Is Industrial Talc Litigation The Next Major Mass Tort?

Will Industrial Talc Litigation Become Another Asbestos?

 

 

 

 

 

 

 

Is Industrial Talc the next “major mass tort or MDL” to watch, now that talc litigation is  becoming more common in Mass Torts? Major verdicts against cosmetic talc defendants, including Johnson & Johnson (“J & J”), suggest that talc litigation, at a minimum, is a potential major threat to talc defendants other than J&J, extending into more general product manufacturing sectors including the “personal care product” industry, see J&J MDL 2738 Mass Tort Nexus Briefcase.  In 2016, J & J and other defendants suffered three large verdicts for exposure to its baby powder in St. Louis, Mo.: $72 million, $70 million and $55 million. All three verdicts, in a jurisdiction considered favorable to asbestos plaintiffs, included substantial punitive damages, see J&J Talc Cases In St Louis, MO State Court.

The plaintiffs in each of these cases alleged that exposure to talc contained in J&J’s baby powder caused them to contract ovarian cancer. Also in 2016, a Los Angeles jury awarded $18M to a plaintiff who sued a cosmetic talc defendant alleging exposure to cosmetic talc caused the plaintiff to contract mesothelioma.

There is a current ovarian cancer claim trial against J&J in Los Angeles Superior, Judge Maren Nelson that started July 10, 2017, see J&J Faces First CA Talc Cancer Trial in Los Angeles Court, where plaintiff Eva Echeverria claims that J&J baby powders caused her ovarian cancer, in the consolidated J&J Talc Litigation JCCP No. 4872 (Eva Echeverria v. Johnson & Johnson, Case No. BC628228).

Assuming talc litigation is not going away any time soon, several questions are raised. Are all talc claims the same? What is the relationship between talc and asbestos, if any? What defendants are at risk in the talc litigation? What are the insurance implications of talc claims, and are they alike or different from asbestos and other long-tail coverage claims?

Talc History

There are two types of talc: industrial talc which is used most frequently in rubber, plastics and ceramics; and cosmetic talc which is of a higher grade and is used in conjunction with products that involve direct human exposures such as cosmetics, pharmaceuticals and food additives.

Talc manufacturers and companies that have incorporated talc into their products have been, and continue to be, sued. Industrial talc defendants have been involved in litigation for decades. In lawsuits involving industrial talc, plaintiffs generally allege that the talc is contaminated with asbestos. The injuries alleged are mesothelioma, lung cancer and asbestosis. To date, there have been no claims against industrial talc defendants alleging that asbestos in the talc caused ovarian cancer. Industrial talc defendants have aggressively defended the cases and, although suffering some adverse verdicts, they won more cases than they have lost. However, will thousands of new industrial talc claims result in acceptance of litigation and pressure to settle as a suddenly arising “cost of doing business’, such as the view taken by pharmaceutical and medical device manufacturers who incorporate “litigation costs” into corporate filings and simply classify it as an expense of doing business?

Cosmetic talc cases fall into two distinct categories: 1) cosmetic talc alleged to cause ovarian cancer; and 2) cosmetic talc alleged to cause mesothelioma. The J & J verdicts were ovarian cancer cases. There was no claim that the talc was contaminated with asbestos.

While the J & J St. Louis verdicts received significant attention in the national media, cases alleging that asbestos-containing cosmetic talc caused an asbestos-related disease such mesothelioma have been percolating, and some recent notable verdicts have been obtained. In 2015, a Los Angeles jury awarded $13M to a woman who alleged talcum powder sold by Colgate-Palmolive was contaminated with asbestos causing her to contract mesothelioma.  These cases, if they emerge as viable litigation, could make cosmetic talc defendants targets by substituting them for insolvent asbestos defendants and anyone else who may be named, which would present an extreme and unforeseen threat to cosmetic talc defendants and affiliated industry.

Cosmetic Talc Litigation – Ovarian Cancer

Cases alleging injury from cosmetic talc are relatively new, as best exemplified by the recent high-profile J & J verdicts. These cases did not depend on asbestos contamination, nor did they allege mesothelioma. Instead, they alleged that talc itself causes ovarian cancer. The ovarian cancer talc cases indeed represent an entirely new class of toxic product liability litigation. The approximately 14,000 ovarian cancer deaths a year, in conjunction with the widespread use of talc in everyday products such as baby powder, renders these cases a serious threat to certain defendants and their insurers.
According to the National Institute of Health, there are 22,280 new ovarian cancer diagnoses each year in the U.S. and 14,240 women die of the disease every year. This is seven times the number of annual mesothelioma diagnoses.

The American Cancer Society estimates that there are only 3,000 new mesothelioma diagnoses a year,  with mesothelioma lawsuit filings being stable and not increasing. Like any other business, plaintiffs’ firms are always looking to maintain and grow revenue. Litigation against cosmetic talc defendants alleging ovarian cancer offers a way to substantially increase their bottom line. Indeed, “do you have ovarian cancer?” and “did you use talcum powder?” ads are commonplace on television.

Because everyone can credibly claim exposure to cosmetic talc, the primary issue that will be litigated is the science underlying the causal connection between talc exposure and ovarian cancer. While plaintiffs prevailed in the St. Louis actions, Imerys Talc and J & J persuaded a New Jersey trial court in 2016 to dismiss with prejudice two ovarian cancer cases after granting their motions to bar expert testimony due to inadequate science supporting their opinions. Apparently pressing their advantage, the defendants persuaded the federal talc MDL in New Jersey to conduct a “science day” in which the litigants would attempt to generally demonstrate that cosmetic talc does or does not cause ovarian cancer. The plaintiffs’ bar quickly responded with their own proposed “science day” in California state court, presumably where they perceive a jurisdictional advantage. The “science” of whether cosmetic talc causes ovarian cancer will be the field of battle on which the sustainability of these claims will live or die.

The sustainability of ovarian cancer talc cases will depend on how the courts resolve the science questions surrounding causation. This will depend in large part on the plaintiffs’ bar’s ability to persuade courts outside jurisdictions traditionally favorable to asbestos claimants of the merit of their claims.

Cosmetic Talc Cases Alleging Asbestos-Contamination

In addition to the emergence of ovarian cancer cases, cosmetic talc defendants are also at risk of becoming responsible for mesothelioma cases alleging that their products were contaminated with asbestos. If plaintiffs can meet their burden of proving asbestos contamination in their products, the issue of product identification will largely be moot due to the ubiquitous use of talc in everyday products to which any plaintiff can presumably credibly claim exposure.

Allegations of asbestos contamination in talc have a long and disputed history. The FDA launched an investigation in 2010 based on reports that talc from South Korea and China contained asbestos. After extensive testing of various U.S. consumer products, the FDA found no asbestos contamination in the products. However, it described its results as inconclusive and only “informative” because it was unable to secure samples from all of the common talc suppliers.

The issue of whether cosmetic talc is contaminated by asbestos is disputed by the plaintiffs’ bar. The cosmetic talc defendants present an attractive target, especially given the declining pool of solvent asbestos defendants. In addition, while mesothelioma case filings have been relatively flat, the expected decline of mesothelioma claims has failed to emerge.

If mesothelioma cases do trend upward, plaintiffs’ lawyers will have additional incentive to identify new solvent defendants to satisfy the potential liabilities. Cosmetic talc defendants, generally not burdened by years of asbestos liabilities, make attractive defendants. In addition, because the traditional asbestos defendants that used and sold asbestos products have gone bankrupt, plaintiffs’ lawyers have increasingly struggled to demonstrate proximate cause against individual defendants and have been forced to make ever-more tenuous arguments that even de minimus exposures to asbestos caused their clients’ mesothelioma. The widespread use of cosmetic talc overcomes most traditional product identification, proximate cause defenses. Instead, the principal issue becomes only whether a particular product was contaminated with asbestos.
The plaintiffs’ bar will attempt to meet its burden of demonstrating asbestos contamination in cosmetic talc by arguing that traditional testing methods are not precise enough to detect it at low levels and that there is no safe level of asbestos exposure. In previous cases, plaintiffs have employed experts to challenge defendants that maintained talc samples. As these cases are being litigated in the same jurisdictions that handle most asbestos cases, these allegations will  be difficult for defendants to rebut.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Who’s Liable if Industrial Talc Litigation Explodes

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

Exceptional advancements in the science of diagnosing and predicting cancer in just the last few years will provide plaintiffs, policyholders and insurers the opportunity to craft new trigger theories to their advantage and to circumvent past judicial decisions that were to their disadvantage. We have already seen the insurance industry using alleged advancements in asbestos science to attempt to limit the scope of historical “occurrence” policies. There is no insurance precedence with respect to trigger and talc ovarian cancer claims. Expect both sides to bring new experts and theories with respect to biologic and genomic issues, including molecular cancer experts opining about genetic alterations pre-existing before manifestation of a tumor. Resolution of these issues will be especially challenging because much less is known about females’ “defense systems” as opposed to airborne exposure through the lungs.

The science of ovarian cancer cosmetic talc claims is likely different from asbestos claims, but that will be a question for the experts and courts. Because plaintiffs will have an easy time in most cases demonstrating exposure to consumer products (e.g., for baby powder, theoretically from birth to present), both kinds of cosmetic talc claims generally would be linked together based on length and type of exposure.  .

Hiding Data That Showed Potential Dangers: The standard complaints utilized in the St. Louis cases allege that J&J knew about the risks of ovarian cancer as early as 1971. The complaints allege that “nearly all” of 23 known epidemiologic studies on cosmetic talc reported an associated risk with ovarian cancer, and assert alleged instances in which J&J “knowingly released false information” about the safety of talc in coordination with the Cosmetic Toiletry and Fragrance Association. Media reports suggest that, in post-trial interviews, jurors indicated that these allegations were part of the motivation for the large punitive damages award.

Question: Will industrial and cosmetic “personal care” products made with talcum powder and the emerging confirmed links to “asbestos” and “mesothelioma” become the new long term mass tort resulting in thousands of complaints against nontraditional and unsuspecting defendants? Such as the Los Angeles County, California Superior Court lawsuits where a 2015 “cosmetic talc” trial resulted in an $18 million verdict award based on “cosmetic talc exposure in a barbershop” against Old Spice, Clubman, Kings Men and Mennen Shave Talc, as well as a prior 2015 trial verdict of $13 million against Colgate-Palmolive for exposure to talc in its baby powder.

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JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

 The Judicial Panel on Multidistrict Litigation (JPML) has entered an order consolidating the Proton Pump Inhibitor (PPI) MDL 2757 (Nexium, Prevacid, et al) on August 2, 2017 see JPML Consolidation Order of August 2, 2017, assigning PPI MDL 2757 to Judge Claire C. Cecchi, US District Court of New Jersey based on the July 27, 2017 consolidation hearings at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing on January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the July 27th Los Angeles hearings have had a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which its attorney said is currently named in 100 cases.

 Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine and a 2016 study from John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

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Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

“Another Example of Corporate America and Undue Influence on Official Release of Damaging Scientific Data”

Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup Weed Killer

Documents released in a lawsuit against Monsanto, see Roundup (Monsanto) MDL 2741 USDC ND California, raised new questions about the company’s efforts to influence public opinion by collusion and steering of data published by mainstream media, various authors and scientific research publications and revealed an internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world, used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most US regulators, the Federal Mass Tort Litigation against Monsanto and Roundup,  pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released, the number of filed cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research, when an academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process, see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction, however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

 

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GSK Asks Supreme Court to Let it Wriggle Out of Jurisdiction in Paxil Birth Defect Case

paxil birth defectsGlaxoSmithKline, the maker of antidepressant Paxil that causes profound birth defects, according to plaintiffs, asked the US Supreme Court to release it from the jurisdiction of an Illinois trial court because the mothers and children are from out-of-state.

The case is GlaxoSmithKline LLC v. MM. Ex Rel Meyers, et al, Petition No. 16-1171. The Appellate Court of Illinois First District, Fifth Division, ruled the trial court had “specific personal jurisdiction” over the global company because the plaintiff’s claims “arise out of or relate to” Glaxo’s activities in Illinois.  See 61 NE3d 1026 (Aug. 26, 2016).

Six pairs of mothers and children from Florida, Colorado, Virginia, Michigan, Illinois and Wisconson, sued the giant pharma company in the Circuit Court of Cook County, IL. Each claims the GSK failed to warn about Paxil’s dangers if used during pregnancy, that Paxil was defectively designed, the GSK was negligent, breached warranties and negligently misrepresented and concealed the risks of Paxil.

GSK, of course, wants a very strict threshold for exercising jurisdiction — that the defendant’s activities in the forum state directly caused the plaintiff’s injury. In another case before the Supreme Court, Bristol-Myers Squibb is making a similar argument in an effort to escape jurisdiction of California state courts. See US Supreme Court to Rule on California State Jurisdiction Over Plavix Litigation.

Creating a conflict

GSK has many connections to Illinois:

  • It employs 16,232 people in the US, 217 of whom reside in Illinois.
  • It has an agent for service of process in Illinois.
  • Between 2000 and 2006, GSK had anywhere between 79 and 121 employees marketing specifically Paxil in Illinois.
  • GSK does business in and derives substantial revenue from Cook County, Illinois.
  • The company conducted clinical trials of Paxil in Illinois.

GSK argues that some of the plaintiffs saw their doctors and ingested Paxil outside of Illinois, and that the company is incorporated in Delaware with corporate headquarters in Pennsylvania and North Carolina. This, according to Glaxo, creates an “intolerable” conflict in the courts that the Supreme Court must resolve:

  • Six courts adhere to a proximate causation standard.
  • Five courts (including Illinois) have adopted a but-for causation standard.
  • Four other courts apply “an even looser standard that does not require any showing of causation.

Glaxo’s lawyers argue that a proximate causal link is required to exercise jurisdiction or else “a large company with nationwide operations is subject to jurisdiction on essentially any claim in essentially any state.” It calls this approach “universal general jurisdiction,” which it wants the high court to reject.

Catastrophic birth defects

The plaintiffs allege that there was a “significantly increased risk of congenital defects in babies whose mothers ingested” the drug. This knowledge was “scientifically knowable through appropriate research and testing.” Plaintiffs allege that the FDA requires defendant GSK “to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and [Paxil].”

Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession.

The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

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Viibryd linked to Acute Pancreatitis and Sleep Paralysis

ViibrydViibryd, manufactured by Forest Laboratories was approved by the FDA in 2011 for the treatment of major depressive disorder (MDD) in adults.

  • After reviewing an FDA Letter to Forest Labs written on September 6, 2016, we believe new warnings will shortly be added to the Viibryd label related to a link between the drug and acute pancreatitis.
  • Additionally we expect to see new warnings related to sleep paralysis also added to the Viibryd label and prescribing information.

Although this drug affects serotonin, it functions slightly different from most SSRIs because it also acts as a partial antagonist of the 5­HT1A receptor.  Approved in 2011, Viibryd quickly became the third-most prescribed antidepressant by 2014, according to Mental Health Daily. Cymbalta and Prestiq being the two antidepressants prescribed more often that Viibryd.

Although sleep paralysis is a serious condition and which cause psychological harm in the most severe cases, the condition is generally not severe. Sleep paralysis is a condition in which a person is awake but can not move or speak. Generally, sleep paralysis occurs upon waking and last less than one minute.

However acute pancreatitis can lead to serious injury and even death. Pancreatitis, especially if it reoccurs, can lead to pancreatic cancer, which is almost uniformly fatal.

Added to Mass Tort Nexus Watch List

To the best of our knowledge no lawsuits have been filed related to these newly discovered conditions linked to Viibryd however, we expect that when the new warnings are added, it may lead to investigations by law firms and education campaigns directed toward  users of Viibryd. The result of these investigations and public education campaigns are likely to lead to Viibryd lawsuits being filed.

The potential Viibryd Litigation will be discussed at the November 11th -14th Four Days to Mass Tort Nexus Course in Fort Lauderdale. For Information on other topics that will be discussed by our panel at the November Course visit this link:  Panel Discussions

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