Johnson & Johnson hit with $498 million verdict in Pinnacle hip implant case

J&J hit with $498 million verdict in Pinnacle  hip implant  case
by Sindu Sindhar
Law360, New York (March 17, 2016, 12:57 PM ET) -- Johnson & Johnson was hit with an eye-popping $497.6 million verdict Thursday in the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit, a major win for the plaintiffs in the litigation who had this time put forth the consolidated claims of five patients alleging problems from the devices.

After a two-month trial and days of deliberations, a Dallas jury found in favor of all five plaintiffs in the trial, delivering a verdict that included $360 million in punitive damages, lead plaintiffs' attorney Mark Lanier of the Lanier Law Firm confirmed to Law360 Thursday.

The punitive damages are expected to be reduced to $10 million based on the statutory cap in Texas, according to John Beisner of Skadden Arps Slate Meagher & Flom LLP, an attorney for J&J. The plaintiffs had tried to argue that the commercial bribery exception to the Texas statutory punitive damages cap would apply, claiming that one of the surgeons who had treated some of the trial plaintiffs was a "highly paid" consultant for DePuy and J&J and that those payments swayed his decisions to use the devices. The jury on Thursday rejected the commercial bribery allegations.

The jury found for the plaintiffs on their failure-to-warn and design defect claims, holding both J&J and DePuy liable, Lanier said. About $240 million of the punitive damages were assessed directly against J&J while DePuy is on the hook for the other $120 million. The $140 million in compensatory damages will be divided among the plaintiffs based on the extent of their individual injuries, Lanier said. Juries are generally just asked to award damages without factoring in the cap, which the judge usually applies later, after sometimes asking the parties to brief him on the issue.

"The jury was very careful and deliberate in the way they went about working through the evidence, and it took a week to come to the conclusion," Lanier told Law360. "I'm not surprised by the outcome."

The defendants will appeal the verdict, according to DePuy spokeswoman Mindy Tinsley. The products at issue included the Pinnacle Acetabular Cup System, a metal hip implant product with a cobalt-chromium liner that the company brands the "Ultamet" liner.

“We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active and comfortable lives,” Tinsley said. “DePuy acted appropriately and responsibly in the design and testing of ULTAMET Metal-on-Metal, and the product is backed by a strong record of safety and effectiveness in reducing pain and restoring mobility for patients suffering from chronic hip pain.”

The trial had involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty, where a hip joint is replaced with a prosthetic. In their case, the prosthetics were DePuy Pinnacle metal-on-metal devices, which they alleged cause serious health problems including inflammation of surrounding tissues, bone erosion and metallosis, a toxic condition allegedly caused when the device’s components grind against each other and shed metal debris into the bloodstream.

Beisner indicated that he believed J&J would prevail on its arguments at appeal to the Fifth Circuit.

"We expect this to be a pyrrhic victory for plaintiffs’ counsel as the grounds for appeal are strong and the punitive damages will be reduced to around $10 million subject to the Texas statutory cap," he said Thursday.

U.S. District Judge Ed Kinkeade, who is presiding over the trial and the MDL, had ruled on Jan. 8 that the five cases had enough issues in common that they would be consolidated for trial. In particular, all five plaintiffs here underwent similar implantation surgeries, their doctors received similar warnings, and the patients all alleged similar injuries, according to his ruling.

Aoki, who had filed her suit in March 2013, was implanted with a DePuy Pinnacle metal-on-metal device in 2010. She contended that after DePuy's other hip implant product, the DePuy ASR Hip System, was recalled in 2010, J&J doubled down on marketing the metal-on-metal device as a replacement.

She claimed that the ASR recall spurred J&J into "damage control" mode, where it assured surgeons that the metal-on-metal device was safe but knew it posed the risk of complications including metallosis. She claimed in particular that more than 1,300 adverse event complaints had been made to the U.S. Food and Drug Administration about the devices — among the roughly 150,000 such devices sold — and that J&J knew that patients implanted with those devices wound up with unsafe levels of cobalt and chromium in their bloodstream.

The first bellwether trial in the MDL ended in a significant verdict for J&J, in which a federal jury in October 2014 unanimously cleared DePuy Orthopedics of similar accusations.

The jury had found in favor of Johnson & Johnson on all counts, rejecting plaintiff Kathy Herlihy-Paoli's claims of negligence, defective design, failure to warn and violations of the Montana Consumer Protection Act after an eight-week trial in Dallas. The product at issue in the trial was the Ultamet metal-on-metal articulation.

The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.

The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault of Neblett Beard & Arsenault and Jayne Conroy of Simmons Hanly Conroy.

Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts of Locke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The five cases consolidated for trial are Aoki v. Johnson & Johnson Services et al., case number 3:13-cv-01071; Christopher et al v. Johnson & Johnson Services Inc. et al., case number 3:14-cv-01994; Greer v. DePuy Orthopaedics Inc. et al., case number 3:12-cv-1672; Klusmann et al v. DePuy Orthopaedics Inc. et al., case number 3:11-cv-02800; and Peterson et al v. Johnson & Johnson Services Inc. et al, case number 3:11-cv-01941, all in the U.S. District Court for the Northern District of Texas.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

GM Ignition Engineers Gagged By Orwellian Rules, Jury Told - Law360

GM Ignition Engineers Gagged By Orwellian Rules, Jury Told - Law360

Law360, New York (March 15, 2016, 11:20 PM ET) -- As GM refrained from urgently investigating reports of failing ignition switches, engineers deep within the organization were effectively prevented from sounding alarms by a policy that forbade terms like “problem,” “bad” and “rolling sarcophagus,” a former automotive industry engineer testified in a bellwether trial Tuesday.

(Credit: AP)

The company is engaged in a three-week trial over the claims of Louisiana driver Dionne Spain and passenger Lawrence Barthelemy, whose Saturn roadster spun out on an icy bridge two years ago. They walked away with few injuries. But the plaintiffs blame the now-infamous ignition switch, whose hair trigger could shut down the car while it was moving, even at high speeds. General Motors LLCclaims the switch wasn’t involved in Spain and Barthelemy's crash.

Slides shown in court Tuesday laid out a list of terms engineers were directed to avoid. They included “safety,” “big time,” “good,” “defect,” “ghastly,” “Challenger,” “powder keg,” “deathtrap,” “widow-maker” and “Cobain.”

“This practice of limiting how engineers can describe situations was one of the factors that allowed this situation to stay down and not get the attention that it needed for such a long time,” former Delphi engineer Steve Loudon told the court. Loudon spent his career in automotive electronics, writing software that controls airbags, among other things. He’s now a frequent expert witness in car-defect cases.

“You’re limiting [engineers] from being as precise and accurate as they could be,” Loudon said.

But in a deposition played soon after, a GM employee offered a defense of the policy. “‘Problem’ is judgmental: You’ve already decided that there was a problem,” engineer Eric Buddrius said on video.

Meanwhile on Tuesday, on a different floor of the same building, a Second Circuit panelappeared troubled by the landmark bankruptcy ruling that largely shielded the post-Chapter 11 version of General Motors from liability tied to the deadly ignition-switch defects, with one appellate judge wondering how the decision could have been made in the bankruptcy context at all.

2nd Circ. Has Doubts About New GM's Ch. 11 Liability Shield - Law360

2nd Circ. Has Doubts About New GM's Ch. 11 Liability Shield - Law360

2nd Circ. Has Doubts About New GM's Ch. 11 Liability Shield - Law360

Law360, New York (March 15, 2016, 3:39 PM ET) -- A Second Circuit panel appeared troubled Tuesday by a landmark bankruptcy ruling that largely shields the post-Chapter 11 version of General Motors from liability tied to deadly ignition-switch defects, with one appellate judge wondering how the decision could have been made in the bankruptcy context at all.

(Credit: AP)

At a closely watched appeal in which various claimant groups are seeking leave to target General Motors LLC, or New GM, Circuit Judges Chester J. Straub, Denny Chin and Susan L. Carney all expressed displeasure at U.S. Bankruptcy Judge Robert Gerber's April 2015 decision to wall off the $47 billion auto giant.

That decision came just months before a $900 million settlement between Old GM and criminal prosecutors.

Front-and-center in Tuesday's arguments was a stipulation between Chapter 11 GM and plaintiffs in which, according to Judge Gerber's opinion, "at least 24 Old GM personnel (all of whom were transferred to New GM), including engineers, senior managers and attorneys, were informed or otherwise aware of the ignition switch defect" before a 2009 sale agreement rescued the automaker.

“Old GM knew,” Judge Straub told the automaker's counsel Arthur Jay Steinberg of King & Spalding LLP. “The very same people who knew went to New GM. No one told the court. No one told the claimants. How are we to deal with that?”

Senior NFL official acknowledges football's link to brain disease CTE | Sport | The Guardian

Senior NFL official acknowledges football's link to brain disease CTE | Sport | The Guardian

An NFL official has acknowledged a link between football and a degenerative brain disease for the first time.

Jeff Miller, the NFL’s senior vice president for health and safety, spoke about the connection during an appearance Monday at a congressional committee’s round table discussion about concussions.

Peyton Manning retires – and ends the world's most exhausting hagiography

 

Read more

Representative Jan Schakowsky (D-Illinois) asked Miller: “Do you think there is a link between football and degenerative brain disorders like CTE?”

Miller, who was referring to chronic traumatic encephalopathy (CTE), began by discussing the work of Boston University neuropathologist Dr Ann McKee, who has found CTE in the brains of 90 out of 94 former pro football players.

“Well, certainly, Dr McKee’s research shows that a number of retired NFL players were diagnosed with CTE, so the answer to that question is certainly ‘yes,’ but there are also a number of questions that come with that,” Miller said.

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Schakowsky repeated the question: “Is there a link?”

“Yes. Sure,” Miller responded.

The NFL has not previously linked playing football to CTE, a disease linked to repeated brain trauma and associated with symptoms such as memory loss, depression and progressive dementia. It can only be detected after death. Among the players found to have CTE in their brains were Hall of Famers Junior Seau and Ken Stabler.

During Super Bowl week, Dr Mitch Berger, a member of the NFL’s head, neck and spine committee, would not draw a direct line from football to CTE.

OTHERWISE: Could three seemingly simple laws really reduce US gun deaths by more than 90 percent?

OTHERWISE: Could three seemingly simple laws really reduce US gun deaths by more than 90 percent?

from CNN:

from CNN:

Passing federal laws that require universal background checks for firearm purchases, background checks on ammunition purchases and firearm identification could reduce the rate of U.S. gun deaths by more than 90%, according to a new study.  "We wanted to see which restrictive gun laws really work, as opposed to saying 'restrictive laws work,' and figure out if we are pushing for a law which might not work," said Bindu Kalesan, assistant professor of medicine at Boston University and lead author of the study...  in The Lancet.

Researchers arrived at the projection by looking at the number of gun-related deaths in every state in 2010 and the types of laws that existed in those states in 2009, including restrictive laws, such as background checks and child access prevention laws, and permissive laws, such as stand-your-ground laws.  They took into account differences in rates of gun ownership, unemployment and homicides that did not involve guns deaths.  Out of the 25 existing state laws that Kalesan and her colleagues studied, nine were associated with lower rates of gun-related deaths.

The researchers found the largest effects for universal background checks, which were associated with a 39% reduction in death, and ammunition background checks, which were associated with an 18% reduction in death. Laws around firearm identification, which make it possible to determine the gun that fired a bullet, were associated with a 16% reductions in deaths.

Researchers projected that federal laws expanding background checks for firearms purchases would reduce the U.S. gun death rate by 57%, while background checks for ammunition purchases would cut gun death rates by 81% and firearm identification would reduce the rate by 83%. The researchers said it would take many years to lower the rates so far.  Although a federal policy known as the Brady Law requires background checks on individuals who want to buy a firearm from a licensed dealer, it leaves a large gap, as an estimated 40% of firearms are acquired through unlicensed sellers, such as some online and at gun shows....

The researchers found that nine of the 25 laws they analyzed were linked to higher rates of gun-related deaths. Another seven laws did not seem to have an impact one way or the other on gun-related deaths.  Some of the laws that were linked with greater numbers of gun related deaths came as a surprise to the researchers. For example, bans on assault weapons, such as semi-automatic guns, were associated with a 15% increase in mortality....

In an editorial published with the study, Harvard School of Public Health Professor David Hemenway said the study was "a step in the right direction" to understand the scientific evidence about policies to reduce gun violence. But, he said, cutting mortality rates so dramatically is more complicated than simply implementing background checks for firearms and ammunition. "That result is too large -- if only firearm suicide and firearm homicide could be reduced so easily," Hemenway wrote.

Alabama gives up same sex marriage fights//Howard Wasserman /Prawfs Blog

 Alabama Probate judges are issuing marriage licenses to same sex couples - because they are obeying a federal court order, although the Alabama Chief Justice's directive to follow Alabama law remains in place, as Martin Lederman and Howard Wasserman explain. - gwc

Alabama Supreme Court dissmisses same-sex marriage mandate // Prawfs Blawg

The Supreme Court of Alabama today dismissed the mandamus action, and all pending motions, filed by several advocacy groups to stop probate judges from issuing marriage licenses to same-sex couples. I have not had a chance to read it yet; it includes a lengthy opinion from Chief Justice explaining why he is no longer recusing himself from the action and why Obergefell is evil.

The upshot is that there is no longer any state-court order obligating probate judges to act inconsistently with Obergefell. Some still might, of course, but they cannot rely on the state court to justify doing so.
More (no pun intended) later this weekend.

Abolish Absolute Governmental Immunity in Snow and Ice Cases | New Jersey Law Journal

When Chris Christie became Governor of New jersey, pledging to "turn Trenton upside down" he aimed for the repudiation of the state Supreme Court's dedication to equitable school funding and open housing.  Although he has not achieved that, he has got a Republican majority which has been chipping away at the court's legacy of expansion of tort liability.  The Law Journal Editorial Board is not reconcile dto that path.  Here it urges the court to take a modest step forward to hold liable government enterprises like the state's mass transit operator NJ Transit. - gwc

Abolish Absolute Governmental Immunity in Snow and Ice Cases | New Jersey Law Journal

by the Editorial Board

In the petition for certification now before it in Mann v. New Jersey Transit —a snow and ice case—the New Jersey Supreme Court has an opportunity to answer a question that has long discomfited some judges on the Appellate Division: Should a mass transit operator's Tort Claims Act liability for dangerous conditions of its property be subject to the same duty of care as a public housing authority's?


At common law, the sovereign was immune to suit absent consent. But as government expanded, providing housing and mass transit, pressure grew for government to bear liability comparable to that of private businesses. The 1946 Federal Tort Claims Act was among the first to do so. In the 1968 case Jackson v. Hankinson and Bd. of Ed. of New Shrewsbury, our Supreme Court said:

"And although there has thus far been no express and complete disavowal of active wrongdoing terminology, there has been a shift towards frank recognition that municipal entities, along with all others, should justly be held accountable for injuries resulting from their tortious acts and omissions under ordinary principles of negligence, except, as a matter of policy, in situations involving so-called discretionary determinations and the like."

Later that year, in Miehl v. Darpino, the court refused to extend a cause of action to a snow hazard created by plowing snow into a bank that made it hazardous to cross at an intersection. The municipality's efforts to clear the roads should not create liability where none would exist if they had not acted at all, the court decided. Spurred by the prospect that the court could sweep away governmental immunity, the Legislature in 1972 adopted the Tort Claims Act. Though Title 59 generally embraced the court's call for reform, it codified the Miehl rule, retaining governmental immunity for injuries "caused solely by the effect on the use of streets and highways of weather conditions."

Twenty years later, the court construed the Tort Claims Act in Bligen v. Jersey City Housing Authority (1993). In an opinion by Justice Marie Garibaldi, the court found that neither the Tort Claims Act nor the principle of common law governmental immunity barred imposition of liability upon a public housing authority. The court distinguished the agency's role as property manager of its "internal driveways" from the statute's grant of immunity for snow removal on "streets and highways."

Since then, the Appellate Division has sharply limited Bligen to its facts. Other public entities have been held to be immune in a raft of snow and ice cases, a result often thought to be commanded by Miehl, commonly referred to as the "common law rule". If by that courts mean that Miehl preceded the Tort Claims Act, then the designation is accurate. But if one has in mind a mass transit operator like New Jersey Transit, the common law rule has long been that of Kelly v. Manhattan Ry. Co. (1899), a snow and ice case:

"...[I]n the approaches to the cars, such as platforms, halls, stairways and the like, a less degree of care is required, and for the reason that the consequences of a neglect of the highest skill and care which human foresight can attain to are naturally of a much less serious nature. The rule in such cases is that the carrier is bound simply to exercise ordinary care in view of the dangers to be apprehended."

In the 1998 case Lathers v. Township of West Windsor, which involved a fall on an icy path at a municipal building, the court felt constrained by Bligen and its progeny. But one panel member invited our Supreme Court to "review the existing law, perhaps to declare that sidewalk ice or snow hazards be treated as any other dangerous condition under the Tort Claims Act." The Supreme Court denied certification.

This past December, Judge Jack Sabatino, concurring in the dismissal of yet another snow and ice case—Mann v. New Jersey Transit Corporation—renewed that call. Sabatino pointed out the elementary nature of the negligence claim and the need to treat like cases alike. No substantial basis exists to distinguish New Jersey Transit's 159 stations from the extensive properties of municipal housing authorities. Fear of excessive liability should be tamped down by the requirement of Title 59 that liability for unsafe conditions of public property is to be found only if the public entity's conduct is "palpably unreasonable." Governmental entities also have the benefit of the Brooks v. Odom (1997) rule that "a plaintiff must sustain a permanent loss of the use of a bodily function that is substantial."

The court now has before it a petition for certification. The construction for which Sabatino calls is well within the court's power to develop tort law through statutory interpretation, as it did in Bligen. If the court embraces the recognition of a duty on public mass transit operators to assure safe transit on their properties, the Legislature can study the issue and address it. But our 40 years of experience with the Tort Claims Act shows that the slippery slope arguments that are often raised are no threat here. The massive New York City bus and subway system, for example, has not been reduced to insolvency by the long established duty of ordinary care. In Bethel v. NYCTA (1998) the New York Court of Appeals declared that on or off the rails the Transit Authority has the duty of ordinary care in the management of its hundreds of stations, terminals, fleets of vehicles and rolling stock.

Our Supreme Court long ago recognized the anomaly of governmental immunity for negligent maintenance of facilities. It is time to finally abandon the rule of absolute immunity, which encourages the derisive view that slipshod efforts are "close enough for government work." We think the court should grant the petition and eliminate the anomaly of absolute immunity in snow and ice cases against some but not other public agencies.Read more: http://www.njlawjournal.com/id=1202751473821/Abolish-Absolute-Governmental-Immunity-in-Snow-and-Ice-Cases#ixzz42Ke2Nf3a

Lessons From Flint | Legal Planet

 Lessons From Flint | Legal Planet

by Jim Salzman // UCLA School of Law


A public-minded researcher discovers serious contamination of drinking water. His efforts to alert local officials are rebuffed. Concerned over how this will affect their reputation and the town’s economy, the authorities sit on the evidence and deny any problems. All the while, trusting people continue to drink unsafe water.

While the setting may call to mind recent events in Flint, Michigan, this is actually the plot from Henrik Ibsen’s classic 1882 play, An Enemy of the People. The places and dates have changed, but the challenges of providing drinking water remain. Just how safe really is our water and how can we make it safer?

We marked the fortieth anniversary of the Safe Drinking Water Act in 2014. In many respects, it was a date well worth celebrating. Most Americans take tap water for granted. We enjoy some of the safest and most reliable drinking water in the world. More than 90 percent of customers receive water that meets all standards all the time. This is a far cry from a century ago, when waterborne illnesses and deaths were commonplace. The famed aviator brother, Wilbur Wright, died of typhoid in 1914. The 1916 polio epidemic required quarantines in New York City, where 9,000 cases were reported. Today, these and other waterborne diseases have virtually disappeared in America. Glass half full.

Yet the glass remains half empty. Just ask the residents in Charlestown, West Virginia, where two years ago a chemical spill shut down water supplies, or in Toledo, Ohio, where seven months later an algal bloom closed their water system. The threats in those cases were due to causes beyond the reach of the Safe Drinking Water Act – a breach in a chemical storage tank atop a river bank in Charlestown, and excessive nutrients from agriculture flowing into Lake Erie in Toledo. These incidents made clear that action to ensure safe drinking water needs to start well upstream of the water treatment plant.

The Flint case is different and more disturbing.

We, as water drinkers, must ultimately rely on the actions of regulators and water authorities, trusting that the water coming out of our tap is in fact safe to drink. Few consumers have the technological savvy or means to test their water for arsenic, Cryptosporidium, lead, or the myriad other potential threats, much less at concentrations of parts part million. One can use the popular water filters, which will remove some pollutants but not lead and many others. Ultimately, we have no choice but to trust the experts.

That’s why Flint is so particularly damaging. Local, state, and federal regulators’ failure to act in a timely manner harmed not only Flint residents but undermined the public’s confidence in our water supply management more generally. In California, the ongoing drought has water suppliers looking closely at directing highly treated waste water back into the mains for household use. Will consumers trust the authorities to treat the water sufficiently?....

Alabama Supreme Court dismisses SSM mandamus //PrawfsBlawg

 Alabama Probate judges are issuing marriage licenses to same sex couples - because they are obeying a federal court order, although the Alabama Chief Justice's directive to follow Alabama law remains in place, as  Martin Lederman  and Howard Wasserman explain. - gwc  3/6/16

Alabama Supreme Court dissmisses same-sex marriage mandate // Prawfs Blawg

The Supreme Court of Alabama today dismissed the mandamus action, and all pending motions, filed by several advocacy groups to stop probate judges from issuing marriage licenses to same-sex couples. I have not had a chance to read it yet; it includes a lengthy opinion from Chief Justice explaining why he is no longer recusing himself from the action and why Obergefell is evil.

The upshot is that there is no longer any state-court order obligating probate judges to act inconsistently with Obergefell. Some still might, of course, but they cannot rely on the state court to justify doing so.
More (no pun intended) later this weekend.

OTHERWISE: Civilian Complaint Review Board - APU and Police Discipline

OTHERWISE: Civilian Complaint Review Board - APU and Police Discipline