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King’s Bench Petition Denied

Today the Pennsylvania Supreme Court denied Bayer’s King’s Bench Petition in the Yaz/Yasmin litigation. In plain English, this means that these lawsuits, many of which were pending since 2009, and which were put on hold late last year, can now go forward.

Some Background

Several thousand women from across the country have sued Bayer in state Court in Philadelphia. The basis of the lawsuit is that Bayer Corporation, and its subsidiaries, which manufacture Yaz, Yasmin, and Ocella, failed to warn consumers that these drugs increase the risk of blood clots and gallbladder surgery. Women who suffered these injuries are requesting compensation.

The defendants took advantage of a relatively obscure legal principle called forum non conveniens, or “inconvenient forum”, to argue that women who do not live in Pennsylvania should not be allowed to bring a lawsuit Pennsylvania, where Bayer is headquartered. Bayer argued that although it is headquartered in Pennsylvania, only its subsidiaries (and related companies) are involved in Yaz, Yasmin, and Ocella, and they are in New Jersey and Germany. In turn, the women suing argued that Bayer is located in Pennsylvania and therefore lawsuits in Pennsylvania are appropriate.

The judge considered Bayer’s arguments and denied its motion to have the out-of-state cases dismissed. Bayer asked the judge to reconsider, which was denied. Bayer then appealed to the state’s intermediate appellate court, which denied the appeal. The company also made an extraordinary petition, known as a “King’s Bench Petition” to the Pennsylvania Supreme Court, claiming that the trial court judge was wrong and the Supreme Court should intervene to correct her errors. (The King’s Bench terminology is derived from the days in England when the King heard extraordinary petitions. Over time, judges were appointed to hear these petitions, which evolved into today’s appeals courts.)

Following the appeal, the trial court judge determined that it would be imprudent to bring an out-of-state case to trial while the appeal was pending, so on December 21, 2011, she ordered a halt to all trials involving out-of-state plaintiffs “pending the PA Supreme Court’s decision” on this issue. On February 2, 2012, the Pennsylvania Supreme Court issued its decision: a unanimous denial of the petition in all nine cases that were on appeal.

Practical Implications

The PA Supreme Court’s decision not to consider Bayer’s arguments, has three main implications. First, until now, there was the possibility that thousands of cases would be dismissed from the Pennsylvania trial court and would have to be re-filed in another jurisdiction, causing needless delay and expense for the plaintiffs. Now, the plaintiffs will most likely be able to avoid this delay. Second, cases that were being prepared for trial can now be given trial dates, which leads to the third implication: This will keep the pressure on Bayer during the settlement negotiations that have been ordered. With any luck, it will increase the chances that women across the country are able to come to an agreement with Bayer regarding these cases, so that they can receive reasonable compensation and encourage drug companies to provide adequate warnings.

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Background

On December 8, 2011, an FDA advisory committee held hearings on the safety of Yaz and Yasmin. After nearly a full day of testimony, the committee voted 21-5 that the information about the risks of Yaz provided to doctors and patients were inadequate. The panel voted narrowly, however, that the benefits outweigh the risks overall, and therefore voted not to remove Yaz from the market. The second vote was 15-11.

In the weeks following the votes described above, some disturbing details have come to light about the members of the expert panel that is advising the FDA.

• Five members of the committee, including the committee chair, have financial ties to Bayer
• A sixth member was stripped of his voting rights for an “intellectual conflict of interest” because he had the foresight to question the safety of Yaz a few years ago.
• A detailed report on the safety of Yaz, authored by former FDA Commissioner David M. Kessler, M.D., was not considered by the committee. The report was submitted in the Yaz litigation under seal, and although the Judge ordered it released to the public, the order did not come out until after the deadline for submitting materials to the advisory committee. The FDA declined to make an exception in this case.

Further Developments

Simple maths suggests that if the committee members with financial ties to Bayer were not permitted to vote, and if the sixth expert who was disqualified at the last minute was allowed to vote, then the committee might have decided, 12-10 to recommend removing Yaz and Yasmin from the market.

In addition, Lopez McHugh has reviewed the transcript of the vote and found that several of the experts who voted to keep Yaz on the market had significant concerns about the safety of the drug. For example:

• Dr. Clark voted to keep Yaz on the market, but thought there was a “modest increase in absolute risk.” (Transcript, p. 109).
• Dr. Johnson, the chairperson of the committee, explained that she does not think “there is one advantage for this pill over any other,” and if an additional study found an increased risk, would vote to remove Yaz from the market. (Transcript, p. 110).
• Dr. Morrato explained that the absolute risk was low, but if she were making a comparative assessment, she would vote no. (Transcript, p. 110).
• Dr. Hennessy explained that “it was a difficult vote,” and that the drug “out to be rarely used”. (Transcript, p. 112).
• Dr. Burke believed that Yaz had a “moderate increased risk,” but didn’t believe it was necessary to take off the market “at this point.” (Transcript, p. 112).
• Dr. Espey compared the risk of blood clots on Yaz to the risk of blood clots while pregnant, apparently ignoring the fact that there are other methods of birth control with lower risk. (Transcript, p. 109).
• Several other experts appeared to follow the same logic as Dr. Epsey, and compared Yaz to the risk of getting pregnant rather than comparing Yaz to other forms of birth control (Dr. Hoeger, Dr. Tepper, and Dr. Rice, p. 110; Dr. Wild, p. 111; and Dr. Raymond, p. 112).

The experts who voted to remove Yaz from the market expressed additional concerns. For example:

• Dr. Orzsa explained that there was no benefit from Yaz over any other drug, and pointed out that even a “small” increase in risk could cause thousands of unnecessary [life-threatening] blood clots. (Transcript, p. 110).
• Dr. Woods saw no clear benefit and a modest, but “potentially catastrophic risk.” (Transcript, p. 110).
• Dr. Kaboli saw no clear benefit, so no reason to subject women to even a small increase risk.  He stated that he wouldn’t recommend it to his patients and wouldn’t have his daughter take it. (Transcript, p. 111).
• Dr. Winterstein took issue with how the question was worded–weighing overall risk against overall benefit (prevention of pregnancy), rather than comparing to potentially safer drugs on the market. (Transcript, p. 111).
• Dr. Suarez-Almazor explained that she did not believe there was clear evidence of benefits over other oral contraceptives. Further, she was “disturbed” by the fact that every independent study showed an increased risk while only the industry-sponsored studies showed no increased risk. (Transcript, p. 111).

As the above examples demonstrate, even if the FDA decides to keep Yaz on the market, a panel of experts had serious concerns about the risks versus the benefits of Yaz.

New Vote?

The non-profit group Project on Government Oversight has written an open letter to the FDA, calling for it to put aside the committee vote and hold new hearings, this time with experts that do not have ties to Bayer. Whether the FDA addresses the Project’s concerns remains to be seen. Updates will be posted here.

If you suffered blood clots, pulmonary embolism, or stroke while on Yaz, Yasmin, Ocella, or Beyaz, then you should consider calling for a free case evaluation. You can contact Lopez  McHugh using the form on the right, or by clicking here.

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With the recent Yaz settlement news, people are starting to wonder whether there will be a Yaz settlement in 2012. In early January two judges involved in the litigation put trial deadlines on hold and ordered mediation. The both sides were ordered to attempt to negotiation a Yaz settlement in good faith.

To date, there has been no additional public information released regarding a Yaz settlement in 2012, but no news is probably good news. If settlement talks break down, then the judges can be expected to issue orders scheduling cases for trial.

Lopez McHugh represents a number of women who were injured by Yaz, and is working diligently both to recover compensation for them and to bring details of Yaz and Yasmin to light. For example, we previously reported that although an FDA advisory panel narrowly voted to keep Yaz and Yasmin on the market, several of the expert advisers had financial ties to Bayer, the manufacturer. When counting the votes of the experts who were independent of Bayer, it appears that a majority thought the risks of Yaz outweighed the benefits.

For more information, or to discuss your specific situation, free of charge, click here to contact us, or call 877-703-7070.

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