The latest slew of overturned verdicts against Merck, the makers of the withdrawn painkiller Vioxx, is yet another indication of the increasing difficulty that plaintiffs’ lawyers are experiencing in winning lawsuits against big drug companies. The latest ruling overturned a $26 million jury verdict against Merck in Texas based on the grounds that there was insufficient evidence to link use of Vioxx to a plaintiff’s fatal heart attack. The initial lawsuit was brought by Carol Ernst, whose husband, Robert, died in 2001 after taking Vioxx. The verdict reversal came after the appeals court found the plaintiffs had not proven that Vioxx caused Mr. Ernst’s death.

“The appellate court recognized that there was insufficient evidence supporting the jury’s verdict and, accordingly, rendered a final judgment in the case in favor of Merck,” said Ted Mayer, outside counsel for Merck.

Separately, an appeals court in New Jersey overturned a verdict in another Vioxx case. The court ruled that the jury should not have been allowed to award punitive damages against Merck or to find that Merck had committed consumer fraud.

These overturned rulings now leave lawyers for plaintiffs with just three victories, all with relatively small awards, in the nearly 20 Vioxx cases that have reached juries. And plaintiffs are likely to face a continued uphill battle, as these rulings may act to discourage lawyers from pursuing lawsuits against drug makers—even though the two sides have already agreed to a $4.85 billion settlement that will largely end the Vioxx litigation.

A report about to be published by the Journal of the American Medical Association (JAMA) states Merck intentionally deceived the Food & Drug Administration in order to win approval of the drug. The report concludes that Merck deceived the FDA by withholding data showing Vioxx had a higher than reported risk of death and by submitting research reports Merck employees wrote, rather than independent scientists.

Vioxx is no longer on the market since Merck voluntarily withdrew the drug in 2004, but this new report may still lead to further damages against the company. The law has different levels of legal culpability and if the JAMA report is found true, it may raise Merck’s culpability. Although many lawsuits against Merck currently allege negligent testing of the drug, future lawsuits may now be amended to include intentional misconduct. If Merck covered up the data in order to win FDA approval, that can be considered intentional misconduct.

So far Merck has been sued by 26,500 former Vioxx patients and has set aside $4.85 billion to settle the claims. This amount was probably determined after Merck did a cost benefit analysis of taking the claims to trial, and possibly losing. If Merck did intentionally cover up data this settlement fund will surely rise. Not only because the plaintiffs chances of winning have risen, but also because the plaintiffs are more likely to ask for, and receive, a higher damage award.

Damages sought for the cost of a Vioxx patient’s heart attack or stroke (hospital stay, loss of work, etc.) do not increase because Merck may have intentionally covered up data. But damages in a case like this do cover punitive damages—which can be inflated to punish intentional misconduct.

THE OUTCOME: Drugmaker Merck & Co. won the latest Vioxx trial when an Atlantic City jury ruled Merck’s withdrawn painkiller Vioxx was not a major cause of 68-year-old Elaine Doherty’s heart attack in January 2004.

KEY ISSUES: Jurors said that most felt Doherty’s obesity and other cardiac risk factors caused her heart attack. The jurors voted unanimously that Merck failed to warn Doherty about the drug’s risks, the first time that issue has been considered in a Vioxx trial.

THE SCORECARD: Merck has won four of the seven Vioxx cases to reach verdicts, including three of the four cases in New Jersey. It still faces at least 16,000 Vioxx lawsuits.

As trials continue against Merck, the maker of Vioxx, attorney David I. Fuchs predicts a change in verdicts from state to state, based on the political views of the jury in each jurisdiction.

In South Florida, where Fuchs practices law, juries tend to be much more conservative in their awards, even though the area is considered to be a “bastion of liberalism.”

“When you go north and west in Florida,” Fuchs said, “our verdicts tend to be more plaintiff-oriented with verdicts settling higher, even though it is a socially conservative area.”
Fuchs said he can’t explain why the trend exists in Florida, but the same phenomenon worked against Vioxx in Texas where the first trial ended last month. The Texas jury stung Merck with a $253.5 million liability verdict, a high verdict for a politically conservative state.

The judge will slash the award to about $26 million because Texas law caps punitive damages. While Merck plans to appeal, attorneys will continue to fight more than 5,000 lawsuits filed in state and federal courts. Half of the cases are in New Jersey, where Merck is located, with the rest spread across the country.

In Florida, Fuchs said juries tend to frown upon frivolous lawsuits and will punish a plaintiff who cannot prove his or her case. He said the most damaging proof for Merck was probably the internal memo. “The memorandum showed that if there was a delay in posting the drug warnings, Merck would make an extra $229 million, which is about the same amount jurors awarded the plaintiff,” Fuchs explained.
All of the cases will have this memo working against them but will affect juries differently, Fuchs said. “Even though we are dealing with a huge company that has had the type of negative publicity of Merck, some people will feel that it is somehow against their religion to hit a company for money.”
Verdicts will vary according to judge as well, said Fuchs. “We can’t pick our judge. If we could, we’d all be millionaires and wouldn’t have to practice law much longer,” Fuchs explained. “We pray it’s a judge who will give us a fair shake.”

Fuchs said that although judges are instructed to leave any subjective biases aside, they are human, and they do make mistakes.

Final Word from Fuchs:

“Two judges may interpret the law quite differently,” Fuchs said, referencing the liberal and conservative minds of the justices on the U.S. Supreme Court. “If you have a fair jury and an opened-minded, fair judge, I think Merck’s in trouble.”

About The Attorney

David I. Fuchs has been representing clients in his South Florida practice for more than eleven years. He is a member of the Florida, New York and District of Columbia Bar Associations.

Chemical name / Brand name
Celecoxib / Celebrex
Valdecoxib / Bextra
Rofecoxib / Vioxx
Diclofenac / Cataflam, Voltaren, Arthrotec (combination with misoprostol)/
Diflunisal / Dolobid
Etodolac / Lodine, Lodine XL
Fenoprofen / Nalfon Nalfon 200
Flurbiprofen / Ansaid
Ibuprofen / Motrin, Motrin IB, Motrin Migraine Pain, Advil, Advil Migraine Liqui-gels, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen, Profen, Ibuprohm, Children’s Elixsure, Vicoprofen (combination with hydrocodone), Combunox (combination with oxycodone)
Indomethacin / Indocin, Indocin SR, Indo-Lemmon, Indomethegan
Ketoprofen / Oruvail, Orudis, Actron
Ketorolac / Toradol
Mefenamic / Acid Ponstel
Meloxicam / Mobic
Nabumetone / Relafen
Naproxen / Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin / Daypro
Piroxicam / Feldene
Salsalate / Disalcid
Sulindac / Clinoril
Tolmetin / Tolectin, Tolectin DS, Tolectin 600

Note: There are many OTC combinations with ibuprofen: Advil Cold & Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprohm Cold & Sinus, Sine-Aid IB, Children’s Motrin Cold.

SOURCE: Food & Drug Administration

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC) non-selective NSAID medications. A list of these products is available online at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday,” said Dr. Steven K. Galson, Acting Director of FDA’s Center for Drug Evaluation and Research (CDER). “FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks.”

FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex.

FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency’s Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

For more information on these drug changes, visit the FDA’s Web site at www.fda.gov/cder or call 1-888-INFO-FDA (888-463-6332).