Personal Injury and Social Security Disability Blog

Drug Makers Near Old Goal: A Legal Shield

I wrote recently about the legal doctrine of pre-emption that is threatening to steal legal rights from American consumers. Now the New York Times has published a lengthy but excellent article on the subject of the legal shield sought by drug manufacturers. Here are excerpts, but I encourage you to read the article.

The Supreme Court appears to be on the verge of endorsing a doctrine that the F.D.A. should not be second-guessed by courts.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines.

Consumers Beware - Pre-emption By Preamble Steals Your Legal Rights

Recent actions by federal regulatory agencies, combined with a U.S. Supreme Court decision are extremely troubling to consumer advocates. The gist of the problem is that federal agencies under the Bush administration are taking the stance that their rules trump state court verdicts.For example, if a federal agency said a prescription drug was safe, then a state jury verdict finding the drug to be unsafe would be void.

Aside from the overarching argument that federal agencies have no constitutional right to exert control over state courts, the problem with this approach is that political considerations can decide whether the agencies find certain products to be safe. If a giant pharmaceutical company makes a large contribution to a presidential candidate, there will be a natural tendency for the president to influence the federal agency to protect the financial interests of the pharmaceutical company. Some consumer advocates think that's exactly what's happening now.

Who gets hurt by this process? Consumers who have legitimate legal claims against manufacturers, but are prevented from filing those claims.

The Dallas Morning News ran an interesting story about this Pre-emption by Preamble." Here are excerpts.

If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can't sue the maker for injury if it met agency standards.

The Consumer Product Safety Commission says you can't sue a mattress maker if your mattress bursts into flame despite meeting commission standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration proposals for stronger roofs.

Plaintiffs' attorneys call it "silent tort reform." But it's part of tension existing since the nation's founding: conflict between state and federal law.

If they clash, state laws give way. That's in Article Six of the Constitution. But in areas where there is no federal law, federal courts must defer to laws of the state where a lawsuit is heard. That includes product liability.

A developing body of judicial opinion could place new limits on the rights of those who buy or use products, consumer advocates say. It also could mean the savings of billions of dollars by companies insulated from lawsuits.

What's riling plaintiffs' lawyers, consumer groups and some regulators is agencies' assertions their rules override state product liability laws. Most such claims are rooted in statements in the introductions to their rules, not the rules themselves.

"These pre-emption preambles may be only the beginning," New York University law professor Catherine Sharkey wrote in the DePaul Law Review. She projected preambles may "displace competing or conflicting state regulations or common law as a matter of course."

The practice varies by agency but is spreading. "It's absolutely a trend," said Deepak Gupta, staff lawyer for Ralph Nader's public citizen Litigation Group.

One example of what this means to the average person is found in NHTSA proposals for new SUV rollover rules.         

Attorneys general from 26 states asked the organization in 2005 to drop lawsuit protection from the rules, which could go into effect as early as July 1.

"State governments and the federal government will have to cover millions of dollars in health care costs which they will pass along to taxpayers, costs that, by all rights, should be the responsibility of manufacturers," the attorneys general wrote.

Sen. Patrick Leahy, D-Vt., at hearings last fall, said agencies have issued at least a dozen rules to shield drug and other product manufacturers from liability.   

Indeed, plaintiffs lawyers say "pre-emption by preamble" has been coming in waves during the Bush administration.

             

Researchers Find Potentially Dangerous Side Effects Of Arthritis Drug Celebrex

This article was posted today by the University of Buffalo (UB) in its online journal, The Spectrum. The conclusion is that the arthritis drug Celebrex can induce irregular heartbeat rhythms. Here are excerpts:

      On average, over one million Celebrex prescriptions are filled each month, according to the Celebrex Web site. Unlike Vioxx, an arthritis medication that was taken off the market in 2004 due to patients reporting cardiovascular side effects, Celebrex has never been pulled off pharmaceutical shelves. Celebrex is a product of Pfizer.

   Celebrex works by inhibiting an enzyme called COX-2, which has been shown to induce arrhythmia. According to the American Heart Association Web site, "arrhythmias can occur in a healthy heart and be of minimal consequence." However, "they also may indicate a serious problem and lead to heart disease, stroke or sudden cardiac death."

   Increased risks of heart attack or stroke are listed as possible side effects of Celebrex and other non-steroidal anti-inflammatory drugs (NSAID) on the Food and Drug Administration's Web site. Still, Randall D. Shortage, Ph.D., associate professor of biological sciences, said UB's research finding raises new questions about the drug.

Eli Lilly In Settlement Talks With U.S. Over Zyprexa

The New York Times is reporting that drug maker Eli Lilly is in settlement talks with the federal government regarding  the company’s marketing of the antipsychotic drug Zyprexa. The talks could result in Lilly’s paying more than $1 billion to federal and state governments -- the largest such settlement in history. Here are excerpts from the Times article:

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.

Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government programs that are the biggest customers for the drug. Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.

“We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information,” Lilly said in a statement Wednesday afternoon. “As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.”

The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.

While expensive for Lilly, the settlement would end a four-year federal investigation and remove a cloud over Zyprexa. While Zyprexa prescriptions are falling, its overall dollar volume of sales is rising because Lilly has raised Zyprexa’s price about 40 percent since 2003.

In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

ER Doctors Less Likely To Prescribe Painkillers To Minorities

Here's a strange and troubling tidbit from today's Dallas Morning News. A recent study revealed that emergency room physicians prescribe narcotic painkillers more frequently to white patients than to minority patients. What's especially odd about this fact is that whites are more likely to abuse painkillers than are blacks or Latinos. Here are excerpts:

Even for the severe pain of kidney stones, minorities were prescribed narcotics such as oxycodone and morphine less frequently than whites.

The analysis of more than 150,000 emergency room visits over 13 years found differences in prescribing by race in both urban and rural hospitals, in all U.S. regions and for every type of pain.

The study appears in Wednesday’s Journal of the American Medical Association. Prescribing narcotics for pain in emergency rooms rose during the study, from 23 percent of those complaining of pain in 1993 to 37 percent in 2005.

The study’s authors said doctors may be less likely to see signs of painkiller abuse in white patients, or they may be undertreating pain in minority patients.

In the study, opioid narcotics were prescribed in 31 percent of the pain-related visits involving whites, 28 percent for Asians, 24 percent for Hispanics and 23 percent for blacks.

Challenge To Vioxx Settlement Withdrawn

The challenge to the Vioxx settlement made on ethical grounds was voluntarily withdrawn in a brief filed on December 22. The supporting papers in the motion to withdraw state that the parties are meeting on the issue and have made "great progress," but do not specify what that progress is.

Vioxx Lawyers Move To Change Settlement Agreement

The New York Times is reporting that several plaintiff's lawyers have "asked the federal judge overseeing the $4.85 billion Vioxx settlement to give them the freedom to keep some of their clients outside the settlement while still allowing other clients to accept it."

One portion of the proposed agreement has been a big problem for a number of lawyers representing Vioxx plaintiffs. Merck is demanding that lawyers advise ALL their clients to accept the agreement. The obvious problem for the lawyers is that while the agreement might be best for some of the clients, it won't necessarily be best for all of them. So the lawyer is put in a position of deliberately giving bad advice to some clients -- a grievable offense. Here are excerpts from the article:

In an emergency motion with Judge Eldon E. Fallon of Federal District Court in New Orleans, the plaintiffs’ lawyers said the provision would prevent them from offering the best independent judgment for each client. Agreeing to the provision might open them to future lawsuits from disgruntled clients, they said.

“The Settlement Agreement, which allows Merck to dictate the advice a lawyer will offer, is improper in all states,” the lawyers wrote in the motion, which was filed Monday.

Merck and several large plaintiffs’ law firms agreed to the settlement last month as a way to resolve more than 50,000 claims from people who assert that Vioxx, a painkiller that was pulled from the market in 2004, caused them to suffer heart attacks and strokes. Merck had won most of the 18 suits that reached juries in both state and federal court.

The requirement that lawyers agree to recommend the deal to all their clients — and withdraw from representing those who do not agree — is a crucial part of the agreement.

Merck wants lawyers to put all their clients into it so that it will not face the prospect that they will settle their weaker claims while withholding their stronger cases for trial in the future. Merck also wants to be sure that plaintiffs who do choose to go ahead will have to find new lawyers, a process that will probably be difficult because the firms with the most experience in the case are all part of the agreement.

For the deal to take effect, 85 percent of all plaintiffs, as well as 85 percent of plaintiffs who have stronger cases because they took the drug continuously for more than a year, must agree to its terms.

But Benjamin Zipursky, a professor at Fordham Law School who has closely followed the case, said the all-or-nothing requirement might pose ethical problems.

“The question is, is this really independent advice given to each client if the lawyer obligates himself or herself to say this to all the clients,” Mr. Zipursky said.

Mr. Mayer, the Merck lawyer, said the federal court might not be able to change the settlement, since the Vioxx cases were not being tried as a class action, in which any overall settlement requires judicial approval. He declined to say what the company would do if Judge Fallon ordered the two sides to change the agreement.

The motion will be heard in mid-January.

Merck Recalls Hepatitis A Vaccine, VAQTA

Merck & Co. has voluntarily recalled VAQTA (Hepatitis A vaccine, Inactivated) in prefilled syringes after tests revealed a decreased antigen content in some syringes that was below the established minimum specification. As a result, some patients who were vaccinated with the affected lots may be insufficiently protected from hepatitis A.

Vaccine claims are very complex, and must be made under the National Vaccine Injury Compensation program, which is administered by the United States Court of Federal Claims in Washington, D.C.

FDA Recommends Warnings For Tamiflu and Relenza

Reuters reports that the Food & Drug Administration is recommending new warnings about psychiatric problems sufferedby some patients taking Tamiflu and Relenza influenza medications. Excerpts from the story:

In documents...posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened to note, "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behavior" observed in some patients taking the drug.

FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu, known generically as oseltamivir, is a pill, while Relenza, generically zanamivir, is inhaled.

A Roche spokesman said no causal relationship between Tamiflu and these psychiatric events has been proven.

"Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously," spokesman Terence Hurley said in a statement.

About 48 million people have taken Tamiflu worldwide, including 21 million kids, since approval in 1999, he said.

A Glaxo spokeswoman said a review of premarketing and post-approval trial data showed no signal of these types of adverse events on patients taking Relenza.

FDA staff reviewed nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

Merck Agrees To Settlement Of Some Vioxx Claims

Announcement was made today of a proposed settlement agreement between Merck, the manufacturer of Vioxx pain medication, and attorneys representing certain plaintiffs in lawsuits claiming that heart attacks or strokes were caused by the intake of Vioxx.

The settlement proposal is quite complex, and is not a "done deal" yet. Here is the official press release from Merck:

Merck Agreement to Resolve U.S. VIOXX® Product Liability Lawsuits

Agreement Provides for $4.85 Billion Payment

WHITEHOUSE STATION, N.J., Nov.  9, 2007 - Merck & Co., Inc. today announced that it has entered into an agreement with the law firms that comprise the executive committee of the Plaintiffs' Steering Committee of the federal multidistrict VIOXX litigation as well as representatives of plaintiffs' counsel in state coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against the Company in the United States.  The agreement, which also applies to tolled claims, was signed by the parties this morning after they met with three of the four judges overseeing the coordination of more than 95 percent of the current claims in the VIOXX litigation. If certain conditions under the agreement are met, the Company will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter into the resolution process.  This is not a class-action settlement.  Claims will be evaluated on an individual basis. "This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines," said Richard T. Clark, chairman, president and chief executive officer of Merck.  "The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount." The conditions in the agreement, which is open only to those cases filed or tolled on or before Nov. 8, 2007, include: To qualify, claimants will have to pass three gates: an injury gate requiring objective, medical proof of MI or ischemic stroke (as defined in the agreement), a duration gate based on documented receipt of at least 30 VIOXX pills, and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury; Individual cases will be examined by administrators of the resolution process to determine qualification based on objective, documented facts provided by claimants, including records sufficient for a scientific evaluation of independent risk factors; The agreement provides that Merck does not admit causation or fault; Neither stroke claims that are hemorrhagic in nature nor transient ischemic attacks will qualify; Law firms on the federal and state Plaintiffs' Steering Committees and firms that have tried cases in the coordinated proceedings must recommend enrollment in the program to 100 percent of their clients who allege either MI or ischemic stroke; The parties agree to seek court orders from the four coordination judges requiring plaintiffs' attorneys to promptly register all of their VIOXX claims, whether filed or tolled, and to identify the alleged injury - in order to establish the universe of all existing claims in the United States; Participation conditions: payment obligations under the agreement will be triggered only if, by March 1, 2008 (subject to extension by Merck), plaintiffs enroll in the settlement process: (a) 85 percent or more of all currently pending and tolled MI claims, (b) 85 percent or more of all currently pending and tolled ischemic stroke claims; (c) 85 percent or more of all eligible claims involving a death; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use; and This agreement applies only to U.S. legal residents and those who allege that their MI or ischemic stroke occurred in the United States. Under the agreement, separate funds will be created by the Company in the amount of $4 billion for MI claims and $850 million for ischemic stroke claims.  Once triggered, Merck's total payment for both funds of $4.85 billion is a fixed amount to be allocated among qualifying claimants based on their individual evaluation.  While at this time the exact number of claimants covered by this agreement is unknown, the total dollar amount is fixed.  Payments to individual qualifying claimants could begin as early as August 2008 and then will be paid over a period of time.  Merck retains its right to terminate this process without any payment to any claimant, and to defend each claim individually at trial if any of the participation conditions in the agreement are not met. The Company expects to record a fourth-quarter 2007 pre-tax charge in the amount of $4.85 billion to cover the cost of the agreement. "This agreement is the product of our defense strategy in the United States during the past three years and is consistent with our commitment to defend each claim individually through rigorous scientific scrutiny.  Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine if they qualify for payment," said Bruce N. Kuhlik, senior vice president and general counsel of Merck. "This agreement also makes sense for the Company because since 2004, we have reserved approximately $1.9 billion for defending VIOXX litigation and, absent this agreement, could anticipate that the litigation might stretch on for years." "Creating a process to look at individual claims is the fairest way to efficiently and quickly provide payment to qualified claimants," said Russ Herman, Liaison Counsel in the federal multidistrict VIOXX litigation and Chair of the Plaintiffs' Negotiating Committee.  "Specific causation has been a very difficult issue.  This is an opportunity to end a long and difficult litigation that has stretched on for more than three years.  A fair resolution is in everybody's best interest.  This agreement would only apply to claims already filed or tolled." "This is the right time for an agreement," said Mr. Kuhlik.  "Recent court rulings confirmed that the window has closed for filing suits in a number of states, consistent with our view that statutes of limitations have expired in almost every state.  Additionally, three of the coordination judges have issued orders that require non-eligible and non-participating plaintiffs to provide documentation of the factual basis for their claims early in the litigation process.  Merck reserves the right under this agreement to terminate our involvement unless the vast majority of eligible claimants elect to participate." Forty-two states, Puerto Rico and the District of Columbia have statutes of limitations of three years or less.  Already, New Jersey Superior Court Judge Carol Higbee and Federal District Court Judge Eldon Fallon have issued orders in cases from New Jersey and eight other jurisdictions ruling that the statutory period for making VIOXX personal injury claims has passed.  Merck voluntarily withdrew VIOXX from the marketplace on Sept. 30, 2004. The discussions between Merck and the plaintiffs were originally requested by Judge Fallon, Judge Higbee, California Superior Court Judge Victoria Chaney, and Texas County Court Judge Randy Wilson.  Judges Fallon, Higbee and Chaney, who met with the parties prior to the agreement being signed, issued case management orders that will require plaintiffs seeking to pursue VIOXX claims outside this resolution process to provide in a timely fashion certified copies of their medical and pharmacy records, as well as expert causation opinions. Merck has submitted a similar order to Judge Wilson. The Company will continue to defend all claims that are not included in the resolution process. Plaintiffs requesting additional information should contact the Chair of the Plaintiffs' Negotiating Committee for further information: Russ Herman of Herman, Herman, Katz & Cotlar, LLP at (504) 581-4892. Status of Litigation Juries have now decided in favor of the Company 12 times and in plaintiffs' favor five times.  One Merck verdict was set aside by the court and has not been retried.  Another Merck verdict was set aside and retried, leading to one of the five plaintiff verdicts.  There have been two unresolved mistrials. As of Oct. 9, 2007, in the United States, the Company had been served or was aware that it had been named as a defendant in approximately 26,600 lawsuits, filed on or before Sept. 30, 2007, which include approximately 47,000 plaintiff groups, alleging personal injuries resulting from the use of VIOXX, and in approximately 264 putative class actions alleging personal injuries and/or economic loss. Merck has entered into a tolling agreement with the multidistrict litigation Plaintiffs' Steering Committee that establishes a procedure to halt the running of the statute of limitations for certain categories of claims allegedly arising from the use of VIOXX by non-New Jersey citizens.  The Tolling Agreement requires any tolled claims to be filed in federal court.  As of Sept. 30, 2007, approximately 14,100 claimants had entered into Tolling Agreements.  The parties agreed that April 9, 2007, was the deadline for filing Tolling Agreements and no additional Tolling Agreements are being accepted. The claims of over 5,550 plaintiff groups had been dismissed as of Sept. 30, 2007.  In addition, about 20 cases scheduled for trial were either dismissed or withdrawn from the trial calendar by plaintiffs before a jury could be selected.