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)

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Tuesday, November 26, 2013

Frustration From a Deal on Flawed Hip Implants -

Celeste Laney calls the settlement "a joke"
Frustration From a Deal on Flawed Hip Implants -
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.

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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.

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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). 

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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

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Tuesday, November 12, 2013

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

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 -
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.

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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:

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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.

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