Transvaginal Mesh Lawsuit Plaintiff Recovers $2.1 Million, as Johnson & Johnson Loses 4th Pennsylvania Trial

Ethicon polypropylene pelvic mesh
Ethicon polypropylene pelvic mesh

A Pennsylvania jury awarded $2.1 million to a woman who suffered serious complications after Ethicon, Inc.’s Gynecare Prolift mesh deteriorated in her body.

The May 26 verdict in the Philadelphia Court of Common Pleas, marks the fourth consecutive defeat for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)

“Thousands of women across the country, including many of our own clients, are pursuing similar pelvic mesh claims against Johnson & Johnson and Ethicon. We are pleased with the jury’s finding, and will continue to monitor upcoming trials,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

J&J TVM litigation

This latest trial involved a woman who was implanted with Prolift mesh in 2006 to treat stress urinary incontinence and pelvic organ prolapse. According to her complaint, erosion of the mesh into her vagina and bladder resulted in permanent complications, including constant pelvic pain, incontinence, urinary tract infections, and severe pain with sexual intercourse. The jury deliberated for just nine hours before delivering its decision last Friday.

Last week’s verdict came just a month after another Pennsylvania jury ordered Johnson & Johnson and Ethicon to pay $20 million in punitive and compensatory damages to a woman who suffered complications related to Ethicon’s Gynecare TVT-Secur implant. Philadelphia juries have awarded $12.5 million and $13.5 million to two other transvaginal mesh plaintiffs.

Transvaginal mesh lawsuits involving Johnson & Johnson and other device makers began to mount in U.S. courts following issuance of a 2008 U.S. Food & Drug Administration (FDA) alert warning that the devices had been linked to at least 1,000 reports of serious injuries over a three year period. The agency updated its warning July 2011, after the number of reported transvaginal mesh complications related to prolapse repair tripled. Among other things, the FDA modified its previous stance that such injuries were rare.

In 2012, Ethicon announced it would stop selling four pelvic mesh devices, including Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M. The company attributed its decision to commercial concerns and maintained that the products were safe. However, the FDA had recently ordered Ethicon and 20 other vaginal mesh manufacturers to conduct further research into the risks associated with their implants.

 

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Corporate Defendants Win in Supreme Court Ruling on Jurisdiction for Out-of-State Plaintiffs

Reversing the Montana Supreme Court, the US Supreme Court decided BNSF Railway Co. v. Tyrrell, No. 16-405, on May 30, 2017, holding that a state court cannot assert jurisdiction over claims made by nonresident plaintiffs who were injured while working outside the state.

The US Supreme Court sided with defendant BNSF Railway Co., saying that such lawsuits must be filed in the state where the employee is “at home” — where it is incorporated or headquartered.

The justices ruled that §56 of the Federal Employers’ Liability Act (FELA) does not address personal jurisdiction and thus limiting the courts in which a railroad is subject to suit.

Daimler ruling applies

Importantly, the Court ruled that state courts must follow its 2014 ruling in Daimler AG v. Bauman, 134 S. Ct. 746, that the due process clause forbids a state court from exercising general personal jurisdiction. This broad interpretation affects another appeal filed by Bristol-Meyers Squibb, which desperately wants the US Supreme Court to reverse the California Supreme Court court, and to apply the Daimler rulingwhich states may take “general jurisdiction” only over companies that are “at home” in the state.

“Daimler involved no FELA claim or railroad defendant, but the due process constraint described there applies to all state-court assertions of general jurisdiction over nonresident defendants; that constraint does not vary with the type of claim asserted or business enterprise sued. Here, BNSF is not incorporated or headquartered in Montana and its activity there is not ‘so substantial and of such a nature as to render the corporation at home in that State,’” the Court ruled. (Emphasis added.)

Whether a court can take personal jurisdiction is a frequent legal issue in mass tort litigation. See GSK Asks Supreme Court to Let it Wriggle Out of Jurisdiction in Paxil Birth Defect Case and
US Supreme Court to Rule on California State Jurisdiction Over Plavix Litigation

Under FELA, railroads are liable to employees for injuries they suffer on the job. In this case, plaintiffs who lived outside Montana and had suffered injuries outside Montana sued BNSF Railway Company in Montana under FELA. BNSF did business in Montana but was incorporated and had its principal place of business elsewhere.

Because the railroad has 2,000 miles of track and more than 2,000 employees in the state, the Montana Supreme Court upheld personal jurisdiction over BNSF under FELA §56, which states that a cause of action may be brought in a district “in which the defendant shall be doing business at the time of commencing such action” and further provides that the jurisdiction of the federal courts is concurrent with that of the state courts.

Principles of personal jurisdiction

The Supreme Court held that §56 does not address personal jurisdiction but rather is a venue provision that also clarifies that state courts have subject matter jurisdiction over FELA claims. Therefore, Section 56 alone did not establish a basis to summon BNSF into court in Montana.

Turning to ordinary principles of personal jurisdiction, the Court reasserted the holdings in Daimler AG v. Bauman, and Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011), that courts may assert general jurisdiction over corporations only when they are essentially “at home” in the forum state.

Rejecting the Montana Supreme Court’s suggestion that Daimler was distinguishable from this case involving a FELA claim against a railroad, the Court emphasized that “[t]he Fourteenth Amendment due process constraint described in Daimler . . . applies to all state-court assertions of general jurisdiction over nonresident defendants; the constraint does not vary with the type of claim asserted or business enterprise sued.”

Because BNSF was not incorporated in Montana and did not maintain its principal place of business there, it was not subject to general personal jurisdiction in Montana. The Court said BNSF’s presence and activities in Montana do not support personal jurisdiction for unrelated claims like those of the plaintiffs, which had “no relationship to anything that occurred or had its principal impact in Montana.”

Justice Ginsburg delivered the opinion of the Court, joined by Chief Justice Roberts and Justices Kennedy, Thomas, Breyer, Alito, Kagan, and Gorsuch. Justice Sotomayor filed an opinion concurring in part and dissenting in part.

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Jury Selection Starts Today for Second Xarelto Bellwether Trial

By Joseph VanZandt.

The second bellwether trial involving bleeding risks with the blood thinner Xarelto is slated to begin today. The trial is part of the multidistrict litigation (MDL) pending in the United States District Court for the Eastern District for Louisiana before Judge Eldon Fallon.

The Jere Beasley Report explains that Xarelto is an anticoagulant (blood thinner) initially approved in 2011 to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) following knee and hip replacement surgery. It was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation (A-fib) and for treatment of DVT and PE. Xarelto carries a significant risk of severe, uncontrolled internal bleeding and has been linked to bleeding-related deaths.

The second trial involves Joseph Orr, Jr., a Louisiana resident, who filed suit on behalf of his deceased wife, Sharyn Orr. Mrs. Orr suffered a fatal brain bleed while taking Xarelto. She was 67 years old at the time of her death and had been taking the drug to treat A-fib for just over a year when she suddenly become severely ill.

Mrs. Orr was transported to the hospital where a CT scan of her head revealed she was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke. Although she needed a surgery, she was not stable enough until the next day when Xarelto had the chance to clear her system. Unfortunately, the procedure came too late and Mrs. Orr’s neurologic condition continued to worsen until May 4, 2015, when she passed away.

More than 16,000 Xarelto lawsuits have been filed in the federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana.

German drug manufacturer Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals developed and marketed Xarelto as a blood thinner that does not require coagulation monitoring, the Plaintiffs assert. They argue that the Defendants failed to develop a monitoring test specific to Xarelto and failed to instruct doctors on how to use currently available tests to measure Xarelto’s anticoagulant effect on patients’ blood. Such monitoring would allow doctors to assess whether patients benefited from the use or were at risk of severe internal bleeding.


By Joseph VanZandt, a Medical Devices and Drugs attorney with Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. in Montgomery, AL.


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What Trump and the New Commissioner mean for the FDA

Trump FDA deregulation
President Trump claims that 75% to 80% of all governmental regulations are unnecessary.

By Joseph DiNardo, Esq. and Erin Delaney, Esq.

There is much uncertainty throughout the pharmaceutical industry as a new U.S. Food and Drug Administration (FDA) Commissioner is chosen and steps are taken to deregulate government agencies.

President Donald Trump has stated one of his goals is to speed up the drug approval process to lower drug prices, promote competition, benefit small start-ups and bring innovative new treatments to market faster.

However, many industry leaders are concerned that dramatically speeding up the current approval process could put patients at risk. This, in turn, could subject manufacturers to costly litigations.

CEO of Pfizer favors deregulation

The high cost of obtaining approval for a new drug, estimated at $2.6 billion, has been blamed for hindering pharmaceutical start-ups from entering the market. As a result, certain pharmaceutical executives, like the CEO of Pfizer Inc., have publicly favored deregulation, claiming it will help create more competition and lower drug prices.

Others in the pharmaceutical industry disagree, opining that current FDA rules and regulations provide a level playing field for both small and large companies. Lowering the bar for drug approvals, they contend, would allow the wealthiest pharmaceutical companies to inundate the market with countless new drugs and associated advertising, eclipsing any potential advances of smaller companies.

President Trump, who has stated that 75% to 80% of all governmental regulations are unnecessary, issued an executive order on January 30, 2017, aimed at significantly reducing them. The order requires all executive government agencies identify at least two regulations to be repealed for each newly-proposed regulation.

There are 40 MDLS where plaintiffs allege the drug companies engaged in false and misleading marketing and sales practices, including Vioxx, Tylenol, Celexa, Lipitor, Avandia and Plavix.

FDA may not be affected

While not immune to the executive order, the FDA, which regulates food, drugs, medical devices, blood donations, vaccines, biologic products, animal and veterinary products, cosmetics and tobacco products, may not be markedly affected by it. Many FDA regulations deal with process and merely codify or interpret the law. Accordingly, even if certain agency regulations were repealed, congressional mandates, including statutory safety and efficacy standards under the Food, Drug and Cosmetic Act (FDCA), would not change.

Further, a number of regulations are no longer applicable and could be repealed without consequence. Arguably, some existing regulations could even increase protection and transparency for the public if rescinded.

It is not the executive order that has the industry buzzing, however, but rather the potential actions of the new FDA commissioner under the Trump administration, who is likely to share the President’s goal of streamlining the FDA’s drug approval process to decrease the amount of time it takes for new drugs and medical devices to get to market. In an attempt to restructure and quicken the process, the commissioner may choose to institute various levels of approvals, focusing on biomarkers and short-term surrogate endpoints.

Although legislation is in place that requires substantial evidence of a drug’s efficacy prior to it being sold in the marketplace, some suggest if the new commissioner were so inclined, the commissioner need only to interpret existing regulations loosely to weaken the efficacy standard.

12 years from lab to patient

Under the current system, it takes a new drug, on average, 12 years to make it from a research lab to the patient. The FDA’s role is minimal throughout the preclinical research stage, which can take one to six years, but increases if the drug is successful and the FDA approves the commencement of human trials.

Phase one allows researchers to test the drug for the first time in a small group of healthy volunteers, identifying side effects and basic product characteristics, adjusting dosages and evaluating safety. Phase two involves evaluating

Phase two involves evaluating efficacy and short-term side effects for different dosages within a larger randomized or controlled group of people, often measuring biomarkers or laboratory results rather than clinical outcomes. Phase three, a large clinical trial, uses a group of people more similar to those to whom the product would be marketed to determine a risk/benefit ratio. Each phase takes about one to two-and-a-half years.

Ninety percent of the drugs and biologics that proceed through clinical trials fail, whether it’s due to safety or efficacy. If a drug completes phase three of the trials, the manufacturer will file a New Drug Application with the FDA, getting a response, on average, in about 12 months for standard review and eight months for priority review.

Nevertheless, according to 2016 data, the majority of new drugs are approved through an expedited approval process. The approval process has also already been shortened for certain drugs and medical devices by the 21st Century Cures Act, which was signed by President Barack Obama last year.

Safety and efficacy

Some experts argue that safety and efficacy go hand-in-hand; side effects that would never be approved for an over-the-counter drug may be approved for a drug that treats a life-threatening illness if it were proven to be an effective treatment. The type, nature, length and size of clinical trials are already becoming increasingly flexible, allowing deviations from the typical structure on a case-by-case basis in consideration of factors such as whether the condition is widespread, rare, chronic, short-term or life-threatening, the frequency of the symptoms, and the toxicity of the drug on test subjects.

For instance, the FDA may approve orphan drugs, which treat diseases that typically affect less than 200,000 people, based on only one positive clinical trial and/or on surrogate endpoints, while mass-market drugs typically require two to three trials to prove safety and efficacy. In doing so, the FDA provides patients access to a drug, often where there was a previously unmet medical need, while the company continues to study its clinical benefits.

Even so, the FDA maintains that “a randomized, controlled, clinical trial… of a size and duration that reflect the product and target condition remains the gold standard for determining whether there is an acceptable benefit/ risk profile for drugs and biologics.” A neurologist at the Mayo Clinic told Business Insider he commends the idea of speeding up the development of new treatments, but worries that in doing so patients could be exposed to “costly, ineffective and potentially dangerous drugs.” Likewise, the CEO of Ovid Therapeutics Inc., a pharmaceutical company that develops drugs for rare diseases, told Reuters, “any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach.”

In a January 2017 FDA evaluation of 22 case studies with divergent results, early clinical studies were promising. Should the commissioner decide to base approval on initial safety reports or on surrogate endpoints, these drugs could have been approved. However, “[p]hase 3 studies did not confirm phase 2 findings of effectiveness in 14 cases, safety in 1 case, and both safety and effectiveness in 7 cases… In two cases, the phase 3 studies showed that the experimental product increased the frequency of the problem it intended to prevent.” The side effects of these drugs in phase three trials ranged from mere uselessness to serious adverse events, including death.

Testing requirement

Further, removing the requirement of extensive clinical testing could mean that courts will see more lawsuits and multidistrict litigations similar to those currently filed against 3M involving its Bair Hugger Forced Air Warming device. In that litigation, it is alleged that the company knew of the threat of contaminants due to the device, and the risk of infection, but failed to warn of the risk. The plaintiffs further allege that 3M continued to market its product as safe for use during surgeries and attempted to “conceal and discredit peer-reviewed scientific studies that undermined their ability to market the Bair Hugger.” Notably, the FDA approved the Bair Hugger device for use in 1987 under Section 510(k) of the FDCA, which is an expedited process that allows for less clinical testing if a substantially similar device is already on the market.

It is also unclear how rules and regulations that promote a quicker approval process will affect the doctrine of federal preemption. Just like Bayer Corp. has done with some success in suits alleging injuries sustained from the implantation of Essure Permanent Birth Control, a manufacturer’s defense often rests on the fact that the FDA approved the drug or device’s design, manufacturing method, labels, warnings and instructions for use prior to its release into the market.

This defense has held up in the past, especially for devices approved in the premarket approval process, based on the FDCA’s statutory requirements for safety and effectiveness, with defendants arguing the FDA subjected their product to the “highest level of scrutiny that exists in the federal regulatory system.” If the statutory requirements for a new drug’s approval are weakened, this defense may prove futile for pharmaceutical companies in future litigations to the advantage of plaintiffs.

40 MDLs

Congruently, there are currently 40 multidistrict litigations pending with the Judicial Panel on Multidistrict Litigation in which plaintiffs allege the defendants engaged in false and misleading marketing and sales practices, including those for Vioxx, Tylenol, Celexa, Lipitor, Avandia and Plavix, to name a few. Allowing a pharmaceutical company to advertise a drug for potentially ineffective uses without proper testing could open the floodgates of similar litigation should the drug fail to work, or worse, cause fatalities, while costing patients hundreds of thousands of dollars per year. For example, Sarepta Therapeutic’s orphan drug, Exondys 51, which the FDA approved for use in September 2016 based on surrogate endpoints, runs patients about $300,000 per year with little to no insurance coverage, but it has not yet been proven effective.

Industry heads such as the CEO of Alnylam Pharma and the head of research and development at Merck and Co Inc. have also expressed concern about how a manufacturer must be able to show insurers and physicians alike through a risk/benefit profile that their drug has value, rather than leaving them to make such a determination on their own. Further, even if deregulation lowers costs to pharmaceutical companies, there have been no assurances that these reduced costs will be passed on to patients. A first-to-market advantage will not do pharmaceutical companies much good if the product is too expensive for patients to afford and insurance companies are not willing to cover the cost.

If current pre-market clinical requirements are reduced, it could arguably endanger patients, who are often the most vulnerable. It may also make it more difficult for pharmaceutical companies to differentiate effective products from new, less effective — or ineffective — treatments flooding an easy-to-enter market. On the other hand, greater flexibility could allow for innovative new products to enter the market faster and reach those waiting on new therapies or a cure. Until the right balance has been struck, the industry may be in for a bumpy, litigation-filled ride.

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Xarelto Lawsuits Near 19,000 as Second Bellwether Trial Starts Next Week

Johnson & Johnson and Bayer AG have been named defendants in at least 18,900 Xarelto lawsuits, most of which are pending in multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana, according to a May 3 filing with the U.S. Securities and Exchange Commission.

Xarelto litigations have also been established in state courts in Pennsylvania, Delaware, California and Missouri, while class action lawsuits have been filed in Canada.

Xarelto Litigation

Xarelto is an oral anticoagulant jointly marketed by Bayer and Johnson & Johnson. The blood thinner was approved by the FDA in 2011, and is currently indicated for the prevention of strokes in atrial fibrillation patients; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee implant surgery.

See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial

Xarelto plaintiffs allege that Bayer and Johnson & Johnson failed to provide adequate warnings about bleeding that may occur with its use, and wrongly promoted the blood thinner as a superior alternative to warfarin, says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs.

Among other things, plaintiffs note that bleeding associated with warfarin can be reversed via the administration of vitamin K. However, there is no approved antidote to stop Xarelto bleeding events.

The multidistrict litigation underway in the Eastern District of Louisiana houses at least 16,670 Xarelto lawsuits. The second bellwether trial beings on May 30 in New Orleans. Verdicts in these trials may provide insight into how juries could rule in similar Xarelto claims. Johnson & Johnson and Bayer prevailed in the first Xarelto trial, which concluded earlier this month. (In Re: Xarelto Products Liability Litigation, No. 2592).

Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.

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3,700 IVC Filter Lawsuits Filed Against Bard and Cook Medical

Bard G2 Express IVC Filter
Bard G2 Express IVC Filter

Cook Medical, Inc. and C.R. Bard, Inc. continue to face mounting lawsuits over their retrievable IVC filters, with 3,769 cases filed against the companies in two federal MDLs.

Cook Medical is a defendant in at least 1,918 product liability claims involving its Gunther Tulip and Celect IVC filter blood clot filters. IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation is pending before US District Chief Judge Richard L. Young in MDL 2570 in the Southern District of Indiana.

In March 2017, Judge Young ordered both sides to appear at three hearings with a proposed settlement framework.

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of 1,851 injury claims. IN RE: Bard IVC Filters Products Liability Litigation is pending before US District Judge David G. Campbell in MDL 2641 in the District of Arizona.

On March 21, 2017, Judge Campbell appointed the Plaintiffs’ Co-Lead/Liaison Counsel and State/Federal Liaison Counsel:

  • Ramon R. Lopez, Lopez McHugh, LLP, Newport Beach, CA.
  • Mark S. O’Connor, Gallagher & Kennedy, PA, Phoenix, AZ.

Failure to Warn

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

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Eliquis Plaintiffs Must Show Cause Why Their Cases Shouldn’t Be Dismissed from MDL

eliquis-internal-bleeding-lawsuitJudge Denise Cote of the U.S. District Court for the Southern District of New York, who is supervising the Eliquis MDL, ordered all plaintiffs to show cause by May 23 why her dismissal of one case should not be applied to all cases.

The case is In Re:  Eliquis [Apixaban] Products Liability Litigation, MDL 2754, No. 17-md-2754, Charlie Utts, et al. v. Bristol-Myers Squibb Company, et al., No. 16-5668, S.D. N.Y., 2017).

On May 8 the judge dismissed the Utts case, one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.

On May 9, Judge Cote gave plaintiffs until May 23 to file amended complaints “and to show cause in a memorandum no longer than 20 pages why the amended complaint should not be dismissed based on the analysis in the May 8 Utts Opinion.”  Future lawsuits transferred into the MDL will have 14 days to provide the same information, the judge said.

The judge added that “it is unlikely that the plaintiffs in any of these actions will have a further opportunity to amend.”  She said the defendants will file a reply or replies by June 20, “at which point the motions to dismiss each action will be considered fully submitted.”

Gastrointestinal bleeding

Plaintiff Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.

Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

The plaintiffs argued that despite there being no antidote for uncontrolled bleeding while taking Eliquis, the dosage recommendation was not individually tailored and that Bristol-Myers and Pfizer did not recommend constant monitoring of blood clotting times in patients.

Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says.

Well-Known to FDA

“These two complaints concern features of the design of the drug that were well known to the FDA [Food and Drug Administration] when it approved the drug,” Judge Cote wrote.

“Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label’s disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants’ files that might support their failure to warn claims,” the judge continued.

“They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs,” the judge continued.  “But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b)[Fed. R. Civ. P., 12(b)].  Accordingly, the claims in the [second amended complaint], which reduced to their essence are attacks on the design of this drug, will be dismissed.”

 

The Uttses are represented by Hunter J. Shkolnik and Nicholas Farnolo of Napoli Shkolnik in Melville, N.Y.

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A Closer Look at Advertising Response within a Guaranteed Cost Structure

The three co-founders of Amicus Media Group: George Young, Bill Tilley and Chad Nell.
The three co-founders of Amicus Media Group: George Young, Bill Tilley and Chad Nell.

By George Young, Partner, Amicus Media Group

In a world where consumers are presented with an overwhelming choice of television, radio, and online platforms, how can a law firm be assured that media time purchased to generate cases will perform? What if media time is purchased and no one calls or responds?  Performance media addresses ROI concerns, as this model to media depends on paying for the responsive results, instead of the media time itself.

Performance media addresses ROI concerns, as this model to media depends on paying for the responsive results, instead of the media time itself.

By taking a closer look at performance media, we can begin to understand why law firms use this model to reach potential clients at a guaranteed cost and improve profitability with less risk.

Performance Media as a Model of Predictability

Comparing the cost structure between different models of media buying, a more predictable model emerges through performance media campaigns. In the traditional model of dedicated media purchased for attorney advertising, the law firm provides a budget to the advertising agency for buying media time to drive calls or leads to the firm from people who have been harmed by a dangerous drug, medical device, or any other type of injury case.  The typical cost to media for generating a call will likely fluctuate from week to week, as media spot cost, call response, and other factors will ultimately affect the lead cost and unpredictably impact the campaign effectiveness.

While the performance model for attorney advertising similarly requires the law firm to provide a marketing budget to the media agency the key difference is that the cost to generate a call or lead from advertising is secured at a guaranteed rate for an actual response.  As the financial risk is shifted from the law firm to media, the onus to perform is placed squarely on the media running the campaign. The risk of budget burning for subpar results is mitigated for the law firm, due to the potential client response cost being known.  

As a clear example, consider the traditional media cash buying model of advertising where the law firm commits to specific times and networks and is required to pay for media time regardless whether the target audience responds. In contrast, if the same advertising spot runs as a national or regional performance campaign and no one responds, zero dollars are owed. Certainly, performance media offers a reliable model by guaranteeing a more predictable cost of advertising.

How and Why Networks offer Guaranteed Cost Structures

While only a few agencies can offer performance media, this type of advertising holds several key advantages for the networks as well as law firm advertisers.  Performance media provides stations the capability of adding revenue spots to the daily inventory of avails on demand, where they can fill unsold schedule openings, or replace last minute cancellations.  These media avails can be provided to law firms at a much lower cost compared to advertisers that buy specific media time slots.  Consequently, performance media allows networks to monetize inventory that historically would likely go unsold and therefore air non-revenue broadcasts such as public service announcements or promotional spots. Performance media offers a flexibility in programming that ensures every possible commercial break is monetized.

Where Performance Media Campaigns Work Best

Performance advertising is also called “Opportunity Media”, as television and radio networks may place the spot during any time of day where an open avail (opportunity) in their schedule exists.  As such, traditional prelogs (schedules indicating when spots are expected to run) and post logs (schedules showing when spots went live) are not provided by the networks.   Instead, each week the networks bill for the total number of calls or leads generated by the previous week’s advertising.   While performance marketing can deliver significant cost savings to law firms compared to specific advertising time purchased, there are instances where traditional media cash buy may propose a more reasonable option. An example where a traditional media cash buy might be strategic would include instances where a law firm requires complete control over spot placement or online display of the advertising.

Considerations when Launching a Performance Media Campaign:

Each year law firms across the country use performance media to save millions of dollars in acquiring mass tort, personal injury, and other types of cases.  

Performance Media Attributes include:

  • Campaign Launch Timeline:  Expect about 2 weeks to get the phones ringing and 4-6 weeks for full call volume to emerge.  
  • Refundable Deposit:  A refundable deposit is typically held on account equal to about three weeks of billing.
  • Billing:  Television networks bill each Monday for the previous week’s calls/leads. The marketing agency remits same day payment.   
  • Cancellation: 21-day notice is required to pull a campaign for any reason.

Another necessary consideration for the success of either a traditional cash buy or performance media advertising campaign is managing the intake of audience responses. Although most of the avails (and thus most of the calls and leads) will be generated during daytime hours, and correspond with operating hours of the law firm, the intake center activity extends beyond business hours.  Commonly, the law firm engages a 24/7/365 legal intake call center solution, as potential clients often see or hear an advertisement during the daytime hours, and later decide to respond by calling at any time of day or night.

For competitive law firms, performance media provides a cost-effective solution for finding new clients through a marketing channel that removes much of the risk of lead generation performance from the law firm and shifts the risk of results directly to media. Its unique combination of scalability, favorable cost per intake economics and predictability makes it a powerful strategy in the face of fierce competition for case acquisition.


AMICUS MEDIA GROUP, LLC

Amicus Media Group is a full-service media agency comprised of some of the nation’s most respected professionals in media, communications, marketing, finance, and practice management to offer law firms the highest level of expertise in case acquisition and practice growth. 

Amicus Media Group offers direct response marketing services for lead generation campaigns. Agency services span from negotiating rates, broadcast planning and scheduling, media buying, campaign management, performance marketing, intake and creative production. Holding key relationships with top media executives throughout the nation, Amicus Media Group establishes a combined multi-decade prowess in legal marketing.  

To contact Amicus Media Group call (888) 700. 1088 or email George Young at GeorgeYoung@AmicusMediaGroup.com or Chad Nell at ChadNell@AmicusMediaGroup.com

 

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Invokana Cases Move Forward with Discovery Plan, Bellwether Case Selection, Scheduling of Trials

The federal multidistrict litigation overseeing hundreds of products liability lawsuits involving Invokana and Invokamet are moving forward in the U.S. District Court, District of New Jersey. On May 1, 2017, the court has established an initial discovery plan addressing, among other things, bellwether case selection protocol, scheduling and trial dates. The Court had previously indicated that the litigation’s first bellwether trials could begin in September 2018.

There are 288 lawsuits filed in MDL 2750 before US District Judge Brian R. Martinotti in IN RE: Invokana (Canagliflozin) Products Liability Litigation. Plaintiffs who suffered ketoacidosis or kidney damage allegedly related to the use of Invokana or Invokamet.  They accuse the drugs’ manufacturers of failing to warn patients about the serious risks potentially associated with the medications.

In an order dated May 5, 2017, the court has barred the filing of multi-plaintiff complaints, apart from those that name a derivative plaintiff, such as a spouse. Multi-plaintiff cases already pending in the litigation as of May 5 are to be severed.

“We are pleased that the Court is moving forward with plans for bellwether trials, as verdicts in these cases could give some insight into how other juries might decide similar lawsuits involving Invokana or Invokamet,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

FDA Boxed Warning

In related news, the FDA issued a safety alert on May 17 that Invokana and Invokamet have an increased risk of leg and foot amputations.

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Invokana and Invokamet Side Effects

Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. The agency approved Invokamet in November 2014. Both drugs lower blood glucose levels by preventing the absorption of sugar by the kidneys, thereby causing it to be eliminated via urine.

The FDA has since issued several safety alerts to warn of side effects potentially associated with the use of Invokana and other SGLT2 inhibitors. In December 2015, for example, the agency announced that the labels for all drugs in this class would be updated to include information about diabetic ketoacidosis, a potentially deadly complication related to the accumulation of toxic acids (ketones) in the bloodstream. The labels were also modified with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.

In June 2015, the FDA mandated stronger kidney warnings for several SGLT2 inhibitors, including Invokana and Invokamet, after the medications were cited in more than 100 reports of acute kidney injury.

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European Study Says Depakote Caused Thousands of Severe Birth Defects

A new European study finds that pregnant women who took epilepsy drug valproate — sold in the US as Depakote — were four times more likely to give birth to a baby with birth defects.

The report, jointly issued by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration, confirmed that the drug is “highly teratogenic”, meaning that it can disturb the development of an embryo.

A total of 129 lawsuits, involving about 698 plaintiffs, have been filed against Abbott Laboratories in In Re Depakote, Case No. 12-CV-52-NJR-SCW, in the Southern District of Illinois before US District Judge Nancy J. Rosenstengel.

  • Plaintiffs recovered $38 million in punitive and compensatory damages against Abbot in May 2015. Attorneys from Williams Kherkher argued that Abbott underplayed the risk of birth defects, making it appear that Depakote had about the same level as other anti-epileptic drugs available.  As attorneys John Eddie and John Boundas were able to argue, in reality it was the most dangerous anti-epileptic drug.
  • Last November there was a £10.7m ($13.8 million) settlement in France for people harmed by sodium valproate during pregnancy.

On the market since 1967

Valproate — known in France under the brand name Depakine — has been on sale there since 1967, and in Britain under the name Epilim since 1973. In the US, Depakote was approved by the FDA in June 1996 to treat epilepsy.

Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

The FDA warned doctors in December, 2009, that fetal exposure to valproate sodium (Depacon, Abbott), valproic acid (Depakene, Stavzor, Abbott), and divalproex sodium (Depakote, Depakote CP, Depakote ER, Abbott) is associated with birth defects, according to the US Food and Drug Administration (FDA).

The FDA said the drug can cause birth defects including neural tube, craniofacial, and cardiovascular defects, and warned doctors to “inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

Depakote litigation

The first cases were filed in state court in 2010 and removed to federal court on January 18, 2012. Judge Rosenstengel said, “the bellwether process and global settlement efforts have failed,” after several trial dates fell through. As a result, “The Court intends to hold joint trials as to common issues of fact and law to the maximum extent possible.”

The judge intends to try the majority of the cases in joint trials by the end of 2017.

Judge Rosenstengel dismissed nine cases on April 12 under the Indiana repose issue, ruling that all the acts leading to the alleged birth defects in the nine cases took place in Indiana, and that Indiana’s 10-year statute of repose therefore applied. An Illinois statute favored by the plaintiffs would have allowed the claims to go forward.

Abbott agreed to pay $1.5 billion to settle civil claims and criminal charges from the FDA that the drugmaker misbranded Depakote and Depakote ER between 1998 and 2006. Abbott also received repeated notices from the FDA between 1982 and 2009 that the company was misbranding the drug or promoting it for unapproved uses, the plaintiffs said.

The plaintiffs are represented by Christopher Cueto and Michael Gras of the Law Office of Christopher Cueto Ltd., Janet G. Abaray of Burg Simpson Eldredge Hersh & Jardine PC, John T. Boundas of Williams Kherkher Hart Boundas, and Bruce L. Sampson Jr. of Bracewell LLP.

 

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