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Sixth Circuit Upholds Preemption of Design Defect Claims

James Beck, a defense lawyer with Reed Smith, blogged on Friday about the first time that an appellate court has held that a claim that a brand-name manufacturer were negligent in the design of its drugs has been preempted because it would be impossible for the drug company to comply both with federal regulations and state tort law.

It's the first appellate authority to recognize impossibility preemption of a design defect case against a brand-name manufacturer since the U.S. Supreme Court issud its ruling in Mutual Pharmaceutical Co. v. Bartlett two years ago, Beck says.

The U.S. Court of Appeals for the Sixth Circuit ruled that it would have been impossible for Ortho-McNeil-Janssen Pharmaceuticals to come up with an alternative design for one of its birth control patches either before it was approved by the Food and Drug Administration or after it was approved. The appeals court also rejected the argument that Ortho could have complied with state tort law by never starting to sell its birth control patch.

Alabama Legislators Move to Shield Brand-Name Drugmakers from Generic Liability

Alabama lawmakers have passed a bill to shield brand-name drug companies and medical-device manufacturers from liability for generic versions of their products, Reuters' Brendan Pierson reports. Last year, the Alabama Supreme Court ruled that drugmakers and device makers could face liability for innovating a product that harmed patients who take generic versions of their drugs.

Alabama Governor Robert Bentley is expected to sign the bill.

FDA to Expand Electronic Health Records Pilot to Track Product Safety

According to a report in iHealthBeat, the Food and Drug Administration is going to expand a pilot that is using electronic health records, as well as claims data, to monitor the safety of medical devices the agency regulates: "Specifically, FDA said the [Mini-Sentinel] system can examine: More than 350 million person years of observation; Four billion pharmaceutical dispensings; and 4.1 billion patient meetings." Now, the pilot is being rolled out on a full scale.

Families Sue Gunmaker Over Sandy Hook Shooting

The families of 20 first-graders killed by Adam Lanza at a Connecticut elementary school have sued the manufacturer of the military assault rifle used in the school shooting, Bloomberg's Phil Milford and Christian Dolmetsch reports. Lawyers for the families said in a statement that the Bushmaster Firearms International LLC rifle was specifically designed for combat, not for defending one's home or for hunting.

Milford and Dolmetsch report that the complaint alleges "Bushmaster knew or should have known that selling assault rifles to civilians posed an 'unreasonable and egregious' risk of injury to others."

The lawsuit also names names "Camfor, a firearm wholesaler, and Riverview Gun Sales, the East Windsor store where the gun was purchased by Lanza's mother, Nancy," the Connecticut Law Tribune reported. Lanza also killed his mother with the gun before killing 20 children, six adults and himself at the Sandy Hook Elementary School.
 

@SupremeCtofPA Decides Against Changing Products Law

The Pennsylvania Supreme Court has decided it will not follow the Restatement (Third) of Torts, which "would have allowed defendants to introduce elements regarding the foreseeability of a product's risks, and whether alternative, safer designs were available when the product was manufactured," The Legal Intelligencer's Max Mitchell reports. The Second Restatement does not consider the feasibility of an alternative design or a manufacturer's conduct. The court did adapt PA's products law to allow juries to consider "consumer expectation and risk-utility balancing tests."
 

'Regulatory Engineering' Can Address Legal Issues with Drones

Entrepreneur Jay Bregman wants to add regulatory engineers at a new startup to help companies use drones without running afoul of products liability and privacy law, C|NET's Steve Shankland reports: "His as-yet-unnamed startup plans to bake those rules into drone control software so drone makers and operators can fly the robotic devices without fear." Bregman said that the Federal Aviation Administration just doesn't have the bandwidth to regulate thousands and thousands of drones, so technology could enforce regulations via software code.

Motions Debate Access to Evidence of 'Misrepresentation' in Asbestos Case

Submitted by Amaris Elliott-Engel on Tue, 10/07/2014 - 18:35

I'm writing several times a day about products liability for Law.com/The National Law Journal. Occasionally I cross-post a blog I find particularly interesting.

Garlock Sealing Technologies LLC and two other related defendants are opposing motions to keep sealed the names of asbestos plaintiffs and the amounts of settlements they have reached with those plaintiffs.

The judge presiding over the Garlock’s bankruptcy proceedings has set up a process to unseal evidence that led him to make findings of alleged misrepresentation by plaintiffs.

Garlock also wants to unseal questionnaires submitted by claimants in its bankruptcy case and submissions made by claimants to trusts formed out of other companies’ asbestos-related bankruptcies.

“A large portion of the asbestos claimants whose names appear in the estimation record have open claims and are therefore the putative creditors (and parties in interest) in this case,” Garlock said. “The [U.S. Court of Appeals for the Fourth Circuit] has held that parties should be allowed to litigate anonymously only in ‘extraordinary circumstances’ justifying a ‘rare dispensation.’”

Claimants’ names are routinely disclosed in asbestos tort litigation and in marketing materials disseminated by the law firms representing them, Garlock said.

In a separate motion , the official committee of asbestos personal injury claimants objected to Garlock’s request to seal some of the bankruptcy filings, including the major expense authorizations that memorialize the reasons Garlock settled mesothelioma cases for the amounts it did and trial evaluation forms completed by Garlock’s outside counsel about cases going to trial.

“Until now, the debtors have been enthusiastic advocates of disclosure, casting themselves as crusaders on the public’s behalf,” the committee said. “Now, without any sense of irony, the debtors maintain that their own documents—critical pieces of the ‘full story’—should remain sealed and shielded from public scrutiny.”

Those documents cannot be shielded by attorney-client or work-product privilege because Garlock had its attorneys testify during the proceeding held to estimate its liability to asbestos plaintiffs about why they settled cases, the committee said.

According to the committee, those “contemporaneous documents” are at odds with why Garlock says it settled its cases.

Last winter, U.S. Bankruptcy Judge George Hodges of the Western District of North Carolina estimated that Garlock likely owes $125 million to asbestos plaintiffs. He rejected the plaintiffs' argument that Garlock's liability is around $1 billion to $1.3 billion after finding evidence of misrepresentation by plaintiffs' lawyers in several cases that Garlock settled in the past or in which Garlock lost jury verdicts.

According to both sides, the parties agree that there should be redactions of most plaintiffs’ Social Security numbers, birth dates, the identities of minors, account numbers and medical information except that related to asbestos exposure.

Black Lung Rates Highest Since 1970s

According to the Huffington Post, "the proportion of coal miners who suffer from an advanced form of black lung disease has skyrocketed in central Appalachia in recent years, according to experts with the National Institute for Occupational Safety and Health." Health officials says the nearly 10-fold increase is likely due to "workers' overexposure to coal dust, with many miners now working longer hours, or an 'increased toxicity' in dust composition -- that is, even unhealthier air in today's mines," Huffington Post further repors.

Public Granted Access to Evidence of Misrepresentation by Plaintiffs Lawyers in Asbestos Case

Submitted by Amaris Elliott-Engel on Mon, 07/28/2014 - 20:26

I've been covering an asbestos bankruptcy  in which there are major allegations that plaintiffs lawyers misrepresented that their clients were exposed to certain sources of asbestos in the tort system, while indicating something different when seeking payments from opaquely-run trusts formed out of the bankruptcy of companies that made products containing asbestos. Last week, a district court ruled that court proceedings should not have been closed to the public and the press on the issue. I reported on the case for Law.com:

A trial held to estimate the liability of a company undergoing an asbestos-related bankruptcy should not have been closed to the public and press, a federal district court judge, sitting on appeal, has ruled.

U.S. District Judge Max O. Cogburn Jr. of the Western District of North Carolina remanded the case back to a bankruptcy courtroom in order for the lower court to conduct fact-finding about the public's right of access because of the common law or because of the First Amendment.

Senior Bankruptcy Judge George R. Hodges has been presiding over gasketmaker Garlock Sealing Technologies LLC's bankruptcy. During hearings held to estimate Garlock's liability to claimants who allegedly developed fatal mesothelioma because of exposure to asbestos from Garlock products, Hodges closed part of the trial.

Hodges concluded that past settlements Garlock had entered into were not a reliable way to estimate the company's liability. Discovery into 15 of those cases showed a pattern of misrepresentation by plaintiff's lawyers. Plaintiffs' counsel allegedly indicated their clients were exposed to certain sources of asbestos in the tort system, while indicating something different when seeking payments from opaquely-run trusts formed out of the bankruptcy of companies that made products containing asbestos.

Later, Hodges rejected the request to unseal the evidence upon which he concluded that there was a pattern of misrepresentation regarding claims made against Garlock.

Hodges should not have relied upon a confidentiality order alone to close the estimation trial because that “shifted the presumption that favors open courts to a presumption favoring the closure of proceedings based on confidentiality designations by counsel,” the district court found.

Legal Newsline, a business-oriented news outlet owned by the Institute for Legal Reform, an affiliate of the U.S. Chamber of Commerce, was the media outlet that sought access to the Garlock case.

“The court finds that, although done with the best judicial intentions of providing for the efficient administration of justice, Judge Hodges' decision to seal the estimation hearing and maintain the seal as to judicial filings and the transcript of those proceedings after his estimation order was contrary to the requirements of prevailing case law,” Cogburn said.

Separately, Cogburn has ordered that the Garlock's claims. asserting that plaintiffs' lawyers violated the Racketeer Influenced and Corrupt Organizations Act and engaged in fraud, be consolidated in front of one U.S. magistrate judge for pretrial case management, including any motions by the plaintiffs' counsel to transfer venue to their home districts.


 

Top Plaintiffs Attorneys Diving Into GM Litigation

Some of the leading plaintiffs attorneys in the country are lining up to sue over General Motors' handling of defective ignition switches, the Wall Street Journal's Ashby Jones reports. GM CEO Mary Barra said an internal report prepared by former U.S. Attorney Anton Valukas "demonstrated a 'pattern of incompetence and neglect' in the auto maker's 11-year failure to recall cars equipped with a defective ignition switch," WSJ further reports.

After the article was published, the U.S. Judicial Panel on Multidistrict Litigation ordered GM cases to be consolidated in Southern District of New York where GM's bankruptcy is pending.

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