Medical Implant, Device and Prescription Drug Cases

John D. Winer, San Francisco

A. Generally.

It seems like every year a nationwide problem occurs stemming from the defective design and manufacture of medical implants, prescription drugs or medical devices that are inserted in patients’ bodies.

In recent years, hundreds of thousands of patients have been injured by breast implants, penile implants, contaminated sutures, and dangerous prescription drugs such as Rezulin, Fen-Fen and Vioxx.

Unfortunately for the victims of these defective implants, drugs and other medical devices, in California, the usual product liability laws that protect consumers from defective products do not apply.

Most significantly, liability cannot be established on a strict liability theory based on the defective design of the product. Rather, in cases involving defective drugs, implants and medical devices, the plaintiff has to prove that the product was negligently designed which is a much more difficult standard to establish. It has been said that negligence focuses on the “reasonableness” of the defendant’s conduct, but strict liability is ordinarily based solely on the nature of the product.

Because of the more difficult standard of proof in medical implant, drug and device cases, the cases are extraordinarily expensive to prove and they are usually aided by a number of victims coming together to bring an action against the manufacturer.

B. Who Can Sue in a Medical Product Case.

A person who has been injured as a result of a defective medical implant, prescription drug or other device can bring a lawsuit if he or she can establish fault on the part of the manufacturer, supplier or seller of the device or the physician who inserted the device or prescribed the drug, if they can establish negligence of the physician.

Both minors and adults can bring these cases, but in cases with minors, a parent or guardian must bring the case in their behalf.

The spouse of the injured plaintiff can also bring suit for loss of consortium damages; that is, damages for the loss of society, comfort and care of the injured plaintiff. See the section on Damages in this article.

C. Who Can Be Sued for Medical Product Injuries.

i. Manufacturers, suppliers and sellers.

Plaintiff can sue the manufacturer, supplier or seller of a negligently designed or manufactured product if plaintiff can establish the fault of the defendant.

ii. Physicians, hospitals and other healthcare providers.

In addition, a plaintiff can bring a lawsuit against a physician, other healthcare provider or hospital who implanted a medical device or prescribed the defective drug, if plaintiff can establish that it was below the standard of care for the healthcare provider to implant the device or prescribe the drug in question. In order to do this, plaintiff must establish that a reasonable healthcare provider under the circumstance would not have used the device or prescribed the drug.

Basically, plaintiff must establish that the healthcare provider knew or should have known of the dangerous propensities of the implant or drug or knew or should have known it was contraindicated for plaintiff, and failed to act reasonably under the circumstances, both in terms of using the device or prescribing the drug and failing to warn of its known dangers.

D. Design Defect Immunity for Drug and Medical Device Manufacturers.

i. Manufacturers are immune from strict product liability law in most circumstances.

As a matter of law, manufacturers are immune from design defect strict liability for injuries attributable to prescription drugs and medical devices so long as:

• the drug/device was properly prepared (i.e., there was no manufacturing defect).
• it was accompanied by warnings of its dangerous propensities that were known or scientifically knowable at the time of distribution (i.e., no warning defect).

Thus, a manufacturer’s liability for a “design defect” will occur only if the plaintiff can establish negligence.

ii. Immunity granted for public policy reasons.

The rationale of the courts behind the design defect immunity is that to hold drug or medical product manufacturers to design defect strict liability standards would frustrate the broad public interest and availability of affordable drugs and medical devices to alleviate pain and suffering or to sustain life. Exposure to potential strict liability might cause these manufacturers to be reluctant to embark on research and develop new beneficial pharmaceuticals and medical devices.

iii. Plaintiff cannot even bring a case on a breach of warranty theory.

Further, a plaintiff in a prescription drug or medical device case cannot bring a cause of action for breach of warranty.

iv. Cases in which design immunity has been applied.

To this date, design immunity has been applied in California in cases involving:

• prescription implants.
• implants used to alleviate impotency.
• IUDs.
• viscoelastic fluids used as intraocular surgical aids.
• prescription implants used for strictly cosmetic purposes.

E. What must a Plaintiff Prove to Win a Prescription Drug Case.

i. Plaintiff must prove something went wrong in manufacturing process or inadequate warning label.

The producer of a prescription drug may be found liable only if:

• something went wrong in the manufacturing process so that the drug was not prepared or manufactured as it was intended to be by the manufacturer.
• the product was not accompanied by a warning of dangers that the manufacturer knew or should have known about at the time the drug left its control (i.e., plaintiff cannot establish liability on the basis that after the drug or device in question was put on the market, the manufacturer learned that it was dangerous unless after that knowledge, the manufacturer continued to produce and distribute the drug without appropriate warnings).

ii. Focus of case not on deficiency of the product but fault of defendant.

Thus, a case against the manufacturer of a prescription drug focuses not on the “deficiency in the product” but on the fault of the producer in failing to warn of dangers inherent in its use that were known or knowable to the manufacturer.

iii. Immunity applies even if defendant could have produced safer drug or product for the same price.

The immunity applies even if the manufacturer could have designed a safer drug without affecting its efficacy.

iv. Warning to a physician of risks of the product is enough.

Further, the manufacturer in most cases need not warn a patient of the risks of a drug if it warns the prescribing physician. However, an otherwise adequate warning may become inadequate if over promotion of the drug causes the prescribing doctor to disregard the warnings.

Warnings that a manufacturer places on non-prescription drug packaging need only be in English, even if advertisements in other languages are used to promote the sale of the product.

F. Marketshare Liability Theory.

In a California case, a plaintiff sued several companies alleging that together they produced 90% of the drug, DES, marketed at the time the plaintiff’s mother took doses that injured the plaintiff. The California Supreme Court, as an exception to the usual rule that a plaintiff must show that the particular defective item that caused the injury was marketed by the defendant or defendants, found marketshare liability against the manufacturers.

Under this theory, a plaintiff can recover on a proportional basis from members of the group of producers if:

• the injuries were caused by a drug, individual batches or doses of which were produced from an identical formula by several manufacturers.
• the injuries were caused by a defect common to all batches of the product (because, e.g., the common formula or design was defective in view of the use for which product was marketed).
• the plaintiff, through no fault of his or her own, cannot identify the producer of the particular batch that caused the injuries.
• the plaintiff sues defendants who marketed a “substantial” share of the batches from which the injurious dose must have come.

Under such circumstances, each defendant that could have produced the injury-causing dose must pay damages in the proportion to its “share of the market” as determined by the trier of fact.

A defendant may avoid liability by proving that it could not have been the source of the particular dose that injured the plaintiff.

The marketshare liability theory has been used rarely, in a very narrow class of defective product cases.

G. Establishing Causation.

i. A “substantial factor” standard.

One of the most difficult tasks in a medical product or prescription drug case is proving that the product caused the plaintiff’s injury or disease process. In order to prove causation, plaintiff must establish that the drug or product was a substantial factor in causing the injury or disease from which the plaintiff suffers.

ii. Causation defenses.

The defendants will usually claim that the plaintiff’s problems stem from:

• the underlying disease process for which the drug was being prescribed or device implanted.
• some other disease process that developed after the drug was prescribed or after the device was implanted but completely independent of the drug or device.
• the plaintiff’s symptoms are psychological or faked.

iii. How plaintiff can prove causation.

Thus, to prevail on a causation theory, plaintiff must establish that:

• the plaintiff did not have the disease or injury before the prescription or implantation.
• the plaintiff did develop the disease or injury in a time period after the prescription or implantation that makes medical sense (i.e., depending upon the drug or the product, that the disease did not develop either too soon or too far away in time from the prescription or implant of the device).
• that the drug or medical device was capable of causing the disease.
• expert testimony that the existence of the plaintiff’s disease is consistent with ingestion of the drug or the implantation of the medical device.
• studies indicate that a sufficient number of other patients who have ingested the drug or have had the device implanted in them have developed similar diseases and symptomatology.

iv. Breast implant cases.

The best example of the causation battles that can occur in this type of case involve the breast implant cases. Tens of thousands of women plaintiffs claimed very similar injuries caused by leaking implants. As the number of claims grew, there was a general acceptance that the implants were causing the disease processes in question. However, the breast implant manufacturers began commissioning studies indicating that there was no relationship between the leaking implants and the plaintiff’s injuries.

Independent studies sometimes proved the plaintiff’s position and sometimes refuted it. However, plaintiffs generally prevailed because of the strength in numbers.

This establishes the importance of epidemiological evidence in prescription drug and medical device cases to establish a scientific relationship between the drug or device and the plaintiff’s injuries.

H. Investigation.

i. What a plan needs to discover through investigation.

The key to the investigation in a medical device or prescription drug case involves:

• establishing evidence that the manufacturer knew, or should have known, of the risks of the product and warned of those risks.
• evidence establishing that there was an insufficient warning of knowable risks to the physician prescribing the product for the patient.
• that the plaintiff did in fact ingest the drug or had the device implanted.
• that the evidence indicates that plaintiff developed the disease in a reasonable time after having the device implanted or the drug prescribed.
• that the evidence indicates that the product in question was capable of causing the disease from which the plaintiff suffers.
• plaintiff was not suffering from the disease before the drug was ingested or the device was implanted.
• there is no logical reason other than the defective device or drug for why the plaintiff should be suffering from their disease.

ii. Research is the key to investigation.

Thus, the investigation begins with research as to the information which was available to the manufacturer at the time that the product was manufactured and discovery of what actual information the manufacturer had in its possession at the time.

iii. Obtaining and maintaining the product in question.

Then, the actual product, or a similar product in the case of drugs, should be obtained to perform testing, proving the product’s dangerous propensities.

iv. Obtaining the warnings.

Next, the actual warnings available to the physician or patient should be obtained from the drug or product manufacturer, plaintiff, pharmacy, doctor or medical supply store.

Warnings from competitors with similar products or drugs should be obtained to see if the defendant’s warnings were insufficient.

v. Obtaining and retaining the medical records.

The plaintiff’s medical records should be obtained to determine that:

• the plaintiff was not suffering from the disease process before ingestion/implantation of the product in question.
• there is a sufficient temporal relationship between the implantation/ingestion of the product and the plaintiff’s injuries.
• there is no other reasonable medical or environmental cause for the onset of the illness.

vi. Medical research should be collected.

All medical literature linking the drug or medical device to plaintiff’s injuries, disease and symptoms should be collected.

I. Retaining Expert Witnesses in Medical Device/Prescription Drug Cases.

i. Liability experts.

First, plaintiff is going to have to retain experts who are going to be helpful on the issue of liability. These will generally be researchers in the areas of medical devices or prescription drugs and will be able to testify on the information which was available to the defendant manufacturer at the time it produced the drug or product.

In addition, plaintiff will need to retain toxicologists, pharmacologists, psychopharmacologists and other medical and scientific experts to establish the fact that the drug or medical device had dangerous propensities beyond those that were warned of by the manufacturer.

ii. Causation expert.

Further, plaintiff will probably have to retain an epidemiologist and statistician to testify to the likely relationship between the drug or product and the plaintiff’s disease. Further, in the case of drugs, psychopharmacologists and device cases, different medical specialists must be called to testify that:

• it is likely that the plaintiff did not suffer from the claimed disease process prior to the ingestion/implantation.
• the plaintiff is in fact suffering from a disease that is commonly caused by the product in question.
• there is a reasonable temporal relationship between the ingestion of the drug or implantation of the product and the onset of the plaintiff’s disease.

iii. Damage expert.

Finally, the same or different expert may need to be retained to talk about the extent of the plaintiff’s disease, likelihood that it will continue into the future and the cost of future care resulting from the disease and likelihood of loss of any earning capacity. Vocational, life care planning experts as well as economists can testify on these damage issues.

J. Comparative Negligence in a Medical Implant, Device or Drug Case.

If plaintiff can establish that the defective product was a substantial factor in bringing about plaintiff’s injury, his or her own comparative negligence will not eliminate his or her claim but, rather, reduce the recovery by the proportion of his or her fault. For instance, if the plaintiff is found to be 20% at fault for causing his or her own injury, the verdict will be reduced by 20%.

K. Compensatory Damages in Medical Implant, Device and Drug Cases.

In a medical manufacture case, plaintiff can recover for past medical expenses, future predicted medical expenses, past wage loss, future predicted wage loss and for past and future pain and suffering.

The medical expenses are determined by the testimony of physicians or other health care providers. Frequently, an economist or an expert in the industry determines the amount of future wage loss; however, no expert can testify to the value of pain and suffering.

Pain and suffering is typically the most significant element of a plaintiff’s damage and it includes emotional distress. Contrary to popular belief, there is no formula for pain and suffering awards and it varies greatly from case to case depending upon the location of the case, the seriousness of the injury and how well the case is presented.

L. Claim for Loss of Consortium.

A plaintiff’s spouse can also sue and recover damages for ‘loss of consortium.” A spouse is allowed to recover damages for the loss of society, comfort and care that result from the injured spouse’s unavailability due to their injury and having to watch the plaintiff suffer. In order to recover these damages, a spouse must be named as a party to the lawsuit and must have been married to the plaintiff at the time of the injury.

There are advantages and disadvantages to filing a loss of consortium claim that should be discussed with an attorney before filing.

M. Punitive Damages.

Under California law, if a plaintiff can prove that the conduct of the wrongdoer was fraudulent, malicious or despicable, he or she is entitled to recover punitive damages which are intended to punish the wrongdoer and provide an example for the rest of society. The focus of this type of case is generally on the wrongdoing of the defendant as opposed to the injury to the plaintiff. The amount of punitive damage will vary depending upon the heinousness of the defendant’s misconduct and its economic status. The law recognizes that large companies have to pay more money in punitive damages to be adequately punished than small companies or individuals. In motor vehicle cases, punitive damages are most frequently awarded against drunk drivers.

N. Time Limitations.

To be safe, a medical implant, device or drug case should be brought within one year of the date of the accident though it may be alright waiting two years and the time period may be extended if plaintiff did not discover the defective condition of the product until some time after the date of the accident. However, plaintiff has a duty to affirmatively try to find the cause of his or her injury.

Further, if the case also involves a claim against a public entity, the claim must be brought within six months.

The statute of limitations in medical malpractice cases is different than the statute of limitations in most cases. First of all, one must always remember that if the case involves a government entity, a claim must be brought within six months of the date of injury.

In all other cases, the complaint must be filed within three years from the date of injury or one year from the date a reasonable person should have discovered the malpractice and injury, whichever is sooner.

The law regarding the statute of limitations in medical mishap cases is extremely complex and confusing. Therefore, a patient should always consult with an attorney as soon as possible when they suspect malpractice.

When suing a doctor, to be safe, an intent to sue letter or complaint should be filed within one year from the date of malpractice; however, the time period can be extended beyond the one year limitation or even the three year limitation under certain circumstances.

O. Considerations in Evaluating Cases for Settlement.

i. Many different factors are taken into consideration when evaluating settlements.

There are many, many factors which are utilized when evaluating a case for settlement. The perception that many of the public have that a case settles for three times the medical bills and wage loss cannot be further from accurate. There are cases that settle for millions of dollars in which there are no medical bills or wage loss and there are cases that settle for a few thousand dollars in which there are hundreds of thousands of dollars of medical bills and wage loss. Following are some of the factors that are relevant to evaluating the case for settlement purposes:

ii. Liability.

The clarity of liability (i.e., fault) in the case is a critical settlement factor.

In a case in which liability is unclear or the plaintiff has a substantial chance of losing, the settlement value of the case has to be reduced significantly to factor in the plaintiff’s chances of losing.

Theoretically, if the value of an injury claim is $100,000, but plaintiff only has a 50/50 chance of winning, a $50,000 settlement may be appropriate. However, plaintiffs must always realize that cases against large defendants or in cases in which the defendant is insured, that the plaintiff has a lot more to lose than the defendant. In the example above, if the insurance company turns down a $50,000 demand and the plaintiff wins $100,000, payment of an additional $50,000 will mean very, very little to a large insurance company or corporation. On the other hand, if the plaintiff turns down the insurance company’s $50,000 offer and wins nothing at trial, it could create a devastating financial blow in which the plaintiff is unable to pay for his or her bills.

iii. Comparative fault of the plaintiff.

If a plaintiff is found to be partially at fault for causing his or her own injury, then their potential jury award is reduced on the basis of their percentage of fault. In other words, if a case were to go to trial, and plaintiff were to receive a $100,000 verdict, but was found to be 25% at fault, the plaintiff’s verdict would be reduced to $75,000. Thus, when settling a case, plaintiff should reduce his or her expectations of a settlement by the likely finding of percentage of fault that would occur if a case were to be tried.

iv. Likely jury verdict value of the case.

In cases in which insurance policy limits are not an issue, most good attorneys attempt to settle the case based upon what a jury would be likely to award if the case went to trial.

Determining what a jury will award in a given case is more of an art than science; however, reasonable estimates can be made based upon what jurors have awarded in similar cases in similar venues (i.e., locations). Most verdicts are reported in “jury sheets” that lawyers read and utilize when attempting to assess the value of any particular case.

v. Aggravated liability.

In cases in which a jury is likely to get angry at a defendant for misconduct that was something more than negligent, it is known that jurors are likely to “spike” their verdict and award more money for a plaintiff’s injury than they would if a defendant’s misconduct was merely negligent.

Aggravated liability situations, such as a defendant who was found to be driving drunk or a defendant who intentionally hurts a plaintiff will increase the risk to the defendant of a large jury award and this should be taken into consideration in settlement.

vi. Punitive damage exposure.

If the defendant’s misconduct is so bad that there is a risk for punitive damages, i.e., the jury awarding damages specifically to punish the defendant, this should become a major factor in settlement negotiations. A potential award of punitive damages is complicated by the fact that under the law, the insurance company is not allowed to pay an award for punitive damages; however, normally, the defendant, through a personal attorney, attempts to apply pressure on the insurance carrier to pay more in settlement so that the defendant will not be exposed to the punitive damage risk.

vii. The character and credibility of the parties.

A plaintiff’s case is worth more if he or she is likeable and believable. It is known that jurors will award more money to people that they like and believe than people whom they dislike and don’t believe.

To a lesser extent, this is also true for defendants. A likeable or believable defendant is likely to fare better in a lawsuit than someone with the opposite traits.

viii. The extent of the injury.

Theoretically, the more serious an injury, the greater should be the value of the plaintiff’s case.

ix. Objective evidence of injury.

Injuries that can be visualized or that are able to be demonstrated by radiographic evidence such as x-rays, MRIs, CAT scans or other scientific tests, will normally result in higher settlements than injuries which depend upon the believability of the plaintiff to prove.

There are many injuries which may have severe consequences for the plaintiff which are not diagnosable by objective tests. This can include severe back problems, headaches and pain anywhere in the body. Experience has shown that jurors are hesitant to award large damages in cases in which there is no objective evidence of injury; thus, the settlement value of any case is increased by objective evidence of injury and decreased by the lack of it.

However, a credible plaintiff can sometimes overcome the lack of objective evidence of an injury and this must also be taken into consideration in the right case.

x. Past and future medical bills of the plaintiff.

As long as a plaintiff can establish that past medical expenses and likely future medical expenses are reasonable and related to their injuries, the bills will be an important consideration in settlement.

However, the defense will generally claim some amount of overtreatment and, thus, some portion of the medical bills should be excluded from settlement consideration. Further, the defense will argue that plaintiff will be unlikely to need or have the claimed future treatment and/or the future treatment would not be related to the subject incident.

xi. Past wage loss and future wage loss.

Wage loss is another important consideration in evaluating a claim as long as plaintiff can establish that he or she was reasonably off work or will be reasonably off work due to the subject incident. The defense will likely take the position that the amount of the wage loss should be discounted because plaintiff should have been back to work sooner and, in the case of future wage loss, the defense will claim that plaintiff could be doing some type of work which would pay them as much or almost as much as the work they were doing before the incident.

Also, for plaintiffs who are self-employed or do not have a strong consistent earning history before the accident/incident, it can become very difficult to establish a wage loss claim.

xii. Is the injury permanent.

In cases in which plaintiff has a permanent injury and some objective evidence of that injury, there will likely be a higher settlement value because the case will have more jury appeal.

xiii. Venue (where the claim will be tried).

It is beyond question that cases tried in certain locations, particularly urban locations, result in much higher verdicts than cases tried in more rural counties. This is a factor that must be taken into consideration in settlement.

xiv. Policy limits and defendant’s assets.

No matter how severe the injury, the plaintiff’s ability to recover damages against defendant will be limited by either the defendant’s policy limits or the personal assets of the defendant.

However, in cases involving motor vehicles, the plaintiff may have his or her own uninsured or underinsured motorist insurance which would provide additional coverage for the plaintiff’s injury and allow the plaintiff to receive further compensation in a settlement with their own insurance carrier.

xv. Target defendants.

Even though jurors are not supposed to consider the wealth of a defendant or whether or not the defendant is a corporation in their verdict, they are far more likely to make larger awards against large companies than they are people who they perceive to be middle class or poor. So this becomes another important settlement consideration.

xvi. Reputation and ability of attorneys.

The claims representative or defense attorney will report to the insurance carrier or defendant the ability of the plaintiff’s attorney and the likelihood that the attorney will try a case and try it well.

In situations in which the defense believes that the plaintiff’s attorney will not be willing to take the case to trial, there is little incentive to offer a significant amount of money in settlement.

On the other hand, if the defense believes that a plaintiff’s attorney will not only go to trial, but will receive an optimum verdict, the defense’s risk is increased and thus the settlement value of the case is increased.

By the same token, plaintiffs must also take into consideration the reputation and ability of the defense attorney. If the case is against a good defense attorney, plaintiff will likely receive less money from the jury; thus, the settlement value of the case, to some extent, is decreased.

xvii. Expense of litigation.

The expense of litigation should also be considered in settlement. There are some cases which, if worked up properly, could result in the expenses actually being higher or almost the entire amount of an eventual settlement or verdict.

Some insurance companies and corporations are cost conscious and will take into consideration the expense of proceeding in the case versus early settlement.

However, just because a case may cost the defense $200,000 to litigate does not mean that in a case they otherwise evaluate as being worth $25,000, they are going to offer the plaintiff $200,000 in settlement.

Rather, in the above example, it may cause the corporation or insurance company to raise their offer five or ten thousand dollars or to try to settle the case early for $25,000 before expenses are actually incurred. Corporations and insurance companies are loathe to make offers of settlements based on the cost of defense because of a concern that they will be seen as an easy target for plaintiffs.

For instance, it is known that almost any medical mishap case will cost several hundred thousand dollars or more to litigate through trial. Does that mean that anytime anybody files a case against a drug manufacturer that the defense will automatically offer hundreds of thousands of dollars? Of course not. They want to send a clear message to plaintiffs attorneys and potential claimants that they are willing to aggressively defend claims, thus discouraging future claims.