Friday, December 27, 2013

Abbott Labs Settles With U.S. Over Kickback Claims - NYTimes.com



 "(Reuters) - Abbott Laboratories has agreed to pay the United States $5.48 million to resolve allegations that it paid improper kickbacks to induce doctors to use some of its products, the U.S. Department of Justice said on Friday.
The settlement resolves allegations that Abbott paid well-known doctors for teaching assignments, speaking engagements and conferences, expecting that they would arrange for the hospitals with which they were affiliated to buy Abbott's carotid, biliary and peripheral vascular products.
This activity violated the federal Anti-Kickback Act and led to the submission of false Medicare claims, the government said, in a case brought under the federal False Claims Act."

'via Blog this'

Thursday, December 26, 2013

Judge rules proof of direct causation unnecessary for BP oil spill claimants

Federal judge rules proof of direct causation unnecessary for BP oil spill claimants:
[JURIST] US District Judge Carl Barbier for the US District Court Eastern District of Louisiana [official website] ruled on December 24, 2013  [order, PDF] on Tuesday that BP [corporate website] could not require businesses to provide proof their economic losses were directly caused by the 2010 Deepwater Horizon Oil Spill under the terms of their prior settlement agreement. Under the $9.2 billion settlement, BP had agreed that businesses in certain geographical regions were presumed to have economic losses from the oil spill if those losses followed a specific pattern. BP had challenged those terms [Bloomberg report], arguing that businesses could only recover if their damages directly linked to the spill, and stating that spill payments had been wrongly inflated through fake claims and poorly calculated economic losses. 

Barbier wrote that "the delays that would result from having to engage in a claim-by-claim analysis of whether each claim is 'fairly traceable' to the oil spill...are the very delays that the Settlement, indeed all class settlements, are intended to avoid" and that not only was the framework BP previously agreed "an efficient and 'economically appropriate' method of determining causation," but that a showing of direct causation "would bring the claims administration process to a virtual standstill." BP has indicated that it will appeal the ruling. However, Barbier did side with BP on one issue, holding that spill-related losses should be calculated with matched revenue and expenses, overruling a previous decision that said that some expenses and revenue did not need to be matched.


Tuesday's ruling is the most recent development in a long series of legal battles that have arisen from the Deepwater Horizon Crisis in April 2010, which killed 11 people and released millions of barrels of oil into the Gulf of Mexico. The US Court of Appeals for the Fifth Circuit [official website] in October reversed a district court ruling that interpreted a settlement agreement [JURIST reports] between BP and the class of parties injured in the Deepwater Horizon oil spill in a way that permitted recovery for artificial and inflated claims. 

In September, Halliburton Energy Services [corporate website; JURIST news archivepleaded guilty[JURIST report] to charges that it had destroyed evidence in connection with its role in the BP oil spill in US federal court. 

In January a judge for the US District Court for the Eastern District of Louisiana accepted aplea agreement [JURIST report] between BP and the US Department of Justice (DOJ) [official website] for the company's criminal liability in the spill. 

Earlier in January Transocean Ltd. [corporate website] pleaded guilty [JURIST report] to "negligently discharging oil into the Gulf of Mexico," in violation of the Clean Water Act (CWA) [EPA summary] and agreed to pay $1 billion in civil penalties and $400 million in criminal penalties for its role in the Deepwater Horizon spill. According to JURIST Guest Columnist Tim McEvoy, the BP settlement is an appropriate step [JURIST op-ed] toward dealing with the spill's harmful consequences.


'via Blog this'

Friday, December 20, 2013

Payouts to NFL Players with Mild Dementia Clarified // NY Times

Banner 2Much remains unknown about the proposed settlement in the NFL Concussion Litigation.  The agreement has not been filed, but there is some information online.  See plaintiffs steering committee website. - GWC
Payouts to NFL Players with Mild Dementia Clarified  NY Times
by Ken Belson
A persistent criticism of the $765 million settlement the N.F.L. agreed to in August is that only retired players in the worst health will receive payouts.
Under the terms of the settlement, the finer points of which are still being worked out, former players with amyotrophic lateral sclerosis (often known as A.L.S. or Lou Gehrig’s disease), Parkinson’s disease or other serious conditions could receive up to $5 million
But for the past four months, lawyers for the N.F.L. and lawyers for the more than 4,500 former players who sued the league, claiming it deliberately hid information from them about the dangers of concussions, have been sorting out another category that would allow retirees with mild dementia to be compensated as well.
According to the plan announced in August, retirees who receive a diagnosis of full-blown dementia will be eligible for payments of up to $3 million. Retired players will receive less than the maximum if they played fewer than five seasons, are of a certain age, had a stroke, or sustained head trauma unrelated to football (in a car accident, for instance).
The extra category, which was part of the original agreement but had not been fleshed out when the settlement was announced, would allow retired players who have mild dementia to receive up to $1.5 million with the understanding that if they developed full-blown dementia, they could receive as much as $1.5 million more, for a maximum total of $3 million.

Wednesday, December 18, 2013

Court to Smokers: Get Sick First – New York Personal Injury Law Blog

Court to Smokers: Get Sick First – New York Personal Injury Law Blog:
by Max Herman - Guest blogger
So you find out that for the last 10 years you’ve been exposed to radiation, dioxin or carcinogenic smoke.  And you also find out that your exposure is due to the negligence of another.  Of course, you haven’t developed any symptoms, yet the doctors tell you your likelihood of developing cancer has been substantially increased.   You’re scared, angry and realize that for the rest of your life you’re going to need medical surveillance if you’re going to beat the disease to its potential punch.“But who’s going to pay for that monitoring?” you wonder.  I don’t know, but if you’re in New York, I know it won’t be the guy who caused your exposure.In a surprising (to me and several Federal District Courts) turn of events, the New York Court of Appeals released a decision today answering two questions asked by the Second Circuit:Does New York State recognize an independent claim for medical monitoring?And if so, what are the elements and when does the limitations period accrue?The highest court in the state answered the former in the negative and declined to answer the latter as academic.


'via Blog this'

Cantor Fitzgerald Settles 9/11 Suit Against American Airlines for $135 Million - NYTimes.com

Judge Alvin Hellerstein has overseen
the litigation arising from the 9/11 catastrophe
Cantor Fitzgerald Settles 9/11 Suit Against American Airlines for $135 Million - NYTimes.com:

by Benjamin Weiser
"More than a dozen years after the Sept. 11 attacks, a last major piece of litigation against the airline industry and other defendants moved toward an end on Tuesday, as the Wall Street firm Cantor Fitzgerald revealed that it would settle its lawsuit for $135 million.
Cantor had accused American Airlines of negligence in allowing five terrorists to board the plane in Boston that crashed into the World Trade Center’s north tower, killing 658 of Cantor’s almost 1,000 employees in New York.
No amount of money, of course, could compensate Cantor or its families for the losses on Sept. 11, but the agreement, announced less than a month before the case was to be tried in Manhattan, followed years of legal sparring over what damages Cantor could seek.
After the proceeding, Cantor’s chairman, Howard W. Lutnick, said in a statement: “For the insurance companies, this was just another case, just another settlement, but not for us. We could never, and will never, consider it ordinary. For us, there is no way to describe this compromise with inapt words like ordinary, fair or reasonable. All we can say is that the legal formality of this matter is over.”
'via Blog this'

Tuesday, December 17, 2013

Workers' Compensation: Governor Cuomo Announces Significant new Protections for World Trade Center Workers

Workers' Compensation: Governor Cuomo Announces Significant new Protections for World Trade Center Workers:
from Jon Gelman's Workers Compensation Blog
Governor Andrew M. Cuomo today announced World Trade Center workers who performed rescue, recovery and clean-up in the year after 9/11 now have significant new protections for workers’ compensation benefits. The World Trade Center Registry was reopened and the deadline for joining extended to September 11, 2014; certain previously time-barred World Trade Center claims are being reopened and considered timely; and qualifying health conditions were added to the law.
New York State is committed to caring for those who stood up in the face of danger to assist in the rescue and recovery efforts during and after the horrific attacks at the World Trade Center,” Governor Cuomo said. “That is why we are providing new protections for the workers, including first responders, clean-up crews and volunteers, who answered the call for help and ensuring they have access to workers’ compensation benefits for the future. I urge those who worked at Ground Zero and other recovery sites to file a WTC-12 form today to apply for the benefits they deserve.”
Filing a WTC-12 form with the Workers’ Compensation Board preserves the workers’ compensation rights for those who performed rescue, recovery and clean-up after theWorld Trade Center attacks.

'via Blog this'

Contractors assault on NY Scaffold Law

a familiar sight

Having failed to budge the courts from the strict liability long imposed on contractors when workers fall from heights, New York's construction industry has mounted a major campaign to reduce verdicts by imposing "comparative negligence" on workers who suffer injury.  Workers are in fact often careless.  That's a fact of life.  So the law has sought to compel employers and and owners to protect workers from their own failings.  But with typical sky is falling rhetoric the industry seeks relief from the scaffold law that has seen Manhattan grow ever higher and dense despite the liability burden. - GWC

Contractors and Workers at Odds Over Scaffold Law
by Kirk Semple// NY Times

In 1885, as new engineering inventions were ushering in the era of the skyscraper, lawmakers in New York State enacted a lawintended to safeguard construction workers who were finding themselves facing increasing dangers while working at ever-greater heights.

Connect With NYTMetro

Metro Twitter Logo.
Follow us on Twitterand like us on Facebookfor news and conversation.
Michael Appleton for The New York Times
A construction worker standing on scaffolding on Greenwich Avenue. A counter-lobby of unions, worker’s advocates and trial lawyers is pushing back to preserve the law.

Readers’ Comments

Share your thoughts.
That measure, which became known as the Scaffold Law, required employers on building sites to ensure the safety of laborers working above the ground. Since then, some form of the legislation has remained on the books despite repeated attempts to repeal it.
But a lobby of contractors, property owners and insurers has in recent months renewed a campaign against the law, arguing that no less than the future of the state’s construction industry is at stake.
They argue that the law is antiquated and prejudicial against contractors and property owners, and essentially absolves employees of responsibility for their own accidents, leading to astronomical settlements. The payouts, they contend, have in turn led to skyrocketing insurance premiums that are hampering construction and the state’s economic growth.
On Tuesday, a coalition of contractors, including a newly formed alliance of firms owned by women and minorities, announced the start of an advertising and lobbying blitz in Albany and New York City. But a counter-lobby of unions, worker’s advocates and trial lawyers is pushing back just as fiercely. The law, they argue, is essential to ensuring the safety of workers in some of the world’s most dangerous jobs, particularly those employed by shoddy contracting firms that cut corners to save money. The law, they say, holds developers and contractors accountable for keeping job sites safe.
Gov. Andrew M. Cuomo, on Monday, acknowledged the politically loaded atmosphere surrounding the Scaffold Law, but suggested that he was open to the possibility of modifying the law.
The law states that contractors and property owners are responsible for ensuring that scaffolds, hoists and other devices that enable above ground building construction and repair “shall be constructed, placed and operated as to give proper protection to a person so employed.”
When injuries result from a violation of those terms, the law says, contractors and owners are liable. There is no mention of worker responsibility. Under the law, however, the plaintiff still must show that a violation of the law’s standards occurred and that the violation caused the injury.
But those seeking to change the law want to incorporate a standard of “comparative negligence.” This amendment — described in a state bill submitted earlier this year — would require a jury or arbiter to consider whether the liability of the defendants — and thus the amount of damages — should be reduced for cases in which the worker’s negligence or failure to follow safety procedures contributed to the accident.

New York high court rejects medical monitoring claim against Philip Morris USA

Philip Morris has a long history of fraudulent marketing.
Its Marlboro brand is designed to produce the highest quantity of
nicotine, the addictive substance in cigarettes
In a dramatic example of the timidity which infects our judiciary the New York Court of Appeals has rejected an appeal to follow Massachusetts and West Virginia in recognizing a medical monitoring action by long-time heavy smokers.  In Caronia v. Philip Morris USA the court’s majority trod the well worn path of recognizing the public benefits of early (pre-manifestation) lung cancer screening, but staying its hand citing the usual pandora's box, where will it ever end.  Judge Benjamin Cardozo famously overcame that shibboleth when in 1916 he ruled in MacPherson v. Buick that any consumer had the right to sue the manufacturer of a defective automobile even if he had not bought it directly from the maker.

But now only Chief Judge Jonathan Lippman and colleague Jenny Rivera were ready to take Cardozo's place. In a vigorous dissent the Chief Judge declared:
“It is difficult to envision a scenario more worthy of the exercise of this Court's equitable powers.  Indeed, it is contrary to the spirit of New York law to deny these plaintiffs an opportunity to seek relief in equity where the policy justifications for the proposed medical monitoring cause of action are so compelling."  
Lippman cited four grounds: 
* monitoring claims promote the "important public health interest in fostering access to medical testing for individuals whose exposure to toxic chemicals creates an enhanced risk of disease, particularly in light of the value of an early diagnosis and treatment for many cancer patients" 

* “implementing a medical monitoring program has economic benefits not only for plaintiffs, but also for tobacco companies, since the cost of monitoring and treatment upon early detection pales in comparison to the expenses of treatment post-diagnosis, not to mention those incurred by defendants in wrongful death suits”.

* “requiring defendant to cover the costs of reasonably necessary medical monitoring would serve an important deterrence function.  As evidenced by the District Court's dismissal of plaintiffs' negligence, strict liability and breach of warranty claims, the burdens of proof for injury, causation and timeliness in tort make the threat of legal action ineffective at deterring the kind of misconduct alleged here.” 

* “it is just to shift the cost of medical monitoring onto the tortfeasor because it would be inequitable for an individual wrongfully exposed to dangerous toxins, but unable to prove that cancer or disease is likely, to have to pay the expense of medical monitoring when such intervention is clearly reasonable and necessary”.

A first: Glaxo will stop paying doctors to pitch drugs

Glaxo paid $3 billion in fines to settle
allegations of fraud regarding this diabetes drug
The depth of the corruption of the pharmaceutical industry is illustrated by the fact that in a first Glaxo Smith Kline announces that it will stop paying doctors to promote drugs and stop paying sales people by the number of prescriptions written. The cynic in me says - wait for the fine print. Take a look at its history of fraud and you will see why I have my doubts.
- GWC

by Katie Thomas - New York Times
The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest.

Monday, December 16, 2013

Just what risks do athletes "assume"?

Ryan Freel, a 36 year old form major league baseball player known for his hustle committed suicide at 36.  Post-mortem tests show he suffered from traumatic brain injury.    What is to be done ~ especially about football?

OTHERWISE: The selling of ADHD - NY Times


OTHERWISE: The selling of ADHD - NY Times: "The profound corruption of our pharmaceutical industry is explored in this report. - gwc
The Selling of A.D.H.D.
by Alan Schwarz // The NY Times"



'via Blog this'

Wednesday, December 11, 2013

194 child shootings this year

Slate: 194 kids 10 or under shot this year.  Situation Normal All F*cked Up, as the WWII expression goes.

DePuy Hip Implant Deal Excludes Thousands

DePuy Hip Implant Deal Excludes Thousands: by Amanda Bronstad
National Law Journal
Just weeks after DePuy Orthopaedics Inc. announced a $2.5 billion settlement to resolve the bulk of the litigation over its recalled hip implants, some lawyers have raised concerns about the thousands of patients excluded from the deal and the process that determines how the plaintiffs will be compensated.
The settlement resolves about 8,000 lawsuits filed nationwide against DePuy, a unit of Johnson & Johnson. DePuy agreed to provide a $2.475 billion cash fund to compensate patients for costs associated with "revision surgeries," or those designed to remove its implants — the "ASR XL" or "ASR resurfacing devices," which plaintiffs claimed caused pain, clicking and grinding of the hips, as well as high metal content in blood tests.
The deal, announced at a Nov. 19 hearing in Toledo before U.S. District Senior Judge David Katz, also includes up to $1 billion in reimbursements to health care insurance firms that paid for those surgeries.
But plaintiffs in about 4,000 cases won't be eligible to participate in the settlement, which is also contingent on at least 94 percent of patients submitting claims. DePuy has the right to walk away if too many opt out.
Some already have raised concerns about the settlement.



Read more: http://www.law.com/jsp/nj/PubArticleNJ.jsp?id=1202631268495&DePuy_Hip_Implant_Deal_Excludes_Thousands_#ixzz2nAqKtjC2

'via Blog this'

Monday, December 9, 2013

25 years ago - the Exxon Valdez oil spill - a look back.

The Times takes a look back at the lessons of the Exxon Valdez oil spill 25 years ago.  An important effect is the strict liability and broader recoveries imposed via the Oil Pollution Act of 1990.  It made possible the quite smooth (all things considered) compensation scheme for the BP Gulf oil spill - he Deepwater Horizon Settlement.

Sunday, December 8, 2013

The Punishment Cure - NYTimes.com

There is too many millionaires in the Senate - and the House for reality to hold much sway. - GWC
The Punishment Cure - NYTimes.com:
by Paul Krugman

The G.O.P. answer to the problem of long-term unemployment is to increase the pain of the long-term unemployed: Cut off their benefits, and they’ll go out and find jobs. How, exactly, will they find jobs when there are three times as many job-seekers as job vacancies? Details, details.

'via Blog this'

Is The United States Supreme Court Poised To Overrule or Modify Basic Inc. v. Levinson? - Litigation, Mediation & Arbitration - United States

Is The United States Supreme Court Poised To Overrule or Modify Basic Inc. v. Levinson? - Litigation, Mediation & Arbitration - United States: by Eric A. Boden//Schnader Harrison

On November 15, 2013, the U.S. Supreme Court granted a petition for writ of certiorari to Petitioner Halliburton Company ("Halliburton") in the case entitled Halliburton Co. v. Erica P. John Fund, Inc., f/k/a Archdiocese of Milwaukee Supporting Fund, Inc. Halliburton appeals to the Supreme Court from a decision by the U.S. Court of Appeals for the Fifth Circuit affirming the certification of a class in a securities fraud class action and rejecting Halliburton's attempt to introduce price impact evidence at the certification stage to rebut the presumption of reliance afforded by the fraud-on-the-market theory (see fn 1, infra). By granting Halliburton's writ of certiorari, the Supreme Court has agreed for the second time in connection with this class action to revisit its 1988 landmark ruling in the case of Basic Inc. v. Levinson, 485 U.S. 224 (1988) ("Basic"), a decision which eased the obstacles to certification of putative classes in securities class actions.

On appeal, Halliburton presents the Supreme Court with two questions: (i) whether the Court should "overrule or substantially modify [Basic] to the extent that it recognizes a presumption of class wide reliance derived from the fraud-on-the-market theory," and (ii) whether, "in a case where the plaintiff invokes the presumption of reliance to seek class certification, the defendant may rebut the presumption and prevent class certification by introducing evidence that the alleged misrepresentations did not distort the market price of its stock." Halliburton Petition for Writ of Certiorari ("Halliburton Pet."), 2013 WL 4855972 (2013).


'via Blog this'

Saturday, December 7, 2013

Corps wasn't held accountable for MR-GO damage, but case was worth fighting: Joseph M. Bruno | NOLA.com

mrgo.JPG
Corps wasn't held accountable for MR-GO damage, but case was worth fighting: Joseph M. Bruno | NOLA.com: by Joseph M. Bruno
It has been eight years since Hurricane Katrina exposed the fatal flaws in the Lake Pontchartrain and Vicinity Hurricane Protection System. Even though thousands died and billions of dollars were lost because of its neglect, the United States Army Corps of Engineers was granted immunity. The corps will never again be known as the greatest engineering firm in the world.



'via Blog this'

Friday, December 6, 2013

Environment, Law, and History: The Environmental Moment

Environment, Law, and History: The Environmental Moment:
Environmental History has a review by Gary Kroll of The Environmental Moment, 1968–1972, a collection of primary-source documents edited by David Stradling (U Washington Press, 2012). The book contains a number of classic legal sources, including the National Environmental Policy Act and Justice Douglas's iconic dissent in Sierra Club v. Morton ("Mineral King"), in which he argued for granting standing to inanimate natural objects, as well as "voices—Reagan, Joseph Ling, and John Maddox—of those who opposed or criticized the costs of new forms of regulation."
'via Blog this'

Thursday, December 5, 2013

BP, Anadarko Ask Appeals Court to Reverse Spill Decision - Bloomberg

BP, Anadarko Ask Appeals Court to Reverse Spill Decision - Bloomberg:
Anadarko Petroleum Corp. (APC) and BP Plc (BP/)  asked an appeals court to toss out a judge’s finding they were both liable under the U.S. Clean Water Act for the 2010 Gulf of Mexico oil spill.
U.S. District Judge Carl Barbier found BP and Anadarko, partners in the doomed Macondo project, are automatically responsible under the law for polluting the water because they owned the well. The 2012 ruling allowed the federal government to seek fines of as much as $1,100 per barrel of oil spilled -- multiplied by as much as 4.2 million -- without having to prove the issue of liability at trial.
Both companies contend in filings with the U.S. Appeals Court in New Orleans that Barbier improperly decided the matter before trial. Anadarko also says the government is trying to shift the burden to the owners of the spilled oil rather than who’s responsible for the discharge.
“This isn’t a circumstance where the government gets to just make things up as it goes along,” Anadarko attorney David Salmons told the appellate panel at a hearing today. “The question is where the discharge is from, not where the oil is from.”
Neither company has much chance of prevailing before the appeals court, said law professor David Uhlmann.

'via Blog this'

Tuesday, December 3, 2013

Nocera: Asbestos Litigation a Giant Scam // NY Times

The Asbestos Scam  - by Joe Nocera // NY Times
Congresswoman Carolyn Malony was diagnosed recently with lung cancer. She quit smoking - at 69, and filed suit against asbestos manufacturers - no tobacco companies. Joe Nocera is outraged. He claims the evidence of synergy (multiiplying effect) of smoking and asbestos exposure is based on "muddled science". As to insulation workers - that is clearly not correct. But the evidence is doubtless thinner as the asbestos exposure drops and the tobacco smoking increases. Twenty years ago the New Jersey Supreme Court authorized apportionment of causation between smoking and asbestos in the case Dafler v. Raymark Industries.

Nocera is quick to embrace attacks on litigation. He got caught short on BP when he wrongly declared Deepwater Horizon settlement administrator Patrick Juneau to have been a plaintiff's lawyer who hired corruptly. Wrong on both counts. I recall no Nocera apology when Juneau was cleared by former FBI Director Louis Freeh.  Here too Nocera should have done his homework and read something more than industry press releases before launching into his diatribe. - GWC


"[Congresswoman Malony's] "claim for “asbestos exposure” is that when she was young, her father and her brother worked as boiler makers, and she came into contact with asbestos dust because they all lived under the same roof. Plus, she says in her legal filing, she “visited and picked up my father and brother at the various work sites, including Navy Yards, Bridges, Hospitals, Schools, Powerhouses, and other sites where I breathed the asbestos dust.”Her lawyer at Weitz & Luxenberg — which has feasted for decades on asbestos lawsuits — told The New York Post that “it has been conclusively proven that cigarette smoking and asbestos exposure act synergistically to cause lung cancer.” Actually, it hasn’t been: There are plenty of studies saying there is no synergy at all. At best, the science is muddled.Not that that matters. No doubt McCarthy’s lawsuit will be bundled by her law firm with other cases to force a company that had nothing to do with her disease to pay up. I hope McCarthy wins her battle with lung cancer. It is an awful disease. But the right thing for her to do is drop this lawsuit. All it has really accomplished is showing how asbestos litigation is a giant scam."

Wednesday, November 27, 2013

FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling

After the Supreme Court in Mutual Pharmaceutical v. Bartlett (2013) deferred to the FDA's view in its amicus brief that generic drug makers were not free to change labeling without agency consent,  Public Citizen petitioned the FDA to change the rule.  The FDA responded favorably to Public Citizen's request that the FDA create "parity" among drug manufacturers: all should have the duty to respond to new health information and to warn patients and their doctors.

As Professor Alberto Bernabe observes much of  the public debate on the FDA's  new proposed rule (which would effectively overturn Mutual Pharmaceutical) centers on whether it will lead to more litigation.  But as he notes - the FDA understands that the right question is will it lead to safer products?  As the FDA observes in the proposed rule  "the most critical safety-related label changes, boxed warnings and contraindications, occurred a median 10 and 13 years after drug approval (and the range spanned from 2 to 63 years after approval) underscoring the importance of persistent and vigilant postmarket drug safety surveillance."

The passive surveillance system which characterizes our quasi free-market regulatory approach has demonstrated its inadequacy.  Unfortunately, in my view, court are unlikely to recognize a common law duty of manufacturers to active survey and report on the actual performance of their products in the market.   Patients remain the subject of a vast, poorly controlled human experiment.  As I argued in Punctuated Equilibrium courts should recognize a duty of "product stewardship".
- gwc

Torts Blog: FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling:

by Prof. Alberto Bernabe

 "Earlier this month, Pharmalot reported that the FDA has in fact proposed a new rule. The proposed rule will allow generic drugmakers to update labeling with new safety information before an FDA review of the change. The agency would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time.

As expected, the rule is controversial.  Some agree that the new approach is a good idea (here, for example); others argue it is a bad idea (here and here, for example).  For more comments see here." (go to original for other links)



'via Blog this'

Tuesday, November 26, 2013

Frustration From a Deal on Flawed Hip Implants - NYTimes.com

Celeste Laney calls the settlement "a joke"
Frustration From a Deal on Flawed Hip Implants - NYTimes.com:
By Barry Meier
Patients injured by a flawed hip implant sold by Johnson & Johnson have directed their anger at myriad places over the years. The regulatory system that allowed the product’s sale. The company that repeatedly denied problems with the device. Even the doctors who implanted the hips.
When the metal parts of the Articular Surface Replacement rubbed together inside a patient, they created harmful debris. Now, some patients have found a new target for their ire: the legal system and the lawyers they hired to sue Johnson & Johnson.



'via Blog this'

Saturday, November 23, 2013

BP Declares Total War on Trial Judge in Gulf Spill Case - Businessweek

The Deepwater Horizon oil rig is seen burning on April 21, 2010 in the Gulf of Mexico
Deepwater Horizon rig ablaze - April 2010
BP Declares Total War on Trial Judge in Gulf Spill Case - Businessweek: by Paul M. Barrett
"BP has escalated an extraordinary courtroom attack on the federal judge in New Orleans presiding over the multibillion-dollar litigation concerning the 2010 Gulf of Mexico oil spill. The assault on U.S District Judge Carl Barbier concerns one particular battle in a larger legal war, and the oil company’s aggressive strategy could come back haunt it on other fronts."
Last month the U.S. Court of Appeals for the Fifth Circuit in New Orleans blocked certain spill-settlement payments for private business claims that BP (BP) had alleged were exaggerated or “fictitious.” The ruling amounted to an embarrassing rebuke of Judge Barbier, who had appointed and vigorously defended the claims administrator. Now BP has returned to the Fifth Circuit, accusing Barbier in a filing yesterday of defying the appellate court by failing to stop disputed payments to businesses whose losses the oil company contends had absolutely nothing to do with the April 2010 spill.
“The district court has refused to enjoin payments to claimants that suffered no harm traceable to the oil spill,” BP’s lead appellate lawyer, Theodore Olson, told the Fifth Circuit in a filing he called an “emergency motion.” Judge Barbier’s inaction will cause “hundreds of millions of dollars” to be “irretrievably scattered to thousands of claimants who are not proper class members,” Olson added.

'via Blog this'

Thursday, November 21, 2013

Concurring Opinions » Stipulated Damages, Exculpatory Clauses and Unconscionability

Concurring Opinions » Stipulated Damages, Exculpatory Clauses and Unconscionability:
by Dave Hoffman
On re-reading Discover Bank v. Superior Court (Cal. 2005) I found myself getting hung up on a conceptual problem you might be able to help me with. The Discover Bank court considered the validity of class action arbitration waivers. Holding such waivers unconscionable as a matter of law, the court halted (that is, until Concepcion) arbitration’s inexorable conquest of consumer litigation. 
 The court reasoned was that such waivers presented issues of both procedural and substantive unconscionability. Procedural, the waivers were default-forcing “bill stuffers” and consequently not meaningfully chosen. Substantively, “they may operate effectively as exculpatory contract clauses . . . because . . . damages in consumer cases are often small . . and the class action is often the only effective way to halt and redress [wrongdoing.]“ The question I have is what distinguishes “exculpatory clauses” – typically thought to be against public policy – from ordinary “stipulated damages” clauses, which are subject to reasonableness review. I unaware of any scholarship that tries to define exactly what stipulated damages are (and are not). 


'via Blog this'

Monday, November 18, 2013

Supreme Court grants review to reconsider "fraud-on-the-market" theory of reliance in class-action securities litigation (CL&P Blog)

The Supreme Court has taken the opportunity to put another lance in the side of securities investors who seek redress for misrepresentation.  It would deliver the blow by permitting rebuttal at the class-certification stage of the presumption of class-wide reliance on the alleged misrepresentations made by the company.  - GWC
Supreme Court grants review to reconsider "fraud-on-the-market" theory of reliance in class-action securities litigation (CL&P Blog):
The Supreme Court has granted review in yet another class action, and this one has large implications for the future of securities-fraud litigation. In Haliburton v. Erica P. John Fund, the Court will decide whether to overrule or substantially modify the rule inBasic, Inc. v. Levinson (1988), which adopted the "fraud-on-the-market" theory of reliance in securities-fraud litigation.
Put simply, that theory says that stock prices of a publicly-traded company go up and down based on all the known relevant information about the company. So, in an open securities market, people can assume (and have a right to assume) that all material information is available to current and potential investors. The idea, then, is that when the company makes material misstatements about the company''s financial situation or expected course of conduct, it defrauds the entire market, and the company's stock price is affected for all shareholders. Basic therefore held that an individual shareholder was entitled to a presumption of reliance on the company's material misstatements, even if he or she did not knowingly rely on them. Among other things, that presumption greatly simplifies class certification in a securities-fraud case. On the other hand, imagine the difficulty if the law required a showing of individual actual reliance on material misstatements.
See the cert stage BRIEFS


'via Blog this'

Tuesday, November 12, 2013

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants - NYTimes.com

This settlement is only possible because J&J took advantage of the substantial equivalence loophole that enabled them to avoid full FDA pre-market review.  If they had not been able to claim that their new metal-metal design was not substantially equivalent to pre-1976 devices they would have had to run extensive clinical rials, etc.  That would have gained them immunity thanks to the Supreme Court pre-emption 8-1 ruling in 2008 Riegel v. Medtronic, from which only Ruth Ginsburg dissented. That deplorable ruling immunized companies like Medtronic from liability for the thousands of people in whom defective pacemaker wires were implanted. - GWC
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants - NYTimes.com:
By BARRY MEIER
Published: November 12, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.


'via Blog this'

Monday, November 11, 2013

OTHERWISE: Bystanders shot by police face aggressive NYC legal defense // NY Times

16 bystanders have been shot by the NYPD in the past three years.  A 2010 4-3 decision by the new York Court of Appeals has left them with little prospect of compensation by the City.  Maybe there should be a no-fault fund? - GWC

OTHERWISE: Bystanders shot by police face aggressive NYC legal defense // NY Times:





'via Blog this'

Friday, November 1, 2013

CDC should set up youth sports concusssion surveillance system - Institute of Medicine

The Institute of Medicine in a new report has called for the Centers for Disease Control to establish a national surveillance system for your concussion injuries. - gwc

Report Brief - Institute of Medicine:
Sports-Related Concussions in Youth: Improving the Science, Changing the Culture finds that while some studies provide useful information, much remains unknown about the extent of concussions in youth; how to diagnose, manage, and prevent concussions; and the short- and long-term consequences of concussions as well as repetitive head impacts that do not result in concussion symptoms.

Charting the Unknowns

Currently, there is a lack of data concerning the overall incidence of sports-related concussions in youth, although the number of reported concussions has risen over the past decade. A number of factors may have contributed to this increase, including more awareness and better recognition of such injuries.

Among male athletes at the high school and collegiate levels, football, ice hockey, lacrosse, wrestling, and soccer consistently are associated with the highest rates of concussions. Among female athletes, high school and collegiate sports associated with the highest rates of concussions are soccer, lacrosse, basketball, and ice hockey. There has been little research on the frequency of concussions among athletes in intramural and club sports and in athletes younger than high school age.

To help close data gaps, the committee calls for the Centers for Disease Control and Prevention to establish and oversee a national surveillance system to accurately determine the incidence of sports-related concussions, including those in youth ages 5 to 21.

'via Blog this'

Wednesday, October 30, 2013

When Judges Don’t Know Everything - NYTimes.com

Linda Greenhouse on judicial imperfection.  - gwc
When Judges Don’t Know Everything - NYTimes.com:
Judge Richard Posner, on judging:
“By self-awareness and discipline, a judge can learn not to allow his sympathies or antipathies to influence his judicial votes – unduly. But the qualification in ‘unduly’ needs to be emphasized. Many judges would say that nothing ‘outside the law,’ in the narrow sense that confines the word to the texts of formal legal documents, influences their judicial votes at all. Some of them are speaking for public consumption, and know better. Those who are speaking sincerely are fooling themselves.”


'via Blog this'

Monday, October 28, 2013

Study: U.S. Hospitals Admit 7,500 Kids A Year With Gunshot Wounds

Study: U.S. Hospitals Admit 7,500 Kids A Year With Gunshot Wounds:
An abstract of the study, titled "United States Gunshot Violence--Disturbing Trends," was presented on Sunday by researchers at the American Academy of Pediatrics (AAP) National Conference and Exhibition in Orlando, Fla. The study also found that states with higher numbers of firearm ownership had higher proportions of childhood gunshot wounds.
"Handguns account for the majority of childhood gunshot wounds and this number appears to be increasing over the last decade," Arin Madenci, MD, MPH, the author's lead study, said in a statement issued by the AAP. "Furthermore, states with higher percentages of household firearm ownership also tended to have higher proportions of childhood gunshot wounds, especially those occurring in the home."

'via Blog this'

Penn State to Pay $59.7 Million to 26 Sandusky Victims - NYTimes.com

Penn State to Pay $59.7 Million to 26 Sandusky Victims - NYTimes.com: "Rodney A. Erickson, the president of the university, issued a statement calling the announcement a step forward for victims and the school.
“We cannot undo what has been done, but we can and must do everything possible to learn from this and ensure it never happens again at Penn State,” said Erickson, who announced on the day Sandusky was convicted in June 2012 of 45 criminal counts that Penn State was determined to compensate his victims."



'via Blog this'

Saturday, October 26, 2013

New Case Management Order in New Jersey DePuy ASR Recall Litigation Extends Discovery to June 2014, More than 650 Metal Hip Lawsuits Filed in Consolidated Proceeding

New Case Management Order in New Jersey DePuy ASR Recall Litigation Extends Discovery to June 2014, More than 650 Metal Hip Lawsuits Filed in Consolidated Proceeding: "A new order has been issued in a consolidated DePuy ASR lawsuit litigation (http://www.depuy-asr-hip-recall.com/) currently underway in New Jersey’s Bergen County Superior Court, Bernstein Liebhard LLP reports.
According to a Case Management Order filed with the Court on October 17th, discovery for all matters related to the DePuy ASR metal-on-metal hip replacement has been extended to 2014. This follows a discovery end date for 2013, which will expire on or before the end of the year. Further discussion of discovery deadlines will take place at the consolidated proceeding’s next status conference on November 21, 2013, the order states.
Court records indicate that over 650 DePuy ASR recall lawsuits have been filed in the New Jersey litigation, and similarly allege that the metal-on-metal hip, which was taken off the market in August 2010 after it became associated with excessively high early failure rates, may cause serious complications in recipients. (In Re DePuy ASR Hip Implants Litigation, BER-L-3971-11)"



'via Blog this'

Thursday, October 24, 2013

Watch PBS Frontline: League of Denial | Dave Pear's Blog

Watch PBS Frontline: League of Denial | Dave Pear's Blog: "Last night, PBS aired their full two-hour documentary League of Denial on Frontline and the accompanying book from Mark Fainaru-Wada and Steve Fainaru is now available online at Amazon: League of Denial: The NFL, Concussions and the Battle for Truth."



'via Blog this'

Wednesday, October 23, 2013

Jury Finds Bank of America Liable in Mortgage Program Nicknamed the 'Hustle' - NYTimes.com

Jury Finds Bank of America Liable in Mortgage Program Nicknamed the 'Hustle' - NYTimes.com:
by Landon Thomas, Jr.
Bank of America, one of the country’s largest banks, was found liable on Wednesday for having purposely sold defective mortgages, a result that will be seen as a victory for the government in its aggressive effort to hold large American banks accountable for their role in the housing crisis.
Moreover, the jury also found a top executive at Bank of America’s Countrywide unit liable, pinning some — if not all – of the responsibility for the bad acts on an individual.
During the trial, federal prosecutors accused Rebecca Mairone, a top executive at Countrywide at the time, of having opted for quantity over quality in its mortgage writing program, which resulted in the bank churning out housing loans that were destined to fail.
In its case, federal lawyers claimed that Ms. Mairone, who now works at JPMorgan Chase, led a program nicknamed the “hustle,” derived from HSSL, or the “high-speed swim lane.” The program linked bonuses to how fast bankers could originate loans. As a result, the credit quality of the borrower was given short shrift, the government contended. When these loans were sold on to mortgage giants like Fannie Mae andFreddie Mac, they failed, generating more than $1 billion in losses.
'via Blog this'