Mass Torts Law Blog

Democrats Endorses Bill in Congress to Hold Generic Drugmakers Liable

Craig S. Hilliard — Mon, 23 Apr 2012 13:50:52 +0000

Bills were just recently introduced in the US House of Representatives and the US Senate which would effectively overrule the Supreme Court’s decision 2011 decision in Pliva v. Mensing by “allow[ing] generic drug companies to be held liable under state tort law for failing to update warning labels with known dangers.” In a 5-4 split, the Supreme Court’s decision in Mensing held that generic drug-makers are not liable for label warnings because they are legally required to use the same label as brand-name makers. In the dissent, Supreme Court Justice Sonia Sotomayor noted, “As the majority itself admits, a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. The majority offers no reason to think – apart from its new articulation of the impossibility standard- that Congress would have intended such an arbitrary distinction.”

As expected, the 2011 decision created uproar with concerned and affected consumers as well as with the legal community. Following the ruling, generic drug-makers have been successfully moving to be dismissed from mass torts and class actions across the country, including the Darvocet multidistrict litigation currently centralized in Kentucky. It appears that the new legislation would require generic drug-makers to follow the same guidelines that brand name makers use for updating product safety on their labels. “The Mensing decision creates a troubling inconsistency in the law governing prescription drugs,” said Senator Patrick J. Leahy (VT), who sponsored the bill along with six other Democrats, in a statement on April 18, 2012. Some argue that the likelihood of the bill passing in the House, which is controlled by Republicans, is slim.

Federal Judge Appoints Plaintiffs’ Leadership Team in Actos Litigation

Martin P. Schrama — Wed, 14 Mar 2012 14:49:33 +0000

The Honorable Rebecca F. Doherty, who is overseeing the federal Actos cases centralized in Louisiana, has appointed 19 plaintiffs’ attorneys to manage the litigation. As we have previously reported, recent studies allegedly show that diabetics taking Actos may be at an increased risk of developing bladder cancer. A recent Bloomberg article stated that Takeda Pharmaceutical Company, the Asian-based manufacturer of Actos, could face upwards of 10,000 lawsuits in the United States. Eli Lilly & Company, which is also currently involved in the Darvocet litigation, has been named as a co-defendant based on allegations that the company withheld information from consumers about the associated risks and failed to provide adequate label warnings.

According to a March 12, 2012 note posted on the Court’s website, Judge Doherty advised that“[t]he Court has determined to effect the selection of lead counsel, liaison counsel, and plaintiffs’ executive and steering committees before the March 22nd- 23rd status conference.” The selection will allow for the plaintiffs’ attorneys to meet and confer while in Lafayette for the initial March conference.

If you feel you have experienced adverse side-effects from taking Actos, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the manufacturers of Actos.

Judge Martinotti Schedules First New Jersey Nuvaring Trial

Kevin M. Hart — Tue, 28 Feb 2012 20:33:18 +0000

At a Case Management Conference on February 27, 2012, Judge Martinotti, who is overseeing all New Jersey state cases in the Nuvaring litigation, scheduled the first trial to begin on February 4, 2013. The parties expect the trial to last approximately one month, given the Court’s schedule and various holidays. At this point, it is unclear which case will be chosen to be tried first. However, Judge Martinotti has ordered that nine selected cases, known as bellwether cases, be prepared to start trial that day. The actual order of these first nine cases will be determined at a later date. This would be the first Nuvaring trial, both in the state and federal courts, since the initial complaint was filed in 2007.

If you, or someone you know, has experienced adverse effects as a result of using Nuvaring, contact Stark & Stark to speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the manufacturer of Nuvaring.

New Bill Could Restrict Medical Device Approval Process

Stefanie Colella-Walsh — Tue, 21 Feb 2012 15:21:24 +0000

A recent Bloomberg article, reported that House Democrat Edward Markey (MA) has sponsored a bill that would prevent manufacturers from asserting that their new medical devices are “substantially equivalent” to existing, approved devices, under certain circumstances. While the bill was apparently developed as a result of a 1999 recall of vaginal mesh manufactured by Boston Scientific, it is particularly relevant given the recent litigation over the 2010 recall of the DePuy Orthopaedics’ ASR hip replacement devices.

The ASR device was approved for U.S. marketing through the 510(k) premarket approval process, which permits the manufacturers to claim their new products are “substantially equivalent” to preexisting ones. If successful, the manufacturers are able to avoid exposing their devices to more thorough clinical trials, which can often take years and can further delay introduction to the market. However, many times, the immediately preexisting device was also approved in the same manner, so that the lineage originates at an old, untested device.

The new bill would allow the Food and Drug Administration (FDA) to deny a manufacturers ability to claim its device is “substantially equivalent” to a preexisting device if the preexisting device was recalled or if the FDA was in the process of deciding to remove it. The manufacturers would also be required to demonstrate the difference between their new device and the problematic device as well as advise Congress if any device in the product’s lineage had been recalled.

In support of the bill, Representative Markey commented, “If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies.” He further opined that the bill ensures “that devices do not mimic the mistakes made by other products.”

At this time, it is unclear whether the bill will garner the necessary support of Congress and President Obama to become law.

If you have had a hip replacement, which used the DePuy ASR or 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.

Johnson & Johnson Continued Marketing FDA Rejected Hip Device in Europe

Craig S. Hilliard — Tue, 21 Feb 2012 15:18:39 +0000

According to a recent New York Times article, Johnson & Johnson continued to market an artificial hip replacement in Europe, despite the Food and Drug Administration (FDA) rejecting its sale in the United States, based on safety concerns. The company also continued to sell a similarly designed device in the United States, the articular surface replacement (ASR) device, which had not been required to undergo a similar safety review. Both models utilized an all-metal hip socket that experts have allegedly concluded was faulty in design.

The FDA advised Johnson & Johnson in August 2009, that the company studies and clinical data submitted to gain approval to market the model in the United States, which was already being sold in Europe, were inconclusive to determine the device’s safety and effectiveness. Based on a review of publicly available documents, it appears that Johnson & Johnson did not discuss the advisory letter from the FDA in its financial reports or with analysts. Interestingly, it was only a few months after receiving this confidential correspondence from the FDA that Johnson & Johnson began to officially phase out the ASR models. As we have previously reported, Johnson & Johnson formally recalled the ASR models in August 2010, based on the premature failure rate.

There is no allegation that Johnson & Johnson broke the law by its failure to disclose the FDA’s decisions to the European markets. However, some commentators suggest that the rejection by the FDA further supports the allegation that Johnson & Johnson was aware of the flawed design in the ASR, but continued to market it in the United States. In January 2012, the company took a $3 billion charge, mostly related to anticipated medical and legal expenses associated with the 2010 recall and subsequent litigation.

Judge Asked To Consider Possible FDA Conflicts of Interest in YAZ Litigation

Martin P. Schrama — Mon, 30 Jan 2012 13:02:30 +0000

Recently, the Plaintiffs’ Steering Committee in the Yaz and Yasmin litigation opposed a motion to exclude the opinions of former Food and Drug Administration (FDA) commissioner, David Kessler, concerning possible conflicts of interest. The Plaintiffs’ attorneys have asked Judge Herndon, who is overseeing the federal Yaz and Yasmin cases, to allow in evidence showing that conflicts of interest may have tainted the meetings of an independent advisory committee to the FDA that was asked to consider the health risks associated with Yaz and Yasmin.

Specifically, it is alleged that four members of the FDA advisory committee that voted not to remove Yaz and Yasmin from the U.S. market received significant sums of money from Bayer and Bayer Pharmaceuticals, the manufacturers of Yaz and Yasmin. Ultimately, the FDA advisory committee voted 15-11 to keep the oral contraceptives on the market, concluding that the benefits of Yaz and Yasmin outweigh the risks. Plaintiffs contend that either Bayer hid the ties to the four members of the advisory committee from its experts or its experts intentionally omitted the ties from their reports. Not surprisingly, the FDA has defended the findings of its advisory committee.

As previously reported, Judge Herndon recently ordered both sides to mediation, which postponed the initial trial date to April 30, 2012, if mediation is not successful.

If you feel you have experienced any side-effects from taking YAZ® or Yasmin®, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the YAZ® or Yasmin® manufacturers.

Stark & Stark Shareholder Comments on Status of Darvocet & Darvon Litigation

Stark & Stark — Fri, 27 Jan 2012 14:23:43 +0000

Kevin M. Hart, Chair of Stark & Stark’s Mass Tort Litigation Group, was quoted in the January 25, 2012 New Jersey Law Journal article, Suits Allege Lilly Failed To Warn of Darvocet’s and Darvon’s Health Risks. The article discusses a recent case in which former Darvocet and Darvon users are claiming that the manufacturer of the drugs, Eli Lilly & Co., failed to warn users of the serious side effects associated with the painkiller, including heart problems such as angina, arteriosclerotic heart disease and mitral regurgitation.

Plaintiffs from all over the country, including Pennsylvania, Texas, California, Mississippi, North Carolina and South Carolina state that propoxyphene, the active ingredient in Darvocet, Darvon and generic versions of the drugs, is only marginally effective for pain relief and that any benefit was outweighed by the risk of cardiovascular problems.

Mr. Hart, who filed the nine suits, also names aaiPharma Inc., of Wilmington, N.C., and Xanodyne Pharmaceuticals of Newport, K.Y. as defendants in the suit. Mr. Hart states that about 175 similar cases are pending in the MDL, and he expects his cases to be moved to Kentucky as well. Additoonaly, Mr. Hart states that the first trials are at least two years away.

Pennsylvania Follows Federal Judge and Sends Yaz cases to Mediation

Kevin M. Hart — Tue, 17 Jan 2012 14:12:29 +0000

On January 6, 2012, Judge Moss, who is overseeing the state Yaz cases in Philadelphia, followed in Judge Herndon’s footsteps and ordered the parties into mediation. Like Judge Herndon, who is overseeing the federal Yaz cases, Judge Moss also appointed Professor Stephen Saltzburg of George Washington School of Law as Special Master, for the purposes of mediation. Judge Moss has ordered the Philadelphia liaison counsel to coordinate with the MDL leadership teams and to participate in all organizational meetings with Professor Saltzberg.

Plaintiffs are hopeful that the sudden push by the Court to mediation will open the doors to a global Yaz settlement.

First Federal Yaz Trial Sent to Mediation, NJ Trials Still On…For Now

Stefanie Colella-Walsh — Fri, 13 Jan 2012 13:43:20 +0000

The first federal Yaz trial is not moving forward as planned. While the highly anticipated trial was originally scheduled to begin the second week of January 2012, Judge Herndon, who is overseeing the federal Yaz cases in the Southern District of Illinois, has now ordered both sides to mediation.

On December 31, 2011, Judge Herndon appointed Professor Stephen Saltzburg of George Washington School of Law as Special Master, for the purposes of mediation. Professor Saltzberg previously handled the mediation in over 25,000 Seroquel lawsuits. In his Order, Judge Herndon opined that the interests of the plaintiffs and defendants will be “better served” by entering into mediation. He further ordered the parties to meet with Professor Saltzburg without delay and to negotiate in good faith. Pending the outcome of the mediation, Judge Herndon’s December 31, 2011, Order has stayed the scheduling in the balance of the bellwether federal cases.

However, Judge Martinotti, who is overseeing the New Jersey Yaz cases in Bergen County, New Jersey, has advised counsel for both parties to continue with bellwether discovery, including depositions. While probably hopeful that the mediation in the federal case will have a positive effect on all Yaz cases, nationwide, Judge Martinotti likely does not want to delay the New Jersey cases, in the event that a settlement is not reached. A Case Management Conference is currently scheduled for February 2012.

Interestingly, the alternative plan to send the parties to mediation comes on the heels of the Food and Drug Administration (FDA) voting 21 to 5 that the label on Yaz and Yasmin did not adequately warn users about the risk of blood clots, which is higher than other oral contraceptives. The FDA further found that the label did not adequately warn about the increased risks for those users who smoke or are overweight.

FDA Concludes Yaz Label Inadequate

Craig S. Hilliard — Wed, 11 Jan 2012 13:42:02 +0000

In early December 2011, an advisory panel of the Federal Drug and Administration (FDA) convened for 9 hours of hearings concerning the increased risk of blood clots for users of Yaz and Yasmin. It was reported that several independent studies found women who took Yaz and/or Yasmin were more likely to suffer a blood clot than women taking other forms of birth control, which do not contain the hormone drospirenone. Following testimony, the panel voted 21 to 5 that the label was inadequate and should be changed by Bayer to explain the increased risk. Eleven experts also voted for a Yaz recall, but were out-voted by the other 15 members who opined that the benefits outweighed the risks. To date, Bayer has failed to issue a voluntary recall.

As previously reported, other possible side effects of Yaz and/or Yasmin also include heart attack, pulmonary embolism and stroke.

Currently, more than 10,000 suits have been filed nationwide.