Drug & Device News

The devices, implanted into women for treatment of pelvic organ prolapse or urinary incontinence, allegedly caused bleeding and pain and, in some cases, required subsequent surgeries. They have attracted more than 35,000 lawsuits, one of the largest dockets on record, in six separate multidistrict proceedings. Monthly status conferences in Charleston, WV, host between 50 and 125 attorneys at a time.

Goodwin's original plan called for individual trials of bellwether cases ' those most representative of the litigation overall ' against the four manufacturers with the oldest and largest number of cases. The first trials, against C.R. Bard Inc., came this year. A jury awarded $2 million to a woman on Aug. 15, including punitive damages, and Bard settled the second case. The plaintiffs in the third trial abruptly withdrew their case. The final trial was set to begin in December. Bellwether trials against the other defendants ' American Medical Systems Inc., Ethicon Inc. and Boston Scientific Corp. ' are scheduled next year.

During a Sept. 19 hearing, Goodwin, frustrated with the process, asked attorneys to suggest a way to consolidate the cases for trial. The move came as a broad settlement appeared distant. Although American Medical Systems, one of the defendants, agreed on June 14 to pay $54.5 million to settle some cases, the deal did not resolve the majority of the more than 10,000 pending against the Endo Health Solutions Inc. subsidiary.

Meanwhile, new cases are joining the pile. Any trial plan would need to address what some plaintiffs attorneys estimate could amount to as many as 60,000 cases involving 80 products. ' Amanda Bronstad, The National Law Journal

Change Would Let Generic Drug Companies Make Not-Yet Approved Label Changes

The U.S. Food and Drug Administration (FDA) has proposed changing its rules to allow makers of generic versions of name-brand drugs to change their drug safety labels to reflect new information, even if the name-brand manufacturer's product label has not been changed. Currently, brand-name drug manufactuers' safety information must be approved by the FDA, yet they may change it immediately if new safety concerns surface, waiting until later to obtain FDA approval of the new warning's content and language. Generic drug manufacturers are not free to do this; they must stick with the FDA-approved language until an official change is authorized by the agency.

This means that when generic drug products are prescribed, healthcare providers and their patients sometimes are not fully informed of new safety concerns. Under the proposed rule, generic manufacturers could change their labels prior to obtaining FDA approval but would be required to immediately inform the agency of those changes, just as name-brand drug makers currently do. The FDA would then review the change, along with the generic's corresponding name-brand manufacturer's proposed changes, and make a decision that would bring all players' labels back into line with one another. “This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in a release. “More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

This change would also alleviate a problem for injured consumers created by the current scheme ' if a person uses a generic drug product and is injured by it, he cannot maintain a failure-to-warn lawsuit against the generic manufacturer because the latter had no control over the warning label it could use; and he cannot successfully sue the brand-name drug company because the product he actually used was not made by that drug manufacturer. If the proposed rule is implemented, generics producers could be held independently responsible for failure to warn.

Trial over Billion-Dollar Molecules Yields $400,000 Verdict

In closing arguments for Medivation Inc., lawyers at Latham & Watkins accused a UCLA researcher of cheating the pharmaceutical company out of a $1 billion prostate cancer treatment and asked a jury to award $15 million. But on Nov. 15, 2013, the jury in San Francisco Superior Court gave them far less: $406,917. The panel found that UCLA chemistry professor Michael Jung had breached his stock option agreement with the San Francisco'based drug company. However, the jury rejected Medivation's remaining claims for intentional misrepresentation and false promise.

Medivation had accused Jung, who was part of a sponsored research team, of concealing promising discoveries and using his position on Medivation's scientific advisory board to gain inside knowledge of its business plans. Testimony during the month-long trial before Judge John Munter frequently veered into the chemical details of the compounds at the heart of the dispute ' sometimes even down to the atom.

Medivation began funding the UCLA research in 2005 in exchange for the right to license promising molecules. The following year, Medivation chose to license one of those molecules, which it used to develop Xtandi, an FDA-approved prostate cancer treatment. Today the company is valued at $3 billion. But Medivation said that Jung concealed two other promising compounds in violation of their agreement. In 2007, UCLA sold licensing rights to those compounds to Aragon Pharmaceuticals Inc., which sold the disputed compounds to Johnson & Johnson earlier this year for $1 billion in cash and contingency payments. Along with Jung, Medivation also sued the UC Regents, Jung's fellow researcher Dr. Charles Sawyers, and Aragon. Medivation settled with Sawyers, and Munter dismissed its claims against the University of California and Aragon, leaving Jung as the sole defendant. ' Max Taves, The Recorder

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New Plan in Mesh Litigation

The first three trials over alleged defects in several women's health products ended with decidedly mixed results. With the parties no closer to settlement, the federal judge overseeing the transvaginal mesh device litigation is weighing an entirely new trial plan in hopes of resolving the nation's largest mass tort. U.S. District Judge Robert Goodwin has suggested consolidating the cases for trial ' although the details of just how that would happen remain unclear.

“He's trying to get his arms around probably one of the most complex MDLs that's ever existed,” said Joseph Rice, founding partner of Motley Rice, whose colleague, Fred Thompson, is coordinating co-lead counsel for the plaintiffs. He referred to multidistrict litigation, in which cases are consolidated to more efficiently resolve common pretrial disputes.

The devices, implanted into women for treatment of pelvic organ prolapse or urinary incontinence, allegedly caused bleeding and pain and, in some cases, required subsequent surgeries. They have attracted more than 35,000 lawsuits, one of the largest dockets on record, in six separate multidistrict proceedings. Monthly status conferences in Charleston, WV, host between 50 and 125 attorneys at a time.

Goodwin's original plan called for individual trials of bellwether cases ' those most representative of the litigation overall ' against the four manufacturers with the oldest and largest number of cases. The first trials, against C.R. Bard Inc., came this year. A jury awarded $2 million to a woman on Aug. 15, including punitive damages, and Bard settled the second case. The plaintiffs in the third trial abruptly withdrew their case. The final trial was set to begin in December. Bellwether trials against the other defendants ' American Medical Systems Inc., Ethicon Inc. and Boston Scientific Corp. ' are scheduled next year.

During a Sept. 19 hearing, Goodwin, frustrated with the process, asked attorneys to suggest a way to consolidate the cases for trial. The move came as a broad settlement appeared distant. Although American Medical Systems, one of the defendants, agreed on June 14 to pay $54.5 million to settle some cases, the deal did not resolve the majority of the more than 10,000 pending against the Endo Health Solutions Inc. subsidiary.

Meanwhile, new cases are joining the pile. Any trial plan would need to address what some plaintiffs attorneys estimate could amount to as many as 60,000 cases involving 80 products. ' Amanda Bronstad, The National Law Journal

Change Would Let Generic Drug Companies Make Not-Yet Approved Label Changes

The U.S. Food and Drug Administration (FDA) has proposed changing its rules to allow makers of generic versions of name-brand drugs to change their drug safety labels to reflect new information, even if the name-brand manufacturer's product label has not been changed. Currently, brand-name drug manufactuers' safety information must be approved by the FDA, yet they may change it immediately if new safety concerns surface, waiting until later to obtain FDA approval of the new warning's content and language. Generic drug manufacturers are not free to do this; they must stick with the FDA-approved language until an official change is authorized by the agency.

This means that when generic drug products are prescribed, healthcare providers and their patients sometimes are not fully informed of new safety concerns. Under the proposed rule, generic manufacturers could change their labels prior to obtaining FDA approval but would be required to immediately inform the agency of those changes, just as name-brand drug makers currently do. The FDA would then review the change, along with the generic's corresponding name-brand manufacturer's proposed changes, and make a decision that would bring all players' labels back into line with one another. “This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in a release. “More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

This change would also alleviate a problem for injured consumers created by the current scheme ' if a person uses a generic drug product and is injured by it, he cannot maintain a failure-to-warn lawsuit against the generic manufacturer because the latter had no control over the warning label it could use; and he cannot successfully sue the brand-name drug company because the product he actually used was not made by that drug manufacturer. If the proposed rule is implemented, generics producers could be held independently responsible for failure to warn.

Trial over Billion-Dollar Molecules Yields $400,000 Verdict

In closing arguments for Medivation Inc., lawyers at Latham & Watkins accused a UCLA researcher of cheating the pharmaceutical company out of a $1 billion prostate cancer treatment and asked a jury to award $15 million. But on Nov. 15, 2013, the jury in San Francisco Superior Court gave them far less: $406,917. The panel found that UCLA chemistry professor Michael Jung had breached his stock option agreement with the San Francisco'based drug company. However, the jury rejected Medivation's remaining claims for intentional misrepresentation and false promise.

Medivation had accused Jung, who was part of a sponsored research team, of concealing promising discoveries and using his position on Medivation's scientific advisory board to gain inside knowledge of its business plans. Testimony during the month-long trial before Judge John Munter frequently veered into the chemical details of the compounds at the heart of the dispute ' sometimes even down to the atom.

Medivation began funding the UCLA research in 2005 in exchange for the right to license promising molecules. The following year, Medivation chose to license one of those molecules, which it used to develop Xtandi, an FDA-approved prostate cancer treatment. Today the company is valued at $3 billion. But Medivation said that Jung concealed two other promising compounds in violation of their agreement. In 2007, UCLA sold licensing rights to those compounds to Aragon Pharmaceuticals Inc., which sold the disputed compounds to Johnson & Johnson earlier this year for $1 billion in cash and contingency payments. Along with Jung, Medivation also sued the UC Regents, Jung's fellow researcher Dr. Charles Sawyers, and Aragon. Medivation settled with Sawyers, and Munter dismissed its claims against the University of California and Aragon, leaving Jung as the sole defendant. ' Max Taves, The Recorder

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