of the allegedly false representations made in Zofran’s product labeling, the fraud-based claims premised on that misrepresentation satisfy the requirements of Rule 9(b),” the judge said. “Whether those representations were actually false is, of course, a question for another day.”

See Zofran Memorandum And Order On Defendant’s Motion To Dismiss Fraud-based Claims

There are three categories of alleged misrepresentations in this case.

  • The first category consists of statements allegedly made by GSK in its advertising, marketing, and promotional materials—in other words, statements made generally to the marketplace.
  • The second category consists of specific statements made by GSK representatives to prescribing physicians, including statements made by sales representatives to physicians, or specific written materials provided to individual physicians.
  • The third category consists of statements made in Zofran’s product labeling.

Serotonin receptor antagonist

The allegations are in either the master complaints or the individual short-form complaints. The plaintiffs are represented by Tobias L. Millrood of Pogust Braslow & Millrood LLC, Kimberly D. Barone Baden of Motley Rice LLC, M. Elizabeth Graham of Grant & Eisenhofer PA, and Robert K. Jenner of Janet Jenner & Suggs LLC and and Kimberly Dougherty of Andrus Wagstaff.

Zofran is an anti-emetic referred to as selective serotonin 5-HT3 receptor antagonists. Serotonin signaling in the body triggers nausea and vomiting. The active ingredient in Zofran, ondansetron, is believed to alleviate symptoms of nausea and vomiting by inhibiting the body’s serotonin signaling.

Serotonin signaling regulates developmental processes that are critical to normal embryonic development. Inhibiting serotonin signaling during embryonic development can therefore increase the risk of birth defects.   According to the complaint, pre-clinical studies conducted by or on behalf of GSK in the 1980s revealed that Zofran ingested by mammals—in particular, rats and rabbits—during pregnancy crosses the placental barrier, exposing the fetus to the drug. The complaint alleges that subsequent scientific research has confirmed that Zofran also crosses the placental barrier during human pregnancies.

According to the complaint, animal studies conducted by or on behalf of GSK in the 1980s in Japan revealed clinical signs of toxicity, intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defects, impairment of ossification (incomplete bone growth), and other malformations in fetuses exposed to Zofran during gestation. The complaint also alleges that from 1992 to the present, GSK has received reports—either directly or through studies published in medical literature—of birth defects in children exposed to Zofran or ondansetron during pregnancy.

GSK marketing scheme

Around 1997, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare practitioners and consumers as a safe and effective treatment for pregnancy-related nausea and vomiting.

According to the complaint, “[a]s a result of GSK’s fraudulent marketing campaign,” by 2002 Zofran had become the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States.

Since 1993, the prescribing information for Zofran has included the following statement about its use during pregnancy:

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses of up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

The complaint alleges that “[t]his statement is false and misleading because animal studies conducted by or on behalf of GSK outside of the United States have in fact revealed evidence of teratogenic effects due to ondansetron.”  It further alleges that the statement is false and misleading “because [d]efendants failed to conduct post-market studies that were properly designed to identify Zofran’s true teratogenic risk.”

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U.S. Invokana Sales Slide As Injury Lawsuits Mount

By Sandy Liebhard

Johnson & Johnson continues to face legal challenges over Invokana. In addition to slowing U.S. sales, the Type 2 diabetes drug continues to be the subject of a growing product liability litigation involving diabetic ketoacidosis and other side effects allegedly associated with its use.

According to Johnson & Johnson’s most recent earnings report, U.S. sales of Invokana fell by $50 million (16.8%) during the first quarter of 2017, to $270 million. However, sales were up 32% in international markets, to $37 million.

Invokana Side Effects

Brought to market in March 2013, Invokana was the first SGLT2 inhibitor approved in the U.S. to treat Type 2 diabetes. Johnson & Johnson also markets a sister diabetes medication called Invokamet, which also contains metformin.  These drugs work by preventing the absorption of glucose by the kidneys, resulting in its elimination from the body via urine.

Since Invokana’s approval, SGLT 2 inhibitors have been the subject of several of U.S. Food & Drug Administration (FDA) safety alerts:

  • September 2015: The agency announced that the labels for Invokana and Invokamet would be updated to include information about a possible increased risk of bone fractures.
  • December 2015: New warnings about diabetic ketoacidosis and serious urinary tract infections were added to the labels of all SGLT2 inhibitors, including Invokana and Invokamet.
  • May 2016: The FDA announced it was investigating a possible link between Invokana, Invokamet and an increased risk of lower limb amputations (mostly involving the toes).
  • June 2016. Kidney warnings already included on the labels of Invokana, Invokamet, Farxiga and Xigduo XR were strengthened after the drugs were linked to more than 100 reports of acute kidney injury.

Invokana Litigation

More than 230 Invokana lawsuits have been centralized in federal multidistrict litigation now underway in the U.S. District Court, District of New Jersey. All of the pending cases were filed by people who allegedly developed diabetic ketoacidosis, kidney damage and other serious complications due to treatment with Invokana or Invokamet.

US District Judge Brian R. Martinotti will convene “Science Day” on May 21. This event will give the parties the opportunity to inform the Court of the medical and scientific issues central to Invokana and Invokamet lawsuits in a non-adversarial and off-the-record setting.

The Court has also indicated its intention to begin bellwether trials in September 2018. These trials will act as test cases, and could provide insight into how juries might decide similar Invokamet and Invokana lawsuits in the future.


Sandy A. Liebhard, a founding partner at Bernstein Liebhard LLP, has represented plaintiffs in complex litigation for more than 20 years. As an author for RXInuryHelp.com, Mr. Liebhard has written extensively on the litigation involving proton pump inhibitors (Nexium, Prilosec, PrevAcid, etc.) and kidney injuries; Risperdal and gynecomastia; the Bair Hugger forced-air warming blanket; talcum powder and ovarian cancer; transvaginal mesh; power morcellators; defective hip implants; and more.

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FDA Warns about Fradulent Cancer Cures

Cevrogin is promoted with unapproved claims to treat or cure various types of cancer.

The FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.

It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.

The illegally sold products cited in the warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims about preventing, reversing or curing cancer, killing/inhibiting cancer cells or tumors, or other similar anti-cancer claims. 

The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.

Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment. Avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult with their healthcare professional about proper prevention, diagnosis, and treatment of cancer.

Warning and Online Advisory Letters

Company Name Cancer Product Name and Image
Warning Letters
AIE Pharmaceuticals, Inc. Cevrogindisclaimer icon, Cholestrien, ImmunProdisclaimer icon, and Livral Complex
Amazing Sour Sop, Inc. Sour Sop Capsulesdisclaimer icon, Sour Sop Leavesdisclaimer icon, and Sour Sop Tea Bagsdisclaimer icon
BioStar Technology International, LLC Angiostop, Ashwagandha, Asparagus Extract, OliveLeafQi, and Revivin
Caudill Seed & Warehouse Inc. Vitalicadisclaimer icon
DoctorVicks.com Freeda Vitamins – Garlic 400 mg, Freeda Vitamins – Quercetin 50 mg, Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg, Maxi Health – Livamax with Milk Thistle, Maxi Health – Maxi Omega-3 2000, Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU, and Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula
Everything Herbs Cleavers, Inkberry, Korean Ginseng, Lapachodisclaimer icon, Red Clover, and Whole Apricot
Hawk Dok Natural Salve, LLC Skin Cancer Treatmentdisclaimer icon, and Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores
Healing Within Products & Services, Inc. Astragalus Glycerite, Black Salve, Healthy Prostate & Ovary, Original Herbal Tea Remedy, ProBoost Thymic Protein A, and Siberian Chaga Mushroom Extract
LifeVantage Corporation Protandim NRF2 Synergizerdisclaimer icon
Nature’s Treasure, Inc. Colostrum LD® Capsules, Dysbiocide, KR22 Oxicelldisclaimer icon, and Matcha Tea
Oxygen Health Systems, LLC Graviola, Graviola Max, Liposomal Complete Complex Plus, Liposomal Curcumin, Liposomal Vitamin B17 Amygdalin, Liposomal Vitamin C, Palladium Lipoic Complex, Premium Flax, Rerum Bluedisclaimer icon, and Super Liposomal Plus
Sunstone, Inc. Chelated Boron, Circulatory Detox & Support Syrup, Essiac Tea, Fermented Yeast Culture, Premium Organic, 8 oz., Virxcan-X Salvedisclaimer icon, and Virxcan-X Tablets
The Vibrant Health Store, LLC dba Dr. Christopher’s Herbs Black Drawing Ointment, Burdock Root, Kid-e-Trac, Liver D-Tox Formula, Rash Ointment, Red Clover Blossoms, Relax-Eze, and St. John’s Wort
The Vitamin C Foundation Cardio-C, Chewables Vitamin C, Sodium Ascorbate, True Liposomal Vitamin C, and World’s Finest Vitamin C Powder
Online Advisory Letters
CellMark Biopharma LLC CellAssure
Landis Revin, LLC Trevinol ES Fibrin Defense Systemic Enzyme, Trevinol ES Health Joint & Inflammation Support, Trevinol Professional Blend
Nathans Natural Levodyn
www.healinginabottle.com Immuno Boost Eximiusdisclaimer icon

 

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J&J Trial: “Medical and Scientific Certainty” that Talc Caused Cancer

Johnson & Johnson has known about cancer risks since the 1970s.
Johnson & Johnson has known about cancer risks since the 1970s.

A Harvard epidemiologist told a Missouri jury Monday that he has reached “medical and scientific certainty” that a woman’s daily use of Johnson & Johnson’s talcum powder products for four decades was the primary reason she developed ovarian tumors, according to Law360.

During the 10th day of the trial in St. Louis, plaintiff Lois Slemp called to the stand epidemiologist and gynecologist Dr. Daniel Cramer. Slemp’s is the fifth case over the alleged link between J&J’s talcum powder products and ovarian cancer to head to trial in the city. J&J’s talc supplier, Imerys Talc America Inc., is a co-defendant.

Click to read the full article on Law360.

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European Agency Warns of Toe Amputations Caused by Invokana, Farxiga and Xigduo

The European Medicines Agency (EMA) reported that a potential increased risk of lower limb amputation (mostly affecting the toes) exists in patients taking the SGLT2 inhibitors canagliflozin (Invokana), dapagliflozin (Farxiga and Xigduo) and empagliflozin (Jardiance) used for type 2 diabetes.

The review of SGLT2 inhibitors was prompted by an increase in lower limb amputations (mostly affecting the toes) in patients taking canagliflozin in two clinical trials, CANVAS and CANVAS-R. The studies, which are still ongoing, involved patients at high risk of heart problems and compared canagliflozin with placebo.

Some 230 lawsuits against the makers of Invokana are centralized before US District Judge Brian R. Martinotti in New Jersey in MDL 2750, IN RE: Invokana (Canagliflozin) Products Liability Litigation.

About 20 lawsuits against the makers of Farxiga are centralized before US District Judge Lorna G. Schofield in the Southern District of New York in MDL 2776, IN RE: Farxiga (Dapagliflozin) Products Liability Litigation.

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.

Increased risk of toe amputation

All patients with diabetes (especially those with poorly controlled diabetes and problems with the heart and blood vessels) are at higher risk of infection and ulcers (sores) which can lead to amputations. The mechanism by which canagliflozin may increase the risk of amputation is still unclear.

An increase in lower limb amputations has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines.

Further data are expected from ongoing studies with canagliflozin, dapagliflozin and empagliflozin.

A warning of the potential increased risk of toe amputation will be included in the prescribing information for these medicines. For canagliflozin, the prescribing information will also list lower limb amputation as an uncommon side effect (occurring in between 1 and 10 patients in 1,000). Doctors may consider stopping treatment with canagliflozin if patients develop significant foot complications such as infection or skin ulcers.

The review of SGLT2 inhibitors was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC recommendations have now been endorsed by the Committee for Medicinal Products for Human Use (CHMP), and will be sent to the European Commission for a final legally-binding decision valid throughout the EU.

Symptoms

  • The diabetes medicine canagliflozin may increase the risk of lower limb amputation (mostly affecting the toes).
  • The risk of lower limb amputation with canagliflozin may also apply to other diabetes medicines in the same class, dapagliflozin and empagliflozin.
  • All patients with diabetes are at increased risk of infection and sores which can lead to amputations. It is not known how canagliflozin may increase the risk of toe amputation.
  • If you are taking medicines containing canagliflozin, dapagliflozin and empagliflozin to treat your type 2 diabetes, it is particularly important that you check your feet regularly and follow your doctor’s advice on routine preventative foot care and adequate hydration.
  • Tell your doctor about any wounds or discoloration, or if your feet are tender or painful.
  • If you have any questions or concerns about your treatment, speak to your doctor, pharmacist or nurse.

SGLT2 Inhibitor and Diabetic Ketoacidosis

Invokana, Jardiance, Farxiga and other SGLT2 inhibitors are approved to lower blood sugar in patients with Type 2 diabetes. In May 2015, the FDA announced that it was investigating 20 reports of diabetic ketoacidosis that had occurred in people taking SGLT2 inhibitors. While some patients had been using the medications to treat Type 1 diabetes (an off-label use), a number of the ketoacidosis reports involved patients undergoing treatment for Type 2 diabetes. While ketoacidosis is often associated with Type 1 diabetes, it is unusual in patient with Type 2.

On December 4th, the FDA announced that new information about a potential association with diabetic ketoacidosis would be included on the labels for Invokana and other SGLT2 inhibitors. The alert indicated that from March 2013 to May 2015, the FDA had identified 73 cases of ketoacidosis in patients with Type 1 or Type 2 diabetes treated with SGLT2 inhibitors.

Diabetic ketoacidosis occurs when dangerous levels of toxic acids called ketone accumulate in the body. The condition can lead to hospitalization, diabetic coma and even death. “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing,” the FDA said in its December 4th communication.

Patients who used Invokana or another SGLT2 inhbitor may be entitled to compensation if they were hospitalized with ketoacidosis while undergoing treatment.

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JAMA Study: Xarelto Causes More Bleeding Than Pradaxa

In a new-user cohort study of 118,891 patients, rivaroxaban (Xarelto) treatment was associated with greatly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding.

In this observational study published in JAMA Internal Medicine, Xarelto use was associated with increased intracranial and major extracranial bleeding events compared with Pradaxa use.

Plaintiffs have filed 16,285 lawsuits in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana. As a bellwether trial is underway in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.

Xarelto and Pradaxa are non–vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes.

Pradaxa settlement

German drug maker Boehringer Ingelheim settled 4,590 cases involving Pradaxa (Dabigatran) for a total of $650 million in May 2014. Patients and their families claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed.

The average case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.

The JAMA study compared risks of thromboembolic stroke, intracranial hemorrhage intracranial hemorrhage, major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran (Pradaxa) or rivaroxaban treatment for stroke prevention.

The study found that treatment with Xarelto 20 mg once daily was associated with statistically significant increases in intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, compared with Pradaxa 150 mg twice daily.

The researchers also noted that, in 2014, rivaroxaban was prescribed two to three times more often than Pradaxa for AFib patients in the U.S., and they said that may be due to doctors falsely believing that Xarelto posed less risk of major bleeding events than Pradaxa.

Uncontrollable bleeding

The lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding in some people. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks.

The first bellwether trial involves a Louisiana man with atrial fibrillation, who took Xarelto and suffered life-threatening gastrointestinal bleeding.  Joseph Boudreaux Jr. took Xarelto for just under one month in 2014 before he was hospitalized for severe internal bleeding, according to the lawsuit. Boudreaux, Jr. et al v. Janssen Research & Development LLC et al (2:14-cv-02720)

He needed several blood transfusions and was hospitalized for five days as a result of his Xarelto bleeding episode. He then required follow-up medical treatment following his stay in the hospital.

Boudreaux filed a Xarelto lawsuit against Janssen and Bayer in December 2014, accusing the two manufacturers of concealing their knowledge of Xarelto’s defects from physicians and patients like himself.

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Holding Brand Name Drug Makers Liable for Generic Versions

Today, nearly 8 in 10 prescriptions filled in the US are for generic drugs, according to the FDA. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.

But who is liable when a generic drug makes sells a bioequivalent drug to a patient who suffers a personal injury from taking it?

Two US Supreme Court cases insulate the generic makers from responsibility, so long as they included the branded drug maker’s warnings. But now courts in California, Vermont, and Illinois have accepted the notion of “innovator liability,” imposing liability on the branded drug maker for injuries caused by a generic drug equivalent.

Research shows that generics work just as well as brand-name drugs. A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. See JAMA. 2008;300(21)2514-2526.

The FDA says that any generic drug modeled after a single, brand name drug must perform about the same in the body as the brand-name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

Immunizing generic drug makers

California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

Two notorious US Supreme Courts rulings have immunized generic drug makers from liability in product liability and failure to warn claims.

  • PLIVA, Inc. v. Mensing, 564 U.S. 604  (2011), holds that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claim alleging a failure to provide adequate warning labels.
  • Mutual Pharmaceutical Co. v. Bartlett, 570 US 2468 (2013), holds that generic drug manufacturers cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.

However, in California, Vermont, and Illinois, these rulings did not protect branded manufacturers from innovator liability claims, because the companies controlled the text of the warning labels.

Plaintiffs argue that the physicians “reasonably and foreseeably” relied on the representations of branded manufacturers when prescribing a generic drug, because physicians understood that generics are bioequivalent to and have the same labeling as branded drugs.

In the event that the branded manufacturer made misrepresentations or engaged in other unlawful activities such as “off-label” marketing, plaintiffs further argue that physicians relied on the branded manufacturers’ misrepresentations, understood that generics are bioequivalent to the branded product, and prescribed the generic based on the branded manufacturers misrepresentations.  

Innovator liability

Only California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

California

Conte v. Wyeth, 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (2008), involved a user of generic metoclopramide who brought an action against Wyeth, the manufacturer of Reglan, the name-brand form of metoclopramide, for fraud, fraud by concealment, and negligent misrepresentation.

The court of appeals held that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent.

In T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), the court of appeals imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.

Note: This decision is currently under appeal. If Novartis wins this appeal Conte would not be overturned, innovator liability would simply end at the point (if) the brand manufacturer discontinued the marketing of the brand drug.

Vermont

Vermont chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010). The plaintiff filed suit against the brand name and generic manufacturers of metoclopramide for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment.  

A federal court interpreted state law, imposing a duty on Wyeth because it was “fair” to do so, and there is no reason, under Vermont law, to limit defendant’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent.

Illinois

Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, was a wrongful death action against SmithKline Beecham Corporation involving a man who committed suicide after taking paroxetine, the generic version of Paxil.

A federal court interpreted Illinois law to impose a duty of reasonable conduct upon GSK. The plaintiff’s common law negligence and negligent misrepresentation claims survived summary judgment.

Note: Under Illinois law a product liability claim under an innovator liability theory would likely fail where as a negligence claim would survive.

Innovator Liability and Zofran

In an unusual move, Judge Dennis Sailor presiding over MDL 2657, has approved two master complaints, one for branded drug use and a separate Master Complaint for plaintiffs that wish to pursue GSK under innovator liability theories.

Judge Sailor is overseeing 364 lawsuits in MDL 2657 in federal court in Massachusetts, IN RE: Zofran (Ondansetron) Products Liability Litigation.

The most significant difference in the Zofran Brand Master Complaint and the Zofran Generic Master Complaint is in paragraph 101 of the generic master complaint:

101. Defendants knew or should have known that consumers such as Plaintiffs would foreseeably use the generic bioequivalent of Zofran and rely upon representations and omissions of Defendants as the holders of the NDA for Zofran.

Although the Master Complaint does not contain language that limits its use to claims governed by the laws of the three “innovator liability states,” the defense is free to argue these claims based on the laws of the state of original jurisdiction.  For states that do not have settled caselaw related to innovator liability, it is likely that the defense will prevail in most cases.  

Mensing and Bartlett both turned on an “impossibility preemption argument,” in that is not possible for a generic manufacturer to legally alter the warning label. The generic label most conform exactly to brand label.

What if the brand drug manufacturer also makes a generic version of its own drug?  Obviously, the brand manufacturer would control both the brand label as well as the generic label under this circumstance and the impossibility preemption reasoning of Mensing and Bartlett would not apply.

Novartis purchased GlaxoSmithKline’s oncology division in March of 2015. Along with Glaxo’s cancer business came the right to sell Zofran. Novartis also owns Sandoz, which manufacturers a generic version of Zofran. Therefore there is a strong argument that Mensing and Bartlett do not provide protection for Zofran Generics made by Sandoz after May 2015.

 

 

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Taxotere Judge Sets Science Day

US District Judge Kurt D. Engelhardt ordered the parties in Taxotere litigation in MDL 2740, where 949 cases are filed in the Eastern District of Louisiana, charging that the chemotherapy drug caused disfiguring, permanent and total hair loss among patients.

Defendants include Sanofi S.A., Aventis Pharma S.A., Sanofi US Services Inc. f/k/a Sanofi-Aventis U.S. Inc., and Sanofi-Aventis U.S. LLC.

“Science Days” have become a tradition in mass tort litigation. In the last few years, there is a Science Day somewhere, in some courtroom, going on.  Trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them.

Taxotere and Hair Loss

A total of 799 Taxotere lawsuits have been filed by plaintiffs who experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

In other orders, the judge:

  • Scheduled a follow-up meeting with the settlement committees on May 12, 2017, after the conclusion of the general status conference scheduled for this date.
  • Approved an exemplar Short Form Complaint to use when filing new cases.

The plaintiffs’ Plaintiffs’ Co-Liaison Counsel are:

  • Dawn M. Barrios of Barrios, Kingsdorf & Casteix, New Orleans, LA.
  • Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, New Orleans, LA.

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Hearing Set for MDL in Ethicon Physiomesh Hernia Repair Product Litigation

The Judicial Panel on Multidistrict Litigation will hold a hearing on May 25, 2017 on a plaintiffs’ motion to create a new MDL No. 2782 for Physiomesh Flexible Composite hernia mesh litigation against Ethicon and Johnson & Johnson.

The hearing will take place in the John H. Wood, Jr. United States Courthouse Courtroom in San Antonio, Texas.

More than 330,000 Physiomesh devices have been sold worldwide, and the plaintiffs believe about 50% of those products were sold in the United States. It is expected that hundreds of additional cases will be filed in the near future.

So far, 18 actions are pending in 9 federal district courts.

Unique 5-layer design

Physiomesh is a synthetic mesh hernia repair device is an implantable synthetic surgical mesh product sold for use in hernia repair implanted through laparoscopic herniorrhaphy.

Physiomesh has a unique design incorporating five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design has never been used in any other hernia repair product sold anywhere in the world.

The multi-layer coating was promoted by the defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation and fixation of the mesh into the abdomen. However, the plaintiffs intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications.

Additional surgeries needed

In addition, the polypropylene mesh portion of the Physiomesh was insufficient to withstand normal abdominal forces, which often resulted in herniation through the mesh itself, recurrent hernia formation and/or rupture and deformation of the mesh itself. The defendants ultimately voluntarily withdrew the Physiomesh device from the market in May 2016, which the plaintiffs intend to establish was a direct consequence of the frequency and severity of the complications experienced with this product worldwide.

The lawsuits charge that the devices implanted in their bodies were defectively designed or manufactured, and that the defendants failed to provide appropriate warnings and instructions regarding the dangers posed by these devices. The plaintiffs suffered serious and often permanent physical injuries from the implantation of the Physiomesh, often requiring additional surgeries, additional medical expenses, and unresolved medical complications. Where applicable, these implant plaintiffs’ spouses have alleged claims for loss of consortium.

The Judicial Panel on Multidistrict Litigation has previously created MDLs for similar implantable surgical mesh devices:

  • In re Protegen Sling and Vesica Systems Prods. Liab. Litig., MDL No. 1387 (J.P.M.L. 2001)
  • In re Kugel Mesh Hernia Patch Litigation, 493 F.Supp.2d 137, MDL No. 1842 (J.P.M.L. 2007)
  • In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 588 F. Supp. 2d 1374, MDL No. 2004 (J.P.M.L. 2008)
  • In re Avaulta Pelvic Support Sys. Prods. Liab. Litig., MDL No. 2187 (J.P.M.L. 2010)
  • In re American Medical Systems, Inc., et al., Pelvic Repair Systems Prods. Liab. Litig., 844 F.Supp.2d 1359, MDLs Nos. 2325, 2326, 2327 (J.P.M.L. 2012) (3 separate pelvic mesh MDLs)
  • In re Coloplast Corp. Pelvic Repair Support Sys. Prods. Liab. Litig., 883 F.Supp.2d 1348, MDL 2387 (J.P.M.L. 2012)
  • In re Cook Medical, Inc., Pelvic Repair Sys. Prods. Liab. Litig., 949 F.Supp.2d 1373, MDL 2440 (J.P.M.L. 2013)
  • In re Neomedic Pelvic Repair Sys. Prods. Liab. Litig., 999 F.Supp.2d, MDL 2511 (J.P.M.L. 2014)
  • In re Atrium Medical Corp. C-Qur Mesh Prods. Liab. Litig., MDL 2753 (J.P.M.L.2016).

Recommended judges

If the Panel transfers the cases to the Middle District of Florida, the plaintiffs recommended Judges Paul G. Byron, James D. Whittemore and Susan C. Bucklew. In the Southern District of Illinois, the plaintiffs recommended Judge David R. Herndon who is presiding over two MDLs, In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Prods. Liab. Litig., MDL 2100, and In re Pradaxa (Dabigatran Etexilate) PL, MDL 2385.

In the Praxada MDL, Judge Herndon helped to facilitate a global settlement of over 2,600 constituent cases in under 22 months. Judge Herndon managed this settlement quickly and efficiently. Similarly, in the Yaz MDL which involved nearly 12,000 cases, Judge Herndon facilitated a mass settlement initiative in under 27 months.

The plaintiffs’ attorneys include:

  • Henry G. Garrard, III, James B. Matthews and Josh B. Wages of  Blasingame, Burch, Garrard & Ashley, in Athens, GA.
  • Douglas A. Kreis, Bryan F. Aylstock, and Daniel Thornburgh D. Thornburgh of Aylstock, Witkin, Kreis & Overholtz in Pensacola, FL.
  • Donald A. Migliori of Motley Rice in Mount Pleasant, SC.
  • Jonathan D. Orent of Motley Rice LLC in Providence, RI.
  • Joseph A. Osborne of Osborne & Associates Law Firm in Boca Raton, FL.

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