Pharmaceutical

New Jersey Jury Awards $18 Million To Accutane Users

July 2nd, 2012  |  Published in Accutane, Pharmaceutical

ATLANTIC CITY, NJ – A state court jury has determined Roche Holding AG, manufacturer of the popular acne medication Accutane, must pay $18 million in damages to two former users who developed inflammatory bowel disease because of the drug.

The trial, which concluded last Friday after nearly two-months of testimony, involved the combined claims of four individual plaintiffs treated with Accutane who also developed inflammatory bowel disease, or IBD. The two prevailing plaintiffs, Kathleen Rossitto and Riley Wilkinson, received $9 million each, however the jury found in favor of Roche in the two other cases and awarded no damages, according to a Courtroom View Network video webcast of the verdicts being read in court.

In all four cases, attorneys for the plaintiffs argued Roche knew of the risks associated with Accutane but failed to properly warn doctors and patients. During closing arguments, David Buchanan of Seeger Weiss repeatedly told the jury Roche purposely ignored studies suggesting Accutane caused bowel problems. “Roche had internally concluded Accutane has been causally associated with inflammatory bowel disease,” he said. “They want to focus on what is outside of Roche’s walls and not inside their internal conclusions.”

Buchanan referenced expert witness testimony from Dr. David Sachar, a former adviser to the Food and Drug Administration, stating Roche had access to studies suggesting out of 100 patients with IBD who also take Accutane, 80% of those IBD cases were caused by the Accutane itself. “There’s a reason why Roche does not want to talk about the numbers from the study,” said Buchanan, who also noted Roche’s attorneys declined to cross-examine Dr. Sachar on those claims, instead relying on testimony from their own expert witness.

Representing Roche, Orlando Richmond of Butler Snow argued strongly to the jury against the connection alleged between Accutane and IBD, citing that similar bowel conditions have been known to the medical community since the 19th century. “The vast majority of these (IBD) cases are idiopathic, meaning the cause is unknown,” said Richmond. “It’s always been the case. It was the case during the 90′s, and it’s the case now.”

Richmond also referred to one of Roche’s expert witnesses, a pediatrician who testified individuals from the same young adult age range are the most likely to both take Accutane and to independently develop IBD, which would explain the apparent overlap in some cases without also suggesting Accutane caused the disease. The jury seemed to accept this argument for two of the four plaintiffs by determining Accutane did not cause their health problems.

Accutane was first manufactured in 1982, and Roche claims to have treated over 13 million acne patients since then. In 2009 Roche stopped manufacturing Accutane after patents on the drug expired, but the generic version known as isotretinoin is still widely produced and prescribed for acne treatment throughout the United States.

Nine of the 13 Accutane lawsuits to reach a jury to date resulted in verdicts against Roche, though a number have been reversed on appeal. The first case went to trial in New Jersey in 2007, and since then Judge Carol Higbee has had responsibility for thousands of similar Accutane lawsuits consolidated at the state court level in Atlantic City with federal claims consolidated in Florida before United States District Judge James Moody.

All of the New Jersey Accutane trials have been video recorded in full and archived by Courtroom View Network. New Jersey, along with many other states, allows for video coverage of civil trials, though news media cameras are generally not permitted in federal court.

The lead case caption is Kathleen Rossitto v. Hoffmann-La Roche Inc., ATL-l-7481-10-MT, New Jersey Superior Court, Atlantic County (Atlantic City).

 

David Buchanan explains to the jury what Roche knew internally about the risks associated with Accutane.

 

Verdict For Defendants In Zoloft Suicide Trial

May 15th, 2012  |  Published in Pharmaceutical, Uncategorized

Late last Friday, after nearly four weeks of trial proceedings, an Orlando jury returned a verdict in favor of the defendants in a civil trial alleging the antidepressant Zoloft caused Gary Torrence to commit suicide.

Our friends at Legal Newsline have more details on the case available here. This was the second time the case went before a jury after an earlier mistrial last year. Pfizer, the drug’s manufacturer, was no longer a party to the case when when trial proceedings began last month.

The full trial was video recorded and webcast gavel-to-gavel, which is available for viewing via Courtroom View Network.

Fosamax Trial Begins Against Merck in New Jersey

March 7th, 2012  |  Published in In re: Fosamax, Mass Torts, Pharmaceutical

ATLANTIC CITY, NJ – Opening statements took place Monday in a civil trial against drug manufacturer Merck & Company (NYSE: MRK) involving the widely-prescribed drug Fosamax.

The lawsuit in Atlantic County Superior Court claims the drug, which is used to treat the bone disease osteoporosis, caused serious injury to plaintiff Jo-Ann Sessner’s jaw, and that Merck failed to warn of Fosamax’s potential serious side effects.

Many patients who took Fosamax have filed lawsuits alleging the drug caused a condition called osteonecrosis of the jaw, where the actual jaw bone dies and can lead to the need for extensive surgery. Sessner’s case is the second to actually go to trial in state court and only the sixth Fosamax trial over all after four others in federal district court. One of those federal lawsuits resulted in the only plaintiff’s award to date.

Sessner’s attorney, Tim O’Brien of Levin Papantonio, told the jury during opening statements taking Fosamax ultimately hurt his client. “It did nothing for her,” he said to the court. “It only did things to her.” He went on to describe how osteonecrosis could only occur because of taking Fosamax, and that Merck intentionally withheld evidence of side effects to protect profits. “What Merck does is scare women,” he said while describing the company’s aggressive marketing of the drug to women with bone diseases like osteoporosis.

Representing Merck, attorney Christy Jones of Butler Snow told jurors Fosamax did its job and benefited Sessner. “It was a good thing Ms. Sessner was prescribed Fosamax,” said Jones. “It was a good thing because it prevented fractures, and some 10 years later Ms. Sessner has never had another fracture. Fosamax worked.” Sessner originally began taking Fosamax after suffering a hip fracture without any fall or injury due to low bone density.

Jones told jurors the evidence would show Sessner developed osteonecrosis in her jaw, after a tooth became infected and had to be removed. “This infection has nothing to do with Fosamax, but it’s that infection that ultimately led to the jaw problems and the injuries,” she said. Jones also pointed to other factors, like smoking, that put Sessner at risk for jaw problems.

Jones represented Merck at the first Fosamax trial last year in New Jersey, and the jury ultimately found Fosamax did not cause osteonecrosis in that case. With her trademark dark clothing and hypnotic southern accent, she also scored a victory for Johnson & Johnson in this same court last year at a trial involving the antibiotic Levaquin.

The current trial will run through at least mid-April, and based on prior cases Sessner’s attorneys will likely ask for millions of dollars in damages. The full trial will be webcast live via Courtroom View Network, which also webcast the first Fosamax trial in state court last year.

The case is Jo Ann Sessner v. Merck Sharp & Dohme, Corp., ATL-L-3394-11.

Merck To Face Second Fosamax Trial in State Court

February 22nd, 2012  |  Published in In re: Fosamax, Pharmaceutical

ATLANTIC CITY, NJ – Opening statements are scheduled for March 1st in the second lawsuit to go to trial in state court involving the widely-prescribed drug Fosamax.

Plaintiffs Amelia Flores and Jo Ann Sessner filed lawsuits against the drug’s manufacturer, Merck & Company (NYSE: MRK), alleging they suffered jawbone injuries after taking Fosamax to treat osteoporosis, a disease that causes a loss of bone density.

Merck faces a number of lawsuits after patients taking Fosamax, also known as as a bisphosphonate or alendronate sodium, developed osteonecrosis of the jaw. This condition results in death of the actual jaw bone, which can cause serious dental problems and require surgery. In New Jersey, a number of individual cases were consolidated into a mass tort overseen by Judge Carol Higbee, which also includes Teva Pharmaceuticals (NASDAQ: TEVA) and Bayer Pharmaceuticals, who marketed generic versions of the drug.

Merck denies the allegations, and during earlier trials claimed other underlying health conditions caused patient’s jaw problems, and that the company provided adequate warnings about potential side effects to physicians and patients. Last year, in the first New Jersey state court trial, the jury returned a verdict in favor of Merck, determining Fosamax did not cause osteonecrosis.

Besides the cases in state court, a number of Fosamax cases were consolidated in federal court before U.S. District Judge John Keenan in New York City. So far five cases have gone to trial, resulting in three verdicts for Merck, one plaintiff’s verdict and one mistrial. In the sole plaintiff’s victory, jurors initially awarded a Florida woman $8 million dollars, but Judge Keenan later reduced that to $1.5 million.

The current trial is scheduled to last at least three to four weeks and will be webcast live, gavel to gavel, by Courtroom View Network. CVN also recorded the only other New Jersey Fosamax trial so far, Rosenberg v. Merck in March of last year.

The cases are Jo Ann Sessner v. Merck Sharp & Dohme, Corp., ATL-L-3394-11 and Amelia Flores v. Merck Sharp & Dohme, Corp., ATL-L-744-09 in the Superior Court of New Jersey, Atlantic County.

Watch In re Fosamax live on Courtroom View Network starting February 27th for jury selection or March 1st for opening statements.

 

Hutchison Endoscopy Trial Resumes

January 23rd, 2012  |  Published in CVN Docket, Endoscopy Center Cases, Pharmaceutical

LAS VEGAS, NV – A civil trial has resumed after a nearly three-month break in a lawsuit against Teva Pharmaceutical Industries (NASDAQ: TEVA) and their distributor Baxter International (NYSE: BAX) related to Hepatitis-C contamination at a Las Vegas endoscopy clinic.

propofolThe trial was halted last October by the Nevada Supreme Court, while they considered a motion from the defendants for a change of venue, which claimed pre-trial publicity from large verdicts in previous related cases would prevent the selection of an impartial jury in Clark County. The Supreme Court issued an opinion denying the motion last December, and trial proceedings resumed earlier this month. Read the the court’s decision here.

In the underlying case, plaintiff Stacy Hutchison alleges Teva and Baxter are responsible for her contracting Hepatitis-C, due to the companies’ sale of the anesthetic Propofol in large containers, later used by Dr. Dipak Desai for multiple uses with contaminated needles at his endoscopy clinics. Dr. Desai, who has declared bankruptcy, is awaiting trial on criminal charges later this year. Defendants also include Sicor, Inc. and McKesson Medical-Surgical (NYSE: MCK). 

Hutchison’s case is one of many similar lawsuits filed against the pharmaceutical companies in Las Vegas. Jurors returned a $90 million verdict against Teva and Baxter in another trial a few weeks prior to the start of Hutchison’s, and the first Propofol-related case to go to trial resulted in a verdict exceeding $500 million, the largest in the state’s history. 

The defendants, represented on appeal by Lewis Brisbois Bisgaard & Smith and Texas-based McDonald Devin, in their initial brief to the court, claimed it would be “impossible” to select an unbiased jury due to the “vast number of Clark County residents who have a direct interest in this litigation and due to media coverage that has been overwhelmingly negative to towards the defendants.” They requested the trial be transferred to Reno. 

Hutchison’s attorneys opposed the request, as did the trial court judge, and ultimately the Supreme Court, which wrote “…the record evidence demonstrated that, although this case and related cases received a fair amount of pretrial publicity…it was not of a kind or to the extent that it tainted the jury pool.” 

The trial is scheduled to continue through at least January 30, with another related endoscopy clinic trial set to begin next month. Despite the unusually lengthy recess, the jury remained under instructions from the court not to independently research or speak about the trial. 

Courtroom View Network is providing a gavel-to-gavel video webcast of the Hutchison trial, as it has done for the three other endoscopy clinic trials to date. The case is Stacy Hutchison v. Teva and Baxter, Case Number 08A562216, Clark County Circuit Court, Nevada before Hon. Jerry Wiese.

Tanna Accutane trial begins in New Jersey

November 15th, 2011  |  Published in Accutane, Pharmaceutical, Toxic Torts

tanna accutane blogNew Jersey is home to another Accutane toxic tort trial, as plaintiff Priya Tanna sues Roche to recover for her permanent injuries. Tanna started using the prescription Accutane as a 15 year old and has since developed Inflammatory Bowel Disease (IBD). 

During his opening statements, plaintiff’s counsel Paul Smith asserted that Accutane’s brochure was misleading because it never mentioned IBD, latency or the permanency of resulting conditions. Further, he shared images of Roche’s internal documents that show Accutane knew about such toxicity effects like IBD.

Defense counsel, Marie Woodbury of Shook, Hardy & Bacon, LLP stated that this trial is actually about Tanna’s medical history and the conversations she had with her two dermatologist, Doctors Vierra and Barber.

“The warning information that was communicated to Priya Tanna’s doctors was adequate, appropriate, accurate and acknowledged by these doctors,” Woodbury said. “Roche has a 7-step warning system to make sure that doctors understand the importance of communicating risks to patients.”

Woodbury asserts that Roche followed the 7-step process and it was the shortfall of Tanna’s doctors that led to her lack of information or misinformation. Woodbury stated that the aim of the 7 step warning process is to make sure “that no one makes a casual decision to prescribe Accutane.”

Watch this Priya Tanna Accutane Trial live on CVN.

accutane resized 600Paul Smith breaks his case down into three parts.

marie woodbury resized 600Marie Woodbury shows the jury the blister pack for Accutane as the last step in the 7-step process.

Washington v. Teva Hepatitis Trial: Another Mega Verdict

October 26th, 2011  |  Published in Endoscopy Center Cases, Pharmaceutical, Products Liability, Toxic Torts

Richard Friedman Glenn Kerner Jennifer LevyWashington v. Teva (Las Vegas, Nevada)

Pharmaceutical giant Teva’s Las Vegas nightmare continued with a third consecutive $100M+ verdict in the Propofol endoscopy center Hepatitis C litigation.

Washington v. Teva involved different plaintiff attorneys and different defense attorneys from the first two trials, Chanin and Sacks, but the result was similar — $104M in damages.

Richard Friedman (Friedman Rubin) described to the jury the 1995 New England Journal of Medicine article noting infection clusters associated with Propofol use, and the reasons why Propofolwas more likely than prior types of anesthesia to result in outbreaks. “Over the last two decades,” said Mr. Friedman, “the public health authorities have recognized this is a really big deal. And the only people who don’t think it’s a big deal are the witnesses hired by the defendants.”

According to Mr. Friedman, the Centers for Disease Control determined in the 1990′s that the heart of the problem was 50ml and 100ml vials, which looked like multidose vials. The use of the larger vials resulted in the spread of disease because health care providers might use just 15ml of Propofol for one patient. Then, rather than waste the remaining 35ml in a 50ml vial, they would use the same vial with a new needle for the next patient. Even with the new needle, contamination could occur. The CDC suggested that “ideally, the 50- and 100-ml vials should be eliminated or modified so they cannot be used in this manner.”

“Even back in 1995,” said Mr. Friedman, “twelve years before Mr. Washington was infected, the Centers for Disease Control, the medical community…recognized that to have these outbreaks of infections you needed two things. You needed a vial big enough, and you needed a nurse, doctor, medical practitioner, busy enough, uneducated enough, in a hurry enough, or just human enough, to make the mistake of going into the vial more than once.”

“Before they came out with their own product, [Teva was] aware of the dangers of a 50- and 100ml vial, and we know that because they specifically told the FDA about those dangers [when applying for permission to sell a 20ml pre-filled syringe]. They knew if they came out with a 50- or 100ml vial people were going to multidose. They knew if they came out with a 50ml vial people were going to get sick. They knew if they came out with a 50ml vial, people were going to die. It wasn’t a question of if. It was only a question of when. The record at that point was already clear.”

“What you’re going to hear,” said Mr. Friedman, “is that while they were citing the New England Journal article and the CDC studies to the FDA to get permission to get a competitive advantage by making a 20ml pre-filled syringe, already filled with product, with a cap at the top, so there’s no ability to contaminate it…There was also a lot of money to be made on the 50s and the 100s. So on April 19, 1999, [Teva] launched their version of Propofol. And what they launched were..100-, 50-, 20ml vials, and the pre-filled syringe.”

Teva’s timely knowledge of the risk was apparent, said Friedman, because in May, 2000 — seven years before Mr. Washington was infected out of a 50 ml vial — Teva’s head of sales, Craig Lea, asked the FDA for permission to sell a 10ml vial and specifically stated that 10ml was closer to a typical dose and would “reduce the temptation and the opportunity for dosing patients from a single drug container. This is critically important…[to] enhance patient safety.”

The problem became acute, said Mr. Friedman, when demand for Propofol was so strong that Teva had difficulty producing enough product. Because the production lines could fill 10ml and 50ml vials at about the same speed, the 50ml production lines were approximately five times more profitable because they could produce five times more product. As a result, Teva began to emphasize the larger vials in its product line.

For Teva, Glenn Kerner (Goodwin Proctor) told the jury, “This case is not about Propofol. It’s not about a defective product.  It’s about a defective clinic.” What happened to Mr. Washington was the result of the “disgraceful” conduct of the clinic’s owner, Dipak Desai, and none of the defendants in the case was responsible, said Mr. Kerner. The Propofol was not recalled, nor was there any manufacturing problem. The Propofol manufactured by Teva and sold by Baxter performed exactly as it was supposed to — there was no malfunction. Each and every vial was clean, sterile, and free from contamination when it arrived at the endoscopy center.

“There’s nothing wrong with a multi-dose vial. Multi-dose vials don’t spread disease,” said Mr. Kerner. “What went wrong begins and ends with Dr. Desai and his clinic,” said Mr. Kerner. The only way Mr. Washington could have been infected from the 50ml vial was if that vial had been “grossly misused with a dirty syringe,” said Mr. Kerner. And, the vial would have to have been used on multiple patients, including Mr. Washington, even though it was labeled “single use.”

For Baxter, Jennifer Levy (Kirkland & Ellis) told the jury that Baxter did not attempt to convince Dr. Desai’s endoscopy clinic to use any particular size or type of anaesthetic. Instead, they simply provided a catalog listing, and the physician indicated which products they wanted. Ms. Levy also showed that the size of a vial does not by necessarily indicate whether it should be used for individual or multiple doses. Other anaesthetics might come in relatively small vials, such as 5ml or 10ml, and be specifically intended and labeled for multiple doses.

The jury found both Teva and Baxter liable on both negligence and product defect theories, and found that compensatory, punitive, and loss of consortium damages were warranted.

The jury awarded $7M in compensatory damages to Michael Washington, $7M in loss of consortium damages to Josephine Washington, $60M in punitive damages against Teva, and $30M in punitive damages against Baxter, for a total damage award of $104M.

The two prior verdicts in this litigation (Chanin and Sacks) were rendered in cases asserted by Robert Eglet (Mainor Eglet) and Will Kemp (Kemp Jones & Coulthard). In the prior cases, the juries rejected defective product theories, but found the defendants liable for failure to warn, failure to monitor, and/or breach of the implied convenant of fitness for a particular purpose.

Craig Lea

Propofol Warning

CVN webcast the Washington v. Endoscopy Center trial live, gavel-to-gavel.

Subscribe to CVN and watch the Endoscopy Litigation for as little as $99 per month, cancel any time.

$182.6M Verdict in Sacks Propofol Hepatitis Case

October 25th, 2011  |  Published in Endoscopy Center Cases, Pharmaceutical, Products Liability

Robert Eglet Will Kemp Mark Tully Philip HymansonSacks v. Teva & Baxter (Las Vegas, Nevada)

A Las Vegas jury awarded $182.6M in compensatory and punitive damages against Pharmaceutical maker Teva, and two of Teva’s distributors, Baxter and McKesson.

The case involved a 2008 Hepatitis C outbreak in Las Vegas among patients at a group of Endoscopy clinics owned by subsequently indicted physcian Dipak Desai. The clinics improperly used containers of the anesthetic Propofol for multiple patients.  This “double-dosing” allowed blood-borne pathogens — Hepatitis C virus in particular — to be transferred among patients.

For the plaintiffs, Robert Eglet (Mainor Eglet) argued that Teva should not have supplied “jumbo” 50 ml Propofol vials to endoscopy clinics that would only be performing brief procedures typically requiring 20ml or less of the anaesthetic, because the larger vials created a substantial risk that the clinic would re-use vials rather than dispose of the mostly-full vials after each procedure. According to Mr. Eglet, Teva used the larger vials because it was more profitable to do so, even though the pharmaceutical companies knew of the risk that endoscopy clinics would double-dose if given the larger vials. Similar outbreaks had previously occurred at other endoscopy centers.

Also for the plaintiffs, Will Kemp (Kemp Jones & Coulthard) told the jury, “In 1995, the most prestigious medical journal in the world says ‘eliminate or modify the 50ml vial,’” and yet Teva failed to do so. A drug manufacturer has a continuous duty to monitor the medical literature and other sources of information, Mr. Kemp explained. However, Teva was unaware of many articles, including a report from the Centers for Disease Control, indicating that larger anesthesia vials created a health risk. Morever, said Mr. Kemp, Teva’s failure to monitor had a demonstrable impact, because after they learned of the risks, endoscopy center physicians stopped ordering the larger vials.

On behalf of the manufacturer, Teva, Mark Tully (Goodwin Proctor) told the jury that there is nothing unique about a 50ml vial that causes it to be misused. Any size vial can be misused. However, said Mr. Tully, large vials can also be broken down into smaller syringes, which lets them be divided between multiple patients without risk. So the risk to patients is not created by the vial size or the desire to multi-dose, but the by “outrageous” and unanticipated misuse at the endoscopy center.

Moreover, said Mr. Tully, colonoscopies seldom require less than 10ml, and often require more than 20ml. Whether it was injection practices, or failing to clean and disinfect medical equipment, it was the clinic that was responsible. The pharmaceutical companies were simply the wrong defendants for the case.

On behalf of the distributors, McKesson and Baxter, defense attorney Philip Hymanson (Greenberg Traurig) told the jury that the plaintiffs were simply going after deep pockets, because no one knows for sure what happened in the endoscopy centers — whether the infection resulted from Propofol or from dirty endoscopes. But regardless of the mechanism, the real cause was the culture of unsafe practices in the endoscopy center, said Mr. Hymanson. The Propofol was manufacturered and delivered properly. The clinics were able to purchase any size vial, and any size vial could have been used safely — or unsafely, if the clinic did not follow proper procedures. A Dear Doctor letter would not have made a difference, said Mr. Hymanson.

The jury found that with respect to all three plaintiffs — Anne Arnold, Anthony Devito, and Richard Sacks — that the Propofol vials were not defectively designed, but that Teva had violated its duty to monitor; that Teva, Baxter and McKesson had failed to send a Dear Doctor letter; and that Teva, Baxter, and McKesson had breached the implied warranty of fitness for a particular purpose.

The jury found that compensatory damages, loss of consortium damages, and punitive damages were warranted.

The jury awarded $20.1M in compensatory damages ($8.5M to Ann Arnold, $900K to James Arnold, $5M to Anthony Devito, $700K to Donna Devito, and $5M to Richard Sacks).

The jury awarded punitive damages of $162.5M ($89.375M against Teva, $55.250M against Baxter, and $17.875M against McKesson).

Harry Hull CDC Epidemiologist

CVN webcast the Sacks v. Teva trial live, gavel-to-gavel.

Sacks Hepatitis C Propofol Trial Begins in Las Vegas

September 16th, 2011  |  Published in CVN, Endoscopy Center Cases, Pharmaceutical, Products Liability

Sacks v. Teva -- Propofol hepatitis C trial in Las Vegas.Sacks v. Endoscopy Center  (Las Vegas, NV)

Plaintiff attorneys Robert Eglet (Mainor Eglet) and Will Kemp (Kemp, Jones & Coulthard) and defense attorney Mark Tully (Goodwin Proctor), began the second trial involving a 2008 Hepatitis C outbreak in Las Vegas.

This trial involves five plaintiffs, Anne and James Arnold, Tony and Donna Devito, and Richard Sacks, who were allegedly infected with Hepatitis C during routine endoscopy procedures because the health care providers re-used, or “double-dosed,” from large vials of the anesthetic Propofol. The plaintiffs claim that the Pharmaceutical companies should have provided single-dose vials to the endoscopy center, and that they inadequately warned the enodoscopy center not to re-use the larger vials.

According to Mr. Eglet, the defendants knew, based on 148 prior Propofol incidents, that their 50 milliliter Propofol infusion vials looked like multi-diagnose vials and that anesthesia providers were in fact reusing syringes on the larger Propofol vials. 

According to Mr. Kemp, the defendands should have sent a Dear Doctor letter to health care providers alerting them to the risks posed by the larger Propofol vials.

For the defense, Mark Tully (Goodwin Proctor) emphasized the health care providers’ responsibility for the Hepatitis C outbreak and the plaintiff’s injuries.

Holding two Propfol infusion vials before the jury, Mr. Tully said, “these bottles of Propofol with respect to every procedure were perfectly manufactured…without any contamination whatsoever” when they left the manufacturer. They were “labeled exactly as they should have been when they left the distributors” and whatever “happened at the clinic happened solely at the clinic.” “What went wrong had nothing to do with the bottles of Propofol,” Mr. Tully stated.

The defendants face almost 300 lawsuits stemming from the 2008 Nevada Hepatitis C outbreak.

The trial is ongoing and includes testimony from numerous experts and lay witnesses. Gavel to gavel coverage is provided by Courtroom View Network.

CVN webcast Richard Sacks v. Endoscopy Center of Southern Nevada, Gastroenterology Center of Nevada, LLP, et al.

 

FDA Panels Coming to CVN

April 20th, 2011  |  Published in FDA Panels, Pharmaceutical

FDA Advisory Committees and PanelsCourtroom View Network announces live coverage of upcoming FDA Committee Hearings and Advisory Panels. CVN’s live coverage of the FDA hearings complements CVN’s in-court coverage of pharmaceutical trials, and will be of interest to legal professionals and others who closely follow the pharmaceuticals industry.

The next three FDA Hearings that CVN will webcast live are:

APR 27-28: Antiviral Drugs Committee applications for the Hepatitis C treatments Boceprevir (Merck) and Telaprevir (Vertex).

MAY 12: Orthopaedic Devices Panel application for the premarket approval of Augment Bone Graft (Biomimetic).

JUN 29: Microbiology Devices Panel classification of TB rapid detection tests.

Additional details are below. Subscribe to CVN and watch FDA panel hearings both live and on-demand from your office.

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Antiviral Drugs Advisory Committee

On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.

Microbiology Devices Panel of the Medical Devices Advisory Committee

On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex.

The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. The FDA has 32 advisory committees, one of which, the Medical Devices Advisory Committee, has 18 panels.

Subscribe to CVN and watch selected FDA panel hearings both live and on-demand from your office or anywhere.