Monday, February 24, 2014

Judge Selects Four Bellwether Cases in Ethicon Transvaginal Mesh Litigation in West Virginia

Judge Selects Four Bellwether Cases in Ethicon Transvaginal Mesh Litigation in West Virginia

ethicon johson johnsonU.S. District Judge Joseph R. Goodwin has selected four bellwether cases in the Ethicon multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia.
The four bellwether cases are:
  • Carolyn Lewis, et al. v. Johnson & Johnson, et al. 2:12-cv-04301 TVT
  • Judy Brown, et al. v. Ethicon, Inc., et al. 2:12-cv-07314 TVT
  • Jo Huskey, et al. v. Ethicon, Inc., et al. 2:12-cv-05201 TVT-O
  • Tonya Edwards, et al. v. Ethicon, Inc., et al. 2:12-cv-09972 TVT-O
The first bellwether case, Lewis v. Johnson & Johnson, will be tried on January 14, 2014, with the second bellwether case, Brown v. Ethicon, scheduled for May 27, 2014. As detailed in court documents, Judge Goodwin will hear a case involving Ethicon’s Gynecare Prolift transvaginal mesh product in the third bellwether trial.
With the selection of these bellwether cases, Judge Goodwin has set forth a pretrial management schedule. By September 16, 2013, the plaintiffs have been ordered to submit a list of expert witnesses and deposition dates. Following this, the defendants will deliver a list of their experts and deposition dates by September 27, 2013.
Carey Danis & Lowe transvaginal mesh lawyers is a national law firm that represents individuals who claim to have been injured by Johnson & Johnson’s transvaginal mesh devices, such as the Ethicon Gynecare Prolift. Carey Danis & Lowe is pleased to see the Ethicon MDL moving forward with the selection and scheduling of bellwether cases.
Women have filed transvaginal mesh lawsuits citing intense pelvic region pain, bleeding, infection, organ damage, mesh erosion, mesh contraction, and painful intercourse. Carey Danis & Lowe encourages anyone who has experienced an injury that they believe is linked to an implant of a transvaginal mesh device to contact one of our experienced transvaginal mesh lawyers today.

Thursday, February 20, 2014

J&J Says It Prevails in Suit Over Vaginal-Mesh Sling

J&J Says It Prevails in Suit Over Vaginal-Mesh Sling


Johnson & Johnson said a judge threw out a woman’s lawsuit arguing a vaginal-mesh implant was defectively designed, ending the first trial of claims the sling caused patients’ injuries.
U.S. District Judge Joseph Goodwin in Charleston, West Virginia, today granted a directed verdict for J&J on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat incontinence was improperly designed, Matthew Johnson, a spokesman for J&J’s Ethicon unit, said in an e-mail. Ethicon made and sold the sling. The ruling couldn’t be confirmed in court records and a lawyer for the plaintiff didn’t immediately return a call seeking comment.
Lewis had sought to have a jury rule on whether the sling’s design caused painful deformities to her vagina. It was the first case over the TVT Retropubic sling to go to trial.
J&J, based in New Brunswick, New Jersey, is facing more than 12,000 federal-court claims the TVT Retropubic and its other vaginal-mesh inserts eroded and shrank over time, causing pain and injuries. Those cases have been consolidated before Goodwin for pretrial information exchanges.
The judge concluded that Lewis’s attorneys “failed to present sufficient evidence to support her claim that a defect in the device caused her injury,” Johnson said in the e-mailed statement.

Organs Studied

Thomas Cartmel, one of Lewis’s lawyers, didn’t immediately return a call for comment today on the decision to throw out the case, which came before J&J would have been forced to present evidence in its defense during the week-long trial.
Last year, the U.S. Food and Drug Administration ordered J&J, C.R. Bard Inc. (BCR) and 31 other vaginal-implant makers to study rates of organ damage and complications linked to the implants.
Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.
Thousands of women contend they’ve been injured by meshes that have eroded. Patients have sued J&J, Murray Hill, New Jersey-based Bard; Endo Health Solutions Inc. (ENDP) of Chadds Ford, Pennsylvania; and Natick, Massachusetts-based Boston Scientific Corp. (BSX)
J&J officials decided last year to stop selling some lines of vaginal-mesh implants after being hit with a wave of suits over the devices. J&J, the world’s biggest maker of medical products, contended in court filings that its Prolift and TVT Retropubic devices are safe and effective and that the company gave adequate warning of any risks associated with them.
Last year, a New Jersey jury ruled that J&J must pay $11.1 million in damages to a woman who blamed Prolift for her injuries in the first case over any of the company’s implants to go to trial.
The case is Lewis v. Johnson & Johnson, 12-cv-04301, U.S. District Court, Southern District of West Virginia (Charleston).

Sunday, February 16, 2014

Using Polygraphs to Reduce the Impact of Perjury In Domestic Violence Cases

Reducing the Impact of Perjury In Domestic Violence Cases 

by Jon Marin
Uncertain justice

Physical and sexual violence committed against children by adults in their household is a serious problem. So is actual violence committed by men and women against their intimate partners. The heightened official attention these problems have received in recent years has defused dangerous situations, assisted victims, and brought violent men and women to justice.
Unfortunately, official action taken upon false allegations of such criminal behavior have also caused great harm to many innocent children, women, and men.
The adjudication of accusations of domestic violence encounters systematic bias against the accused (perpetrator) that is not present, or less present, in ordinary criminal matters. The bias rarely if ever results from malice on the part of judges, but arises instead from the nature and context of the charges and the limited evidence often available in such cases. The key evidence is commonly limited to the testimony of the parties and other persons who may, and often do, have an undisclosed or under-disclosed interest in the outcome.

Asymmetric consequences of error
Humans are good at deception, poor at detecting deception. 

The "he said /she said" nature of most domestic violence and abuse hearings causes the probability of erroneous outcomes to be unacceptably high. People begin to lie as little children, and continue to lie, more or less frequently, throughout their lives. They get very strong feedback on their proficiency - listeners tend to react unpleasantly when they catch someone lying. Though skill levels vary, most adults are pretty good liars when they have to be.
Humans are much less proficient at detecting deception.
People make subjective judgments of veracity all the time, of course, but the feedback is weak. Often, they simply never learn that they have been deceived. When they do, it is generally too late to reconstruct the details of the deceiver's voice, posture, and mannerisms at the time of the deception. Their memory of such details is no better when they learn they mistakenly judged someone to be deceptive.
This proficiency difference is reflected in the relative scarcity among attorneys of really good cross-examiners, the reverence in which they are held by their fellow attorneys, and the high fees they command. It is also reflected in the ongoing efforts to develop and prove novel lie detection methods, such as the analysis of stress in the voice, in minute short-lived contractions of the facial muscles, or in involuntary movements of the eyes.
The outcome of "he said/she said" cases is likely to be frequently wrong, even when the "playing field" is level in all respects. In the adjudication of domestic violence complaints, unfortunately, many factors combine to tilt the field severely.

The scales of justice are unbalanced 

It is a basic principle of decision theory that a rational decision-maker should minimize the net cost of false positive and false negative errors. Application of this principle in domestic violence proceedings tilts them markedly in favor of the accuser. Judges are rational decision-makers by profession. They know that the real-world consequences of mistakenly finding in favor of a guilty man can be catastrophic, resulting in further acts of violence up to and including murder.
They know that such eventualities, though rare, attract the attention of the entire community when they occur. And they know that such a turn of events can damage their careers, cause painful lifelong self-recrimination, and further erode public confidence in the courts. Conversely, the harm from erroneously finding an innocent man or woman guilty - loss of income, reputation, and access to children - though substantial to the individual, is of modest or no consequence to the judicial system, and certainly less sensational. The likelihood of such an error coming to light is small. No one, including the judge, ever has reason to believe that a mistake was made. So wrongly-convicted, non- violent individuals go on their way, glue their life back together as best they can, and are seldom heard from again. The asymmetry creates a powerful incentive for judges, sitting as finder-of-fact, to find DV accusers to be truthful and render judgment accordingly. Though some, perhaps many, judges will have the strength to resist the incentive, none can be unaware of it. A heavy thumb is pressing down on one side of Lady Justice's scales.

Other factors accentuate the tilt:
Credibility: Motivation to lie 

Judges, like everyone else, are naturally inclined to disbelieve witnesses who have a clear motive to lie. For the accused, the prospect of punishment constitutes a clear motive to lie. The accuser ("victim") takes the witness stand with a presumption of credibility which the accused ("perpetrator") must overcome. Even where the accused is able to do so, their motive to lie remains. Credibility becomes a wash.
Absence of effective appeal 

The potential fallout facing a trial court for finding against an honest accuser pales in comparison to the fallout an appellate court could face for overturning a trial court's decision in favor of an honest accuser. Fortunately for appellate courts, their rules and traditions permit them to limit their review to errors in procedure and the law, but defer questions of fact to the finder of fact - the trial judge - enabling them to sidestep the danger. Applied to "he said / she said" DV cases, the limitation of review renders practically null the possibility of successful appeal. Where a trial judge has determined the accuser to be truthful, and found as a matter of fact that the accused committed or threatened acts of violence, little else matters. Unless a judge's errors have been absolutely egregious they will be dismissed on appeal as harmless error.

Unaccountable power and judicial immunity 

Trial judges are human. They know that few DV findings are appealed, and that appeals rarely succeed. They know that their findings of fact will be decisive and that in their findings they are free to indulge not only the conflicts of interest due to the asymmetric consequences of error, but all manner of preconception, prejudice, and political inclination, all without fear of review. Some judges may have the strength to resist the temptations inherent in the situation; perhaps most do. There is no way to know who, or how many. What is certain is that the temptation is present, uncontrolled, and unchecked. Unaccountable power is abhorrent in a democracy. The risk is real, and reflects badly upon the entire judicial system.

Toward better justice 

The article, He Said / She Said by Jonathan Marin proposes an approach that can sharply reduce the incidence and impact of perjured testimony in DV proceedings, with important benefits to society as a whole. The text on the web is a somewhat- extended edition of the version that appeared in Polygraph, Volume 29 Number 4 (2000) p. 299. The article describes how polygraph results when taken in combination in "he said/she said" situations, where one of a pair of opposed witnesses is almost certainly lying, can be reliably used to exclude untrustworthy testimony.
The underlying statistical concept is simple enough: If you roll one die, the chance of getting a six is 16.66%. Roll two dice, and the chance of getting two sixes is only 2.77%. The statistical gain applies to pairs of polygraph results viewed together. If the probability that either result alone will be wrong - whether false positive or false negative - is 14% (slightly less than that of getting a "six" on a single roll of a die) then outcome error rates of less than 4.0% can be confidently predicted. However, both of the polygraphists involved must use standardized, validated, techniques and, irrespective of other credentials, must have personally demonstrated an accuracy rate of at least 86% in a controlled protocol. Because the proposal advocates utilizing paired results solely to exclude untrustworthy testimony rather than admitting the results themselves into evidence, long standing precedent against the admissibility of polygraph results need not change.

The ideas are extended and detailed in a FAQ. 

Applied to domestic violence and abuse cases, paired polygraph testing would: Reduce the number of groundless accusations. Reduce the incidence of meritorious suits stymied by perjury- dependent defenses. Reduce the load on the courts, thereby speeding justice for meritorious litigants. Reduce the incidence of tried cases that are decided incorrectly due to perjured testimony. Increase courts' willingness to penalize frivolous litigants and their attorneys. These benefits derive from the fact that litigants and their attorneys will understand that they have little hope of winning if their opponent's key witnesses will be allowed to testify unopposed about the dispositive facts in the case. The high costs of litigation provide a strong incentive against sustaining a case in the face of such odds.
Litigants who nevertheless persevered would risk being found frivolous by the court and burdened with their opponents' legal fees as well as their own. Rational accusers' ("victims") attorneys will advise their clients in their own best interest to abandon their case, and rational attorneys for the accused ("perpetrators") will advise them to acknowledge their guilt, when so indicated by the paired polygraph results.
Paired polygraph testing should not be applied to all testimony in dispute. It's use should be limited to witnesses where: The facts in dispute make it likely that the case will hinge on whom the finder of fact believes. The nature of the transaction makes it unlikely that either party could be honestly mistaken. The paired testing approach adapts well to the issue of post- adjudication relief. The accused would challenge the accuser to participate in paired testing, stipulating to incur substantial penalties if he failed and the accuser passed. They would both be examined. If the accused passed and the accuser failed, then appellate courts and other review authorities would be obliged to exclude that witness's testimony from the record on review - to treat the record as if that witness's testimony did not exist.
The Equal Justice Foundation can arrange paired polygraph testing in actual cases in conjunction with the Veritas Center, which maintains a roster of polygraphists who have rigorously established their personal proficiency at 86% accuracy or better. The Center assigns examinations randomly to polygraphists on its roster; a polygraphist who examines an attorney's client in one case may well be examining the opponent in a future one. The Center manages the flow of examination charts and videotapes, maintains an appeal procedure, and handles the reporting of results. To prevent even the appearance of impropriety, the Center collects fees and expenses before the polygraphists are assigned and later pays them; the polygraphists never have any financial contact with litigants or their attorneys.
Paired polygraph testing does not provide the absolute certainty that DNA often can. But it will help exonerate innocent persons accused of offenses that, by their nature, seldom produce forensic evidence. Exclusion based upon paired- test results, under the tight constraints proposed is a sensible and realistically achievable approach that will reduce the frequency of abuses and false allegations that so strain the process of adjudicating domestic violence.

Topamax Lawsuits won by Plaintiffs

Topamax Lawsuits won by Plaintiffs

Plaintiffs beat Johnson Janssen_logo-JnJ& Johnson in the first two Topamax bellwether trials in the last month and a half. In Philadelphia, a jury found that taking the seizure medication Topamax during pregnancy can cause deformities such as cleft lip. When the lip or palate has failed to properly fuse, one develops a cleft lip. Such a deformity can adversely affect eating, talking and social standing. Those with cleft lip can become shy and withdrawn. People with cleft palates are also more likely to develop ear infections.

Topamax cases filed

More than 130 Topamax Lawsuits have been filed for children allegedly suffering from this malady after their mothers took Topamax while pregnant.

$11 Million in Damages

In Philadelphia, a jury awarded Haley Powell $11 million in damages. Ms. Powell is the mother of a boy born in 2007 with a cleft lip and other deformities. The award is meant to cover medical expenses that will include surgeries, but it is likely to be appealed by defense, as virtually all such verdicts are. The verdict in Ms. Powell and her child’s case was the second win in two trials for plaintiffs against Johnson & Johnson.

$4 Million in First Topamax Trial

On October 30, a jury awarded a mother and her child $4 million in the first Topamax trial. Records in that case indicate J & J’s Janssen subsidiary withheld safety information about Topamax’s pregnancy risks and hid important information from consumers and the medical community. In this case, April Czimmer had born a son with several birth defects alleged to have occurred because Ms. Czimmer took Topamax during the first trimester of her pregnancy. Ms. Czimmer testified at trial that she took Topamax for six months while pregnant. Her attorneys alleged that the maker of Topamax failed to provide adequate warnings about the risk of birth defects.
Johnson & Johnson argues in these and all other Topamax cases that it provided adequate Topamax warnings.

Topamax Approved in 1997

Approved by the FDA in 1997, Topamax has been available for use since 2006. The drug is approved for treatment of epilepsy, migraines and weight loss. In 2011, the FDA issued a warning about Topamax increasing the risk of oral cleft birth defects. The FDA warned doctors not to prescribe Topamax to pregnant women or to women of child bearing years at risk of pregnancy.

Contact a Topamax Lawyer

If you or someone you love has been injured by Topmax, contact a Topamax Lawyer regarding a Topamax Lawsuit at 508-499-3366 or schedule and an appointment for a free initial consultation online. 

Friday, February 7, 2014

Abbott Androgel Lawsuit

Abbott Androgel Lawsuit


An Abbott Androgel Lawsuit was filed this week in federal court by Stephen Benn against Abbott Laboratories and Abbvie, the makers and distributors of Androgel.
The companies advertised to convince millions of men that natural aging – mood swings, slowing down, lowered libido, that sort of thing – is a sign of testosterone deficiency and can be solved with a testosterone supplement such as Androgel.

Problem-Solution

Abbott and Abbvie aren’t the first drug companies to trumpet a natural problem or human challenge and diagnose it all at once, then sell people the solution for it. They are some of the more successful companies to do so. Diagnosis of Low T have increased enormously with or without proper testing, driving annual Androgel savings to more than $1.37 billion.

A Questionable Quiz

On its web site, Abbott posted a special quiz that its creator said was scribbled on toilet paper. He called it a “crappy” test. Other drug companies have posted similar tests, but so far as we know this is the first one to actually be called “crappy” by its creator.
Benn’s lawsuit petition reads: “Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism or ‘low testosterone,’ when in fact the drug causes serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.”

“Disease Awareness” Campaign

It further states that defendants engaged in “aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel.” Further, it accuses defendants of an aggressive unbranded “disease awareness” campaign to entice men into believing they could be suffering from low testosterone or “Low T.’”
The defendants’ ad campaign included the creation and operation of the website www.IsItLowT.com, said the complaint.
The quiz asked men (we haven’t checked if it’s still on the site) whether they have experienced a recent deterioration in their ability to play sports. Do they fall asleep after dinner? Lack energy? Feel sad or grumpy, or crappy? (Just kidding about that last one).

A Crappy, Sexy Quiz

The complaint states that Dr. John Morley, director of endocrinology at St. Louis University School of Medicine, developed the quiz in exchange for a $40,000 grant to his university. Morley, the complaint states, was directed to make the quiz “somewhat sexy.”

Marketing made Easy

Benn says in his suit: “Dr. Morley drafted the questionnaire in 20 minutes in the bathroom, scribbling the questions on toilet paper and giving them to his secretary the next day to type up. Dr. Morely admits that he has ‘no trouble calling it a crappy questionnaire’ and that it is ‘not ideal.’”
The complaint adds that symptoms raised in the quiz can all be due to natural aging, but defendants convinced millions of men to discuss testosterone replacement therapy with their doctors, “and consumers and their physicians relied on defendants’ promises of safety and ease.”

Disease Mongering

The Benn petition calls this “disease mongering” – a term coined by Georgetown University Medical Center’s Dr. Adriend Fugh-Berman.
“However, says the complaint, “consumers of AndroGel were misled as to the drug’s safety and efficacy, and as a result have suffered injuries including life-threatening cardiac events, strokes, and thrombolytic events.”
Benn and four other plaintiffs filed their lawsuits Monday, Feb. 3, one day after a physician-written Op-Ed column in The New York Times declared Low T to be overdiagnosed. The author also referenced an earlier study that showed testosterone therapy may double the rate of heart attack in older men, and triple it in younger men with a history of cardiac problems.
For a free initial consultation schedule an appointment online or call 508-499-3366.

Monday, February 3, 2014

Androgel Lawsuit in Supreme Court

Androgel Lawsuit in Supreme Court


In March 2013 the androgel pictureU.S. Supreme Court heard a case that concerns Americans and Big Pharma. Like brand-name drug “preemption,” which insulates drug makers from liability lawsuits, as well as the duplicitously named  “Citizen’s United” decision and many others in recent history, this case pits the rights and the pocketbooks of American citizens against those of international drug makers.
This Androgel Lawsuit was brought because brand-name drug makers want to pay generic drug companies for delaying the time when the generics copy a brand-name drug and put it on the market. Delaying a generic drug’s entry into the market can add billions in profits for pharmaceutical companies, at the expense of people – and/or their insurance companies – who must continue to pay full price for that brand-name drug.
These types of payments have been made before as a form of settlement in patent litigation, though their legality has always been questioned by any consumer groups who happen to be paying attention. Big Pharma began making such payments about ten years ago.

Pay to Delay

People, health care entities and retailers call “foul” on these payments, referring to them as “pay to delay”  schemes. Drug companies abhor that nomenclature, of course. They prefer the euphemism, “reverse settlements.”
The ironic aspect of these cases is that the corporations which sue one another – the patent-holding brand-name drug makers and the generic drugmakers (accused in these cases as patent violators) – both support the payment scheme.
Both the brand name and generic drug makers see the settlements as a way of settling a legal dispute; each side gets something it wants. (Consumers get the hindmost.)
The Federal Trade Commission (FTC), by contrast, considers the payments collusion, a means to halt marketplace competition, a clear violation of U.S. antitrust laws.

Androgel at the Center in Test Case

The FTC chose to challenge the payment scheme in the case of the testosterone supplement AndroGel, which is the case the FTC brought before the Supreme Court in March. The case involves an AndroGel patent, a new version of an old drug. The brand-name drug manufacturer, Solvay, had acquired a new patent with a slightly different formula; a new patent, the company argues, grants the patent holder a whole new period of patent protection before a generic version can be launched on the market.
But generic competitors challenged Solvay’s patent. They argued that the patent on the synthesized testosterone used in AndroGel had expired decades ago. They argued that the changes Solvay made in the “new” formula did not sufficiently justify a new patent and hence a whole new round of patent protection from generic drug encroachment.
Both sides gathered evidence for two years as the litigation progressed. As the lawsuit moved into its third year, one generic company won FDA approval for its competitive product. It prepared to market it at a price six times less than the cost of brand-named AndroGel. Such a cost savings for consumers would have cut $400 million out of AndroGel’s annual sales.
At that juncture, Solvay and the generic companies reached a settlement.  The generics agreed not to market their cheaper drugs for nine years. Solvay, in exchange, agreed to pay the generics  nearly $42 million annually, a nice chunk of change for doing nothing and letting Solvay continue to enjoy its monopoly market share.
Those who defend this sort of settlement say each side gets something it wants. But what about the people who are actually paying for AndroGel, or whatever brand name drug that has paid off the generics at the expense of the people who actually use the products? It is a kind of monopoly, and price fixing, and anti-competition anathema to a free market.
The FTC appealed to the Supreme Court after a federal appeals court upheld the Solvay payments to the generics. The FTC explained to the justices that drug prices drop 85 percent once a generic hits the market and competes with the brand-name version.
U.S. Solicitor General Donald Verrilli, of Georgetown Law School said, the payments are not settlements but “old-fashioned, naked” agreements not to compete.
The FTC says generics win 73 percent of the time when they challenge patents such as this in the AndroGel case they took before the high court; but generics usually choose to settle because they can make more money by settling with the brand-name drug maker than by taking them to trial.
Lawyers for the brand name drug makers, in a vein similar to their responses in drug preemption litigation and in Citizen’s United, argue that Congress can act through legislation to stop these payments, if it so chooses. Considering how difficult it is to get any Congress – and the current one is easily the most combative and least productive one in history – to agree to do anything, this is barely an argument that bears mentioning. The best argument the drug companies have is probably that a patent is a license given by the federal government to have a monopoly for a certain limited period of time, though that argument, too, seems specious at best.
The Supreme Court’s decision on the AndroGel patent, pay-to-delay case is expected this Spring.
PI Law Group is investigating testosterone supplement injuries for potential Androgel Lawsuits. If you or someone you love has been injured by Androgel or some other testosterone supplement, schedule a free initial consultation online or call us at 508-499-3366.