C.R. Bard Pelvic Mesh Internal Memoranda Show Company Knew of Risks

The litigation against manufacturers of pelvic mesh devices continues to increase nationwide. A pelvic mesh implant is a synthetic material implanted and tied to ligaments or bone to lift and support internal organs. The implants were introduced over a decade ago, and can serve as an alternative to a hysterectomy. Thousands of women, who were allegedly uninformed about the dangers involved with the mesh implants, have since complained of injuries, including severe pain, infections and bleeding that often require follow-up surgeries.

C.R. Bard, maker of the Avaulta pelvic mesh device, was recently involved in a dispute concerning the admissibility of several internal memoranda created by Bobby Orr, head of Bard’s Advanced Surgical Concepts Division. Back in 2008 and 2009, Orr drafted memoranda discussing various options and materials that could be used to make new pelvic mesh products safer. Plaintiff sought to introduce the memos in the jury trial of Carolyn Jones v. C.R. Bard to support her claim for design defect. The manufacturer argued the memos discussed hypothetical design changes that were discussed after the Avaulta device had been designed, shipped, and implanted in plaintiff. As such, the manufacturer argued the memos were not helpful to the issue of design defect and should be inadmissible.

The Court disagreed with these arguments and allowed plaintiff to introduce the memos at trial. The Court wrote that “While the Orr memoranda post-dated that critical point in time, each piece of scientific literature found in the memoranda was published prior to it. The pre-launch, peer-reviewed body of literature referenced by Mr. Orr, and his comments respecting it, may thus relate to what Bard should have known prior to launch and the feasibility of a then-safer alternative.” Accordingly, the memoranda were found to be admissible before the jury at trial.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against a manufacturer of the vaginal mesh device.

Johnson & Johnson Reportedly Agrees to Settle DePuy ASR Lawsuits for $4 Billion

As we have previously reported, DePuy Orthopaedics, Inc. has recalled its ASR hip replacement device. There are thousands of cases pending across the country related to the ASR device. These cases continue to proceed in state and federal courts.

The New York Times reports that DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, has agreed to settle the majority of the pending ASR lawsuits. The agreement, if accepted by the court, would be one of the largest product liability settlements involving a medical device ever entered. The deal would provide compensation to approximately 7,000 to 8,000 patients who had a replacement operation.

If you have had a hip replacement, which used the DePuy ASR or DePuy Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort Attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufactures.

 

Vaginal Mesh MDL Consolidated in West Virginia

As we have previously reported, the vaginal mesh implant litigation continues to move forward across the country. A mesh implant is a synthetic material implanted and tied to ligaments or bone to lift and support internal organs. The implants were introduced over a decade ago and serve as an alternative to hysterectomy. Thousands of women have since complained of injuries including severe pain, infections and bleeding that often require follow-up surgeries.

The federal multi-district litigation (MDL) cases Nos. 2325, 2326, 2327 and 2387 have been consolidated under Judge Goodwin in District Court in West Virginia. After years of litigation, the parties have selected bellwether cases and anticipate trials in the upcoming months.

It is important that women with a vaginal mesh implant understand their legal rights. Many pelvic mesh cases also have been filed and tried in New Jersey state court.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Johnson & Johnson.

Online Resources Allow Consumers to be Better Informed about Pharmaceutical Dangers

There are a number of online resources that allow consumers to obtain safety and efficacy information relevant to medications, pharmaceuticals and medical devices. The non-profit organization Public Citizen publishes a list of the worst and best pills currently available on the market. The website hosts data and information pertaining to the side effects, reliability and use of various medications. The website also contains medication-specific information along with other resources and consumer guides.

 A recent article in the New York Times discussed a new technology that will analyze data from drug and medication queries entered into Google, Microsoft and Yahoo search engines. Using this technology, scientists at Microsoft, Stanford and Columbia University have begun to detect and monitor unreported prescription drug side effects before they are found by the Food and Drug Administration’s (“FDA”) warning system. This automated software is a powerful tool that researchers hope will help improve knowledge of drug-drug interactions. Additionally, medical providers hope to learn of possible side effects earlier, potentially allowing for earlier recalls of dangerous medications. It is thought by some that the public health could be greatly improved through this technology. The FDA launched the Sentinel Initiative in 2008 that will allow the FDA to electronically track the safety of drugs, biologics and medical devices once they reach the market. 

FDA Considers Change in Labeling Requirements for Generic Manufacturers

According to recent reports, the FDA is considering new labeling requirements for the manufacturers of generic drugs, which could lead to a change in a company’s responsibility to consumers. Currently, generic manufacturers are required by federal law to have the same labels as the branded version. As a result of this federal law, the United States Supreme Court held in Pliva v. Mensing that generic manufacturers could not be held liable in state court for failure to warn claims. According to a 2011 petition by Public Citizen, a national consumer organization, approximately 90% of all prescriptions issued in 2010 were for generic drugs. The proposed revision would allow the generic manufacturer to change the label warnings without FDA approval, thereby eliminating the legal loophole currently available to generic manufacturers.

The Court’s decision in Mensing has had devastating effects on thousands of plaintiffs nationwide who have had their claims dismissed, in cases such as the Darvocet litigation, because they had ingested the generic version of the drug rather than the branded version. As it stands, these plaintiffs are essentially left without any legal recourse for injuries allegedly sustained as a result of these generic drugs.

First DePuy ASR Trial Comes to a Close

As we previously reported, the first trial of the approximately ten thousand DePuy ASR hip replacement lawsuits commenced in Los Angeles, California in late January 2013.

The Los Angeles jury heard closing arguments the last week of February.  Plaintiff’s attorney asked the jury for $5.3 million in compensatory damages and an additional $179 million in punitive damages for the injuries caused by the device. A verdict is expected shortly. Interestingly, the FDA changed its regulations pertaining to hip replacement devices following the DePuy recall. Specifically, the FDA issued guidelines for patients implanted with metal on metal hip implants, advising physical examinations, diagnostic imaging and metal ion testing as needed.

If you have had a hip replacement, which used the DePuy ASR or DePuy Pinnacle devices, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against the DePuy manufacturers.

New Study Shows Pradaxa More Dangerous Than Previously Believed

As, we have previously reported, the number of Pradaxa lawsuits continues to grow across the country.  The number of lawsuits has increased by nearly 17% in recent months and now approaches 200 nationwide.

The medication resource center, DrugRisk, continues to receive, organize and disseminate safety issues relating to Pradaxa.  New reports indicate Pradaxa is more dangerous than previously thought.  While the FDA issued an update that the drug carries similar risks to its generic counterpart warfarin, a new report issued by the American College of Cardiology warns that Pradaxa use can significantly increase the risk of bleeding complications compared to warfarin. The Institute for Safe Medication Practices ranked Pradaxa among the most dangerous of outpatient drugs, reporting that bleeding caused by Pradaxa is nearly 5 times more likely to result in death than its generic counterpart warfarin.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

Secondary Service Connection for Diagnosable Illnesses Association with Traumatic Brain Injury

I have previously reported on the BIAA white paper authored by Brent Masel, M.D. describing traumatic brain injury as a chronic disease. The Federal Register has published a proposed rule of the Department of Veteran Affairs (VA) which is proposing an amendment to its adjudication regulations concerning service connection.

Florida Court finds PET Scan Satisfies Frye Requirements

Previously, a Florida Court in the matter of Gammad v. ATP Agri-Services, Inc., held a Frye Hearing to determine the admissibility of a SPECT scan. Apparently, defendant had previously filed a motion to bar the admissibility of the SPECT scan. Judge Barton, in a prior Order, dated September 22, 2012, found that SPECT was not new or novel science, and that plaintiffs had demonstrated that the basic underlying principles of SPECT imaging had been sufficiently tested and accepted by the relevant scientific and medical communities.

Making Employment of People with Disabilities a National Priority

We have known for quite some time the effect that physical and mental disabilities can have on one’s ability to actively and gainfully participate in the labor force. I have reported quite often on studies and cases involving persons with traumatic brain injury and the effect that has on one’s earning capacity. I have just had an opportunity to review the report of the United States Senate, Committee on Health, Education, Labor, and Pensions (Tom Harkin, Chairman) in a study entitled: Unfinished Business: Making Employment of People With Disabilities a National Priority.

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